Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

Social

Search

Subscribe

Life Sciences and Healthcare Group

Life Sciences Podcast

Patent Counseling + Prosecution

FDA Regulatory + Life Sciences Compliance

FDA + Healthcare Regulatory and Compliance 

Life Sciences Transactions + Licensing

Resources

Editors

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

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

poon_meghan_blog_150x150.png

poon_meghan_common_640x280.jpg

poon_meghan_heroretina_2700x1160.jpg

poon_meghan_mobileretina_750x1040.jpg

poon_meghan_social_600x600.jpg

Partner

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

schonig_wolfgang_blog_150x150.png

schonig_wolfgang_common_640x280.jpg

schonig_wolfgang_heroretina_2700x1160.jpg

schonig_wolfgang_mobileretina_750x1040.jpg

schonig_wolfgang_social_600x600.jpg

Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

life-sciences-featured-image.jpg

life-sciences-featured-image

Announcements

Welcome to Mofo Life Sciences

Blog - Terms of Use

Cookies

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

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

MoFo Tech Blog

MOFO TECH

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

Employment Law Commentary

EMPLOYMENT LAW COMMENTARY

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

Socially Aware

SOCIALLY AWARE

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

Government Contracts Insights Blog

GOVERNMENT CONTRACTS INSIGHTS

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

Class Dismissed Blog

CLASS DISMISSED

MoFo Life Sciences

  Linkedin

MoFo LinkedIN

Life Sciences Blog - RSS

Stay Connected

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

Because No One is Immune to the Law

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

AI + Robotics

Agtech

Antitrust

Asia

Bioinformatics

Biotech

Blockchain

Cell + Gene Therapy

CFIUS

Corporate + Venture Capital

COVID-19

Data Analytics

Digital Health

Employment

European Union

Financing

Global

Healthcare

Intellectual Property

Licensing + Commercial

Litigation

Medical Devices + Diagnostics

Pharma

Privacy + Data Security

Product Liability + Class Action

Rare Disease

Regulatory

Startup

United Kingdom

United States

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

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

LinkedIN

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).

Associate

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

bondoc_brigid_blog_150x150.png

bondoc_brigid_common_640x280.jpg

bondoc_brigid_heroretina_2700x1160.jpg

bondoc_brigid_mobileretina_750x1040.jpg

bondoc_brigid_social_600x600.jpg

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

silverman_lisa_blog_150x150.png

silverman_lisa_common_640x280.jpg

silverman_lisa_heroretina_2700x1160.jpg

silverman_lisa_mobileretina_750x1040.jpg

silverman_lisa_social_600x600.jpg

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

Lisa N. Silverman Ph.D.

Lisa Silverman

230124-fda-covid.jpg

230124-fda-covid

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>

Jeffrey Schmidt

Karen Potter

240628-lab.jpg

240628-lab

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.

