Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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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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Key Developments in MedTech M&A: Momentum Despite Macroeconomic Uncertainty

Is Your Claim Open or Closed? Claim Construction Takes on a New Meaning in Eye Therapies, LLC v. Slayback Pharma, LLC

Need to FAST Track Your Patent? The USPTO increases the Annual Limit to 20,000

What Makes a Good Cell and Gene Therapy Application?

A Tip for Improving Your “Improved” Jepson Claim: Include Written Description Support

LinkedIN

On May 1, 2020 the last part of the German Trademark Law Modernization Act (Markenrechtsmodernisierungsgesetz – “MaMoG”), which contains practical relevant amendments to the procedural rules of the German trademark system, took effect. In particular, an administrative procedure for the revocation and the invalidation of trademarks based on relative grounds has been implemented, adding a new, cost-effective, and procedurally expedient tool to the range of possible methods of attacking adverse trademark registrations. It is expected that the amendments will be accompanied by a higher fluctuation of registrations and increases in demand for strategic counseling.In our alert, we will provide you with a short overview of the new types of proceedings available and highlight their strategical relevance and effects.Read <a href="https://www.mofo.com/resources/insights/Germany-Adopts-Administrative-Trademark-Cancellation-Actions.html" target="_blank">our alert</a>.

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Germany Adopts Administrative Trademark Cancellation Actions

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

mofolifesciences-eu

On May 1, 2020 the last part of the German Trademark Law Modernization Act (Markenrechtsmodernisierungsgesetz – “MaMoG”), which contains practical relevant amen

Germany Adopts Administrative Trademark Cancellation Actions

European Union

Intellectual Property

Patent applicants facing a funds shortage because of COVID-19 may be glad to hear that many patent offices have extended certain patent prosecution deadlines. For example, the <a href="https://www.uspto.gov/about-us/news-updates/uspto-extends-certain-patent-and-trademark-deadlines-june-1" target="_blank">U.S. Patent Office</a> has extended various patent deadlines until June 1, 2020 and the European Patent Office has also extended certain time limits at least until June 2, 2020. A small number of jurisdictions have closed down their patent offices completely, but most are still accepting electronic filings. Jurisdictions vary wildly in the duration of the extensions, the deadlines eligible for extension, and the justification required.Given the wide variance among patent offices, it is prudent not to assume a deadline is extended due to office closures or other COVID-19 related reasons. Further, since extension policies are subject to further changes (sometimes abruptly), we advise businesses and patent practitioners to confer frequently with U.S. and foreign patent practitioners to confirm relevant extension policies are still in place. Moreover, we anticipate a heavy influx of filings once patent offices return to normal operations; the influx of filings may lead to failure in electronic filing systems, which is not an excusable delay in some jurisdictions and can lead to abandonment of patent applications. To preserve patent rights, it is prudent to address all prosecution matters by their original due dates if possible.Update: On May 27, the <a target="_blank" href="https://www.uspto.gov/sites/default/files/documents/Patents-Notice-CARES-Act-2020-05.pdf?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=">U.S. Patent Office</a> further extended various patent deadlines until July 1, 2020.  Businesses and patent practitioners should continue to consult the respective patent office websites and patent counsels to confirm relevant extension policies are still in place. Should you have any questions about U.S. and foreign patent prosecution strategy, our U.S. and foreign offices are operating remotely and are ready to provide assistance.

