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

Social

Search

Subscribe

Life Sciences and Healthcare Group

Life Sciences Podcast

Patent Counseling + Prosecution

FDA Regulatory + Life Sciences Compliance

FDA + Healthcare Regulatory and Compliance 

Life Sciences Transactions + Licensing

Resources

Editors

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

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

poon_meghan_blog_150x150.png

poon_meghan_common_640x280.jpg

poon_meghan_heroretina_2700x1160.jpg

poon_meghan_mobileretina_750x1040.jpg

poon_meghan_social_600x600.jpg

Partner

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

Meghan Poon

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

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

schonig_wolfgang_blog_150x150.png

schonig_wolfgang_common_640x280.jpg

schonig_wolfgang_heroretina_2700x1160.jpg

schonig_wolfgang_mobileretina_750x1040.jpg

schonig_wolfgang_social_600x600.jpg

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

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

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

Wolfgang Schönig

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

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

life-sciences-featured-image.jpg

life-sciences-featured-image

Announcements

Welcome to Mofo Life Sciences

Blog - Terms of Use

Cookies

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

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

MoFo Tech Blog

MOFO TECH

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

Employment Law Commentary

EMPLOYMENT LAW COMMENTARY

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

Socially Aware

SOCIALLY AWARE

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

Government Contracts Insights Blog

GOVERNMENT CONTRACTS INSIGHTS

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

Class Dismissed Blog

CLASS DISMISSED

MoFo Life Sciences

  Linkedin

MoFo LinkedIN

Life Sciences Blog - RSS

Stay Connected

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

Because No One is Immune to the Law

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

AI + Robotics

Agtech

Antitrust

Asia

Bioinformatics

Biotech

Blockchain

Cell + Gene Therapy

CFIUS

Corporate + Venture Capital

COVID-19

Data Analytics

Digital Health

Employment

European Union

Financing

Global

Healthcare

Intellectual Property

Licensing + Commercial

Litigation

Medical Devices + Diagnostics

Pharma

Privacy + Data Security

Product Liability + Class Action

Rare Disease

Regulatory

Startup

United Kingdom

United States

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

What is “Healthy?” Are Fats In?

Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

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

grohmann_robert_blog_150x150.png

grohmann_robert_common_640x280.jpg

grohmann_robert_heroretina_2700x1160.jpg

grohmann_robert_mobileretina_750x1040.jpg

grohmann_robert_social_600x600.jpg

Counsel

Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

content_(1).jpg

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

content_(1)

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

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

The U.S. Department of Agriculture (USDA) Plant Variety Protection Office (PVPO) has waived the deposit requirement for asexually reproduced plants until further notice due to “continued and ongoing technical challenges and infeasibilities.” The <a href="https://www.ams.usda.gov/content/usda-announces-delay-germplasm-deposit-requirement-asexually-reproduced-varieties-protected" target="_blank">announcement</a> specified that any future requirements for a deposit will not be applied retroactively. As of this writing, there are no hints of a date for such potential future requirements.This change is now reflected in the requirements for a Plant Variety Protection (PVP) certificate <a href="https://www.ams.usda.gov/services/plant-variety-protection/pvpo-requirements" target="_blank">listed on the PVPO website</a>:“The deposit of propagating material for asexually reproduced plant varieties is not required. The applicant must sign a declaration that the propagating material will be maintained at a specific location, subject to PVPO inspection, and if requested by PVPO, the applicant has three months to provide the propagating material or risk losing protection.”The availability of PVP rights for asexually reproduced plants is still relatively new in the United States, as the PVPO only started accepting applications for asexually reproduced plants as of January 6, 2020. Initially, the deposit requirement was delayed until January 6, 2023, due to feasibility concerns. With no viable solutions at the end of the three-year delay, the decision to waive the deposit requirement provided a timely resolution. Now—more than three months out from the initial expected date for deposit requirements for asexually reproduced plants, and more than three years out from the entrance of asexually reproduced plants into the PVP system to begin with—there is less uncertainty on how such deposits may be handled. Although deposits for asexually reproduced plants may still be required at some point in the future, the lack of retroactive application of such future requirements represents at least a reliable interim reprieve for producers of these plants.The prior uncertainty surrounding deposit requirements for asexually reproduced plants was likely a deterrent for many potential applicants considering PVP protection, especially since a deposit is not formally required to obtain a plant patent for asexually reproduced varieties. Without the cost and technical challenges associated with a deposit, PVPs for asexually reproduced plants may soon enjoy more widespread popularity.For more on PVPs for asexually reproduced plants read our previous blog post on the topic: <a href="https://lifesciences.mofo.com/topics/pvp-office-now-accepting-applications-for-asexually-reproduced-plants" target="_blank">Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants</a><a href="https://lifesciences.mofo.com/topics/pvp-office-now-accepting-applications-for-asexually-reproduced-plants">.</a>Please reach out to MoFo’s <a href="https://www.mofo.com/capabilities/plant-intellectual-property" target="_blank">Plant IP</a> team if you have any questions regarding this change or PVPs. We regularly monitor these developments and will post future updates on our blog.

