Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Partner

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

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On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in <a href="https://www.bing.com/ck/a?!&&p=5fe7fbcfa8dbe8bdJmltdHM9MTcyMzU5MzYwMCZpZ3VpZD0wOTdiNTBhYS0wMTY4LTY2MDYtMjJhYi00NGU3MDBkMjY3NmQmaW5zaWQ9NTE5Nw&ptn=3&ver=2&hsh=3&fclid=097b50aa-0168-6606-22ab-44e700d2676d&psq=Allergan+USA%2c+Inc.+v.+MSN+Laboratories+Private+Ltd.%2c+No.+24-1061+(Fed.+Cir.+2024)&u=a1aHR0cHM6Ly9jYWZjLnVzY291cnRzLmdvdi9vcGluaW9ucy1vcmRlcnMvMjQtMTA2MS5PUElOSU9OLjgtMTMtMjAyNF8yMzY2MDc0LnBkZg&ntb=1">Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024)</a> clarifying the scope of obviousness-type double patenting (ODP) in the aftermath of its In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023) decision last year.In a potentially significant win for patentees, the Federal Circuit in Allergan held that “a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.” This represented a reversal of the district court’s determination that claim 40 of the ’356 patent at issue was invalid under the doctrine of ODP over claim 33 of the ’011 patent and claim 5 of the ’709 patent. The relationship among these patents is depicted in the following figure from the decision. The first filed ’356 patent has a longer patent term due to grant of patent term adjustment (PTA) due to delays caused by the U.S. Patent and Trademark Office (USPTO) during prosecution.  <div data-reactroot=""><img class="rich-text-embed-image" alt="Expiration graphic" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltc446430cde1004b1/66be59411257f55a24b40b44/expiration-without-pta.jpg?format=auto&amp;quality=60"/></div>The district court considered the “first-filed, first-issued” distinction of the ’356 patent at issue to be “immaterial” and, instead, focused only on the patent expiration dates for its ODP analysis based on its reading of In re Cellect, which held that “ODP for a patent that has received PTA, regardless [of] whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.”The Federal Circuit, however, noted that the district court’s reading of In re Cellect was incorrect since the holding of In re Cellect “answered a different question than that at issue here.” The Federal Circuit explained that “[In re] Cellect does not address, let alone resolve, any variation of the question presented here—namely, under what circumstances can a claim properly serve as an ODP reference—and therefore has little to say on the precise issue before us.” Rather, the Federal Circuit noted that its holding in In re Cellect “is only controlling in this case to the extent that it requires us to consider, in our ODP analysis, the ’356 patent’s June 24, 2026 expiration date (i.e., the expiration date after the addition of PTA), not the March 24, 2025 expiration date that it would have shared with the ’011 and ’709 reference patents in the absence of a PTA award.” The Federal Circuit further explained that its holding “is the only conclusion consistent with the purpose of the ODP doctrine, which is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.”The Federal Circuit clarified that “the fact that the ’356 patent expires later is of no consequence here because it is not a ‘second, later expiring patent for the same invention” and that “[a]s the first-filed, first-issued patent in its family, [the ’356 patent] is the patent that sets the maximum period of exclusivity for the claimed subject matter and any patentably indistinct variants.”This decision clarifies the scope of the doctrine of ODP following last year’s In re Cellect decision by establishing that the filing and issuance dates of a patent are relevant to an ODP analysis. This decision also clarifies that applicants are entitled to PTA caused by delays of the USPTO during prosecution of a first-filed patent application, no matter when the first patent issues or how long the PTA extends the life of the patent. This decision is important because, as recognized by the Federal Circuit, a first-filed application often requires “greater time and effort by the applicant and examiner alike” and, thus, is often awarded PTA; whereas, a later-filed continuing application “proceeds much more efficiently through prosecution” and, thus, is more likely to receive little or no award of PTA. Accordingly, this decision removes the risk of invalidation by ODP over a later-filed, later-issued, earlier-expiring reference claim having a common priority date.

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Associate

Dr. Jeff Schmidt is a member of the firm’s Patent Group. His practice focuses on patent prosecution in the areas of life sciences, biotechnology, and pharmaceuticals, which includes the preparation an

Jeffrey W. Schmidt Ph.D.

