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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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 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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Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

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Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

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Update: On November 2, FDA <a href="https://www.fda.gov/food/cfsan-constituent-updates/fda-proposes-rule-revoke-regulation-allowing-use-brominated-vegetable-oil-bvo-food" target="_blank">issued a proposed rule</a> to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. FDA is basing the proposed rule on studies it conducted that FDA says demonstrate adverse health effects in animals approximating real-world human exposure levels. Comments on the proposed rule can be submitted until January 17, 2024.This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California.  The law bans the manufacture, sale, and distribution of four food additives used in over 12,000 different food products: brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3. The History and the AdditivesThe California Food Safety Act makes California the first state in the country to ban the use of brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3 in food products.  But these types of bans are not novel.  All four ingredients are currently banned in the European Union.[1] <ul dir="ltr"><li dir="ltr">Brominated vegetable oil (BVO), which can be added to beverages to keep citrus flavor from separating, has also been banned in Japan in part over allegations about neurologic symptoms in people who drink large amounts of citrus soda.[2] While BVO is regulated as a food additive, the U.S. Food and Drug Administration (FDA) has stated that over the years, many beverage makers have reformulated their products to replace BVO with alternative ingredients, and few beverages sold in the United States today contain the additive.[3]  In May 2022, the FDA published a study suggesting that high levels of BVO had negative effects on rodents and the FDA is currently working on a proposed rule to remove authorization for the use of BVO as a food ingredient.[4]</li></ul><ul dir="ltr"><li dir="ltr">Potassium bromate, which can be added to baked goods to help dough strengthen and rise, allegedly has harmful effects on the respiratory and nervous systems when consumed in large quantities. In addition to the European Union, potassium bromate is currently prohibited in China, South Korea, Sri Lanka, Canada, Brazil, Peru, India, Colombia, and Singapore.[5]</li></ul><ul><li dir="ltr">Propylparaben, which is used in food preservation, has been allegedly linked to reproductive health concerns. In addition to the European Union, propylparaben is currently prohibited in Japan, China, Sri Lanka, and Singapore.[6]</li></ul><ul dir="ltr"><li>Red Dye No. 3, which is a color additive providing a bright, cherry-red color, has been banned for use in cosmetics and externally applied drugs in the United States since 1990, when the FDA determined that it “causes a carcinogenic response in rats.”[7] The European Union restricted its use in food to only candied cherries and cocktail cherries in 1994.  Australia and New Zealand also restrict its use to just cocktail cherries and frosting.[8]  In October 2022, 24 scientists and consumer and health groups, including the Washington, D.C.-based nonprofit watchdog and consumer advocacy group, the Center for Science in the Public Interest, called on the FDA to ban the use of Red Dye No. 3 in foods.</li></ul>The Law and the ImpactThe California Food Safety Act passed the state legislature on September 12, 2023, almost unanimously with only six no votes. The law will go into effect on January 1, 2027, allowing manufacturers time to reformulate products without the prohibited food additives.  California Governor Gavin Newsom dubbed the law a “positive step forward” while the FDA reviews the additives and considers additional regulations.[9] The National Confectioners Association (NCA), however, has accused California lawmakers of “making decisions based on soundbites rather than science.”[10]  The NCA further cautioned that this is a “slippery slope” and it could create confusion around food safety and increase food costs for consumers.[11] Violations of the California Food Safety Act will be punishable by a civil penalty of up to $5,000 for the first violation and up to $10,000 for each subsequent violation.While it is too soon to tell the impact that the law will have on California’s grocery store aisles, manufacturers may need to change their operations to accommodate the new California Food Safety Act.  Given that these additives have been banned in several countries, it is likely the change will not be a complex one, but California’s law could kickstart a trend among other states. For example, a similar bill to ban the same four additives, plus titanium dioxide, was introduced by New York’s legislature in March 2023.[12] And California’s new law could signal a trend that may influence the FDA’s rulemaking on food additives. On the class action side, the law could further usher in a wave of “healthy” food lawsuits, where plaintiffs challenge the ingredients in and labeling of food products. Morrison Foerster will continue to monitor the impact of the California Food Safety Act and any FDA actions on food additives and is available to provide legal guidance to clients on the potential regulatory, advertising, and class action litigation matters.[1] <a href="https://www.msn.com/en-us/health/nutrition/california-ban-on-4-food-additives-sparks-outrage-slippery-slope/ar-AA1hWCxi" target="_blank">https://www.msn.com/en-us/health/nutrition/california-ban-on-4-food-additives-sparks-outrage-slippery-slope/ar-AA1hWCxi</a>.[2] https://www.foodnetwork.com/healthy/articles/brominated-vegetable-oil-dangers-side-effects.[3] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo" target="_blank">https://fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo</a>.[4] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo" target="_blank">Id.</a>[5] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo" target="_blank">Id.</a>[6] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo">Id.</a>[7] 55 Fed. Reg. 3520 (Feb. 1, 1990), available at <a href="https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf">https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf</a>.[8] <a href="https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf">Id.</a>[9] <a href="https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf">Id.</a>[10] <a href="https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/">https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/</a>.[11] <a href="https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/">Id.</a>[12] https://legislation.nysenate.gov/pdf/bills/2023/S6055A.

