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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On May 14, 2019, the Council of the European Union adopted the amending Regulation (EC) No. 469/2009, effectively exempting certain manufacturing activities in 

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Manufacturing Waiver Weakens SPC Protection in Europe

Manufacturing Waiver Weakens SPC Protection in Europe | MoFo Life Sciences

On May 14, 2019, the Council of the European Union adopted the <a href="http://www.europarl.europa.eu/doceo/document/TA-8-2019-0401_EN.html?redirect" target="_blank">amending Regulation (EC) No. 469/2009</a>, effectively exempting certain manufacturing activities in the EU from the scope of Supplementary Protection Certificates that have not yet been granted (“New SPC Regulation”). The New SPC Regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will be binding in all Member States of the EU without any further act of national implementation.BackgroundA Supplementary Protection Certificate (“SPC”) enables a patent holder to extend the market exclusivity of an approved medicinal product for a maximum of five years after the patent covering such product expires. The SPC is intended to compensate the patent holder for the revenue lost as a result of not being able to market the product during the lengthy regulatory approval process, and to amortize the patented product’s high research and development costs. Hence, the EU, by offering strong and extended patent protection, intends for SPCs to promote the research and innovation necessary to develop medicinal products and prevent pharmaceutical companies’ relocation to countries outside the Union market.The generic’s industry, however, also deserves a certain level of protection. Ensuring access to competitively priced pharmaceuticals, the timely availability of generics and biosimilars is tremendously important in healthcare systems in Europe and around the world.Yet, the current regime on SPC protection in Europe has resulted in a double standard. Generics companies located outside the EU are allowed to (1) produce generics and biosimilars that will be exported to countries outside the EU, or (2) stockpile such products in order to launch them in the EU on the day after an SPC has expired. Manufacturers of generics or biosimilars based in the EU, however, are prohibited from taking similar actions while the respective SPC is in force, even if they intend to export the product outside the EU. This major competitive disadvantage has the potential to delocalize manufacturing and discourage investment in Europe.The New SPC Regulation aims to correct this imbalance and level the playing field between manufacturers of generics and biosimilars based inside and outside the EU.What will change?The New SPC Regulation allows companies to manufacture generics or biosimilars in the EU for the purpose of (1) exporting them to countries outside the EU where protection does not exist or has expired and (2) stockpiling the product for six months or less in order to launch those products in the EU on the day after the corresponding SPCs have expired, in each case contingent on their fulfillment of the following obligations, which are laid out in the New SPC Regulation.Manufacturers of generics or biosimilars are obliged to:<ul><li style="margin-bottom: 10px;">inform (1) the competent authority in the Member State where the manufacturing is to take place or where the first related act prior to the manufacturing is to take place, and (2) the SPC holder with a standard form for notification that is attached to the New SPC Regulation; and</li><li style="margin-bottom: 10px;">inform the competent authority and the SPC holder no later than three months before (1) the start date of the manufacturing in the relevant Member State, or (2) the first related act prior to manufacture, whichever is earlier; and</li><li style="margin-bottom: 10px;">notify the competent authority as well as the SPC holder about any changes before those changes take effect; and</li><li style="margin-bottom: 10px;">in cases of manufacturing for the purpose of export, affix the black and white logo on the outer packaging of products in a size as to be sufficiently visible:</li></ul><img height="102" width="150" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blteaa65c9134a88000/6273176f0d4d8e1d7f10f2e6/eu-spc-logo.jpg?format=auto&quality=60" type="asset" sys-style-type="download"> Source: <a href="http://www.europarl.europa.eu/doceo/document/TA-8-2019-0401_EN.html?redirect" target="_blank">http://www.europarl.europa.eu/doceo/document/TA-8-2019-0401_EN.html?redirect</a>;<ul><li style="margin-bottom: 10px;">pay fees that a Member State may require for notifications to be made to the competent authorities which should be set out at a level which does not exceed the costs considering the expenditures for the administration; and</li><li style="margin-bottom: 10px;">ensure that all of the relevant contractual parties are fully informed and aware that (1) manufacturing is taking place under the manufacturing waiver regime and (2) any act outside the scope of the manufacturing waiver infringes the SPC as long as the SPC applies.</li></ul>Does the manufacturing waiver apply to all SPCs?The regime of the manufacturing waiver applies to SPCs with applications that were filed on or after the date the New SPC Regulation enters into force (“Effective Date”). The manufacturing waiver will not apply to SPCs that have been granted before the Effective Date. Beginning on July 1, 2022, the manufacturing waiver will apply to SPCs with applications that were filed before the Effective Date and that take effect on or after the Effective Date.What will not change?During the term of the SPC, a diversion in the EU of a product made under the exception remains prohibited (e.g., a product that was manufactured for export purposes cannot be placed or re-imported into the EU; a product manufactured for storing purposes to be placed on the market in the EU one day after the SPC expires cannot not be commercialized in the EU as long as the SPC is in force). Furthermore, the manufacturing waiver does not apply to any act carried out to import products into the EU market merely for the purpose of repackaging, re-exporting or storing (i.e., any act outside the scope of the New SPC Regulation remains prohibited).OutlookThe manufacturing waiver’s effect on the research, development, and production of innovative medicines in the EU remains to be seen. Whether the New SPC Regulation’s objectives will be achieved is also uncertain. Of particular interest is whether the waiver will sufficiently balance patent holders’ and generics and biosimilars manufacturers’ different interests. So too is the waiver’s ability to correct the imbalance between manufacturers of generics and biosimilars inside and outside the EU, and whether six months is a sufficient period of stockpiling to achieve the day-one launch. Finally, one hopes the manufacturing waiver will have a positive effect on public health expenditures, and result in better and more affordable access to medicines.

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