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

Should the recent bill entitled the Patent Eligibility Restoration Act of 2023 (PERA) become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101.By way of the Patent Act of 1952, the United States Congress established four statutory categories defining limits on inventions eligible for patent protection that are still in use today: process, machine, manufacture, and composition of matter.<a href="#_ftn1" target="_self" dir="ltr" id="_ftnref1">[1]</a> On its face, this framework would appear to allow for the patenting of medical diagnostics, which often revolve around a process and/or machine (e.g., a diagnostic device). However, the current patent-eligibility environment in the United States surrounding medical diagnostics is unforgiving and those seeking to patent such inventions face significant challenges in trying to protect their innovations. This is largely due to courts having created, in their established role of interpreting and applying laws, judicially recognized exceptions to the four broad categories of patent-eligible subject matter that bar the patenting of abstract ideas, laws of nature, and natural phenomena.<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a>Foundational to a medical diagnostics invention is the underlying correlation of a result to a condition (e.g., the level of a protein correlating with presence of a human disease). Mayo, an opinion handed down by the Supreme Court in 2012, cemented the basic idea that, for medical diagnostics, such underlying correlations are laws of nature and are not patent-eligible without claiming significantly more than the natural law itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). A patchwork of additional jurisprudence has built up over the decade since Mayo, establishing additional patent-eligibility roadblocks for the patenting of medical diagnostics. Recently, U.S. Senators Tillis and Coons introduced legislation aiming to provide clarity to patent eligibility in a bill titled the Patent Eligibility Restoration Act of 2023 (PERA).<a href="#_ftn3" target="_self" id="_ftnref3">[3]</a> Should this bill become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101. There is currently no language in PERA expressly stating that medical diagnostics inventions are per se patent-eligible. However, as both senators have singled out the field of medical diagnostics in <a href="https://www.tillis.senate.gov/2023/6/tillis-coons-introduce-landmark-legislation-to-restore-american-innovation" target="_blank">public statements regarding the bill</a>, it is readily apparent that a driving purpose of PERA is to foster innovation in this space by eliminating the current hurdles to patent eligibility (e.g., Senator Coons is quoted as stating “[c]ritical technologies like medical diagnostics and artificial intelligence can be protected with patents in Europe and China, but not in the United States”). Here, we discuss select aspects of the bill that would change the current legal landscape in this field to allow for the direct patenting of medical diagnostics in the United States (e.g., a method of diagnosing a disease in an individual).Restarting the clock on statutorily defined patent subject-matter eligibilityAs noted above, judicially recognized exceptions to the four categories of patent-eligible subject matter are significant obstacles when pursuing patent protection of medical diagnostics. PERA would expressly eliminate all current judicial exceptions to patent subject-matter eligibility. This does not mean that exceptions will not exist. Rather, PERA will establish new exceptions (many of which are based on currently practiced and accepted exceptions). Specifically, PERA provides that “[w]hoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in subsection (b) and to the further conditions and requirements of this title” (emphasis added).Hope for broader subject-matter eligibility of medical diagnosticsWith relevance to medical diagnostics, under the Eligibility Exclusions detailed in PERA (subsection (b)), it is stated that “a person may not obtain a patent for any of the following, if claimed as such; . . . (C) A process that (i) is a mental process performed solely in the human mind; or (ii) occurs in nature wholly independent of, and prior to, any human activity.” This language would appear to stop exceptions to patent eligibility short of the current reach of judicially recognized exceptions. For example, one could apply the language of PERA to claims in question in Mayo and reasonably conclude that the active steps therein (e.g., administering a drug and determining the level of an analyte) are human activities that do not occur in nature wholly independent of, and prior to, any human activity.<a href="#_ftn4" target="_self" dir="ltr" id="_ftnref4">[4]</a> This aspect of PERA signals that medical diagnostics will be patent-eligible should they be carefully drafted to include features readily distinguishable from capabilities of the human mind and/or features demonstrating human activity related to performance of such medical diagnostics.We find additional confirmation that PERA will allow for medical diagnostics to be generally subject-matter-eligible under subsection (c). Subsection (c) states that “eligibility shall be determined . . . (B) without regarding to . . . (ii) whether a claim element is known, conventional, routine, or naturally occurring.” There are two aspects worthy of discussion here as they represent a distinct departure from current patent subject-matter eligibility law. Firstly, under current law, having a claim element that is directed to the naturally occurring (such as the underlying correlation of a medical diagnostics) results in an analysis of the claimed invention where one is forced to establish why the subject matter is in fact patent-eligible. Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). The language in subsection (c) flips this current notion on its head and in some regards preserves more of a presumption of patent eligibility, whether or not there is a claimed feature that can be attributed to a naturally occurring phenomenon. Under PERA, it seems likely that one will then need to establish why a claimed invention, when viewed as a whole, is not eligible for patent protection for reasons other than containing a naturally occurring phenomenon, as one element.Secondly, subsection (c) expressly prohibits assessing, for purposes of subject-matter eligibility, whether a claimed element is “conventional” or “routine.” Current subject-matter eligibility law is becoming increasingly entangled with assessing conventionality.  Such language could change how court cases are being decided today. In CareDx, for example, a Federal Circuit court held that claims to noninvasive detection of graft rejection in transplant patients were unpatentable subject matter under 35 U.S.C. § 101 because they involved detection of a natural phenomenon using only conventional techniques. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371, 1381 (Fed. Cir. 2022). In a similar fashion, in Ariosa Diagnostics, a Federal Circuit court held that claims to detecting paternally inherited nucleic acid of fetal origin performed on material serum or plasma were also not subject-matter-eligible as they only recited known methods of analyzing fetal DNA. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). Under PERA, subject-matter eligibility determinations may avoid such a reliance on conventionality of techniques. This would be a significant change in patenting medical diagnostics as there is a commercial drive for developing medical diagnostics that can be performed using “conventional” or “routine” techniques (e.g., conventional PCR or mass spectrometry) to enable widespread adoption.Next stepsPERA is still in its infancy as a bill. We are continuing to monitor developments related to PERA and will provide relevant updates. If you have any questions about this topic or would like to discuss patenting your own medical diagnostics inventions, please reach out to MoFo’s Patent Strategy + Prosecution team.Special thanks to Janet Xiao, Meghan Poon, and Laura Ray for the development of this article.<a href="#_ftnref1" target="_self" dir="ltr" id="_ftn1">[1]</a> Title 35, United States Code, section 101.<a href="#_ftnref2" target="_self" dir="ltr" id="_ftn2">[2]</a> E.g., Diamond v. Diehr, 450 U.S. 175, 185 (1981).<a href="#_ftnref3" target="_self" dir="ltr" id="_ftn3">[3]</a> Patent Eligibility Restoration Act of 2023, S.2140, June 22, 2023.<a href="#_ftnref4" target="_self" id="_ftn4">[4]</a> U.S. Patent Nos. 6,355,623 and 6,680,302.

A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

Patent Agent

Dr. Michelle Bradley focuses her work on patent drafting and IP due diligence inquiries, including freedom-to-operate and patentability analyses, with an emphasis on biotechnology and pharmaceuticals.

Michelle Celine Bradley Ph.D.

Michelle Bradley

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

John D Chapman Ph.D.

John Chapman

mofolifesciences-health-it.jpg

A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

Recent Digital Health-Related FDA Announcements

mofolifesciences-health-it

By way of the Patent Act of 1952, the United States Congress established four statutory categories defining limits on inventions eligible for patent protection that are still in use today: process, machine, manufacture, and composition of matter.

Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion. This article originally appeared on JDSupra and is reprinted with permission.In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications submitted to the US Food and Drug Administration contained artificial intelligence and machine learning (AI/ML) components.According to Brigid Bondoc, Partner at Morrison Foerster in Washington, DC, the FDA shares an industry optimism that "AI/ML can help bring safe, effective, and high-quality treatments to patients faster," to quote Patrizia Cavazzoni, M.D., the director of the Center for Drug Evaluation and Research (CDER) at the FDA.How the agency evaluates and manages emerging AI/ML technologies in drug and biologic applications were addressed in the panel "Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape," presented by Morrison Foerster (MoFo), on May 11, 2023, at the Association for Corporate Counsel (ACC) live CLE event "2023 Life Sciences Conference: Future-Ready Resilience: Preparing to Face Challenges in the Uncertain Future."The panel, consisting of Bondoc; Anna Yuan, Senior Associate at MoFo; Wendy Chow, counsel to MoFo; and Lauren Wu, Head of Privacy, Sr. Dir. of Legal for Regulatory and Compliance, US Privacy Officer, and Global DPO at Evidation Health, discussed the evolving FDA policies and regulation on AI, data privacy implications, and protecting AI technology in life sciences.FDA RegulatoryBondoc presented the big picture on the FDA's AI regulation, where the agency actively monitors AI/ML software in medical devices and clinical developments. The agency may expand coverage into FDA-regulated activities, such as automation and learning of medical devices, diagnostic and therapeutic development efficiency, regulatory assessment, and post-market surveillance.The 21st Century Cures Act excludes five types of software from the FDA's medical device definition and regulation, including administrative support software, wellness, and electronic patient records. Still, the act allows the FDA to "claw back any exception if it identifies risks associated with the software as a medical device," said Wu. With AI technologies, wellness, and electronic records, "the waters get muddier," commented Wu—for example, what to do with a pedometer that monitors sleep and blood pressure. It may become more than a wellness device and move into the regulated medical device space.The FDA appears flexible and careful in developing an AI/ML regulation framework, offsetting the need to facilitate innovation while protecting public health. For example, Bondoc pointed to the agency's drafted guidance on Predetermined Change Control Plans (PCCP) for AI/ML-enabled device software functions, attempting to address a significant issue facing emerging technology.Historically, changes to a cleared or approved medical device that could significantly affect the safety or effectiveness of the device required submitting a premarket notification 510(k). Yet, the notification program is "fundamentally at odds with the use of AI/ML in medical devices that facilitate continual improvements and modifications to the device based on data gathered while in use," said Bondoc. The FDA aims to develop a regulatory approach tailored to AI/ML-enabled devices, allowing for safe and rapid modifications in response to new data while ensuring safety and effectiveness.The FDA sees ethical, privacy, and security issues using AI/ML in drug development. The agency is also concerned with the lack of transparency in algorithms that can lead to amplification errors or preexisting biases. "Although recognizing the problem, the potential regulatory solutions have yet to be provided," said Bondoc. Still, the agency aims to prevent algorithmic discrimination and advance the use of AI/ML techniques. It recently released a discussion paper, "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." And to further address issues of AI in drug manufacturing, the FDA released “Artificial Intelligence in Drug Manufacturing.”Protecting AI Technology in Life SciencesYuan confirmed an eight-fold increase in AI patents from 2017 to 2020, citing WIPO Technology Trends 2019: Artificial Intelligence and Mondaq, and observed a shift in the types of things patented. In the past, patents were more theoretical, such as novel AI algorithms for speech recognition. Nowadays, there are more patents on concrete, practical applications of machine learning in drug discovery and medical diagnostics.Patent applications include novel, practical applications of AI algorithms, drugs developed by AI, and computer hardware configurations and optimizations to facilitate AI training and inference processes. The patents fall into two buckets: one, the application of known AI to specific fields and sectors, and two, new AI models and algorithms. Yuan said the first is generally a higher value in patenting with broader and more detectable claims vis-à-vis the second with narrow and mathematically oriented claims.Privacy and AIThe use of AI/ML in life sciences involves data from individuals, even protected health information (PHI). At some point, whether it is the process's training input, inference, or output, the data use may run afoul of state privacy laws, implicate new legislation regulating AI and automated decision-making, or trigger federal law, including the Health Insurance Portability and Accountability Act (HIPAA) or the Federal Trade Commission Act prohibiting unfair and deceptive practices, such as the sale and use of racially biased programs.Chow also detailed the states with comprehensive privacy laws, including California, Virginia, and Tennessee, with numerous state laws pending in Connecticut, Indiana, Iowa, Montana, and Washington. State legislatures complement privacy laws with laws regulating AI and automated decision-making, such as the New York AI Bias Law. Still, Wu put privacy legislation into context: "It's not necessarily the driver for AI; it's a stakeholder."

