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

Life Sciences IP Litigation

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

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

Subject Matter Eligibility of AI Medical Treatments

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

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

The Future of Food: Exploring the World of Cell-Cultivated Cuisine (Blog Post)

LinkedIN

The <a href="https://www.congress.gov/118/bills/s150/BILLS-118s150es.pdf" target="_blank">Affordable Prescriptions for Patients Act (APPA) of 2023</a> unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of reducing drug prices. The APPA would revise certain provisions of 35 U.S.C. § 271(e) to limit the number of patents a drug manufacturer can assert in a patent infringement lawsuit against biosimilars and generics companies. Specifically, the revisions to § 271(e) state that a drug manufacturer may assert no more than 20 patents in an infringement action and that no more than 10 of the 20 patents shall have been newly issued or licensed to the drug manufacturer, as defined by section 351(l)(1)7(A) of the Public Health Service (PHS) Act.The limit on the number of patents that can be asserted may be increased (i) if the drug manufacturer makes a request without undue delay and (ii) if the interest of justice so requires or for good cause shown. Good cause will be established if the biosimilars or generics drug company fails to provide information that would enable a drug manufacturer to form a reasonable belief that a claim of infringement could reasonably be asserted. Good cause may be established if there is a material change to the biological product or process with respect to the biological product by the biosimilars or generics company, if there is a delay by the USPTO in issuing the patent of the drug manufacturer, or for another reason the court deems appropriate.More recently, companion bill H.R. 9070, titled Affordable Prescriptions for Patients Act (APPA) of 2024, was introduced to the House on July 18, 2024 by U.S. Representatives Darrell Issa (R-Calif.) and Hank Johnson (D-Ga.).Whether the bill passes the House of Representatives remains to be seen. Should the bill pass, the impact on biosimilar litigation is hard to predict. While there have been cases in which more than 20 patents are asserted, including litigations regarding Humira, in other litigations the patents at issue have not exceeded 20.Subscribe to the MoFo Life Sciences blog to stay up to date on legislative changes affecting biotechnology and pharmaceutical companies.

Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

chandler_paige_blog_150x150.png

chandler_paige_common_640x280.jpg

chandler_paige_heroretina_2700x1160.jpg

chandler_paige_mobileretina_750x1040.jpg

chandler_paige_social_600x600.jpg

Associate

Dr. Paige Chandler focuses her practice on patent drafting and prosecution and IP due diligence, with an emphasis on biomedical physiology.

Paige N. Chandler Ph.D.

Paige Chandler

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. 

Seagen Inc. v. Daiichi Sankyo Co. Ltd. et al. (AAA Arbitration, Eastern District of Texas, District of Delaware, and Patent Trial and Appeal Board)

Evolve BioSystems, Inc. v. Abbott Laboratories (Northern District of Illinois)

Driscoll’s, Inc. v. California Berry Cultivars, LLC (Eastern District of California)

Bayer CropScience LP v. Tenfold Tech., LLC (Eastern District of Texas)

The Regents of the University of California v. California Berry Cultivars, L.L.C. et al.  (California Superior Court and Northern District of California)

Arch Development Corp. v. Genentech, Inc. (Northern District of Illinois, Patent Trial and Appeal Board, and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. (Northern District of California and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. and ImmunoGen, Inc. (Patent Trial and Appeal Board and Federal Circuit)

Focal Therapeutics, Inc. v. Senorx, Inc. (Patent Trial and Appeal Board)

chivvis_matthew_blog_150x150.png

chivvis_matthew_common_640x280.jpg

chivvis_matthew_heroretina_2700x1160.jpg

chivvis_matthew_mobileretina_750x1040.jpg

chivvis_matthew_social_600x600.jpg

Matthew protects his clients’ intellectual property and defends his clients wrongly accused of infringement. His hearing and trial experience is extensive. Whether exploring complex technical issues regarding a biologic drug, or digging into the finer points of patent law, he excels at keeping his opponents on their toes.

