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Good day, and welcome to the patently Strategic Podcast, where we discuss all things at
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the intersection of business, technology and patents. This podcast
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is a monthly discussion amongst experts in the field of patenting. It is for inventors,
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founders and IP professionals alike, established or aspiring.
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And in today's episode, we're officially kicking off our third season.
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It's going to be a big year for patents, and we couldn't be more excited
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excited about the lineup we're bringing you. Starting in April, we'll be releasing huge interviews
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with distinguished industry heavyweights delving into much needed meaningful
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solutions for patent reform. Shortly after, we'll be starting
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a series of interviews with some incredibly savvy investors to help better understand what
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investors want in patents. We typically think about the primary
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audiences for patents being the pto in courts, but many inventors
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and startups care more initially anyway. About investors this is a
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very important perspective, since it's taking the innovation world by storm.
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We're also going to take a look at what generative AI like Chat gpt could
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mean for the patent world. Pulling from some of the most frequent questions
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we get from live inventor training events, we'll go even deeper on prior explorations
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into software patenting by looking at the interplay between patents,
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copyrights, and open source. We're also working on a collaborative effort to
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do a tangential dive into the world of copyrights and trademarks in
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the wave of pop culture cases that could have major implications
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for copyright law this year, and for those wanting to better understand the levers
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at the heart of patent law, we have a series planned for further exploration into
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claim types and strategies. But first, in this month's episode,
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we're leading off with a close look at a Supreme Court patent case that could
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have profound impacts on the invention enablement problems we covered
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heavily in season two. scotus is set to hear opening arguments in Amgen
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versus Sanofi on March 27. So we're leading off with this topic
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to help get folks booted up who might want to follow along as the case
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unfolds over the coming months. For the first time in over 75
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years, the Supreme Court is evaluating the meaning and scope of
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the enablement requirement. For those who have been following along, you'll know
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that this has become one of the bigger issues plaguing patenting, and especially so
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in the life sciences. Enablement, like its wicked sibling eligibility,
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have been two grounds for rejection and invalidation that haven't historically
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been all that common, but are becoming increasingly prevalent in
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the less predictable arts like immunology, molecular biology,
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chemistry, and diagnostics. This is in part due to something called
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a genus claim, which has been a critical patent feature for chem,
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biotech, and pharmaceutical industries. Derived from their
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traditional biological definitions. A genus is a group
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defined by common characteristics, and a species is a logical division
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of a genus in chemical, biotech, and pharma patents. A genus
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claim covers a group of structurally and or functionally related
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chemicals, whereas a species claim covers a single compound without
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coverage of analogs derivatives or compounds in the same family.
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Why this particularly matters for pharmaceuticals is that one successful
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drug needs to be able to recoup the massive R and D costs from the
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countless failures that preceded it, and that requires adequate coverage
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and exclusivity over a period of time. A lot of drugs would
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be pretty easy to design around. If a patent only narrowly claims
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a specific chemical species, a competitor would simply have
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to use a different functional group or additive with the same properties,
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and bam. They have a new non infringing therapeutic based
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on an R and D investment they didn't make. It would be impractical,
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if not impossible, to reduce to practice every possible
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applicable species. The broader genus claims have historically been the
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umbrella tool of choice for many innovators in this space.
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Where the genus claims have run into trouble is with the interpretation and court
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based expansion of one of the core statutes that governs patentability.
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This fundamental tenet of patent law is the concept of enablement.
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When a patent publishes, the information contained in the patent becomes part
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of the public record. So enablement requirements aim to ensure that
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society receives something useful in exchange for the exclusive rights
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granted to the inventor. This is the grand bargain of the patent system.
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Codified in section 112 of Us. Code title 35
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are the minimum requirements for the quality and quantity of
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information that must be contained in a patent application to justify the grant
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of a patent. Section 112 basically says that a patent
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application must describe the invention in full, clear,
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concise and exact enough terms to demonstrate that the inventor had
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possession of the invention at the time of filing. This is called the written
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description requirement and to enable those skilled in the art to make and use
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the invention or the enablement requirement. A 1916
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Supreme Court decision further defined the standard for determining whether
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the description meets the enablement requirement by raising the question of
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whether or not the experimentation needed to practice the invention is undue or
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unreasonable. To this day, even though the statute does not use
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the term undo experimentation, it has been interpreted to
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require that the claimed invention be enabled so that any person skilled in the art
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can make and use the invention without undue experimentation. The big
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question this all culminates in is the focus of the upcoming Supreme Court case that
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is the focus of today's conversation. What do genus claims require
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from an enablement perspective? Will the enablement standard be governed
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by the black and white codified section 112 statutory requirement that
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the specification must only teach those skilled in the art how to make
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and use the claimed invention? Or will the Supreme Court lean on court based additions
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to the standard that the specification must enable those skilled in the art to,
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quote, reach the full scope of claimed embodiments? Without undue
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experimentation to get genus level coverage. The latter would
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require the inventor to actually reduce to practice every single species they
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intend the genus to cover. And that brings us to the particulars
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of the case at hand. Amgen v. Sanofi has a long case history
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that goes back nearly a decade, with the involved parties trading turns
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on offense and defense, with two juries coming down on the side of
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Amgen but district and Federal Circuit court judges ultimately
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ruling in favor of Sanofi. The battle centers around competing versions of
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cholesterol lowering drugs produced by the two companies.
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Amgen makes Rapatha and sanofi makes prolulent with us.
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Sales handled by regeneron, the drugs are monoclonal antibodies
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that lower the levels of ldl or low density lipoprotein
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cholesterol, aka. The bad cholesterol. Amgen initially
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sued, arguing that patents protecting ripatha were being infringed
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by Prowulent. regeneron and Sanofi argued that amgen's patents
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weren't valid in the first place. Twice, district court juries found amgen's
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patents valid, concluding that Sanofi failed to prove that the claims lacked
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enablement or written description. Sanofi's subsequent motion for judgment
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as a matter of law for lack of enablement, however, was successful
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at the district court level and was later affirmed on appeal at the Federal
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Circuit, which concluded that amgen's claims were invalid on grounds of
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enablement because, quote, undue experimentation would be required
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to practice the full scope of claims. In a rare move for patent
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law and against the Solicitor general's recommendation, the Supreme Court will
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now hear the case, giving Amgen a final opportunity to resurrect its
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patents and hopefully more broadly, provide clarity for the industry.
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On the enablement standard for genus claims, santa fe is arguing
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that Amgen is asserting a monopoly over an entire genus of functionally
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defined claims that are not enabled since they cover thousands of possible
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antibodies. While the application only highlights a limited number
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of examples, Sanofi's arguments hinge on the Federal circuit's full scope enablement
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standard, where every species in a genus must be reduced to practice.
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Sanofi believes that beyond the lack of enablement, the functional genus claims
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and their overly broad protections stifle innovation by monopolizing entire
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classes of rival drugs. Amgen, on the other hand, is arguing
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that the Federal Circuit has gone off the rails on enablement laws,
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that it's defying more than a century of Supreme Court precedent on the issue,
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invading the jury's role, imposing a full scope requirement that's not
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contained in the patent act, and is frustrating the purpose of patent
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law by invalidating patents for breakthrough inventions. By demanding
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disclosure about theoretical far corners, amgen contends that
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imposing these standards and invalidating genius claims on perceived
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size alone will have a devastating impact on breakthrough innovations
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in biotech and pharmaceutical industries. They state that given the
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significant investments required to discover and develop new innovative
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therapeutics, the patents must provide a meaningful scope of protection
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broader than just the specific examples the inventors disclose.
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In the void of those protections, the system will encourage copies,
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not the next big breakthrough, making it all too easy to
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create MeToo drugs that only require minor changes and not
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the same research investment. amgen's key argument is that their application
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provides the necessary roadmap for someone skilled in the art to make and use
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its drug and all covered species without undue experimentation,
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whether it's five or 5000, and that the law is codified
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does not require the applicant to include examples for every possible permutation.
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Regardless of how this plays out, it's hard to imagine the High Court's ruling not
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having significant consequences for the industry. Their willingness to
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hear the case alone signals that big changes could be on the horizon. With district
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and federal circuit courts ruling one way in, lockstep and the Solicitor
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General recommending that the Supreme Court not even take the case.
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Combined with the fact that the Court takes up few cases on petition and even
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fewer yet for patent law, there's little reason to believe the Supreme Court
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would take the case to simply step in and just rubber stamp prior rulings.
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In any case, the stakes are incredibly high and there truly
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is a very important balance to strike in all of this. While broader protection
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is necessary for life changing pharmaceutical patents to have any real value,
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enablement requirements are the check in the system that prevent massive land grabs
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and exclusive rights for things that applicants didn't actually invent.
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And I can't think of a better person to help break this all down for
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us. Dr. Ashley slote, president and Director of Patent Strategy at aurora,
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leads our discussion today along with our all star patent panel exploring
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the scientific background around antibodies necessary to understand the claims. A Brief
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History of Amgen versus Sanofi an overview of the enablement
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factors and tests that have been historically applied in courts and
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how they might apply to this case and a discussion around open questions
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and the potential unintended consequences of the Supreme Court
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only taking up one half of the two sided enablement coin. This ends
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up being a really great, spirited conversation with panel members
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coming down strongly on both sides of the case, with very compelling arguments
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really highlighting the complexities and fundamental issues the court will have to face.
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The group also leads off with a short brainstorming session around embodiment
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drafting, some dialogue around a lesser known process for strategically
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slowing prosecution, and an icebreaker that shines some revealing light
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into the survival instincts of your beloved hosts and panelists.
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Ashley is joined today by our always exceptional group of IP experts,
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including David Cohen, principal at Cohen Sciences kristen
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hansen, patent strategist here at aurora, david Jackerel, president of
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Jacob Consulting and ty Davis, patent strategy associate at aurora.
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And if you'd like to help us navigate this complex world both before and after
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the Supreme Court discussion, I have great news. aurora is now hiring
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for a part time biomedical sciences patent agent. This is
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a salaried fully remote position with a flexible work week and benefits.
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Work where you want, when you want, with a great team on engaging subject matter,
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and even get the opportunity to join us on this podcast. Learn more
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and apply at aurorapatants. Comcareers. We'll also
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include that link in the show. Notes if you still haven't had your
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fill of enablement, I do encourage you to check out several related episodes
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from season two, including episode five, fortifying Life Science Patents,
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where we explore both eligibility and enablement issues currently confronting life
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Science patents. Episode eight on Means Plus Function,
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where we discuss enablement standards around the use of functional claim language,
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and episode ten on The Unpredictable Arts, where we cover practical tips
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for getting more predictable results when patenting biological, chemical and
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emerging technologies. Now, without further ado take
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it away, ashley, the icebreaker I have for today was if
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you could take three things to a desert island, what would they be?
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Could we start with one thing? Sure.
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Years ago there was one of these sort of team building exercises
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at a company I was working in, and they
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brought in a trainer and there was a scenario,
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some scenario you were in the wilderness and
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it was like this what what item would you
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take with you? And I said,
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Take a flashlight. And I've never
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forgotten. And this other woman in in,
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you know, our cluster, said, oh, are you afraid of the dark?
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Anyway, when it came time to reveal
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the correct answers, the first thing was a flashlight.
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So I'm sticking with flashlight for my I
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like it. It does seem reasonable. That would be helpful. That's not the thing I
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had been thinking but now I'm reevaluating right
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for the second and third, I would take extra batteries.
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That's what I would do.
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I take a water filter and sunscreen.
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Fair. I don't know about the third. When I first
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read it, I was thinking much less practical.
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A bikini. I was thinking a guitar,
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because endless hours of entertainment,
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what do you do? Something to make fire would probably
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be I think that might it's not quite as good as a
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flashlight, but you can also cook food if you
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happen to catch any fish or anything. So maybe
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a guitar and flint and steel. There you go.
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I like it. I think I
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would cheat, let's say 3d printer,
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but I'm also going to need the computer,
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cad software and electricity,
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of course. Yeah. How do you order more powered
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3d printer? 20 tons of
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filament? Or maybe the ideal
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answer is like a fully charged sat phone.
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Get off of the ice.
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I don't need the other two because I'm getting out of
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here. Yeah,
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I was thinking a warm blanket because I am very cold and even
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an island I feel like would be cold at night, so I would
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want a warm blanket. But then the water filter also
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occurred to me, but I was thinking maybe some kind of machete because I don't
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know what's on this island. Kill something to eat or
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I don't know, make a shelter, cut down some branches. I don't
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know. I've seen Survivor. You need some stuff. Right.
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Make it in the parade. Exactly.
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Right. Duct tape. Yeah, duct tape.
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A boat to get off the island.
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Christian. Then a flare, a satellite phone
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and a boat.
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Well, to miss how tropical it is. I mean, if it's like really tropical.
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I don't know. Could be persuaded to stay.
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All right, so strategy, tidbits problems,
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practice issues, technical issues. I have just a random
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thing I learned to share. Does anybody else have any thoughts,
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comments,
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insights? I guess I
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wonder, do people put an embodiment
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section typically in their application at
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the very end where you list out all your
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claims and narrative form? Is that standard?
