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.

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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

The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five areas to watch:1. What is the impact on other technology?The Court emphasized that “aspects of antibody science remain unpredictable.” How will courts evaluate the predictability of other technologies, such as nucleic acid and gene editing technologies, small molecules, and artificial intelligence?Providing some direction, the Court explained that it might suffice to disclose one or a few examples if there is “some general quality” running through the class that would reliably enable a person skilled in the art to make and use the entire class of molecules. This suggests that other technologies may be better situated to withstand enablement attacks. As an example, unlike antibodies, the target of an antisense oligonucleotide can be determined by its sequence alone, suggesting that the reasoning applied by the Court to antibodies to limit the scope of claims may not be as generalizable as it first appears.2. What is the outlook for other antibody claim types?It is not yet clear how the Court’s decision will be applied to other antibody claim types, particularly where the innovation is not centered on antigen binding properties of an antibody. Examples include chimeric antigen receptor therapies, antibody-drug conjugates, modifications to antibodies outside of the antigen binding region (e.g., Fc mutations), and methods that use antigen binding moieties. Functional genus claims that sweep in a broad class of well-characterized antigen binders may not suffer from the same unpredictability in determining the sequence of antibody variable domains that are responsible for conferring antigen or epitope binding, which the Court relied upon heavily in making its determination. These types of inventions may be in a stronger position to obtain broader claims. 3. How will AI impact antibody patents going forward?Predictability of a given technology is an important consideration for enablement. In this case, the Court noted that translating an antibody’s amino acid “sequence into a known three-dimensional structure is still not possible.”But artificial intelligence (AI) and machine learning based computational models for predicting protein structures are rapidly evolving.[1] Will courts respond in the future by allowing broader functional claims as the link between amino acid sequence, three-dimensional structure, and functional properties becomes more predictable?At a minimum, applicants should consider how developments in AI can be harnessed to enable broader claim scope at the time of filing a new application and even during prosecution as these developments continue to play out.4. Will the doctrine of equivalents (DOE) be applied more regularly moving forward?The doctrine of equivalents has rarely been applied to claims reciting sequences of large molecules. But in Ajinomoto v. ITC (2019), the Federal Circuit made it clear that DOE can apply to a claim reciting amino acid sequences.In the future, we may see more examples of patent owners asserting DOE, particularly when enablement of broader, literally infringed claims is questionable. Patent owners and applicants should monitor how DOE-related issues play out in the district courts and at the Federal Circuit.5. Are claims that recite conservative substitutions or percentage identity thresholds still viable?While not ruling out enablement of such claims, the Supreme Court’s opinion may cast a shadow over enablement of claims reciting conservative substitutions or percentage identity thresholds for antibodies or other proteins. The Court noted that conservative substitution “requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too,” concluding that it was “[n]ot much different” than a roadmap for de novo antibody discovery.The Court left the door open for enablement of conservative substitution for other claims, such as where the inventor identifies a quality common to the functional embodiments. But the holding could have a wide-ranging impact on protein and nucleic acid claims beyond antibodies, such as enzyme and nucleic acid sequences that allow sequence variation.Subscribe to MoFo Life Sciences to stay up to date on the latest developments impacting IP protection of life science tools, biologics, and pharmaceuticals. [1] See, e.g., Ruffolo et al., Fast, accurate antibody structure prediction from deep learning on massive set of natural antibodies, Nat. Commun. 14, 2389 (2023).

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. 

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The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants.

