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.

Wolfgang Schönig

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

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

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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.

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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

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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

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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

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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>.

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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

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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

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On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue patents. PTE was established under the Hatch-Waxman Act as a mechanism by which the term of a patent may be extended for up to five years to compensate for delays in obtaining regulatory approval for certain products such as pharmaceuticals and medical devices.<a href="#_ftn1" target="_self">[1]</a> PTE therefore can be an important mechanism for extending exclusivity for valuable products in the life sciences. Notably, the amount of PTE available for any given patent depends upon the issue date of the patent, which is the subject that the Court addressed in this decision.The case involves Merck’s U.S. Patent No. RE44,733 (“the RE’733 patent”), which includes claims directed to “sugammadex,” the active ingredient in Merck’s BRIDION® drug for reversing neuromuscular blockades. The RE’733 patent is a reissue of U.S. Patent No. 6,670,340 (“the original patent”), which included claims directed to sugammadex. The RE’733 patent retains the claims of the original patent and also includes 12 additional, narrower claims directed to sugammadex.<a href="#_ftn2" target="_self">[2]</a> After regulatory approval of sugammadex, the U.S. Patent and Trademark Office (USPTO) awarded five years of PTE to RE’733 based on the issue date of the original patent.<a href="#_ftn3" target="_self">[3]</a>Merck asserted the RE’733 patent against defendant-appellants (collectively “Aurobindo”), who sought regulatory approval to sell generic versions of BRIDION®. Aurobindo argued at trial that the USPTO miscalculated the PTE award of the RE’733 patent in view of the plain text meaning of 35 U.S.C. § 156(c).<a href="#_ftn4" target="_self">[4]</a> 35 U.S.C. § 156(c) provides that:The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued…(emphasis added). Aurobindo argued that the plain text of 35 U.S.C. § 156(c) required the USPTO to calculate PTE using the issue date of the reissued RE’733 patent, not the issue date of the original patent.<a href="#_ftn5" target="_self">[5]</a> Under this reasoning, Aurobindo asserted that the RE’733 patent was entitled to only 686 days of PTE, not the five years awarded by the USPTO, and that the term of the RE’733 patent had therefore expired.<a href="#_ftn6" target="_self">[6]</a> The district court interpreted “the patent” in 35 U.S.C. § 156(c) as referring to the original patent, finding that the RE’733 patent was entitled to the five years of PTE awarded by the USPTO.<a href="#_ftn7" target="_self">[7]</a>On appeal, the Federal Circuit agreed with the district court that the RE’733 patent was entitled to five years of PTE based on the issue date of the original patent.<a href="#_ftn8" target="_self">[8]</a> The Court considered the specific context of the use of “the patent” in 35 U.S.C. § 156(c) and the broader purpose of the Hatch-Waxman Act.<a href="#_ftn9" target="_self">[9]</a> The Court reasoned that construing “the patent” as used in 35 U.S.C. § 156(c) as meaning the original patent was the only construction that comported with the purpose of the Hatch-Waxman Act, which is to compensate “patent owners who were actually disabled from benefiting from patent protection during the pendency of regulatory review.”