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Does everyone do that? We've been doing it more and more,
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especially for particular clients. I mean, the summary kind of suffices
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that for a while, but now kind of been putting it at the end.
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If you're going anywhere outside the Us. You really do want to pay to
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have that in there.
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There's a lot of software that will auto generate that for you as well.
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But it's just becoming more important for European practice,
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I think. I've been stuck a handful of times where
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I can't get a claim from further down my claim list
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because it's from a different embodiment in my spec. Right.
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So doing those permutations of embodiments has
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been helpful. So another thing I've
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noticed is some people, rather than
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dependency, rather than going back to a particular
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embodiment or claim, they'll say any of the above.
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What about that one? I think that holds
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less weight. In Europe, we went through an opposition proceeding
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with the client and those
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kinds of statements, especially early in the spec, for whatever reason, at least, the examining
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the opposition division kind of viewed that as almost like
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a summary intro section and didn't give it as much weight.
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I think there's still value in saying, like, other parts of the spec saying
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this could be applied to any of the other devices. For example, any of the
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devices of figures one through ten. Because you're
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kind of being a little bit more specific there. But at least in my limited
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experience of how at least the opposition division views that it's,
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for whatever reason, given less weight. I see.
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Ashley. Ashley, did we have
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a claim that said any of the above
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embodiments and in particular the embodiments of examples
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two through four and they were kind of more specific in that way?
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Yeah, that was in an example embodiment section
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at the end. Yeah,
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I've seen that happen. Right,
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so you would say any of the above, but in particular
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this and this and this and sort of have it both ways.
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Yeah. I don't know if it works. I haven't
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pushed that through.
18:31.490 --> 18:34.746
I think the other thing I've seen from even just a mixing and matching
18:34.778 --> 18:38.420
embodiments again from the same prior opposition proceeding was that
18:39.750 --> 18:43.202
especially in the chemical sciences, you get a whole bunch of lists of things,
18:43.256 --> 18:46.734
right? Like the first polymer could be any one of laundry
18:46.782 --> 18:50.802
list. The second polymer could be any one of laundry lists. In Europe
18:50.866 --> 18:53.702
allows you to choose one from one list,
18:53.836 --> 18:57.286
but not choose two from separate lists. So you
18:57.308 --> 19:01.190
would have to have a section that said the first polymer is
19:01.260 --> 19:05.354
this. And then the second polymer could be chosen from this list.
19:05.472 --> 19:09.066
Or the first polymer is this. And the second polymer could be chosen from
19:09.088 --> 19:12.406
this list. They don't like, I'm sure there's
19:12.438 --> 19:17.294
some statutes somewhere in their coding, but you
19:17.332 --> 19:20.842
can't choose multiple species from multiple lists. You're only allowed
19:20.906 --> 19:24.030
one laundry list from a species selection.
19:25.090 --> 19:28.546
So where this client ran a foul of it
19:28.568 --> 19:31.954
is that their technology had developed substantially over
19:31.992 --> 19:35.506
time from that really early filing. And so while they had coverage for
19:35.528 --> 19:39.720
it, it was coverage in the laundry list. Whereas the true technology
19:40.330 --> 19:43.558
laid in other polymers that
19:43.564 --> 19:46.886
they hadn't really fully reduced to practice yet because at the time they thought that
19:46.988 --> 19:50.570
these two polymers were the thing. But then their technology evolved where
19:50.640 --> 19:53.654
one polymer was the same, but the other one had changed.
19:53.782 --> 19:57.306
And unfortunately, the way it was all crafted at
19:57.328 --> 20:00.986
that early date, you kind of had to select from two
20:01.008 --> 20:04.286
different lifts to make it work. And they
20:04.308 --> 20:05.280
didn't like that,
20:09.810 --> 20:13.522
let me say. Do you think that part of the problem
20:13.576 --> 20:16.994
there was filing too early or
20:17.032 --> 20:20.686
was it life? I wasn't part of that original
20:20.798 --> 20:23.986
decision. I mean, I think at the time it does work. Like what they were
20:24.008 --> 20:27.426
doing did work. I think they might have moved away from it
20:27.528 --> 20:31.558
for more flexibility and I think maybe cheaper manufacturing of
20:31.564 --> 20:35.138
their product. I think so. It's hard to say because I wasn't
20:35.154 --> 20:37.880
there at the ground floor of kind of what they had at that time.
20:38.330 --> 20:41.240
It was fully enabled, I think, though, and stuff like that at that time.
20:42.090 --> 20:45.498
I don't know. It's hard to say though, like should they have waited a
20:45.504 --> 20:48.906
little bit or something and maybe captured other embodiments or
20:48.928 --> 20:52.534
fully reduced them to practice? And this relates
20:52.582 --> 20:55.502
a little bit to the Amgen case we're going to talk about today, right?
20:55.556 --> 20:59.118
Yes, exactly. Long lists. And do
20:59.124 --> 21:03.360
you even have protection for such long lists if you don't have data
21:03.970 --> 21:08.160
on all of those combinations? Interesting questions,
21:08.950 --> 21:11.460
which I don't know if we'll answer today, but we can try.
21:12.630 --> 21:15.794
The only thing I came across, I've always historically kind of had
21:15.832 --> 21:19.362
the view that you can't slow prosecution. Like you can expedite prosecution,
21:19.426 --> 21:23.446
but you can't slow it down. But it came across this and
21:23.468 --> 21:27.942
it looks like there is a way to suspend activity
21:28.006 --> 21:31.434
on your case. And actually, I think intel is one of the biggest users of
21:31.472 --> 21:34.842
this, but you can actually ask for
21:34.896 --> 21:36.540
suspension for cause,
21:37.950 --> 21:41.258
obviously cost the petition fee. You can't have
21:41.264 --> 21:44.506
an outstanding action item or you can do some kind of limited suspension
21:44.538 --> 21:48.350
of action after an rc. A cpa isn't as common anymore.
21:48.850 --> 21:52.394
And then for a processing fee, that's only a three month delay.
21:52.522 --> 21:55.920
And then you can defer examination not exceeding three years.
21:57.990 --> 22:01.742
I think that deferral of examination is three years from the earliest
22:01.806 --> 22:05.074
priority date. Okay, good to know. And that
22:05.112 --> 22:08.626
cost like three years on every continuation. You know what
22:08.648 --> 22:11.720
I mean? It's it's it's very limited. Yeah.
22:12.570 --> 22:16.054
And the cause can catch you up. I mean, it has to be definitely for
22:16.092 --> 22:18.680
cause. And the reasonings are pretty clear.
22:19.850 --> 22:23.766
If you all have seen this before, what are the causes that I'd
22:23.798 --> 22:26.490
have to look it up? I don't remember, but I remember them being kind of
22:26.560 --> 22:30.818
strange, stipulations. These are codified
22:31.014 --> 22:34.510
causes. There could be business
22:34.580 --> 22:36.000
causes, too. Right.
22:37.810 --> 22:41.120
I seem to recall something about cost,
22:42.790 --> 22:45.906
as in something is happening with the business and
22:45.928 --> 22:49.506
there's a reasonable cause to delay. And it was
22:49.608 --> 22:53.090
fee related and not because you couldn't
22:54.150 --> 22:58.278
pay the fee or pay the council to do it, but because
22:58.444 --> 23:02.150
something else was going on in your business. But I don't remember exactly.
23:02.220 --> 23:05.190
I'd have to look it up. Yeah. Interesting.
23:05.340 --> 23:09.166
Okay. And then obviously, the office can suspend
23:09.218 --> 23:12.438
activity on cases for various reasons. I think we've
23:12.454 --> 23:16.026
seen a lot about the hyatt cases where his patents have been
23:16.048 --> 23:19.610
pending for a long time with the suspended activities.
23:20.430 --> 23:23.754
Anyway, so interesting piece of tidbit.
23:23.802 --> 23:25.680
So you can slow it down.
23:27.090 --> 23:30.266
All right. So getting into the meat of today, says, Dave,
23:30.298 --> 23:34.314
as you already alluded to kind of talking about section
23:34.362 --> 23:38.922
112, particularly written description enablement
23:38.986 --> 23:41.518
and not really best mode, but best mode is in the same paragraph. So it's
23:41.534 --> 23:45.342
kind of in there, but just kind of give everybody a reminder of
23:45.416 --> 23:48.854
what the statute actually says. It says,
23:48.892 --> 23:52.534
the specification shall contain a written description of
23:52.572 --> 23:55.782
the invention and of the manner and process of making
23:55.836 --> 23:59.350
and using it in such full, clear, concise and exact terms
23:59.420 --> 24:03.274
as to enable any person skilled in the art. To which it pertains or
24:03.312 --> 24:07.066
with which it is most nearly connected to, to make and use the
24:07.088 --> 24:10.406
same, and shall set forth the best mode contemplated by the inventor
24:10.438 --> 24:13.722
or joint inventor of carrying out the invention. So I've highlighted
24:13.786 --> 24:17.920
obviously the written description, the kind of qualifying statement there is
24:18.850 --> 24:23.662
manner in process of making and using it enablement clear
24:23.716 --> 24:27.298
and concise terms to enable person to make and use the same and
24:27.304 --> 24:28.770
then like it's the best mode.
24:30.310 --> 24:33.666
Honestly, the conclusion that I come to and you'll kind of see
24:33.688 --> 24:37.206
and be interesting, the dialogue here. I have some questions at the end to kind
24:37.228 --> 24:40.646
of spur some thoughts and deeper thinking on it,
24:40.668 --> 24:44.438
but I almost feel like and there's some great
24:44.524 --> 24:47.846
quotes from former Chief Justice raider in
24:47.868 --> 24:51.066
a dissenting opinion on, I think, a 2010 case about this,
24:51.088 --> 24:54.426
too, which I fully agree with, that maybe enablement and
24:54.448 --> 24:58.170
written description really shouldn't be separate. Can they really be separated?
24:59.550 --> 25:03.006
I think some of the reason why it stated the way
25:03.028 --> 25:06.106
it is, I think the original intent was that written description,
25:06.138 --> 25:09.178
you prove possession of the invention,
25:09.354 --> 25:12.718
whereas enablement is more to teach somebody a
25:12.724 --> 25:15.706
skill in the art, how to make and use the invention, kind of help promote
25:15.738 --> 25:19.058
the progress of the useful arts. And then best mood, right? You can't keep the
25:19.064 --> 25:22.962
best mood for yourself. But I feel like
25:23.096 --> 25:26.014
I know there's a lot of like, if you look online, there's tons of analogies
25:26.062 --> 25:29.974
around how you could in theory prove possession but not
25:30.092 --> 25:33.158
teach someone how to make and use it. But I don't really think you can.
25:33.324 --> 25:37.174
But anyways, we'll go through the court case in detail. I have a
25:37.212 --> 25:40.890
few things I pulled for the district court part
25:40.960 --> 25:44.746
as well. But again, really curious about you all's dialogue about it
25:44.768 --> 25:48.918
too. So the overview I start with in Ray wands,
25:49.014 --> 25:52.490
partly just because this is kind of where some of this all began.
25:53.070 --> 25:56.358
This is where the wands factors come from. And interestingly,
25:56.454 --> 25:59.818
wands was an antibody case. And interestingly,
25:59.914 --> 26:02.800
30 plus years later, we're back at an antibody case,
26:03.170 --> 26:06.500
still talking about enablement and can't seem to figure it out.
26:07.190 --> 26:10.946
We also talk about the written description test. There's two tests that can be used
26:10.968 --> 26:14.766
to identify whether a written description meets
26:14.798 --> 26:19.570
the criteria of the written description. And then we'll talk about Amgen versus Sanofi
26:20.070 --> 26:24.134
and talk about some background of pcst nine and the ldl R
26:24.172 --> 26:27.094
receptor and the antibodies that they were developing at that time. And then again,
26:27.132 --> 26:30.666
questions for discussion, that these are things that kept me going through my
26:30.688 --> 26:34.650
head when I was working through this. But again, curious what everybody thinks.
26:36.110 --> 26:39.786
So, in Ray wands, the whole purpose of the wands patents were to create an
26:39.808 --> 26:43.306
immunoassay to detect hepatitis B surface antigen.
26:43.418 --> 26:47.086
So obviously, hepatitis B, bad deal would
26:47.108 --> 26:50.510
be great if you could detect it in amino acids. The interesting
26:50.580 --> 26:54.254
thing is that they were using they were trying to get igm antibodies
26:54.302 --> 26:58.382
instead of the typical igg antibodies, which are used for immunoassays.
26:58.526 --> 27:01.806
So as a quick primer on antibody basics
27:01.838 --> 27:04.900
for anybody who doesn't know antibodies thank you.
27:06.630 --> 27:09.918
They're quite little miracles, I hearkens.
27:09.934 --> 27:13.814
Back to my love of immunology. There are five different
27:13.852 --> 27:17.754
kinds of antibodies or classes of antibodies. And you can see that
27:17.792 --> 27:21.782
this bottom piece is the FC region. It's relatively static.