Nature's Path Foods

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Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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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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Lena is an associate in the Litigation Department in Morrison Foerster’s San Francisco office. Lena’s practice focuses on commercial and class actions litigation, with an emphasis on false advertising, unfair competition, and antitrust. Lena regularly counsels clients in the food and beverage, dietary supplement, cosmetics, retail, and technology sectors.











Lena Gankin

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Marcus Grimes is an associate in the Litigation Department in Morrison Foerster’s San Francisco office.

Marcus Grimes

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This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California.  The law bans the manufacture, sale, and distribution of four food additives used in over 12,000 different food products: brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3. 

Golden State Crackdown—Unpacking California’s Landmark Food Safety Act

Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application and have different expiration dates due only to patent term adjustment (PTA).The case involves several Cellect patents (’369, ’742, ’626, ’621, and ’036) related to image sensors in personal digital assistants and phones. These patents are in a single patent family with a shared priority claim and 20-year expiration date. However, the patents received varying amounts of PTA due to delay in examination by the U.S. Patent Office. After Cellect sued Samsung for infringement, Samsung requested ex parte reexamination of Cellect’s patents, asserting that they were unpatentable for ODP over earlier-expiring family members. The examiner agreed in each of the reexaminations and the Patent Trial and Appeal Board (the “Board”) affirmed the unpatentability findings.<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt45b201f9a4e9a120/6504a54720c4f9e2476fe36e/Screenshot_2023-09-15_113915.jpg?format=auto&amp;quality=60" alt="Patent Term Adjustment "/></div>On appeal, Cellect argued that PTA should be treated like patent term extension (PTE) for purposes of considering ODP, citing Novartis v. Ezra.[1] In Novartis, the Court held that PTE can be applied to a terminally disclaimed patent and that PTE extends disclaimed patents from the date resulting from the terminal disclaimer. Cellect stressed that, based on Novartis, a statutorily mandated extension should not be reduced by a judge-made doctrine like ODP.The Federal Circuit affirmed the Board, noting the “distinct purposes”[2] of PTE and PTA. Specifically, PTE is applied to a single patent to compensate for regulatory delay during FDA approval, whereas PTA is applied for delay by the Patent Office. Pointing to statutory language under 35 U.S.C. § 154 for PTA that differs from the provisions in § 156 for PTE, the Federal Circuit concluded that “ODP for a patent that has received PTA, regardless whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.”[3]Finally, although holding the issue forfeited in this case, the Federal Circuit commented on the issue of “retroactive”[3] terminal disclaimer, observing that “terminal disclaimer is not an escape hatch to be deployed after a patent expires.”[4] Because the challenged patent claims had already expired, terminal disclaimer could not be used to cure the ODP issue.This decision underscores the significance of ODP and the importance of properly managing large patent families and/or portfolios of patents with different terms. Patent applicants should continue to employ strategies to mitigate ODP risk, such as invoking restriction requirements and filing divisional applications, which are protected by the 35 U.S.C. § 121 safe harbor. Applicants must now carefully consider the consequences of whether and when to file a terminal disclaimer.  Applicants should also be discerning about whether to file continuing applications and which claims to pursue in such applications, especially if PTA could be involved, given the potential ODP impact.[1] Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018).[2] In re: Cellect, LLC, No. 2022-1293 (Fed. Cir. 2023), p. 18.[3] In re: Cellect, LLC, No. 2022-1293 (Fed. Cir. 2023), pp. 20-21.  See also 35 U.S.C. § 154(b)(2)(B) (“No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer.”).[4] In re: Cellect, LLC, No. 2022-1293 (Fed. Cir. 2023), p. 25.

