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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Partner

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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USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

Patent Term Extension for Medical Devices

Patent vs. Trade Secret Considerations for Cell and Gene Therapies

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In the November 20, 2024 Federal Register Notice, the United States Patent and Trademark Office (USPTO or the “Office”) released its <a href="https://www.federalregister.gov/documents/2024/11/20/2024-26821/setting-and-adjusting-patent-fees-during-fiscal-year-2025" target="_blank">final rule on patent fee adjustments</a> (“Final Rule”).  These fee adjustments, set to take effect on January 19, 2025, aim to promote efficient patent prosecution practices while also generating sufficient revenue to recover the Office’s patent operational costs.  Here, we examine some important changes that patent applicants should understand when they consider patent filing and prosecution strategies while balancing the impact of the fee increases.Prolonged Prosecution Will Cost MoreThe Office has introduced new surcharges for continuing applications, including continuations, divisionals, and continuations-in-part.  These include a $2,700 fee for continuing applications filed more than six years after the earliest benefit date, and a $4,000 fee for filings more than nine years after the earliest benefit date.  The Federal Register Notice defines “earliest benefit date” as the date from which the 20-year patent term is calculated and does not include priority claims to provisional applications.  These new fees appear to be designed to discourage prolonged prosecution through continuing application practice, allegedly because the volume and rapid increase of continuing applications negatively impacts the Office’s workload and docketing practices.  Up until now, it is generally recommended to maintain pendency within a family wherever feasible in order to preserve the opportunity for prosecuting additional claims until very late in the 20-year patent term, especially if the patent family covers a product such as a drug or biologic.  For example, serial no-fee continuation applications can be used to keep a patent family open.  With the new fees, one clear adjustment for applicants and their counsel is to monitor the six-year and nine-year deadlines from the earliest priority date and perform a cost-benefit analysis considering these additional fees to decide whether a patent family should be kept open.  Applicants may also wish to consider filing continuing applications earlier, for instance by parallel filings instead of serial filings, in order to avoid the new time-based increased fees while advancing overall family prosecution. Another major change that will make prolonged prosecution of the same application more costly is the increase in Request for Continued Examination (RCE) fees.  The Office will increase the undiscounted fee for filing a first RCE by 10% from $1360 to $1500, and for a second RCE by 43% from $2000 to $2860.  The Office has justified these changes as intended to help promote more compact prosecutions by reducing RCE filings in favor of appeal or reaching agreement with an examiner.  It is also worth noting that the Final Rule officially sets the expiration of the After Final Consideration Pilot Program 2.0 (AFCP 2.0) for December 14, 2024, which was discussed <a href="/topics/beyond-final-rejection-what-s-next-for-patent-prosecution-after-uspto-terminates-after-final-consideration-program-" target="_self">here</a>.  With the discontinuation of the AFCP 2.0, which provides more time for an examiner and includes an interview component, the examiner may have less incentive to consider a standard After Final Response or grant an interview.  Considering the increased RCE costs, applicants should consider engaging an examiner early during prosecution, for instance, before and/or after filing a response to a non-final rejection, in order to attempt to resolve issues prior to receiving a final rejection.  If an RCE is necessary, applicants should consider the first RCE as a “last” opportunity to put the application in the best condition for a Pre-Appeal Brief Request for Conference or a full appeal.  This may include ensuring all potential claim amendments, arguments, and evidence are of record in the submission of the first RCE, including declarations that can help bolster applicant arguments in the Pre-Appeal Brief Request for Review or the complete appeal brief. Information Disclosure Statement (IDS) Submission Will Be More Expensive (and More Complicated)The Office has introduced new IDS size fees based on a cumulative number of references cited and imposed a new IDS certification requirement.  An IDS with more than 50 references will now trigger a $200 fee, with more than 100 references will result in a $500 fee, and more than 200 references will require an $800 fee.  IDS sizes are measured based on the cumulative number of references cited for a particular application, rather than the number of references filed in any single IDS.  Additional filings that increase the reference count from one fee tier to another require payments of the difference between the new size fee and what has previously been paid.  It is worth noting that references cited in parent applications will not count toward these thresholds unless resubmitted in child applications.  If applicants choose not to resubmit references in a child application, however, these references will not appear on the face of the patent issued from the child application. The new IDS size fees are accompanied by the requirement that an IDS must contain “a clear written assertion” by the applicant and patent owner that the IDS is accompanied by an appropriate IDS size fee or that no IDS size fee is required.  It should be noted that under the new requirement, an authorization to charge fees to a deposit account is not a compliant “clear written assertion” unless it specifically refers to the particular IDS fee that should be charged.  The Office stated that the new IDS size fees are intended to encourage applicants to avoid filing large IDS submissions by eliminating clearly irrelevant, marginally relevant, or cumulative information.  While IDS submission has always required anyone substantively involved in prosecution to determine a reference’s materiality, which in some cases involves judgment calls, the new fees and assertion requirement will undoubtedly make the preparation of IDSes more expensive and more complicated.  Applicants should more actively consider materiality and cumulativeness of references in order to avoid unnecessary citation.  However, while applicants balance the duty of disclosure and cost considerations, care should be taken not to inadvertently exclude material and noncumulative information from an IDS submission, and documentation of the decision to not cite a particular reference may be recommended. Other Increases in Prosecution CostsThe Office has introduced fee increases to several other aspects of application filing and prosecution.  One increase is in fees associated with design patent applications, including filing, search, examination, and issue fees for design applications.  The Office alleges these increases are necessary to account for inflationary cost increases and recover design costs associated with handling and examination in view of surging design applications since 2014.  The Office has also increased excess claim fees to recover additional search and examination costs associated with larger claim sets, including a 50% increase from $100 to $200 for each claim in excess of 20, as well as a 25% increase from $480 to $600 for each independent claim in excess of three.  Finally, the Office has drastically increased fees associated with applications for Patent Term Extension (PTE) from $1180 to $2500 in order to reflect the full cost of PTE services.  While this increase is lower than the previously proposed increase to $6700, it nevertheless represents a greater cost for seeking regulatory approval for a patented invention, such as FDA approval for a drug or biologic. With January 19, 2025 less than two months away, a comprehensive review of patent portfolios is recommended to determine whether an action can be taken now to avoid the increased fees.  The budget impact of the fee changes on prosecution costs in 2025 should also be discussed.

Associate

Dr. Bu Yin has nearly 10 years of experience in life sciences patent application drafting, global portfolio management, and strategic counseling. Dr. Yin frequently counsels on issues relating to pate

Bu Yin Ph.D.

Bu Yin

Patent Agent

Corey Garyn focuses his work on patent drafting and prosecution in the biomedical sciences.

Corey M. Garyn Ph.D.

Corey Garyn

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On December 4, 2024, nearly seven months after issuing a Notice of Proposed Rulemaking that proposed major and controversial changes to terminal disclaimer practice, which we previously discussed in an <a href="https://lifesciences.mofo.com/topics/240512-uspto-considers-changing-terminal-disclaimer-practice">earlier blog post</a>, the USPTO announced that it is withdrawing its proposed rule.The proposed rule would have amended 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 received <a href="https://www.regulations.gov/document/PTO-P-2024-0003-0001/comment">more than 300 comments</a> from various stakeholders during its 60-day comment period that was open from May 10, 2024 to July 9, 2024. They include 256 unique comments from stakeholders both supporting and opposing the proposed rule. The USPTO explained that its decision to withdraw its proposed rule was “[i]n light of resource constraints.”One of the controversial aspects of the proposed rule related to whether the USPTO actually has the authority to implement such a rule, or if such a rule would instead require legislative action by Congress given the fundamental changes to substantive patent rights that would be affected.Despite its decision to withdraw the controversial proposed rule, the USPTO recently finalized its rules relating to fee adjustments that will be effective on January 19, 2025.  Although the increase in certain fees on the finalized fee schedule are not as high as originally proposed, there are substantial increases in fees for continuing prosecution applications, particularly those filed more than six years after the priority date. However, the USPTO ultimately did not implement the tiered terminal disclaimer fees that had been proposed. The USPTO rationalized that a purpose of its withdrawn proposed rule and the fee increases was aimed at general goals of increasing efficiency of patent rights and reducing barriers to entry. With the recent resignation of USPTO Director Kathi Vidal and the upcoming presidential administration change, it is unclear whether we can expect future proposed rules aimed at achieving similar goals, and, if so, what form they will take.Continue to follow the <a href="https://lifesciences.mofo.com/">MoFo Life Sciences blog</a> to keep up to date on further USPTO developments.

