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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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

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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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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.

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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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Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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10/27/2021 Update: The adopted regulation ((EU) 2021/1873) is now officially published in the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1873&from=EN">Journal of the EU</a>.In accordance with the vote of the Council of the European Union on October 5, 2021, the European Union has adopted a new regulation aimed at extending the term of protection provided by Community Plant Variety Rights (CPVR) under Regulation (EC) No. 2100/1994, for varieties of certain plant species (CPVR Extension Regulation), which is available here: <a target="_blank" href="https://data.consilium.europa.eu/doc/document/PE-50-2021-INIT/en/pdf">2021/0019(COD)</a>.  The CPVR Extension Regulation enters into force 20 days after its publication in the <a target="_blank" href="https://eur-lex.europa.eu/oj/direct-access.html">Official Journal of the European Union</a>.The plant species benefitting from the CPVR Extension Regulation are Asparagus officinalis, L. (asparagus), and the species groups of flower bulbs, woody small fruits, and woody ornamentals. For varieties of these species and groups of species, the CPVR term originally granted under Article 19(1) of Regulation (EC) No. 2100/94 is extended by five years, from 25 years to 30 years.On the date the CPVR Extension Regulation enters into force, this term extension will apply to both new CPVR granted on or after that date and existing CPVR for varieties of these species (according to recital (4) of the CPVR Extension Regulation). According to Article 2 of the CPVR Extension Regulation, however, the extension of the CPVR term may be reduced if national plant variety rights already existed for a plant variety before the grant of the CPVR.These particular species and species groups are the focus of the CPVR Extension Regulation because technical problems arise in the breeding of varieties of these species “due to complex genetic backgrounds or due to the slow or technically complicated reproduction” according to the recitals of the CPVR Extension Regulation. As a result, once CPVR are granted, it takes much longer for varieties of these species to become profitable for the breeder than for varieties of most other species. The CPVR Extension Regulation aims to create incentives for the breeding of varieties of these more challenging species. Extending the duration of the CPVR protection will mean that the holder of the CPVR can profit from these varieties over a longer period of time.

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European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species

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10/27/2021 Update: The adopted regulation ((EU) 2021/1873) is now officially published in the Journal of the EU.
In accordance with the vote of the Council of t

European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species

With an expanding global population and finite resources, our food systems are under significant pressure. Alternative proteins are increasingly presented as the solution to relieving the pressure that our food systems are under and to improving global food security. They can provide excellent nutritional value while also helping food systems become more sustainable and environmentally friendly. Investing in and partnering with companies specialised in the production of alternative proteins is fast becoming a key trend.Read the <a href="https://www.mofo.com/resources/insights/210602-alternative-protein-industry-series" target="_self">full client alert</a>.

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Andrew Boyd is an M&A partner based in the London office. He specializes in advising on strategic cross-border mergers and acquisitions, private equity and joint venture transactions with particular e

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

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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.

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Simon Arlington is a partner based in the Corporate Group focusing on M&A and private equity.

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Alternative Protein Industry Series

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With an expanding global population and finite resources, our food systems are under significant pressure. Alternative proteins are increasingly presented as the solution to relieving the pressure that our food systems are under and to improving global food security. They can provide excellent nutritional value while also helping food systems become more sustainable and environmentally friendly. Investing in and partnering with companies specialised in the production of alternative proteins is fast becoming a key trend.