27:21.846 --> 27:26.102
And then these are the variable regions which are the things that bind antigens
27:26.246 --> 27:28.300
epitopes in the body.
27:29.870 --> 27:33.726
So igg is probably the one we think the most of. This is the
27:33.748 --> 27:37.038
antibody that crosses the placenta because it's small.
27:37.204 --> 27:40.410
This is the antibody that's really the workhorse
27:40.490 --> 27:44.718
of the adaptive immune response. So when your immune
27:44.734 --> 27:48.754
response is in full gear and you're trying to
27:48.792 --> 27:52.302
kill cells that are infected with a virus.
27:52.446 --> 27:56.206
A lot of the idg is the workhorse of this existence
27:56.238 --> 27:57.940
serum in monomeric form.
28:00.150 --> 28:03.014
So that's like the main one I think most people think of. But there's also
28:03.052 --> 28:06.322
igm, which is a pretty powerful antibody, too. It's the earliest antibody
28:06.386 --> 28:09.898
that's created it's, usually in pentameric form. So five of them are kind of
28:09.904 --> 28:13.338
together. And that's why Ostein doesn't traverse the
28:13.344 --> 28:17.798
placenta because it's freaking huge. But it's
28:17.814 --> 28:21.466
also involved in activation of the complement pathway. So that
28:21.488 --> 28:25.006
means that, like, a garbage collector of the immune system can come and bind the
28:25.028 --> 28:29.162
FC region of igm and then kind of engulf
28:29.226 --> 28:32.990
whatever is attached to it. So it's really great for
28:33.060 --> 28:36.882
kind of killing things that need to be killed once that antibody binds to it.
28:37.016 --> 28:40.930
Not to say that igg can do it, but igm is a good fixer.
28:41.750 --> 28:45.166
iga is your mucosal
28:45.198 --> 28:49.434
surface antibody. It's secreted a lot in your mucosal surface,
28:49.502 --> 28:53.266
is a great frontline defense that your epithelial cells to attack viruses
28:53.298 --> 28:56.706
and bacteria. It's a good neutralizing
28:56.738 --> 29:00.758
antibody. igd, it's never been known
29:00.774 --> 29:04.380
what it does in all the years. We still don't really know what it does.
29:04.830 --> 29:07.690
It's expressed on immature B cells.
29:08.190 --> 29:11.658
What it does. It's probably needed. I'm actually curious now if somebody ever did
29:11.664 --> 29:15.118
a knockout mouse of igd and what happened, but anyways, we don't really know
29:15.124 --> 29:18.734
what igd does. It just kind of hangs out there. And then ig is
29:18.772 --> 29:22.646
your histamine allergic
29:22.698 --> 29:26.770
reaction antibody. So that's involved with cells,
29:28.390 --> 29:31.966
with activating cells of the more allergic reaction.
29:31.998 --> 29:35.554
So eosinophils neutrophils. But for discussion
29:35.602 --> 29:39.334
today, we're most curious about igm in
29:39.372 --> 29:43.110
Ray, wands and then igg for Amgen B sanofi.
29:44.090 --> 29:46.550
They may have questions about antibodies.
29:49.290 --> 29:52.758
It's kind of something that jumped out at me about the Amgen.
29:52.854 --> 29:56.470
One of the Amgen claims is they talk about these antibodies and these epitopes.
29:56.550 --> 30:00.414
And then one of the dependent claims is wherein the epitop is
30:00.452 --> 30:04.586
a functional epitope, which in patent
30:04.618 --> 30:08.686
terms, that really jumped out at me. Like, functional is like a big
30:08.788 --> 30:12.474
keyword, obviously. Right. But is that a standard
30:12.612 --> 30:16.098
bio term that someone would know?
30:16.184 --> 30:20.222
Like, oh, this epitope is non functional and this epitope is functional?
30:20.286 --> 30:23.810
Or is that like a standard biological term
30:24.470 --> 30:27.606
or not? The way I would interpret that is
30:27.628 --> 30:30.914
that so epitopes are the things that antibodies recognize.
30:31.042 --> 30:34.886
And honestly, I don't think we know enough about antibodies and
30:34.908 --> 30:38.506
the cells that produce antibodies to make an
30:38.528 --> 30:41.978
educated guess about what thing they're going to bind on what, you know, like,
30:42.144 --> 30:45.930
that's why I mean, that's why vaccines are hard to make,
30:46.000 --> 30:49.786
right? That's why it's hard to you'll see from all the
30:49.808 --> 30:53.226
research that Amgen and Ray and wand did, it's really
30:53.248 --> 30:56.974
hard to make to get an antibody, to find an antibody that is
30:57.012 --> 31:00.730
specific for a thing. So when they say a functional epitope,
31:00.890 --> 31:03.998
what it says to. Me is that I'm sure there's tons of
31:04.004 --> 31:07.538
things that antibodies buying that are not functional, but it's a way to
31:07.704 --> 31:11.026
take something and then engulf it, neutralize it,
31:11.208 --> 31:14.834
change it, whatever. But that just
31:14.872 --> 31:17.380
because the antibody binds, like, over here,
31:18.550 --> 31:22.214
doesn't mean it's going necessarily to block a receptor from binding. But maybe because
31:22.252 --> 31:25.826
the antibody bind over here, it's going to cause some other pathway
31:25.858 --> 31:29.426
to kick off over here. But it didn't bind a functional epitop of the protein.
31:29.538 --> 31:33.014
So that's how, for the pcsk Nine protein,
31:33.062 --> 31:36.262
clearly, it has ligand binding activity.
31:36.326 --> 31:39.626
Right. It binds the ldl receptor and causes it
31:39.648 --> 31:41.690
to be internalized and degraded.
31:42.510 --> 31:46.074
But in theory, other antibodies could exist that bind psk
31:46.122 --> 31:50.174
Nine and other areas that may be block binding to hdl or
31:50.212 --> 31:53.666
actually ldl proper and not the receptor, which I have a diagram of that,
31:53.688 --> 31:58.206
too. So that's what I would say from a functional
31:58.238 --> 32:01.970
epitope versus, you know, other epitope.
32:03.830 --> 32:07.138
I think a lot of parts of proteins have a function.
32:07.224 --> 32:10.278
We just don't know what they are and how to tease that out, because I
32:10.284 --> 32:14.262
think there's a lot of compensatory things, and then proteins change
32:14.316 --> 32:17.330
shape when you start messing with their amino acid residues,
32:17.490 --> 32:20.714
but maybe they're still kind of functional for some things we
32:20.752 --> 32:24.106
just don't understand. That's. Part of my beef, I think,
32:24.128 --> 32:27.994
a little bit with the court's handling of amgen is
32:28.032 --> 32:31.318
that I think a lot of, like, the so called unpredictability
32:31.414 --> 32:35.406
is just inherent in physiology. It's not I
32:35.428 --> 32:39.146
think they did a good job, probably, of guiding somebody about how antibody
32:39.178 --> 32:41.630
science has been around for decades.
32:42.290 --> 32:46.254
So I think that's well vetted out. I think it's more the fact that physiology
32:46.302 --> 32:49.586
is hard and physiology is unpredictable. But I
32:49.608 --> 32:53.730
don't think we should be preventing companies from creating therapeutics
32:54.070 --> 32:57.510
just because physiology is hard and we don't fully understand everything.
32:57.660 --> 33:00.520
Even in a very non nascent field,
33:01.450 --> 33:07.474
when you say functional, maybe ready
33:07.532 --> 33:11.014
to do the function that you're talking about in the claim.
33:11.142 --> 33:15.718
So primed or set up or I'm
33:15.734 --> 33:19.690
still kind of struggling with just the concept, but yes,
33:19.840 --> 33:22.762
in the psk Nine claims,
33:22.826 --> 33:26.766
they were very particularly, I think, interested in I think I
33:26.788 --> 33:28.240
have the claim somewhere here.
33:29.890 --> 33:33.390
Yeah. Sorry to jump ahead. No, it's okay. Yeah, they're interested
33:33.460 --> 33:37.402
in the areas that they were interested in blocking
33:37.466 --> 33:40.734
psk Nine blinding to the ldl receptor.
33:40.862 --> 33:44.882
So it's going to be any functional epitope that
33:44.936 --> 33:49.266
would otherwise promote pcsk Nine binding to ldlr.
33:49.378 --> 33:53.174
So it's going to be a pocket in psk Nine that
33:53.212 --> 33:56.694
binds to ldlr, and they basically want to create something that prevents that from
33:56.732 --> 33:58.760
happening. Okay.
33:59.710 --> 34:02.620
Yeah. That is interesting language, though, David. I agree.
34:04.190 --> 34:07.850
That would send me for the hills. Don't say that in a claim.
34:08.190 --> 34:11.686
Right, okay. And then antibody
34:11.718 --> 34:15.614
design, because there's a lot of talk about antibody design again,
34:15.652 --> 34:19.614
antibody design has been around since, like, the 1970s,
34:19.652 --> 34:23.006
and probably actually it was well known in the 1970s. So it's
34:23.028 --> 34:26.862
actually, I think, been around probably for better part of a century,
34:26.926 --> 34:30.302
honestly. But typically what happens is you immunize an animal,
34:30.366 --> 34:33.726
typically a rabbit, with your protein
34:33.758 --> 34:36.622
of interest or an epitope of it, and lots of adjuvant.
34:36.766 --> 34:40.466
It's usually some kind of bacterial products that ramp
34:40.498 --> 34:43.506
up the immune system, because immune system isn't going to react to just a random
34:43.538 --> 34:46.726
protein fragment. It needs something to ramp it
34:46.748 --> 34:51.042
up. So sometimes it's like a lipopolysaccharide
34:51.106 --> 34:54.534
piece from a bacteria or all sorts of weird things
34:54.572 --> 34:57.420
and adjuvant. So the idea is just to ramp up the immune system.
34:57.870 --> 35:01.882
Of course, your immune system gets ramped up. The B cells start
35:01.936 --> 35:05.226
secreting antibodies. And of course it's like lots of antibodies,
35:05.258 --> 35:08.954
right? Because it's not only antibodies to your protein or different parts of your protein,
35:09.002 --> 35:11.790
different epitopes, but it's also to the stuff in the adjuvant,
35:13.410 --> 35:17.058
a whole bunch. It's a mixed bag of things. And then you
35:17.144 --> 35:20.290
eventually isolate those lymphocytes. If you put lymphocytes
35:21.110 --> 35:24.526
basically white cells out of blood. If you put them into a tissue culture dish,
35:24.558 --> 35:27.906
they're going to die. They're not immortal. So what
35:27.928 --> 35:31.126
you do is you fuse them with tumor cells, usually some
35:31.148 --> 35:34.498
kind of myeloma cells. You put them into specific media where it kills
35:34.514 --> 35:38.242
anything that hasn't fused. So you get these fused hybridomas,
35:38.306 --> 35:41.526
as they're called, and then you usually do some kind of screening
35:41.558 --> 35:45.066
mechanism to try to find the ones of interest. And so you
35:45.088 --> 35:48.300
basically do a limiting dilution assay to get one cell
35:48.670 --> 35:52.138
per well. And then you do some kind of binding assay to
35:52.144 --> 35:55.722
see if it is binding to the thing of interest. And then you would expand
35:55.786 --> 35:59.358
the selected clones and probably do more testing right, to see
35:59.444 --> 36:03.454
in this case how much it bound to your particular
36:03.572 --> 36:07.106
high affinity antibody, low affinity antibody, is it what kind of
36:07.128 --> 36:10.318
binding affinity does it have? Whatever, maybe what epitopes
36:10.334 --> 36:13.634
does it bind to? What's it actually binding to? That's kind of the general
36:13.672 --> 36:17.298
process. But again, this was well known. It was
36:17.464 --> 36:20.646
stated in Ray wands that this was well known at the time of
36:20.668 --> 36:24.086
filing nra wands, and that was in the late 1970s,
36:24.108 --> 36:27.302
I think. So now we're 30 plus 30
36:27.356 --> 36:31.122
years after nra wands. So now antibiotchlogy is like really
36:31.196 --> 36:34.842
well known, right? Because you have 30 plus years plus all the years
36:34.896 --> 36:38.426
pre nra wands. So I think we can say that
36:38.448 --> 36:41.290
antibody design and screening is quite well known.
36:41.790 --> 36:45.386
So in general, nra wands, and for those who didn't know what enray meant,
36:45.418 --> 36:48.960
it just means in the matter of so in this case,
36:50.770 --> 36:54.446
there's no defendant because it's just an appeal from the at
36:54.468 --> 36:57.742
that time, the Board of Patent Appeals and interferences,
36:57.886 --> 37:00.578
which is now the ptab, in a slightly different form.
37:00.744 --> 37:04.338
But it was just his appeal from that decision. So there was no
37:04.424 --> 37:08.278
defendant, there was no infringing party or anything like that. They just didn't like what
37:08.444 --> 37:11.766
the bpai had said. So the
37:11.788 --> 37:15.314
suit was brought by two of the three inventors, jack wans
37:15.362 --> 37:19.230
and Vincent Zorovsky, and the base of their patent was upheld.
