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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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

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As many life sciences companies and investors are aware, the U.S. Department of the Treasury (“Treasury”) recently announced a new “pilot program” for the Committee on Foreign Investment in the United States (“CFIUS”) effective November 10, 2018. The pilot program implements certain provisions of the Foreign Investment Risk Review Modernization Act of 2018 (“FIRRMA”), which brought sweeping change to CFIUS’s authority to conduct national security reviews of foreign acquisitions of and investments in U.S. businesses in high-technology fields.What companies and investors may not yet fully appreciate, however, is the scrutiny that the new CFIUS pilot program brings to foreign investors that focus on research and development in pharmaceuticals and biotechnology, as well as to the U.S. businesses active in these sectors that seek to raise such financing. This Client Alert addresses issues that life sciences companies and investors should be considering in light of these new requirements.

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Of Counsel

Bob Litt, former General Counsel for the Director of National Intelligence, is of counsel and co-chair of Morrison & Foerster’s Global Risk and Crisis Management group. He advises industry-leading org

Robert S. Litt

Robert Litt

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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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New CFIUS Pilot Program: What Life Sciences Companies and Investors Need to Know

Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

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As many life sciences companies and investors are aware, the U.S. Department of the Treasury (“Treasury”) recently announced a new “pilot program” for the Commi

New CFIUS Pilot Program: What Life Sciences Companies and Investors Need to Know

Today, the Court of Justice of the European Union (“CJEU”) has issued its much awaited decision on the classification of genome-editing tools such as CRISPR/Cas9, Talen or zinc finger within the framework of the EU’s Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment (“GMO Directive”).In essence, the court held that:<ol><li>Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.</li><li>Only organisms obtained by mutagenesis techniques that have conventionally been used in a number of applications and have a long safety record are exempt from those obligations (“Exempted Technologies”). Such exemptions would not apply for new technologies like CRISPR/Cas9.</li><li>Genetically modified varieties of beet, fodder plant, cereal, potato and oil and fibre plant obtained by mutagenesis techniques, except for Exempted Technologies, can only be listed in the ‘common catalogue of varieties of agricultural plant species the seed of which may be marketed’ if appropriate measures to avoid risks to human health and the environment have been taken.</li><li>The EU Member States are free to adopt stricter regulations regarding Exempted Technologies in compliance with general EU law principles (in particular, the principle of free movement of goods).</li></ol>

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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CJEU Raises Bar for Use of CRISPR in Europe's Agribusiness: What You Need to Know

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Today, the Court of Justice of the European Union (“CJEU”) has issued its much awaited decision on the classification of genome-editing tools such as CRISPR/Cas

CJEU Raises Bar for Use of CRISPR in Europe's Agribusiness: What You Need to Know

The EU Trade Secrets Directive, officially titled “Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure” (the “TSD”), is a legal instrument by the European Union (EU) that is intended to harmonize the currently fragmented laws regarding trade secrets across the EU Member States. While the TSD does not have direct legal effect, each of the Member States are required to transpose the TSD into its respective national laws by June 9, 2018.  Germany has recently published its first draft bill on a new trade secrets act, which is now subject to public consultation and anticipated to be passed in the fall.  The German draft bill aims at implementing the TSD at the so-called “minimum harmonization” level and does make much use of the right of the Member States to go beyond such minimum provided by the TSD.In a previous client alert, we outlined the content of the TSD (and the Defend Trade Secrets Act of the US) and the likely implications for trade secret holders with an international footprint (see “Harmonization of Trade Secrets in Europe and New US Trade Secrets Law Gets the Green Light—What Do These Changes Mean for Companies in Germany, the UK and the US?”).In the following, we will outline the key aspects of the draft bill with a particular focus on regulations beyond the mandatory provisions of the TSD as well as deviations from current provisions under German law, and discuss potential implications of the draft bill for companies operating in Germany.  In a nutshell, the draft bill:<ul><li>Brings the definition of trade secrets to an international standard by switching from the fairly subjective approach that is currently in effect to a more objective approach, which will require trade secrets holders to implement reasonable measures to protect their trade secrets, akin to the concept known under TRIPS (The Agreement on Trade-Related Aspects of Intellectual Property Rights);</li><li>Does away with existing restrictions by codifying commonly accepted permitted uses of trade secrets, e.g., in the context of reverse engineering or whistleblowing;</li><li>Fundamentally improves the rights of trade secrets holders in litigation by introducing more practical measures to ensure secrecy of certain information in litigation, hopefully helping to overcome Germany’s reputation as a “lose the trial or lose the trade secret” jurisdiction; and</li><li>On the remedy side, adds clarity on certain civil remedies like the right to request destruction and recall of infringing products, but, on the other hand, provides for exceptions that may pave the way for the grant of compulsory licenses in certain scenarios; misappropriation of trade secrets remains a criminal offence under German law, however.</li></ul>