Jeffrey Schmidt

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

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Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories

The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v. University of Massachusetts, PGR2023-00014.) The PTAB found UMass’s claims directed to methods of treating vitiligo with a functionally defined genus of compounds failed to meet enablement and written description requirements. Enablement of genus claims was addressed by the Supreme Court in last year’s Amgen case. (See Amgen v. Sanofi, 598 U.S. 594). Importantly, this PTAB decision demonstrates that method claims are not insulated from the Amgen ruling, stating that “the specification must provide some guidance regarding structure for a recited element of the claim.”Forte Biosciences, Inc. (“Forte”) challenged the patentability of claims 1–5 on enablement, written description, and obviousness grounds.Claim 1 is illustrative of the challenged claims and is shown below.<ol><li>A method of treating a subject who has a vitiligo lesion, the method comprising: identifying a subject in need of treatment; and administering a therapeutically effective amount of an inhibitor of IL-15 or the IL-15 receptor to the subject.</li></ol>The PTAB found the challenged claims unpatentable for lack of enablement and written description under 35 U.S.C. § 112(a). The PTAB did not reach the obviousness challenge.The PTAB’s Post-Amgen Enablement AnalysisIn deciding whether the challenged claims are enabled under 35 U.S.C. § 112(a), the PTAB applied the Amgen court’s analysis regarding genus claims encompassing entire classes of functionally defined compounds and considered the Wands factors to determine whether undue experimentation is required to make and use the claimed invention. Amgen v. Sanofi, 598 U.S. 594.The Amgen court held that, “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Amgen, at 610. Essentially, “[t]he more one claims, the more one must enable.” Id. This concept of quid pro quo is at the heart of the U.S. patent system.The PTAB determined that the inhibitors claimed in the UMass’s patent are even broader than the genus of antibodies at issue in Amgen, as neither the specification nor the claims of the UMass’s patent provide any structural requirement for the claimed inhibitors. Forte Biosciences, at 30. For instance, claim 2 of the UMass’s patent states that inhibitors can be small molecules, antibodies, peptides, or nucleic acids, none of which share any common structural features. Id. at 30–31. Due to the complicated and unpredictable nature of IL-15/IL-15R inhibition, the PTAB rejected UMass’s argument that IL-15/IL-15R inhibitors and their mechanisms were well known in the art and held that a skilled person would have to engage in extensive experimentation to identify and test each compound covered by the claim scope to determine whether the compound works.Furthermore, the PTAB also rejected UMass’s argument that the challenged claims are directed towards methods of treatment for vitiligo instead of the inhibitors for IL-15 or IL-15R themselves, thereby avoiding the “how to make” requirement for the inhibitors. The PTAB held that, if a challenged claim recites a functionally defined genus of compounds, as is the case with UMass’s method of treatment claims, “the specification must provide some guidance regarding structure for a recited element of the claim[.]” Id. at 37. This is to prevent a skilled person from having to engage in extensive trial and error to determine which compound falls within the claim scope. Id. Consequently, the PTAB found the challenged claims were unpatentable due to lack of enablement.The PTAB’s Written Description Analysis of Genus ClaimsThe PTAB agreed with Forte’s characterization that the challenged claims were directed broadly to methods of treating vitiligo by administering an inhibitor of IL-15 or IL-15R in a therapeutically effective amount, while UMass’s patent only disclosed a single working example, i.e., ChMBC7, which is an antibody inhibitor targeting a mouse protein, IL-2R β/IL-15R β.Furthermore, the PTAB rejected UMass’s argument that, because the challenged claims are method claims and not composition of matter claims, the written description inquiry should only consider whether the patentee possessed the claimed methods of administering a therapeutically effective amount of an inhibitor to treat vitiligo, rather than whether the patentee possessed the entire genus of the claimed inhibitors. Forte Biosciences, at 16–17. The PTAB emphasized that, regardless of whether a claim is for a compound itself or a method involving the compound, the patentee must provide a description detailed enough to differentiate infringing compounds or methods from non-infringing ones. Id. at 16. Thus, the PTAB found UMass’s contention unpersuasive.Additionally, the PTAB agreed with Forte that UMass’s patent lacked descriptive support for the challenged claims because the evidence showed: (1) that not all IL-15 or IL-15R inhibitors are therapeutically effective; (2) that the specification does not disclose structural features of the IL-15 or IL-15R inhibitors necessary or sufficient to perform the claimed methods; (3) a lack of information to allow a skilled artisan to understand or determine whether an inhibitor actually meets the functional requirement in the challenged claims; and (4) unpredictability across the breadth of the claimed genera (e.g., small molecules, peptides, antibodies, or nucleic acids).In sum, the PTAB found that the challenged claims are directed to methods using a wide range of different types of compounds that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not always function as inhibitors. Hence, the PTAB held that UMass’s patent did not disclose a representative number of species or a sufficient correlation between structure and function to demonstrate possession of the claimed methods of treatment using a functionally defined genus of compounds.TakeawaysThis recent PTAB decision underscores the importance of enablement and written description considerations for functionally defined genera recited in method claims under Amgen. The broad nature of claims containing functionally defined genera inherently increases the difficulty of meeting the enablement requirement across the full scope of the claims. Similarly, the written description requirement mandates that claims must be supported by what is described in the specification. Therefore, practitioners may strategically consider the inclusion of functional limitations in method claims and contemplate multiple backup positions with varied claim scope in view of the enablement and written description requirements.

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Of Counsel

Mark D. McBriar focuses his practice on patent drafting and prosecution, IP due diligence, freedom to operate, patentability evaluations, re-examinations, and litigation support. Dr. McBriar works wit

Mark D. McBriar Ph.D.

Mark McBriar

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The PTAB Axes Skin Treatment Patent Under Amgen

Article III standing can differ from the statutory requirements of 35 U.S.C. § 281 in patent cases. In certain instances, a secured creditor can obtain rights that become actionable only upon default, which may include the ability to license or enforce a patent. However, these rights may not necessarily correspond to patent ownership. Because Article III standing must exist when a case is filed, parties planning to file a complaint should consider the issue carefully beforehand. The precedential decision of Intellectual Tech LLC v. Zebra Techs. Corp.<a href="#fn1" target="_self">[1]</a> illustrates this scenario.OnAsset granted a security interest in U.S. Patent No. 7,233,247 to Main Street Capital Corporation (“Main Street”) as part of a loan agreement.<a href="#fn2" target="_self">[2]</a> Several years later, OnAsset formed Intellectual Tech LLC (“IT”) as its subsidiary and assigned the same patent to IT,<a href="#fn3" target="_self">[3]</a> which then granted a security interest in the patent to Main Street.<a href="#fn4" target="_self">[4]</a> Subsequently, OnAsset and IT each defaulted on their respective agreements,<a href="#fn5" target="_self">[5]</a>which afforded Main Street the option to sell, assign, transfer, and/or enforce the patent.<a href="#fn6" target="_self">[6]</a> IT later sued Zebra Technologies (“Zebra”) for infringing the patent.<a href="#fn7" target="_self">[7] </a>The district court granted Zebra’s motion to dismiss for lack of Article III standing, determining that Main Street’s right to license deprived IT of all its exclusionary rights, even if those rights were not exercised.<a href="#fn8" target="_self">[8]</a>On appeal, the Federal Circuit emphasized that Article III standing is a jurisdictional requirement not curable by joinder and, in contrast,<a href="#fn9" target="_self">[9] </a>whether a party qualifies as a “patentee”<a href="#fn10" target="_self">[10]</a> under 35 U.S.C. § 281 is not a jurisdictional requirement<a href="#fn11" target="_self">[11] </a>and is curable by joinder.<a href="#fn12" target="_self">[12]</a> In reversing the lower court’s ruling, the Federal Circuit found that (1) the triggering of Main Street’s unexercised option to assign did not automatically deprive patent owner IT of all its rights,<a href="#fn13" target="_self">[13] </a>and (2) the shared ability to license while a default existed did not divest IT of all exclusionary rights, noting that IT still suffers an injury-in-fact from infringement even if Main Street and IT can both license the patent.<a href="#fn14" target="_self">[14]</a> The Federal Circuit concluded that, because Main Street did not exercise any options under the agreements, IT was not presently divested of all exclusionary rights.<a href="#fn15" target="_self">[15]</a>For further information, read our <a href="https://www.mofo.com/resources/insights/240626-federal-circuit-wades-into-article-iii" target="_self">more detailed client alert</a>.***** <a href="#fnref-1" target="_self">[1] </a>Intellectual Tech LLC v. Zebra Techs. Corp., No. 2022-2207 (Fed. Cir. May 1, 2024).<a href="#fnref-2" target="_self">[2]</a> See Intellectual Tech LLC, 2022-2207, slip op. at 3.<a href="#fnref-3" target="_self">[3]</a> See id.<a href="#fnref-4" target="_self">[4]</a> See id.<a href="#fnref-5" target="_self">[5]</a> See Intellectual Tech LLC, 2022 WL 1608014, at *3–4.<a href="#fnref-6" target="_self">[6]</a> See id., at *3. See also Sections 3(j), 6(b), and 6(c) of the Agreements.<a href="#fnref-7" target="_self">[7] </a>See Intellectual Tech LLC, 2022 WL 1608014, at *1.<a href="#fnref-8" target="_self">[8] </a>See id., at *7.<a href="#fnref-9" target="_self">[9] </a>See Intellectual Tech LLC, 2022-2207, slip op. at 9.<a href="#fnref-10" target="_self">[10]</a> See id. See also 35 U.S.C. § 100(d).<a href="#fnref-11" target="_self">[11]</a> See Intellectual Tech LLC, 2022-2207, slip op. at 10.<a href="#fnref-12" target="_self">[12]</a> See id., at slip op. at 11.<a href="#fnref-13" target="_self">[13]</a> See id., at slip op. at 11–12.<a href="#fnref-14" target="_self">[14]</a> See id., slip op. at 14.<a href="#fnref-15" target="_self">[15]</a> See id., slip op. at 16.

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Federal Circuit Wades Into Article III Standing in Patent Cases Once Again

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Article III standing can differ from the statutory requirements of 35 U.S.C. § 281 in patent cases. In certain instances, a secured creditor can obtain rights that become actionable only upon default, which may include the ability to license or enforce a patent.

Federal Circuit Wades Into Article III Standing in Patent Cases Once Again

On May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies.Specifically, the USPTO proposes amending the patent rules “to require that a terminal disclaimer filed to obviate nonstatutory double patenting include an agreement by the disclaimant that the patent in which the terminal disclaimer is filed, or any patent granted on an application in which the terminal disclaimer is filed, will be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting in which: (1) any claim has been finally held unpatentable or invalid under 35 U.S.C. 102 or 103 in a Federal court in a civil action or at the USPTO, and all appeal rights have been exhausted; or (2) a statutory disclaimer of a claim is filed after any challenge based on 35 U.S.C. 102 or 103 to that claim has been made.”The USPTO explains that this new requirement “solves the current problem of requiring a competitor to invalidate multiple patents tied by terminal disclaimers in order to have freedom to operate” and, thus, “has the likely advantages of reducing litigation and administrative proceeding costs and increasing predictability….”Although the proposed rule characterizes this as a “voluntary agreement” regarding enforceability of the patent, there is little that is voluntary about this proposed requirement. In essence, the proposed rule change would impose the requirement that in order to obviate a nonstatutory double patenting rejection, the disclaimant would need to agree that its patent would only be enforceable if it is not tied (and has never been tied) to any patent having a claim that was invalidated under 35 U.S.C. § 102 or § 103 for anticipation or obviousness, respectively. This means if a challenger is successful in invalidating “any” claim in a challenged patent under § 102 or § 103, then any other patents “tied” to that challenged patent by one or more terminal disclaimers would be unenforceable. Notably, the validity of the other patents would not be affected, as only their enforceability is affected by the voluntary agreement included in the terminal disclaimers. However, what is the point of obtaining a valid patent that you cannot enforce?This reflects a major change in current practice as it exists today where invalidation of one patent by a challenger does not affect the patent holder’s ability to enforce its other patents against the same (or a different) challenger, even if they are tied together by terminal disclaimers.Among the many concerns with this proposed rule is that once a terminal disclaimer is filed in an application it cannot be withdrawn after the patent is issued. The finality of such an action coupled with the effect of this proposed rule would result in applicants being forced into a “voluntary agreement” that may restrict their ability to enforce their own patents many years down the road.The USPTO will be accepting comments over the next 60 days relating to this proposed rule change.These proposed rule changes also coincide with the USPTO’s proposed changes in its fees, which include increasing the cost of filing a terminal disclaimer. Currently, the USPTO charges $170 to file a terminal disclaimer regardless of when it is filed. Under the proposed fee changes, this fee would be increased to $200 if the terminal disclaimer is filed prior to the first action on the merits, and would be further increased to $500 to $1,400 if filed after the first action, depending on the stage of prosecution. The judicially created doctrine of obviousness-type double patenting was created in an effort to prevent the unjustified extension of patent term, with the “solution” to this concern being the terminal disclaimer. The USPTO’s recently proposed fee changes that tie significantly increased filing fees for terminal disclaimers to the particular timing of their submission—coupled with today’s proposed rulemaking that would render patents tied together by terminal disclaimers unenforceable—is incongruous with the purpose behind this judicially created doctrine.