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. 

Patent Term Adjustment Takes a Hit in Cellect Decision

Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application and have different expiration dates due only to patent term adjustment (PTA).

Patent Term Adjustment Takes a Hit in Cellect Decision

Should the recent bill entitled the Patent Eligibility Restoration Act of 2023 (PERA) become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101.By way of the Patent Act of 1952, the United States Congress established four statutory categories defining limits on inventions eligible for patent protection that are still in use today: process, machine, manufacture, and composition of matter.<a href="#_ftn1" target="_self" dir="ltr" id="_ftnref1">[1]</a> On its face, this framework would appear to allow for the patenting of medical diagnostics, which often revolve around a process and/or machine (e.g., a diagnostic device). However, the current patent-eligibility environment in the United States surrounding medical diagnostics is unforgiving and those seeking to patent such inventions face significant challenges in trying to protect their innovations. This is largely due to courts having created, in their established role of interpreting and applying laws, judicially recognized exceptions to the four broad categories of patent-eligible subject matter that bar the patenting of abstract ideas, laws of nature, and natural phenomena.<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a>Foundational to a medical diagnostics invention is the underlying correlation of a result to a condition (e.g., the level of a protein correlating with presence of a human disease). Mayo, an opinion handed down by the Supreme Court in 2012, cemented the basic idea that, for medical diagnostics, such underlying correlations are laws of nature and are not patent-eligible without claiming significantly more than the natural law itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). A patchwork of additional jurisprudence has built up over the decade since Mayo, establishing additional patent-eligibility roadblocks for the patenting of medical diagnostics. Recently, U.S. Senators Tillis and Coons introduced legislation aiming to provide clarity to patent eligibility in a bill titled the Patent Eligibility Restoration Act of 2023 (PERA).<a href="#_ftn3" target="_self" id="_ftnref3">[3]</a> Should this bill become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101. There is currently no language in PERA expressly stating that medical diagnostics inventions are per se patent-eligible. However, as both senators have singled out the field of medical diagnostics in <a href="https://www.tillis.senate.gov/2023/6/tillis-coons-introduce-landmark-legislation-to-restore-american-innovation" target="_blank">public statements regarding the bill</a>, it is readily apparent that a driving purpose of PERA is to foster innovation in this space by eliminating the current hurdles to patent eligibility (e.g., Senator Coons is quoted as stating “[c]ritical technologies like medical diagnostics and artificial intelligence can be protected with patents in Europe and China, but not in the United States”). Here, we discuss select aspects of the bill that would change the current legal landscape in this field to allow for the direct patenting of medical diagnostics in the United States (e.g., a method of diagnosing a disease in an individual).Restarting the clock on statutorily defined patent subject-matter eligibilityAs noted above, judicially recognized exceptions to the four categories of patent-eligible subject matter are significant obstacles when pursuing patent protection of medical diagnostics. PERA would expressly eliminate all current judicial exceptions to patent subject-matter eligibility. This does not mean that exceptions will not exist. Rather, PERA will establish new exceptions (many of which are based on currently practiced and accepted exceptions). Specifically, PERA provides that “[w]hoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in subsection (b) and to the further conditions and requirements of this title” (emphasis added).Hope for broader subject-matter eligibility of medical diagnosticsWith relevance to medical diagnostics, under the Eligibility Exclusions detailed in PERA (subsection (b)), it is stated that “a person may not obtain a patent for any of the following, if claimed as such; . . . (C) A process that (i) is a mental process performed solely in the human mind; or (ii) occurs in nature wholly independent of, and prior to, any human activity.” This language would appear to stop exceptions to patent eligibility short of the current reach of judicially recognized exceptions. For example, one could apply the language of PERA to claims in question in Mayo and reasonably conclude that the active steps therein (e.g., administering a drug and determining the level of an analyte) are human activities that do not occur in nature wholly independent of, and prior to, any human activity.