USDA PVP Office Waives Deposit Requirement for Asexually Reproduced Plants

pierre-jerome_edith_blog_150x150.png

pierre-jerome_edith_common_640x280.jpg

pierre-jerome_edith_heroretina_2700x1160.jpg

pierre-jerome_edith_mobileretina_750x1040.jpg

pierre-jerome_edith_social_600x600.jpg

Patent Agent

Dr. Edith Pierre-Jerome focuses her practice on patent drafting and prosecution in areas related to molecular and cellular biology, biochemistry, microbiology, and plant genetics.

Edith A. Pierre-Jerome Ph.D.

Edith Pierre-Jerome

freeman-rosenzweig_liz_blog_150x150.png

freeman-rosenzweig_liz_common_640x280.jpg

freeman-rosenzweig_liz_heroretina_2700x1160.jpg

freeman-rosenzweig_liz_mobileretina_750x1040.jpg

freeman-rosenzweig_liz_social_600x600.jpg

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

ellison_cory_blog_150x150.png

ellison_cory_common_640x280.jpg

ellison_cory_heroretina_2700x1160.jpg

ellison_cory_mobileretina_750x1040.jpg

ellison_cory_social_600x600.jpg

Sr Patent Agent

Cory Ellison is a patent agent in the San Francisco office of Morrison & Foerster. Dr. Ellison’s practice involves patent application drafting, patent prosecution, matters pertaining to plant variety 

Cory Ellison Ph.D.

Cory Ellison

230315-life-sciences-blog.jpg

USDA PVP Office Waives Deposit Requirement for Asexually Reproduced Plants

230315-life-sciences-blog

The U.S. Department of Agriculture (USDA) Plant Variety Protection Office (PVPO) has waived the deposit requirement for asexually reproduced plants until further notice due to “continued and ongoing technical 

In <a href="https://cafc.uscourts.gov/opinions-orders/22-1116.OPINION.2-13-2023_2079642.pdf" target="_blank">ChromaDex Inc. v. Elysium Health Inc.</a>,[1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a dietary supplement company and licensee of the ’807 patent brought a patent infringement suit against Elysium. The district court initially found the ’807 patent invalid under 35 U.S.C. § 101 as directed to a natural product. The Federal Circuit affirmed the district court’s decision, concluding that the dietary supplement in the asserted claims was not markedly different from naturally occurring milk.The ’807 patent relates to nutritional supplements containing isolated nicotinamide riboside (NR), a form of naturally occurring vitamin B3 present in non-isolated form in cow’s milk and other products. Claim 1 of the ’807 patent recites:A composition comprising isolated nicotinamide riboside in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer's solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration.Elysium argued that the claimed composition reads on naturally occurring milk, which comprises NR, tryptophan, and the sugar lactose, and that the only difference between the two is that the claims recite that the NR is “isolated.” ChromaDex responded that the claimed NR composition is different from the naturally occurring form because it contains a stable isolated form of NR, which is bioavailable, sufficiently pure, and at a higher concentration than the NR found in naturally occurring milk. According to ChromaDex, NR is found only in trace amounts in naturally occurring milk and is primarily bound to whey protein.The Federal Circuit rejected ChromaDex’s arguments and sided with Elysium. Specifically, the court found that naturally occurring milk inherently increases NAD+ biosynthesis via tryptophan, regardless of the trace amounts of NR, and that the claims did not recite that the isolated NR must be bioavailable. In view of the decision in Myriad,[2] simply isolating the NR was found to be insufficient for patent eligibility; the claimed composition was not markedly different from naturally occurring milk. The court also distinguished its previous decision in Natural Alternatives,[3] where it found claims to specific formulations including natural products were patent-eligible because the natural products were incorporated into a dosage form with a particular characteristic. In contrast, the claims in ChromaDex did not require any minimum quantity of NR and they did not connect the recited increase in NAD+ biosynthesis to the isolated NR.This case demonstrates the continued relevance of subject matter eligibility to pharmaceutical and food supplement claims. The decision reaffirms Myriad by asserting that the mere recitation of “isolated” is not sufficient to confer subject matter eligibility and highlights key considerations for drafting claims. For example, patent applicants should provide description of any advantages and improved properties of a formulation over its natural counterpart in the specification and draft claims that provide a connection between the modifications to the natural product and the improved function. Applicant should also consider composition or formulation claims that recite specific thresholds or amounts outside those found in nature to reduce the impact of subject-matter eligibility issues.[1] ChromaDex, Inc. v.Elysium Health, Inc., No. 2022-1116 (Fed. Cir. Feb. 13, 2023).[2] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (Jun. 13, 2013)[3] Natural Alternatives International, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. Mar. 15, 2019).

Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid

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. 

230314-mofolifesciences-biotech.jpg

Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid

230314-life-sciences-blog

InChromaDex Inc. v. Elysium Health Inc., [1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a dietary supplement company and licensee of the ’807 patent brought a patent infringement suit against Elysium.

Update: USDA announced on March 23, 2023 that the Interagency Working Group on Competition and Intellectual Property in Seeds and Other Agricultural Inputs was officially <a href="https://www.ams.usda.gov/press-release/usda-launches-interagency-working-group-competition-and-intellectual-property-seeds" target="_blank">launched</a>. On March 6, 2023, the U.S. Department of Agriculture (USDA) released its report on “<a href="https://www.ams.usda.gov/sites/default/files/media/SeedsReport.pdf" target="_blank">More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs</a>,” which was prepared in consultation with the U.S. Patent and Trademark Office (USPTO), Department of Justice (DOJ), and Federal Trade Commission (FTC). The report is a response to President Biden’s Executive Order issued on July 9, 2021, titled “<a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/" target="_blank">Promoting Competition in the American Economy</a>,” which promotes a whole-of-government approach to competition and includes initiatives across federal agencies. One of these initiatives directed the USDA, in consultation with the USPTO, to prepare a report on concerns and strategies for ensuring “that the intellectual property (IP) system, while incentivizing innovation, does not also unnecessarily reduce competition in seed and other input markets beyond that reasonably contemplated by the Patent Act.” The report was prepared after a 90-day comment period, a public listening forum, and input from multiple interested parties.While many commenters agreed that fair protection of IP was critical to continued innovation and investment in seed systems, concerns were raised that the current system and practices for protecting and enforcing IP rights for plant innovations may not promote fair competition. There were several primary areas of concern, including the following:<ul><li>Difficulties in accessing information on existing IP rights associated with a particular plant variety. Commenters noted the various IP systems for protecting plant-related innovations and the lack of a consolidated source of information.</li><li>Application of patent standards on the examination of plant-related innovations. Concerns were raised around incomplete searching of non-patent sources.</li><li>Use and enforcement of IP rights for plant-related inventions, and the increased use of licenses that override research and breeding exemptions.</li><li>Commenters licensing IP from larger firms were concerned about the effects of consolidation on their choice of products and the competitive market environment.</li></ul>In addition to these concerns, many commenters called for greater investment in public infrastructure around seed systems and plant breeding. The decades of underinvestment in public infrastructure were stated to have significantly reduced public infrastructure capacity, as well as farmer choice and the availability of varieties tailored to local circumstances. In addition, decentralized variety development capacity has been lost, which has resulted in vulnerable supply chains.The report identifies three key topic areas to address these challenges:<ol><li>Provide and enforce robust and reliable IP rights that enhance innovation and promote fair competition;</li><li>Ensure that IP owners can exercise their rights within the scope of fair competition provided by law; and</li><li>Rebuild critical national infrastructures for variety development and the provision of seed and other planting stock to create resilient seed supply chains.</li></ol>In order to deliver on these recommendations, the USDA will:<ul><li>Establish a new Farmer Seed Liaison who will coordinate information sharing and work to reduce confusion for all parties operating in the complex seed system;</li><li>Form a working group with the USPTO to promote fair competition in the seed market, which will also work with the DOJ and FTC; and</li><li>Enhance transparency to farmers; for example, by expanding the FarmerFairness.gov portal, which enables farmers and seed businesses to report tips and complaints related to seed markets.</li></ul>The USDA-USPTO Working Group on Competition and Intellectual Property has created the following joint initiatives:<ol><li>Exploring joint USPTO-USDA opportunities for collecting broader stakeholder input from researchers, plant breeders, farmers, and others in the seed and agricultural input markets;</li><li>Pursuing additional opportunities to enhance the quality of the patent examination process for innovations related to agricultural products and processes, including for prior art search capabilities and additional training and guidance for patent examiners;</li><li>Collaborating on new programs to enhance the transparency of IP information for agriculture-related innovations and assess the availability and viability of patented and off-patented germplasm; and</li><li>Considering and evaluating new proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the broader adoption of research or plant breeders’ exemptions when U.S. utility patents cover seeds. </li></ol>The USPTO will be hosting a series of outreach events and listening sessions on these topics, and invites public participation in the process.Please reach out to MoFo’s <a href="https://www.mofo.com/capabilities/plant-intellectual-property" target="_blank">Plant IP</a> team if you have any questions on the USDA-USPTO Working Group or the joint initiatives included in this report. We regularly monitor these developments and will post future updates on our blog.

ward_michael_blog_150x150.png

ward_michael_common_640x280.jpg

ward_michael_heroretina_2700x1160.jpg

ward_michael_mobileretina_750x1040.jpg

ward_michael_social_600x600.jpg

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

bendix_claire_blog_150x150.png

bendix_claire_common_640x280.jpg

bendix_claire_heroretina_2700x1160.jpg

bendix_claire_mobileretina_750x1040.jpg

bendix_claire_social_600x600.jpg

Dr. Claire Bendix’s work focuses on patent preparation, patent prosecution, and matters pertaining to plant variety protection both in the United States and abroad. She also has experience in conducti

Claire L. Bendix Ph.D.

Claire Bendix

221205-pvp-blog-image.jpg

USDA and USPTO Promoting Fair Competition and Innovation in the Seed Marketplace

221205-pvp-blog-image

On March 6, 2023, the U.S. Department of Agriculture (USDA) released its report on “More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs,” 

USDA and USPTO Promoting Fair Competition and Innovation in the Seed Marketplace

The proliferation of private investor-backed management of health care practices continues to draw <a href="https://www.fiercehealthcare.com/regulatory/ftc-doj-promise-heavier-scrutiny-pe-deals-healthcare" target="_blank">scrutiny</a> from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local level but have varying degrees of authority across the country to review or approve health care consolidation transactions. There are a growing number of states that are proposing or enacting laws requiring regulatory review of health care transactions that will significantly reshape the health care investment landscape. States have typically limited review and approval of health care transactions to larger provider types, such as hospitals. Recently, however, some states have expanded statutory requirements for review of health care transactions to physician provider groups and even management service organizations. For example, Massachusetts, Nevada and Washington have all enacted laws that require notice of material changes for certain transactions involving physician practices and other entities. Recently, New York and California, two of the states that are most active in reviewing and enforcing the corporate practice of medicine prohibitions and the activities of physician entities, have taken more direct steps towards broadening the reach of state regulatory authority to cover a wide array of transactions and entities.   I.	New York State Department of Health ProposalOn February 1, 2023, Governor Kathy Hochul released the New York State Executive Budget (“State Budget”) for fiscal year 2023-24. Embedded within the executive budget is a <a href="https://assembly.state.ny.us/leg/?default_fld=&bn=A03007&Summary=Y&Text=Y" target="_blank">proposal</a> that would give the State Department of Health (DOH) new authority to review and approve certain “material transactions” involving physician practices and other “health care entities” taking place in the state (“Proposal”). If enacted, this bill would add a new Article 45-A to the New York Public Health Law and subject health care transactions involving private equity and investor-backed entities to review. In articulating the purpose of the Proposal, the Governor cited an increasing number of physician practices that are managed by investor-backed entities, noting that these entities have assumed characteristics associated with clinics, insurers, and diagnostic and treatment centers, but remain “largely unregulated by the state.”a. 	Definition of “Health Care Entity” and “Material Transaction”The Proposal defines a “health care entity” to include a management services organization or similar entity providing all or substantially all of the administrative or management services under contract with one or more physician practices, provider organizations, health insurance plans, or any other kind of facility, organization, or plan providing health care service. Additionally, a “material transaction” is broadly defined to include mergers, acquisitions or affiliations with a health care entity, as well as “an affiliation or contract formed between a health care entity and another person” and the “formation of an … [MSO] for the purpose of administering contracts with health plans, third-party administrators, pharmacy benefit managers, or health care providers.” 	b.	Review ProcessUnder the Proposal, the health care entities engaging in a material transaction must submit written notice of the transaction to DOH at least 30 days prior to the closing date. If DOH does not respond within the 30-day timeframe, the transaction will be deemed approved, but DOH may extend the 30-day period if “necessary to conduct a thorough examination and complete analysis” of the transaction. The Proposal authorizes DOH to hire independent third-party entities to assist in a review and to charge the cost of retaining such third-party entities to the applicant. Furthermore, DOH will publicly post all written notices received regarding proposed transactions and will request public comments on the transactions. In its review, DOH would be authorized to consider a variety of factors, such as the financial condition of the transaction parties, the character and competence of the parties, the source of funds for the transaction, and whether the benefits of the transaction outweigh the potential negative effects on cost, access, health equity, and health outcomes.  	c. 	Penalties for NoncomplianceThe Proposal would grant DOH the power to impose a civil penalty of up to $10,000 for each day that a transaction is out of compliance, which would presumably extend into perpetuity until and unless an application is filed. The Proposal would also enable DOH to pursue an injunction against the closing of a material transaction that has not been submitted for review to DOH.	d. 	Key TakeawaysThe Proposal expands the scope of DOH regulatory authority to a very broad range of “health care entities,” which includes purely administrative service organizations, such as MSOs. The approval and public comment process under the Proposal could severely impact the landscape of health care related transactions within the State of New York, especially given that the factors to be considered in approving such a transaction include highly subjective criteria, such as the “character and competence of the parties.” Investors and entities in the health care space should carefully follow the progress of the Proposal, which could significantly hinder new investments in health care companies if adopted.II.	