Five Questions after Amgen v. Sanofi

Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion. This article originally appeared on JDSupra and is reprinted with permission.In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications submitted to the US Food and Drug Administration contained artificial intelligence and machine learning (AI/ML) components.According to Brigid Bondoc, Partner at Morrison Foerster in Washington, DC, the FDA shares an industry optimism that "AI/ML can help bring safe, effective, and high-quality treatments to patients faster," to quote Patrizia Cavazzoni, M.D., the director of the Center for Drug Evaluation and Research (CDER) at the FDA.How the agency evaluates and manages emerging AI/ML technologies in drug and biologic applications were addressed in the panel "Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape," presented by Morrison Foerster (MoFo), on May 11, 2023, at the Association for Corporate Counsel (ACC) live CLE event "2023 Life Sciences Conference: Future-Ready Resilience: Preparing to Face Challenges in the Uncertain Future."The panel, consisting of Bondoc; Anna Yuan, Senior Associate at MoFo; Wendy Chow, counsel to MoFo; and Lauren Wu, Head of Privacy, Sr. Dir. of Legal for Regulatory and Compliance, US Privacy Officer, and Global DPO at Evidation Health, discussed the evolving FDA policies and regulation on AI, data privacy implications, and protecting AI technology in life sciences.FDA RegulatoryBondoc presented the big picture on the FDA's AI regulation, where the agency actively monitors AI/ML software in medical devices and clinical developments. The agency may expand coverage into FDA-regulated activities, such as automation and learning of medical devices, diagnostic and therapeutic development efficiency, regulatory assessment, and post-market surveillance.The 21st Century Cures Act excludes five types of software from the FDA's medical device definition and regulation, including administrative support software, wellness, and electronic patient records. Still, the act allows the FDA to "claw back any exception if it identifies risks associated with the software as a medical device," said Wu. With AI technologies, wellness, and electronic records, "the waters get muddier," commented Wu—for example, what to do with a pedometer that monitors sleep and blood pressure. It may become more than a wellness device and move into the regulated medical device space.The FDA appears flexible and careful in developing an AI/ML regulation framework, offsetting the need to facilitate innovation while protecting public health. For example, Bondoc pointed to the agency's drafted guidance on Predetermined Change Control Plans (PCCP) for AI/ML-enabled device software functions, attempting to address a significant issue facing emerging technology.Historically, changes to a cleared or approved medical device that could significantly affect the safety or effectiveness of the device required submitting a premarket notification 510(k). Yet, the notification program is "fundamentally at odds with the use of AI/ML in medical devices that facilitate continual improvements and modifications to the device based on data gathered while in use," said Bondoc. The FDA aims to develop a regulatory approach tailored to AI/ML-enabled devices, allowing for safe and rapid modifications in response to new data while ensuring safety and effectiveness.The FDA sees ethical, privacy, and security issues using AI/ML in drug development. The agency is also concerned with the lack of transparency in algorithms that can lead to amplification errors or preexisting biases. "Although recognizing the problem, the potential regulatory solutions have yet to be provided," said Bondoc. Still, the agency aims to prevent algorithmic discrimination and advance the use of AI/ML techniques. It recently released a discussion paper, "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." And to further address issues of AI in drug manufacturing, the FDA released “Artificial Intelligence in Drug Manufacturing.”Protecting AI Technology in Life SciencesYuan confirmed an eight-fold increase in AI patents from 2017 to 2020, citing WIPO Technology Trends 2019: Artificial Intelligence and Mondaq, and observed a shift in the types of things patented. In the past, patents were more theoretical, such as novel AI algorithms for speech recognition. Nowadays, there are more patents on concrete, practical applications of machine learning in drug discovery and medical diagnostics.Patent applications include novel, practical applications of AI algorithms, drugs developed by AI, and computer hardware configurations and optimizations to facilitate AI training and inference processes. The patents fall into two buckets: one, the application of known AI to specific fields and sectors, and two, new AI models and algorithms. Yuan said the first is generally a higher value in patenting with broader and more detectable claims vis-à-vis the second with narrow and mathematically oriented claims.Privacy and AIThe use of AI/ML in life sciences involves data from individuals, even protected health information (PHI). At some point, whether it is the process's training input, inference, or output, the data use may run afoul of state privacy laws, implicate new legislation regulating AI and automated decision-making, or trigger federal law, including the Health Insurance Portability and Accountability Act (HIPAA) or the Federal Trade Commission Act prohibiting unfair and deceptive practices, such as the sale and use of racially biased programs.Chow also detailed the states with comprehensive privacy laws, including California, Virginia, and Tennessee, with numerous state laws pending in Connecticut, Indiana, Iowa, Montana, and Washington. State legislatures complement privacy laws with laws regulating AI and automated decision-making, such as the New York AI Bias Law. Still, Wu put privacy legislation into context: "It's not necessarily the driver for AI; it's a stakeholder."

