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

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

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

Meghan Poon

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

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

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

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

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

Wolfgang Schönig

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

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Navigating U.S. Regulatory Requirements for Genetically Modified Microorganisms Using Interactive Tool

On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. APHIS concluded that a new genetically engineered tomato produced by Norfolk Plant Sciences is unlikely to pose an increased plant pest risk compared to a conventional tomato, and is therefore not subject to regulation under the SECURE rule. This means that these tomato plants, which have been engineered to produce deep purple tomatoes with enhanced nutritional quality, may be legally imported, moved interstate, or “released” into the environment (including, for example, in a field trial) in the United States without a permit from APHIS.Notably, this finding also means that subsequent genetic transformation events involving the same combination of plant species, trait, and mechanism of action (“PTMOA”) as Norfolk Plant Sciences’ purple tomatoes are also no longer regulated under the SECURE rule. Thus, other subspecies and varieties of Solanum lycopersicum that have been modified to produce the same trait by the same mechanism of action—even if by different transgenic events—are now exempt under § 340.1(c) of the SECURE rule. More information on this so-called PTMOA exemption is available in APHIS’s “Guide for Requesting a Confirmation of Exemption from Regulations under 7 CFR part 340” (published August 31, 2022; document ID BRS-GD-2020-0001). This approach is different from the “event-by-event” regulation that was previously required, and represents the first time that APHIS has made an RSR determination under its new rules.Additional information about the contours of the SECURE rule and the genetic engineering that Norfolk Plant Sciences used to produce their purple tomato is provided below.About the SECURE RuleThe SECURE rule (7 CFR part 340) governs how APHIS regulates certain organisms developed using genetic engineering, with the goal of protecting U.S. agriculture from plant pest risks under the Plant Protection Act of 2000 (7 U.S.C. §§ 7701 et seq.). It replaced the previous version of 7 CFR part 340, which had been in place largely unchanged since APHIS’s biotechnology regulations were established in 1987, in phases between May 18, 2020 and October 1, 2021.The new regulations completely overhauled and streamlined the regulatory process for assessing the plant pest risk of organisms developed using genetic engineering, taking into account advances in scientific understanding, and focusing more on the properties of the engineered organism and less on the method(s) used to produce it.The revised regulations exempt certain types of modifications from regulation; such exemptions are self-determined, though developers may voluntarily request confirmation from APHIS that a given exemption applies. This exemption/confirmation process replaced the previous “Am I Regulated?” process on June 17, 2020, and APHIS has since issued 15 confirmation letters as of this writing, with the earliest in April 2021.However, no plant had made it through the new RSR process until now. The RSR process is an option for instances in which no SECURE rule exemptions apply to a given engineered plant, but the developer feels that the plant nonetheless does not pose an increased plant pest risk and should therefore not be regulated by the SECURE rule. The RSR process replaced the previous “petition” process for requesting deregulation from 7 CFR part 340 due to low likelihood of posing a plant pest risk.The RSR process became available for corn, soybean, cotton, potato, tomato, and alfalfa on April 5, 2021, and for all other plant species on October 1, 2021. APHIS received Norfolk Plant Sciences’ RSR request on August 4, 2021 and responded on September 6, 2022 (both the request and the response documents are available under RSR number 21-166-01rsr). As of this writing, Norfolk Plant Sciences’ tomato is the only RSR request publicly available on APHIS’s website.Under the RSR process, APHIS reviews “the biological properties of the plant; and the trait (or new characteristic); and the mechanism of action (or how the genetic modification causes the new trait to occur)” in order to evaluate plant pest risk. There are two potential steps to this process, depending on what APHIS determines during the first step. In Step 1, APHIS identifies whether the engineered plant poses a plausible pathway to increased plant pest risk compared to a “comparator” plant. If APHIS finds no such pathway, the RSR process concludes, and APHIS notifies the requestor that the plant in question is not subject to regulation under the SECURE rule. This was the outcome for Norfolk Plant Sciences’ tomato.On the other hand, if APHIS does determine that the engineered plant may plausibly pose an increased plant pest risk, there are several potential next steps. First, the developer may accept that the plant is regulated under the SECURE rule, and then either request a permit before moving or releasing the plant, or take no further action and not move or release the plant. Alternatively or additionally, the developer may request that APHIS proceed to Step 2 of the RSR process, which entails a more involved review, subsequent publication in the Federal Register, and solicitation and review of public comments before a final determination. As of this writing, no plant has gone through this second step of the RSR process.About the Purple TomatoAs described in its RSR request, Norfolk Plant Sciences created its purple tomato plant by Agrobacterium-mediated insertional mutagenesis of the “MicroTom” tomato variety, and subsequent crossing into other tomato varieties. The plants are engineered to increase expression of their natural anthocyanin pigments, which is what causes the fruits to have a deep purple color and also enhances their nutritional value.Specifically, the inserted DNA contains two transcription factors from the snapdragon plant (Antirrhinum majus), which serve to activate production of the tomato’s native anthocyanin biosynthesis pathway, causing increased anthocyanin production. Each of these two transcription factor genes, called Del and Ros1, is expressed from the T-DNA under a native tomato promotor that causes fruit-specific expression. The T-DNA also includes the nptII selectable marker with a promotor and terminator from Agrobacterium tumefaciens, which have a decades-long history of safe use and consumption.Complete genome sequencing revealed that the T-DNA was inserted at a single site in chromosome 4, accompanied by several small deletions. Phenotypic evaluation of the transformed plants revealed that they grew effectively the same as non-transgenic tomatoes, except that they produce deep purple fruit with significantly higher anthocyanin content. Photos of the plants and fruit are available in the published RSR request.APHIS considered the information disclosed in Norfolk Plant Sciences’ RSR request, alongside “publicly available resources, and APHIS’ familiarity with tomato and knowledge of the trait, phenotype, and mechanism of action” and “did not identify any plausible pathway by which [the] modified tomato, or any of its sexually compatible relatives, would pose an increased plant pest risk relative to a comparator tomato” (21-116-01 RSR Response, page 1). As such, APHIS concluded that these purple tomatoes are not subject to regulation under the SECURE rule.Other Regulatory AgenciesIt is important to note that deregulation from APHIS’s SECURE rule does not mean that the plant is wholly removed from U.S. federal regulatory oversight. For example, regulations implemented by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and/or other arms of USDA (such as Plant Protection and Quarantine (PPQ) import and export regulations, and/or Agricultural Marketing Service (AMS) labeling requirements) may still apply. Along those lines, Norfolk Plant Sciences’ RSR request states that Norfolk Plant Sciences submitted a food and feed safety and nutritional assessment of the Purple Tomato to FDA under the voluntary <a href="https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=NewPlantVarietyConsultations&sort=BNF_No&order=DESC&type=basic&search=">Biotechnology Notification Consultation program</a>, which was received as BNF number 178. As of this writing, FDA has not yet published a completed consultation for Norfolk Plant Sciences’ purple tomato.ConclusionThis regulatory review is an important milestone for regulation of genetically engineered plants in the United States. It is the first public test of the SECURE rule’s RSR process since its implementation more than a year ago, when it became one of the most scientifically progressive such review processes in the world, at least on paper. The deregulation of Norfolk Plant Sciences’ purple tomatoes shows that USDA-APHIS is embracing its new product-focused regulations. Although the review took more than a year—significantly longer than the 180 days promised by APHIS for Step 1—the process will likely become more efficient as the agency and developers become more familiar and comfortable with the new system. It will be interesting to see how the exemption and review processes grow and possibly become more streamlined with additional use.

Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

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Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

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Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

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On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. 

The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies. The benefits provided by ML are wide-ranging and include providing earlier and more accurate diagnoses by detecting patterns in clinical data associated with disease, improving surgical outcomes through preoperative and intraoperative surgical guidance, and enabling the development of personalized diagnostics and therapeutics. Medical device companies should look to build a robust patent portfolio for their ML inventions. This raises the question of how to build a patent portfolio for ML inventions in the medical device field. ML involves the training of mathematical models to draw conclusions from data, such as medical images or other clinically relevant data. While mathematical models by themselves are not eligible for patenting, their application to achieve practical results is patentable. Broadly speaking, patents for ML‑based inventions fit into three broad categories. <ul><li>Applications of ML. This category includes patents directed to novel results achieved using ML. Examples of ML applications in the medical device field include automatic identification of anatomical structures in imaging, automatic diagnoses from patient data, and patient recovery tracking. Patents in this category are often the most valuable, both because of their breadth of coverage and because infringing activity can be readily detected, often from advertising materials and use of the product. </li><li>Structure of the ML model. The structure of the ML model refers to the structure of the mathematical algorithm itself and how it processes data. Although mathematical algorithms by themselves are not eligible for patenting, the application of a novel ML model to a practical application can be patented. Patents in this category are often less valuable because their scope is narrower and detection of infringement is more difficult.</li><li>ML model training. This category includes patents directed to the process for training an ML model to achieve its purpose. Training of an ML model is critical to how well it performs and thus can be one of the most important aspects of developing an ML solution. However, infringement of patents in this category is often very difficult to detect because the process for training is typically not advertised or apparent from the use of the product.</li></ul>Although patents directed to the applications of ML are typically the most valuable, medical device companies should also pursue patents to ML model structure and training because these patents contribute to the benefits that a robust patent portfolio provides, including:<ul><li>Deterring others from practicing the invention. Patents, of course, can be used to prevent others from making and using an invention. However, patents that are unlikely to ever be asserted still serve as a deterrent from copying and as a roadblock to the ability of competitors to innovate their own products. </li><li>Providing freedom to operate. Filing a patent application ensures that an invention is in the public space and thereby cannot be patented by anyone that invents the same thing later. Preventing others that create the same invention at a later date from patenting the invention ensures a company’s ability to practice its own technology. This is an important countervailing consideration to keeping an ML invention as a trade secret since trade secret protections do not protect against independent invention and patenting.</li><li>Advertising to investors. This benefit is most relevant to emerging companies looking for investments or acquisitions. Patents can serve as advertisements of the technical capabilities and sophistication of a company. They provide investors with the ability to “look under the hood” and make their own independent assessment of the value of the underlying ML technology.</li></ul>Given the increasing importance of ML in the medical device market, robust patent portfolios protecting ML innovations can help ensure that medical device companies reap the benefits of their valuable innovations.