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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

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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

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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).

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

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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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

Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are complex and rapidly evolving. Careful consideration of the risks and benefits of each, along with their distinct enforcement considerations, are essential to developing an overall IP strategy to provide robust protection of cell and gene therapy products.What to PatentThe core protection for a biologic typically lies in composition of matter patents that cover the product itself. Additional patent applications can be filed to cover improvements as they are discovered, which can add years of exclusivity. Common types of improvement patents for cell and gene therapies include sequence modifications, delivery methods, formulations, patient populations, and manufacturing methods.Patent vs. Trade Secret ProtectionWhile patents offer strong exclusionary protection, it is important to weigh whether keeping certain information as a trade secret is more valuable. A number of factors may impact this decision:<ul><li>Reverse-engineering: If the public-facing product is easily reverse-engineered, trade secret protection will offer little value. However, a trade secret may offer complementary protection in instances where the key innovation is not easily derived from the product. Examples may include AI methods to identify or refine product candidates, which are not themselves public facing.</li><li>Patent eligibility: Certain biologic technologies may face challenges with patent eligibility, especially those derived from natural products or those directed to measuring a natural correlation. However, there are strategies to mitigate these challenges. For example, natural receptors isolated from humans are not patent eligible by themselves but may be patent eligible when introduced into a new cell type or when modified for therapeutic uses.</li><li>Business model: If the business model relies on licensing the technology to others, patents are critical to providing value. Filing patent applications may also be beneficial to demonstrate innovation and secure investment.</li><li>Detecting infringement: If infringement would be difficult to identify, a trade secret might serve as a better option. Assays used in screening or product development and aspects of manufacturing may fall within this category. However, given the importance of manufacturing for cell and gene therapies, manufacturing patents can also provide meaningful coverage against both biosimilars and innovators.</li></ul>Considerations for Patent Infringement vs. Trade Secret EnforcementDeveloping an effective IP protection strategy for cell and gene therapy products also requires understanding and anticipating the complexities of enforcement mechanisms for both patents and trade secrets, including advantages and challenges of each approach. Biologics innovators often use patent infringement litigation and trade secret misappropriation litigation, separately or in combination, to safeguard their proprietary technologies, secure market exclusivity, or prevent competitors from undermining their market position. When planning to enforce a cell and gene therapy patent portfolio or assert trade secret claims, there are several considerations that can guide planning:<ul><li>Goals of enforcement: Defining the business and legal objectives of any enforcement campaign is crucial in determining whether (and when) to pursue a patent infringement litigation or trade secret misappropriation suit. Depending on the forum the lawsuit is brought in, enforcement of patents or trade secrets may allow the intellectual property owner to seek a court order for defendants to stop using confidential information or infringing a patent (“injunctive relief”), financial compensation (“damages”), an exclusion order preventing importation of a product into the U.S., or other forms of relief. The desired outcome – whether it is market exclusion, financial compensation, settlement leverage, or another goal – is likely to meaningfully shape the enforcement strategy and forum.</li><li>Relationship to the competitor: As a threshold matter, trade secret cases typically originate from a relationship between the parties where confidential trade secret information was shared, often under an agreement (e.g., under a non-disclosure agreement during collaborations or licensing discussions) or during the course of employment. Patents may be enforced, however, even if the patent owner did not have any prior relationship with the defendant, allowing for potentially broader enforcement.</li><li>Timing of the action: The timing of the litigation is particularly important in considering whether a patent infringement and/or trade secret misappropriation claim represents a viable or attractive option for enforcement. For example, patent infringement claims and trade secret claims have different windows for bringing suit. Typically, there is a six-year window for recovering damages in a patent infringement case. Trade secret claims, however, have a shorter, tighter timeframe for filing suit, based on jurisdictional statutes of limitation. These timing considerations require careful planning to avoid losing the right to sue or collect potentially significant monetary damages. Additionally, patent litigation relating to cell and gene therapy products may present additional challenges, such as the “safe harbor” provision under 35 U.S.C. § 271(e)(1), which exempts certain activities relating to FDA regulatory approval from infringement liability, potentially delaying the patent owner’s ability to enforce a patent until after FDA approval of the infringing product.</li><li>Pleadings and discovery: The logistics and early-stage burden on the plaintiff may differ significantly between patent infringement and trade secret misappropriation suits. While asserted patents (and possibly exemplary claims) must be identified when filing a patent infringement case, depending on the jurisdiction, plaintiffs retain the flexibility to identify the specific asserted patent claims later when the facts of the case are more well developed. By contrast, trade secret litigation requires the trade secret owner to identify the trade secrets with reasonable particularity up front, often before the case is allowed to proceed to discovery and with a limited ability to modify the results. This requires plaintiffs involved in trade secret misappropriation litigation to carefully and strategically balance how broadly or narrowly the trade secrets will be defined early on in the litigation before they have the benefit of all of the underlying facts from the other side.</li></ul>ConclusionFor more information, please join our presentation on November 19, 2024, titled “Protecting and Enforcing Biologics IP,” that will be offered both online and in person in Cambridge, Massachusetts. We will discuss how to develop a comprehensive patent and trade secret IP strategy with examples including evaluating patents versus trade secrets and how to overcome common obstacles to securing patent protection, with specific examples relevant to cell and gene therapies. We will also discuss strategies and considerations for protecting biologics IP, including best practices for preparing for effective patent and trade secret litigation.<a href="https://www2.mofo.com/l/323401/2024-09-27/b4dqg" target="_blank">Register for in-person attendance</a><a href="https://mofo.zoom.us/webinar/register/WN_OXuSXeM8T--jfB3yxq5ULQ#/registration" target="_blank">Register for Zoom attendance</a>

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. 

Alyssa B. Monsen

Alyssa Monsen

Andrew Murtha focuses his practice on patent drafting and prosecution, with an emphasis on molecular biology, immunology, and food + Agriculture.

Andrew N. Murtha Ph.D.

Andrew Murtha

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A recent decision by the Patent Trial and Appeal Board (PTAB) sheds light on certain pitfalls patent applicants may encounter when submitting declarations under 37 C.F.R. § 1.132 (“Rule 132 Declarations”). Rule 132 Declarations are frequently used in life sciences patent prosecution to submit data in support of a patent application.  They are an important tool for rebutting obviousness rejections raised under 35 U.S.C. § 103 by establishing that an applicant’s invention produces unexpected results.In Ex parte Eidschun, Appeal 2023-003437 (PTAB Oct. 18, 2024),[1] the PTAB found a Rule 132 Declaration submitted by the applicant-appellant to be ineffective for rebutting a prima facie case of obviousness and affirmed the Examiner’s rejections. The claims at issue were directed to a method for metal finishing. The claims recited a variety of different acids and oxidizing agents and combinations thereof that could be used in the method, as well as concentration ranges for these reagents.  During prosecution, the Examiner rejected the claims as allegedly being obvious over a combination of prior art references. In response, applicant argued against the prima facie case of obviousness and also submitted a Rule 132 Declaration[2] describing a series of experiments to demonstrate unexpected results. The Rule 132 Declaration purported to show unexpected results compared to a prior art reference cited in the rejection and also compared to “current conventional anodizing systems.”[3] The Examiner maintained the obviousness rejections, and applicant appealed to the PTAB.The PTAB’s Analysis of the Rule 132 DeclarationThe PTAB affirmed the Examiner’s rejections and provided three reasons for finding the Rule 132 Declaration ineffective to rebut the prima facie case of obviousness.  First, the PTAB found that unexpected results were not shown because the Rule 132 Declaration did not provide a comparison of the claimed invention with the closest prior art.[4] The PTAB indicated that the cited prior art reference discussed in the Rule 132 Declaration did not provide a disclosure sufficiently specific for comparison.[5] Also, the comparison to current conventional anodizing systems did not identify any specific prior art and merely provided variable ranges. Providing additional data without identifying and comparing with the closest prior art was not enough.[6]Second, the PTAB found that even if it showed a difference between the results obtained from the claimed invention and the reference examples, the Rule 132 Declaration failed to establish that one of ordinary skill in the art would have considered those differences to be unexpected.[7] The declarant’s reference to the results as “unexpected results” was insufficient.Third, the PTAB found that the evidence submitted in the Rule 132 Declaration was not commensurate in scope with the claims.[8] Whereas the independent claim recited eight acids and five oxidizing agents alone or in any combination, the Rule 132 Declaration provided data for only one acid and one oxidizing agent.  Furthermore, the Rule 132 Declaration did not indicate any specific concentrations tested, instead referring only to the same concentration ranges recited in the claims. Thus, the PTAB deemed that no specific composition within the scope of the claims had been compared to prior art.[9]TakeawaysRule 132 Declarations remain an important tool by which applicants can submit data showing unexpected results to rebut an obviousness rejection raised in patent prosecution. To maximize the effectiveness of a Rule 132 Declaration, applicants should consider several factors. When providing comparative data, applicants should consider using the closest prior art as the point of reference. Furthermore, comparisons based on reference examples not grounded in any identified prior art may be less effective than comparison to a specific prior art disclosure. Applicants should take care to explain why a difference in results, even if superior, would be unexpected to one of ordinary skill in the art, rather than simply making a conclusory statement regarding unexpected results. Applicants should consider showing comparisons based on specific compositions tested, not based merely on ranges or other generic descriptions. Finally, applicants should be mindful of the scope of the data relative to the claims, providing sufficient examples to span the scope of the claims or explaining why a limited set of examples is illustrative of the full claim scope. Alternatively, applicants may consider filing narrowing claim amendments to more closely align the claim scope with the comparative data.[1] A copy of <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt16069c88d3dafda1/671fdc05622c5629e3aa2e45/241028-ptab-decision.pdf" target="_blank">Ex parte Eidschun, Appeal 2023-003437 (PTAB Oct. 18, 2024)</a>.[2] A copy of the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blta1c4adaba0200472/671fdbbc2339aa621a240ad5/241028-rule132-declaration.pdf" target="_blank">Rule 132 Declaration</a>.[3] See Rule 132 Declaration, at 2.[4] See Ex parte Eidschun, at 5.[5] See id.[6] See id. See also at 6.[7] See id., at 6.[8] See id.[9] See id.

Dr. Qiwen Zhong focuses on patent prosecution, freedom-to-operate analyses, and IP due diligence, with an emphasis on chemistry and pharmaceuticals.
Qiwen obtained her J.D. from UCLA School of Law whe

Qiwen Zhong Ph.D.

Qiwen Zhong

Establishing Unexpected Results: PTAB Highlights Pitfalls for Rule 132 Declarations

