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.

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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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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.

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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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

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Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could not be marketed. PTE is available for patents covering certain human drugs, food or color additives, animal drugs, veterinary biological products, and medical devices. On average, a granted PTE application adds 1059 days (nearly three years) to a patent’s term.[1]Although PTE is available for medical device patents, it has previously been underutilized in this area.  A study examining PTE applications from 1984-2024 found that only 125 PTE applications were granted for medical devices during that period, while 670 PTE applications were granted for drugs and an additional 140 were granted for biologics.[2] The study’s authors speculated that this may be due at least in part to the fact that not all medical devices are eligible for PTE. However, even taking this into account, the number of PTE applications for medical devices still appears lower than expected based on the total number of eligible device-related regulatory submissions.[3] Medical Device Eligibility CriteriaAs noted above, not all medical devices are eligible for PTE. Devices subject to review under section 515 of the Federal Food, Drug, and Cosmetic Act (FFDCA) are eligible for PTE under 35 U.S.C. § 156. Section 515 applies to class III medical devices, which are high-risk medical devices that are life-sustaining or critical to human health and must undergo pre-market approval.[4] Other types of medical devices, including class II devices that undergo regulatory review under section 510(k) of the FFDCA instead of section 515, are not eligible for PTE.As with all PTE-eligible products, only one patent corresponding to a given regulatory review period can receive PTE.[5] Thus, if multiple patents cover a medical device subject to a single regulatory review period, only one of those patents can receive PTE. Furthermore, the PTE must be based on the first approval for the product under the provision of law under which such regulatory review period occurred.[6]Patent Term Extension Application ProcessAny application for PTE, regardless of whether the application is for a medical device, drug, or other eligible product, must be submitted to the USPTO Director within the 60-day period beginning on the date when the product received regulatory approval.[7] A narrow exception is available if the patent is set to expire before regulatory approval is obtained, in which case an interim extension may be requested starting six months before and ending 15 days before the patent is set to expire.[8]An application for PTE must contain the identity of the approved product and the federal statute under which regulatory review occurred. The application must also identify the patent for which PTE is being sought and list one or more claims that cover the approved product. Additionally, the application must contain “information to enable the Director to determine…the eligibility of a patent for extension and the rights that will be derived from the extension.”[9] This includes information about the term of the patent, the nature of the product, details regarding the regulatory review period, and approved uses for the product. Furthermore, the application must include a brief description of activities undertaken by the applicant during the applicable regulatory review period and “such patent or other information as the Director may require.” If the Director determines that the patent is eligible for PTE and that the above requirements have been satisfied, the Director will issue a certificate of extension. Length of Patent Term ExtensionThe length of PTE for a medical device is calculated based on the portion of the regulatory review period for the device that occurred after the patent’s issue date. The post-issuance regulatory review period is reduced by any amount of time that the applicant failed to exercise due diligence during the regulatory review period.[10] That figure is then reduced by one-half of the post-issuance testing period to arrive at the final PTE duration.[11]In any case, the amount of PTE available for any given application may not exceed five years, and the PTE may not extend the term of the patent beyond fourteen years from regulatory approval.[12] As noted above, the average amount of PTE granted is almost three years. It should be noted that there are limitations on a patent holder’s enforcement rights during the PTE period of a patent’s term. During this period, enforcement of the patent is limited to any use of the approved device that was approved before the expiration of the original term of the patent and on or after the expiration of the regulatory review period upon which the PTE was based.[13] Practice Tips for Effective Medical Device Patent Term Extension ApplicationsAs a preliminary matter, applicants should reach out to patent and regulatory counsel when seeking to patent a medical device to determine if the patent is eligible for PTE. If an applicant is seeking multiple potentially eligible patents directed to a single device, the applicant should work with counsel to select the best patent(s) for which to request PTE. As noted above, 35 U.S.C. § 156(c)(4) provides that only one patent corresponding to a given regulatory review period can receive PTE. However, applicants can still apply for PTE on multiple patents and withdraw all but one of the applications near the end of the process. Because the PTE application process can be lengthy, this approach can maximize the amount of time available to applicants to decide which patent should ultimately receive PTE. When it comes time to select which patents should receive PTE, applicants should consider factors such as the scope of protection afforded by each patent, the strength of the patent against potential invalidity challenges, and the expiration date of the patent.In addition, applicants should ensure that their applications comply with all statutory requirements and include sufficient details to allow the Director to make a determination regarding PTE eligibility. Under 35 U.S.C. § 156(e), the Director’s determination that a patent is eligible for extension may be made “solely on the basis of the representations contained in the application for the extension” (emphasis added). Accordingly, applicants should ensure that their applications for PTE are thorough and complete prior to submission. Finally, applicants should take actions that maximize PTE duration. For example, applicants should prioritize early issuance of patents that may be candidates to receive PTE. Because the PTE calculation is based on the post-issuance regulatory review period, achieving early issuance can help an applicant accrue as much PTE as possible. Applicants should also act with due diligence during regulatory review. As discussed above, PTE is reduced by any amount of time that the applicant fails to exercise due diligence during the regulatory review period. Thus, applicants should take care to abide by deadlines and be responsive to requests or other communications from the FDA to avoid unnecessary reductions in PTE.[1] “Applications for patent term extension and patent terms extended under 35 U.S.C. § 156.” United States Patent and Trademark Office, https://www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156, accessed Nov. 19, 2024.[2] Kuo, C. Benson, and Frances Richmond. “Use of patent term extensions to restore regulatory time for medical devices in the United States.” Expert review of medical devices, 1-7, June 3 2024, doi:10.1080/17434440.2024.2363298.[3] Id.[4] 21 U.S.C. § 360e.[5] 35 U.S.C. § 156(c)(4).[6] 35 U.S.C. § 156(a)(5).[7] 35 U.S.C. § 156(d)(1).[8] 35 U.S.C. § 156(d)(5).[9] 35 U.S.C. § 156(d)(1)(C).[10] 35 U.S.C. § 156(c).[11] Id.; MPEP § 2758.[12] 35 U.S.C. § 156(g)(6)(A); 35 U.S.C. 156(c)(3).[13] 35 U.S.C. § 156(b)(1).