<a href="#_ftn10" target="_self">[10]</a> The Court noted that their decision is consistent with how the USPTO has handled such cases and that Section 2766 of the USPTO’s Manual of Patent Examining Procedure was consistent with this statutory interpretation.<a href="#_ftn11" target="_self">[11]</a>Under the Federal Circuit’s construction, Merck is compensated “for the period of exclusivity lost due to regulatory delay”—the period of time after the original patent issued during which Merck was unable to commercially market BRIDION® due to regulatory review.<a href="#_ftn12" target="_self">[12]</a> Under Aurobindo’s proposed construction of “the patent,” which the court rejected, the calculus should be tied to the issue date of the RE’733 patent, which naturally would occur later than the issue date of the original patent, and therefore would have resulted in less compensation for the period of exclusivity that Merck lost due to regulatory review.<a href="#_ftn13" target="_self">[13]</a>The Federal Circuit held that “in the context of reissued patents, ‘the patent’ in [35 U.S.C. § 156(c)] refers to the original patent that includes claims that are directed to a drug product.”<a href="#_ftn14" target="_self">[14]</a> In this case, the original patent included claims directed to sugammadex, and therefore the patent was entitled to the five years of PTE awarded by the USPTO.Two footnotes in the opinion suggest how courts could address other factual scenarios not raised in the current case. In one instance, the Court commented that if the original patent included claims directed to a drug product subject to regulatory review, and those claims were canceled during reissue, the canceled claims would no longer be PTE eligible regardless of whether they were canceled before or after regulatory review.<a href="#_ftn15" target="_self">[15]</a> In another instance, the Court noted that the case did not address the situation “where the original patent did not include any claims directed to the drug product and was later reissued to include broader claims directed to such product,”<a href="#_ftn16" target="_self">[16]</a> suggesting such situation could turn on factors such as whether the reissued patent was issued before or after regulatory review.The reissue process can be used to strengthen patents by adding additional claims or modifying existing claims. In view of this case, patentees need not per se avoid seeking reissue on patents that may serve as a basis for PTE. However, given the limited factual scenario presented and the suggestion that other scenarios may be treated differently, patentees should use caution in considering the types of claim amendments presented in reissue for patents that may be subject to PTE.<hr class="divider"><a href="#_ftnref1" target="_self">[1]</a> See 35 U.S.C. § 156.<a href="#_ftnref2" target="_self">[2]</a> Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) at 6.<a href="#_ftnref3" target="_self">[3]</a> Id. at 4.<a href="#_ftnref4" target="_self">[4]</a> Id. at 8.<a href="#_ftnref5" target="_self">[5]</a> Id.<a href="#_ftnref6" target="_self">[6]</a> Id.<a href="#_ftnref7" target="_self">[7]</a> Id. at 8-9.<a href="#_ftnref8" target="_self">[8]</a> See id. at 17.<a href="#_ftnref9" target="_self">[9]</a> Id. at 11-12.<a href="#_ftnref10" target="_self">[10]</a> Id. at 14.<a href="#_ftnref11" target="_self">[11]</a> Id. at 16; see M.P.E.P. § 2766 (“With respect to calculating the amount of extension to which the reissued patent is entitled to receive, so long as the original patent claimed the approved product and the reissued patent claims the approved product, the original patent grant date would be used to calculate the extension to which the reissued patent would be entitled.”)<a href="#_ftnref12" target="_self">[12]</a> Id. at 13.<a href="#_ftnref13" target="_self">[13]</a> See id.<a href="#_ftnref14" target="_self">[14]</a> Id. at 17.<a href="#_ftnref15" target="_self">[15]</a> See id. at Footnote 10 (“If the original patent included claims directed to a drug product subject to regulatory review and the patent owner subsequently cancels those claims, section 156 of course would not apply, whether the cancellation occurred before or after regulatory review. This is because cancelled claims are treated as void ab initio. Fresenius, 721 F.3d at 1346.”)<a href="#_ftnref16" target="_self">[16]</a> Id. at Footnote 11.