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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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Anna Yuan’s practice focuses on patent prosecution, IP due diligence, post-grant proceedings, and IP litigation support. 

Anna Yuan

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Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion. This article originally appeared on JDSupra and is reprinted with permission.

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

Last week, the USPTO released its <a href="https://www.uspto.gov/about-us/performance-and-planning/strategy-and-reporting?MURL=StrategicPlan" target="_blank">2022‒2026 Strategic Plan</a>. The Strategic Plan outlines the USPTO’s overarching goals for the coming years. How are these initiatives likely to affect patent applicants and owners?1. Improving patent application pendencyThe USPTO is continuing its efforts to reduce patent application pendency (currently about 25 months to final disposition) by “reimagining patent examination processes” and by providing alternative application processing options for patent applications.Based upon this initiative, the USPTO may continue to expand its offerings for expedited examination for certain technologies and/or expand the number of permitted annual Track I requests from the current level of 15,000. Practitioners should continue to take advantage of the available programs to expedite prosecution at the USPTO and be on the lookout for new mechanisms to expedite prosecution.   2. Updating search strategiesApplicants can expect changes in USPTO search practices. While the practical impact of such changes is unclear, they may enable more reliable identification of the most relevant prior art.First, the USPTO hopes to optimize the strategic integration of AI and robotic process automation (RPA) into the patent application system, including for enhanced and more efficient access to prior art.Second, the USPTO plans to provide examiners with new training and tools to search databases maintained by the FDA. This builds on the <a href="https://lifesciences.mofo.com/topics/the-uspto-and-the-fda-join-hands-to-promote-competition" target="_blank">unprecedented collaboration</a> between the USPTO and FDA in 2022. Companies should ensure consistency in their patent and regulatory strategies and provide any relevant correspondence with FDA to the USPTO to comply with their duty of disclosure.3. Potential small claims courts for IP litigationThe USPTO plans to independently study the feasibility of small claims courts for patents and trademarks, collect and analyze public comments, and submit a report to Congress. The report will indicate whether there is a need for small claims courts, the feasibility and potential structure of each court, and the relevant legal, policy, and practical considerations in establishing a small claims court for either patents, trademarks, or both.Interested stakeholders should watch for future requests for comments regarding the small claims courts, for an opportunity to weigh in.4. Scrutiny of micro and small entity designationsThe USPTO makes it clear that it will be vigilant in identifying applications “including erroneous or suspicious designations of micro or small entity status,” particularly in view of the recent changes in the increasing associated fee discounts. The Unleashing American Innovators Act of 2022 increased small entity patent fee discounts to 60% (up from a 50% discount), and micro entity discounts to 80% (up from a 75% discount).<a href="#_ftn1" target="_self" id="_ftnref1">[1]</a> The Unleashing America Invents Act also changed the penalty for false assertions of entity status. Under the old law, fraudulent assertion of small entity status would be considered inequitable conduct that might jeopardize enforcement of the patent. But an incorrect assertion of small (or micro) entity status made in good faith could be “excused” upon correction of the entity status and payment of the fee deficiency.Under the new law, the USPTO Director has discretion to impose penalty fines that are not less than three times the fee deficiency when an entity “is found to have falsely asserted entitlement to a fee reduction.”Applicants should investigate and verify entitlement to small entity status before it is first claimed (e.g., when filing the application), again when the issue fee payment is made, and again when each maintenance fee payment is made.5. Steps to curb abuse of Patent Trial and Appeal Board (PTAB) proceedingsThe USPTO’s Strategic Plan notes that it will take “steps to prevent abusive behaviors from arising” in PTAB proceedings.This sends a strong message that USPTO Director Kathi Vidal plans to carefully scrutinize PTAB proceedings for potential abuse. In 2022, for example, Director Vidal issued a decision finding that a petitioner abused the inter partes review (IPR) process by filing the IPR “in an attempt to extract payment” from the patent owner, and “by offering to undermine and/or not vigorously pursue this matter in exchange for a monetary payment.”<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a> The decision was the first time a USPTO Director levied sanctions in a patent review.<a href="#_ftnref1" target="_self" id="_ftn1">[1]</a> To qualify for “small entity” status, a business must have no more than 500 employees, including affiliates. 13 CFR § 121.802. Additionally, the business must not have assigned, granted, conveyed, or licensed any rights in the invention to any entity that does not qualify for small entity status (and must be under no obligation to do so). Id. Individuals and nonprofit organizations can also qualify. MPEP § 509.02. “Micro entity” status (which is rare) additionally requires that the applicant qualify on either a “gross income” or “institution of higher education" basis. 37 CFR § 1.29.<a href="#_ftnref2" target="_self" id="_ftn2">[2]</a> <a href="https://www.uspto.gov/sites/default/files/documents/ipr2021_01064_paper_102_decision.pdf?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=" target="_blank">OpenSky Industries, LLC v. VLSI Technology LLC</a>, IPR2021-01064, Paper 102 (Oct. 4, 2022).