yuan_anna_blog_150x150.png

yuan_anna_common_640x280.jpg

yuan_anna_heroretina_2700x1160.jpg

yuan_anna_mobileretina_750x1040.jpg

yuan_anna_social_600x600.jpg

Of Counsel

Anna Yuan’s practice focuses on patent prosecution, IP due diligence, post-grant proceedings, and IP litigation support. 

Anna Yuan

230427-ai-image.jpg

230427-ai-image

Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion. This article originally appeared on JDSupra and is reprinted with permission.

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

On April 3, 2023, FDA released the draft guidance titled “<a href="https://www.fda.gov/media/166704/download" target="_blank">Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions</a>” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine learning device software function (ML-DSF) while continuing to provide reasonable assurance of device safety and effectiveness. FDA is accepting <a href="https://www.regulations.gov/docket/FDA-2022-D-2628" target="_blank">comments</a> on the draft guidance until July 3, 2023.Background:Historically, changes to an approved or cleared medical device that could significantly affect the safety or effectiveness of the device or that constitute a major change or modification in the intended use of the device required submission of a new 510(k). This framework is at odds with the use of artificial intelligence and machine learning in medical devices, which enable and encourage continuous improvements and modifications to the device based on information gathered during use. FDA has been engaged in the process of developing a regulatory approach tailored to AI/ML-enabled devices that allows for safe and rapid modifications in response to new data while ensuring safety and effectiveness.The idea of using a “predetermined change control plan” (PCCP) was first mentioned by FDA in its 2019 discussion paper entitled “<a href="https://www.fda.gov/media/122535/download" target="_blank">Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)</a>” and has been widely discussed in the industry. In FDA’s <a href="https://www.fda.gov/media/145022/download" target="_blank">Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan</a> published in January 2021, FDA committed to publishing PCCP guidance. In addition, <a href="https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf" target="_blank">Section 3308 of the Consolidated Appropriations Act</a>, also referred to as the Food and Drug Omnibus Reform Act (FDORA), added section 515C to the Food, Drug and Cosmetic Act, granting FDA authority to approve a PCCP “submitted in an application . . . that describes planned changes that may be made to the device . . . if the device remains safe and effective without any change.” In addition to FDA’s discussion of AI/ML-enabled devices, the White House released a <a href="https://www.whitehouse.gov/ostp/ai-bill-of-rights/" target="_blank">Blueprint for an AI Bill of Rights</a> on October 4, 2022, which discusses principles regarding the design, use, and deployment of automated systems.The draft guidance is applicable to ML-DSFs that the manufacturer “intends to modify over time” including those “for which modifications to the ML model are implemented automatically . . . as well as for ML-DSFs for which modifications to the ML model are implemented manually.”[1] The term “PCCP,” as used in the guidance, “refers to a plan that includes device modifications that would otherwise require a premarket approval supplement, De Novo submission, or a new premarket notification.”[2] Proactively pre-specifying and seeking market authorization for intended modifications to an ML-DSF in a PCCP removes the need to submit additional marketing submissions for each future modification that is delineated and implemented in accordance with the PCCP. Modifications to an ML-DSF that “could significantly affect, or that could affect, the safety or effectiveness of the device”[3] require premarket authorization, unless those modifications are covered by a PCCP. In addition, the modifications cannot change the intended use of the device or the benefit-risk profile.Elements of a PCCP:A PCCP is to be composed of three elements: (i) a Description of Modifications; (ii) a Modification Protocol; and (iii) an Impact Assessment.1. Description of ModificationsA PCCP must contain a detailed description of the specific, planned device modifications. The description of modifications includes three sub-elements: (i) an enumerated list of individual proposed device modifications; (ii) a specific rationale for the change to each part of the ML-DSF; and (iii) reference to the labeling changes associated with each modification. FDA recommends that a PCCP include specific modifications that can be verified and validated. These modifications should be “presented at a level of detail that permits understanding of the specific modifications that will be made to the ML-DSF.”