Matthew Chivvis

Matthew A. Chivvis

240816-life-sciences-blog.png

Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

240816-life-sciences-blog

The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. 

Intellectual Property

Healthcare

Pharma

On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in <a href="https://www.bing.com/ck/a?!&&p=5fe7fbcfa8dbe8bdJmltdHM9MTcyMzU5MzYwMCZpZ3VpZD0wOTdiNTBhYS0wMTY4LTY2MDYtMjJhYi00NGU3MDBkMjY3NmQmaW5zaWQ9NTE5Nw&ptn=3&ver=2&hsh=3&fclid=097b50aa-0168-6606-22ab-44e700d2676d&psq=Allergan+USA%2c+Inc.+v.+MSN+Laboratories+Private+Ltd.%2c+No.+24-1061+(Fed.+Cir.+2024)&u=a1aHR0cHM6Ly9jYWZjLnVzY291cnRzLmdvdi9vcGluaW9ucy1vcmRlcnMvMjQtMTA2MS5PUElOSU9OLjgtMTMtMjAyNF8yMzY2MDc0LnBkZg&ntb=1">Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024)</a> clarifying the scope of obviousness-type double patenting (ODP) in the aftermath of its In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023) decision last year.In a potentially significant win for patentees, the Federal Circuit in Allergan held that “a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.” This represented a reversal of the district court’s determination that claim 40 of the ’356 patent at issue was invalid under the doctrine of ODP over claim 33 of the ’011 patent and claim 5 of the ’709 patent. The relationship among these patents is depicted in the following figure from the decision. The first filed ’356 patent has a longer patent term due to grant of patent term adjustment (PTA) due to delays caused by the U.S. Patent and Trademark Office (USPTO) during prosecution.  <div data-reactroot=""><img class="rich-text-embed-image" alt="Expiration graphic" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltc446430cde1004b1/66be59411257f55a24b40b44/expiration-without-pta.jpg?format=auto&amp;quality=60"/></div>The district court considered the “first-filed, first-issued” distinction of the ’356 patent at issue to be “immaterial” and, instead, focused only on the patent expiration dates for its ODP analysis based on its reading of In re Cellect, which held that “ODP for a patent that has received PTA, regardless [of] whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.”The Federal Circuit, however, noted that the district court’s reading of In re Cellect was incorrect since the holding of In re Cellect “answered a different question than that at issue here.” The Federal Circuit explained that “[In re] Cellect does not address, let alone resolve, any variation of the question presented here—namely, under what circumstances can a claim properly serve as an ODP reference—and therefore has little to say on the precise issue before us.” Rather, the Federal Circuit noted that its holding in In re Cellect “is only controlling in this case to the extent that it requires us to consider, in our ODP analysis, the ’356 patent’s June 24, 2026 expiration date (i.e., the expiration date after the addition of PTA), not the March 24, 2025 expiration date that it would have shared with the ’011 and ’709 reference patents in the absence of a PTA award.” The Federal Circuit further explained that its holding “is the only conclusion consistent with the purpose of the ODP doctrine, which is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.”The Federal Circuit clarified that “the fact that the ’356 patent expires later is of no consequence here because it is not a ‘second, later expiring patent for the same invention” and that “[a]s the first-filed, first-issued patent in its family, [the ’356 patent] is the patent that sets the maximum period of exclusivity for the claimed subject matter and any patentably indistinct variants.”This decision clarifies the scope of the doctrine of ODP following last year’s In re Cellect decision by establishing that the filing and issuance dates of a patent are relevant to an ODP analysis. This decision also clarifies that applicants are entitled to PTA caused by delays of the USPTO during prosecution of a first-filed patent application, no matter when the first patent issues or how long the PTA extends the life of the patent. This decision is important because, as recognized by the Federal Circuit, a first-filed application often requires “greater time and effort by the applicant and examiner alike” and, thus, is often awarded PTA; whereas, a later-filed continuing application “proceeds much more efficiently through prosecution” and, thus, is more likely to receive little or no award of PTA. Accordingly, this decision removes the risk of invalidation by ODP over a later-filed, later-issued, earlier-expiring reference claim having a common priority date.

