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.

Social

Search

Subscribe

Life Sciences and Healthcare Group

Life Sciences Podcast

Patent Counseling + Prosecution

FDA Regulatory + Life Sciences Compliance

FDA + Healthcare Regulatory and Compliance 

Life Sciences Transactions + Licensing

Resources

Editors

230315-new-mofo-life-sciences-logo.jpg

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.

poon_meghan_blog_150x150.png

poon_meghan_common_640x280.jpg

poon_meghan_heroretina_2700x1160.jpg

poon_meghan_mobileretina_750x1040.jpg

poon_meghan_social_600x600.jpg

Partner

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.

Patent Strategy + Prosecution

Patent Prosecution | Patent Firm

Band 1: Intellectual Property: Patent Prosecution, California

Tier 1: Patent Strategy & Management

Recommended: Patent Prosecution

Patent Strategy Firm Of The Year

 Intellectual Property: Patents: Prosecution

Recommended for Patent Prosecution in California and DC Metro Area

Highly Recommended: Patent Prosecution, California

Patent Prosecution, US 

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>

schonig_wolfgang_blog_150x150.png

schonig_wolfgang_common_640x280.jpg

schonig_wolfgang_heroretina_2700x1160.jpg

schonig_wolfgang_mobileretina_750x1040.jpg

schonig_wolfgang_social_600x600.jpg

Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

Life Sciences: IP/Patent Litigation

Life Sciences

Global: Life Sciences

Asia-Pacific Region: Life Sciences

Healthcare: Life Sciences

China Healthcare and Life Sciences: Foreign Firms

US: Biotechnology Law

Japan: Life Sciences

China: Life Sciences: International Law Firm

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

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

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.

life-sciences-featured-image.jpg

life-sciences-featured-image

Announcements

Welcome to Mofo Life Sciences

Blog - Terms of Use

Cookies

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

Brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry.

MoFo Tech Blog

MOFO TECH

Equips our clients with the most up-to-date and relevant information on employment and labor law issues.

Employment Law Commentary

EMPLOYMENT LAW COMMENTARY

Stay on top of emerging issues and stay informed of developments related to the law and business of social media.

Socially Aware

SOCIALLY AWARE

In-depth analysis of developments and trends impacting government contracting.

Government Contracts Insights Blog

GOVERNMENT CONTRACTS INSIGHTS

Provides insights and reports on the most current class actions lawsuits and product liability issues that affect consumer-facing companies.

Class Dismissed Blog

CLASS DISMISSED

MoFo Life Sciences

  Linkedin

MoFo LinkedIN

Life Sciences Blog - RSS

Stay Connected

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.