On October 1, 2024, the United States Patent and Trademark Office (USPTO) announced that it is terminating its After Final Consideration Pilot Program 2.0 (AFCP 2.0), which is set to expire on December 14, 2024. The expiration follows a brief extension from September 30, 2024 to December 14, 2024 to allow applicants to adjust to the upcoming program termination in the event they are in the process of preparing a response under the AFCP 2.0.Under AFCP 2.0, applicants can file a response to a final office action that includes a non-broadening amendment to at least one independent claim and, if the examiner determines that not all pending claims are in a condition for allowance, the examiner will schedule an interview with the applicant. No additional fees for filing a response under AFCP 2.0 have been required.AFCP 2.0 was created on May 19, 2013, with the goal “to improve pendency by reducing the number of Requests for Continued Examination (RCE) and encourage increased collaboration between the applicant and examiner to effectively advance prosecution of the application.” Although the initial pilot program was scheduled to run for one year, it has been repeatedly extended over the years, until now.The USPTO’s decision to terminate its AFCP 2.0 program is largely due to its high cost of administering the program without receiving any payment in return, which was estimated to cost more than $15 million in fiscal year 2022 alone. Earlier this year, the USPTO proposed a new fee for filing a request under AFCP 2.0 that would range from $100 to $500 depending on the entity status. However, the USPTO decided to terminate the program after receiving feedback from commenters expressing concerns about AFCP 2.0 and the proposed new fee. Thus, applicants interested in filing a response under AFCP 2.0 must do so on or before December 14, 2024.Moving forward, applicants who disagree with a final office action rejecting their claims can still file a standard After Final Response, but whether the Examiner enters the amendment and finds the response sufficient to result in allowable claims remains at the discretion of the examiner. With the discontinuance of the AFCP 2.0 program, there may be little incentive for an examiner to consider an After Final Response submission. Also, unlike under AFCP 2.0 where an examiner may be required to schedule an interview, an examiner can refuse an applicant’s request for an interview following a final office action outside of this program.Although an RCE remains an option, this option can be expensive and necessitates a relatively high filing fee – which may only increase with the USPTO’s proposal for significant fee increases for 2025. As an alternative, the USPTO offers another pilot program that involves filing a Pre-Appeal Brief Request for Review, which is considered by a panel of examiners including the supervisory patent examiner (SPE), the examiner, and at least one additional examiner or a quality assurance specialist. The Pre-Appeal Brief Request for Review approach can be particularly helpful by quickly advancing the case in situations where the examiner and applicant have reached an impasse and/or the examiner’s rejection is clearly erroneous.A Pre-Appeal Brief Request for Review must be filed at the time of filing a Notice of Appeal and is limited to five pages of concise argument. There is a Notice of Appeal fee ranging from $168 to $840, depending on entity status, but there is no additional fee for submitting a Pre-Appeal Brief Request for Review. The panel typically renders a decision within about one to two months. If the Pre-Appeal Brief Request for Review is successful, the rejection(s) will be reversed and the application will either be allowed or a new office action will issue. If the Pre-Appeal Brief Request for Review is unsuccessful, i.e., there remains at least one issue for appeal, an applicant can decide to file an RCE (which withdraws the application from appeal and reopens prosecution) or can continue with the appeal process by filing a complete appeal brief.If an appeal brief is filed, the appeal proceeds so that the Patent Trial and Appeal Board (PTAB) can render a decision.  This requires a further “forwarding” fee ranging from $472 to $2,360 (depending on entity status) once the briefing is complete, and the fee for an optional request for oral hearing ranges from $272 to $1,360 (depending on entity status).  A decision by the PTAB takes, on average, 12 months after the PTAB receives the appeal (which can be several months after filing the Notice of Appeal). However, a petition under the Fast-Track Appeals Pilot Program along with a $420 petition fee can reduce the 12-month period by a half. During the time period after filing an appeal brief but before a decision is rendered, the applicant may decide to withdraw the case from appeal by filing an RCE, thereby reopening prosecution. In summary, while the USPTO is allowing the AFCP 2.0 program that has run for more than 10 years to finally expire, other avenues remain open to advance a rejected application to allowance, including by filing a Notice of Appeal with a Pre-Appeal Brief Request for Review.

Beyond Final Rejection: What’s Next for Patent Prosecution After USPTO Terminates its After Final Consideration Program?

Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product.[1] The Leahy-Smith America Invents Act provides exceptions for certain disclosures that would otherwise be considered prior art under 35 U.S.C. § 102.[2] Specifically, 35 U.S.C. § 102(a)(1) provides, in part, that a person is not entitled to a patent if the claimed invention was in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. One such exception is the pre-filing grace period (safe harbor) provision of 35 U.S.C. § 102(b)(2)(B), which provides that disclosure in a patent or patent application shall not be prior art if the disclosed subject matter was, prior to the effective filing date of the patent or application, publicly disclosed by the inventor or a third party who derived the disclosure from the inventor. The Federal Circuit held that a private sale does not satisfy this requirement and could not be relied on to disqualify prior art, demonstrating the narrowness of this pre-filing grace period provision.PTABKaijet Technology International Limited, Inc. filed a petition for inter partes review of U.S. Patent No. 10,572,429 (“the ’429 patent”), challenging claims of the ’429 patent as obvious over various combinations of prior art, including U.S. Patent Application Publication No. 2018/0165053 (“Kuo”).[3] Both the ’429 patent and Kuo concern ports and docking stations for connecting an end-user device (e.g., a laptop) to a peripheral device (e.g., a printer). Sanho argued that a private sale of a product embodying the claimed invention from the inventor to Sanho constituted a public disclosure prior to Kuo’s effective filing date, thus disqualifying Kuo as prior art under section 102(b)(2)(B).[4] After Sanho received a prototype of the product from the inventor’s company, Sanho placed an order for the product.[5] The PTAB held that the sale did not amount to a public disclosure because there was no showing that the sale was publicized in any way or that the order was fulfilled. As a result, Kuo was eligible as prior art, and the PTAB determined that the challenged claims were unpatentable.[6]Federal CircuitOn appeal, the sole issue was whether a non-confidential but otherwise private sale resulted in the subject matter of an invention being “publicly disclosed” for purposes of section 102(b)(2)(B).[7]Sanho contended that the plain meaning of the phrase “publicly disclosed” in section 102(b)(2)(B) should be construed to include all disclosures described in section 102(a)(1), including situations in which the invention was “on sale.”[8] However, the Federal Circuit disagreed, clarifying that Helsinn referred to a situation where a private commercial sale constituted a disclosure under section 102(a)(1), and the “on sale” bar in section 102(a)(1) serves a different purpose than the “publicly disclosed” requirement in section 102(b)(2)(B).[9]Sanho also argued that prior legislative treatment concluded that a “public use” was synonymous with a “public disclosure” as long as the recipient of a product incorporating the invention is not subject to any secrecy obligations. However, the Federal Circuit again disagreed, emphasizing the fundamentally different purposes of sections 102(a) and 102(b) with the respective phrases “public use” and “publicly disclosed.”[10]Sanho further contended that the meaning of the phrase “publicly disclosed” in section 102(b)(2)(B) was identical to the meaning of the terms “disclosed” and “disclosure” used elsewhere in section 102.[11] Again, the Federal Circuit disagreed and emphasized that the congressional intent of using two different phrases—“disclosed” and “publicly disclosed”—suggests that the phrases have different meanings.[12] Moreover, the Federal Circuit noted that Sanho’s isolation of the phrase “publicly disclosed” violated “the cardinal rule that a statute is to be read as a whole.”[13]In concluding that the PTAB unequivocally did not err in finding Kuo to qualify as prior art, the Federal Circuit explained that the private sale did not “publicly disclose” the subject matter of the invention because (1) the sale was between two parties made via the private messaging service WeChat, (2) there was no teaching that the features of the invention were disclosed to others beyond Sanho, and (3) there was no testimony regarding whether the order was fulfilled or if the products were ever manufactured.[14]TakeawaysPrivate but non-confidential sales of a product allegedly embodying an invention do not necessarily amount to a public disclosure to constitute an exception under section 102(b)(2)(B). Interestingly, several key questions were not at issue on appeal and thus were not considered by the court: (1) whether the inventor’s disclosure needs to be fully enabling to qualify for this exception, (2) what evidence is sufficient to demonstrate that a sale publicly disclosed the invention’s relevant subject matter under this provision, and (3) whether to apply the prevailing standard for when a printed publication is sufficiently publicly accessible to qualify as prior art. We expect additional case law to address these questions.<hr class="divider">[1] See Sanho Corp. v. Kaijet Technology International Limited, Inc., No. 2023-1336 (Fed. Cir. July 31, 2024) (“Fed. Cir. Decision”). [2] Specifically, 35 U.S.C. § 102 precludes patentability of a claimed invention that has been “available to the public” (e.g., patented, described in a printed publication, in public use, or on sale) before the effective filing date of the claimed invention. [3] See Kaijet Technology International Limited, Inc. v. Sanho Corporation, IPR2021-00886, at *1 and *5–6 (P.T.A.B. Oct. 25, 2022). [4] See id. [5] See id. at *3–4. [6] See id. at *4.[7] See Fed. Cir. Decision at *2.[8] See id. at *8, relying on Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. 123 (2019). [9] See id. at *12.[10] See id. See also Egbert v. Lippmann, 104 U.S. 333 (1881) (where the court did not hold that a public use must necessarily amount to a public disclosure). [11] See id. at *5. [12] See id. at *8–9. [13] See id. at *10 (quoting King v. St. Vincent’s Hosp., 502 U.S. 215, 221 (1991)).[14] See id. at *14–15.

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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

Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product.  The Leahy-Smith America Invents Act provides exceptions for certain disclosures that would otherwise be considered prior art under 35 U.S.C. § 102

Under lock and key – Private sales may not qualify as public disclosure