schmidt_jeffrey_blog_150x150.png

schmidt_jeffrey_common_640x280.jpg

schmidt_jeffrey_heroretina_2700x1160.jpg

schmidt_jeffrey_mobileretina_750x1040.jpg

schmidt_jeffrey_social_600x600.jpg

Dr. Jeff Schmidt is a member of the firm’s Patent Group. His practice focuses on patent prosecution in the areas of life sciences, biotechnology, and pharmaceuticals, which includes the preparation an

Jeffrey W. Schmidt Ph.D.

Jeffrey Schmidt

potter_karen_blog_150x150.png

potter_karen_common_640x280.jpg

potter_karen_heroretina_2700x1160.jpg

potter_karen_mobileretina_750x1040.jpg

potter_karen_social_600x600.jpg

Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

240815-pills-life-sciences.png

240815-pills-life-sciences

Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories

Litigation

The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v. University of Massachusetts, PGR2023-00014.) The PTAB found UMass’s claims directed to methods of treating vitiligo with a functionally defined genus of compounds failed to meet enablement and written description requirements. Enablement of genus claims was addressed by the Supreme Court in last year’s Amgen case. (See Amgen v. Sanofi, 598 U.S. 594). Importantly, this PTAB decision demonstrates that method claims are not insulated from the Amgen ruling, stating that “the specification must provide some guidance regarding structure for a recited element of the claim.”Forte Biosciences, Inc. (“Forte”) challenged the patentability of claims 1–5 on enablement, written description, and obviousness grounds.Claim 1 is illustrative of the challenged claims and is shown below.<ol><li>A method of treating a subject who has a vitiligo lesion, the method comprising: identifying a subject in need of treatment; and administering a therapeutically effective amount of an inhibitor of IL-15 or the IL-15 receptor to the subject.</li></ol>The PTAB found the challenged claims unpatentable for lack of enablement and written description under 35 U.S.C. § 112(a). The PTAB did not reach the obviousness challenge.The PTAB’s Post-Amgen Enablement AnalysisIn deciding whether the challenged claims are enabled under 35 U.S.C. § 112(a), the PTAB applied the Amgen court’s analysis regarding genus claims encompassing entire classes of functionally defined compounds and considered the Wands factors to determine whether undue experimentation is required to make and use the claimed invention. Amgen v. Sanofi, 598 U.S. 594.The Amgen court held that, “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Amgen, at 610. Essentially, “[t]he more one claims, the more one must enable.” Id. This concept of quid pro quo is at the heart of the U.S. patent system.The PTAB determined that the inhibitors claimed in the UMass’s patent are even broader than the genus of antibodies at issue in Amgen, as neither the specification nor the claims of the UMass’s patent provide any structural requirement for the claimed inhibitors. Forte Biosciences, at 30. For instance, claim 2 of the UMass’s patent states that inhibitors can be small molecules, antibodies, peptides, or nucleic acids, none of which share any common structural features. Id. at 30–31. Due to the complicated and unpredictable nature of IL-15/IL-15R inhibition, the PTAB rejected UMass’s argument that IL-15/IL-15R inhibitors and their mechanisms were well known in the art and held that a skilled person would have to engage in extensive experimentation to identify and test each compound covered by the claim scope to determine whether the compound works.Furthermore, the PTAB also rejected UMass’s argument that the challenged claims are directed towards methods of treatment for vitiligo