The Importance of Patents for ML-Based Medical Device Inventions

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Christopher Gloria is a partner in the firm’s Patent Group. Mr. Gloria’s practice concentrates on domestic and international patent prosecution, IP due diligence, and IP litigation support including patent infringement and validity determinations.

Christopher Gloria

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The Importance of Patents for ML-Based Medical Device Inventions

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The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies.

On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a <a href="https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-16299.pdf">Notice</a> in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings before the USPTO or Patent Trial and Appeal Board (PTAB). It is an outgrowth of President Biden’s 2021 <a href="https://lifesciences.mofo.com/topics/biden-administration-executive-order-on-promoting-competition-in-the-american-economy-drug-pricing-and-healthcare-industry-initiatives">Executive Order on Promoting Competition in the American Economy</a>, in which the acting U.S. Food and Drug Administration (FDA) Commissioner <a href="https://www.uspto.gov/sites/default/files/documents/EO14036-FDALettertoPTO.pdf">wrote to</a> the acting USPTO Director highlighting numerous areas in which the USPTO and FDA could work together to reduce drug costs. In particular, the Notice emphasized the duty to disclose material information and statements from communications with the FDA. Companies that make submissions to both the USPTO and the FDA, such as pharmaceutical companies and medical device manufacturers, should pay special attention to the Notice.Disclosing Information Received from the FDAAs part of an abbreviated new drug application (ANDA), generics can provide arguments that patents covering the innovator drug are invalid in a Paragraph IV certification. The Paragraph IV certifications are then communicated to the patent owners by the FDA.The duty of “reasonable inquiry” under 37 C.F.R 11.18(b)(2) requires that each party submitting a paper to the USPTO perform an inquiry that is reasonable under the circumstances to confirm the accuracy and consistency of statements made therein, but does not detail what is involved in a reasonable inquiry.The Notice now expressly clarifies that the duty of reasonable inquiry includes reviewing paragraph IV certifications received by patent owners to determine their materiality to patentability of any pending matters before the USPTO. “If the content of the detailed statement, or other information that is part of the ANDA process, is deemed material to patentability in a pending USPTO matter, then such information must be submitted to the USPTO during the pendency of the matter, to meet the duties of candor and good faith and disclosure under 37 CFR 1.56, 1.555, 42.11(a) or (c), or 11.18(b)(2),” the Notice states.Additionally, the Notice warns that merely submitting the FDA’s listing of paragraph IV certifications to the USPTO does not satisfy the duty of disclosure, since these lists “do not include patent numbers, relevant claims, or an explanation of the basis for the certification.”Importance of Consistency in Statements Before the USPTO and FDAThe Notice underscores the importance of consistency in statements made before the USPTO and the FDA. Specifically, the Notice states that “providing material information to other Government agencies, including the FDA, while simultaneously withholding the same information from the USPTO undermines both the intent and spirit of the duty of disclosure and violates those duties.”A recent Federal Circuit decision, <a href="https://cafc.uscourts.gov/opinions-orders/20-1799.opinion.9-1-2021_1828017.pdf">Belcher Pharmaceuticals v. Hospira</a> (Fed. Cir. Sept. 1, 2021), was cited as an example in which “inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market—can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product.”In <a href="https://www.ipwatchdog.com/2021/09/02/federal-circuit-upholds-delaware-courts-inequitable-conduct-analysis/id=137298/">Belcher</a>, the Federal Circuit affirmed a district court’s ruling that a patent covering a formulation of the drug epinephrine is unenforceable due to inequitable conduct. In a new drug application (NDA) filed with the FDA, Belcher’s Chief Scientific Officer had submitted several prior art references disclosing an “old” pH range for the epinephrine formulation. During prosecution before the USPTO, however, Belcher failed to disclose the references submitted to the FDA, and argued that the claims were patentable because the same pH range was “was unexpectedly found to be critical by the Applicant to reduce the racemization of l-epinephrine.”Key TakeawaysBelcher illustrates the key tension between relying on existing information for regulatory approval and establishing novelty and non-obviousness for patentability purposes. Parties involved in proceedings before the USPTO or PTAB that are seeking FDA approval should take special care to ensure consistency and coordination of strategies. As part of the duty of reasonable inquiry, parties should ensure that information and statements received from or submitted to the FDA are reviewed by both FDA regulatory counsel and patent counsel for potential materiality to patentability and disclosure to the USPTO or PTAB. This duty cannot be avoided by deliberate schemes to prevent individuals with the duty of disclosure from obtaining knowledge of material information, which the Notice indicates is “inappropriate.”Finally, parties should err on the side of disclosure to avoid allegations of inequitable conduct. As stated in the Manual of Patent Examining Procedure and reiterated in the Notice, “[in] close cases where the materiality or consistency of the information is in question, the applicant should consider submitting this information to the USPTO.” Given the significant leadership attention this topic has received at both the FDA and the USPTO, and the political pressure on both agencies to assist in the Biden administration’s efforts to reduce drug costs, the FDA and USPTO are likely both considering enforcement tools that may be employed to ensure appropriate disclosures.

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

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

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Patent Agent

Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligen

Kelsey J. Roberts Kingman Ph.D.

Kelsey Roberts Kingman

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. 

﻿Originally published on the Future Food-tech Alternative Proteins website.Morrison Foerster recent participated in the Future Food-Tech Alternative Proteins Summit, where investors, brands, and start-ups met to unlock new partnership opportunities and showcase innovation across plant-based, cell-based, and microbial fermentation.Ahead of the summit, Michael Ward, partner and Co-Chair of the firm’s global Food & Agriculture Industry Group, shared his thoughts on why partnership is so important in the industry.“At Morrison & Foerster, innovation is rooted in our collaborative, comprehensive approach through the full business life cycle for the food & agriculture industry. We work with start-ups, investors, and global brands on strategies to mitigate climate risk, reduce carbon, maximize social and environmental impacts, and ensure that technologies are implemented at scale and safeguarded by global intellectual property protection”Read the <a href="https://www.futurefoodtechprotein.com/10-reasons-why-partnerships-are-critical-to-the-alternative-protein-sector/" target="_blank">full article</a> to hear from other industry pioneers, and learn more about alternative proteins in our series of alerts below.<a href="https://www.mofo.com/resources/insights/211028-alternative-protein-industry-series">Alternative Protein - A Comparison of the Regulation of Insect Protein as Food and Feed</a><a href="https://www.mofo.com/resources/insights/210602-alternative-protein-industry-series">Alternative Protein Industry Series</a><a href="https://www.mofo.com/resources/insights/220223-quick-guide-jvs-alternative-protein-industry">Quick Guide to JVs in the Alternative Protein Industry</a>

Partnering with the Alternative Protein Sector

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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Partnering with the Alternative Protein Sector

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Morrison Foerster recent participated in the Future Food-Tech Alternative Proteins Summit, where investors, brands, and start-ups met to unlock new partnership opportunities and showcase innovation across plant-based, cell-based, and microbial fermentation.

Our <a href="https://federalcircuitry.mofo.com/topics/last-week-in-the-federal-circuit-august-15-august-19-the-court-rebuffs-patent-owner-s-attempt-to-read-anda-application-in-isolation">Federal Circuitry blog</a> recently discussed the Court's decision in <a href="https://cafc.uscourts.gov/opinions-orders/21-2342.OPINION.8-18-2022_1993064.pdf">Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc</a>., No. 21-2342.You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA saysFor our case of the week, we turn to the ANDA world. As readers know and in the simplest of terms, an ANDA is an Abbreviated New Drug Application, which a generic drug manufacturer (which we’ll off-and-on refer to as the ANDA applicant) files with the FDA to seek approval to sell a generic version of a brand name drug. Before the generic goes on the market, the brand manufacturer can file an action to enjoin the generic from reaching the market. Ordinarily, it does so under Section 271(e)(2), which makes it an (artificial) act of infringement for an ANDA applicant to file an ANDA that infringes the brand manufacturer’s patent claims. Section 271(e)(2) requires comparing the patent claims to the ANDA’s specification—as the proposed generic product must meet the ANDA’s specifications.<a href="https://federalcircuitry.mofo.com/topics/last-week-in-the-federal-circuit-august-15-august-19-the-court-rebuffs-patent-owner-s-attempt-to-read-anda-application-in-isolation">Read more</a>.

Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation

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Brian Matsui