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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Last week, the USPTO released its <a href="https://www.uspto.gov/about-us/performance-and-planning/strategy-and-reporting?MURL=StrategicPlan" target="_blank">2022‒2026 Strategic Plan</a>. The Strategic Plan outlines the USPTO’s overarching goals for the coming years. How are these initiatives likely to affect patent applicants and owners?1. Improving patent application pendencyThe USPTO is continuing its efforts to reduce patent application pendency (currently about 25 months to final disposition) by “reimagining patent examination processes” and by providing alternative application processing options for patent applications.Based upon this initiative, the USPTO may continue to expand its offerings for expedited examination for certain technologies and/or expand the number of permitted annual Track I requests from the current level of 15,000. Practitioners should continue to take advantage of the available programs to expedite prosecution at the USPTO and be on the lookout for new mechanisms to expedite prosecution.   2. Updating search strategiesApplicants can expect changes in USPTO search practices. While the practical impact of such changes is unclear, they may enable more reliable identification of the most relevant prior art.First, the USPTO hopes to optimize the strategic integration of AI and robotic process automation (RPA) into the patent application system, including for enhanced and more efficient access to prior art.Second, the USPTO plans to provide examiners with new training and tools to search databases maintained by the FDA. This builds on the <a href="https://lifesciences.mofo.com/topics/the-uspto-and-the-fda-join-hands-to-promote-competition" target="_blank">unprecedented collaboration</a> between the USPTO and FDA in 2022. Companies should ensure consistency in their patent and regulatory strategies and provide any relevant correspondence with FDA to the USPTO to comply with their duty of disclosure.3. Potential small claims courts for IP litigationThe USPTO plans to independently study the feasibility of small claims courts for patents and trademarks, collect and analyze public comments, and submit a report to Congress. The report will indicate whether there is a need for small claims courts, the feasibility and potential structure of each court, and the relevant legal, policy, and practical considerations in establishing a small claims court for either patents, trademarks, or both.Interested stakeholders should watch for future requests for comments regarding the small claims courts, for an opportunity to weigh in.4. Scrutiny of micro and small entity designationsThe USPTO makes it clear that it will be vigilant in identifying applications “including erroneous or suspicious designations of micro or small entity status,” particularly in view of the recent changes in the increasing associated fee discounts. The Unleashing American Innovators Act of 2022 increased small entity patent fee discounts to 60% (up from a 50% discount), and micro entity discounts to 80% (up from a 75% discount).<a href="#_ftn1" target="_self" id="_ftnref1">[1]</a> The Unleashing America Invents Act also changed the penalty for false assertions of entity status. Under the old law, fraudulent assertion of small entity status would be considered inequitable conduct that might jeopardize enforcement of the patent. But an incorrect assertion of small (or micro) entity status made in good faith could be “excused” upon correction of the entity status and payment of the fee deficiency.Under the new law, the USPTO Director has discretion to impose penalty fines that are not less than three times the fee deficiency when an entity “is found to have falsely asserted entitlement to a fee reduction.”Applicants should investigate and verify entitlement to small entity status before it is first claimed (e.g., when filing the application), again when the issue fee payment is made, and again when each maintenance fee payment is made.5. Steps to curb abuse of Patent Trial and Appeal Board (PTAB) proceedingsThe USPTO’s Strategic Plan notes that it will take “steps to prevent abusive behaviors from arising” in PTAB proceedings.This sends a strong message that USPTO Director Kathi Vidal plans to carefully scrutinize PTAB proceedings for potential abuse. In 2022, for example, Director Vidal issued a decision finding that a petitioner abused the inter partes review (IPR) process by filing the IPR “in an attempt to extract payment” from the patent owner, and “by offering to undermine and/or not vigorously pursue this matter in exchange for a monetary payment.”<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a> The decision was the first time a USPTO Director levied sanctions in a patent review.<a href="#_ftnref1" target="_self" id="_ftn1">[1]</a> To qualify for “small entity” status, a business must have no more than 500 employees, including affiliates. 13 CFR § 121.802. Additionally, the business must not have assigned, granted, conveyed, or licensed any rights in the invention to any entity that does not qualify for small entity status (and must be under no obligation to do so). Id. Individuals and nonprofit organizations can also qualify. MPEP § 509.02. “Micro entity” status (which is rare) additionally requires that the applicant qualify on either a “gross income” or “institution of higher education" basis. 37 CFR § 1.29.<a href="#_ftnref2" target="_self" id="_ftn2">[2]</a> <a href="https://www.uspto.gov/sites/default/files/documents/ipr2021_01064_paper_102_decision.pdf?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=" target="_blank">OpenSky Industries, LLC v. VLSI Technology LLC</a>, IPR2021-01064, Paper 102 (Oct. 4, 2022).

USPTO Releases 2022‒2026 Strategic Plan

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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

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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. 

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USPTO Releases 2022‒2026 Strategic Plan

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Last week, the USPTO released its 2022‒2026 Strategic Plan. The Strategic Plan outlines the USPTO’s overarching goals for the coming years. 

On June 1, 2023, the Supreme Court issued a decision in <a href="https://www.supremecourt.gov/opinions/22pdf/21-1326_6jfl.pdf" target="_blank">United States ex rel. Schutte v. SuperValu, Inc.</a>, clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court held that a defendant that submits a false claim does so knowingly when it subjectively believes the claim is false at the time of submission. We have been tracking this decision in our <a href="https://www.mofo.com/resources/insights/230410-true-facts-about-false-claims?utm_source=publication&utm_medium=email" target="_blank">FCANewsletter</a> and our <a href="https://govcon.mofo.com/topics/supreme-court-weighs-in-on-the-role-of-subjective-intent-under-the-false-claims-act" target="_blank">Government Contracts Insights</a> as it changes the law of several circuits, which had held that an FCA defendant has not knowingly presented a false claim if its claim was consistent with an “objectively reasonable interpretation” of the relevant law, regardless of what the defendant believed about the claim.Read the <a href="https://www.mofo.com/resources/insights/230606-look-to-defendants-subjective-beliefs" target="_blank">full client alert</a>.

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Joe Palmore co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Chambers USA describes him as “an outstanding oral advocate,” who is “calm, focused, effective and doesn’t back down,” and has “complete command of the facts.” Joe “writes great briefs” (Chambers USA), with one client recounting that “the Court mirrored the language he thoughtfully chose in its ultimate order” (Legal 500).

Joseph R. Palmore

Joseph R. Palmore is co-chair of the firm's Appellate and Supreme Court Practice Group and Managing Partner for the Washington, D.C. office. Before joining Morrison Foerster, Joe was an Assistant to the Solicitor General at the United States Department of Justice and the Deputy General Counsel of the Federal Communications Commission (FCC).

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