instead of the inhibitors for IL-15 or IL-15R themselves, thereby avoiding the “how to make” requirement for the inhibitors. The PTAB held that, if a challenged claim recites a functionally defined genus of compounds, as is the case with UMass’s method of treatment claims, “the specification must provide some guidance regarding structure for a recited element of the claim[.]” Id. at 37. This is to prevent a skilled person from having to engage in extensive trial and error to determine which compound falls within the claim scope. Id. Consequently, the PTAB found the challenged claims were unpatentable due to lack of enablement.The PTAB’s Written Description Analysis of Genus ClaimsThe PTAB agreed with Forte’s characterization that the challenged claims were directed broadly to methods of treating vitiligo by administering an inhibitor of IL-15 or IL-15R in a therapeutically effective amount, while UMass’s patent only disclosed a single working example, i.e., ChMBC7, which is an antibody inhibitor targeting a mouse protein, IL-2R β/IL-15R β.Furthermore, the PTAB rejected UMass’s argument that, because the challenged claims are method claims and not composition of matter claims, the written description inquiry should only consider whether the patentee possessed the claimed methods of administering a therapeutically effective amount of an inhibitor to treat vitiligo, rather than whether the patentee possessed the entire genus of the claimed inhibitors. Forte Biosciences, at 16–17. The PTAB emphasized that, regardless of whether a claim is for a compound itself or a method involving the compound, the patentee must provide a description detailed enough to differentiate infringing compounds or methods from non-infringing ones. Id. at 16. Thus, the PTAB found UMass’s contention unpersuasive.Additionally, the PTAB agreed with Forte that UMass’s patent lacked descriptive support for the challenged claims because the evidence showed: (1) that not all IL-15 or IL-15R inhibitors are therapeutically effective; (2) that the specification does not disclose structural features of the IL-15 or IL-15R inhibitors necessary or sufficient to perform the claimed methods; (3) a lack of information to allow a skilled artisan to understand or determine whether an inhibitor actually meets the functional requirement in the challenged claims; and (4) unpredictability across the breadth of the claimed genera (e.g., small molecules, peptides, antibodies, or nucleic acids).In sum, the PTAB found that the challenged claims are directed to methods using a wide range of different types of compounds that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not always function as inhibitors. Hence, the PTAB held that UMass’s patent did not disclose a representative number of species or a sufficient correlation between structure and function to demonstrate possession of the claimed methods of treatment using a functionally defined genus of compounds.TakeawaysThis recent PTAB decision underscores the importance of enablement and written description considerations for functionally defined genera recited in method claims under Amgen. The broad nature of claims containing functionally defined genera inherently increases the difficulty of meeting the enablement requirement across the full scope of the claims. Similarly, the written description requirement mandates that claims must be supported by what is described in the specification. Therefore, practitioners may strategically consider the inclusion of functional limitations in method claims and contemplate multiple backup positions with varied claim scope in view of the enablement and written description requirements.