<a href="#_ftn4" target="_self" dir="ltr" id="_ftnref4">[4]</a> This aspect of PERA signals that medical diagnostics will be patent-eligible should they be carefully drafted to include features readily distinguishable from capabilities of the human mind and/or features demonstrating human activity related to performance of such medical diagnostics.We find additional confirmation that PERA will allow for medical diagnostics to be generally subject-matter-eligible under subsection (c). Subsection (c) states that “eligibility shall be determined . . . (B) without regarding to . . . (ii) whether a claim element is known, conventional, routine, or naturally occurring.” There are two aspects worthy of discussion here as they represent a distinct departure from current patent subject-matter eligibility law. Firstly, under current law, having a claim element that is directed to the naturally occurring (such as the underlying correlation of a medical diagnostics) results in an analysis of the claimed invention where one is forced to establish why the subject matter is in fact patent-eligible. Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). The language in subsection (c) flips this current notion on its head and in some regards preserves more of a presumption of patent eligibility, whether or not there is a claimed feature that can be attributed to a naturally occurring phenomenon. Under PERA, it seems likely that one will then need to establish why a claimed invention, when viewed as a whole, is not eligible for patent protection for reasons other than containing a naturally occurring phenomenon, as one element.Secondly, subsection (c) expressly prohibits assessing, for purposes of subject-matter eligibility, whether a claimed element is “conventional” or “routine.” Current subject-matter eligibility law is becoming increasingly entangled with assessing conventionality.  Such language could change how court cases are being decided today. In CareDx, for example, a Federal Circuit court held that claims to noninvasive detection of graft rejection in transplant patients were unpatentable subject matter under 35 U.S.C. § 101 because they involved detection of a natural phenomenon using only conventional techniques. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371, 1381 (Fed. Cir. 2022). In a similar fashion, in Ariosa Diagnostics, a Federal Circuit court held that claims to detecting paternally inherited nucleic acid of fetal origin performed on material serum or plasma were also not subject-matter-eligible as they only recited known methods of analyzing fetal DNA. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). Under PERA, subject-matter eligibility determinations may avoid such a reliance on conventionality of techniques. This would be a significant change in patenting medical diagnostics as there is a commercial drive for developing medical diagnostics that can be performed using “conventional” or “routine” techniques (e.g., conventional PCR or mass spectrometry) to enable widespread adoption.Next stepsPERA is still in its infancy as a bill. We are continuing to monitor developments related to PERA and will provide relevant updates. If you have any questions about this topic or would like to discuss patenting your own medical diagnostics inventions, please reach out to MoFo’s Patent Strategy + Prosecution team.Special thanks to Janet Xiao, Meghan Poon, and Laura Ray for the development of this article.<a href="#_ftnref1" target="_self" dir="ltr" id="_ftn1">[1]</a> Title 35, United States Code, section 101.<a href="#_ftnref2" target="_self" dir="ltr" id="_ftn2">[2]</a> E.g., Diamond v. Diehr, 450 U.S. 175, 185 (1981).<a href="#_ftnref3" target="_self" dir="ltr" id="_ftn3">[3]</a> Patent Eligibility Restoration Act of 2023, S.2140, June 22, 2023.<a href="#_ftnref4" target="_self" id="_ftn4">[4]</a> U.S. Patent Nos. 6,355,623 and 6,680,302.

A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

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Patent Agent

Dr. Michelle Bradley focuses her work on patent drafting and IP due diligence inquiries, including freedom-to-operate and patentability analyses, with an emphasis on biotechnology and pharmaceuticals.

Michelle Celine Bradley Ph.D.

Michelle Bradley