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.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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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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In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

Earlier in 2024, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent Cooperation Treaty (PCT) and is also rolling out a new Gene Editing (GE) Decree. Together, these changes reflect major updates to Uruguay’s intellectual property (IP) system broadly.Plant regulation and IP are particularly important in Uruguay, and the country is often on the shortlist of top target destinations for IP filings in agriculture, as it has the capacity to grow food for its own population as well as much of the rest of the world.For further information, read our more detailed <a href="https://www.mofo.com/resources/insights/240808-updates-in-uruguay-accession" target="_self">client alert</a>.Marley Macarewich, a summer associate in Morrison Foerster’s San Francisco office, contributed significantly to this post.

Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

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Associate

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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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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Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

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Earlier in 2024, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent Cooperation Treaty (PCT) and is also rolling out a new Gene Editing (GE) Decree. 

After overhauling its <a href="https://www.aphis.usda.gov/biotechnology" target="_blank">biotechnology regulations</a> for <a href="https://lifesciences.mofo.com/topics/purple-tomato-is-first-genetically-engineered-plant-to-be-deregulated-through-usda-s-new-regulatory-status-review-process?_gl=1*1ko2alj*_ga*MTQxNjc1MjY0LjE3MTg3NDExMTY.*_ga_3HVRG7GH76*MTcyMTI4MjEwOC4xNy4xLjE3MjEyODIxNjQuMC4wLjA." target="_blank">plants developed</a> using <a href="https://www.mofo.com/resources/insights/231115-comment-morphing-us-biotechnology-regs" target="_blank">genetic engineering</a>, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its regulatory procedures, both by opening the door to major regulatory changes for microbes developed through genetic engineering and by surveying the results of its previous changes for plant regulation.In July, APHIS requested public comment regarding modified microbe regulation and released a biotechnology regulation enforcement summary. Comments are due September 3, 2024. In June, APHIS released its biotechnology regulation impact report for 2023. These announcements, which highlight the morphing U.S. regulatory landscape for genetically engineered plants and microbes, are described in detail below.Invitation for Public Comment on Modified Microbe RegulationOn July 2, 2024, APHIS announced the opening of a 60-day public comment period on a Request for Information (RFI) that explores options to reduce the regulatory burden for modified microbes (available now in the <a href="https://www.regulations.gov/document/APHIS-2024-0002-0001" target="_blank">Federal Register</a>). APHIS requests comments from the public regarding pathways to commercialization, including needs, ideas, and concerns, regarding possible risk-based deregulation of modified microbes and other potential regulatory and non-regulatory pathways to commercialization.Comments should be received on or before September 3, 2024, and can be submitted either electronically through the <a href="https://www.regulations.gov/" target="_blank">Federal eRulemaking Portal</a> (Docket No.: <a href="https://www.regulations.gov/document/APHIS-2024-0002-0001" target="_blank">APHIS-2024-0002</a>) or mailed in.APHIS BRS InvestigationsSeparately, on July 9, 2024, APHIS <a href="https://www.aphis.usda.gov/news/agency-announcements/aphis-posts-investigative-enforcement-services-annual-enforcement-data-0" target="_blank">released</a> its Enforcement Services Annual Enforcement Data Report overviewing how it enforced its regulations in the 2023 fiscal year. For example, the Report summarized enforcement data regarding regulatory correspondence to parties involved in an alleged violation, charging a stipulated penalty, and referring the case to the USDA or U.S. Department of Justice for further action.Among this data, APHIS included a section on enforcement relating to its Biotechnology Regulatory Services (BRS), which included initiation of one case by APHIS’s Investigative and Enforcement Services (IES). This summary is notable as it is one of the first published reports of enforcement and associated penalties from the revised biotechnology regulations for plants produced through genetic engineering.APHIS Releases 2023 Impact Report – Safe Biotechnology ProductsIn June, APHIS <a href="https://www.aphis.usda.gov/news/agency-announcements/aphis-releases-2023-impact-report" target="_blank">issued</a> its 2023 Impact Report noting its accomplishments last year. One of the areas of focus was on safe biotechnology products, through which APHIS promoted crops that help achieve climate goals and are healthier to eat, while ensuring that these products are safe to eat and grow. The full report can be found on the <a href="https://www.aphis.usda.gov/sites/default/files/aphis-impact-report-2023.pdf" target="_blank">USDA website</a>.The activities described in the report represent robust use of APHIS’s revised regulations for engineered plants. The report also shows that the agency is gaining momentum and becoming increasingly nimble at administering its now four-year-old revised regulations.Many if not all of these topics and more will likely be discussed live with the public at APHIS’s annual stakeholder meeting, which is scheduled for <a href="https://www.aphis.usda.gov/biotechnology/meetings" target="_blank">November 14, 2024, and the agency is soliciting topics for discussion by email</a>.For further information, read our more detailed client alert. Marley Macarewich, a summer associate in Morrison Foerster’s San Francisco office, contributed significantly to this post.

Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS

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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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Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS

New DCMA Defective Pricing Pilot Team Will Possess Audit Resolution Authority

In July, APHIS requested public comment regarding modified microbe regulation and released a biotechnology regulation enforcement summary. Comments are due September 3, 2024. In June, APHIS released its biotechnology regulation impact report for 2023.

