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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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.

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UPDATE: The stop-gap spending bill has been revised to remove the provision discussed herein. However, life sciences companies should nonetheless take note of efforts by congress to enact patent-related reforms such as this.On December 17, 2024, Congress presented a short-term funding bill that, if passed, would prevent a partial government shut down and fund the government through March 14, 2025.[1] On top of additional spending for disaster relief, the draft funding bill includes a more than 500-page health care package with a short section that may raise the eyebrows of everyone working at life sciences and pharmaceutical companies. Specifically, Section 904, which outlines amendments to 35 U.S. § 271(e) and would impose a limit on the number of patents that can be asserted in litigation over approval of biosimilars under Section of 351(k)[2] of the Public Health Service Act. The proposed legislation would restrict innovators in the biologics space (referred to herein as “reference product sponsors”) to asserting “not more than 20 patents” in litigation against applicants for approval of a biosimilar under Section of 351(k) of the Public Health Service Act (referred to herein as “subsection (k) applicants”).[3] There is some complexity around the “20-patent limit” under the proposed amendments, and this article explains which patents would be covered under that limit, which would not be covered, and how the limit may be modified by the courts.Covered PatentsThe patents covered under the new 20-patent limit must satisfy each of the following criteria:<ul><li>Claim the biological product or a method or product used in the manufacture of the biological product;</li><li>Be disclosed by the reference product sponsor to the subsection (k) applicant as a patent the reference product sponsor believes covers making, using, offering to sell, or importing into the United States the biological product;[4] and</li><li>Have an actual filing date of more than four years after the date the reference product is approved or include a claim to a method of manufacturing process that is not used by the reference product sponsor.</li></ul>Notably, patents directed to a method for using the product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use,[5] would not be included in the 20-patent limit.Increases to the LimitThe proposed statutory language outlines the ways a court can increase the number of patents that the reference product sponsor can assert against the subsection (k) applicant.If a request to increase is made without undue delay, and if the interests of justice require or good cause is shown, the court:<ul><li>Shall increase the number of patents that the reference product sponsor can assert if the subsection (k) applicant fails to provide enough information in the subsection (k) application to enable the reference product sponsor to form a reasonable belief as to if an infringement claim could reasonably be asserted, and</li><li>May increase the number of patents that the reference product sponsor can assert: if there is a material change in the product or subsection (k) application, if the patent would have issued ahead of the effective date of the biosimilar application approval but for patent office delay, or for other reasons deemed to be good cause by the court.</li></ul>The limit is also not imposed if the subsection (k) applicant has not completed all necessary disclosures related to patents covering the biological product. The necessary actions are described under paragraphs (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of § 351(l) of the Public Health Service Act and are intended to ensure both parties exchange necessary information regarding the subsection (k) biological product, patents covering the biological product, and potential infringement of the patents.ImplicationsAs drafted, the amendments to 35 U.S. § 271(e) would limit the number of patents that innovators of biologics will be able to assert in infringement suits against biosimilar applicants. The impact of this legislation would be felt most directly by life sciences companies with large patent portfolios for their approved biologics. The 20-patent limit would be a relief for biosimilar applicants, who sometimes face upwards of that number of patents at least in the initial stages of litigation before that number is whittled down. However, the law’s impact would be blunted by the substantial limitations on which patents are subject to the restrictions. First, only patents filed after approval of the product will likely be subject to the limit. Second, courts are given wide discretion to increase the limits beyond 20 patents. Accordingly, even if this change to 35 U.S. § 271(e) is enacted via this bill or some other future bill, life sciences companies should not be deterred from pursuing additional patent protection for biological products based on this legislation.<blockquote>While there remains uncertainty regarding the ultimate fate of this bill, there is unlikely to be serious debate about these patent-related provisions before passage. The deadline for Congress to enact a funding bill to avoid a government shutdown is Friday, December 20, 2024, at midnight. </blockquote>[1] <a href="https://www.congress.gov/bill/118th-congress/house-bill/10445" target="_blank">H.R. 10445 - 118th Congress (2023-2024): Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 | Congress.gov | Library of Congress</a>.[2] <a href="https://www.law.cornell.edu/uscode/text/42/262" target="_blank">42 U.S. Code § 262 - Regulation of biological products | U.S. Code | US Law | LII / Legal Information Institute</a>.[3] Section 904(a)(2) (emphasis added).[4] Patents described in paragraph (3)(A) of § 351(l) of the Public Health Service Act, including newly issued or licensed patents under paragraph (7) of § 351(l).[] Section (B)(i) of the amendment to 35 U.S. § 271(e) provides that covered patents include those “that claim the biological product … (or a use of that product) or a method or product used in the manufacture of such biological product.” (emphasis added). Despite this reference to “or use of that product,” section (E)(ii) explicitly states that the provisions of the law “shall not apply with respect to any patent that claims, with respect to a biological product, a method for using that product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use.”