Alternative Protein Industry Series

On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or Restricted (the “Catalog”). This is the first time the Catalog has been revised in 12 years.The amendment of the Catalog as related to certain high-tech industries has attracted much media attention, particularly to the restriction on the export of drone technologies, certain information-processing technologies for artificial intelligence interactive interface and individualized information push services based on data analysis, and technologies related to password security and information defense and countermeasures. This article, however, will focus on the revisions related to the Life Sciences industry, after a brief introduction to China’s technology export regulations.Technology export from China is governed by China’s Technology Import and Export Regulations (TIER). The scope of technology export regulated by TIER is very broad, and includes all acts of technology transfer from within China to outside China, whether by way of trade, investment, or economic and technological cooperation. Specifically, TIER regulates outbound assignments of patents and patent applications, patent licenses, transfers of technological secrets, provision of technological services, and other forms of outbound cross-border technology transfers. TIER categorizes technology exports into three categories: technologies that may be “freely” exported (the “Free Technologies”), technologies the export of which is restricted (the “Restricted Technologies”), and technologies the export of which is prohibited (the “Prohibited Technologies”). The Catalog, jointly promulgated by MOFCOM and MOST, includes the lists of the Restricted Technologies and the Prohibited Technologies. Under TIER, export of the Prohibited Technologies is prohibited, export of the Restricted Technologies is subject to MOFCOM’s prior approval, and the regulatory requirement for the export of the Free Technologies is the after-the-fact registration of the relevant technology export contract, which shall become effective according to its own terms and not conditioned on the registration.MOFCOM’s approval of export of the Restricted Technologies is generally a two-step process before provincial-level branches of MOFCOM (“Local Commerce”). After it receives an application for approval of the export of a Restricted Technology, Local Commerce will conduct a review of the Restricted Technology together with other applicable governmental agencies, e.g., the local branch of China Intellectual Property Administration, the local branch of MOST, the Ministry of Agriculture and Rural Affairs, or the National Forestry and Grassland Administration, depending on the nature of the Restricted Technology. Such review may take up to 30 business days before an approval or disapproval decision can be made. The approval is not the final approval of the technology export, but will be a Provisional License for Technology Export (the “Provisional License”). The technology export applicant may not engage in any substantive negotiation of the technology export or sign any technology export contract until after the issuance of the Provisional License. After the technology export contract is signed, the applicant must apply for the final Technology Export License by submitting to Local Commerce the Provisional License, a copy of the technology export contract, a list of the Restricted Technologies to be exported under the contract, and documents evidencing the legal status of the contracting parties. Local Commerce will conduct an authenticity review of the technology export contract, and will make a decision on whether to approve the technology export within 15 business days after receiving the required documents. The approval decision will be in the form of a Technology Export License. It is worth noting that, regardless of any effective date set forth in a technology export contract, with respect to any Restricted Technology, the contract is effective only upon the issuance of the Technology Export License.As a result of the adjustment of the Catalog, the following Life Sciences-related technologies (categorized into different industries) have been deleted from the Catalog, meaning that their export is no longer prohibited or restricted but will only be subject to after-the-fact registration of the relevant technology export contract:<ul><li>Medicine manufacturing industry <ul><li>Caffeine manufacturing technology using chemical synthesis or semisynthesis</li><li>Riboflavin (VB2) manufacturing techniques</li><li>Chemical synthetic or semisynthetic drug manufacturing technology</li><li>Biotechnology for the manufacturing of penicillin, streptomycin, cephalosporin C, or aureomycin</li><li>Thrombin-like snake venom single-component preparation techniques</li><li>Natural medicine manufacturing technology</li><li>Preparation and processing technologies for functional polymer materials with biological activities</li></ul></li><li>Professional device manufacturing industry <ul><li>Enzyme-labeled monoclonal antibody preparation technology</li></ul></li></ul>The following Life Sciences-related technologies (categorized into different industries) have been added to the Catalog as Restricted Technologies, meaning that their export will be subject to the approval process described earlier in this article:<ul><li>Agriculture <ul><li>Crop (including forage grass) seed resources and their propagation technology, particularly those on the Catalog for the Classification of Crop Seed Resources for Export</li><li>Artificial propagation technology for agricultural wild plants, particularly those listed in the Catalog of Wild Plants Subject to Special State Protection and the Convention on International Trade in Endangered Species of Wild Fauna and Flora</li><li>Genetic engineering (genes and vectors) <ul><li>Newly discovered plant male sterile genes, restoration genes and vectors</li><li>Newly discovered disease- or pest-resistant genes and vectors</li><li>Newly discovered stress-resistant genes and vectors</li><li>Newly discovered quality genes and vectors</li><li>Newly discovered yield-related genes and vectors</li><li>Other newly discovered important genes and vectors</li><li>Unique gene manipulation technology</li></ul></li></ul></li><li>Medicine manufacturing industry <ul><li>All bacterial and viral strains that are obtained using genetic engineering and can be industrially produced, and their culturing technology (this has been an expansion from a limited number of strains specifically identified in the previous version of the Catalog)</li><li>Inactivated vaccine for enterovirus 71 (EV71)</li><li>Rotavirus oral live vaccine</li><li>Viral strains for EV71 vaccine</li><li>Viral strains for CA16 vaccine</li><li>Core techniques and technology for pentavalent and hexavalent rotavirus vaccine production</li><li>Polysaccharide-protein binding technology</li><li>Medical diagnostic devices and equipment manufacturing technology (including domestically made next-generation gene analyzers and third-generation single-molecule sequencers)</li></ul></li></ul>When responding to questions from the press, MOFCOM suggested that the latest amendment to the Catalog was intended to simplify the Catalog. This intention was not clearly reflected in the revisions related to the Life Sciences industry, however. As summarized above, MOFCOM seems to have added an equal or greater number of technologies related to the Life Sciences industry to the Catalog compared to the number deleted. Some of the newly added Restricted Technologies, such as “newly discovered important [plant] genes and vectors,” “bacterial and viral strains obtained using genetic engineering and which can be industrially produced,” and “medical diagnostic devices and equipment manufacturing technology,” appear to have been very broadly defined. MOFCOM also announced that it will further simplify the Catalog in the near future, and whether there will be more deletions from than additions to the Catalog of Life Sciences-related technologies in the next round of amendment to the Catalog remains to be seen.Corresponding to the export Catalog, China also has a Catalog of Technologies the Import of Which is Prohibited or Restricted. MOFCOM further announced that it will significantly simplify that catalog in the near future. For more information on China’s technology import regulations, please refer to the author’s article <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltab5f0746dbcea5cc/627317778e09542a15b7deef/191200-crossing-borders.pdf" target="_blank">here</a>.