37:19.330 --> 37:22.586
So what the Federal Circuit had said
37:22.608 --> 37:26.058
at that time was that they had provided sufficient experimental support
37:26.144 --> 37:30.006
for the breadth of the requested claims in the context that experiments
37:30.038 --> 37:34.038
in genetic engineering produced, at best, unpredictable results.
37:34.054 --> 37:37.486
And I love that quote because that encapsulates my frame of mind a little bit
37:37.508 --> 37:40.666
with all of this. Is that your genetic engineering,
37:40.698 --> 37:43.040
you're trying to get B cells to produce something,
37:43.490 --> 37:47.002
and at best you're going to get unpredictable results because of just the nature
37:47.066 --> 37:50.686
of how it like I said, you're injecting something into an animal that's
37:50.718 --> 37:54.126
just not your protein. It's a whole bunch of other junk to rev
37:54.158 --> 37:57.198
up the immune system. So trying to find the needle in the haystack, that's what's
37:57.214 --> 38:00.886
always going to be. Just one other stat about this. I looked
38:00.908 --> 38:05.010
this up, so I remember it being a crazy frequency. So in a limiting dilution
38:05.090 --> 38:08.438
assay. So the frequency of a B cell that
38:08.444 --> 38:12.086
is specific for your epitope of interest, so like your protein fragment
38:12.118 --> 38:15.462
that you put in the injection here, the average
38:15.526 --> 38:19.866
frequency is 0.5% to 5% in
38:19.888 --> 38:23.978
the normal B cell repertoire. So when the B cell spits out all these antibodies,
38:24.074 --> 38:27.578
your antibody of interest, it's going to be a mixed
38:27.594 --> 38:31.806
bag, right? Probably is 0.5% to 5% in
38:31.828 --> 38:35.770
a normal repertoire. So to put that into perspective, it's not a
38:35.780 --> 38:39.154
lot that you're looking for. And then the other part that was
38:39.192 --> 38:43.022
interesting, that the court had said regarding the Wands patent, it provided considerable
38:43.086 --> 38:45.606
guidance, high level of skill in the art,
38:45.708 --> 38:49.414
methods needed were well known. And so again,
38:49.452 --> 38:53.398
kind of encapsulates that kind of the pieces were there and
38:53.484 --> 38:57.480
it was upheld. So the Wands factors came from this.
38:57.850 --> 39:00.822
This is our test for enablement quantity of experimentation,
39:00.886 --> 39:04.326
necessary amount of direction or guidance, presence or absence
39:04.358 --> 39:07.466
of working examples, nature of the invention, state of the art,
39:07.648 --> 39:10.938
relative skill of those in the art, predictability or unpredictability of
39:10.944 --> 39:14.686
the art, breadth of the claims. But there's also a separate test
39:14.708 --> 39:18.366
for written description. And this kind of dates back to this.
39:18.548 --> 39:22.106
regents of University of California versus lilian Co. And I couldn't
39:22.138 --> 39:25.406
even in this case find the explicit stating of these two tests.
39:25.438 --> 39:29.166
But it kind of picks up in later court
39:29.198 --> 39:32.786
cases that these are like two tests that are used and you actually see
39:32.808 --> 39:36.786
it in amgen's case as well, but they have
39:36.808 --> 39:40.854
a representative species test. So do you have a
39:40.892 --> 39:44.002
representative number of species that fall within the genus
39:44.066 --> 39:47.574
which we've kind of heard this and been talking about this. And then are there
39:47.612 --> 39:51.070
structural features common to the members of the genus so that one of the skill
39:51.090 --> 39:54.778
in the art could visualize and recognize the members? So I
39:54.784 --> 39:58.374
think, again, that's things we've been talking about right. Is there some common feature
39:58.422 --> 40:01.566
amongst all of these? And then do you show a
40:01.588 --> 40:05.066
representative number of species that are captured by the genus?
40:05.258 --> 40:08.746
So, again, fast forward 30 plus years still in antibodies,
40:08.858 --> 40:12.170
but this time it's amgen versus Sanofi,
40:12.250 --> 40:15.454
federal Circuit 2020. And I'll give some background around the balancing
40:15.502 --> 40:19.346
around with the court, but the purpose of the amgen patents were to
40:19.368 --> 40:23.006
produce an antibody to bind pcsk Nine to prevent it from binding
40:23.038 --> 40:26.622
to ldlr, to reduce ldl cholesterol
40:26.686 --> 40:30.086
levels. So, remember, ldl is the bad cholesterol, hdl is the good
40:30.108 --> 40:34.274
cholesterol. And so when you have pcsk
40:34.322 --> 40:37.842
Nine, it basically binds
40:37.906 --> 40:41.706
the ldl receptor and I think basically
40:41.808 --> 40:45.606
promotes more ldl receptor
40:45.638 --> 40:49.206
from materializing. But there's also been studies that show that psk
40:49.238 --> 40:52.826
Nine can also bind ldl and can also bind hdl.
40:52.858 --> 40:56.254
And the purpose of that is a little bit less well understood, but the whole
40:56.292 --> 40:59.614
goal was to have actually, sorry.
40:59.652 --> 41:03.246
When Pspcsk Nine binds the
41:03.268 --> 41:07.170
ldl receptor, it prevents it from being able to bind ldl,
41:07.830 --> 41:11.218
whereas if you can block psk Nine, then you can get it
41:11.224 --> 41:15.086
to bind ldl, and so you can kind of get rid of ldl
41:15.118 --> 41:18.546
in the system. So with monoclonal antibodies, the whole
41:18.568 --> 41:22.530
goal of their Ripatha antibody, which was the subject of their patent,
41:22.610 --> 41:25.846
was the idea to create antibodies to bind psk Nine, to prevent it
41:25.868 --> 41:29.158
from binding to the ldl to the ldl receptor.
41:29.334 --> 41:33.046
But again, it might have other effects, other binding
41:33.078 --> 41:37.020
domains for other things like hdl and ldl. Yeah, let me just
41:38.270 --> 41:42.154
it's more than just the purpose of binding
41:42.202 --> 41:45.498
is to internalize it. So ultimately the goal
41:45.514 --> 41:48.590
is to prevent the internalization of ldl.
41:49.570 --> 41:53.742
Right. So it can actually bind with prevent internalization
41:53.806 --> 41:57.006
of ldlr receptor or the ldl receptor.
41:57.198 --> 42:00.546
Right, right. The receptor and the ldl, I think,
42:00.568 --> 42:02.260
are internalized together.
42:03.990 --> 42:08.194
Yes, when they bind together. But when Pspcsk Nine binds,
42:08.242 --> 42:11.826
it's also internalized, but then it's degraded into the lysosome.
42:12.018 --> 42:15.320
I see. Okay. Destroyed. I see. Right.
42:16.010 --> 42:18.934
That was kind of the hope. And they developed a whole product line around it.
42:18.972 --> 42:22.490
rapata. So this is kind of the bouncing around that happened.
42:22.560 --> 42:26.154
They went to the district court at the first pass.
42:26.352 --> 42:29.898
The patents were found to be not invalid for lack of
42:29.904 --> 42:33.420
written description and enablement. The patents were found to be not
42:33.890 --> 42:37.374
found to be non obvious. Not obvious. And there was found to be no
42:37.412 --> 42:40.922
willful infringement. But apparently amgen had woken
42:40.986 --> 42:44.046
a sleeping giant in sanafi because that should have been enough. Right.
42:44.068 --> 42:47.602
Sanofi is off the hook. They didn't infringe, but Sanofi said,
42:47.656 --> 42:50.834
well, you woke us now.
42:50.952 --> 42:54.990
So Sanofi appealed to the Federal Circuit and basically
42:55.080 --> 42:59.202
said, especially on the written description and enablement
42:59.266 --> 43:02.706
pieces. And Federal Circuit basically told the district court
43:02.738 --> 43:06.840
that they had given the jury improper instructions in
43:07.290 --> 43:11.446
telling the jury how to decide written description and enablement. So they remanded
43:11.478 --> 43:14.940
it back to the district court. The jury said again
43:15.310 --> 43:19.270
that it was valid for written description enablement.
43:19.430 --> 43:23.662
The judge used kind of like a lesser known tool to
43:23.716 --> 43:27.694
kind of go over the jury's head and said no,
43:27.732 --> 43:32.142
no, I disagree with you jury. You've said this twice now that
43:32.276 --> 43:36.066
I disagree that it's not enabled, but there is written description support.
43:36.248 --> 43:39.886
So then amgen appealed to the Federal circuit, which is what we're discussing
43:39.918 --> 43:43.940
today. And then of course, as we know or see
43:44.550 --> 43:48.178
it stands. That final decision from the district court stands. And so the amgen
43:48.194 --> 43:50.280
appeals to the Supreme Court, which is yet to come.
43:53.610 --> 43:56.818
This is an older quote from an older
43:56.834 --> 44:00.386
case, but it says, to prove that a claim is invalid for lack of enablement,
44:00.418 --> 44:03.606
a challenger must show by clear and convincing evidence that a person of ordinary
44:03.638 --> 44:07.242
skill in the art would not be able to practice the claimed invention without
44:07.296 --> 44:11.278
undue experimentation. This undue experimentation tends to be read
44:11.444 --> 44:15.230
back into the statute, but it does not exist in the statute.
44:16.370 --> 44:20.462
We tend to say it is. So here
44:20.516 --> 44:24.302
amgen's claims for two of their patents, the same written description.
44:24.446 --> 44:28.482
So claim one is a monoclonal antibody that
44:28.536 --> 44:31.954
when bound to pcsk Nine binds at least to one
44:31.992 --> 44:36.254
of the following residues of pcsk Nine. So there's, I think, 15 residues
44:36.302 --> 44:39.806
there and where in the monoclonal antibody blocks binding
44:39.838 --> 44:43.606
a pcsk Nine to the ldl receptor, claim 29.
44:43.628 --> 44:47.346
This is just a representative, I don't think I grabbed them all. But claim
44:47.378 --> 44:51.126
29 was a pharmaceutical composition having the same characteristics
44:51.158 --> 44:54.426
of claim one. But it blocks the binding of pcsk Nine to
44:54.448 --> 44:58.838
ldlr by at least 80%. So kind of a binding functional requirement.
44:59.014 --> 45:02.890
And then claim one of the seven four one patent was
45:03.040 --> 45:06.778
again an isolated monocle antibody that binds pcsk Nine
45:06.944 --> 45:10.574
where the monoclonal antibody binds an epitope on pcsk Nine
45:10.612 --> 45:13.966
comprising at least one of those two residues and where
45:13.988 --> 45:17.490
in the monocle antibody it blocks binding pcsk Nine to ldlr.
45:17.910 --> 45:22.180
So they did have testimony that,
45:22.870 --> 45:26.546
for example, there's two experts that testified seemingly there was a Doctor reese, and he
45:26.568 --> 45:30.226
testified that I don't believe based on good protein structural principle,
45:30.258 --> 45:33.798
an antibody could bridge across without interacting with
45:33.884 --> 45:37.318
those amino acids in between. So that this was in response to them asking
45:37.404 --> 45:41.306
him if just one amino acid was enough or if
45:41.328 --> 45:45.126
like two were enough on disparate sides of the binding pocket.
45:45.238 --> 45:48.646
And he basically said that I don't think an antibody
45:48.678 --> 45:52.320
could bind just one and not hit other ones in between,
45:53.090 --> 45:56.906
but also that if it were only binding
45:56.938 --> 46:00.426
one in a structural limitation, it wouldn't
46:00.458 --> 46:04.554
suffice the functional limitation which is blocking binding a pcsk
46:04.602 --> 46:08.338
Nine. So their claim has these two facets of it, right, the structural piece and
46:08.344 --> 46:11.634
a functional piece that for
46:11.832 --> 46:15.410
yes, their structural piece is such that it says at least one of.
46:15.560 --> 46:19.378
But then their functional piece brings in this added complexity that has to block
46:19.554 --> 46:23.830
pcsk Nine binding to the receptor. And so arguably
46:24.970 --> 46:29.666
just one amino acid binding just one amino acid wouldn't fulfill
46:29.698 --> 46:32.746
the functional feature of the claim. So, I mean,
46:32.848 --> 46:35.578
right. There might be a problem a little bit. Right. Then why not claim at
46:35.584 --> 46:39.450
least two or three amino acids? But that's another discussion point.
46:39.600 --> 46:42.814
Actually have a question about that. Okay. Claim one
46:42.852 --> 46:46.602
in 165. Well, both of them are claiming an antibody,
46:46.746 --> 46:50.400
isolated monoclonal antibody. Then they say
46:51.250 --> 46:53.830
when bound to pce canine,
46:54.010 --> 46:57.186
the monoclonal antibody binds to at least one
46:57.208 --> 47:00.466
of those residues. But that's already kind
47:00.488 --> 47:04.580
of like claiming a thing by its function.
47:06.790 --> 47:09.734
Am I getting that's already functional language in the first half?
47:09.772 --> 47:13.734
Right. Yeah. There's no explicit step there, and there maybe should
47:13.772 --> 47:17.670
be, but there's no structure. There's no structure of the antibodies.
47:18.090 --> 47:21.910
Yeah, I mean, they do maybe this is a
47:21.980 --> 47:25.626
112 F means plus function discussion, but they
47:25.648 --> 47:29.626
do, I think, have 26 sequence listings for
47:29.648 --> 47:33.790
antibodies in their spec and a few three dimensional
47:34.130 --> 47:37.662
images of the antibody. It does make you wonder
47:37.716 --> 47:40.830
if to some degree, should they or claims be limited to that,
47:40.980 --> 47:44.366
then that's what I think, because this
47:44.388 --> 47:48.898
is preposterously broad to me field.
47:49.064 --> 47:52.334
But to just say an isolated monoclonal antibody
47:52.462 --> 47:56.406
and not explicitly say which antibodies, what their
47:56.428 --> 47:59.494
layout is, how they look, and they do have some
47:59.532 --> 48:03.640
examples of those, but if you transfer this to any other field,
48:04.490 --> 48:09.238
you can get what you disclose and their equivalents.
48:09.414 --> 48:13.226
And I'm not sure we know what the equivalent would be to this
48:13.248 --> 48:16.826
isolated monoclonal antibody just from
48:16.848 --> 48:18.460
their spec. Yeah.
48:21.890 --> 48:25.214
So it's hard to define where proteins bind to each other.
48:25.332 --> 48:28.714
Right. That's a really hard science. And then to boot,
48:28.762 --> 48:32.174
to find, to make an antibody that very
48:32.212 --> 48:35.374
specifically targets that same pocket, I think is really hard.
48:35.412 --> 48:37.666
But if you were to this is where I like, have a little bit of
48:37.688 --> 48:41.326
like because if you were to really strictly claim
48:41.358 --> 48:45.300
an antibody, structurally, your body is going to make
48:46.070 --> 48:49.710
20 of them different next time you immunize.
48:49.870 --> 48:53.480
Right. So it'd be really easy to design around because
48:55.050 --> 48:58.146
the antibody could bind any subset
48:58.178 --> 49:01.478
of these epitopes and still exhibit the same function. So that's where I
49:01.484 --> 49:04.780
mean, I agree. And I don't know how you would do it, right?
49:05.630 --> 49:09.366
Because even if you said I guess you could say it's an igg antibody,
49:09.478 --> 49:12.770
right. Because at least you're kind of but there's tons
49:12.790 --> 49:15.950
of subtypes of igg, so is that enough?
49:16.100 --> 49:19.742
But then there's I don't know. This is why I have a hard time because
49:19.796 --> 49:23.986
to really claim it takes so long to develop an antibody and
49:24.008 --> 49:27.358
then to be able to easily design around by just immunizing another animal and finding
49:27.374 --> 49:31.678
a different one, it would be a maximum
49:31.774 --> 49:34.930
year exercise. And I think
49:35.000 --> 49:38.678
the purpose of some of this analysis and case law is
49:38.764 --> 49:42.086
and the reason they're kind of pointing back
49:42.108 --> 49:45.800
at amgen and saying, we don't like this. It's too broad. It's to that
49:46.330 --> 49:49.750
is they don't want to stifle future innovation by giving
49:49.820 --> 49:53.842
this sort of monopolized product that
49:53.996 --> 49:58.102
ends up in a product to one player.
49:58.246 --> 50:01.550
Right? And I'm not sure that this claim does that,
50:01.620 --> 50:05.054
but I think that's the bigger concern. So then
50:05.092 --> 50:08.442
to get around that kind of concern in other fields,
50:08.586 --> 50:12.030
you end up describing more explicitly
50:12.870 --> 50:16.530
examples that could be used and more explicitly
50:16.870 --> 50:20.114
exactly the how of what you're doing.
50:20.312 --> 50:23.666
So the reason they brought in macro into this,
50:23.688 --> 50:27.606
which is a software case, is because they are making a
50:27.628 --> 50:31.142
parallel to blackbox software that
50:31.196 --> 50:35.366
says maybe I have a machine learning something that
50:35.388 --> 50:38.690
does these five things. But I never say in my specification
50:38.770 --> 50:42.522
what these five things are. And I also never say like in detail
50:42.656 --> 50:46.698
and I also never say what that machine learning system looks like. And when
50:46.704 --> 50:50.362
you begin to put that together, you have written description problems
50:50.416 --> 50:54.094
but you also have enablement problems later. Right? Because you don't have
50:54.132 --> 50:57.520
enough of the actual guts of what's going on.
50:57.890 --> 51:01.498
Right, this is more complex than that. So it's
51:01.514 --> 51:04.674
kind of peculiar to me that they dragged that in, but I can understand the
51:04.712 --> 51:08.034
sentiment. Yeah, I agree with
51:08.232 --> 51:13.090
as I was reading this case, I had the same thoughts kristen, you did coming
51:13.160 --> 51:16.658
from other technology areas because this also isn't my
51:16.744 --> 51:20.326
background. But then Ashley, you just said something that is kind
51:20.348 --> 51:25.494
of like the other side of that coin, which is that these
51:25.532 --> 51:29.718
biotech companies put tons of resources into developing these
51:29.884 --> 51:33.279
very useful drugs or antigens or
51:33.779 --> 51:37.610
whatever and how do they protect them in a way that
51:37.680 --> 51:41.680
doesn't let their competitor just super easily design around it?
51:42.290 --> 51:45.866
It is an interesting question, but I totally
51:45.898 --> 51:49.982
agree with kristen's analysis. From the patent law
51:50.116 --> 51:51.230
perspective,
51:53.970 --> 51:57.358
they're not teaching someone how to make and use exactly
51:57.444 --> 52:01.106
what they've said in the claim. So it does seem to be an
52:01.128 --> 52:04.226
issue. Well, I would argue that they don't in the claim, but I think
52:04.248 --> 52:05.460
they do in the spec.
52:08.550 --> 52:12.006
Yeah, some exactly. So like there's a few I think one of
52:12.028 --> 52:15.286
the again, this is not my field, so actually if
52:15.308 --> 52:18.882
I'm wrong but I know one of the experts
52:18.946 --> 52:22.374
said you can't even reliably take a protein
52:22.422 --> 52:25.978
sequence and know how it will fold from first. No, it's true,
52:26.064 --> 52:29.578
but again, I think that's a physiology problem.
52:29.664 --> 52:32.190
You know what I mean? It's like this science,
52:34.210 --> 52:37.866
the basis of these cases is antibody science
52:37.978 --> 52:40.986
and that has been around for better part of a century.
52:41.098 --> 52:44.574
So that's how they predictable. But yes, protein chemistry and
52:44.612 --> 52:48.638
protein binding and protein three dimensional proteins change shape
52:48.654 --> 52:51.858
too when they bind each other, right? There's these you know, it was always a
52:51.864 --> 52:55.698
joke in grad school. It was like oh, it underwent a conformational change when
52:55.704 --> 52:59.026
you couldn't explain something because you know, proteins change when they
52:59.048 --> 53:03.154
bind to each other and when they bind to receptors receptors internalize
53:03.202 --> 53:07.080
or they change shape, all sorts of weird things happen that we don't understand.
53:08.090 --> 53:11.338
I definitely see it's a tricky problem. This particular
53:11.424 --> 53:15.242
case to me seems like a land grab, though. It seems
53:15.296 --> 53:19.274
like they found a few things that worked and now they're trying to grab the
53:19.312 --> 53:23.390
entire country. But maybe
53:23.540 --> 53:27.440
again, it's not my field. But if they had
53:27.890 --> 53:31.742
identified a protein structure of
53:31.796 --> 53:35.860
the antibody that bound to these particular
53:37.190 --> 53:40.818
residues of the pcsk nine and
53:40.824 --> 53:44.580
then they said, okay, the antibody has to have this
53:45.530 --> 53:49.234
whatever DNA sequence, this protein, this amino acid
53:49.282 --> 53:53.158
sequence, that to me would be a little bit different. Because now
53:53.324 --> 53:56.134
you're saying we found a thing.
53:56.332 --> 53:59.462
Sure, you can change a whole bunch of other stuff, but this is the key
53:59.516 --> 54:03.114
nugget that binds to these key residues and that's what we
54:03.152 --> 54:06.938
found. And then sure, anybody who just adds some junk on
54:06.944 --> 54:10.726
the end can't just copy that and design around it, but that's not what they're
54:10.758 --> 54:14.206
saying, right? They're saying like, we found a few things that work and
54:14.228 --> 54:17.840
now we're going to block anyone from finding anything else that works.
54:18.210 --> 54:21.390
Well, maybe they did this in their examples in the spec
54:21.460 --> 54:25.422
and so maybe we have a handful of examples that do exactly what david's requesting
54:25.566 --> 54:29.134
and so then the claim would necessarily
54:29.182 --> 54:32.434
be limited to those pieces and their
54:32.472 --> 54:36.274
equivalents. But how big is the and their equivalence,
54:36.322 --> 54:40.360
right? And how much is the undue experimentation in this field?
54:40.810 --> 54:44.914
That's another thing. I think this needs a redefinition
54:45.042 --> 54:48.714
of undue experimentation because of the complexity of this
54:48.752 --> 54:52.058
field. Right? But I don't know how you do that in a
54:52.064 --> 54:56.086
court. From a blocking
54:56.118 --> 54:59.334
perspective. I think the interesting thing is that sanofi
54:59.382 --> 55:02.542
did create an antibody that performed a function that was different
55:02.596 --> 55:05.914
and didn't infringe. You know what I mean? So from a blocking
55:05.962 --> 55:10.202
perspective, it's not as broad as it appears because sanofi
55:10.346 --> 55:14.066
created an antibody that got around this that was
55:14.088 --> 55:17.966
the first district court where they didn't infringe,
55:18.158 --> 55:21.730
right? And so I definitely see the point.
55:21.800 --> 55:25.906
But also I wonder how blocking it truly is because sanofi was able
55:25.928 --> 55:29.250
to do it with reasonable time frame.
55:29.670 --> 55:33.186
But all fair points. This is where I'm kind of bipolar
55:33.218 --> 55:36.262
on this topic because in one sense I'm like, gosh, the amount of
55:36.316 --> 55:39.514
time and money that they poured into this to get it, and then to do
55:39.552 --> 55:42.922
point mutations of every of those 15
55:42.976 --> 55:46.410
amino acids on ldlr to figure out
55:46.480 --> 55:49.766
which one is the important amino acid. That would take freaking
55:49.798 --> 55:54.410
forever to do point mutations. And what, the protein doesn't
55:54.930 --> 55:58.366
fold well then is ambient not binding because it
55:58.388 --> 56:01.754
didn't fold appropriately? Or is it not binding because it's really not the right epitope?
56:01.802 --> 56:04.942
You know what I mean? It's a kind of a pandora's box. So I also
56:04.996 --> 56:08.240
get not doing all those point mutations to figure it out.
56:09.190 --> 56:12.526
So some of the things that the federal circuit did say was that the binding
56:12.558 --> 56:16.226
limitation is itself enough here to require undue experimentation. So the
56:16.248 --> 56:20.962
whole idea that screening these things for a binding limitation
56:21.026 --> 56:23.378
would be a lot of work. Right. So even if you found a whole bunch
56:23.394 --> 56:26.370
of antibodies, that you'd have to figure out their binding feature.
56:26.450 --> 56:29.894
Right. And then the Federal Circuit also said,
56:29.932 --> 56:33.386
we also agree with the district court that this invention is in an
56:33.408 --> 56:36.758
unpredictable field of science with respect to satisfying the full scope of the functional
56:36.774 --> 56:39.734
limitations, which I would disagree a little bit. Because if we go back to nra
56:39.782 --> 56:43.200
Wands, they said that this was like a highly predictable field.
56:44.210 --> 56:47.658
Same field 30 plus years later, and now they're saying it's
56:47.674 --> 56:51.114
unpredictable. But yet anti science is highly predictable.
56:51.162 --> 56:52.830
At least it wasn't in Ray Juan.
56:56.470 --> 56:59.854
But how big does this have to be before it becomes unpredictable
56:59.902 --> 57:03.266
again? Right? You're saying that the experimentation that would
57:03.288 --> 57:06.614
have to be done to just identify what was going on in
57:06.652 --> 57:10.214
the amgen claim basically is
57:10.332 --> 57:14.118
really involved in extremely lengthy of time. So does that become
57:14.284 --> 57:17.954
more unpredictable, as larger as that gets larger?
57:18.082 --> 57:21.466
I don't know. Does complexity and length of
57:21.488 --> 57:25.098
time mean unpredictable or does it just mean having patience in
57:25.104 --> 57:28.554
the process? Right. And that's why I wonder what this case too,
57:28.592 --> 57:32.170
a little bit, is that, yes, it's like a long process
57:32.240 --> 57:35.834
and yes, you get a lot of hits, but there is well known screening methods,
57:35.962 --> 57:39.486
well known creation methods, well known. So is
57:39.508 --> 57:43.186
it just that people don't want to go through this lengthy couple
57:43.208 --> 57:47.074
of year process to design around and build upon, or is it really
57:47.112 --> 57:50.260
undue experimentation? I think there's like
57:50.710 --> 57:54.242
a patience versus unpredictability true,
57:54.296 --> 57:56.600
unpredictability question. Okay.
