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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Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

April 2025 Update on Regulation of New Genomic Techniques in the EU

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

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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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 September 12, 2024, Morrison Foerster, in collaboration with Bayer Co.Lab, hosted a pivotal panel discussion under the title “MoForum Charting the Biotech Startup Journey” at Morrison Foerster’s Berlin office.The event provided an in-depth exploration of the biotech startup ecosystem, particularly focusing on the journey from foundation and early-stage funding to growth, scaling, and successful exits. The event was a tremendous success, drawing attention to the vibrant biotech scene in Berlin and Germany and providing valuable insights into the challenges and opportunities faced by startups in this dynamic sector.Wolfgang Schönig, a partner at Morrison Foerster specializing in Life Sciences Transactions and Licensing, led through the evening. He was joined by an esteemed panel of industry leaders, including Ruth Shah (Head of Bayer Co.Lab Berlin), Anela Vukoja (Principal at Apollo Health Ventures), Elisa Kieback (Co-founder and CTO of T-knife Therapeutics), Stefanie Urlinger (Chief Scientific Officer of Cimeio Therapeutics), Nikita Sharma (Principal at Versant Ventures), and Jan‑Philipp Kruse (Senior Director at Lilly Ventures).Key Takeaways from the Panels DiscussionThe panel discussion was segregated into four different chapters curated along the lifecycle of a Biotech company. The topics covered in the discussion and key take aways include:<ul><li>Chapter 1: Foundation and Early-stage Funding The discussion highlighted the critical role of technology transfer and the need for streamlined processes to facilitate the transition from academic research to commercial ventures. Panelists emphasized the importance of public funding in setting attractive incentives for private investments. Key takeaways included the need for academia to be measured by tech transfer impact and the importance of creating good data to attract private investments.</li><li>Chapter 2: Growth and Scaling Insights from this session underscored the necessity of shifting from an academic to a commercial mindset for successful growth and scaling. The panelists discussed the challenges of attracting growth funding and the strategic importance of establishing a U.S. presence to attract more risk-tolerant investors. Critical aspects covered included the need to professionalize processes, particularly regarding quality and compliance, and the importance of having a clear focus and a lean operational model.</li><li>Chapter 3: Partnering and Internationalization This segment of the discussion focused on the significance of forming partnerships with Big Pharma and the advantages of operating across multiple biotech hubs, including the United States and Germany. The panelists shared their experiences and strategies for successful international expansion. Key points included the benefits of different ecosystems and the importance of new ways to collaborate.</li><li>Chapter 4: Achieving Successful Exits The final chapter dealt with exit strategies, highlighting various scenarios and the importance of aligning these with the goals of stakeholders. The discussion provided insights into managing stakeholder relationships throughout the exit process to ensure the continuation of innovation. The panelists discussed the different opinions on exit scenarios and the critical milestone of bringing innovation forward.</li></ul>ConclusionThe MoForum on Charting the Biotech Startup Journey offered invaluable insights and fostered discussions that underscored the collaborative spirit necessary to drive innovation in the biotech sector. Morrison Foerster and Bayer Co.Lab are proud to have facilitated this engaging and informative event.Watch this spot for further information on the German and Berlin Biotech scene.<div data-reactroot=""><img class="rich-text-embed-image" alt="Panelist group 1" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltdf181cb90a577444/66e9d0b98dc03a91091b5170/Panelists-life-sciences-blog.jpg?format=auto&amp;quality=60"/></div><div data-reactroot=""><img class="rich-text-embed-image" alt="Group photo 1" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blte90deeae9321508c/66e9d2f4a924ba3445df2574/panel-discussion-life-sciences.jpg?format=auto&amp;quality=60"/></div><div data-reactroot=""><img class="rich-text-embed-image" alt="Terrace photo" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltc4e0b9d4966489b2/66e9d2dd44a1ad887c36a4c1/crowd-terrace-life-sciences.jpg?format=auto&amp;quality=60"/></div>

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Counsel

Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

MoForum: Bayer Co.Lab Edition – Charting the Biotech Startup Journey

The <a href="https://www.congress.gov/118/bills/s150/BILLS-118s150es.pdf" target="_blank">Affordable Prescriptions for Patients Act (APPA) of 2023</a> unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of reducing drug prices. The APPA would revise certain provisions of 35 U.S.C. § 271(e) to limit the number of patents a drug manufacturer can assert in a patent infringement lawsuit against biosimilars and generics companies. Specifically, the revisions to § 271(e) state that a drug manufacturer may assert no more than 20 patents in an infringement action and that no more than 10 of the 20 patents shall have been newly issued or licensed to the drug manufacturer, as defined by section 351(l)(1)7(A) of the Public Health Service (PHS) Act.The limit on the number of patents that can be asserted may be increased (i) if the drug manufacturer makes a request without undue delay and (ii) if the interest of justice so requires or for good cause shown. Good cause will be established if the biosimilars or generics drug company fails to provide information that would enable a drug manufacturer to form a reasonable belief that a claim of infringement could reasonably be asserted. Good cause may be established if there is a material change to the biological product or process with respect to the biological product by the biosimilars or generics company, if there is a delay by the USPTO in issuing the patent of the drug manufacturer, or for another reason the court deems appropriate.More recently, companion bill H.R. 9070, titled Affordable Prescriptions for Patients Act (APPA) of 2024, was introduced to the House on July 18, 2024 by U.S. Representatives Darrell Issa (R-Calif.) and Hank Johnson (D-Ga.).Whether the bill passes the House of Representatives remains to be seen. Should the bill pass, the impact on biosimilar litigation is hard to predict. While there have been cases in which more than 20 patents are asserted, including litigations regarding Humira, in other litigations the patents at issue have not exceeded 20.Subscribe to the MoFo Life Sciences blog to stay up to date on legislative changes affecting biotechnology and pharmaceutical companies.

Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

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Associate

Dr. Paige Chandler focuses her practice on patent drafting and prosecution and IP due diligence, with an emphasis on biomedical physiology.

Paige N. Chandler Ph.D.

Paige Chandler

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. 

Seagen Inc. v. Daiichi Sankyo Co. Ltd. et al. (AAA Arbitration, Eastern District of Texas, District of Delaware, and Patent Trial and Appeal Board)

Evolve BioSystems, Inc. v. Abbott Laboratories (Northern District of Illinois)

Driscoll’s, Inc. v. California Berry Cultivars, LLC (Eastern District of California)

Bayer CropScience LP v. Tenfold Tech., LLC (Eastern District of Texas)

The Regents of the University of California v. California Berry Cultivars, L.L.C. et al.  (California Superior Court and Northern District of California)

Arch Development Corp. v. Genentech, Inc. (Northern District of Illinois, Patent Trial and Appeal Board, and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. (Northern District of California and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. and ImmunoGen, Inc. (Patent Trial and Appeal Board and Federal Circuit)

Focal Therapeutics, Inc. v. Senorx, Inc. (Patent Trial and Appeal Board)

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Matthew protects his clients’ intellectual property and defends his clients wrongly accused of infringement. His hearing and trial experience is extensive. Whether exploring complex technical issues regarding a biologic drug, or digging into the finer points of patent law, he excels at keeping his opponents on their toes.

Matthew Chivvis

Matthew A. Chivvis

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Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

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The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. 

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.

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