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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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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China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to the country’s Catalogue of Technologies Prohibited and Restricted for Export (the “Export Catalogue”) for public consultation (the “Proposed Amendment”). The Proposed Amendment is subject to change but, once finalized, would be another significant revamp after two other major amendments of the Export Catalogue, first in 2008 and then again in 2020. The amended Export Catalogue seeks to introduce “cell cloning and gene editing for human use,” “CRISPR gene editing,” and “synthetic biology” to the control list.China’s biopharmaceutical industry has been facing increased pressure in recent years from various directions, such as practical challenges in access to advanced technologies and certain Chinese companies being placed on the Entity List under the U.S. Export Administration Regulations. In response, China has been strengthening its own export control over China-originated cutting-edge biotechnologies, highlighting concerns over national security and public interest and also the redirected focus on domestic markets.For more information and insights on this topic, read MoFo’s full <a href="https://www2.mofo.com/e/323401/eyes-new-export-controls-email/8tg89/566349410?h=j01MklwE1Klh2BmSQhR6j-jwxYg3CiKXWLJiofJ_190" target="_blank">client alert</a>.<div></div>

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Associate

Tyler’s experience encompasses various aspects of transactional and contentious IP matters, including cross-border M&A transactions, technology transfer and licensing, IP and data-driven strategic coo

Tyler Xiu

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Dr. Bu Yin has nearly 10 years of experience in life sciences patent application drafting, global portfolio management, and strategic counseling. Dr. Yin frequently counsels on issues relating to pate

Bu Yin Ph.D.

Bu Yin

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Gordon is a partner whose practice focuses on advising clients about intellectual property, licensing, outsourcing, and technology transactions.
He has advised clients in the IT, telecommunications, f

Gordon A. Milner

Gordon Milner

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Managing Partner, Shanghai

Chuan focuses his practice on cross-border M&A transactions; sophisticated technology, media, and telecom (TMT) transactions; and complex IP/commercial matters across Greater China.

Chuan Sun

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

Janet Xiao Ph.D.

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

Janet Xiao

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China Eyes New Export Controls for Life Sciences Technologies

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China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to the country’s Catalogue of Technologies Prohibited and Restricted for Export (the “Export Catalogue”) for public consultation (the “Proposed Amendment”). 

China Eyes New Export Controls for Life Sciences Technologies

As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new agency will bring together industry, academia, and government through public-private partnerships for high-risk, high-reward endeavors intended to drive breakthroughs in biomedicine and health. ARPA-H seeks to capitalize and expand on recent advances in biomedicine to revolutionize the prevention and treatment of cancer, infectious diseases, and Alzheimer’s and other diseases, and potentially to uncover cures. Its impact on Americans could be profound.  Read the <a href="https://govcon.mofo.com/topics/us-government-launches-billion-dollar-biomedical-agency">full blog post</a>.

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Tina is a partner in Morrison & Foerster’s Government Contracts practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmace

Tina Reynolds

Tina is co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She counsels a wide variety of government contractors on compliance with federal acquisition and ethics regulations. She drafts and negotiates contracts on their behalf and has been involved with numerous internal investigations and compliance reviews, and with bid protest, contract claims, and False Claims Act litigation. She also advises on M&A transactions involving government contractors.

Tina D. Reynolds

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U.S. Government Launches Billion-Dollar Biomedical Agency

New DCMA Defective Pricing Pilot Team Will Possess Audit Resolution Authority

As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). 


U.S. Government Launches Billion-Dollar Biomedical Agency

Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office requirements for the written descriptions and disclosures that are necessary to obtain a patent for biologic products. The sequence listings are used by patent offices during examinations to search for identical or similar sequences when assessing novelty and nonobviousness of the invention sought to be patented. Sequence listings also become publicly available when a patent application is published, allowing the public to access the sequence information. This is especially important when reviewing the patent landscape for freedom to operate analyses for third-party patents.Starting July 1, 2022, all World Intellectual Property Organization (WIPO) member patent offices, including the U.S. Patent and Trademark Office (USPTO), will transition to new sequence listing procedures that will require sequence information be provided in .xml format. Since 1992 – the first year the USPTO required a separate sequence listing – the format for sequence listings has been ASCII .txt.The new format, designated WIPO standard ST.26, is intended to synchronize sequence listings among different patent offices and various international sequence repositories and therefore enable better sequence searches. Where ASCII .txt files are generally smaller in size and easier to interpret, XML files allow for more in-depth annotation via computer tags that also expedite structured information retrieval.More information about the sequence listing changes is available from WIPO and can be found <a target="_blank" href="https://www.wipo.int/standards/en/sequence/faq.html">here</a>. In order to comply with the new standards, WIPO has developed a software tool (“<a target="_blank" href="https://www.wipo.int/standards/en/sequence/?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term">WIPO Sequence</a> tool”) that both generates and validates sequence listings. The WIPO Sequence tool can also be used to convert the previous WIPO standard ASCII ST.25 listings from .txt format to .xml format. There is no transition period in the new rules, and the ability to file a sequence listing in the previous ST.25 format will disappear as of July 1, 2022.The new sequence listing standard will apply to any patent application filed on or after July 1, 2022, including any continuation or divisional application in which the original sequence listing had been prepared in the ST.25 ASCII .txt format. If an applicant desires to continue prosecution of an application family with a new patent filing, the preparation of the sequence listings must be made or converted to the new format. Practitioners and applicants should be aware of the extra time that may be needed to implement the new format. In addition, due to the format differences under the new rules, care also should be taken to ensure that a new matter is not being added when a sequence listing is converted to the new ST.26 format. The sequence listing changes may also have a profound negative impact on the ease with which patent sequences from any published application can be reviewed by the public. XML files are not instantly readable and will require a dedicated display program in order to interpret the sequence input. When downloaded, XML listings will include various coding elements, and it will be necessary to upload an XML file on the WIPO Sequence tool (or another XML viewing platform) in order to decipher the information. While WIPO has indicated that Patent Cooperation Treaty (PCT) applications will have their listings available as XML files, it is not clear how individual patent offices will publish listings under the new standards. Producing a PDF copy of the XML file will most likely present a very difficult task for any practitioner or applicant because there is no way to convert the file via the WIPO Sequence tool.These changes are significant and will impact the accessibility and ease with which applicants and practitioners alike approach the preparation and analysis of sequence listings. Life sciences patentees are encouraged to seek input from counsel to discuss the sequence listing changes in order to ensure compliance with the new rules.

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Patent Agent

Dr. Elizabeth (Liz) Newman focuses her work on patent  drafting and assisting prosecution. She also has experience in IP due diligence  inquiries, including freedom-to-operate analyses, with an emphas

Liz Newman Ph.D.

Liz Newman

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

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The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022