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Alayna’s practice focuses on patent preparation, prosecution, and counseling for a variety of technology areas, such as medical devices and imaging systems, software, machine learning, and industrial processing.

Alayna Y. Choo

Alayna Choo

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Jon Bockman is the head of the firm’s Technology Patent Practice. In this capacity, he leads the firm’s prominent group of patent practitioners with degrees in electrical engineering, mechanical engineering, computer science, computer engineering, chemical engineering, biomedical engineering and physics. 

Jonathan Bockman

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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230124-fda-covid

Patent Term Extension for Medical Devices

On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative action. This follows from a string of other recent Notices where the USPTO is seeking public input on other areas of patent law, including a recent Notice of Proposed Rulemaking on Terminal Disclaimer practice.The USPTO explained that the current experimental use exception is a common law exception that was created to prevent punishing someone who infringes a patent “merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the [invention] to produce its desired effects.” This led to the availability of the experimental use exception based on whether the alleged infringement involved profit-making or other commercial purposes. The USPTO describes the current state of the experimental use exception as being a “very narrow and strictly limited experimental use defense.”The USPTO’s request for public input on the “narrow” experimental use exception appears to stem, at least in part, from divergent views of the exception and its narrow breadth. The USPTO explains that some argue that “a narrow exception enhances innovation by rewarding innovators with robust patent rights, while others noted that restricting researcher access to patented technologies would impede innovation.”This is not the first time there has been discussion of codifying the common law experimental use exception. Unsuccessful attempts at enacting legislation to codify the exception occurred in Acts proposed in 1990 and again in 2002. This stands in contrast to many foreign jurisdictions where statutory experimental use exceptions have been enacted, including jurisdictions where life sciences research and development are robust. This includes European countries, such as Germany, the UK, France, Spain, Italy, Switzerland, and the Netherlands, Asian countries, such as Japan and China, and countries across the Americas, such as Canada and many Latin America jurisdictions, including Brazil.A limited type of experimental use exception has, however, been codified in the U.S. in the Hatch-Waxman Act as 35 U.S.C. § 271(e), which is commonly referred to as the “safe harbor” exception rather than the experimental use exception. Section 271(e) provides that making, using, offering to sell, or selling certain patented inventions “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products” shall not be considered an act of infringement. This “safe harbor” provision allows, for instance, a company to perform the testing required to obtain regulatory approval of a generic drug product without having to first wait for the patents covering the drug product to expire, thereby accelerating the timeline by which generic drug products can reach the market. Although certain acts can be shielded from liability for patent infringement under the § 271(e) exception where there is regulatory intent, the scope of the exception is ever evolving.The USPTO will be accepting public comments over the next 90 days relating to the experimental use exception.While the USPTO welcomes comments on any issues relating to the experimental use exception and its potential codification, they are particularly seeking out comments relating to the following issues:<ol><li>Please explain how the current state of U.S. experimental use exception jurisprudence impacts investment and/or research and development in any field of technology, including, but not limited to: (a) quantum computing; (b) artificial intelligence; (c) other computer-related inventions; (d) agriculture; (e) life sciences (including prescription drugs and medical devices); and (f) climate-mitigation technologies.</li><li>Do you believe there are any technologies that are negatively affected by the current state of experimental use exception jurisprudence in the United States? If yes, please identify which technologies and explain how you believe they are affected.</li><li>Please explain what impact, if any, a statutory experimental use exception would have on the innovation and commercialization of new technologies, including with respect to: (a) research and development; (b) ability to obtain funding; (c) investment strategy; (d) licensing of patents and patent applications; (e) product development; (f) sales, including downstream and upstream sales; (g) competition; and (h) patent enforcement and litigation.</li><li>Has the current state of experimental use exception jurisprudence impacted decisions you have made with respect to filing, purchasing, licensing, selling, or maintaining patent applications and patents in the United States? If yes, please explain how.</li><li>Please explain whether you believe the United States should adopt a statutory experimental use exception. In doing so, please identify your reasons, including by providing evidence and data to support your views.</li><li>Please explain how a statutory experimental use exception, if any, should be defined. Please include specific limitations and restrictions you believe would be needed to ensure that patent rights are preserved.</li><li>Please identify public policy reasons in support of maintaining the status quo or changing the experimental use exception in the United States.</li><li>Please provide any additional recommendations on how best to enhance and facilitate experimental research on patented inventions in the United States.</li></ol>

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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

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