Because No One is Immune to the Law

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

Agtech

Antitrust

Asia

Bioinformatics

Biotech

Blockchain

Cell + Gene Therapy

CFIUS

Corporate + Venture Capital

COVID-19

Data Analytics

Digital Health

Employment

European Union

Financing

Global

Healthcare

Intellectual Property

Licensing + Commercial

Litigation

Medical Devices + Diagnostics

Pharma

Privacy + Data Security

Product Liability + Class Action

Rare Disease

Regulatory

Startup

United Kingdom

United States

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

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

While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal Circuit provides us with a great lesson on prosecution disclaimer and implications regarding the entanglement of future related applications due to the disclaimer.<a href="#_ftn1" target="_self">[1]</a>Azurity Pharmaceuticals, Inc. (“Azurity”) is the patentee of U.S. Patent No. 10,959,948 (“the ’948 patent”), having certain claims directed to liquid formulations of vancomycin, a glycopeptide antibiotic. Alkem Laboratories Ltd. (“Alkem”) submitted an Abbreviated New Drug Application (with a Paragraph IV notice) for a vancomycin formulation containing propylene glycol. This decision stems from a suit brought by Azurity against Alkem for infringement of certain claims of the ’948 patent. While certain issues arise based on a discovery stipulation, the Federal Circuit spends much of the decision on the merits of prosecution disclaimer, which we focus on below.“A patentee may, through a clear and unmistakable disavowal in the prosecution history, surrender certain claim scope to which he would otherwise have an exclusive right by virtue of the claim language.”<a href="#_ftn2" target="_self">[2]</a> Such prosecution disclaimer applies to “[s]tatements that clearly and unmistakably disavow claim scope to one skilled in the art are binding, ‘even if [the patentee] said more than needed to overcome a prior art rejection.’”<a href="#_ftn3" target="_self">[3]</a>Here, the specific prosecution statements in question were made in the parent application (“the parent ’059 application,” which issued as U.S. Patent. No. 10,959,946).<div data-reactroot=""><img class="rich-text-embed-image" alt="250417-blog-image.png" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt28c6748f70bef17d/680130c2bfe08eb49620540a/250417-blog-image.png?format=auto&amp;quality=60"/></div>During prosecution of the parent ’059 application, Azurity amended formulation claims to contain a “consisting of” transitions phrase following the preamble and argued that “[t]he absence of propylene glycol and polyethylene glycol in the claimed invention, in part, distinguishes it from the cited reference,” Palepu.<a href="#_ftn4" target="_self">[4]</a> Palepu discloses a liquid formulation containing vancomycin and propylene glycol as a polar solvent carrier. In the Notice of Allowance in the parent ’059 application, the Examiner confirmed that the “instant claims exclude the presence of propylene glycol or polyethylene glycol in view of the consisting of language, and thus overcome the teachings of Palepu which requires the propylene glycol or polyethylene glycol to be present with the vancomycin hydrochloride.”In construing the scope of the claims at issue in the ’948 patent, the court emphasizes that the claims of US 16/941,400, which issued as the ’948 patent, “included the same ‘consisting of’ transition phrases added during the prosecution of the parent ’059 application.”<a href="#_ftn5" target="_self">[5]</a> Moreover, in the reasons for allowance, the Examiner emphasizes the “consisting of” language as part of the reasons the claims are allowable over Palepu. In view of the prosecution histories, the court concludes that this “leaves no room to doubt that Azurity adopted the ‘consisting of’ transition specifically to narrow the claims and overcome Palepu and its disclosure of propylene glycol.”<a href="#_ftn6" target="_self">[6]</a> The court notes that “[t]his is true even though the patent at issue, U.S. Patent No. 10,959,948, was allowed without rejection and the originally filed claims included the “consisting of” transition phrase.”<a href="#_ftn7" target="_self">[7]</a>The court made this decision over several arguments presented by Azurity to remove or limit the scope of the disclaimer. For example, Azurity argued that the transition phrase “consisting of” was meant to only exclude propylene glycol as a carrier as taught in Palepu, rather than as a component in the entire composition. Moreover, Azurity argued that Alkem stipulated that flavoring agents (as recited in the claims) could include propylene glycol, and thus the claimed formulations are not devoid of any propylene glycol. But, as summarized above, the statements Azurity repeatedly made during prosecution are not so nuanced. Consequently, while acknowledging that Palepu may only teach propylene glycol as a carrier, the court held that “what matters most is the broad language that Azurity used to distinguish Palepu. Just as the echo matches the shout, Azurity’s repeated, sweeping statements—endorsed by the examiner—return an equally sweeping disclaimer.”<a href="#_ftn8" target="_self">[8]</a>, <a href="#_ftn9" target="_self">[9]</a>Following Alkem’s ANDA submission, Azurity included this statement in another related application: “For the record, Applicant did not disclaim propylene glycol when submitting the arguments in [the ’059 application, which resulted in the claims at issue,] and reserves the right to claim propylene glycol in the instant and future cases in this patent family.”<a href="#_ftn10" target="_self">[10]</a> The court concludes that this statement carries no weight on the above prosecution disclaimer analysis. In reaching this conclusion, the court noted that such statements were “unilateral and belated,” and that “[h]olding patentees to their definitive statements made during prosecution protects the public and promotes the notice function of intrinsic evidence.”<a href="#_ftn11" target="_self">[11]</a> Such conclusion was found to be consistent with precedent, as previous decisions from the Federal Circuit “have focused on how such statements have been relevant to later issued patents.”<a href="#_ftn12" target="_self">[12]</a> It remains an open question whether the result of prosecution disclaimer here would have been different had the “for the record” statement been put on the record during prosecution of the patent at issue.The Federal Circuit concludes that prosecution disclaimer applies to the ’498 patent at issue, and thus the claims at issue specifically carve out a vancomycin formulation having propylene glycol. As Alkem’s ANDA is for a vancomycin formulation containing propylene glycol, the court swiftly upheld a finding of non-infringement.Practice tipsDuring prosecution, it is critical to consider risk of prosecution disclaimer by making sweeping statements regarding claim scope and reference characterization. This is especially true because prosecution disclaimer impacts an instant application as well as future related applications containing the same or similar claim features. While it sometimes may be necessary to make arguments on the record to overcome cited prior art or other rejections, it would always be prudent to take a step back and examine whether such arguments are unnecessarily broad. Whenever possible, statements should be carefully crafted with qualification and specificity. Care should also be taken in reviewing the Examiner’s characterization of the claims, including in the reasons for allowance, so that clarifications can be made on the record in a timely manner.<hr class="divider"><a href="#_ftnref1" target="_self">[1]</a> Azurity Pharms., Inc. v. Alkem Labs. Ltd., 2025 U.S.P.Q.2d 590 (Fed. Cir. 2025).<a href="#_ftnref2" target="_self">[2]</a> Page *5.<a href="#_ftnref3" target="_self">[3]</a> Page *5, citing to Data Engine Techs., 10 F.4th at 1383.<a href="#_ftnref4" target="_self">[4]</a> Palepu, US 2016/0101147.<a href="#_ftnref5" target="_self">[5]</a> Page *7.<a href="#_ftnref6" target="_self">[6]</a> Page *7.<a href="#_ftnref7" target="_self">[7]</a> Page *2.<a href="#_ftnref8" target="_self">[8]</a> Page *7.<a href="#_ftnref9" target="_self">[9]</a> While prosecution history estoppel is not at issue in the instant decision, this discussion provides an opportunity to touch on another avenue that can result in limitations to the ultimate scope afforded to a claim. As discussed above, prosecution disclaimer is the result of a clear and unmistakable surrender of claim scope, which then limits the literal scope of claimed subject matter during claim interpretation. In contrast, prosecution history estoppel is triggered by claim amendments and/or arguments related to the patentability of claims. The resulting focus of prosecution history estoppel is the Doctrine of Equivalents and whether such amendments and/or arguments limit the use of equivalents when assessing what is captured by the scope of a claim.<a href="#_ftnref10" target="_self">[10]</a> Page *4.<a href="#_ftnref11" target="_self">[11]</a> Page *5.<a href="#_ftnref12" target="_self">[12]</a> Page *6.

