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 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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As chair of the biotechnology group and a member of the firm’s food and agriculture steering committee, Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of life science and agriculture. Meghan is passionate about working with cutting edge technologies at the frontier or science that impacts human health and global food security. She has significant experience in diverse technologies including antibodies, cell and gene therapies, diagnostics, and gene edited plants. Meghan manages a cross-technology team to service clients developing technology at the interface of life science and AI.Meghan represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities. She 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.Meghan is a thought leader on intellectual property issues facing pharmaceutical, biotechnology, and agriculture companies and is sought after to speak at events and publish on these issues. Meghan has written numerous articles on the topics of patents vs. trade secrets, subject matter edibility, written description and enablement in life sciences. Meghan is editor of the MoFo Life Sciences Blog, where she directs content.Prior to law school, Meghan earned her PhD in biological chemistry based at the University of California, Los Angeles. Meghan’s Ph.D. work focused on analysis of protein-protein and protein-DNA interactions of site-specific recombinases. 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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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

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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 Schoenig 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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USPTO Reconsiders Obviousness-Type Double Patenting and Proposes a New Examination Framework

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On August 6, 2026, the U.S. Patent and Trademark Office (USPTO) Appeals Review Panel (ARP) issued a precedential decision in <a href="https://www.uspto.gov/sites/default/files/documents/rh2024-002920_arp__final.pdf" target="_blank">Ex parte Baurin</a>, Appeal No. 2024-002920 (ARP Aug. 6, 2026), that both preserves broad obviousness-type double patenting (OTDP) exposure under current law and points toward a potentially narrower, more predictable approach in the future.Under current law, OTDP can arise when patents or applications have common ownership or overlapping inventorship and claim patentably indistinct subject matter. The doctrine is intended to both prevent an unjustified extension of patent exclusivity and guard against the risk that those claims could later be separately owned and enforced in multiple lawsuits. A terminal disclaimer is the current tool to address both concerns by providing a mechanism to disclaim any impermissible extension of patent term and requiring that the patents must remain commonly owned to be enforceable. That remedy, however, may not be available as a practical matter when the relevant patents or applications are separately owned.For applicants, the immediate takeaway is that existing OTDP practice remains in place, including the possibility of rejections based on later-filed, later-expiring patents even where the challenged patent would not extend the period of exclusivity if there are different owners. But the decision also looks beyond the current law. The ARP questioned whether the mere possibility of separate ownership and multiple enforcement actions should independently support an OTDP rejection and outlined a more straightforward framework the USPTO could adopt if the courts or legislation clear the way for change.The DecisionIn Baurin, the ARP reversed an earlier PTAB decision that had rejected an OTDP challenge because the pending claims would expire before the later-filed, later-expiring reference patent and therefore would not extend the period of exclusivity. Although it was undisputed that the pending claims were obvious over the reference claims, the PTAB had concluded that the later-expiring patent could not serve as an OTDP reference because issuance of the pending claims would not extend exclusivity beyond the reference patent’s term.The ARP disagreed, holding that under current Federal Circuit precedent, the anti-harassment rationale can independently support an OTDP rejection even where there is no apparent extension of patent term. The ARP therefore reinstated the USPTO’s OTDP rejections.A Proposed New OTDP FrameworkAlthough the ARP reinstated the rejections under current law, it also looked ahead, outlining a simpler and more predictable approach that the USPTO could adopt if the governing law changes. Under that proposed approach, OTDP examination would focus primarily on preventing an unjustified extension of patent exclusivity and would use filing dates and other facts known during examination to determine whether that concern exists.For patents and applications in different families, which do not share a common priority date, the ARP proposed using patent term filing dates as a proxy for expiration dates. By this framework, examiners “ask a simple question: Does a putative OTDP reference have a later patent term filing date than the patent term filing date of the application under examination?” If the asserted OTDP reference has a later patent term filing date than the application under examination, it ordinarily would not create a term-extension concern, and the OTDP analysis would end. If the reference has an earlier patent term filing date, the examiner could proceed to compare the claims and, if appropriate, issue an OTDP rejection.For patents and applications in the same family, the ARP proposed a different approach because family members ordinarily share the same patent term filing dates. In that situation, the USPTO would instead consider actual filing dates and, where known, issue dates. A later-filed application could be rejected for OTDP over an earlier-filed parent application or patent, but an earlier-filed application would not be rejected based on its later-filed progeny. That approach follows the Federal Circuit’s reasoning in <a href="https://lifesciences.mofo.com/topics/federal-circuit-clarifies-scope-of-obviousness-type-double-patenting-in-allergan-usa-v-msn-laboratories" target="_blank">Allergan USA, Inc. v. MSN Laboratories Private Ltd., 111 F.4th 1358 (Fed. Cir. 2024)</a>, that the first-filed, first-issued patent in a family sets the maximum period of exclusivity for the claimed subject matter and its patentably indistinct variants.Practically, the proposed approach reflects the different ways an extended patent term may exist. Patent term filing dates generally provide a useful indication of relative patent terms across different families. Within a single family, however, those dates ordinarily are the same, and differences in patent terms may instead arise from circumstances such as patent term adjustment (PTA). The ARP therefore proposed using actual filing and issue dates to determine the proper direction of an OTDP rejection within a family.The ARP emphasized that in both scenarios, examiners should rely on known facts, such as an existing terminal disclaimer or established patent term adjustment, rather than speculate about future term changes.The Role of Anti-Harassment Under the Proposed FrameworkThe ARP’s proposed framework would also significantly narrow the role of the anti-harassment rationale in OTDP examination. Although the ARP concluded that existing Federal Circuit precedent currently requires the USPTO to recognize anti-harassment as an independent basis for an OTDP rejection, the panel questioned whether hypothetical harassment should continue to be enough on its own.If the governing law changes to give the USPTO greater flexibility, the ARP stated it generally would not permit hypothetical harassment alone to support an OTDP rejection during examination. The ARP rationalized that absent evidence that an applicant has split ownership of patentably indistinct claims and subjected the public to separate lawsuits, the concern is speculative. Furthermore, requiring a terminal disclaimer on that basis may impose common-ownership restrictions tied to events that may never occur, creating serious problems for foundational and follow-on research conducted by different companies or partially overlapping groups of inventors.The ARP identified two possible ways to address anti-harassment concerns in those circumstances. First, the USPTO could require evidence that the particular applicant previously divided ownership and engaged in harassment, or, second, could require a two-way obviousness showing, where each set of claims must be obvious over the other, before harassment by itself can support an OTDP rejection. Either option would reduce the risk that a later improvement patent could be used against an earlier foundational application merely because the applications share an inventor or later become separately owned.What Applicants Should Expect NowAlthough Baurin does not immediately change OTDP examination, it may mark an important step toward a different approach. Baurin provides a detailed blueprint for a more predictable approach if the anti-harassment rationale becomes limited by the courts. However, this blueprint, which relies on a filing-date framework, is not yet operative; examiners must continue to follow existing OTDP practice.The Federal Circuit may soon provide further guidance. In In re Ablynx N.V., No. 26-1333, an appeal from Ex parte Baumeister, the court is being asked to consider whether the anti-harassment rationale can independently support an OTDP rejection where no time extension is apparent. The outcome could determine whether the USPTO has room to adopt or refine Baurin’s proposed framework for later-filed applications and later-issued patents within and across families.

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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

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Dr. Laura Westergard focuses her practice on domestic and international patent drafting, prosecution, and strategic counseling in the areas of life sciences, biotechnology, and pharmaceuticals.