California Office of Health Care AffordabilityOn June 30, 2022, California Governor Gavin Newsom signed SB-184 into law, which created a new Office of Health Care Affordability (OHCA) within the California Department of Health Care Access and Information. To “increase public transparency,” OHCA is granted authority to “[r]eview and evaluate consolidation, market power, and other market failures through cost and market impact reviews of mergers, acquisitions, or corporate affiliations involving health care service plans, health insurers, hospitals, physician organizations, pharmacy benefit managers, and other health care entities.” 	a. 	Definition of “Health Care Entity”The statute defines “health care entity” as a “payer, provider, or fully integrated delivery system,” including health care service plans, health insurers, hospitals, hospital systems, pharmacy benefit managers, certain physician organizations, other providers (e.g., clinical labs), and other payers. [1] Entities excluded from the definition of health care entity include dentists, pharmacies, drug manufacturers, DME suppliers, home health agencies, and emergency medical transportation service providers.	b. 	Transactions Subject to OHCA ReviewGenerally, transactions that involve a change in ownership, operations, or governance structure that (i) sell, transfer, lease, exchange, option, encumber, convey, or otherwise dispose of a material amount of a health care entity’s assets to one or more entities; or (ii) transfer control, responsibility, or governance of a material amount of the assets or operations of the health care entity to one or more entities will be subject to review. [2] 	c. 	Review ProcessThe cost and market impact review process requires transaction parties to notify OHCA at least 90 days prior to closing. Within 60 days after receipt of the notice, OHCA will either advise the notifying party that OHCA will conduct a cost and market impact review or provide a written waiver from the review. During the cost and market impact review process, OHCA will evaluate (i) changes in size or market share in a given service or geographic region, (ii) prices relative to other providers, (iii) quality, equity, access, and other factors in the public interest, and (iv) benefits of the transaction, such as improvements in access, quality, and efficiency. [3] The review process includes an investigation by OHCA, which may subpoena health care entities and other relevant market participants to submit data and documents. An agreement or transaction subject to a cost and market impact review may not proceed until 60 days after OHCA issues a final report. During this time, OHCA may refer the transaction to the attorney general for review, and the attorney general may pursue litigation to block the transaction or allow it to proceed subject to specified conditions, such as the implementation of monitoring or ongoing reporting requirements.The advance review of these health care transactions is slated to begin on April 1, 2024, and OHCA will begin accepting required transaction notices in January 2024. OHCA is expected to promulgate regulations to provide additional details on the types of transactions subject to review and qualifying factors.	d. 	Key TakeawaysAlthough the statute does not grant OHCA authority to block or challenge health care transactions, OHCA does have the ability to significantly delay transactions that fall under its purview, given that no transaction for which OHCA conducts a review may close for 60 days following its delivery of a final report. Similar to the New York Proposal, SB-184 covers a wide array of transactions, including those that involve, for instance, MSOs, to the extent the transaction would cause a change in responsibility for operations of a health care entity. Investors that use MSOs as the investment vehicle for health care entities should carefully navigate the new requirements and oversight imposed by SB-184, beginning in 2024, and follow the promulgation of regulations over the coming months, which will further clarify the scope and nature of the law.                                                                     ****If you have any questions about the current trends in regulatory oversight of the practice of medicine, please contact Wendy Chow or Rachel Park.[1] <a href="https://casetext.com/statute/california-codes/california-health-and-safety-code/division-107-health-care-access-and-information/part-2-health-policy-and-planning/chapter-26-health-care-affordability/article-1-general-provisions-and-definitions/section-1275002-definitions" target="_blank">CA Health and Safety Code § 127500.2(k)</a>.[2] <a href="https://casetext.com/statute/california-codes/california-health-and-safety-code/division-107-health-care-access-and-information/part-2-health-policy-and-planning/chapter-26-health-care-affordability/article-8-health-care-market-trends/section-127507-health-care-market-trends-role-of-ofice-applicability" target="_blank">CA Health and Safety Code § 127507(c)(2); CA Health and Safety Code §§ 127507(c)(1)(A)-(B).</a>[3] <a href="https://casetext.com/statute/california-codes/california-health-and-safety-code/division-107-health-care-access-and-information/part-2-health-policy-and-planning/chapter-26-health-care-affordability/article-8-health-care-market-trends/section-1275072-cost-and-market-impact-review" target="_blank">CA Health and Safety Code § 127507.2(a)(1).</a>

230301-regulatory-oversight.jpg

States Extend Scope of Regulatory Oversight of Health Care Entities

States Extend Scope of Regulatory Oversight of Health Care Entities