[4] The Description of Modifications should clearly indicate whether the planned modifications will be implemented automatically or manually. FDA recognizes this is an evolving area and is proposing to consider PCCPs for ML-DSFs where modifications are implemented automatically to the extent FDA can “properly review them for substantial equivalence to the predicate or a reasonable assurance of safety and effectiveness.”[5] FDA reiterates that this subset of ML-DSFs is complex and will consider the benefit-risk assessment when reviewing PCCPs with automatically implemented modifications.Not all modifications may be appropriate for inclusion within a PCCP. Types of modifications that are acceptable for inclusion in a PCCP include:<ol><li>Modifications related to quantitative measures of ML-DSF performance specifications (e.g., improvements to analytical performance resulting from re-training the ML model using new data within the intended use population from the same type and range of input signal);</li><li>Modifications related to device inputs to the ML-DSF (e.g., expanding the algorithm to include new sources of the same type of signal); and</li><li>Limited modifications related to the device’s use and performance (e.g., for use within a specific subpopulation).</li></ol>FDA expects that modifications included in a PCCP should maintain the device within both the device’s intended use and indications for use.2. Modification ProtocolThe Modification Protocol describes the methodology used to develop, validate, and implement those modifications in a way that ensures the continued safety and effectiveness of the devices across relevant patient populations. FDA states that the draft guidance is consistent with the principles in the <a href="https://www.whitehouse.gov/ostp/ai-bill-of-rights/">Blueprint for an AI Bill of Rights</a>. The Modification Protocol should have four primary content elements, each with their own requirements:1. Data Management Practices – The Modification Protocol should include an outline of how data to support the proposed modifications will be collected, annotated, stored, retained, controlled, and used. The Modification Protocol should also clarify the relationship between the Modification Protocol data and data that is used to train and test both the initial and following versions of the ML-DSF. This is called the “data sequestration strategy” by FDA to ensure that training data sets and testing data sets are separated. Training data and testing data are sequestered to prevent overfitting and misquotes of test performance.The Modification Protocol should also include a description of the control methods used to prevent data or performance information leaking into the modification development process. In essence, the Modification Protocol should provide information that describes the protocols put in place to prevent access to performance testing data during the training and tuning process.Examples of the types of information to be included in a Modification Protocol describing data management practices are provided in Appendix A of the draft guidance.2. Re-training Practices – The Modification Protocol should include information about re-training practices, including the objective of re-training, a description of the ML model, the device components that may be modified, and triggers for re-training.3. Performance Evaluation – The Modification Protocol should discuss how the performance of the ML-DSF will be evaluated, including the triggers for evaluation, performance metrics to be computed, the statistical analysis plans that will be used to test performance for each modification, and confirmation that failures will be recorded and screened from implementation.4. Update Procedures – The Modification Protocol must include a description of how the devices will be updated to implement the modifications. This includes confirmation that either the verification and validation plans have not changed or that any changes are justified. Differences in performance and testing methods will be communicated to users. The PCCP should include a description of any labeling changes that will result, and the available labeling must include adequate directions for use and reflect information about the currently available versions of the ML-DSF, including information on site-specific modifications. Labeling should not reflect information on modifications that have not yet been implemented in the current version, as it could cause confusion and would be deemed misbranded. Examples of the types of information that should be submitted describing update procedures are also provided in Appendix A of the draft guidance.The PCCP should also clearly delineate which parts of the Modification Protocol are applicable to each modification. For a PCCP with multiple modifications, this may be achieved through a traceability table. The draft guidance includes a sample traceability table that provides an example of how a manufacturer can depict the traceability between the Description of Modifications and the Modification Protocol.3. Impact AssessmentThe draft guidance refers to the Impact Assessment as an assessment of the benefits and risks of the planned modifications and risk mitigations. There are five elements of an Impact Assessment:<ol><li>Comparison of the modified device to the unmodified version of the device;</li><li>Benefits-risk assessment for each individual modification;</li><li>Continued assurance of the safety and effectiveness of the device;</li><li>Impact of one modification on the implementation of another; and</li><li>Collective impact of implementing all modifications.