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Laura Westergard

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The Biotechnology Regulatory Services (BRS) of the USDA Animal and Plant Health Inspection Service (APHIS) held its annual stakeholders meeting on February 26, 2026. While the annual event is typically held in November, the regularly scheduled meeting was delayed due to the government shutdown at the end of 2025. Highlights from the meeting include the following.Continued Efficiency in the Face of AdversityBRS experienced two large disruptions since the previous meeting. First, on December 2, 2024, the U.S. District Court for the Northern District of California <a href="/topics/an-insecure-future-court-ruling-guts-usda-regs-on-genetically-engineered-plants#page=1" target="_self">struck down the SECURE rule, part of the APHIS rules for genetically engineered (GE) organisms</a>. In response, and after only 17 days, APHIS restored its legacy <a href="https://www.aphis.usda.gov/am-i-regulated" target="_blank">Am I Regulated</a> (AIR) system. Second, the agency experienced a loss of staff related to policy changes made by the Trump administration, including up to 25% of employees in some groups. Despite these changes BRS maintained a high rate of efficiency in responding to developers and processing permits. Fiscal year 2025 saw more permits (879) issued than 2024, and 95% of those were issued within the regulatory time frame. Permits for import or interstate movement and permits for release were processed on average within the first third of the regulatory time frames of 60 days and 120 days, respectively. Both types of processing represent a decrease in processing time compared to 2024. Notifications for the introduction of certain regulated articles (under 7 CFR § 340.3) were also efficiently issued. In 2025, 91% of interstate movement notifications were announced in an average of five days, half of the regulatory time frame. Release and import notifications were announced in an average of 10 days, with none exceeding the regulatory time frame of 30 days.Refreshed AIR: the Return of Am I RegulatedWithin three weeks of the vacatur of the SECURE Rule, APHIS had reinstituted the previous regulatory framework of AIR, which sets the definition for a regulated article as an organism that has been genetically engineered and that “has one or more of its components derived from a plant pest or an unclassified or unknown organism”; or “that APHIS determines is a plant pest or has reason to believe is a plant pest.” AIR results can be found on the <a href="https://www.aphis.usda.gov/biotechnology/regulated-article-inquiry?page=1" target="_blank">website</a>. See the <a href="https://www.aphis.usda.gov/sites/default/files/permit-guidance.pdf" target="_blank">permit user guide</a>.The reintroduction of AIR was accompanied by the first update since 1996 to the petition process for seeking regulation of a GE plant under 7 CFR § 340.6. The <a href="https://www.ecfr.gov/on/2019-12-31/title-7/subtitle-B/chapter-III/part-340/section-340.6" target="_blank">petition process</a> has four steps: 1. Developers submit a written petition with data for what they have done and how. 2. APHIS conducts a plant pest risk assessment (PPRA). 3. The PPRA is published and open for <a href="https://www.aphis.usda.gov/plant-feedback" target="_blank">public comments</a>. 4. APHIS reviews the comments and issues a decision.The data provided in the petition submission must include the information required under 7 CFR § 340.6 to allow APHIS to evaluate plant pest risk and may include observational information, experimental results, existing literature or public reports, logical reasoning, and other relevant supporting materials. The amount of data will depend on the crop and the trait. For instance, a typical crop plant would require less background information as it is already well known. BRS continues to strongly recommend a pre-submission consultation.PPRAs will focus on plausible avenues of increased plant pest risk. There is no longer any National Environmental Policy Act (NEPA) review.Trends in What Is RegulatedWhile it is too early to draw conclusions, BRS saw an increase in the number of transgenic organisms seeking deregulation in 2025, which may indicate that the U.S. agricultural industry is warming to transgenics again. 2025 saw transgenic organisms take up 13% of regulated organisms (out of 69), compared to only 8% (of 99) from 2021 to 2024.Small to medium-sized biotech companies continue to be the most frequent permit applicants. However, 20% of AIR review requests in 2025 were submitted by public-sector entities, far above the SECURE era average of 3%.While plants still make up the majority of petition subjects, microbes were 17% of petitions in 2025. Petitions for microbes have grown steadily over the last four years, and petitions for modified invertebrates are still rare but the percentage is growing. Increased Focus on MicrobesAPHIS Plant Protection and Quarantine (PPQ) and BRS have been working together to streamline and reduce delays in the permitting process for microbes in the face of increased interest from developers. 2025 saw an increase from 67 to 283 permits for release of modified microorganisms, and more than 4,600 unique modified microorganisms are now permitted. Currently, BRS is developing new standards for microbes that can be customized for the organisms in question. Under the new standards, a modified microbe would be regulated if the unmodified microbe is known to, or could plausibly, harm plants or if the source of the modification is a donor microbe that poses a plant pest risk. Additionally, kingdom-level permits are available for interstate movement, underscoring the trend toward streamlined processes. Overall, APHIS and BRS reaffirmed to stakeholders their commitment to following the science and working with developers to improve the efficacy of the regulatory process.

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Dr. Deborah Pohlmann focuses on patent preparation and prosecution, specializing in biology.
Prior to joining the firm, Deborah earned her Ph.D. in biology from the Massachusetts Institute of Technolo

Deborah A. Pohlmann Ph.D.

Deborah Pohlmann

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Ralph McNeilage Ph.D.

Ralph McNeilage

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Meghan J. Brady Ph.D.

Meghan Brady

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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. 

Brian P. Sylvester is a partner in our FDA & Healthcare Regulatory and Compliance Group. He is the head of Food Regulatory and an influential thought leader and practitioner in food tech regulation.

Brian P. Sylvester

Brian Sylvester

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USDA APHIS BRS Promises Continued Efficiency

On February 20, 2026, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a closely watched decision in <a href="https://www.cafc.uscourts.gov/02-20-2026-24-1408-regenxbio-inc-v-sarepta-therapeutics-inc-opinion-24-1408-opinion-2-20-2026_2650255/" target="_blank">REGENXBIO, Inc. v. Sarepta Therapeutics, Inc., No. 24-01408 (Fed. Cir. 2026)</a>, clarifying the scope of patent eligibility for engineered cells.Claims at IssueClaim 1 was considered representative and recites:<blockquote>1. A cultured host cell containing a recombinant nucleic acid molecule encoding an AAV vp1 capsid protein having a sequence comprising amino acids 1 to 738 of SEQ ID NO: 81 (AAVrh.10) or a sequence at least 95% identical to the full length of amino acids 1 to 738 of SEQ ID NO: 81, wherein the recombinant nucleic acid molecule further comprises a heterologous non-AAV sequence.</blockquote>The case came to the Federal Circuit on appeal from the U.S. District Court for the District of Delaware, which had held that the challenged claims were patent-ineligible under the “product of nature” doctrine.  The district court concluded that the claimed host cells were analogous to the patent-ineligible claims in the Supreme Court’s decision in Funk Brothers,<a href="#_ftn1">[1]</a> explaining that “[t]aking ‘two sequences from two different organisms and put[ting] them together’ is no different than taking two strains of bacteria and mixing them together.”On appeal, the Federal Circuit rejected the analogy as “flawed” and explained that the better guidepost is the Supreme Court’s decision in Diamond v. Chakrabarty,<a href="#_ftn2">[2]</a> which asks whether the claimed subject matter has “markedly different characteristics” from what occurs in nature and offers “the potential for significant utility.”  Applying the Chakrabarty framework, the Federal Circuit found the claims to be patent-eligible and faulted the district court for effectively treating the invention as nothing more than a juxtaposition of natural sequences.The Federal Circuit emphasized that “[i]t is uncontested that the claimed host cells include a recombinant nucleic acid molecule that does not and cannot exist in nature” and further noted that the patent describes the functional benefits that arise from the engineered cells.  The Federal Circuit explained that unlike the component sequences considered in isolation, embodiments of the claimed cells “are beneficial for gene delivery to selected host cells and gene therapy patients.”Overall, the decision reinforces that genetically engineered cells are not automatically treated as ineligible “products of nature” under Step One of the Supreme Court’s two-step Mayo/Alice test for patent eligibility (which asks first whether claims are directed to a judicial exception such as a product of nature, and then, if so, whether additional claim elements supply an “inventive concept”). Instead, when a claim recites an engineered cell composition that incorporates human-made genetic constructs and the record supports practical, non-natural capabilities, the Federal Circuit’s analysis indicates that eligibility should be evaluated through the Chakrabarty “markedly different” lens rather than treating the claim as a mere combination of natural materials.Takeaway: For innovators, the opinion highlights the value of clearly describing (and claiming) the engineered features that cannot occur in nature and linking them to real-world performance or therapeutic utility. This approach may also strengthen eligibility arguments for other engineered products.<a href="#_ftnref1">[1]</a> Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).<a href="#_ftnref2">[2]</a> Diamond v. Chakrabarty, 447 U.S. 303 (1980).

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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

Recombinant Host Cells Are Patent-eligible: Federal Circuit Revives Regenxbio’s Gene Delivery Patent