On May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies.

USPTO Considers Changing Terminal Disclaimer Practice to Require Agreement Regarding Enforceability

MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now <a href="https://soundcloud.com/user-496742723/03-27-lifescience-podcast01-v1" target="_blank">available</a>. The podcast features interviews with legal experts who share insights and advice you just might need when your life sciences are on the line.The special guest for Episode 1 was Jim Krenn, a MoFo partner whose practice is focused on major corporate transactions for emerging and established companies in the life sciences. Jim, Nate, and Kate discuss strategies to maximize and protect the value of trade secrets, how investing in compliance early pays dividends as companies mature, and where companies may face government scrutiny on the journey from startup to public company.Trade secrets play a central role in raising capital, selling a company, and going public, and the rise of cyber breaches and sophisticated intellectual property theft has pushed investors to look closely at how trade secrets are safeguarded. Jim maps out strategies for maximizing the value of trade secrets at key stages and discusses with Nate and Kate how to protect a critical asset for many life sciences companies.Early-stage companies often focus on development and growth, but an appropriate compliance function is important to control present and future downside risk. Jim explains the decision dynamics at play, and Kate discusses how increased scrutiny on life sciences companies makes good compliance a winning value proposition.Outside scrutiny on company systems peaks when the time comes to take a company public or consider a merger or acquisition. Interested parties pore over compliance functions at this stage, particularly in the highly regulated life sciences industry. Nate and Kate discuss corresponding risks for company insiders.

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Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

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Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. 

Nathaniel Mendell

Nathaniel R. Mendell

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Co-Chair of Emerging Companies + Venture Capital Practice

Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.

Jim Krenn

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MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now available. 