</li></ol>Modifications to an authorized PCCP will generally constitute changes to the ML-DSF that require a new marketing submission for the device, including a modified PCCP. This is because modifications described in the PCCP include device changes that would typically require a PMA supplement, De Novo submission, or 510(k) premarket notification. FDA expects that the modified PCCP will need to be reviewed as part of the premarket review of the modified device because the modification will generally significantly affect the safety or effectiveness of the device. Where modifications to the PCCP are the only significant modifications since the prior device and PCCP authorization, FDA intends to focus review on the proposed PCCP.The draft guidance includes a decision tree[6] for determining whether a modification is within the scope of an authorized PCCP or if a new submission is required:<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt4f5734e3eb37046b/6449a8834205ff10fc2438e4/230426-fda-ai_image.png?format=auto&amp;quality=60" alt="FDA "/></div>Referencing a PCCP in a Submission:FDA considers the PCCP to be part of the technological characteristics of the device. For devices subject to 510(k) requirements, the determination of substantial equivalence where the predicate device was authorized with a PCCP will be determined based on a comparison to the version of the predicate device cleared or approved prior to changes made under the PCCP.Example Scenarios of ML-DSFs That Employ PCCPs:Appendix B to the draft guidance provides examples that “illustrate different ML-DSF scenarios where a PCCP could be employed.”[7] For example, a particular ML-DSF analyzes images of skin lesions by identifying and characterizing features to aid in diagnosis. This ML-DSF was validated with a specific camera and is intended for use by a primary healthcare provider. The device was authorized with a PCCP. The pre-specified modification was for extension for use on additional general-purpose computing platforms, like smartphones and tablets. The general-purpose computing platform must include a 2D-camera that meets the minimum specifications in the PCCP, and the updated device must achieve a minimum performance defined in the Modification Protocol. In a scenario where the manufacturer implements a modification that was already specified in the PCCP and in conformance with the PCCP, the modification would not require a new marketing submission. On the other hand, if the manufacturer wanted to deploy a modified ML model that uses images captured by a thermographic camera, which was not specified in the PCCP, then a new marketing submission would be required because the modification could significantly affect the safety or effectiveness of the device and was not included in the PCCP.Appendix B also provides examples for patient monitoring software, ventilator settings software, an image acquisition assistance device, and feeding tube placement radiograph analysis software, with various hypothetical modification scenarios for each.Takeaways:This draft guidance is a significant step forward in FDA’s ability to effectively regulate AI/ML-enabled medical devices. The PCCP approach has the potential to save manufacturers from continuous submissions and to reduce the uncertainty around what support is required before making changes to devices with AI/ML components. However, as the draft guidance details, there are extensive requirements that manufacturers will need to satisfy in order to utilize the PCCP process. Depending on feedback from stakeholders, the final version of the guidance may be different from the current draft version.Device manufacturers developing ML-DSFs or incorporating them into their medical devices should consider submitting comments to the draft guidance. FDA recommends that the public submit comments to the draft guidance (<a href="https://www.regulations.gov/document/FDA-2022-D-2628-0002" target="_blank">Docket No. FDA-2022-D-2628</a>) within 90 days of publication in the Federal Register, by July 3, 2023. FDA hosted a <a href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-marketing-submission-recommendations-predetermined-change-control-plan-artificial" target="_blank">public webinar</a> for medical device manufacturers and other stakeholders to discuss the draft guidance on April 13, 2023. Webinar materials, including the presentation slides and transcript, are available <a href="https://www.fda.gov/training-and-continuing-education/cdrh-learn" target="_blank">here</a>.Morrison Foerster continues to closely monitor developments regarding AI/ML and FDA’s regulation of medical devices. For questions or assistance, please contact the authors.[1] Draft guidance at 5.[2]Id. at 6.[3]Id. (citations omitted).[4]Id. at 16.[5]Id.[6]Id. at 15.[7]Id. at 8.