57:57.530 --> 58:01.266
And that maybe wouldn't be undue experimentation because that's just what's
58:01.298 --> 58:04.582
required to find out this information. Right.
58:04.636 --> 58:07.960
And actually, there's an interesting to have some quote later.
58:09.690 --> 58:13.466
Yeah, this is the interesting part from one of their
58:13.648 --> 58:17.974
experts. They had another expert, Dr. Jackson. So in the amigen
58:18.022 --> 58:21.914
patent, they disclosed a roadmap for how to make
58:22.032 --> 58:25.854
these antibodies. And their Dr. Jackson expert said
58:25.892 --> 58:29.838
the significant similarity between the research plan
58:30.004 --> 58:33.438
used by Dr. Jackson and the roadmap disclosed in
58:33.444 --> 58:36.926
the patent demonstrates that a person of ordinary skill in the art attempting to obtain
58:36.958 --> 58:40.546
a claimed antibody that is not disclosed or is a
58:40.568 --> 58:44.130
variant of a disclosed antibody would have to do essentially the same amount
58:44.200 --> 58:47.922
of work as the inventors of the patent ensued. And I think that's okay
58:48.056 --> 58:50.246
if you have to do the same amount of work. That's the whole point of
58:50.268 --> 58:53.382
the patent system. You're not given something for free. You got to do the same
58:53.436 --> 58:57.142
work, but you're guided. And so they
58:57.196 --> 59:00.806
use that to say that it creates undue experimentation. And I
59:00.828 --> 59:04.378
would actually argue that it's the opposite, that just because you have to do
59:04.384 --> 59:07.546
the same thing doesn't mean undue experimentation actually means that you did a really good
59:07.568 --> 59:10.700
job of describing it. And it's just a crappy long process.
59:11.230 --> 59:13.820
So I found that really interesting,
59:16.130 --> 59:19.806
disagree with their conclusion there. But I think it sounds
59:19.828 --> 59:23.086
like they gave a really good roadmap and actually the roadmap that
59:23.108 --> 59:26.834
their expert put together versus the roadmap and the patent were super similar.
59:27.032 --> 59:30.654
And so I don't think that's unconventional or undo experimentation.
59:30.702 --> 59:34.338
I think that it's just a long, arduous process. And if you want to
59:34.344 --> 59:38.226
compete in the space, you're going to have to go through the process when
59:38.248 --> 59:41.954
you said something, their physiology is unpredictable. But the prior slide,
59:42.082 --> 59:45.586
you're looking at the antibody technology being unpredictable,
59:45.698 --> 59:48.140
which I don't think it is.
59:49.150 --> 59:52.986
I would argue that it's not. I wonder and
59:53.088 --> 59:56.586
this is all kind of coming together, right? Actually, what you
59:56.608 --> 59:59.942
were saying, I think, was that and kristen,
1:00:00.006 --> 1:00:03.358
you were saying let's just assume for a
1:00:03.364 --> 1:00:07.562
moment that the specification, because there's tons of sequences in there, the specification
1:00:07.626 --> 1:00:11.518
does provide a bunch of different antigen sequences that
1:00:11.604 --> 1:00:16.114
are starting points. I guess maybe if
1:00:16.152 --> 1:00:19.714
the claim was interpreted with the 112
1:00:19.752 --> 1:00:24.190
F type with means plus function type considerations
1:00:24.350 --> 1:00:27.654
now, you wouldn't say this is any antigen that
1:00:27.692 --> 1:00:31.762
binds to this residues. These are the antigens
1:00:31.826 --> 1:00:35.478
that we have disclosed because it's means plus function.
1:00:35.644 --> 1:00:40.694
So I wonder if really if
1:00:40.732 --> 1:00:44.454
you have this good starting point and good is all relative,
1:00:44.502 --> 1:00:47.980
right? But let's say you have a good enough starting point that you know what
1:00:48.830 --> 1:00:52.254
antigens you're trying to test, then you make those
1:00:52.292 --> 1:00:56.314
antigens. And now I think actually you're saying going through the screening
1:00:56.362 --> 1:00:59.646
process is routine. Right. But I think
1:00:59.668 --> 1:01:03.546
an issue comes in when you don't even know what antigen
1:01:03.578 --> 1:01:07.570
you're starting with. If you just have no idea what
1:01:07.640 --> 1:01:10.786
protein sequence you're starting with at all. And you just need to make that up
1:01:10.808 --> 1:01:14.834
from scratch, make every possible protein sequence in the world
1:01:14.952 --> 1:01:17.358
and then test them against these residues.
1:01:17.534 --> 1:01:21.014
Clearly undo experimentation. There's no way no one would know
1:01:21.052 --> 1:01:24.102
how to do that. But it comes back to the spec.
1:01:24.236 --> 1:01:27.206
And I think actually what you brought up is a really good point. If this
1:01:27.228 --> 1:01:30.742
is 112 F, it means plus function
1:01:30.796 --> 1:01:34.390
type language. Now, now you're, you do have a good starting point, which totally,
1:01:34.470 --> 1:01:38.326
I think, changes the calculation about how much experimentation
1:01:38.358 --> 1:01:42.554
is needed. And actually, I think you bring up a good point, too, just from
1:01:42.592 --> 1:01:45.734
a nomenclature perspective, you know, you were using that.
1:01:45.792 --> 1:01:49.530
So antigens are kind of what are used to inject
1:01:49.610 --> 1:01:53.418
the rabbit and then antibiotics are what are created in response to those antigens.
1:01:53.514 --> 1:01:56.786
I wonder if that's another way, because I think they disclosed a whole bunch of
1:01:56.808 --> 1:01:59.810
antibody sequences, I think, but maybe antibody, sorry,
1:01:59.880 --> 1:02:03.586
antibody. No, it's okay. So they did a whole bunch of antibody sequences. But I
1:02:03.608 --> 1:02:07.586
wonder if another way too would be to provide the antigen
1:02:07.618 --> 1:02:10.680
sequences, right? What are the chunks of pcsk? Nine.
1:02:11.450 --> 1:02:14.774
Maybe they do. I don't know. That's what confused me,
1:02:14.812 --> 1:02:18.514
because some of their protein sequences are antigen
1:02:18.562 --> 1:02:21.946
binding proteins. So I interpreted that because I'm not an
1:02:21.968 --> 1:02:26.010
expert, I interpreted that as part of the sequence of the antibiotics.
1:02:27.470 --> 1:02:31.210
Antigen binding. Say it again. Antigen binding antigen
1:02:31.290 --> 1:02:34.686
binding proteins. Light chains and
1:02:34.708 --> 1:02:37.630
heavy chains of antigen binding proteins.
1:02:39.410 --> 1:02:43.698
The light and heavy chains. So that's these
1:02:43.864 --> 1:02:47.186
okay, so those are antibodies, but those
1:02:47.208 --> 1:02:49.250
are sequences of parts of the antibodies.
1:02:51.110 --> 1:02:54.882
Like I said, this is a fixed region based on the class
1:02:54.936 --> 1:02:58.194
and subclass of the antibody. So, like, igg one has around.
1:02:58.232 --> 1:03:02.514
ig two. So anyways, I kind of went through this and did my own factor
1:03:02.562 --> 1:03:06.166
analysis. Open for discussion. So quantity of
1:03:06.188 --> 1:03:10.658
experimentation necessary. Again, I think antibiot generation is well known.
1:03:10.834 --> 1:03:14.214
It's been around for a better part of a century. But physiology is unpredictable,
1:03:14.262 --> 1:03:17.366
right? If you inject the same thing into a rabbit that they injected,
1:03:17.398 --> 1:03:20.602
are you going to get the same thing? No, because is it at the same
1:03:20.656 --> 1:03:23.934
strain of mouse or is the same strain of rabbit? Has that
1:03:23.972 --> 1:03:27.680
rabbit seen other things that your rabbit hasn't seen?
1:03:28.690 --> 1:03:32.366
There's even vendor differences, right? We even saw when
1:03:32.388 --> 1:03:36.430
we did research that C 57 black mice
1:03:36.510 --> 1:03:40.658
from one vendor had different
1:03:40.744 --> 1:03:44.642
things behaved in our experiments differently than C 57
1:03:44.696 --> 1:03:48.410
black from another. They overall behaved
1:03:48.430 --> 1:03:51.318
the same. But there were some nuanced differences where you're like,
1:03:51.484 --> 1:03:54.738
these mice are not they're supposed to be genetically identical, but they're
1:03:54.754 --> 1:03:58.626
not. I think that just physiology is unpredictable,
1:03:58.658 --> 1:04:02.440
and I don't think we should punish companies for physiology being hard.
1:04:03.930 --> 1:04:06.726
Amount of direction and guidance. I think they did give a lot of guidance.
1:04:06.758 --> 1:04:09.018
I think that's even admitted to that, they gave a lot of guidance. They had
1:04:09.024 --> 1:04:12.326
a roadmap for creating these. They had working examples.
1:04:12.358 --> 1:04:16.490
Was it enough? Did it show enough species,
1:04:16.570 --> 1:04:20.186
enough representative species? I don't know. The nature
1:04:20.218 --> 1:04:23.614
of the invention, state of the Art, I think it
1:04:23.652 --> 1:04:26.480
kind of follows with the other ones. I didn't go too deeper into those.
1:04:27.010 --> 1:04:30.430
The relative skill in the Art, I think they even admitted in Ray wands
1:04:30.510 --> 1:04:33.074
again, 30 plus years ago, that the skill in the Art was high at that
1:04:33.112 --> 1:04:36.334
time. So I would argue that skill in the Art is still high for antibody
1:04:36.382 --> 1:04:40.046
science. And then again, physiology is unpredictable.
1:04:40.078 --> 1:04:43.158
But I would say that antibody science is, I mean, for what it is and
1:04:43.164 --> 1:04:47.206
for how long it's been around, it's not that unpredictable. You inject a
1:04:47.228 --> 1:04:50.726
rabbit or a mouse or whatever, an animal with something, you're going
1:04:50.748 --> 1:04:54.058
to get, b cells are going to react to that. You're going to be
1:04:54.064 --> 1:04:57.562
able to get them out. Now, is it going to be the exact
1:04:57.616 --> 1:05:01.258
same thing that amgen created? No, but again, that's the physiology,
1:05:01.274 --> 1:05:03.630
the unpredictability part of physiology.
1:05:06.370 --> 1:05:10.478
Just a quick comment on that. It's possible that
1:05:10.564 --> 1:05:14.270
when wands was putting this predictability
1:05:14.350 --> 1:05:18.414
or unpredictability of the Art up, they meant literally defined
1:05:18.462 --> 1:05:21.550
predictable arts and literally defined unpredictable arts.
1:05:21.630 --> 1:05:25.406
And so typically, this kind of science falls into unpredictable
1:05:25.438 --> 1:05:29.014
art. So maybe it wasn't explicit about what
1:05:29.052 --> 1:05:32.646
they were doing, but that it was categorized in this unpredictability field.
1:05:32.828 --> 1:05:36.598
Yeah, maybe a little bit, at least would weigh into the
1:05:36.604 --> 1:05:39.994
analysis. Yeah. Similar kind of question is actually
1:05:40.032 --> 1:05:43.334
when you say physiology, are you including
1:05:43.382 --> 1:05:47.340
both parts of the claim? Are you including that first part of the claim where
1:05:48.110 --> 1:05:51.514
antibody binding to a residue, is that part of physiology
1:05:51.562 --> 1:05:53.550
or is that not part of physiology?
1:05:57.090 --> 1:06:01.310
I don't think that's unpredictable because pcsk Nine
1:06:01.380 --> 1:06:05.106
does bind to ldlr and it's in that pocket. So if
1:06:05.128 --> 1:06:08.546
you can find something that prevents that binding, it's going to be in
1:06:08.568 --> 1:06:12.850
that pocket. Right. If you were shown
1:06:13.350 --> 1:06:17.362
3d structure, let's even say, of an antibody, would you know whether
1:06:17.416 --> 1:06:20.200
it was going to bind to one of those things? No.
1:06:21.130 --> 1:06:24.754
That's why I think it's unpredictable. Like you might be able to make an antibody,
1:06:24.802 --> 1:06:28.342
but making an antibody that does what you want it to do is unpredictable.
1:06:28.406 --> 1:06:32.140
You have to do it by experimentation. Right, right.
1:06:33.630 --> 1:06:36.410
But that's the whole, like they're teaching with the guidance. Right,
1:06:36.480 --> 1:06:39.926
right. It's still unpredictable, even though they've brought
1:06:39.958 --> 1:06:43.114
some things about it. It's a hard one,
1:06:43.152 --> 1:06:46.166
for sure. kristen had to hop off.
