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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This article was first published by IAM on June 2, 2023 in its <a href="https://www.iam-media.com/report/special-reports/q2-2023/article/mitigating-patent-risk-in-gene-therapy-development" target="_blank">Special Report 2023 Q2: New Frontiers of Pharma and Biotech IP Strategy</a>.Daralyn Durie, Janet Xiao and Katherine McNutt of Morrison Foerster explore strategies to reduce the threat of infringement liability in the complex environment of gene therapy development.The Hatch-Waxman Act created a statutory safe harbor, codified in Section 271(e)(1), Chapter 35 of the US Code, which immunizes drug developers from patent infringement liability for certain activities related to developing and submitting information to regulators. For example, the safe harbor immunizes a generic drug manufacturer from patent infringement liability for using a branded company’s patented drug product to develop and submit information to the FDA as part of the approval process for that generic drug.Recent cases have limited its scope such that it may not protect the use of research tools or intermediate products in the development and submission of information to the FDA for approval of gene therapies. In view of this, gene therapy developers should consider other ways to mitigate exposure to patent infringement liability occasioned by the FDA approval process.Overview of the safe harborThe safe harbor was enacted as part of a response to two perceived distortions of patent terms for products subject to FDA approval. These were based on the interaction of FDA premarket approval requirements and limitations on patent term.First, patent holders effectively lost a portion of their patent term for FDA-approved products “[b]ecause patent applications were filed early in the regulatory process, but market entry was delayed pending regulatory review” (Proveris Sci Corp v. Innovasystems Inc.; 536 F3d 1256, 1265; Fed Cir, 2008).Second, those same patent holders gained a de facto PTE after their patents had expired because the patents delayed competitors’ ability to develop information for FDA approval of their competing products. That is, competitors could be liable for patent infringement if they used the patented, FDA-approved products to submit information to the FDA for approval of their competing products before the patents on the FDA-approved products had expired. To address the first perceived distortion, Congress enacted Section 156 (f)(1), Chapter 35 of the US Code, which provides for PTE to compensate for regulatory delays associated with obtaining FDA approval of a drug product, medical device, food additive or color additive subject to regulation under the Food, Drug and Cosmetic Act. The safe harbor was intended to address the second perceived distortion by immunizing the use of patented products subject to FDA premarket approval in FDA submissions seeking approval for competing products.In relevant part, Section 271(e)(1) provides:It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . 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.Safe harbor in the courtsAlthough Section 271(e)(1) refers broadly to “a patented invention”, courts have interpreted this as limited by the policy considerations and perceived patent-term distortions that motivated the enactment of the statute. Specifically, they have limited “a patented invention” to a patented product subject to premarket FDA approval. This reflects “a ‘perfect’ product fit” between Sections 271(e)(1) and 156, the provisions that Congress enacted to address the “roughly offsetting … dual distorting effects of regulatory approval requirements in this entire area” (Eli Lilly & Co v. Medtronic Inc.; 496 US 661, 672 and 674; 1990). When a patented product does not require FDA pre-market approval, there is no de facto extension of the patent term – competitors may start using that patented product commercially immediately upon expiration of the patent – so the second perceived distortion that the safe harbor was designed to address does not occur. Applying that rationale, the Federal Circuit held in Proveris that Section 271(e)(1) did not immunize the use of a patented device from infringement when the device was “used in the development of FDA regulatory submissions but is not itself subject to the FDA premarket approval process” (536 F3d at 1265).In the gene therapy context, one court, applying Proveris, has held that using an intermediate patented product not subject to FDA approval to develop a gene therapy does not fall within the safe harbor. There, the Delaware district court concluded, at the motion-to-dismiss stage, that gene therapy developer Sarepta had not demonstrated that the safe harbor applied to its use of patented cultured host cells (an “intermediate patented product”) to develop gene therapies for Duchenne muscular dystrophy (REGENXBIO Inc v. Sarepta Therapeutics Inc.; 20-1226-RGA, 2022 WL 609141, at 1; D Del, 4 January 2022).Relying on Proveris, the court concluded that “a patented product that is not subject to FDA premarket approval is not a ‘patented invention’ under Section 271(e)(1)” (Id at 4). The court rejected Sarepta’s argument that the safe harbor should apply