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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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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Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product.[1] The Leahy-Smith America Invents Act provides exceptions for certain disclosures that would otherwise be considered prior art under 35 U.S.C. § 102.[2] Specifically, 35 U.S.C. § 102(a)(1) provides, in part, that a person is not entitled to a patent if the claimed invention was in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. One such exception is the pre-filing grace period (safe harbor) provision of 35 U.S.C. § 102(b)(2)(B), which provides that disclosure in a patent or patent application shall not be prior art if the disclosed subject matter was, prior to the effective filing date of the patent or application, publicly disclosed by the inventor or a third party who derived the disclosure from the inventor. The Federal Circuit held that a private sale does not satisfy this requirement and could not be relied on to disqualify prior art, demonstrating the narrowness of this pre-filing grace period provision.PTABKaijet Technology International Limited, Inc. filed a petition for inter partes review of U.S. Patent No. 10,572,429 (“the ’429 patent”), challenging claims of the ’429 patent as obvious over various combinations of prior art, including U.S. Patent Application Publication No. 2018/0165053 (“Kuo”).[3] Both the ’429 patent and Kuo concern ports and docking stations for connecting an end-user device (e.g., a laptop) to a peripheral device (e.g., a printer). Sanho argued that a private sale of a product embodying the claimed invention from the inventor to Sanho constituted a public disclosure prior to Kuo’s effective filing date, thus disqualifying Kuo as prior art under section 102(b)(2)(B).[4] After Sanho received a prototype of the product from the inventor’s company, Sanho placed an order for the product.[5] The PTAB held that the sale did not amount to a public disclosure because there was no showing that the sale was publicized in any way or that the order was fulfilled. As a result, Kuo was eligible as prior art, and the PTAB determined that the challenged claims were unpatentable.[6]Federal CircuitOn appeal, the sole issue was whether a non-confidential but otherwise private sale resulted in the subject matter of an invention being “publicly disclosed” for purposes of section 102(b)(2)(B).[7]Sanho contended that the plain meaning of the phrase “publicly disclosed” in section 102(b)(2)(B) should be construed to include all disclosures described in section 102(a)(1), including situations in which the invention was “on sale.”[8] However, the Federal Circuit disagreed, clarifying that Helsinn referred to a situation where a private commercial sale constituted a disclosure under section 102(a)(1), and the “on sale” bar in section 102(a)(1) serves a different purpose than the “publicly disclosed” requirement in section 102(b)(2)(B).[9]Sanho also argued that prior legislative treatment concluded that a “public use” was synonymous with a “public disclosure” as long as the recipient of a product incorporating the invention is not subject to any secrecy obligations. However, the Federal Circuit again disagreed, emphasizing the fundamentally different purposes of sections 102(a) and 102(b) with the respective phrases “public use” and “publicly disclosed.”[10]Sanho further contended that the meaning of the phrase “publicly disclosed” in section 102(b)(2)(B) was identical to the meaning of the terms “disclosed” and “disclosure” used elsewhere in section 102.[11] Again, the Federal Circuit disagreed and emphasized that the congressional intent of using two different phrases—“disclosed” and “publicly disclosed”—suggests that the phrases have different meanings.[12] Moreover, the Federal Circuit noted that Sanho’s isolation of the phrase “publicly disclosed” violated “the cardinal rule that a statute is to be read as a whole.”[13]In concluding that the PTAB unequivocally did not err in finding Kuo to qualify as prior art, the Federal Circuit explained that the private sale did not “publicly disclose” the subject matter of the invention because (1) the sale was between two parties made via the private messaging service WeChat, (2) there was no teaching that the features of the invention were disclosed to others beyond Sanho, and (3) there was no testimony regarding whether the order was fulfilled or if the products were ever manufactured.[14]TakeawaysPrivate but non-confidential sales of a product allegedly embodying an invention do not necessarily amount to a public disclosure to constitute an exception under section 102(b)(2)(B). Interestingly, several key questions were not at issue on appeal and thus were not considered by the court: (1) whether the inventor’s disclosure needs to be fully enabling to qualify for this exception, (2) what evidence is sufficient to demonstrate that a sale publicly disclosed the invention’s relevant subject matter under this provision, and (3) whether to apply the prevailing standard for when a printed publication is sufficiently publicly accessible to qualify as prior art. We expect additional case law to address these questions.<hr class="divider">[1] See Sanho Corp. v. Kaijet Technology International Limited, Inc., No. 2023-1336 (Fed. Cir. July 31, 2024) (“Fed. Cir. Decision”). [2] Specifically, 35 U.S.C. § 102 precludes patentability of a claimed invention that has been “available to the public” (e.g., patented, described in a printed publication, in public use, or on sale) before the effective filing date of the claimed invention. [3] See Kaijet Technology International Limited, Inc. v. Sanho Corporation, IPR2021-00886, at *1 and *5–6 (P.T.A.B. Oct. 25, 2022). [4] See id. [5] See id. at *3–4. [6] See id. at *4.[7] See Fed. Cir. Decision at *2.[8] See id. at *8, relying on Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. 123 (2019). [9] See id. at *12.[10] See id. See also Egbert v. Lippmann, 104 U.S. 333 (1881) (where the court did not hold that a public use must necessarily amount to a public disclosure). [11] See id. at *5. [12] See id. at *8–9. [13] See id. at *10 (quoting King v. St. Vincent’s Hosp., 502 U.S. 215, 221 (1991)).[14] See id. at *14–15.