USPTO Releases 2022‒2026 Strategic Plan

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USPTO Releases 2022‒2026 Strategic Plan

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Last week, the USPTO released its 2022‒2026 Strategic Plan. The Strategic Plan outlines the USPTO’s overarching goals for the coming years. 

On June 1, 2023, the Supreme Court issued a decision in <a href="https://www.supremecourt.gov/opinions/22pdf/21-1326_6jfl.pdf" target="_blank">United States ex rel. Schutte v. SuperValu, Inc.</a>, clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court held that a defendant that submits a false claim does so knowingly when it subjectively believes the claim is false at the time of submission. We have been tracking this decision in our <a href="https://www.mofo.com/resources/insights/230410-true-facts-about-false-claims?utm_source=publication&utm_medium=email" target="_blank">FCANewsletter</a> and our <a href="https://govcon.mofo.com/topics/supreme-court-weighs-in-on-the-role-of-subjective-intent-under-the-false-claims-act" target="_blank">Government Contracts Insights</a> as it changes the law of several circuits, which had held that an FCA defendant has not knowingly presented a false claim if its claim was consistent with an “objectively reasonable interpretation” of the relevant law, regardless of what the defendant believed about the claim.Read the <a href="https://www.mofo.com/resources/insights/230606-look-to-defendants-subjective-beliefs" target="_blank">full client alert</a>.

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Joe Palmore co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Chambers USA describes him as “an outstanding oral advocate,” who is “calm, focused, effective and doesn’t back down,” and has “complete command of the facts.” Joe “writes great briefs” (Chambers USA), with one client recounting that “the Court mirrored the language he thoughtfully chose in its ultimate order” (Legal 500).

Joseph R. Palmore

Joseph R. Palmore is co-chair of the firm's Appellate and Supreme Court Practice Group and Managing Partner for the Washington, D.C. office. Before joining Morrison Foerster, Joe was an Assistant to the Solicitor General at the United States Department of Justice and the Deputy General Counsel of the Federal Communications Commission (FCC).

Joseph Palmore

IAP Worldwide Servs., Inc.

Flight Support, Inc.

DynCorp Int’l LLC

Raytheon Co.

DynCorp International, LLC v. United States

URS Federal Servs., Inc.

DynCorp International, LLC

J. Alex Ward

United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim