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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Recent case law highlights enablement and written description challenges for genus claims.[1] Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when literal infringement is unavailable.

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Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents | MoFo Life Sciences

Kelsey J. Roberts Kingman Ph.D.

Bu Yin Ph.D.

Recent case law highlights enablement and written description challenges for genus claims.[1] Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when literal infringement is unavailable.As discussed below, the outlook for successful application of DOE to biologics remains uncertain. But with careful prosecution strategies, patentees can better preserve their DOE arguments to block design-arounds with insubstantial differences and/or those that perform substantially the same function in substantially the same way.DOE for Biologics<a href="https://lifesciences.mofo.com/topics/analyzing-biologics-under-doctrine-of-equivalents-prosecution-history-estoppel">Ajinomoto Co., Inc. v. ITC</a> provides a rare example of successful DOE application to protein sequences.[2] There—applying the “function-way-result” (FWR) test for analyzing equivalence—the Federal Circuit concluded that a bacterial strain engineered to express a particular amino acid sequence was equivalent to a strain engineered to express a different amino sequence of a related protein.[3] In finding that the proteins functioned in substantially the same way, the court relied on the facts that the two proteins were 95% identical in primary amino acid sequence and were predicted to be 85% identical in structure.[4] Thus, when applying the FWR test to large biomolecules, sequence similarity will likely be an important consideration as it was in the Ajinomoto decision.A more recent case, Teva Pharmaceuticals International GmbH v. Eli Lilly & Co., illustrates that relying on DOE to broaden the scope of claims reciting biological sequences (e.g., antibody sequences) can be challenging.[5] There, Teva asserted two claims reciting antibody CDR sequences and variable region sequences against Lilly under DOE. The antibodies at issue shared only 29.9% sequence similarity in the CDRs, and the heavy chain of the closest variant disclosed in Teva’s patent shared only 52.5% similarity with Lilly’s antibody.[6] In this case, the court said that application of DOE would be “a bridge too far” and would effectively read the amino acid sequence limitation out of the claims.[7] Thus, DOE arguments that essentially vitiate the sequence limitations would not be likely to succeed.It is worth noting that the court in Teva decided on the DOE issue using the “insubstantial differences” test, which the court viewed as more appropriate for evaluating equivalents in chemical compounds. Although it is clear from Teva that application of DOE to biologics likely requires “insubstantial differences” between the claimed and accused products, how much sequence identity or similarity in primary amino acid or nucleic acid sequence amounts to insubstantial difference is far from being clear. Moreover, large biological molecules having low sequence identity in primary sequences may nevertheless assume highly similar three-dimensional structures and/or functions – in such cases, would the difference be insubstantial?Despite these uncertainties and the paucity of examples successfully applying DOE to biological drugs and particularly antibodies in district court litigation or before the Federal Circuit, DOE may be an important tool in view of genus claim vulnerabilities. Patent applicants looking to apply DOE in any field must take care during prosecution to avoid estoppel, as discussed below.DOE Prosecution Strategies<ul><li>Consider initially pursuing narrow claims with a high likelihood of patentability without amendments to the claims during prosecution to avoid estoppel issues.[8] Fewer written arguments during prosecution may help reduce the risk of estoppel issues. Consider making greater use of examiner interviews to help focus amendments and arguments.</li><li>Remember that preliminary amendments can also create prosecution history estoppel.[9]</li><li>Take care to avoid new matter or written description rejections when introducing dependent claims. Dependent claim cancellations can also invoke prosecution history estoppel.[10]</li><li>The “disclosure dedication” rule may bar application of DOE for equivalents that are disclosed in the specification.[11] Rather than relying on DOE in such cases, applicants should consider pursuing a continuation application to cover specific competitor products disclosed in the specification but not initially claimed.</li></ul>[1] Amgen Inc. v. Sanofi, No. 21-757, 2023 WL 3511533 (U.S. May 18, 2023).[2] See, generally, 932 F.3d 1342 (Fed. Cir. 2019).[3] Id. at 1356-1357.[4] Id. at 1357.[5] No. 18-CV-12029-ADB, 2022 WL 4824318, at *18 (D. Mass. Oct. 3, 2022).[6] Id. At *16.[7] Id. at *18.[8] Narrowing amendments made during prosecution create a rebuttable presumption that the patentee has surrendered the broader claim scope, typically referred to as “prosecution history estoppel.” This presumption is rebuttable if (1) the equivalent would have been unforeseeable at the time of the amendment; (2) the rationale underlying the amendment is only tangentially related to the equivalent in question; or (3) “there [is] some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1365 (Fed. Cir. 2003.[9] In Amgen Inc. v. Hoechst Marion Roussel, Inc., for example, the Federal Circuit found that a preliminary amendment limiting the claims to a 166-amino acid sequence of human erythropoietin (EPO) surrendered coverage of EPO with a 165-amino acid sequence (the mature, cleaved form of the protein). 457 F.3d 1293, 1297 (Fed. Cir. 2006).[10] Consider UCB, Inc. v. Yeda Research & Development Co., Ltd., 117 F. Supp. 3d 755 (E.D. Va. 2015). There, Yeda added dependent claims reciting “chimeric” claims, which Yeda explained encompassed humanized antibodies. Yeda canceled these dependent claims after the examiner rejected them for lack of written description. Although the independent claim reciting “monoclonal antibodies” had not been amended, the court held that the main claim could not be construed to cover humanized antibodies literally or under DOE in view of the claim cancellation in response to a rejection.[11] In Morphosys AG v. Janssen Biotech, Inc., for example, disclosure of human or humanized anti-CD38 antibodies precluded the patentee from asserting that a claim limited to human antibodies also covered humanized antibodies under DOE. 358 F. Supp. 3d 354 (D. Del. 2019).

Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents

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