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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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Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product.  The Leahy-Smith America Invents Act provides exceptions for certain disclosures that would otherwise be considered prior art under 35 U.S.C. § 102

Under lock and key – Private sales may not qualify as public disclosure

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

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.

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

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

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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240430-when-your-life-sciences-are-on-the-line

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

On March 18, 2024, the USPTO issued a <a href="https://www.uspto.gov/sites/default/files/documents/112f-memo.pdf" target="_blank">memorandum </a>to its Examiners reminding them of the resources and proper analysis for interpreting limitations under 35 U.S.C. § 112(f), which are commonly referred to as “means-plus-function” or “step-plus-function” limitations.  These types of claim formats provide an option to claim an element as a means or step for performing a specified function without reciting any structure, material, or acts. Although § 112(f) limitations have traditionally been less common in life sciences technologies as compared to, for example, electronics and devices, they are sometimes used as a drafting strategy to capture claim scope of interest.The USPTO memorandum does not include any substantive change for how Examiners are to conduct examination of claims involving such limitations, but rather “reinforces the importance” of properly interpreting these limitations.35 U.S.C. § 112(f) provides the following:ELEMENT IN CLAIM FOR A COMBINATION.—An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.According to the memorandum, a limitation that is found to invoke § 112(f) “must be limited to the structure, material, or acts described in the specification as performing the entire claimed function and equivalents to the disclosed structure, materials, or acts.” Since a § 112(f) limitation must be limited to what is described in the specification, the memorandum notes that “an important consideration when searching for and applying prior art” is that, in some cases, § 112(f) limitations will be afforded “a narrower interpretation than a limitation that is not crafted in means-plus-function or step-plus-function format.” The memorandum reiterates the three-prong analysis for determining whether a claim limitation invokes § 112(f).  Specifically, an Examiner should invoke § 112(f) if:            (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;            (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and            (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.The memorandum explains that there is a presumption that § 112(f) is invoked when the claim limitation “explicitly uses the term ‘means’ or ‘step’” and includes functional language, but that this presumption can be overcome if “the claim further includes the structure, material, or acts for performing the function,” thereby resulting in § 112(f) not being invoked.The memorandum also explains that there is a presumption that § 112(f) is not invoked when the claim limitation “does not use the term ‘means’ or ‘step,’” but that this presumption can be overcome if “the limitation recites functional language along with a generic placeholder term instead of ‘means’ and fails to recite sufficiently definite structure for performing the function,” thereby resulting in § 112(f) being invoked.  The memorandum emphasizes that there is flexibility in the generic placeholder terms that can be used instead of “means” and that there are “no absolutes or approved lists” of such terms.The memorandum reiterates the “critical” importance of the Examiner establishing its interpretation of § 112(f) limitations in the record. Finally, once an Examiner has determined that § 112(f) is invoked, “the adequacy of the supporting disclosure must be evaluated under § 112(a) and (b) to determine whether the boundaries of the claim scope are clearly defined, an adequate written description has been provided, and the claim is fully enabled.”  The memorandum explains that if 112(f) is intended to be relied on, the specification should disclose a corresponding structure; not doing so could result in a “lack adequate written description and may not be sufficiently enabled to support the full scope of the claim under § 112(a).” Likewise, for computer-implemented § 112(f) limitations, “the specification must disclose an algorithm for performing the claimed specific computer function, or the claim should be found indefinite.”  Such algorithms can be expressed “in any understandable terms including as a mathematical formula, in prose, in a flow chart, or in any other manner that provides sufficient structure.”Although means-plus-function limitations can be a helpful tool for describing an invention, potential issues may arise if such a limitation is not found to be adequately described in the specification or is described in a way that results in an undesirably narrow interpretation of the limitation.  Applicants should be aware of these possibilities and consider them when drafting a limitation in a means-plus-function or step-plus-function format.  Alternatively, drafting the limitation to avoid invoking § 112(f) may be desirable in some situations, including if there is a concern that the Examiner may narrow interpretation of the limitation to an undesirable scope.  For instance, although a narrow interpretation of the limitation may be beneficial for establishing novelty and non-obviousness, it may make it easier for a competitor to design around the limitation based on its narrow interpretation.The issue of § 112(f) limitations in the context of antibodies is currently at issue in In re Xencor.  The claims at issue in In re Xencor were found to invoke § 112(f) based on claim language reciting “means” with respect to a function performed by the antibody (“for binding human C5 protein”).  The case has been recently remanded back to the USPTO after appeal at the Court of Appeals for the Federal Circuit so that the USPTO can convene their Appeals Review Panel to “clarify the USPTO’s position on the proper analysis of Jepson-format and means-plus-function claims in the field of biotechnology, and particularly in the antibody art” and to issue “a revised decision.”  See In re Xencor, 23-2048 (Fed. Cir. January 23, 2024) (remand order).  In view of the newly issued memorandum, it will be interesting to see how the USPTO implements “means‑plus-function” in the life sciences, and particularly in the antibody technology area.