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Emily Jane Roberts Ph.D.

Emily Roberts

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in <a href="https://www.cafc.uscourts.gov/03-06-2025-23-1762-immunogen-inc-v-stewart-opinion-23-1762-opinion-3-6-2025_2477708/" target="_blank">ImmunoGen, Inc. v. Stewart</a>, in which the court clarified its standards for determining obviousness in the context of a claimed method of treatment involving a specific dosing limitation of a drug, in this case an antibody drug conjugate (ADC).Claims at IssueClaim 1 was considered representative and recites:<ol><li>A method for treating a human patient having an FOLR1-expressing ovarian cancer or cancer of the peritoneum comprising administering to the patient an immunoconjugate which binds to FOLR1 polypeptide, wherein the immunoconjugate comprises an antibody or antigen-binding fragment thereof that comprises the variable light chain (VL) complementarity-determining region (CDR)-1, VL CDR-2, VL CDR-3, variable heavy chain (VH) CDR-1, VH-CDR-2, and VH CDR-3 of SEQ ID NOs: 6-9, 11, and 12, respectively, and a maytansinoid, and wherein the immunoconjugate is administered at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.</li></ol>It was undisputed by the parties that a method of using the recited immunoconjugate (also known as IMGN853) to treat FOLR1-expressing ovarian cancer or cancer of the peritoneum was known in the art at the time of filing. As such, whether the claims were patentable from an obviousness perspective turned on whether the recited dosing limitation of “6 mg per kg of AIDW of the patient” would have been obvious to a person of ordinary skill in the art (POSITA) at the time of filing.Key Arguments and Court FindingsImmunoGen first argued that the dosing limitation could not have been obvious because it was not known that IMGN853 caused ocular toxicity in humans. The Federal Circuit acknowledged that “where a problem was not known in the art, the solution to that problem may not be obvious,” but emphasized that “it does not follow that a claimed solution to an unknown problem is necessarily non-obvious.” The court found no error in the district court’s finding that a POSITA, despite being unaware of IMGN853’s ocular toxicity, would have been motivated to monitor for such side effects when administering the drugs to humans. In supporting its finding, the Federal Circuit reasoned that IMGN853 contains a payload (DM4) known at the time of filing to be associated with ocular toxicity.ImmunoGen further argued that a POSITA would not have been motivated to use AIBW dosing as the method to address the problem of ocular toxicity. The Federal Circuit upheld the district court’s findings that a POSITA “would have understood AIBW to be a ‘potential solution for ocular toxicity’ and that it would have been obvious ‘to experiment with AIBW in attempting to eliminate or ameliorate the toxicities associated with IMGN853.” The court noted that AIBW was a recognized methodology at the time of filing, including its use as an approach for mitigating ocular toxicity, which supported the district court’s conclusion.ImmunoGen also contended that although AIBW was a known methodology at the time of filing, it would not have been obvious to a POSITA to apply AIBW to an ADC, “particularly when no ADC had ever been dosed using AIBW before.” The Federal Circuit, however, also again upheld the district court’s finding, explaining that “AIBW dosing, though never used for ADCs, would have been within the range of knowledge of a person of ordinary skill in the art when confronted with dosing-induced toxicities, and particularly when confronted with dosing-induced ocular toxicity.” The court supported its conclusion by noting that the primary prior art reference, which was ImmunoGen’s own patent application publication, disclosed the relationship between the DM4 payload of IMGN853 and ocular toxicity, and also indicated that the dosing regimen “can be determined by the physician.”ImmunoGen additionally argued that it would not have been obvious for a POSITA “to select the claimed dose of 6 mg/kg AIBW with a reasonable expectation of success.” The Federal Circuit, once again, found no error with the district court’s findings on this issue, noting that AIBW can be equivalent to true body weight (TBW) dosing.  Further, the court held that a reasonable expectation of success is present because the primary prior art reference disclosed dosing patients with IMGN853 at “around 6 mg/kg of TBW,” indicating that “for patients who weigh exactly their ideal body weight, a dose of 6 mg/kg AIBW is identical to a dose of 6 mg/kg TBW, which is expressly disclosed as a suitable dose in [the primary prior art reference].” In other words, even though the prior art reference did not mention AIBW dosing, the court determined that the “natural result flowing” from the AIBW dosing would be the same as the prior art for at least this one type of patient, “regardless whether a doctor knew of AIBW dosing.”  The Federal Circuit agreed with the lower court’s concerns over preventing doctors “from practicing what is already disclosed in the prior art for patients at their ideal body weight.”ImmunoGen’s final argument was that even if a POSITA would have been motivated to use AIBW to address ocular toxicity with a reasonable expectation of success, “the district court clearly erred because it ‘did not actually hold that a skilled artisan had a reasonable expectation of success that a 6 mg/kg AIBW dose would solve ocular toxicity,” which they argue is unpredictable.  The Federal Circuit found no error with the district court’s findings on this point, emphasizing that “the obviousness inquiry is generally agnostic to the particular motivation of the inventor.” The court clarified that there is no requirement to demonstrate that a POSITA “would have had a reasonable expectation of eliminating ocular toxicity using a 6 mg/kg AIBW dose,” especially since “the claims are silent as to any ocular toxicity problem.” Instead, the Federal Circuit explained that the inquiry requires only that a POSITA “would have had a reasonable expectation that dosing a human at 6 mg/kg AIBW would have been effective in treating ovarian and peritoneal cancers, as claimed.” The court considered the evidence, including the primary prior art reference, to support such a reasonable expectation of success.Implications and Strategic ConsiderationsWhile each of the arguments presented by ImmunoGen is supported, at least to some extent, by case law and USPTO guidance, this decision elucidates how courts and, by extension the USPTO, may evaluate and potentially limit such arguments. For instance, solving a specific problem not known in the art can provide evidence of non-obviousness; however, recognition of a generalized problem associated with any component of the drug (such as the DM4 payload of IMGN853 known at the time of filing to be associated with ocular toxicity) may weigh against such an argument. Additionally, while a unique dosing scheme not previously associated with a particular class of treatments can suggest non-obviousness, any overlap that necessarily results from known dosing schemes for the same treatment may counter this argument. Finally, while unpredictability of a claimed treatment can suggest non-obviousness when a unique dosing scheme is used, the reasonable expectation of success is determined by the ability to achieve what is specified in the claims.The decision appears to apply a stringent standard for the non-obviousness of dosing regimen claims for known drugs, even in cases where there is unpredictability in the drug or methods of using it.  While unpredictability is generally a significant factor against the enablement of biotechnology claims, in the context of non-obviousness, the case highlights that unpredictability is a less critical factor.Moreover, this decision underscores the importance of crafting claims in alternative ways to potentially reframe an obviousness analysis. For example, if the claims had been directed to a “method of reducing ocular toxicity” rather than a “method of treatment,” the determination of whether there was a reasonable expectation of success might have been different.

Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods

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