because its use of the patented cultured host cells “w[as] solely related to the development and future submission of a Biologics License Application to the FDA” (Id at 2). As Sarepta was “using the patented cells to develop its own patentable product” rather than “using the patented cultured host cells to obtain FDA approval to introduce generic cultured host cells”, the court found that the rationale underlying the safe harbor did not apply; Sarepta could begin using the patented cultured host cells immediately after the asserted patent expired (Id at 4). The logic was that the patentee would not receive a de facto PTE that the safe harbor was intended to address, notwithstanding that Sarepta’s inability to freely use the patented cultured host cells might delay the development and submission of information to the FDA for approval of its gene therapy.Sarepta is consistent with decisions of some other courts concluding that the use of patented ‘research tools’, themselves not subject to FDA approval, does not trigger the protections of the safe harbor, even when those tools are used to develop information for purposes of regulatory approval of another product. Research tools include “tools that scientists use in the laboratory including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines” (64 Fed Reg 72,090, 72092, footnote 1; 23 December 1999). For example, courts have found that the safe harbor did not cover the use of a patented fluorescent protein and certain G-protein coupled receptors to develop information for regulatory approval of other products (see Allele Biotech & Pharms Inc v. Pfizer Inc.; 20-cv-01958-H-AGS, 2021 WL 1749903, at 7; SD Cal, 4 May 2021- denying motion to dismiss based on safe harbor defense when plaintiff’s complaint alleged that fluorescent protein was used as a research tool and that it was not subject to FDA review and approval; see also PSN Ill LLC v. Abbott Lab’ys; 09 C 5879, 2011 WL 444825, at 1 and 6; ND Ill, 20 September 2011 - denying defendants’ motion for summary judgment based on safe harbor defense when defendants used patented G-protein coupled receptors that did not require FDA approval to screen potential drug candidates and “develop their own patentable product”).At least one court has viewed these issues differently. In that case, the defendants used patented polypeptide markers to measure the molecular weight characteristics of their generic drug products to demonstrate to the FDA that their generic products’ active pharmaceutical ingredient was the same as the active pharmaceutical ingredient in the plaintiff’s branded drug (Teva Pharms USA Inc v. Sandoz Inc.; 09 Civ 10112(KBF), 2013 WL 3732867, at 1; SD NY, 16 July 2013). The court noted that “[t]he claimed markers are not themselves drug products, nor do they need approval from the FDA” (Id at 2). In reaching its conclusion that the safe harbor nonetheless covered the use of the polypeptide markers, Teva relied on the Supreme Court’s decision in Merck KGaA v. Integra Lifesci I Ltd for the proposition that “the Supreme Court held that use of patented peptides to conduct research not ultimately submitted to the FDA, but which furthered research and led to the development of testing for another drug, fell within the safe harbor” (Id at 6; citing Merck, 545 US 193, 206-07; 2005). In Merck, there was no dispute that the asserted patents covered the cyclic RGD polypeptides developed by the petitioner, and the “[r]espondents ha[d] never argued that the RGD peptides were used at Scripps as research tools” (Merck, 545 US 193, 201-02, 205, footnote 7; 2005). Some of the patented peptides at issue in Merck were used for research on other drug candidates, and one of the patented peptides was ultimately submitted for FDA approval in an investigational new drug application (Id at 197-99).Considerations for gene therapy developersGiven that some courts considering the issue have concluded that the safe harbor does not protect the use of research tools or intermediate products not subject to FDA approval to generate information for FDA approval of other products, gene therapy developers may face potentially significant patent infringement liability. For example, using patented research tools or intermediate products, such as host cells used to culture viral vectors that subsequently deliver gene therapies, may lead to patent infringement suits against gene therapy developers. Gene therapy developers should therefore be mindful of potential FTO risks with regard to patents covering research tools or intermediate products, even though those patents may expire before the projected commercialization date of their gene therapies. Defensively, these decisions counsel in favor of considering risk mitigation strategies, including conducting due diligence to determine whether third-party patents cover any intermediate products used in developing or manufacturing their gene therapies.Defensively, patent exhaustion may provide an alternative to the safe harbor for avoiding patent infringement liability based on the use of patented intermediate products not subject to FDA approval. When a patentee authorizes the sale of an item that substantially embodies the patentee’s patent claims, all patent rights to that item are exhausted, and the patentee loses the ability to bring an infringement suit related to that item (Quanta Comput Inc v. LG Elecs Inc.; 553 US 617, 638; 2008). Assuming that those intermediate products are patented, gene therapy developers should investigate whether any third-party supplier sells the intermediate product and whether they have a license from the patentee. To the extent that a gene therapy developer purchases patented products needed to develop gene therapies from a patentee or a licensee of the patent holder, patent exhaustion may be available as an affirmative defense, assuming the licensee has permission from the patent holder to sell the patented product to the developer (see, for example, PSN, 2011 WL 444825, at 9-11 - holding, based on language of license agreements, that patent exhaustion applied to receptors purchased from licensees after concluding that use of receptors was not covered by safe harbor).Gene therapy developers should consider whether to conduct due diligence to verify that their suppliers have such permission. The relevant license agreements may be confidential, making them unavailable to verify that the licensee has the requisite permission to sell the patented product. In that case, a gene therapy developer may be able to seek indemnification against patent infringement liability from the intermediate product supplier. Patent exhaustion may not provide a defense with regard to any subsequent cloning or manufacture of intermediate products by the developer.Once litigation has commenced, gene therapy developers may also be able to limit available damages for the use of an intermediate product by asserting that the patentee or its licensees failed to mark the patented intermediate product. (eg, Id at 12). To the extent that the patentee or its licensees manufacture the patented product and fail to mark that product, damages for infringement may be contained to the period beginning when the accused infringer had actual notice of the accused infringement (35 USC §287(a)). Absent a demand letter, a defendant may not receive actual notice until the complaint is served.From an offensive perspective, gene therapy developers should consider maintaining a broad patent portfolio with regard to innovations related to gene therapies and seeking PTE for patents covering their approved products whenever it is available. Obtaining PTE for patents on approved products may compensate for any regulatory delay in obtaining FDA approval. However, any PTE may not compensate for any time during which a third-party patent prevented the developer from submitting information to the FDA during the approval process.From a portfolio and enforcement perspective, gene therapy developers should consider drafting a varied set of patent claims to cover their gene therapies under development, including patents directed to newly developed research tools or intermediate products that do not require FDA approval. Having patents on research tools or intermediate products may position developers to manage competition and receive passive licensing revenue. Given the safe harbor defense, patents covering research tools or intermediate products that do not require FDA approval may hold significant value as against another developer working on a gene therapy to treat the same condition.Close attention to applicable license agreements and transactions involving intermediate patented products will benefit developers both offensively and defensively. From an offensive perspective, placing limitations on the scope of sales that licensees can make may limit the applicability of an exhaustion defense in subsequent offensive litigation; sales by the licensee that exceed the scope of the license may be found to be unauthorized, such that patent exhaustion would not apply. Defensively, it would behoove gene therapy developers to ensure that any applicable licenses provide, at every step in the chain from the patentee to the developer, all rights necessary for the development and manufacture of gene therapies. Patent exhaustion may not provide a defense if a developer obtains intermediate patented products through a sub-license rather than a purchase and later exceeds the scope of the rights to the patented product granted by the applicable sub-license. Seeking indemnification from suppliers of intermediate products may help gene therapy developers to mitigate the patent risk associated with those intermediate patented products. Indemnification may also assist gene therapy developers in mitigating potential risks related to non-patent claims, but such claims fall beyond the scope of this article.Mitigating risk in the futureThe implementation of statutory or regulatory reform may facilitate gene therapy development. Possibilities range from creating a new set of rules specific to gene therapies to implementing a compulsory licensing scheme for research tools or intermediate products akin to the fair, reasonable and non-discriminatory licensing scheme for SEPs. Unless and until that happens, gene therapy developers should take care to scrutinize any applicable licenses, pursue patents covering research tools or intermediate products and gene therapy products, preserve defenses to patent infringement, such as patent exhaustion, and preserve arguments to limit damages.

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Daralyn Durie is among the top trial lawyers in the country, acting as go-to trial counsel for both plaintiffs and defendants. 

Daralyn Durie

Daralyn Durie | Trials + Intellectual Property

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Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceu

Janet Xiao Ph.D.

Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceutical companies, such as Celgene and Genentech, to emerging startup companies around the world.

Janet Xiao

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Associate

Katie McNutt is an associate in Morrison Foerster’s Intellectual Property Litigation Group.

Katherine E. McNutt

Katherine McNutt

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Daralyn Durie, Janet Xiao and Katherine McNutt of Morrison Foerster explore strategies to reduce the threat of infringement liability in the complex environment of gene therapy development.

Mitigating Patent Risk in Gene Therapy Development

Matthew Ferry and Sarah Bloch authored an article for the Daily Journal discussing the top ten aspects alternative protein companies should consider when planning for and negotiating research and commercial agreements.Read the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltbc857834ffd7f479/64a89947ade08c2fe3cb214e/230705-top-considerations-for-transactions.pdf" target="_self">full article</a>.

Top 10 Considerations for Transactions Involving Alternative Protein Companies

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Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group.
Matt’s practice focuses on strategic transactions involving intellectual property (IP), techno

Matthew Ferry

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Patent Agent

Dr. Sarah Bloch focuses her work on patent drafting and prosecution. Sarah has experience in IP due diligence inquiries, with an emphasis on biotechnology, agriculture, and the food industry.
Sarah ha

Sarah E. Bloch Ph.D.

Sarah Bloch

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Top 10 Considerations for Transactions Involving Alternative Protein Companies

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Matthew Ferry and Sarah Bloch authored an article for the Daily Journal discussing the top ten aspects alternative protein companies should consider when planning for and negotiating research and commercial agreements.

After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration (see <a href="https://www.arc2020.eu/wp-content/uploads/2023/06/ARC2020_-1.-Draft-NGT-proposal.pdf" target="_blank">Proposal</a>). Although the official presentation is scheduled for July 5, 2023, the document was leaked and reveals a significant reversal away from the existing legislation on genetically modified organisms (GMOs), especially in the 2001 GMO Directive (see <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32001L0018" target="_blank">Directive 2011/18/EC</a>) and the 2003 Regulation on genetically modified food and feed (see <a href="https://eur-lex.europa.eu/eli/reg/2003/1829/oj" target="_blank">Regulation 1829/2003/EC</a>). A new risk-based approach leads away from strict authorization procedures and labeling requirements.A. Overview of the planned framework: Introduction of two categories of NGT plantsThe new regulation is applicable to NGT plants and their food and feed. According to Article 3(2) of the Proposal, “‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis, cisgenesis, intragenesis, or a combination thereof, on the condition that the NGT plant does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant.”  “Breeders’ gene pool” has been defined to mean “the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses.”The regulation follows a risk-based approach. Risk profiles associated with NGT plants are very diverse, from plants with risk profiles similar to conventionally bred plants to plants with various types and degrees of hazards and risks that might be similar to those of plants obtained by established techniques of genetic modification. The Proposal therefore adjusts the level of regulatory oversight according to this variety of potential risks posed by NGT plants and products (Recital 12). The Commission plans to introduce two categories of NGT plants (category 1 and category 2 NGT plants), in which category 1 plants are subject to less stringent requirements than category 2 plants.Category 1 plants are considered “equivalent” to conventional plants, and must differ from the recipient or parent plant by no more than 20 genetic modifications of the following types:(1) Substitution or insertion of no more than 20 nucleotides;(2) Deletion of any number of nucleotides;(3) Targeted (a) insertion of a contiguous DNA sequence or (b) substitution of an endogenous DNA sequence with a contiguous DNA sequence, where the contiguous sequence is in the breeders’ gene pool and the modification does not interrupt an endogenous gene (though the definition of NGT does not include temporary insertion of genetic material from outside the breeders’ gene pool during development of the new plant);(4) Targeted inversion of a sequence of any number of nucleotides; or(5) Any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points 1 and/or 2) in a species from the breeders’ gene pool.Further, these 20 or fewer modifications must be in DNA sequences that share “sequence similarity” with the targeted site. The sequence similarity must be able to be “predicted by bioinformatic tools,” though the degree of required similarity is not clear.Thus, the technical scope of “equivalence” is theoretically quite broad, though one will still be required to show that the modified sequence is “predictable” and shares some (presumably relatively high) sequence identity.  Overall, these acceptable modifications seem largely designed to include methods that have a long history of safe use (such as random mutagenesis and subsequent selection, which often result in, for instance, the first and second types of modifications listed above), and modern targeted editing, such as CRISPR, can be used to make any of the above modifications.     1. No authorization or labeling duties for category 1 NGT plantsFor NGT plants that could also occur naturally or be produced by conventional breeding and not harbor traits that can have a negative impact on sustainability, this regulation would provide a procedure to determine that the genetic modifications made and traits achieved are indeed of such a nature (a “notification procedure”), thereby classifying them as category 1 NGT plants. Category 1 NGT plants need to fulfill the criteria of equivalence to conventional plants set out in Article 5 and Annex I of the Proposal, i.e., when it differs from the recipient/parental plant by no more than 20 genetic modifications.Category 1 NGT plants defined in this way will not be subject to the rules and requirements of the EU GMO legislation, unless the new legislation doesn’t introduce new rules (Recital 11). Category 1 NGT plants will also be subject to any regulatory oversight that applies to conventionally bred plants (Recital 23). Despite the fact that category 1 NGT plants will not be subject to the rules and requirements of the EU GMO legislation, they would remain subject to the prohibition of use of GMOs in organic production to meet the demands of the sector (Recital 17).The most striking change in the legal situation is that category 1 NGT plants in the future will no longer have to be authorized before they are placed on the market or used for any other purpose. Articles 6 and 7 of the Proposal provide for a notification procedure to a national authority to prove that the respective NGT plant, or food or feed produced from such plants, meets the requirements for classification as category 1.According to Art. 7(2) of the Proposal, for example, to place a NGT plant on the market, the notification must include:(a) The name and the address of the notifier;(b) The designation of the NGT plant;(c) A description of the trait(s) and characteristics which have been introduced or modified;(d) The information necessary to demonstrate that the plant is a NGT plant; and(e) An identification of the parts of the notification that the applicant requests to be treated as confidential.In addition, it should be noted that there will be no labeling requirement for category 1 plants. The EU Commission explicitly states that labeling can be done “on a voluntary basis” (Recital 29).All recognized – and thus approved – category 1 NGT plants must be entered in a publicly accessible database (Art. 10). Individual Member States may not restrict or even prohibit the deliberate release or placing on the market of category 1 NGT plants and the respective free movement of goods (Art. 9).     2. Authorization requirements for category 2 plants are less strictFor all other NGT plants (category 2 NGT plants), the Proposal provides for a simplification of the authorization procedures of the current GMO legislation, in particular, a risk assessment adapted to the risk profile of the plant (Articles 15 and 22). Given the wide variety of NGT plants, food, and feed, the type and amount of information necessary for the risk assessment will vary on a case-by-case basis (Annex II). Factors to be considered are, inter alia:(a) The trait(s) introduced;(b) The function of the modified or inserted genome sequence(s);(c) The function of any gene disrupted by the insertion of a cisgene/intragene or parts thereof:(d) Prior experience with the consumption of similar plants or their products; and(e) Prior experience with the cultivation of the same plant species or plant species exhibiting similar traits or in which similar genome sequences have been modified, inserted, or disrupted.This, however, only applies to NGT plants for food and feed. Category 2 NGT plants created for uses other than food or feed will only need a notification sent to the national authority (Article 16). However, it is mandatory to label category NGT2 plants and any products obtained from them (Article 26).B. The EU Commission’s reasoningThe Proposal is part of the European Green Deal, a set of proposals to make the EU’s climate, energy, transport, and taxation policies fit for reducing net greenhouse gas emissions by at least 55% by 2030. With a liberalization of the legal situation for NGTs, the Commission hopes that the agricultural sector can also contribute to the targeted greenhouse gas reduction and the EU’s Farm to Fork Strategy, aiming to reduce the environmental and climate impact of food production and consumption in the EU.The EU Commission considers the existing GMO legislation not fit for the purpose of certain plant applications of new genomic techniques and too strict for NGT organisms. The existing authorization procedures and risk assessment requirements can therefore be disproportionate or inadequate (Recital 7).C. OutlookThe Proposal is to be presented by the EU Commission on July 5, 2023. It will then have to go through the regular EU legislative process. The timetable for EU lawmakers is currently tight and quite challenging. After all, new elections to the EU Parliament are due in June 2024. In order not to interrupt the implementation of the project and unnecessarily postpone it, it is hoped there will be a speedy implementation within the next year.The ambitious goals of the Commission are an important sign that could lead to Europe becoming a location for innovation. An overhaul of the outdated strict legal NGT framework will lead to increasing research into future technologies and enhance the competitiveness of the EU agri-food sector, while maintaining a high level of protection of human and animal health and the environment.For a comparison of the EU proposal to U.S. regulation, please see our recent <a href="https://lifesciences.mofo.com/topics/the-eu-s-new-proposal-for-plants-developed-using-new-genomic-techniques-how-does-it-compare-to-u-s-regulation-">blog post</a>.Update July 2023: The EU Commission has officially presented the <a href="https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2023:411:FIN" target="_blank">Proposal on New Genomic Techniques</a>. In addition, the Commission has published accompanying <a href="https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_3568" target="_blank">Q&A</a> on the proposal. The leak discussed in this blog post corresponds to the actual official EU Commission proposal. The legal assessment therefore remains. However, please note that some article numbers and recital numbers have changed.Two minor changes in the central definition of category 1 NGT plants in Annex 1 should be highlighted here. They do not necessarily extend and reduce the scope of category 1 NGT plants, but lead to more legal certainty when categorizing NGT plants:<ol><li>Originally, a targeted insertion or substitution of DNA was not allowed to result in an intragenic plant. The official proposal now states that the targeted insertion or substitution must not interrupt an endogenous gene. The shift to “does not disrupt an endogenous gene” provides more technical guidance as to where to make such edits.</li><li>To be considered an NGT plant in category 1, the plant must be considered “equivalent to conventional plants." Defining this equivalence, the leaked draft stated: “An NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than [20] genetic modifications (…), in predictable DNA sequences. A predictable DNA sequence is any DNA sequence that shares sequence similarity with the targeted site.” Now the official proposal clarifies the meaning and method of similarity prediction: “A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications (…), in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.”</li></ol>Research assistant Tim Stripling substantially contributed to this article.***For more information, read our previous client alert, <a href="https://www.mofo.com/resources/insights/210525-novel-genomic-techniques" target="_blank">The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16</a>

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration.

Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU

After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s <a href="https://lifesciences.mofo.com/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu">recent post</a>. Here, we provide a brief overview of U.S. regulation of plants produced through modern biotechnology and compare that regulatory regime to the EU’s proposed regulation.Update: As of July 5th, the final proposal is publicly available on <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023PC0411" target="_blank">Eur-Lex</a>.Overview of U.S. Regulation of Plants Produced through Modern BiotechnologyThe U.S. regulation of plants produced through modern biotechnology (including, e.g., gene-edited plants) is similar in many respects but also differs considerably from the EU Commission’s proposed risk-based regulatory approach. In general, both reflect the growing international trend towards loosening regulations for gene-edited plants that are closely related to conventional breeding. However, the way this is overseen in the United States does not exactly correspond with the new EU developments.Federal regulation of plants produced through modern biotechnology in the United States is distributed across three federal agencies in an often overlapping manner, with each agency’s regulations reflecting implementations of different statutes, the various motivations and definitions of which do not always align.The United States regulates plants produced through modern biotechnology with the <a href="https://www.usda.gov/topics/biotechnology/how-federal-government-regulates-biotech-plants" target="_blank">Coordinated Framework for the Regulation of Biotechnology</a>, which was established in 1986 as a collaborative approach across the following U.S. agencies: the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA).The EPA regulates the sale, distribution, and use of pesticides, including Plant Incorporated Protectants (PIPs) that <a href="https://www.epa.gov/pesticides/epa-finalizes-rule-accelerate-use-plant-incorporated-biotechnologies-protect-against" target="_blank">could not have been developed through conventional breeding</a>. PIPs are plant-produced pesticidal substances, such as a plant protein that inhibits fungal growth, and the genetic material that can cause a plant to produce that substance. They may or may not be genetically edited.The FDA, in parallel, regulates the safety of food, including animal feed and food additives — <a href="https://www.fda.gov/food/food-new-plant-varieties/new-plant-variety-regulatory-information" target="_blank">regardless of whether they have been genetically edited</a>.The USDA’s regulation <a href="https://www.ams.usda.gov/rules-regulations/be/regulated-entities" target="_blank">includes mandatory labeling/disclosure administered by the Agricultural Marketing Service</a> (USDA-AMS) and regulation of importation, transportation, and environmental release of plants and plant pests developed using genetic engineering that may pose a risk to plant health by the Animal and Plant Health Inspection Service (USDA-APHIS).Of these U.S. regulations, the most comparable to the proposed EU NGT regulation is USDA-APHIS’s Revised Biotechnology Regulations (previously known as the SECURE rule), which were revised in May 2020. Key Differences in U.S. and Proposed EU RegulationThe SECURE rule contains <a href="https://www.ecfr.gov/current/title-7/subtitle-B/chapter-III/part-340" target="_blank">several exemptions</a>, which in many ways sound quite similar to the EU’s category 1 plants—though there are also key differences.Notably, exemptions from USDA-APHIS’s Revised Biotechnology Regulations are self-determined, though developers may voluntarily reach out to USDA-APHIS for confirmation of an exemption.  Additionally, while the proposed EU regulations require all exempt plants to be listed in a single public database, engineered plants that are exempt from the USDA-APHIS requirements can be released or otherwise enter the U.S. market without explicit disclosure by USDA-APHIS. While USDA-APHIS maintains a publicly available database of voluntary requests for confirmation of exemption under the Revised Biotechnology Regulations, companies that self-determine if an exemption applies do not appear in any federal database. Thus, unlike in the proposed EU regulations, USDA-APHIS’s Revised Biotechnology Regulations do not require notification procedures or publication in a database if an exemption applies.Both the proposed EU regulations and USDA-APHIS’s regulations are risk-based approaches.  Notably, however, USDA-APHIS’s analyses are driven wholly by plant pest risk.  In contrast, the EU’s risk assessment as currently written considers a broader array of types of potential risks, such as risks to human health.  In the United States, the FDA would consider human health risks for plants that are intended for human or animal consumption—but, as <a href="https://lifesciences.mofo.com/topics/purple-tomato-is-first-genetically-engineered-plant-to-be-deregulated-through-usda-s-new-regulatory-status-review-process" target="_blank">we have summarized separately</a>, the FDA and USDA do not share implementing regulations, and the USDA-APHIS exemptions do not apply to FDA review.Focusing just on comparing the discrete USDA-APHIS Revised Biotechnology Regulations exemptions themselves with the EU’s proposed category 1 criteria, the acceptable modifications in the EU’s category 1 plants sound much like the USDA-APHIS’s §§ 340.1(b)(1)-(3) exemptions on a technical level (e.g., substitutions, deletions, and changes corresponding to alleles present in a relevant gene pool). However, a major difference is that the §§ 340.1(b)(1)-(3) exemptions are currently limited to single modifications, while the EU criteria include up to 20 modifications (e.g., up to 20 nucleotide insertions, deletion of any number of nucleotides, some types of targeted insertions and substitutions; targeted inversions, etc.; see brief discussion below and <a href="https://lifesciences.mofo.com/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu">our separate post</a> for the full list of criteria). (USDA-APHIS’s Revised Biotechnology Regulations also have other specific exemptions for certain microbial pesticides and PIPs and various narrow situations not discussed here).For example, a gene-edited plant that has a single, targeted modification may qualify for an exemption under § 340.1(b) if that same plant could have been created through conventional breeding — and it would seemingly also be considered a category 1 plant in the EU, assuming its sequence shares “similarity with the targeted site that can be predicted by bioinformatic tools,” which is not an explicit factor under USDA-APHIS’s Revised Biotechnology Regulations.  In contrast, a plant with multiple targeted edits that resulted in substitution of, say, 3 total bases could still seem to equally fall under the EU’s category 1, but would likely not qualify from a current exemption to USDA-APHIS’s Revised Biotechnology Regulations, as <a href="https://www.aphis.usda.gov/brs/pdf/requesting-confirmation-of-exemption.pdf" target="_blank">USDA-APHIS has clarified</a> that “[i]n general, multiple modifications made simultaneously in the same plant developed using genetic engineering will not qualify for an exemption under § 340.1.”Although the EU’s category 1 NGT plants in some respects encompass a wider baseline set of exemptions, USDA’s <a href="https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/confirmations/responses/cr-table" target="_blank">list of exempt genetically modified plants</a> is designed to grow over time. For example, the EU’s category 1 exempts plants with up to 20 genetic modifications of the types referred to in <a href="https://eur-lex.europa.eu/resource.html?uri=cellar:c88fe9ac-1c06-11ee-806b-01aa75ed71a1.0001.02/DOC_2&format=PDF">Annex I</a>, provided they meet the sequence similarity restrictions outlined in <a href="https://lifesciences.mofo.com/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu">our EU proposal overview</a>. In contrast, as noted above, in the United States, a plant with multiple targeted genetic changes (much less 20) would not immediately qualify for a § 340.1(b) exemption, unless the modifications were all present together in the gene pool. <a href="https://www.aphis.usda.gov/brs/pdf/requesting-confirmation-of-exemption.pdf" target="_blank">However</a>, new plants that have the same plant-trait-mechanism-of-action (PTMOA) combination as a plant that USDA-APHIS has previously reviewed and deregulated do qualify for a permit exemption (and these can contain, theoretically, any number of changes), as well as plants that USDA-APHIS determined not to regulate prior to the implementation of its Revised Biotechnology Regulations. Further, plants that are produced by crossing exempt plants are also exempt from USDA-APHIS’s Revised Biotechnology Regulations, even if they wouldn’t meet an individual exemption if the modifications were produced as simultaneous edits. The EU Commission plans to produce a first monitoring report no sooner than three years after the first products have been notified and authorized. The criteria for category 1 NGT plants and their exemptions from Annex I of the proposal are not set in stone and could be changed, e.g., new exemptions could be added, so it is possible that the EU exemptions could, in practice, expand similarly to USDA-APHIS’s Revised Biotechnology Regulations exemptions.The EU’s rules for category 2 plants also seem facially similar to USDA-APHIS’s Revised Biotechnology Regulations permitting and <a href="https://www.mofo.com/resources/insights/220912-purple-tomato-first-genetically-engineered-plant-to-be-deregulated" target="_blank">Regulatory Status Review (RSR) provisions</a> for non-exempt plants, in that they have simplified requirements in comparison to the respective legacy approaches but still require a risk assessment and some level of monitoring. However, the RSR provisions in USDA-APHIS’s Revised Biotechnology Regulations directly broaden the pipeline of exemptions, while the EU categories do not seem as elastic. On the other hand, USDA-APHIS’s Revised Biotechnology Regulations provisions apply broadly to importation, interstate movement, and environmental release, while the EU’s category 2 provisions are mostly aimed at plants produced for food or feed.More broadly, as the EU adopts a single risk-based regulatory approach to gene-edited plants, U.S. regulation remains fragmented across federal agencies. For example, even if a gene-edited, plant-based food falls under one of the USDA permit exemptions described above, that food must still undergo FDA’s <a href="https://www.fda.gov/food/food-new-plant-varieties/consultation-programs-food-new-plant-varieties" target="_blank">Voluntary Plant Biotechnology Consultation Program</a>, or else risk FDA enforcement action.[1]Finally, consumer transparency surrounding gene-edited plants differs significantly between the United States and EU. Both EU and USDA regulations do not require labeling of food that could “occur naturally” (i.e., food that is “<a href="https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-C/part-66" target="_blank">found in nature</a>” in the United States) or be obtained through “conventional breeding.” However, because the USDA does not define these terms, the <a href="https://www.ams.usda.gov/rules-regulations/national-bioengineered-food-disclosure-standard" target="_blank">mandatory label disclosure for U.S. bioengineered food</a> encompasses more food products than the EU’s labeling requirements, which limit labeling to gene-edited plants that do not meet the broad requirements for category 1 NGTs.Overall, the new EU proposal would bring regulations to plants developed using NGTs that are much more in line with U.S. regulations, but exactly how the regulations would cover an individual NGT-produced plant may still differ. It will be interesting to see how the various regulations continue to morph and whether they become streamlined in practice.Elena Klonoski, a summer associate in our Boston office, contributed to the drafting of this post.[1] Edward L. Rubin & Joanna K. Sax, <a href="https://arizonalawreview.org/pdf/60-3/60arizlrev539.pdf" target="_blank">Administrative Guidance and Genetically Modified Food</a>, 60 Ariz. L. Rev. 539, 561 (2018).

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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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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 Bondoc

The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?