Regulatory Analyst

Brandy Guarda is a regulatory analyst supporting the FDA + Healthcare Regulatory and Compliance practice in Morrison Foerster’s Washington, D.C. office. Brandy predominantly focuses on researching and tracking FDA and interagency regulatory guidance, proposed and final rules, legislation, and enforcement actions.

Brandy A. Guarda

Brandy Guarda

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine learning device software function (ML-DSF) while continuing to provide reasonable assurance of device safety and effectiveness. FDA is accepting comments on the draft guidance until July 3, 2023.

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) <a href="https://www.fda.gov/media/155038/download" target="_blank">Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a> (the “Enforcement Policy Transition Guidance”) and 2) <a href="https://www.fda.gov/media/155039/download" target="_blank">Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)</a> (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.Enforcement Policy Transition GuidanceThe 180-day transition period under the Enforcement Policy Transition Guidance will start on the “implementation date,” which will be May 11, 2023, unless the PHE declaration is renewed another time contrary to the <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">Administration’s current plan</a>. The Enforcement Policy Transition Guidance applies to devices that fall under 15 FDA COVID-19 enforcement policies, where FDA has indicated that it does not intend to object to certain modifications or distribution of certain devices in the following categories:<ol><li>remote digital pathology devices;</li><li>imaging systems;</li><li>non-invasive fetal and maternal monitoring devices;</li><li>telethermographic systems;</li><li>digital health devices for treating psychiatric disorders;</li><li>extracorporeal membrane oxygenation and cardiopulmonary bypass devices;</li><li>remote ophthalmic assessment and monitoring devices;</li><li>infusion pumps and accessories;</li><li>face shields, surgical masks, and respirators;</li><li>gowns, other apparel, and gloves;</li><li>sterilizers, disinfectant devices, and air purifiers;</li><li>ventilators and accessories and other respiratory devices;</li><li>FDA-cleared molecular influenza and RSV tests;</li><li>coagulation systems; and</li><li>viral transport media.</li></ol>These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023.The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after the implementation date—expected to be from May 11 to August 8, 2023); Phase 2 (the second 90 days after the implementation date—expected to be from August 9 to November 6, 2023); and Phase 3 (180 days after the implementation date—expected to begin on November 7, 2023). In the Enforcement Policy Transition Guidance, FDA provides phase‑by‑phase compliance guidance for manufacturers of a device that falls under any of the FDA COVID-19 enforcement policies mentioned above. It is important to note that some of the guidance applies to manufacturers regardless of whether they intend to continue distribution of the device after a certain phase. For example, manufacturers should send a notification of intent to FDA regardless of whether they intend to continue distribution of their device after Phase 2.EUA Transition GuidanceThe 180-day transition period under the EUA Transition Guidance, on the other hand, will start when the corresponding EUA declaration terminates (the “EUA termination date”). The EUA Transition Guidance applies to devices that are authorized under any of the EUA declarations related to COVID-19 such as the <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">EUA declaration for COVID-19 in vitro diagnostics</a> (the “EUA devices”). As FDA explains in the guidance, an EUA declaration is not dependent on the PHE declaration, which means that the 180-day transition period for the EUA devices may start well after the PHE declaration expires, that is, possibly well after May 11, 2023.The EUA Transition Guidance requests manufacturers of the EUA devices that FDA deems to be “reusable life-supporting or life-sustaining” to submit a letter of intent to FDA as soon as possible, regardless of their intent to continue distribution of the device after the EUA termination date. Note that this request is effective as of March 27, 2023, and manufacturers should not wait until the transition period or the EUA termination date to submit the intent letter. Section A of the guidance provides the details including the product codes relevant to this request and the information to include in the letter.The EUA Transition Guidance also provides recommendations and policies for manufacturers seeking a full marketing authorization for a device related to any of their EUA devices. The guidance indicates that FDA does not intend to object to continued distribution of the EUA device after the EUA termination date, if (i) the manufacturer submits a marketing submission for a candidate device that is the same as, derivative of, or next generation of the EUA device, (ii) FDA formally accepts the marketing submission before the EUA termination date, and (iii) FDA has not taken a final action on the marketing submission. Since FDA’s formal acceptance of the marketing submission could be delayed due to various reasons, including administrative incompleteness of the submission, manufacturers are advised to submit well before the EUA termination date.FlexibilitiesNotably, both guidance documents indicate FDA’s willingness to be flexible in certain areas. For example, the guidance documents indicate that real-world data from the actual use of the device during the COVID-19 pandemic may be included in the marketing submission. Both guidance documents also recommend manufacturers to engage with FDA early in the transition period to discuss extenuating circumstances such as an ongoing clinical study that makes it difficult to meet certain deadlines provided in the guidance. Further, both guidance documents acknowledge that there may be unique quality system compliance considerations for certain manufacturers and suggest requesting an exemption or variance from a device quality system requirement within the first 90 days of each transition period.Finalization of these guidances does not necessarily mean that the COVID-19 EUA declarations will be terminated soon or that FDA will soon cease accepting and reviewing new EUA requests. At the same time, however, it certainly gets us closer to such transitions. This is an important development, and manufacturers who have distributed devices under an EUA or under one of these enforcement discretion policies during the pandemic should seek the advice of counsel to ensure compliance with the transition.

FDA Issues Final Transition Guidances for COVID-19 Devices

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations:

FDA Issues Final Transition Guidances for COVID-19 Devices

On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&toc=OJ%3AL%3A2023%3A080%3ATOC" target="_blank">Regulation (EU) 2023/607</a> (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745" target="_blank">EU Medical Device Regulation</a> (MDR) and certain related provisions under the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746" target="_blank">EU In Vitro Diagnostic Medical Device Regulation</a> (IVDR).The key elements of the Regulation are:<ul><li>An extension of the validity of certificates (MDR),</li><li>An extension of the transition period (MDR), and</li><li>The removal of time restrictions for sales (the “sell-off” periods) (MDR and IVDR).</li></ul>The Regulation is based on the European Commission’s proposal released on January 6, 2023 (the “Proposal”), which was adopted by the European Parliament and the Council on February 16, 2023. This article provides a brief overview of the above-mentioned key elements of the Regulation. As the text of the Regulation has not changed from the Proposal during the legislative process, we refer to our <a href="https://lifesciences.mofo.com/topics/eu-mdr-and-ivdr-implementation-european-commission-publishes-full-proposal-for-amending-transitional-regime" target="_blank">recent article</a> for a more detailed analysis of the content of the Regulation. It should also be noted that the Regulation’s amendments to the IVDR are limited to the abolition of the sell-off period. The rest of the IVDR’s transitional regime remains untouched. We discussed the IVDR transitional periods in this <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">article</a>.Extension of the transition periodThe Regulation amends the transition periods provided for in Article 120 of the MDR. The extension is gradual and depends on the risk class of the device. The transition period is extended from May 26, 2024 to December 31, 2027 for higher risk devices (e.g., Class III and Class IIb implantable devices, except certain devices exempted by the MDR) and to December 31, 2028 for medium- and low-risk devices (e.g., other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function).To ensure that only safe devices are placed on the market, the extension of the transition periods requires that certain conditions must be met:<ol><li>The devices must continue to comply with the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AMDD);</li><li>There are no significant changes to the design and intended purpose;</li><li>The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the public health protection; and</li><li>By May 26, 2024 at the latest,</li></ol>Extension of the validity of certificatesThe validity of certificates previously issued under the MDD, which are valid on the date of application of the MDR (May 26, 2021) and have not been withdrawn by a notified body, will remain valid for the duration of the proposed extended transition period of the respective risk class applicable to the device as set out above, provided that the conditions above are met.However, the Regulation does not address the formalities of an extended certificate. It is therefore unclear at this stage whether a new certificate or an amended certificate will be issued in the event of an extension, or on what other basis manufacturers can demonstrate that an otherwise expired certificate is in fact still valid. Manufacturers should watch out for forthcoming Q&A guidance documents addressing this issue.Removal of the sell-off periodsThe sell-off date requirement does not appear in the MDR and the IVDR. Therefore, devices placed on the market before the respective end of the transition period can continue to be available on the market without a legal time restriction.ConclusionThe medical device industry and its stakeholders can breathe a sigh of relief. While it took some time for the European Commission and EU Member States to recognize that an extension of the transitional regime was imminent in order to avoid a European healthcare crisis and it was necessary to take action, the adoption of the proposal and its entry into force have been accomplished in an unexpectedly swift process.However, while the time extensions provided by the Regulation may seem comfortable, manufacturers should be aware that important deadlines are fast approaching. Under each scenario, an MDR-compliant quality management system must be implemented and a formal application filed with a notified body by May 26, 2024. Of course, it can be expected that there will be a massive run on notified bodies at the end of this period. Thus, manufacturers would be well advised to prepare and submit their applications as soon as possible. Watch this space for further updates on this and other EU regulatory issues.

Counsel

Robert Grohmann

content_(1).jpg

Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force

content_(1)

On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the EU Medical Device Regulation (MDR) and certain related provisions under the EU In Vitro Diagnostic Medical Device Regulation (IVDR).

Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force