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Briana’s practice focuses on patent preparation, prosecution, and counseling in the areas of biotechnology, pharmaceuticals, and artificial intelligence.

Briana Erin Mittleman Ph.D.

Briana Mittleman

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Lisa N. Silverman focuses on patent portfolio management and strategic patent counseling in the areas of chemistry and life sciences. She has extensive experience in securing U.S. and foreign patent p

Lisa N. Silverman Ph.D.

Lisa Silverman

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative action. This follows from a string of other recent Notices where the USPTO is seeking public input on other areas of patent law, including a recent Notice of Proposed Rulemaking on Terminal Disclaimer practice.The USPTO explained that the current experimental use exception is a common law exception that was created to prevent punishing someone who infringes a patent “merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the [invention] to produce its desired effects.” This led to the availability of the experimental use exception based on whether the alleged infringement involved profit-making or other commercial purposes. The USPTO describes the current state of the experimental use exception as being a “very narrow and strictly limited experimental use defense.”The USPTO’s request for public input on the “narrow” experimental use exception appears to stem, at least in part, from divergent views of the exception and its narrow breadth. The USPTO explains that some argue that “a narrow exception enhances innovation by rewarding innovators with robust patent rights, while others noted that restricting researcher access to patented technologies would impede innovation.”This is not the first time there has been discussion of codifying the common law experimental use exception. Unsuccessful attempts at enacting legislation to codify the exception occurred in Acts proposed in 1990 and again in 2002. This stands in contrast to many foreign jurisdictions where statutory experimental use exceptions have been enacted, including jurisdictions where life sciences research and development are robust. This includes European countries, such as Germany, the UK, France, Spain, Italy, Switzerland, and the Netherlands, Asian countries, such as Japan and China, and countries across the Americas, such as Canada and many Latin America jurisdictions, including Brazil.A limited type of experimental use exception has, however, been codified in the U.S. in the Hatch-Waxman Act as 35 U.S.C. § 271(e), which is commonly referred to as the “safe harbor” exception rather than the experimental use exception. Section 271(e) provides that making, using, offering to sell, or selling certain patented inventions “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products” shall not be considered an act of infringement. This “safe harbor” provision allows, for instance, a company to perform the testing required to obtain regulatory approval of a generic drug product without having to first wait for the patents covering the drug product to expire, thereby accelerating the timeline by which generic drug products can reach the market. Although certain acts can be shielded from liability for patent infringement under the § 271(e) exception where there is regulatory intent, the scope of the exception is ever evolving.The USPTO will be accepting public comments over the next 90 days relating to the experimental use exception.While the USPTO welcomes comments on any issues relating to the experimental use exception and its potential codification, they are particularly seeking out comments relating to the following issues:<ol><li>Please explain how the current state of U.S. experimental use exception jurisprudence impacts investment and/or research and development in any field of technology, including, but not limited to: (a) quantum computing; (b) artificial intelligence; (c) other computer-related inventions; (d) agriculture; (e) life sciences (including prescription drugs and medical devices); and (f) climate-mitigation technologies.</li><li>Do you believe there are any technologies that are negatively affected by the current state of experimental use exception jurisprudence in the United States? If yes, please identify which technologies and explain how you believe they are affected.</li><li>Please explain what impact, if any, a statutory experimental use exception would have on the innovation and commercialization of new technologies, including with respect to: (a) research and development; (b) ability to obtain funding; (c) investment strategy; (d) licensing of patents and patent applications; (e) product development; (f) sales, including downstream and upstream sales; (g) competition; and (h) patent enforcement and litigation.</li><li>Has the current state of experimental use exception jurisprudence impacted decisions you have made with respect to filing, purchasing, licensing, selling, or maintaining patent applications and patents in the United States? If yes, please explain how.</li><li>Please explain whether you believe the United States should adopt a statutory experimental use exception. In doing so, please identify your reasons, including by providing evidence and data to support your views.</li><li>Please explain how a statutory experimental use exception, if any, should be defined. Please include specific limitations and restrictions you believe would be needed to ensure that patent rights are preserved.</li><li>Please identify public policy reasons in support of maintaining the status quo or changing the experimental use exception in the United States.</li><li>Please provide any additional recommendations on how best to enhance and facilitate experimental research on patented inventions in the United States.</li></ol>