1:06:46.208 --> 1:06:49.646
She's an examiner call, and we'll try to wrap up here a little bit,
1:06:49.668 --> 1:06:53.498
too. So both of the cranes, again, they were reasonably broad.
1:06:53.674 --> 1:06:58.606
They did identify specific amino acids, but there probably could have been some gut
1:06:58.638 --> 1:07:02.386
check and saying kind of like what their experts said, you probably can't find an
1:07:02.408 --> 1:07:05.954
antibody that's only going to bind one amino acid and inhibit function. You probably do
1:07:05.992 --> 1:07:09.098
need two plus three plus amino acids.
1:07:09.134 --> 1:07:12.966
They probably should have been more realistic in that at minimum, in that
1:07:12.988 --> 1:07:16.466
sense, that an antibody binding just one amino
1:07:16.498 --> 1:07:20.726
acid. I don't know if that's really a thing for
1:07:20.748 --> 1:07:24.006
the rent description part of this. Obviously the Supreme Court is taking up the enablement
1:07:24.038 --> 1:07:27.706
piece, not written description, but in reviewing the district court what they
1:07:27.728 --> 1:07:31.578
had said. So there's the representative species test, and they looked at amino
1:07:31.594 --> 1:07:34.350
acid sequence similarity, 3d structure,
1:07:34.850 --> 1:07:38.474
and all kind of found that Amgens and the compare antibodies
1:07:38.522 --> 1:07:42.560
were structurally similar. So interestingly, even though sanofi did not
1:07:42.870 --> 1:07:46.866
infringe AMGEN's claim, their antibodies were structurally similar when
1:07:46.888 --> 1:07:50.066
they looked at them, and there was 80% similarity in
1:07:50.088 --> 1:07:53.490
amino acid sequences between amgens and competitor antibodies.
1:07:54.470 --> 1:07:57.998
But interestingly, AMGEN's disclosed antibodies covered more classes
1:07:58.014 --> 1:08:01.362
of antibodies. So I think that weighs in favor of the whole representative species,
1:08:01.426 --> 1:08:04.374
because it wasn't just I think it was probably still all,
1:08:04.412 --> 1:08:07.846
igg would be my guess, but maybe not. Maybe there are some other ones in
1:08:07.868 --> 1:08:11.626
there, but it covered a good swath of classes, which I think goes towards that
1:08:11.648 --> 1:08:15.398
representative species. They say just a molecule antibody, but they showed support for lots
1:08:15.414 --> 1:08:18.746
of different classes. And then they had
1:08:18.768 --> 1:08:22.446
substantial evidence showing that while binding to different residues across the
1:08:22.468 --> 1:08:25.738
sweet spot, that they blocked pcs canine binding
1:08:25.754 --> 1:08:29.630
to the ldl receptor through a variety of binding interactions.
1:08:30.930 --> 1:08:34.386
So I think it's interesting too, sounds like at least based on
1:08:34.408 --> 1:08:38.846
this, that they had some data to suggest that their different antibodies
1:08:38.878 --> 1:08:42.178
that they had created did bind in that sweet spot in a
1:08:42.184 --> 1:08:45.602
few different ways. So maybe that
1:08:45.656 --> 1:08:49.320
lends itself more to a broader claim, to the fact that they were able to
1:08:50.170 --> 1:08:52.774
all bind in that sweet spot, but bind in kind of a little bit different
1:08:52.812 --> 1:08:56.200
ways. But just in general,
1:08:56.650 --> 1:08:59.894
thinking about this, this was a quote back
1:08:59.932 --> 1:09:03.318
from ariad versus lily in 2010 the Federal Circuit
1:09:03.334 --> 1:09:06.582
basically said there was little difference between describing an invention and enabling
1:09:06.646 --> 1:09:10.362
one to make and use it. And that rich description enablement often rise and fall
1:09:10.416 --> 1:09:14.186
together. So I'm kind of surprised that the Federal Circuit has reviewed
1:09:14.218 --> 1:09:17.226
these things in isolation and that the Supreme Court
1:09:17.258 --> 1:09:20.814
is taking these things up in isolation. Because honestly, the more I dig into
1:09:20.852 --> 1:09:24.430
this world, the more I don't think they should be separate,
1:09:25.910 --> 1:09:30.114
especially when both parts of the statute say the
1:09:30.152 --> 1:09:33.630
written description should allow somebody to make and use it and enablement
1:09:33.710 --> 1:09:36.020
should allow somebody to make and use it.
1:09:38.230 --> 1:09:41.446
I don't know. I would love I don't think that
1:09:41.468 --> 1:09:45.142
this is a good example of a case where it does one or the other.
1:09:45.276 --> 1:09:49.282
I don't know if they can be separated, but that's my personal
1:09:49.356 --> 1:09:52.938
opinion. I'm going to read this just because it
1:09:52.944 --> 1:09:57.018
was if you have a chance and you're curious, if you go back to
1:09:57.104 --> 1:10:01.002
the area pharmaceuticals versus eli lilly 2010
1:10:01.056 --> 1:10:04.998
Federal Circuit decision. Former Chief Judge raider
1:10:05.174 --> 1:10:08.602
gives an amazing dissent opinion which encapsulates
1:10:08.666 --> 1:10:11.214
like, I wish I would have read this several days before instead of just like
1:10:11.252 --> 1:10:15.006
this morning, because I'm like, oh, this is like my feeling on it.
1:10:15.188 --> 1:10:19.266
But this is what he says. So the language that the majority uses to explain
1:10:19.368 --> 1:10:22.734
possession, as shown in the disclosure, not only fails to justify
1:10:22.782 --> 1:10:25.842
a separate test, it also fails to distinguish the test
1:10:25.896 --> 1:10:29.254
for written description from the requirements for enablement. The level
1:10:29.292 --> 1:10:32.594
of detail required to satisfy the written description requirement,
1:10:32.722 --> 1:10:35.878
according to the majority, varies depending on the nature and scope of the
1:10:35.884 --> 1:10:39.400
claims and on the complexity and predictability of the relevant technology.
1:10:39.850 --> 1:10:42.986
These considerations, however, mirror the wan's factors for
1:10:43.008 --> 1:10:46.166
enablement, which include as the things we've
1:10:46.198 --> 1:10:49.466
all seen. The Court attempts to distinguish enablement by observing that
1:10:49.488 --> 1:10:52.458
although written description enablement often rise and fall together,
1:10:52.624 --> 1:10:56.426
requiring a written description of the invention plays a vital role in curtailing claims
1:10:56.458 --> 1:11:00.666
that did not require undue experimentation to make and use and thus satisfy enablement,
1:11:00.778 --> 1:11:04.714
but that have not been invented and thus cannot be described.
1:11:04.842 --> 1:11:08.546
Yet if a person of ordinary skill is enabled to make and
1:11:08.568 --> 1:11:12.418
use a novel and nonobvious invention clearly recited in
1:11:12.424 --> 1:11:15.714
the claims. I fail to see how that invention can be said to have not
1:11:15.752 --> 1:11:19.286
been invented or be in some need of some undefined level of
1:11:19.308 --> 1:11:22.886
additional description. It is inconsistent to say
1:11:22.908 --> 1:11:26.434
that on its filing date, the patent does not show that the inventor possessed
1:11:26.482 --> 1:11:30.342
subject matter that the claims actually encompass and the specification
1:11:30.406 --> 1:11:33.754
fully enables. And the other interesting piece
1:11:33.792 --> 1:11:37.194
of history, they learned that prior to 1836,
1:11:37.392 --> 1:11:41.226
your whole invention was just described in a written description. There was no claims.
1:11:41.338 --> 1:11:44.798
So the written description was the claims and
1:11:44.804 --> 1:11:48.718
then it was only after with the 1836 Patent Act
1:11:48.884 --> 1:11:52.494
that claims started being a part of how
1:11:52.532 --> 1:11:56.018
we draft patent applications. And so those claims served the
1:11:56.024 --> 1:11:59.218
purpose of distinguishing the invention while the
1:11:59.224 --> 1:12:02.338
specification as a whole must enable. So that was kind
1:12:02.344 --> 1:12:06.360
of the thought process around, I think, written description enablement is that
1:12:06.970 --> 1:12:10.854
before everything was in that written description, but now they kind of pulled it out
1:12:10.892 --> 1:12:14.370
to distinguish the invention versus enabling,
1:12:14.530 --> 1:12:18.018
what the claim said. But maybe I think those lines
1:12:18.034 --> 1:12:20.442
have blurred a lot. anyways, I don't know if we have time for these.
1:12:20.496 --> 1:12:24.214
I mean, we've kind of talked about these. Can we separate
1:12:24.262 --> 1:12:26.330
enablement from writ description?
1:12:30.110 --> 1:12:33.406
I don't think you can, but there's a lot of blogs out there that think
1:12:33.428 --> 1:12:36.766
you can and some judges clearly think you can. Chief Judge raja doesn't think
1:12:36.788 --> 1:12:40.414
you can. But I don't know, I think we all
1:12:40.452 --> 1:12:41.840
agree with you, actually.
1:12:43.330 --> 1:12:47.506
I don't know. So the more I read it, I get the intent of
1:12:47.528 --> 1:12:51.330
it. The whole possession versus making and using it.
1:12:51.480 --> 1:12:55.438
I mean, that's what examiners say too, right? Like if you have some weird
1:12:55.454 --> 1:12:59.266
things in your claims, they say they invent your possesses and
1:12:59.288 --> 1:13:03.270
stuff. I just don't know if you can really separate them.
1:13:03.340 --> 1:13:06.454
And that's actually what concerns me about the Supreme Court taking it up because
1:13:06.492 --> 1:13:09.978
they worry that they're just going to muddle it more than they're going
1:13:09.984 --> 1:13:13.526
to clarify because they are only looking at enablement and they're not looking at written
1:13:13.558 --> 1:13:14.410
description.
1:13:18.030 --> 1:13:21.726
Good question. They seem really similar. I mean, are there some
1:13:21.908 --> 1:13:25.454
subtle? Is it a genus species thing? I'm not
1:13:25.492 --> 1:13:29.386
sure. Yeah, right. Just sort of as a summary comment
1:13:29.418 --> 1:13:33.410
while you're looking for that, this amgen patent has a ton
1:13:33.480 --> 1:13:36.894
of examples in it. When you start looking into all the sequence
1:13:36.942 --> 1:13:41.154
ids, there's a ton of examples and they even line up
1:13:41.272 --> 1:13:44.906
various protein sequences to show similarities
1:13:45.038 --> 1:13:48.178
and there is a lot of guidance,
1:13:48.274 --> 1:13:53.014
right? So with
1:13:53.052 --> 1:13:56.630
the means plus function claim interpretation,
1:13:57.390 --> 1:14:05.558
including as we were talking about what's
1:14:05.574 --> 1:14:08.906
the word? Like it's equivalent. So you've given
1:14:08.928 --> 1:14:11.740
you a ton of examples, you've given some roadmap, now you get everything.
1:14:12.590 --> 1:14:16.058
Let's say it's a means plus function claim, you're only entitled to what you've
1:14:16.074 --> 1:14:19.514
described and the equivalence. Right? So if they've
1:14:19.562 --> 1:14:25.010
described it well and described some of these common
1:14:25.080 --> 1:14:28.900
features between their different examples, you would imagine that any
1:14:29.670 --> 1:14:33.902
other antibody that has those common features would be equivalent
1:14:34.046 --> 1:14:37.682
in some definition of it. So it gets really complicated
1:14:37.746 --> 1:14:42.658
and I think actually I totally see your perspective as what's
1:14:42.674 --> 1:14:46.150
the role of the patent system? We need to allow
1:14:46.220 --> 1:14:49.494
company, we need to foster innovation and
1:14:49.612 --> 1:14:52.826
allow companies to leverage their work and prevent other people from
1:14:52.848 --> 1:14:55.514
just copying them. And then, as kristin brought up,
1:14:55.712 --> 1:14:59.034
you can't have land grabs either because that
1:14:59.072 --> 1:15:02.846
doesn't foster innovation. No either. So it is a
1:15:02.868 --> 1:15:06.046
tough question that comes down to the specific facts of the case.
1:15:06.148 --> 1:15:11.086
Right. And hopefully the Supreme Court will
1:15:11.108 --> 1:15:14.590
drill into those facts and do the right analysis.
1:15:15.090 --> 1:15:17.920
Yeah, 100%.
1:15:19.910 --> 1:15:23.506
I think to Christmas point too, that it's probably going to be highly dependent on
1:15:23.528 --> 1:15:26.886
each art. But I
1:15:26.908 --> 1:15:30.434
think what does have to remembered by the courts and inventors alike
1:15:30.482 --> 1:15:33.874
is that the patent system isn't meant to make innovation
1:15:34.002 --> 1:15:37.590
and designing around easy, it's meant to
1:15:37.660 --> 1:15:40.922
provide you a path to do it right. And so
1:15:40.976 --> 1:15:44.506
some sciences just take a long time to do, even if
1:15:44.528 --> 1:15:48.566
you have a perfect roadmap and perfect protocols,
1:15:48.678 --> 1:15:51.600
some of it just takes a really long time to do,
1:15:52.370 --> 1:15:55.438
especially in the pharmaceutical antibody, whatever world.