Article III standing can differ from the statutory requirements of 35 U.S.C. § 281 in patent cases. In certain instances, a secured creditor can obtain rights that become actionable only upon default, which may include the ability to license or enforce a patent. However, these rights may not necessarily correspond to patent ownership. Because Article III standing must exist when a case is filed, parties planning to file a complaint should consider the issue carefully beforehand. The precedential decision of Intellectual Tech LLC v. Zebra Techs. Corp.<a href="#fn1" target="_self">[1]</a> illustrates this scenario.OnAsset granted a security interest in U.S. Patent No. 7,233,247 to Main Street Capital Corporation (“Main Street”) as part of a loan agreement.<a href="#fn2" target="_self">[2]</a> Several years later, OnAsset formed Intellectual Tech LLC (“IT”) as its subsidiary and assigned the same patent to IT,<a href="#fn3" target="_self">[3]</a> which then granted a security interest in the patent to Main Street.<a href="#fn4" target="_self">[4]</a> Subsequently, OnAsset and IT each defaulted on their respective agreements,<a href="#fn5" target="_self">[5]</a>which afforded Main Street the option to sell, assign, transfer, and/or enforce the patent.<a href="#fn6" target="_self">[6]</a> IT later sued Zebra Technologies (“Zebra”) for infringing the patent.<a href="#fn7" target="_self">[7] </a>The district court granted Zebra’s motion to dismiss for lack of Article III standing, determining that Main Street’s right to license deprived IT of all its exclusionary rights, even if those rights were not exercised.<a href="#fn8" target="_self">[8]</a>On appeal, the Federal Circuit emphasized that Article III standing is a jurisdictional requirement not curable by joinder and, in contrast,<a href="#fn9" target="_self">[9] </a>whether a party qualifies as a “patentee”<a href="#fn10" target="_self">[10]</a> under 35 U.S.C. § 281 is not a jurisdictional requirement<a href="#fn11" target="_self">[11] </a>and is curable by joinder.<a href="#fn12" target="_self">[12]</a> In reversing the lower court’s ruling, the Federal Circuit found that (1) the triggering of Main Street’s unexercised option to assign did not automatically deprive patent owner IT of all its rights,<a href="#fn13" target="_self">[13] </a>and (2) the shared ability to license while a default existed did not divest IT of all exclusionary rights, noting that IT still suffers an injury-in-fact from infringement even if Main Street and IT can both license the patent.<a href="#fn14" target="_self">[14]</a> The Federal Circuit concluded that, because Main Street did not exercise any options under the agreements, IT was not presently divested of all exclusionary rights.<a href="#fn15" target="_self">[15]</a>For further information, read our <a href="https://www.mofo.com/resources/insights/240626-federal-circuit-wades-into-article-iii" target="_self">more detailed client alert</a>.***** <a href="#fnref-1" target="_self">[1] </a>Intellectual Tech LLC v. Zebra Techs. Corp., No. 2022-2207 (Fed. Cir. May 1, 2024).<a href="#fnref-2" target="_self">[2]</a> See Intellectual Tech LLC, 2022-2207, slip op. at 3.<a href="#fnref-3" target="_self">[3]</a> See id.<a href="#fnref-4" target="_self">[4]</a> See id.<a href="#fnref-5" target="_self">[5]</a> See Intellectual Tech LLC, 2022 WL 1608014, at *3–4.<a href="#fnref-6" target="_self">[6]</a> See id., at *3. See also Sections 3(j), 6(b), and 6(c) of the Agreements.<a href="#fnref-7" target="_self">[7] </a>See Intellectual Tech LLC, 2022 WL 1608014, at *1.<a href="#fnref-8" target="_self">[8] </a>See id., at *7.<a href="#fnref-9" target="_self">[9] </a>See Intellectual Tech LLC, 2022-2207, slip op. at 9.<a href="#fnref-10" target="_self">[10]</a> See id. See also 35 U.S.C. § 100(d).<a href="#fnref-11" target="_self">[11]</a> See Intellectual Tech LLC, 2022-2207, slip op. at 10.<a href="#fnref-12" target="_self">[12]</a> See id., at slip op. at 11.<a href="#fnref-13" target="_self">[13]</a> See id., at slip op. at 11–12.<a href="#fnref-14" target="_self">[14]</a> See id., slip op. at 14.<a href="#fnref-15" target="_self">[15]</a> See id., slip op. at 16.

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Of Counsel

Mark D. McBriar focuses his practice on patent drafting and prosecution, IP due diligence, freedom to operate, patentability evaluations, re-examinations, and litigation support. Dr. McBriar works wit

Mark D. McBriar Ph.D.

Mark McBriar

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Federal Circuit Wades Into Article III Standing in Patent Cases Once Again

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Article III standing can differ from the statutory requirements of 35 U.S.C. § 281 in patent cases. In certain instances, a secured creditor can obtain rights that become actionable only upon default, which may include the ability to license or enforce a patent.

Federal Circuit Wades Into Article III Standing in Patent Cases Once Again

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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Jeffrey Schmidt

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