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Dr. Jeff Schmidt is a member of the firm’s Patent Group. His practice focuses on patent prosecution in the areas of life sciences, biotechnology, and pharmaceuticals, which includes the preparation an

Jeffrey W. Schmidt Ph.D.

Jeffrey Schmidt

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

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On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative action.

USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action

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

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

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

In October 2023, the <a href="https://www.upov.int/portal/index.html.en" target="_blank">International Union for the Protection of New Varieties of Plants (UPOV)</a> published a long-awaited <a href="https://www.upov.int/edocs/expndocs/en/upov_exn_edv.pdf" target="_blank">updated Explanatory Note on Essentially Derived Varieties (EDVs)</a>. The UPOV Convention outlines a popular sui generis form of IP protection for plant varieties and was first established in 1961; EDVs have been a provision of the UPOV Convention since 1991. However, the bounds of what can constitute an EDV have often been difficult to devise in practice, and stakeholders have long been requesting clarification from UPOV, particularly in light of modern breeding techniques that may incorporate, for example, gene editing. This new guidance represents UPOV’s response to these concerns.What Are EDVs?The legal concept of an “essentially derived” variety serves to effectively extend the reach of a Plant Variety Right (PVR; often also used synonymously with Plant Breeders’ Rights, or PBRs) issued under a PVR scheme that is based on the 1991 UPOV Convention. Thus, in order to understand the concept of EDVs, it is first necessary to understand what a PVR is.PVR certificates are a form of IP protection that are separate from patents and are designed specifically for new plant varieties. PVRs protect against unauthorized commercial activity or use of a protected variety, with <a href="https://www.upov.int/databases/en/#QS13" target="_blank">over 150,000 total active titles worldwide as of 2022</a>. The most common legal framework for PVR protection is outlined in the <a href="https://upovlex.upov.int/en/convention" target="_blank">UPOV Convention</a>. Each UPOV <a href="https://www.upov.int/members/en/" target="_blank">Member jurisdiction</a> ultimately provides and implements its own PVR laws and regulations that are consistent with the UPOV Convention to which they are signatory, but UPOV’s “Explanatory Notes” (which provide non-binding guidance for understanding and implementing various terms or provisions of the UPOV Convention) can influence how a Member implements and interprets its PVR laws.There are two current versions of the UPOV Convention, 1978 and 1991, which have some differences in PVR requirements and the scope of protection. One key difference is that the 1991 UPOV Convention introduces the concept of EDVs and provides coverage to the certificate owner of a protected variety over varieties essentially derived from the protected variety (i.e., EDVs).The core definition of an essentially derived variety (EDV) comes from Article 14(5)(b) of the 1991 Act of the UPOV Convention (emphases added):A variety shall be deemed to be essentially derived from another variety (“the initial variety”) when:(i) it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety(ii) it is clearly distinguishable from the initial variety and(iii) except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety.By way of example, the <a href="https://www.ams.usda.gov/services/plant-variety-protection" target="_blank">U.S. Plant Variety Protection</a> law (which is administered by the U.S. Department of Agriculture and is in line with the 1991 UPOV Convention) provides a non-exhaustive list of how EDVs can be made, including by: 1) the selection of a natural or induced mutant or of a somaclonal variant, 2) the selection of a variant individual from plants of the initial variety, 3) backcrossing, 4) transformation by genetic engineering, and 