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Update on the Implementation of the EU Trade Secrets Directive into German Law

Fourth Circuit’s Decision Revitalizes First Amendment Challenge to the TCPA

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The EU Trade Secrets Directive, officially titled “Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) ag

Update on the Implementation of the EU Trade Secrets Directive into German Law

Innovator companies at all stages seek patent protection in order to limit market competition. Many early-stage companies seek patent protection with the additional goal of attracting investment. However, even if patent filings are accelerated in order to raise funds, it is important that early-stage companies not discount the value of developing a thoughtful and comprehensive IP strategy from the outset.<a target="_blank" href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blte2bc4a79c2473d0c/6273176d5f7b601eaaebcffa/180123-life-sciences-patent-fda-considerations.pdf">Read our full article published by Daily Journal</a>.

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Lisa N. Silverman focuses on patent portfolio management and strategic patent counseling in the areas of chemistry and life sciences. She has extensive experience in securing U.S. and foreign patent p

Lisa N. Silverman Ph.D.

Lisa Silverman

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Life Sciences Startups: Patent, FDA Considerations

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Innovator companies at all stages seek patent protection in order to limit market competition. Many early-stage companies seek patent protection with the additi

Life Sciences Startups: Patent, FDA Considerations

In both the U.S. and the EU, it is generally acknowledged that the enforcement and commercialization of IP rights must comply with the applicable antitrust laws. This is particularly true for IP licensing. While the majority of provisions in license arrangements will not be problematic from an antitrust perspective, some restrictions may raise antitrust concerns (particularly due to a potential violation of the respective cartel bans). Both the U.S. and the EU have set up a legal framework of IP-related antitrust legislation, varying in structure and content, but featuring a common core of overall principles. It is the common view in both regimes that IP rights and antitrust laws “share the common purpose of promoting innovation and enhancing consumer welfare.” Nonetheless, where it is applicable, antitrust law poses a potential threat to void relevant clauses or even an entire agreement, and undertakings run the risk of being fined for any violation of antitrust law. Thus, it is indispensable to take into account relevant antitrust law when drafting and negotiating licensing agreements. In the following paragraphs we will discuss the key antitrust concepts that need to be borne in mind when licensing IP in transatlantic business.

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Counsel

Jens is a counsel at Morrison Foerster’s German office in Berlin. He advises clients in all areas of European and German competition law, including merger control filings, cartel authority investiga

Jens Hackl

Jens Hackl is a counsel at Morrison Foerster’s German office in Berlin. He advises clients in all areas of European and German competition law, including merger control filings, cartel authority investigations, cartel damage claims, distribution cartel law, antitrust compliance programs and unfair competition law. Jens has particular industry-specific experience in the areas of media, technology, telecommunication, transport and aviation. In addition, he advises in the fields of state aid and public procurement law.

SoftBank/Clearwire Corporation

Fujisawa Pharmaceutical Co./Yamanouchi Pharmaceutical Co.

SoftBank/Sprint  Nextel

Elpida Memory

International  Air Cargo Cartel Investigation

International  Freight Forwarding Cartel Investigation &amp; Litigation

AirTran  Baggage Fee Antitrust Investigation &amp; Litigation

U.S.  Department of Justice Investigation of Major International Transportation  Company

Semiconductor  Industry Cartel Investigation

Astellas  Pharma Inc.

ACON Laboratories

Epitomics

InSound Medical

Genentech/Tanox

Southwest/AirTran

ON  Semiconductor/Sanyo Semiconductor

Clearwire/Sprint  Nextel

Vice Chair

Jeff Jaeckel

IP Licensing and Antitrust Law – What Companies Have to Consider When Doing Business in the U.S. and the EU