On March 18, 2024, the USPTO issued a memorandum to its Examiners reminding them of the resources and proper analysis for interpreting limitations under 35 U.S.C. § 112(f), which are commonly referred to as “means-plus-function” or “step-plus-function” limitations.

USPTO Issues Reminder to Examiners on Proper “Means-Plus-Function” Analysis

On January 10, 2024, the USPTO released new <a href="https://www.federalregister.gov/documents/2024/01/10/2024-00259/guidelines-for-assessing-enablement-in-utility-applications-and-patents-in-view-of-the-supreme-court" target="_blank" dir="ltr">Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.</a>The guidelines clarify that the USPTO’s framework for assessing enablement is unchanged after the Supreme Court’s decision in Amgen v. Sanofi. Specifically, the USPTO “will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.”The Wands factors include:	(A) The breadth of the claims;	(B) The nature of the invention;	(C) The state of the prior art;	(D) The level of one of ordinary skill;	(E) The level of predictability in the art;	(F) The amount of direction provided by the inventor;	(G) The existence of working examples; and	(H) The quantity of experimentation needed to make and use the 	invention based on the content of the disclosure. (MPEP 2164.01(a).)Although the Supreme Court in Amgen v. Sanofi did not mention the Wands factors, the USPTO guidelines point to the Federal Circuit’s application of the Wands factors in the underlying Federal Circuit case.[1] The USPTO guidelines also point to three post-Amgen Federal Circuit decisions that did apply or at least discuss the Wands factors in finding lack of enablement for genus claims, including for a functionally defined genus of antibodies.[2] The USPTO guidance and the decisions emphasize and cite Amgen v. Sanofi for the proposition that “[t]he more one claims, the more one must enable.”[3]Key Takeaways<ul dir="ltr"><li>The Wands factors are the accepted framework for assessing enablement of genus claims.</li><li>Nested back-up positions covering narrower subgenera should be crafted and include as many exemplified species as possible.</li><li dir="ltr">If possible, enablement of a genus should be strengthened by disclosing “some general quality . . . running through the class that gives it a peculiar fitness for the particular purpose.”[4]</li></ul>[1] Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021).[2] See Baxalta Inc. et al. v. Genentech Inc., 2023 U.S. App. LEXIS 24863 (Fed. Cir. 2023); Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023); and In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential).[3] Amgen, 143 S. Ct. at 1254.[4] See USPTO Guidelines (citing Amgen at 1254–1255).

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Patent Agent

Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligen

Kelsey J. Roberts Kingman Ph.D.

Kelsey Roberts Kingman

USPTO Enablement Guidelines After Amgen v. Sanofi