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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FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

Front-of-pack, Front-of-mind

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality

What is “Healthy?” Are Fats In?

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

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.

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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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Associate

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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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.

UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

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Sr Patent Agent

Cory Ellison is a patent agent in the San Francisco office of Morrison & Foerster. Dr. Ellison’s practice involves patent application drafting, patent prosecution, matters pertaining to plant variety 

Cory Ellison Ph.D.

Cory Ellison

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Patent Agent

Dr. Edith Pierre-Jerome focuses her practice on patent drafting and prosecution in areas related to molecular and cellular biology, biochemistry, microbiology, and plant genetics.

Edith A. Pierre-Jerome Ph.D.

Edith Pierre-Jerome

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UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)

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In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). 

CONSUMER/USER ISSUES[1]The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional health care services models, startups and established companies alike are positioning themselves to take advantage of the growing market for technologies and products that enable non-lab-based diagnostics capable of being purchased without a prescription and conducted entirely at home. But to minimize risk and maximize revenue, companies need to be careful in negotiating crucial provisions when contracting with third parties. MoFo’s LST+L Group provides a list of the top nine issues to consider when drafting and negotiating agreements with consumers around the commercialization of at-home diagnostics in the United States.Companies entering the at-home diagnostics space must take care to ensure that any user agreement governing the relationship between a company and its customers or end-users of a product is sufficient in scope and strength.<ol><li>Include the Ability to Change Your Offering</li></ol>Companies should take care to include the right to modify or discontinue any products or services at will or at least upon reasonable notice. Times are uncertain, and the past few years have demonstrated that companies may need to pivot their business to adapt to changing times. Failure to include the right to modify or discontinue an offering may obligate a company to continue servicing customers long after it has decided to move in a different direction.<ol start="2" class=""><li class="">Understand Your Counterparty and Other Stakeholders</li></ol>A company may have multiple channels for its offerings. A company may provide its offering (a) directly to users, (b) to partners such as employers or other businesses, who then provide this offering to their employees or other individuals, or (c) to a combination of the two.Companies should carefully consider how to structure their agreements so that all necessary parties are bound by terms to protect the company. This may include both a main agreement with a business counterparty and end-user terms binding individual users, such as through terms of service agreed to when opening a user account.<ol start="3" class=""><li class="">Include Favorable Intellectual Property Provisions</li></ol>Companies should take care to include a comprehensive claim of ownership of any and all proprietary rights in their diagnostic products. Additionally, for tests that involve some interaction with users, companies should consider explicitly obtaining from users the right to use users’ de-identified or anonymized information and test results for any and all internal research or commercial purposes, so as to allow for future avenues of research and development in addition to improving the specific product or service offered to the user. Companies should also consider including the right to generate anonymous and aggregate data sets using user information and test results and to use such information for any purpose, including publication and marketing.Moreover, users may, in the course of their communications with a company, provide feedback or suggestions. Without specifying the company’s rights to this feedback, the company may be left with unclear rights to use such feedback or may have an implied obligation to compensate the well-meaning user for such input. Companies should consider including a feedback provision that allows them to freely utilize and incorporate any such feedback into the creation of improvements to their products and services or in the development of new inventions. This is commonly accomplished through the inclusion of a present assignment provision or an unrestricted, royalty-free license to use and otherwise exploit any feedback.<ol start="4" class=""><li class="">Carefully Limit Permitted Purposes Through Use Restrictions</li></ol>Companies should consider including express limitations on the right of any user to use an at-home diagnostic (or the test results of such product) for any commercial purposes, any research or publication purposes, or any purpose other than for an individual user’s personal use. This provision may need to be modified when the counterparty for such user agreement is a business, such as an employer on behalf of a group of employees, a healthcare provider, or a school.<ol start="5" class=""><li class="">Limit the Scope of Any Applicable Software Licenses</li></ol>Many companies are pairing their at-home diagnostic devices with mobile software applications; as such, companies should ensure that their user agreement includes adequately narrow, non-exclusive license grants limited in scope. Companies should also include strong license restrictions that contain, in addition to other customary terms, prohibitions on the use of any software for commercial or research purposes, or any unauthorized reproductions, distributions, modifications, or reverse-engineering.<ol start="6" class=""><li class="">Include Relevant Disclaimers</li></ol>The sale of diagnostic devices, like other goods, is governed by Article 2 of the Uniform Commercial Code (the UCC). The UCC includes implied warranties of merchantability, fitness for a particular purpose, and non-infringement. Unless disclaimed, courts may read these implied warranties into a company’s user agreements. Companies should expressly disclaim these and any and all other warranties of any kind that are not explicitly set forth in the terms and conditions. Questions about liability regarding COVID-19 tests have largely been deferred while most companies have operated under the protection of the Public Readiness and Emergency Preparedness (PREP) Act’s immunity from liability (except for willful misconduct) for claims of loss caused by, arising out of, relating to, or resulting from administration or use of countermeasures to COVID-19.[2]<ol start="7" class=""><li class="">Include Strong Indemnification Provisions</li></ol>Companies should clearly state that individual users are solely responsible for all acts and omissions arising from or in connection with any access or use of at-home diagnostics, and that such users must comply with all provided instructions and terms of use. It is important to allocate responsibility such that the users of the product, not the company, accept all consequences arising from or in connection with any access or use of such products.Companies should consider including favorable indemnity provisions that require users to defend and indemnify the company for all costs and expenses incurred by the company from third-party actions arising out of the user’s actual or alleged (a) access to or use of any products, or (b) violation of any terms, instructions, or applicable law.<ol start="8" class=""><li class="">Include Favorable Limitation of Liability Provisions</li></ol>Companies should take care to include limitations on their liability pursuant to any user agreement, including express disclaimers of any indirect, incidental, consequential, special, exemplary, punitive, or multiple damages, including for lost profits. Such provisions should also be drafted to clearly indicate a company’s aggregate liability amounts, which should be limited to the amount paid for the specific device.<ol start="9" class=""><li class="">Pay Attention to the Privacy Policy</li></ol>The company’s privacy policy should provide sufficient notice to individuals to comply with U.S. and foreign privacy laws regarding the collection, use, retention, disclosure, and other processing of personal information, including through the company’s products and services. This will be of particular salience if a company is marketing at-home diagnostics that require a user to upload data to third-party processors, or if a company will send user information to health consultants, healthcare providers, or other third parties. Additionally, companies should take care to cover any other reporting requirements mandated by public health authorities or other applicable law or regulations. Companies that contract with a business counterparty should similarly take care to provide clarity to both the third-party partner and each individual user regarding the applicable privacy policy.Furthermore, companies active in this space are often anticipating a future merger, sale, or other exit. As such, it is important that companies include the right to transfer their rights to any user information in connection with any actual or proposed asset transfer, merger, or change of control.[1] This is the first in a series of three articles addressing the licensing and regulatory considerations for at-home diagnostic companies.[2] According to the HHS PREP Act website, “[i]n general, the liability immunity applies to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures described in a [PREP Act] Declaration.”

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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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Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group.
Matt’s practice focuses on strategic transactions involving intellectual property (IP), techno