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

In October 2023, the <a href="https://www.upov.int/portal/index.html.en" target="_blank">International Union for the Protection of New Varieties of Plants (UPOV)</a> published a long-awaited <a href="https://www.upov.int/edocs/expndocs/en/upov_exn_edv.pdf" target="_blank">updated Explanatory Note on Essentially Derived Varieties (EDVs)</a>. The UPOV Convention outlines a popular sui generis form of IP protection for plant varieties and was first established in 1961; EDVs have been a provision of the UPOV Convention since 1991. However, the bounds of what can constitute an EDV have often been difficult to devise in practice, and stakeholders have long been requesting clarification from UPOV, particularly in light of modern breeding techniques that may incorporate, for example, gene editing. This new guidance represents UPOV’s response to these concerns.What Are EDVs?The legal concept of an “essentially derived” variety serves to effectively extend the reach of a Plant Variety Right (PVR; often also used synonymously with Plant Breeders’ Rights, or PBRs) issued under a PVR scheme that is based on the 1991 UPOV Convention. Thus, in order to understand the concept of EDVs, it is first necessary to understand what a PVR is.PVR certificates are a form of IP protection that are separate from patents and are designed specifically for new plant varieties. PVRs protect against unauthorized commercial activity or use of a protected variety, with <a href="https://www.upov.int/databases/en/#QS13" target="_blank">over 150,000 total active titles worldwide as of 2022</a>. The most common legal framework for PVR protection is outlined in the <a href="https://upovlex.upov.int/en/convention" target="_blank">UPOV Convention</a>. Each UPOV <a href="https://www.upov.int/members/en/" target="_blank">Member jurisdiction</a> ultimately provides and implements its own PVR laws and regulations that are consistent with the UPOV Convention to which they are signatory, but UPOV’s “Explanatory Notes” (which provide non-binding guidance for understanding and implementing various terms or provisions of the UPOV Convention) can influence how a Member implements and interprets its PVR laws.There are two current versions of the UPOV Convention, 1978 and 1991, which have some differences in PVR requirements and the scope of protection. One key difference is that the 1991 UPOV Convention introduces the concept of EDVs and provides coverage to the certificate owner of a protected variety over varieties essentially derived from the protected variety (i.e., EDVs).The core definition of an essentially derived variety (EDV) comes from Article 14(5)(b) of the 1991 Act of the UPOV Convention (emphases added):A variety shall be deemed to be essentially derived from another variety (“the initial variety”) when:(i) it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety(ii) it is clearly distinguishable from the initial variety and(iii) except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety.By way of example, the <a href="https://www.ams.usda.gov/services/plant-variety-protection" target="_blank">U.S. Plant Variety Protection</a> law (which is administered by the U.S. Department of Agriculture and is in line with the 1991 UPOV Convention) provides a non-exhaustive list of how EDVs can be made, including by: 1) the selection of a natural or induced mutant or of a somaclonal variant, 2) the selection of a variant individual from plants of the initial variety, 3) backcrossing, 4) transformation by genetic engineering, and 5) other methods. (7 USC 57 §2401 (a)(4)(A)).The third and most recent EDV Explanatory Note was published on October 27, 2023, and was prepared to address the fact that the previous EDV Explanatory Note, which was published in April 2017, no longer reflected breeders’ common practices in understanding EDVs and was insufficient to address the development of new breeding technologies (e.g., gene editing). The updated guidelines provide additional guidance for two key terms used in the definition of an EDV: “predominantly derived” and “essential characteristics.” Each of these is outlined below.Predominantly DerivedThe Explanatory Note explains that “predominant” derivation means that more of the genome of the initial variety is retained than would be retained by normal crossing and selection with different parents. This definition reinforces that a variety should only be considered predominantly derived from the initial variety if it retains almost the whole genome of its initial variety. Varieties with a single parent (“mono-parental” varieties) are considered per se predominantly derived from their initial varieties. Mono-parental varieties include varieties that are the result of mutations, gene editing, and the like. The Explanatory Note also states that there is no upper limit on the number of characteristic differences between an initial variety and a variety predominantly derived from the initial variety. Thus, predominant derivation is primarily defined by the genetic similarity between the derived and initial varieties rather than changes in characteristics.Essential CharacteristicsRegarding “essential characteristics,” the Explanatory Note reinforces that these are characteristics that contribute to the “principal features, performance, or value” of a variety. Examples of essential characteristics include morphological, physiological, agronomic, industrial, biochemical, and commercial attributes of a variety. In addition, the Explanatory Note states that a “predominantly derived” variety can still be an EDV of an initial variety even if it doesn’t completely share the essential characteristics of the initial variety, as long as the missing essential characteristics are missing as a result of the act of derivation. The Explanatory Note also allows for essential characteristics to evolve over time.Concluding ThoughtsThis third EDV Explanatory Note appears to elevate the importance of genetic similarity between an EDV and the initial variety and opens the possibility that essential characteristics may not always be 100% shared between an EDV and the initial variety. This new guidance therefore may provide more latitude for creative “essential characteristics” arguments, but, on the other hand, may also narrow the options for “predominantly derived” arguments. On a practical level, these guidelines will most likely impact both traditional breeders of multi-parental varieties and gene editors who make targeted genetic changes in an initial protected variety to produce a new variety. This Note appears to increase the avenues for such edited varieties to be considered EDVs of their initial varieties, which means that, while a developer producing such an edited plant could still seek their own PVR protection for their edited (i.e., derived) variety (assuming it meets all the requirements for protection, e.g., distinctness, uniformity, and stability), depending on how the updated guidance reads on the technical changes in the derived variety, the developer of the derived variety may still face freedom-to-operate concerns regarding the PVR holder of the initial variety. That being said, and as noted above, UPOV Notes are non-binding guidance; it remains to be seen how various jurisdictions with EDV provisions on the books (e.g., the U.S. and many others) will react and how such issues may play out in infringement disputes.Overall, these updates should make the concept of EDVs more straightforward to apply to varieties produced by new breeding technologies. For more updates on plant variety rights, see our other recent <a href="https://www.mofo.com/resources/insights/240131-us-plant-variety-protection-office">post on PBRs in the U.S., Canada, and Japan</a>, and subscribe to our blog.