1:15:55.604 --> 1:15:58.634
It's a long horizon no matter how much you're taught.
1:15:58.682 --> 1:16:02.746
Right, but that doesn't mean that it's undue experimentation
1:16:02.858 --> 1:16:05.578
and it'll be interesting to see if they take that up in the Supreme Court
1:16:05.594 --> 1:16:09.986
too, or whether Congress is at some point because that's not in
1:16:10.008 --> 1:16:12.626
the statute. Again, that's one of those things that have kind of been read into
1:16:12.648 --> 1:16:16.146
the statute that doesn't actually exist in the
1:16:16.168 --> 1:16:18.360
statute. It's kind of precedent. Right.
1:16:18.970 --> 1:16:22.326
So what's the role of that and how codified is
1:16:22.348 --> 1:16:25.926
that going to be? I was curious, and I
1:16:25.948 --> 1:16:29.638
don't really know the difference in mechanics as far as levels
1:16:29.654 --> 1:16:33.078
of courts, but who composes the jury?
1:16:33.174 --> 1:16:36.780
So is that people with ordinary skill in the art?
1:16:43.410 --> 1:16:47.534
I've seen a glimpse of it as it all went over my head, but if
1:16:47.572 --> 1:16:50.926
I was on that jury, I would have a pretty hard time.
1:16:51.108 --> 1:16:54.238
Right? You mean just not in a
1:16:54.244 --> 1:16:57.806
normal district court case? Who composes who's in the jury?
1:16:57.838 --> 1:17:01.934
Yeah, just like any average citizens.
1:17:01.982 --> 1:17:03.540
Right, normal people.
1:17:06.870 --> 1:17:10.566
Actually, I think the court system fails. The patent system is
1:17:10.588 --> 1:17:13.890
that even with the Supreme Court, I don't think it's any secret
1:17:13.970 --> 1:17:17.362
that a lot of the people who are in the different
1:17:17.436 --> 1:17:20.540
courts and even like this of the juries and stuff like that,
1:17:22.110 --> 1:17:25.562
they are not read into the level of detail
1:17:25.616 --> 1:17:29.020
they need to be, to one, understand the technology
1:17:29.890 --> 1:17:33.262
necessarily and then make decisions around
1:17:33.316 --> 1:17:37.166
that technology. Because I think a lot of judges in
1:17:37.188 --> 1:17:41.146
courts show their lack
1:17:41.178 --> 1:17:44.722
of understanding sometimes when you hear them, when they write
1:17:44.776 --> 1:17:49.266
these opinions and stuff like that. So does
1:17:49.288 --> 1:17:53.250
beg the question should the jury selection process be different for patent cases?
1:17:54.790 --> 1:17:58.310
Do you have some people that it's like normal late public. But then you do
1:17:58.380 --> 1:18:01.814
have a special bank of people that you
1:18:01.852 --> 1:18:04.978
pull from that somehow. It's a mixed
1:18:04.994 --> 1:18:08.534
bag. I don't know. Yeah, I agree. You mean actually, it does
1:18:08.572 --> 1:18:13.254
seem like a lack of technical understanding can lead to some poor
1:18:13.382 --> 1:18:16.650
decisions at some of these levels in some of these cases.
1:18:17.390 --> 1:18:21.130
I think what one would say would be that's the role of the experts
1:18:22.350 --> 1:18:26.702
to bring it down, but they're expert forward and their
1:18:26.756 --> 1:18:29.994
questions are asked of them and the jury
1:18:30.042 --> 1:18:33.838
and judges are interpreting what these experts said.
1:18:33.924 --> 1:18:34.880
But yeah,
1:18:37.250 --> 1:18:41.410
I'll just say I agree with actually that the lack of technical understanding
1:18:41.750 --> 1:18:46.706
of other parties involved does lead to some weird
1:18:46.818 --> 1:18:50.514
results sometimes. And you've been a part of some expert testimony
1:18:50.562 --> 1:18:54.454
kind of stuff, dave too, haven't you? Right. Have you been part
1:18:54.572 --> 1:18:58.534
of an actual is there an education
1:18:58.652 --> 1:19:01.570
piece for the jury? Does somebody sit up there and say,
1:19:01.660 --> 1:19:05.418
kind of like what I did here, but like, here's, here's antibodies, here's what
1:19:05.424 --> 1:19:09.050
they look like, here's what they do, here's what they mean to kind of bring
1:19:09.120 --> 1:19:13.370
people along? Or is it kind of like, here's the deep end, here's our expert?
1:19:14.590 --> 1:19:18.286
Right. I believe it's a little bit
1:19:18.388 --> 1:19:22.254
up to, I think, the prosecution and the defense for what
1:19:22.292 --> 1:19:25.918
they present. I think the instructions given to them. So I've
1:19:25.934 --> 1:19:29.922
been involved in arbitration cases, not nothing
1:19:29.976 --> 1:19:34.498
that ever went before a jury and a judge, so I
1:19:34.504 --> 1:19:38.694
don't have a direct experience with that. But I
1:19:38.732 --> 1:19:43.606
think that it's up to the
1:19:43.628 --> 1:19:47.574
prosecution of the defense and what they present, the evidence that they can be
1:19:47.692 --> 1:19:51.066
overall general education about how anybody's work. That could be
1:19:51.088 --> 1:19:54.474
something that they could present. I think you brought up that the
1:19:54.512 --> 1:19:58.010
instructions to the jury weren't quite right. I think what
1:19:58.080 --> 1:20:01.614
the jury does get instructions on from the
1:20:01.652 --> 1:20:03.760
court itself is the law.
1:20:05.090 --> 1:20:08.222
They're explained what the laws are,
1:20:08.276 --> 1:20:12.494
but they're not explained about the technology. I believe, outside of
1:20:12.532 --> 1:20:16.066
whatever the two sides choose to
1:20:16.088 --> 1:20:19.506
present. Interesting. I feel like there should be like you're selected for
1:20:19.528 --> 1:20:22.980
this jury. Now you're going to spend a few hours
1:20:23.670 --> 1:20:27.106
listening to some expert, just some random person you're right.
1:20:27.128 --> 1:20:30.754
That's not in bed with anybody or
1:20:30.792 --> 1:20:34.386
whatever, and you can have legal
1:20:34.418 --> 1:20:37.666
counsel in that room to make sure nothing is said that would sway
1:20:37.698 --> 1:20:41.046
anybody, but just give us a one to four hour
1:20:41.148 --> 1:20:44.018
deluge on this technology. Right.
1:20:44.124 --> 1:20:47.958
I feel like there could be benefit maybe from that. Now some litigators
1:20:47.974 --> 1:20:51.102
are going to comment on this podcast saying that we all don't know
1:20:51.156 --> 1:20:54.560
anything about litigation, we have no idea what we're talking about.
1:20:55.010 --> 1:20:58.160
Probably listen to these chumps over there.
1:21:02.850 --> 1:21:07.374
I was in a jury trial Friday, and I mean, it was extremely
1:21:07.422 --> 1:21:11.214
cut and dry, some of the most simple instructions that you could imagine,
1:21:11.262 --> 1:21:14.354
and it was a pretty hard time interpreting that.
1:21:14.392 --> 1:21:18.318
And so I'm thinking of this and I'm like, I just don't know how
1:21:18.344 --> 1:21:21.474
you get there. You need to read that district court, the district court
1:21:21.522 --> 1:21:23.030
case for this tie,
1:21:25.370 --> 1:21:29.014
I think you'd have to read it 16 times to get the full lay
1:21:29.052 --> 1:21:32.346
of it. The other quick
1:21:32.368 --> 1:21:36.154
thought I had. Again, nothing too crazy. But it's just would have been
1:21:36.192 --> 1:21:39.546
better to not include functional requirements, because it seems like a lot of
1:21:39.568 --> 1:21:42.054
the recent enablement issues identix, wyeth,
1:21:42.102 --> 1:21:46.094
enzo all fell because they had these functional requirements that
1:21:46.132 --> 1:21:49.610
seemed to create uncertainty, at least in the eyes of the court,
1:21:49.770 --> 1:21:53.310
for screening compounds that were covered by the claim. So I do wonder
1:21:53.380 --> 1:21:57.126
if I don't know how you would otherwise claim
1:21:57.178 --> 1:22:00.754
it, right? Because without it's even broader, but I don't know, it seems
1:22:00.792 --> 1:22:03.394
to be a red flag a little bit when you start putting that functional stuff
1:22:03.432 --> 1:22:07.298
in there. There's a quote in this case while functional
1:22:07.314 --> 1:22:10.678
claim limitations are not necessarily precluded in claims that
1:22:10.684 --> 1:22:14.630
meet the enablement requirement, such limitations pose high hurdles,
1:22:14.970 --> 1:22:18.774
filling the enablement requirement for claims with broad functional
1:22:18.822 --> 1:22:21.420
language. Right? Yeah,
1:22:22.750 --> 1:22:24.860
exactly. The judges agree.
1:22:27.390 --> 1:22:29.660
anyways, that was kind of it.
1:22:30.910 --> 1:22:34.698
Yes, this is from the Mpepi. This part was an unfinished
1:22:34.714 --> 1:22:38.638
part, but enablement serves the dual function of ensuring adequate disclosure of
1:22:38.644 --> 1:22:42.202
the claimed invention and that preventing claims broader
1:22:42.266 --> 1:22:45.614
than the disclosed invention. Broad claim language is
1:22:45.652 --> 1:22:49.154
used at the peril of losing any claim that cannot be enabled across
1:22:49.192 --> 1:22:51.890
its full scope. But again, that's the mpep.
1:22:52.790 --> 1:22:55.302
This could be a whole other thing we're not going to go into today.
1:22:55.356 --> 1:22:59.926
But the other part that's been bugging me lately about patent law is that
1:23:00.108 --> 1:23:03.622
there is court precedent that is binding based
1:23:03.676 --> 1:23:07.286
on laws and then there's the mpep. And some
1:23:07.468 --> 1:23:10.558
of the mpep is based on court
1:23:10.594 --> 1:23:13.786
precedent, but some of it is the world that
1:23:13.808 --> 1:23:17.242
the USPTO wants it to be and not as it is or how
1:23:17.296 --> 1:23:21.006
USPTO perceives it to be and not as it is. So if
1:23:21.028 --> 1:23:23.790
you strictly follow all the things of the mpep,
1:23:25.010 --> 1:23:29.690
your patent practice isn't going to be great because the mpp tries
1:23:29.770 --> 1:23:33.306
to mirror court precedent, but it still is an administrative
1:23:33.338 --> 1:23:37.154
body's interpretation of court precedent and a group of people that no court has
1:23:37.192 --> 1:23:40.946
signed off on. Right? And so there
1:23:40.968 --> 1:23:44.434
is good tidbits in the mpep that are directly tied to case law.
1:23:44.552 --> 1:23:47.774
There's other things that are said like this, which I don't know if this ties
1:23:47.822 --> 1:23:50.786
back to any court case or any precedent,
1:23:50.818 --> 1:23:54.246
you know what I mean? I don't know. anyways, that's my beef. There's like a
1:23:54.268 --> 1:23:58.118
paper that just came out by out member who but I want
1:23:58.124 --> 1:24:02.074
to read now. It's about that whole thing of like some stuff is
1:24:02.112 --> 1:24:05.674
actually based on precedent in the mpp. Some is just the
1:24:05.712 --> 1:24:09.242
uspto's interpretation or how they want the world to be,
1:24:09.376 --> 1:24:12.618
but not as it is. And if you follow that strictly, you're probably going
1:24:12.624 --> 1:24:16.686
to be in trouble. Anyway, I'll get my
1:24:16.708 --> 1:24:20.286
soapbox for today, but thanks for
1:24:20.308 --> 1:24:23.282
the good dialogue, everybody, and some really great points.
1:24:23.336 --> 1:24:27.730
I don't know if we solved the problem, but we definitely provided a good quagmire.
1:24:29.830 --> 1:24:31.700
Yeah. Thanks, Ashley. That was great.
1:24:33.990 --> 1:24:37.918
Thanks for participating and we'll
1:24:37.934 --> 1:24:41.458
see you next month. All right, that's all for today, folks. Thanks for listening,
1:24:41.474 --> 1:24:45.234
and remember to check us out@aurorapatants.com for more great podcasts,
1:24:45.282 --> 1:24:49.014
blogs and videos covering all things patent strategy. And if you're an agent
1:24:49.052 --> 1:24:51.878
or attorney and would like to be part of the discussion or an inventor with
1:24:51.884 --> 1:24:56.582
a topic you'd like to hear discussed, email us at podcast@aurorapatants.com.
1:24:56.716 --> 1:25:00.062
Do remember that this podcast does not constitute legal advice, and until
1:25:00.156 --> 1:25:01.740
time keep calm and patent on.