5) other methods. (7 USC 57 §2401 (a)(4)(A)).The third and most recent EDV Explanatory Note was published on October 27, 2023, and was prepared to address the fact that the previous EDV Explanatory Note, which was published in April 2017, no longer reflected breeders’ common practices in understanding EDVs and was insufficient to address the development of new breeding technologies (e.g., gene editing). The updated guidelines provide additional guidance for two key terms used in the definition of an EDV: “predominantly derived” and “essential characteristics.” Each of these is outlined below.Predominantly DerivedThe Explanatory Note explains that “predominant” derivation means that more of the genome of the initial variety is retained than would be retained by normal crossing and selection with different parents. This definition reinforces that a variety should only be considered predominantly derived from the initial variety if it retains almost the whole genome of its initial variety. Varieties with a single parent (“mono-parental” varieties) are considered per se predominantly derived from their initial varieties. Mono-parental varieties include varieties that are the result of mutations, gene editing, and the like. The Explanatory Note also states that there is no upper limit on the number of characteristic differences between an initial variety and a variety predominantly derived from the initial variety. Thus, predominant derivation is primarily defined by the genetic similarity between the derived and initial varieties rather than changes in characteristics.Essential CharacteristicsRegarding “essential characteristics,” the Explanatory Note reinforces that these are characteristics that contribute to the “principal features, performance, or value” of a variety. Examples of essential characteristics include morphological, physiological, agronomic, industrial, biochemical, and commercial attributes of a variety. In addition, the Explanatory Note states that a “predominantly derived” variety can still be an EDV of an initial variety even if it doesn’t completely share the essential characteristics of the initial variety, as long as the missing essential characteristics are missing as a result of the act of derivation. The Explanatory Note also allows for essential characteristics to evolve over time.Concluding ThoughtsThis third EDV Explanatory Note appears to elevate the importance of genetic similarity between an EDV and the initial variety and opens the possibility that essential characteristics may not always be 100% shared between an EDV and the initial variety. This new guidance therefore may provide more latitude for creative “essential characteristics” arguments, but, on the other hand, may also narrow the options for “predominantly derived” arguments. On a practical level, these guidelines will most likely impact both traditional breeders of multi-parental varieties and gene editors who make targeted genetic changes in an initial protected variety to produce a new variety. This Note appears to increase the avenues for such edited varieties to be considered EDVs of their initial varieties, which means that, while a developer producing such an edited plant could still seek their own PVR protection for their edited (i.e., derived) variety (assuming it meets all the requirements for protection, e.g., distinctness, uniformity, and stability), depending on how the updated guidance reads on the technical changes in the derived variety, the developer of the derived variety may still face freedom-to-operate concerns regarding the PVR holder of the initial variety. That being said, and as noted above, UPOV Notes are non-binding guidance; it remains to be seen how various jurisdictions with EDV provisions on the books (e.g., the U.S. and many others) will react and how such issues may play out in infringement disputes.Overall, these updates should make the concept of EDVs more straightforward to apply to varieties produced by new breeding technologies. For more updates on plant variety rights, see our other recent <a href="https://www.mofo.com/resources/insights/240131-us-plant-variety-protection-office">post on PBRs in the U.S., Canada, and Japan</a>, and subscribe to our blog.