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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Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

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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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Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

The Future of Food: Exploring the World of Cell-Cultivated Cuisine (Blog Post)

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

Navigating U.S. Regulatory Requirements for Genetically Modified Microorganisms Using Interactive Tool

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FIRRMA directed the U.S. Department of the Treasury (“Treasury”), as the chair of CFIUS, to issue regulations that, among other things, address national security concerns arising from foreign investment in U.S. businesses with critical technologies, critical infrastructure, and personal data (referred to in the proposed regulations as “TID U.S. businesses”). The proposed CFIUS regulations implement these provisions of FIRRMA by (i) defining what constitutes a TID U.S. business and (ii) expanding CFIUS’s jurisdiction to include not only transactions that result in control of a TID U.S. business, but also “covered investments” that give a foreign person certain rights with respect to a TID U.S. business (together referred to as “covered transactions”). Life Sciences businesses who maintain or collect, directly or indirectly, sensitive personal data of U.S. citizens might fit the definition of a TID U.S. business and will benefit from learning more about these regulations.The major takeaways from the proposed TID U.S. business regulations are:<ul><li dir="ltr">Risk-Based Analysis: Long-time CFIUS practitioners have heard the refrain that CFIUS undertakes a risk-based analysis of transactions presented for review, examining the threat, vulnerabilities, and consequences to U.S. national security of a particular action. The proposed regulations now articulate these specific elements of the analysis that form the basis for CFIUS’s review of a notified transaction.</li><li dir="ltr">CFIUS Filings Mandatory for Some But Not All TID U.S. Business Covered Transactions: The CFIUS pilot program that became effective in November 2018 requires the submission of a declaration (or full CFIUS notice) for covered transactions involving pilot program U.S. businesses, and this program will remain in effect at least until the final FIRRMA-implementing regulations are published. The proposed regulations do not impose a mandatory CFIUS filing for a covered transaction involving a TID U.S. business (outside the current pilot program’s requirements), unless a foreign government has a “substantial interest” in the acquiring party (more to come on this issue in the next alert in our series). </li><li dir="ltr">Critical Technologies Definition Unchanged: The proposed regulations contain the same definition for critical technologies in effect under the current pilot program. A key component of the critical technologies definition will take effect once the U.S. Department of Commerce (“Commerce”) issues regulations defining the scope of “emerging and foundational technologies.” Commerce took the first step in this process in November 2018 by issuing an Advanced Notice of Proposed Rulemaking identifying and requesting comments on the categories of emerging technologies to be covered. Commerce officials’ most recent informal statements indicate that proposed new regulations may be forthcoming before year-end.</li><li dir="ltr">Critical Infrastructure for Covered Investments Defined by Form and Function: Appendix A to the proposed regulations sets forth 28 categories of critical infrastructure (Column 1) and specific functions related to each critical infrastructure category (Column 2). Only a U.S. business that performs one of the specified functions listed in Column 2 of Appendix A with respect to the infrastructure listed in Column 1 is a TID U.S. business for purposes of a critical infrastructure covered investment.</li><li dir="ltr">Expanded (and Evolving) Definition of Sensitive Personal Data: FIRRMA expands CFIUS’s jurisdiction to include covered investments by a foreign person in a U.S. business that maintains or collects sensitive personal data of U.S. citizens that “may be exploited in a manner that threatens to harm national security.” To implement this provision, the proposed rule sets forth a detailed definition of “sensitive personal data” that includes not only traditional personal information (e.g., name, address, telephone number), but also health, financial, behavioral, and genetic information. The proposed regulations note that CFIUS anticipates periodically revising this definition (along with other aspects of the regulations). </li></ul>

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Charles Capito is a partner in both Morrison Foerster’s National Security and Government Contracts + Public Procurement practices.
In the National Security space, he has significant experience couns

Charles L. Capito

Charles Capito

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Senior Advisor, National Security

Joseph Benkert is a senior advisor  in Morrison & Foerster’s National Security practice group. He advises  clients on critical national security matters pertaining to the Committee on  Foreign Investm

Joseph Benkert

Joseph A. Benkert

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Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses

China’s new administrative regulations on human genetic resources as applied to foreign persons

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FIRRMA directed the U.S. Department of the Treasury (“Treasury”), as the chair of CFIUS, to issue regulations that, among other things, address national securit

Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses

On September 23, 2019, China National Intellectual Property Administration (“CNIPA”) announced its proposed amendments to China’s Guideline on Patent Examination (the “Guideline”), which is the counterpart of the Manual of Patent Examining Procedure in the U.S.  The proposed amendments will become effective November 1, 2019.The current Guideline explicitly provides that “human embryonic stem cells and the methods of preparing them are patent-ineligible inventions in accordance with Article 5(1) of the Patent Law.” The Guideline, as amended, has removed this categorical exclusion, and instructs patent examiners in China that they cannot refuse to grant patent rights by reason of “contravening social morality” with respect to inventions on “isolating or obtaining stem cells using human embryos within fourteen (14) days after fertilization that have not been developed in vivo.” Article 5(1) of China’s Patent Law provides that “[n]o patent shall be granted for an invention that contravenes any law or social morality or that is detrimental to public interests.” This provision is in accordance with Article 27.2 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, which permits WTO members to “exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.”  Similar exclusions based on ordre public or morality can be found in Article 53(a) of the European Patent Convention.Whether an invention contravenes social morality is subject to preliminary examination under China’s Patent Law.  This means that patent examiners in China can reject an application based on contravention of social morality even before substantive examination.  This is particularly important in cases where substantive examination is not provided under the Patent Law, i.e., utility model patents and design patents in China.  Although these types of patent applications are not substantively examined, they can nevertheless be rejected based on Article 5(1) of the Chinese Patent Law.  For example, obscene designs are not patent-eligible in China.Article 5(1) also provides a basis for rejecting a Chinese patent application during substantive examination, and for invalidating a Chinese patent claim.  Therefore, passing the preliminary examination or even obtaining an issued patent is no guarantee that CNIPA will not come back to reject a patent application or invalidate an issued patent for contravention of social morality.An obvious example of inventions contravening social morality in the life sciences industry is methods of human cloning.  Other inventions explicitly prohibited from being patent-eligible under the Guideline for contravention of social morality include “human bodies, regardless of the stages of formation and development, including human germ cells, oosperms, embryos and entire human bodies.”  To accommodate the proposed amendment related to human embryonic stem cells, the Guideline, as amended, states explicitly that “human embryonic stem cells are not human bodies at any stage of formation or development.”Unlike in the United States, where patent eligibility or the lack thereof is frequently the subject of heated legal battles and often subject to judicially crafted tests, China’s primary approach to this issue has been administrative.  Even though the Guideline supposedly only binds patent examiners, we can expect that the Patent Reexamination Board of CNIPA (“PRB”), which is the venue where patents can be invalidated in China, will take a position consistent with the Guideline.  PRB decisions of validity or invalidity are of course, subject to judicial appeal and review, but when it comes to issues related to contravention of social morality, it is also unlikely that Chinese courts will take a different position from that of the Guideline.

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China Patent Eligibility Update: Human Embryonic Stem Cells

China Patent Eligibility Update: Human Embryonic Stem Cells

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On September 23, 2019, China National Intellectual Property Administration (“CNIPA”) announced its proposed amendments to China’s Guideline on Patent Examinatio

After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released <a target="_blank" href="https://home.treasury.gov/news/press-releases/sm779">proposed regulations</a> to implement the Foreign Investment Risk Review Modernization Act (FIRRMA). These proposed regulations follow an initial round of FIRRMA-implementing regulations issued in October 2018, which most notably included the Committee on Foreign Investment in the United States (CFIUS) critical technologies pilot program imposing mandatory CFIUS filing requirements on certain foreign investments in U.S. technology and life sciences companies.The draft regulations propose long-awaited answers to questions about how Treasury and the other CFIUS member agencies will conduct national security reviews of foreign investment under the “modernized” FIRRMA construct, and would amend and restate in entirety the existing rules at Part 800 of the Treasury Regulations. As with the October 2018 regulations, the new proposed rules include changes that will fundamentally alter how foreign investors and U.S. businesses approach mergers and acquisitions, equity investments, and real estate transactions going forward. In other ways, the new rules formalize practices that CFIUS has adopted over time to address the current national security and international trade policy environment.This piece — highlighting some of the key takeaways from the sweeping proposal — is the first in a series of four client alerts. The next three will address in more detail the proposed regulations’ treatment of: (1) real estate transactions; (2) transactions involving U.S. businesses relating to critical technologies, critical infrastructure, and sensitive personal data; and (3) the type and composition of foreign investors.

Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations

After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released proposed regulations to implement the Foreign Investment R

Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. She covers that many of these partnerships focus on drug design, but some also focus on drug discovery, or aspects of clinical trial or management. Bethany goes on to discuss that these partnerships are emerging in the absence of clear legal and regulatory frameworks.Read more in PHARMAnetwork Magazine, beginning on <a href="https://www.pharmanetwork.digital/html5/reader/production/default.aspx?pubname=&edid=5cc61e07-6c20-4323-99b1-77b38b939490" target="_blank">page 54</a>.

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Artificial Intelligence and Pharma

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

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Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Be

Artificial Intelligence and Pharma

In the life sciences, artificial intelligence (AI) may be facilitating a sea change in how diseases are diagnosed, prognosed, and treated, and even how therapies are discovered and produced. Indeed, it is possible for AI to provide insights into disease and treatment that could not have been identified by one or a group of human brains. Translating the union of AI with life sciences technologies into patentable inventions within the framework of the current U.S. patent system, however, is not necessarily a straightforward task. Fortunately, the U.S. Patent and Trademark Office (USPTO) is working diligently to provide guidelines for practitioners to make the path to patentability less uncertain.On August 27, the USPTO published a <a href="https://www.federalregister.gov/documents/2019/08/27/2019-18443/request-for-comments-on-patenting-artificial-intelligence-inventions" target="_blank">Notice </a>in the Federal Register requesting information from the public on AI patent-related issues, including feedback on questions pertaining to the intersection of AI and patent law. The life sciences community is likely to provide unique commentary on these and other questions as the strategic application of AI continues to drive innovation in this sector. Input from the life sciences community is certain to aid the USPTO in developing guidance that will provide a more predictable path to navigate patenting of AI technologies.

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Of Counsel

Anna Yuan’s practice focuses on patent prosecution, IP due diligence, post-grant proceedings, and IP litigation support. 

Anna Yuan

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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

AI Patent Policy – Calling all Life Sciences Practitioners

AI Patent Policy – Calling all Life Sciences Practitioners