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

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

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Partner

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

Meghan Poon

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

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

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

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

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

Wolfgang Schönig

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﻿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.

Originally published on the World Agri-tech <a href="https://worldagritechinnovation.com/" target="_blank">website</a>.10 years on from its discovery, CRISPR’s potential for agricultural adaptation has started to gather momentum. In advance of the 2022 World Agri-tech Innovation Summit in London, the industry’s leading specialists weighed in on what new frontiers and capabilities we can expect for the coming decade ahead. Michael Ward, Head of MoFo’s Life Sciences and Patent Practice Groups & IP Group Co-Chair, along with Sarah E. Bloch, Patent Agent, shared their predictions:“From an agricultural perspective, CRISPR has already led to an array of technologies that can advance crop productivity and sustainability. I hope that in the coming decade these efforts can continue to accelerate and have a global impact for both consumers and growers. To achieve this, it will be critical to have clear regulatory pathways that allow safe deployment of CRISPR technology without creating undue barriers to entry, particularly in those jurisdictions that set the standards for others. For example, a clarified regulatory pathway for commercializing CRISPR-edited crops in Europe would enable deployment of valuable technologies not only in Europe, but likely also in many other countries that would likely follow Europe’s lead.”Click here to read the <a href="https://worldagritechinnovation.com/crisprs-next-10-years-from-lab-to-plate/" target="_blank">full article</a> and join MoFo at the <a href="https://www.mofo.com/resources/events/220920-world-agri-tech-innovation-summit" target="_blank">World Agri-tech Innovation Summi</a><a href="https://www.mofo.com/resources/events/220920-world-agri-tech-innovation-summit">t</a> in London, September 20-22, 2022.

CRISPR’s Next 10 Years: From Lab To Plate?

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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

CRISPR’s Next 10 Years: From Lab To Plate?

10 years on from its discovery, CRISPR’s potential for agricultural adaptation has started to gather momentum.

The Beni Suef Economic Court in Egypt has recently ordered the removal of nearly five hectares of illegally grown Early Sweet™ grapevines, totaling 9000 vines and associated seedlings. The farm owner did not have a license to grow or commercialize the Early Sweet™ grapes and was found to be infringing the intellectual property (IP) rights held by Grapa Varieties Ltd. The case against the farm owner was won by Grapa, which specializes in breeding and licensing premium table grape varieties under the ARRA™ and Early Sweet™ brands. The particular IP right at issue was a plant breeders’ right (PBR) owned by Grapa.PBRs are similar to other forms of IP, such as patents, but are a sui generis form of IP protection available in many countries specifically for plant varieties. Egypt introduced its national plant variety protection system in 2002 under Law 82. Although negotiations regarding an association agreement for Egypt to be considered for membership in the International Union for the Protection of New Varieties of Plants (UPOV) began in 1995, Egypt did not accede to UPOV until 2019, after establishing compliance with the 1991 revised version of the UPOV Convention.  Grapa Varieties Ltd. previously dealt with illegal grape exports into Europe in June 2021 when illegally exported grapes were <a href="https://grapaes.com/the-power-of-enforcement/?utm_source=rss&utm_medium=rss&utm_campaign=the-power-of-enforcement">seized in a port and destroyed</a>. However, the new removal order is the first instance when enforcement has protected the PBRs at the origin of the fruit inside Egypt. The Beni Suef Economic Court ruling thus reflects a significant expansion in the industry protection of PBRs in Egypt, and comes as part of a wider crackdown on illegal fruit exports. This crackdown has been assisted by a decree issued last year by Egypt’s Minister of Agriculture, H.E. El-Sayed El-Quseir, which requires all farms to be registered and assessed before gaining the right to export. Infringements, such as from the propagation, sale, display, or export of the variety without a license, now result in a fine and the possibility of a custodial sentence.The order from the Beni Suef Economic Court demonstrates the commitment of Egypt’s phytosanitary authorities to protect the rights of plant breeders and their legitimate licensees within the country. The outcome of this case is likely to resonate throughout the export industry, as repeated incidents of export seizures incur significant financial losses for exporters, and negatively impact Egypt’s international reputation in the agricultural sector. Given that Egypt exports around 150,000 tonnes of grapes a year and has cornered the market as the world’s largest exporter of fresh oranges, relying on seizures at the export stage to protect plant IP would be worrying and expensive. The protection afforded through PBRs within Egypt is thus instrumental in ensuring that the IP holder does not experience a loss in revenue caused by illegal production and importation. <a href="https://grapaes.com/illegal-early-sweet-grapes-uprooted-in-egypt/">Sources</a> believe the citrus market is next in line for the IP shake-up.The <a href="https://www.freshfruitportal.com/news/2022/07/13/grapa-wins-legal-case-against-illegal-planting-in-egypt/">well-publicized protection</a> of Grapa’s PBRs by the Court will boost breeders’ confidence that pursuing illegal plantations, nurseries, and exporters in Egypt is not only achievable, but is expected of the phytosanitary authorities. This will have the additional benefit of strengthening Egypt’s image in international markets, thus improving Egypt’s ability to access new protected plants and create a healthy climate for breeders to invest in Egypt.

IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES

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Associate

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

IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES

The Beni Suef Economic Court in Egypt has recently ordered the removal of nearly five hectares of illegally grown Early Sweet™ grapevines, totaling 9000 vines and associated seedlings. The farm owner did not have a license to grow or commercialize the Early Sweet™ grapes and was found to be infringing the intellectual property (IP) rights held by Grapa Varieties Ltd. The case against the farm owner was won by Grapa, which specializes in breeding and licensing premium table grape varieties under the ARRA™ and Early Sweet™ brands. The particular IP right at issue was a plant breeders’ right (PBR) owned by Grapa.

Liz Freeman Rosenzweig co-authored an article for China IPR examining China's new and much anticipated Seed Law, which went into effect on March 1, 2022."The new Seed Law reflects a significant expansion in the scope of plant breeders' rights (PRB) protection in China," Liz wrote. "PBRs are a sui generis form of intellectual property protection available in many countries for plant varieties, similar to but distinct from patents or other forms of IP."She added: "The first major change in the Seed Law is the introduction of EDVs [essentially derived varieties], which are required to be protected by China if/when it accedes to UPOV '91, the latest UPOV Convention. As China is currently a member of UPOV '78, the inclusion of EDVs is a major step in the direction of accession. Hinting strongly at exactly that, the definition of EDVs in the new Seed Law closely mirrors UPOV's definitions. This is a positive departure from the Draft PVP Regulations, which were the first to formally float the idea of EDVs into the Chinese PVP system, but did not precisely use UPOV's definition."Read the <a href="https://chinaipr.com/2022/05/09/chinas-new-seed-law-molecular-varieties-and-macro-developments/" target="_blank">full article</a>.

China’s New Seed Law: Molecular Varieties and Macro Developments

Liz Freeman Rosenzweig co-authored an article for China IPR examining China's new and much anticipated Seed Law, which went into effect on March 1, 2022.
"The n

China’s New Seed Law: Molecular Varieties and Macro Developments

Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is necessary to support genus claims. The recent BASF v. CSIRO[1] decision provides yet another data point on how the Federal Circuit thinks about this issue. Although broad genus claims continue to be disfavored, this case demonstrates how applicants can maximize the effect of their early-stage data and, by extension, the scope of their patent claims.The patents at issue in this case concern transgenic plants that express a series of enzymes not native to land plants. When introduced in oilseed crops (e.g., canola), these enzymes would allow the plants to transform a short-chain fatty acid they naturally produce (ALA) into the nutritionally beneficial long-chain polyunsaturated fatty acids found in fish and other marine life (EPA and DHA).When it submitted its initial patent filings, the patentee had successfully implemented the technology in the model organism Arabidopsis, but it had not yet implemented the invention in canola or other oilseed plants.In BASF, the Federal Circuit upheld a jury determination that three claims directed to a transgenic canola plant capable of producing long chain polyunsaturated fatty acids were adequately supported by working examples in the model organism Arabidopsis, but invalidated three genus claims covering all plants because they lacked sufficient written description.In upholding the canola claims, the Federal Circuit cited the Arabidopsis working examples together with the prominence of canola in the specification. Three portions of the specification that expressly identify canola were particularly relevant: a list of preferred oilseed plants, a list of “plants of the invention,” and a list of oilseed crop plants.The disclosure in the specification was supplementethd by trial evidence explaining the connection between the model organism Arabidopsis and the claimed plant, canola. Expert testimony established that (1) Arabidopsis and canola are both oilseeds (i.e., they store oil in the cotyledons), (2) the two species both naturally produce ALA, and (3) their shared ability to metabolize oils is due to their low evolutionary distance.The Federal Circuit credited this testimony as demonstrating that proof of concept attained in Arabidopsis was “more than just a stepping stone” and “highly predictive of” achieving production of the desired oils in canola.[2]But the court’s reasoning could logically extend to additional plants. Other plants appear in the preferred embodiment lists and share relevant characteristics with Arabidopsis. The court’s discussion suggests that the Arabidopsis working examples, the specification, and the information explaining the connection between Arabidopsis and other oilseeds could support a subgenus claim covering at least canola, soy, and flax.[3] Of course, there was no such subgenus claim examined by the court, so we cannot say for sure.We do know that the court was unwilling to extend its reasoning to all plants. Despite its willingness to recognize the Arabidopsis data in support of the canola claims, the court clearly rejected the broad genus claim covering all plants: it found nothing in the specification or presented through expert testimony to suggest that success in Arabidopsis meant possession of the invention in all plant cells.[4]Although it invalidates yet another genus claim, BASF is not all bad news for patent applicants in the life sciences field. In fact, patent applicants should look to BASF as a guide for maximizing the power of proof of concept data obtained in model organisms.From prior case law we know that proof of concept in one species can “serve as a stepping stone” to support patent claims directed towards different species, and that actual reduction to practice is not a requirement.[5] But applicants would be wise to enhance the effectiveness of their data, creating “more than just a stepping stone,” by explicitly laying out the connection in the specification between the model organism and the desired species. BASF also provides a lesson on the importance of drafting multiple layers of claims, particularly when an independent claim is directed to a large genus, such as “all plants.” Applicants should present subgenus and species claims of varying and overlapping scope to provide backup positions if a broad genus claim is found to be invalid.By maximizing the power of model organism data through proper disclosure, and by including subgenus claims in an application, a savvy prosecutor can strategically avoid the two extremes of either narrowly claiming the exemplified subject matter or claiming a broad, unsupported genus.  [1] BASF Plant Sci., LP v. Commonwealth Sci. & Indus. Rsch. Org., 28 F.4th 1247 (Fed. Cir. 2022). The opinion was also featured as a “case of the week” on our Federal Circuity blog for its discussion of co-ownership issues arising from a collaboration agreement: <a href="https://federalcircuitry.mofo.com/topics/Last-Week-In-The-Federal-Circuit-March-21-2022-Federal-Circuit-Says-Go-Fish.html">https://federalcircuitry.mofo.com/topics/Last-Week-In-The-Federal-Circuit-March-21-2022-Federal-Circuit-Says-Go-Fish.html</a>.[2] Id. at 1267.[3] Id. at 1265.[4] Id. at 1268-69 (noting that CSIRO did not argue that success in Arabidopsis automatically mean success in all plant cells).[5] Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1349, 1353 (Fed. Cir. 2011).

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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Owen counsels clients in the life sciences, healthcare, food, and agriculture industries on cross-cutting issues involving regulatory compliance, intellectual property, and litigation.

Owen Grayson Hosseinzadeh

Owen Hosseinzadeh

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Stepping Stones to Success: Supporting Claims in the Life Sciences

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Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.
The standard for written description in the life sciences seems to 

Stepping Stones to Success: Supporting Claims in the Life Sciences

Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that <a href="https://recombinetics.com/acceligen/" target="_blank">Acceligen Inc.</a>’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food supply, and the environment.” This is the first such determination for a genetically engineered food-use animal and will allow the company to bypass many of the usual premarket approval requirements.These cattle, called PRLR-SLICK cattle, produce a short and slick hair coat due to a modification made to the prolactin receptor (PRLR) gene. This slick hair coat phenotype gives cattle the ability to regulate body temperature more effectively. This is important for raising cattle in tropical climates and might mitigate the predicted negative effects on livestock productivity associated with climate change.This intentional genomic alteration (IGA) was accomplished using CRISPR-Cas9 gene editing technology on in vitro fertilized calf embryos. Specifically, the IGA introduces a premature stop codon into the PRLR gene, and thereby truncates the encoded protein. IGAs like the alteration made to the PRLR gene in Acceligen’s cattle are intended to “affect the structure or function” of the altered animal, so FDA regulates them under its animal drug framework.Marketing an animal drug typically requires premarket approval, which entails a lengthy New Animal Drug Application (NADA) process through which FDA can evaluate the animal drug for efficacy, safety to the animal, and safety to the consumer. The only other FDA-approved food-use animals—Revivicor’s GalSafe pigs (2020) and the AquaBounty AquAdvantage salmon (2017)—went through the full NADA determination process.FDA discussed its intent to exercise enforcement discretion with respect to NADA requirements for IGA-containing animals as early as 2009, in guidance that has been updated several times, most recently in its 2017 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-187-regulation-intentionally-altered-genomic-dna-animals" target="_blank">Guidance #187, “Regulation of Intentionally Altered Genomic DNA in Animals</a>.” But this is the first time that such enforcement discretion has been applied to an animal intended for food production.When FDA exercises its enforcement discretion over the NADA requirements, it does not also conduct a National Environmental Policy Act (NEPA) review, which can add significant costs and time to the application process. FDA instead considers the potential environmental risks when determining whether to exercise enforcement discretion.FDA examined four categories of risk factors in its risk assessment and concluded that PRLR-SLICK cattle pose a low risk to people, animals, the food supply, and the environment: 1. Molecular characterization<ul><li>PRLR-SLICK cattle have an IGA that mimics genomic sequences found in conventionally raised cattle</li><li>Analyses of the genomic data found evidence of unintended mutations, but based on their types and locations, they are not expected to result in changes to protein expression</li></ul><div> 2. Phenotypic data and animal safety</div><ul><li>PRLR-SLICK cattle have the same phenotype (i.e., short, slick hair coat) as conventionally raised cattle with naturally occurring slick mutations</li><li>PRLR-SLICK cattle appear healthy based on visual observations and animal health records</li></ul><div> 3. Human food safety</div><ul><li>Conventionally raised cattle with the slick phenotype are routinely consumed as human food </li><li>There is no expected change in the compositional or nutritional content of the edible tissues</li></ul><div> 4. Environmental risk</div><ul><li>The slick phenotype is a well-established trait in several breeds of conventionally raised domestic cattle in the United States</li><li>The likelihood of escape and establishment of PRLR-SLICK cattle in the U.S. environment is low due to the ability to rapidly recover escaped animals and the lack of feral cattle populations in the United States</li></ul>The “low-risk” decision is limited to products (e.g., live cattle, semen, embryos, and meat) derived from the existing two cattle reviewed by FDA and their progeny. FDA also intends to treat facilities or farms engaged in standard agricultural practices for PRLR-SLICK cattle the same as facilities or farms that are engaged in these practices for cattle without IGAs.According to FDA’s press release, meat products from PRLR-SLICK cattle are expected to be available for purchase by general consumers as early as 2024. PRLR-SLICK cattle meat and most other food products in which the cattle’s carcass is the predominant ingredient would not be subject to mandatory labeling under U.S. Department of Agriculture’s <a href="https://www.ams.usda.gov/resources/industry-fact-sheet-national-bioengineered-food-disclosure-standard" target="_blank">National Bioengineered Food Disclosure Standard</a>.

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

Brigid DeCoursey Bondoc

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

Brigid Bondoc

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FDA Clears CRISPR-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals

Last Week in the Federal Circuit (September 28 – October 2):  Product-by-Process Methods of Treatment

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Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.
On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U

FDA Clears CRISPR-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals

Investment in the alternative protein industry is surging, and companies are increasingly capitalising on opportunities to partner with each other in this area. Where the partners bring roughly an equal share to the table, these partnerships may be referred to as JVs. JVs are commercial arrangements agreed between those partners for the purpose of achieving a specific objective. They may be contractual JVs between existing entities without forming a new company, or corporate joint ventures, where a new limited liability company or partnership is formed between the partners. JVs are an effective way for companies to pool technology, expertise and resources in order to generate profit and capture market share.Read the <a href="https://www.mofo.com/resources/insights/220223-quick-guide-jvs-alternative-protein-industry" target="_self">full client alert</a>.