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China Technology Export Update: Amendment of The Export Technology Catalog

China Patent Eligibility Update: Human Embryonic Stem Cells

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On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s 

China Technology Export Update: Amendment of The Export Technology Catalog

Morrison & Foerster is pleased to <a target="_blank" href="https://www.mofo.com/resources/news/200417-mofo-expands-corporate-capabilities.html">announce</a> the continued expansion of its New York office and global Corporate Department capabilities with the arrival of corporate partner Mitchell Presser. He joins the firm as a partner in its Mergers + Acquisitions and Private Equity Investments + Buyouts practices and will serve as co-chair of the firm’s Global Corporate Department.Mitchell Presser brings to the firm 30 years of experience in public and private mergers and acquisitions, with a heavy concentration on private equity transactions. Clients across wide-ranging sectors call on Mitchell for his vast experience, as both a lawyer and a principal, executing high-profile M&A and private equity transactions that lead to successful outcomes. He has worked across asset classes, including agriculture, food, financial services, industrials, insurance, sports and entertainment, energy and retail.Mitchell was previously a founding partner of Paine Schwartz Partners (formerly Paine & Partners), a leading U.S. private equity firm managing a $1.2 billion fund focused on investing in food and agriculture. Having served as an investor for more than eight years, Mitchell’s understanding of both the legal and business environments enables him to provide a unique perspective to clients.His joining Morrison & Foerster strengthens the firm’s already robust M&A and private equity global footprint and highlights the continued commitment to growth of the firm’s capabilities and growth in New York.<a target="_blank" href="https://www2.mofo.com/e/323401/people-mitchell-presser-html/5kcrn/164503921?h=gZLF55mZesojIu0CZhQ6YbogQbQXb_i0sgph26DVG0c">Mitchell Presser</a> Co-Chair, Global Corporate Department New York (212) 336-4432 <a href="mailto:mpresser@mofo.com">mpresser@mofo.com</a>

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Morrison & Foerster Expands Corporate Capabilities Adding New Corporate Co-Chair Mitchell Presser