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Patent Offices Extend Certain Deadlines, but Proceed With Caution

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Patent applicants facing a funds shortage because of COVID-19 may be glad to hear that many patent offices have extended certain patent prosecution deadlines. F

Patent Offices Extend Certain Deadlines, but Proceed With Caution

United States

COVID-19

United Kingdom

As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnostics, ventilators, and personal protective equipment capable of helping to contain the surge.While the laws of many countries provide for certain mechanisms that limit the right of patentees to exclude others from using their inventions for the benefit of public welfare, in the face of the COVID-19 crisis, among others, Germany has recently enacted emergency legislation that gives the government additional powers to circumvent patent law and ensure medical supplies, medication, or vaccines can be made available locally. Many more countries are currently discussing similar regulations. The World Health Organization (WHO) supports such endeavors.In this article, we will examine public and patent law mechanisms to suspend patent protection of critical drugs and equipment in Germany, the United Kingdom, and the United States to help fight the corona crisis.<a href="https://www.mofo.com/resources/insights/200414-patent-exceptions-cure-covid-19.html?utm_source=publication&utm_medium=email" target="_blank">Read the alert</a>

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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Senior Counsel

Alistair Maughan co-leads Morrison & Foerster's European Technology & Commercial Practice.

Alistair Maughan

Alistair advises on the deployment of new technology platforms involving, for example, the internet of things, AI and machine-learning, and blockchain and distributed ledger technology.

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Germany, UK, USA: Are Patent Exceptions the Cure to COVID-19?

IR35 Update: UK Government Postpones “Off-Payroll Working” Reforms

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As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnos

Germany, UK, USA: Are Patent Exceptions the Cure to COVID-19?

Healthcare

With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litigation system faces ever‑mounting challenges. Last Friday, the German Federal Constitutional Court declared that the German Act of Approval of the UPC Agreement void due to violations of the principle of due process and the rule of law. Under the multinational UPC Agreement and related acts, the participation of both countries, in addition to France, is mandatory for the UPC to come into existence. As the hotspots of European patent litigation, these recent actions by the UK and Germany raise doubts whether the UPC will ever successfully launch. Read our <a href="https://www.mofo.com/resources/insights/200334-europes-unified-patent-court.html?utm_source=publication&utm_medium=email" target="_blank">client alert.</a>

Hard Knocks Keep Coming for Europe’s Unified Patent Court

With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litiga

Hard Knocks Keep Coming for Europe’s Unified Patent Court

Regulatory

<p style="box-sizing: inherit;margin-top: 0px;margin-right: 0px;margin-bottom: 1.25rem;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;font-size: 1.0625rem;line-height: 1.6;text-rendering: optimizelegibility;font-variant-numeric: normal;font-variant-east-asian: normal;color: rgb(82, 83, 87);hyphens: none;overflow-wrap: normal;">The European Patent Office has denied two patent applications on the grounds that an AI system cannot be listed as the inventor.<p style="box-sizing: inherit;margin-top: 0px;margin-right: 0px;margin-bottom: 1.25rem;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;font-size: 1.0625rem;line-height: 1.6;text-rendering: optimizelegibility;font-variant-numeric: normal;font-variant-east-asian: normal;color: rgb(82, 83, 87);hyphens: none;overflow-wrap: normal;">For the first time, the European Patent Office (EPO) has issued a ruling on its approach to patent applications that designate artificial intelligence (AI) systems as inventors. In January 2020, the EPO published its reasons for rejecting two patent applications where the inventor named on the applications was an AI system called “DABUS.” The UK Intellectual Property Office (UKIPO) has also rejected the applications on similar grounds.  <p style="box-sizing: inherit;margin-top: 0px;margin-right: 0px;margin-bottom: 1.25rem;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;font-size: 1.0625rem;line-height: 1.6;text-rendering: optimizelegibility;font-variant-numeric: normal;font-variant-east-asian: normal;color: rgb(82, 83, 87);hyphens: none;overflow-wrap: normal;"><a href="https://mofotech.mofo.com/topics/can-ai-be-an-inventor.html" target="_blank">Read the full article on our MoFo Tech blog</a>

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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

CAN AI BE AN INVENTOR? NOT AT THE EUROPEAN PATENT OFFICE

The European Patent Office has denied two patent applications on the grounds that an AI system cannot be listed as the inventor.
For the first time, the Europea

CAN AI BE AN INVENTOR? NOT AT THE EUROPEAN PATENT OFFICE

In its landmark <a target="_blank" href="http://curia.europa.eu/juris/document/document.jsf?text=&docid=204387&pageIndex=0&doclang=EN&mode=req&dir=&occ=first&part=1&cid=752477">decision</a> of July 25 2018, the Court of Justice of the European Union (“CJEU”) essentially banned crops obtained by new genome editing techniques from the EU market. The decision left the European biotech industry in awe, as it came unexpectedly and caused its activities to come to a sudden halt. Now, a request by the Council of the European Union (“Council”) to the European Commission seems to have set the ball rolling again. So what happened?A widely criticized decisionThe CJEU decided that organisms obtained by cutting-edge genome editing techniques such as CRISPR/Cas9, Talen, or zinc finger are to be classified as genetically modified organisms (“GMO”). As such, these organisms are subject to the EU’s rigorous <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32001L0018&from=EN">Directive 2001/18/EC</a> (“GMO Directive”). The consequence is a de facto ban of the new technologies in the agricultural sector of the EU due to the established practice of rarely approving GMO crops on the market and leaving the Member States the option of banning GMO crops altogether on a national level.The decision stirred up a fierce controversy. Firstly, it came as a surprise to many, as the <a target="_blank" href="http://curia.europa.eu/juris/document/document.jsf?text=&docid=198532&pageIndex=0&doclang=EN&mode=req&dir=&occ=first&part=1&cid=779174">opinion</a> of the Attorney General was generally interpreted as considering such techniques permissive under the GMO Directive. Moreover, integrating the new mutagenesis techniques, dubbed the “<a target="_blank" href="https://www.politico.eu/sponsored-content/genome-editing-europe-can-embrace-innovation-while-assuring-safety/">printing press of the 21st century</a>”, into the scientific toolbox is widely regarded as essential in order to develop solutions to the most pressing problems of the 21st century. The wide array of plant characteristics that can possibly be achieved includes higher yields, decreased chemical and water usage, and improved resistance to pathogens and drought, as well as increased nutritional value that could help tackle hunger crises, worldwide climate change, water scarcity, and a diminishing biodiversity.In addition, apart from the EU risking its competitive edge in sustainable food production, scientists argue that the desired genome-edited crops are at least equally as safe as the ones stemming from “conventional” mutagenesis techniques with similar alterations, since those could also occur in nature, only on a random and therefore less cost-effective and precise basis. Not only does this fact contradict the decision’s implication of crops obtained by new mutagenesis techniques posing the same risks as traditional GMOs, but it also makes distinguishing how the alterations in question were originally achieved nearly impossible. Thus, an insurmountable hurdle for passing the authorization process is created, since today’s methods do not allow for definitively proving that none of the “new” genome editing techniques were applied in the breeding process of a crop.A silver lining?Despite the clear signal that the CJEU sent to European lawmakers to expressively regulate genome-editing techniques, no corresponding steps were taken for the past year and a half. However, there seems to be a silver lining on the horizon. On November 8, 2019 the Council issued a <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019D1904&from=GA">request to the European Commission</a> to submit a study on the status of new genome-editing techniques in the light of the CJEU’s decision and, if needed, propose changes to the GMO Directive.Although the request mainly focuses on the issue of distinguishability of products resulting from natural mutation from those stemming from new mutagenesis techniques, there is a chance that the request will kick off a fundamental debate about the future role of genetically modified plants and a comprehensive review of their regulation. In this regard, several Members of the European Parliament have already expressed their concerns with the currently missing distinction of new innovations and technologies from traditional GMOs under the GMO Directive, which is widely considered archaic.OutlookThe Commission has not yet reacted to the request, but an answer is likely to be issued early February following paragraph 10 of the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2016:123:FULL&from=EN">Interinstitutional Agreement on Better Law-Making</a>.While the use and commercialization of genome-editing tools is embraced by 13 members of the World Trade Organization, including the U.S., Canada, Australia, and Brazil, the EU risks losing its seat at the table of the major countries defining the future of agriculture and food production. Nevertheless, some European players seem willing to put high bets on a change of policy in a still unforeseeable future by signing the first gene-editing related deals.We are going to keep you informed about any progress on this matter.

Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness

In its landmark decision of July 25 2018, the Court of Justice of the European Union (“CJEU”) essentially banned crops obtained by new genome editing techniques

Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness

Agtech

The whistleblowing rules in Europe are about to change dramatically. The new <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_78_2019_REV_1&from=EN" target="_blank">Directive on the protection of persons who report breaches of Union law</a>, also referred to as the “Whistleblowing Directive,” will require Member States to create rules that mandate organizations with more than 50 workers to set up whistleblowing hotlines and accept reports about violations of the EU law. Many life sciences organizations will be subject to the new rules under which the whistleblowers will be allowed to report about a broad range of violations of EU law including public health, product safety, protection of privacy and personal data.The Whistleblowing Directive also provides for minimum standards on how to respond to and handle concerns raised by whistleblowers. These minimum requirements provide sufficient details so that organizations can start reviewing their existing whistleblowing hotlines (if they already have them in place) and adjusting their internal processes to align with the Whistleblowing Directive.

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Clients seek Alja for her no-nonsense approach to resolving complex local legal issues efficiently while providing strong representation for their most important privacy, whistleblowing, and investigatory matters. Alja is the go-to counsel for EU whistleblowing laws and leads strategy for the firms’ advisory efforts for compliance with whistleblowing rules and procedures globally. 

Alja Poler De Zwart

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EU Adopts Whistleblowing Directive to Protect Whistleblowers

New York Enacts Employee Monitoring Notification Law

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The whistleblowing rules in Europe are about to change dramatically. The new Directive on the protection of persons who report breaches of Union law, also refer

EU Adopts Whistleblowing Directive to Protect Whistleblowers

Privacy + Data Security

The pharmaceutical market presents unique challenges to pharmaceutical companies seeking to launch new products. One such challenge involves the lengthy process of executing clinical trials as a prerequisite for obtaining market authorization.  In this context, the fact that trademark laws in most jurisdictions provide only a five-year grace period for non-use after registration can make a significant impact on retaining trademark rights, as early applicants for pharmaceutical trademarks risk revocation of their marks based on non-use if the marketing approval process outlasts this period. Therefore, the crucial considerations for trademark owners in the pharmaceutical sector are whether to seek registration of their trademarks before the grant of marketing authorization and whether clinical trials can be used to justify non-use of the trademarks after the five-year grace period.The Court of Justice of the European Union (“CJEU”) recently addressed these significant issues in its decision on July 3, 2019 and ruled that use of a European Union trademark (“EUTM”) in connection with pharmaceuticals can only constitute “genuine use” pursuant to Article 18(1) of the Regulation 2017/1001 (“EUTMR”) if the relevant drug has already been authorized for marketing to the public. Notwithstanding this requirement, clinical trials may constitute a “legitimate reason” for non-use of a trademark pursuant to Article 18(1) EUTMR, provided that the circumstances leading to the non-use exceeding the five-year term were beyond the trademark owner’s control.The factsOn September 23, 2003, Viridis Pharmaceutical Ltd (“Viridis”) filed an application for the word mark BOSWELAN with the European Union Intellectual Property Office (“EUIPO”), claiming protection for the goods described as “pharmaceutical and sanitary preparations.” The trademark was granted registration in 2007. On November 18, 2013 Hecht-Pharma GmbH successfully sought revocation of Viridis’ registration before the Cancellation Division of the EUIPO claiming that the mark was not put to genuine use within the five-year period after registration. Both, the EUIPO’s Board of Appeal and the General Court (“EGC”; formerly known as the Court of First Instance) upheld this decision.Viridis appealed to the CJEU, arguing that the BOSWELAN mark had already been put to use in publicly advertised clinical trials. Viridis put forth the view that since clinical trials are mandatory in order to obtain marketing authorization for pharmaceuticals, such use must be sufficient for “genuine use” of a trademark or at least constitute a “legitimate reason” for non-use.  The CJEU confirmed the EGC’s decision and dismissed Viridis’ appeal.Use of a mark within clinical trials as “genuine use” and “preparatory measurements”In its decision, the court ruled that Viridis’ clinical trials cannot be considered genuine use of the mark or preparatory measures that would be a substitute for actual genuine use. According to the CJEU’s established case law, genuine use of a mark requires that the public perceive such use as an indication of the commercial origin of the goods or services for which the mark was registered. This will be the case if the mark is used (i) outwardly on the market for the relevant goods or services and (ii) in order to obtain a market share, in contrast to purely internal processes of the trademark owner. Such requirements, in each instance, necessitate the distribution of goods or services to the relevant public.Clinical trials, however, constitute merely internal processes, because the trials are not directly for the purpose of distribution of the branded drug and are thus not directed to the public in order to obtain or secure a market position. Instead the CJEU notes that the main purpose of clinical trials is to obtain market authorization, and therefore take place outside of the relevant market, aimed only at a narrow circle of participants.The court takes the position that conducting clinical trials and the advertising related thereto cannot constitute genuine use of a trademark or preparatory measures of use because market authorization is a necessary prerequisite for selling or advertising a drug in the EU. Therefore, any use of a trademark on drugs or in advertising prior to authorization cannot be considered use in connection with entering the market or securing a market position.Clinical trials as legitimate reason for non-useThe CJEU further found that conducting clinical trials in the present case could not serve as a “legitimate reason” for non-use of Viridis’ mark, which would have a right-preserving effect in accordance with Article 18(1) EUTMR.The CJEU specifically confirms that clinical studies may in principle be a legitimate reason for non-use, but only if such trials (i) have a direct connection with the trademark, (ii) render use of the trademark impossible or impracticable, and (iii) are not under the control of the owner.Here, the court found that Viridis did not meet the third requirement, since several incidents hindering the completion of the clinical trials could be attributed to Viridis and were therefore under Viridis’ control. In this regard, the CJEU points out that Viridis, without being subject to any legal requirement, decided to register the mark at a very early stage, despite the considerable uncertainty as to both the timing and possibility of marketing of the designated drug. Furthermore, Viridis filed the clinical trial application three years after it filed the EUTM application and several events during the clinical trials indicated that Viridis lacked the financial resources necessary to swiftly execute the trials.Key Takeaways<ul><li>According to the CJEU, use of a pharmaceutical trademark cannot constitute “genuine use” of the trademark within the meaning of Article 18(1) EUTMR before marketing authorization for the designated drug has been obtained, since the trademark cannot be used in relation to delivery of the drug without such authorization.</li></ul><ul><li>Clinical trials may in principle be a “legitimate reason” for non-use of a trademark pursuant to Article 18(1) EUTMR, preserving the rights granted by the trademark. However, as the course and duration of a clinical trial is largely dependent on factors that are within the trademark owner’s responsibility, circumstances such as a very early trademark application combined with a delayed filing of the application for the clinical trial, as well as a lack of efforts to bring the clinical trial to a swift and successful conclusion, will hinder a company’s ability to cite such clinical trials as a “legitimate reason” for non-use.</li></ul><ul><li>When obtaining and maintaining trademark registrations for pharmaceuticals in the EU, particular attention should be paid to the five-year grace period when formulating a conclusive time and budget strategy for obtaining marketing authorization for the relevant drug. As “genuine use” of a trademark in this timeframe might not be possible due to the lack of marketing authorization, pharmaceutical companies should be sure to coordinate scheduling of trademark filings and the application for marketing authorization, and constantly pursue the mandatory clinical trials, in order to be able to claim it a “legitimate reason” for non-use of the mark in a potential revocation proceeding.</li></ul>

CJEU on Genuine-Use of Trademarks in Clinical Trials

The pharmaceutical market presents unique challenges to pharmaceutical companies seeking to launch new products. One such challenge involves the lengthy process