chapman_john_blog_150x150.png

chapman_john_common_640x280.jpg

chapman_john_heroretina_2700x1160.jpg

chapman_john_mobileretina_750x1040.jpg

chapman_john_social_600x600.jpg

Associate

Dr. Chapman provides patent and intellectual property services to clients on pharmaceutical, chemistry, biotechnology, and medical device matters.
He is experienced in drafting patent applications, pr

John D Chapman Ph.D.

John Chapman

xiao_janet_blog_150x150.png

xiao_janet_common_640x280.jpg

xiao_janet_heroretina_2700x1160.jpg

xiao_janet_mobileretina_750x1040.jpg

xiao_janet_social_600x600.jpg

Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceu

Janet Xiao Ph.D.

Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceutical companies, such as Celgene and Genentech, to emerging startup companies around the world.

Janet Xiao

mofolifesciences-health-it.jpg

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

Recent Digital Health-Related FDA Announcements

mofolifesciences-health-it

Knowing what qualifies as prior art is a core requirement of patent practitioners—whether in life sciences, in the technology sectors or in post-grant proceedings. It is important to keep abreast of changes to the rules, especially if the Federal Circuit weighs in. On March 24, 2025, the Federal Circuit issued a precedential decision in In Re Riggs, Case No: 22-1945 (Fed. Cir. Mar. 24, 2025) clarifying the standard for determining whether a published patent application can be considered prior art as of its provisional filing date. Although this case was decided under pre-AIA law, the standard elucidated by the Federal Circuit reinforces the importance of drafting detailed provisional applications and knowing the requirements for establishing prior art under both pre-AIA and AIA law.Read the <a href="https://mofotech.mofo.com/topics/federal-circuit-clarifies-requirements-for-prior-art-under-pre-aia-35-u-s-c-102-e-" target="_blank">full article</a>.

silverman_lisa_blog_150x150.png

silverman_lisa_common_640x280.jpg

silverman_lisa_heroretina_2700x1160.jpg

silverman_lisa_mobileretina_750x1040.jpg

silverman_lisa_social_600x600.jpg

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

Lisa N. Silverman Ph.D.

Lisa Silverman

arjomand_mehran_blog_150x150.png

arjomand_mehran_common_640x280.jpg

arjomand_mehran_heroretina_2700x1160.jpg

arjomand_mehran_mobileretina_750x1040.jpg

arjomand_mehran_social_600x600.jpg

Mehran Arjomand is chair of the firm's Patent Trial and Appeal Board Practice and heads the firm's technology patent practice. Mr. Arjomand began his legal career as a litigator. After five years, he 

Mehran Arjomand

Mehran Arjomand is chair of the firm's Patent Trial and Appeal Board Practice and heads the firm's technology patent practice. Mr. Arjomand began his legal career as a litigator. After five years, he joined Morrison & Foerster, where he developed a strong foundation in USPTO prosecution and procedure. With his combined litigation and prosecution experience, he is able to counsel clients on end-to-end strategies—from patent creation to patent challenges.

Marisa B. Sanders

Marisa Sanders

241114-cell-and-gene-therapies.jpg

241114-cell-and-gene-therapies

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of AI on intellectual property, licensing, contracts, regulatory policy, enforcement, privacy, and venture markets in life sciences.Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks, AI agents are semi-autonomous software systems capable of independently making decisions traditionally reserved for humans, performing complex sequences of tasks, and interacting dynamically with other systems with minimal human intervention. In the life sciences and medtech industries, these agents can autonomously design experiments, analyze research data, monitor clinical trials, optimize manufacturing processes, interact with patients and provide support, and even generate novel hypotheses for investigation.As the medtech industry moves toward wider adoption of AI agents as a service (AIAaaS), businesses should consider adopting a nuanced framework for their commercial contracts.1. Navigating Data Rights and UsageNow more than ever, data is central, making data ownership and usage rights a pivotal point in contract negotiations. Providers typically prefer broader access to anonymized patient data to continually enhance AI model accuracy and capabilities. Healthcare organizations and other customers, however, are typically concerned with patient privacy and compliance obligations, which may lead them to limit data usage strictly. Companies negotiating AIAaaS agreements may therefore wish to explicitly address data access parameters, permissible usage scopes, audit procedures, and specific regulatory obligations (e.g., HIPAA and GDPR compliance).Companies should consider whether particular ownership and usage rights should apply to different categories of data, such as raw input data, generated output, and analytical data related to model and AI agent performance.2. Intellectual Property ClarityIntellectual property (IP) considerations surrounding AI agents can involve complexities such as ownership of algorithms, datasets, user-driven improvements, and AI-generated outputs. Providers generally aim to retain core AI technology rights, whereas healthcare organizations and other customers may seek rights or exclusive access to specific customizations or derivative outputs. Clearly delineating ownership, permitted uses, and restrictions within agreements can help ensure a successful collaboration.3. Addressing Regulatory FrameworksAI agents in medtech operate within a multi-jurisdictional and rapidly evolving regulatory landscape. Agreements should consider the scope of regulatory obligations and which party is responsible for complying with them. For example, parties should determine whether the AI agent qualifies as a medical device under FDA or international regulations and who is responsible for its compliance. The parties should also address compliance with the EU AI Act, particularly if the AI system would be classified as “High Risk” under Article 6. And given the rapidly changing landscape, parties should build in flexibility to adapt as needed when further guidance comes.4. Managing Responsibility and Human OversightAs companies give AI agents more autonomy in clinical settings—particularly in high-risk areas like diagnostics and patient care decisions—clear delineation of the scope of oversight and responsibility for its implementation becomes crucial. The required level of human oversight can vary significantly depending on the AI system’s complexity and risk profile. Additionally, where AI agents directly interact with patients or healthcare professionals, transparency about AI involvement, clarity in operational guidelines, and mechanisms for feedback or reporting concerns can be critical. AIAaaS agreements should articulate specific oversight requirements and define roles and responsibilities.5. Liability Allocation and Third-Party ManagementThe autonomous nature of AI agents introduces unique liability considerations. Parties might consider clearly distinguishing between liability related to inherent AI system errors and liability stemming from misuse or inadequate human oversight. The parties may treat the former as an inherent business risk, potentially offset by a lower-priced service. The latter may be more reasonably allocated to a party. Contracts may also need to reflect any risk allocation requirements mandated by underlying AI model providers as flow-down requirements. Further, vendors may be more able to accept customer-imposed regulatory, quality, and cybersecurity requirements if they can pass those risks in their own AI vendor agreements.As medtech companies increasingly consider AI agents, companies may need to adjust their commercial contracting framework. Thoughtful negotiation around data ownership and usage rights, IP protections, regulatory responsibilities, human oversight, and liability allocation will be critical.

ferry_matt_blog_150x150.png

ferry_matt_common_640x280.jpg

ferry_matt_heroretina_2700x1160.jpg

ferry_matt_mobileretina_750x1040.jpg

ferry_matt_social_600x600.jpg

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

Matthew Ferry

matibag_tricia_blog_150x150.png

matibag_tricia_common_640x280.jpg

matibag_tricia_heroretina_2700x1160.jpg

matibag_tricia_mobileretina_750x1040.jpg

matibag_tricia_social_600x600.jpg

Tricia Matibag is an associate in the Boston office of Morrison Foerster and a member of the firm’s Technology Transactions Group.

Tricia Matibag

230427-ai-image.jpg

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