mcbriar_mark_blog_150x150.png

mcbriar_mark_common_640x280.jpg

mcbriar_mark_heroretina_2700x1160.jpg

mcbriar_mark_mobileretina_750x1040.jpg

mcbriar_mark_social_600x600.jpg

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

240814-skin-treatment-patent.png

240814-skin-treatment-patent

The PTAB Axes Skin Treatment Patent Under Amgen

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.

ff46dbb9-6da7-4fbb-81d3-d63e0db63cd0.jpg

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

ff46dbb9-6da7-4fbb-81d3-d63e0db63cd0

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 May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies.Specifically, the USPTO proposes amending the patent rules “to require that a terminal disclaimer filed to obviate nonstatutory double patenting include an agreement by the disclaimant that the patent in which the terminal disclaimer is filed, or any patent granted on an application in which the terminal disclaimer is filed, will be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting in which: (1) any claim has been finally held unpatentable or invalid under 35 U.S.C. 102 or 103 in a Federal court in a civil action or at the USPTO, and all appeal rights have been exhausted; or (2) a statutory disclaimer of a claim is filed after any challenge based on 35 U.S.C. 102 or 103 to that claim has been made.”The USPTO explains that this new requirement “solves the current problem of requiring a competitor to invalidate multiple patents tied by terminal disclaimers in order to have freedom to operate” and, thus, “has the likely advantages of reducing litigation and administrative proceeding costs and increasing predictability….”Although the proposed rule characterizes this as a “voluntary agreement” regarding enforceability of the patent, there is little that is voluntary about this proposed requirement. In essence, the proposed rule change would impose the requirement that in order to obviate a nonstatutory double patenting rejection, the disclaimant would need to agree that its patent would only be enforceable if it is not tied (and has never been tied) to any patent having a claim that was invalidated under 35 U.S.C. § 102 or § 103 for anticipation or obviousness, respectively. This means if a challenger is successful in invalidating “any” claim in a challenged patent under § 102 or § 103, then any other patents “tied” to that challenged patent by one or more terminal disclaimers would be unenforceable. Notably, the validity of the other patents would not be affected, as only their enforceability is affected by the voluntary agreement included in the terminal disclaimers. However, what is the point of obtaining a valid patent that you cannot enforce?This reflects a major change in current practice as it exists today where invalidation of one patent by a challenger does not affect the patent holder’s ability to enforce its other patents against the same (or a different) challenger, even if they are tied together by terminal disclaimers.Among the many concerns with this proposed rule is that once a terminal disclaimer is filed in an application it cannot be withdrawn after the patent is issued. The finality of such an action coupled with the effect of this proposed rule would result in applicants being forced into a “voluntary agreement” that may restrict their ability to enforce their own patents many years down the road.The USPTO will be accepting comments over the next 60 days relating to this proposed rule change.These proposed rule changes also coincide with the USPTO’s proposed changes in its fees, which include increasing the cost of filing a terminal disclaimer. Currently, the USPTO charges $170 to file a terminal disclaimer regardless of when it is filed. Under the proposed fee changes, this fee would be increased to $200 if the terminal disclaimer is filed prior to the first action on the merits, and would be further increased to $500 to $1,400 if filed after the first action, depending on the stage of prosecution. The judicially created doctrine of obviousness-type double patenting was created in an effort to prevent the unjustified extension of patent term, with the “solution” to this concern being the terminal disclaimer. The USPTO’s recently proposed fee changes that tie significantly increased filing fees for terminal disclaimers to the particular timing of their submission—coupled with today’s proposed rulemaking that would render patents tied together by terminal disclaimers unenforceable—is incongruous with the purpose behind this judicially created doctrine.

On May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies.

USPTO Considers Changing Terminal Disclaimer Practice to Require Agreement Regarding Enforceability

MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now <a href="https://soundcloud.com/user-496742723/03-27-lifescience-podcast01-v1" target="_blank">available</a>. The podcast features interviews with legal experts who share insights and advice you just might need when your life sciences are on the line.The special guest for Episode 1 was Jim Krenn, a MoFo partner whose practice is focused on major corporate transactions for emerging and established companies in the life sciences. Jim, Nate, and Kate discuss strategies to maximize and protect the value of trade secrets, how investing in compliance early pays dividends as companies mature, and where companies may face government scrutiny on the journey from startup to public company.Trade secrets play a central role in raising capital, selling a company, and going public, and the rise of cyber breaches and sophisticated intellectual property theft has pushed investors to look closely at how trade secrets are safeguarded. Jim maps out strategies for maximizing the value of trade secrets at key stages and discusses with Nate and Kate how to protect a critical asset for many life sciences companies.Early-stage companies often focus on development and growth, but an appropriate compliance function is important to control present and future downside risk. Jim explains the decision dynamics at play, and Kate discusses how increased scrutiny on life sciences companies makes good compliance a winning value proposition.Outside scrutiny on company systems peaks when the time comes to take a company public or consider a merger or acquisition. Interested parties pore over compliance functions at this stage, particularly in the highly regulated life sciences industry. Nate and Kate discuss corresponding risks for company insiders.

driscoll_kate_blog_150x150.png

driscoll_kate_common_640x280.jpg

driscoll_kate_heroretina_2700x1160.jpg

driscoll_kate_mobileretina_750x1040.jpg

driscoll_kate_social_600x600.jpg

Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets