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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Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

April 2025 Update on Regulation of New Genomic Techniques in the EU

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

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

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

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

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

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

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

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

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

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Brian Matsui co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Brian is a go-to appellate advocate for sophisticated clients in complex appeals nationwide. 

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Brian Matsui is a partner in Morrison Foerster’s Appellate and Supreme Court practice. For nearly 20 years, Brian has been a go-to appellate advocate for sophisticated clients in complex appeals nationwide. Clients turn to Brian for his substantial experience in patent appeals in the Federal Circuit. He has argued more than 10 times in that Court, winning appeals from both district courts and the Patent Trial and Appeal Board. Brian excels at applying significant legal principles to complex technologies in a way that distills them for the Court. He has done so for companies in a myriad of industries, including mobile device manufacturers, pharmaceutical companies, medical device companies, memory manufacturers, movie studios, and software companies.

Brian Matsui

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

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Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc., No. 21-2342.

Our Federal Circuitry blog recently discussed the Court's decision in <a href="https://cafc.uscourts.gov/opinions-orders/19-2054.OPINION.8-11-2022_1990706.pdf" target="_blank">Hologic, Inc. v. Minerva Surgical, Inc.</a>, No. 19-2054.You should read this case if: you want to know how the Federal Circuit will treat assignor estoppel post-MinervaYou have to feel a little sorry for a party that beats the incredible odds of getting Supreme Court review only to end up with the same result. That’s what happened in our case of the week. Unless you’ve been living under a rock (or the proverbial equivalent of a rock in patent-land—the MPEP maybe), you’re no doubt aware of one of the few relatively recent Supreme Court patent cases: <div><a href="https://www.supremecourt.gov/opinions/20pdf/20-440_9ol1.pdf" target="_blank">Minerva Surgical, Inc. v. Hologic, Inc. </a>(And once again, here’s where a few readers shed a tear for what could have been in American Axle.) As a recap, the Supreme Court granted cert to decide whether the doctrine of assignor estoppel found any support in patent law. Assignor estoppel precludes an assignor of a patent from later challenging that patent’s validity. At least initially, smart money was on the “no” side, as nothing in the U.S. Code expressly provides for assignor estoppel, and this is supposedly a textualist Supreme Court.</div>

Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

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Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

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For most of us, we’re stuck in the August heat, on delayed European vacations, or hopefully just hanging out at the beach. But for the Court it still was work as usual, including a return trip to the Federal Circuit for the defendant in Minerva. Below we provide our usual weekly statistics and a detailed discussion of our case of the week—our highly subjective selection based on whatever case piqued our interest.

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.

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).

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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

Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount of protein in the food products. Read the full article below. Since spring 2020, food manufacturers have been hit with a wave of protein-labeling lawsuits all making the same core allegation: that their products' front-label protein content statements violate U.S. Food and Drug Administration regulations, and mislead consumers, by overstating the amount of protein in the food products. While the plaintiffs admit that the FDA regulations are explicitly applicable to back-label claims, they allege that these same regulations do not apply to the same statements being made on front labels. The defendants argue otherwise, claiming that the plaintiffs' proffered theory would result in the illogical result of having different protein statements on the front and back labels. And indeed, the U.S. District Court for the Northern District of California, in a February ruling in Nacarino v. Kashi Co., described the applicable regulatory scheme as "convoluted."[1] That was true — until recently. Earlier this year, the FDA released new guidance clarifying labeling requirements concerning protein claims, undermining the foundation of the labeling plaintiffs' claims. And the Northern District of California has since dismissed these protein lawsuits with prejudice. These decisions highlight the dispositive impact of preemption arguments. But in two cases, plaintiffs have since appealed the district courts' orders dismissing their claims, bringing the regulatory scheme back into question. District Courts' Distaste for Protein Suits On Feb. 10, in Nacarino v. Kashi Co., Judge Vince Chhabria dismissed with prejudice the plaintiff's claims that Kashi mislabels its food products by miscalculating their protein content.[2] The Nacarino court found that Kashi's use of the nitrogen method for calculating protein is appropriate under FDA regulations, and any claims brought by individuals based on the use of this method were preempted by the Federal Food, Drug, and Cosmetic Act.[3] In making its ruling, the Nacarino court relied heavily on the FDA's newly issued guidance on its website clarifying appropriate methods for calculating front-label protein statements. Less than a week after the Nacarino decision, another court in the Northern District of California followed suit, dismissing with prejudice the allegations of the plaintiff in Chong v. Kind LLC that Kind's front-label protein claims were deceptive and unlawful.[4] In Chong, the court declined to follow its own earlier decision in what it admitted was a "nearly identical" lawsuit from 2020, Minor v. Baker Mills, which had permitted protein-labeling claims to proceed past a motion to dismiss.[5] The Chong court acknowledged that "it has now become apparent ... that Minor was incorrectly decided."[6] Referencing Nacarino, the Chong court held that the plaintiff's claims were preempted because federal regulations establish "that producers may state grams of protein even outside the Nutrition Facts panel calculated by the nitrogen method, and without adjustment for digestibility."[7] Furthermore, the court rejected plaintiff's claims based on Kind's failure to include a percentage of the daily value of protein on the back label, in violation of FDA regulations. The court found that, because they were entirely dependent on violations of the FDCA, the plaintiff's claims under California's Sherman Law were impliedly preempted under the U.S. Supreme Court's 2001 ruling in Buckman v. Plaintiffs' Legal Committee.[8] The plaintiffs in both Nacarino and Chong have since appealed the courts' decisions dismissing their claims with prejudice.[9] Opening briefs are due in June, which will provide additional insight into the plaintiffs' basis for challenging the courts' conclusions that FDA guidance on protein claims is definitive. FDA Regulations and New Guidance Under FDA regulations, food manufacturers may calculate protein content for front-label protein claims at least two different ways: (1) calculating the amino acid content of the food directly, or (2) using the nitrogen method, which requires manufacturers to multiply the nitrogen content of the food by a factor of 6.25.[10] When food manufacturers calculate the percentage daily value of protein on the product's back label, federal regulations require that the percentage be adjusted for digestibility using a "protein digestibility-corrected amino acid score."[11] Because plant-based proteins are not fully digestible by the human body, the amount of protein calculated under the nitrogen method may differ from the amount of protein as adjusted for digestibility and as used for calculating the percentage of daily value on the back label. Plaintiffs have seized on these nuances in the federal regulations to argue that front-label protein claims overstate the amount of protein by failing to account for protein digestibility. In essence, plaintiffs claim that, despite manufacturers calculating protein claims in accordance with FDA regulations for back-label protein statements, using this same calculation for front-label claims is misleading. But no requirement to calculate protein digestibility exists for front-label claims. In its Jan. 11 guidance, the FDA made it clear that, contrary to plaintiffs' claims, food manufacturers are not required to use only an amino acid content method for calculating front-label protein statements, nor are they required to adjust the front-label content claims for digestibility. Indeed, the FDA approves of the use of the nitrogen method for front-label protein claims, and does not require that manufacturers adjust protein content for digestibility when making such claims. Looking Ahead Where plaintiffs' claims rest on an interpretation of the federal regulatory scheme that the FDA recently rejected, decisions from the Northern District of California suggest that preemption arguments may present a viable defense — at least for now. As the U.S. Court of Appeals for the Ninth Circuit grapples with Chong and Nacarino, manufacturers can expect some reprieve from the barrage of these protein case filings. Even if they are named in new filings, manufacturers have additional ammunition in their pockets, and should consider and give great weight to asserting preemption arguments and requesting a stay of their proceedings. This article is for general information purposes and is not intended to be and should not be taken as legal advice. [1] <a target="_blank" href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2023409&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2023409&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Nacarino v. Kashi Co. </a>, No. 21-cv-07036-VC, 2022 WL 390815, at *1 (N.D. Cal. Feb. 9, 2022). [2] Id. [3] Id. at *5. [4] <a target="_blank" href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2027438&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2027438&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Chong v. Kind LLC </a>, No. 21-cv-04528-RS, 2022 WL 464149 (N.D. Cal. Feb. 15, 2022). [5] Id. at *1; <a target="_blank" href="https://advance.lexis.com/api/search?q=2020%20U.S.%20Dist.%20LEXIS%20258880&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2020%20U.S.%20Dist.%20LEXIS%20258880&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Minor v. Baker Mills Inc. </a>, No. 20-cv-02901-RS, 2020 WL 11564643 (N.D. Cal. Nov. 12, 2020). [6] Chong, 2022 WL 464149, at *1. [7] Id. at *3. [8] Id. at *4. [9] Nacarino v. Kashi Co., No. 22-15377 (9th Cir.) (appeal filed March 14, 2022); Chong v. Kind LLC, No. 22-15368 (9th Cir.) (appeal filed March 11, 2022). [10] See 21 C.F.R. § 101.9(c)(7). [11] Id.

Nature's Path Foods

Suja Juices

Claudia M. Vetesi

RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS