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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In November 2021, in its coalition agreement, the newly elected German Federal Government announced its plans to legalize cannabis for recreational use. 

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Germany: Ministry of Health Grants First Glimpse on the Upcoming Cannabis Legalization and Seeks Green Light from the European Commission | MoFo Life Sciences

Robert Grohmann

MoFo research assistant Tim Stripling contributed to this article.In November 2021, in its coalition agreement, the newly elected German Federal Government announced its plans to legalize cannabis for recreational use. Since then, it has been hotly debated by the cannabis industry in Germany and abroad what legalization of cannabis in Germany could look like in practice. On October 26, 2022, the German Ministry of Health finally released a highly anticipated<a href="https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/C/Kabinettvorlage_Eckpunktepapier_Abgabe_Cannabis.pdf" target="_blank"> first official paper</a> on its upcoming reform, which outlines key points of the planned cannabis legalization proposal for the upcoming legislative process (“Key Points Paper” or “Paper”).The Key Points Paper is an initial, non-binding, regulatory proposal. Based on the response from the industry and politics, the Ministry of Health is planning to publish a draft law. Nevertheless, it is of high relevance for stakeholders in the industry as for the first time it gives insight on the overall framework of the upcoming government draft bill and allows for evaluation of market opportunities for the nascent German cannabis market, which, according to a <a href="https://www.dice.hhu.de/fileadmin/redaktion/Fakultaeten/Wirtschaftswissenschaftliche_Fakultaet/DICE/Bilder/Nachrichten_und_Meldungen/Fiskalische_Effekte_Cannabislegalisierung_final.pdf" target="_blank">recent study</a> by the University of Düsseldorf, is expected to be worth at least EUR 4 billion. Key points of the Paper are:<ul><li>Cannabis should no longer be subject to the German Narcotics Act (GNA).</li><li>Possession limit of 20–30 grams per person.</li><li>Distribution through specialized stores and, possibly, pharmacies, with clear rules and licenses.</li><li>Estimated retail price of EUR 10–15 per gram, including a new cannabis tax.</li><li>No tetrahydrocannabinol (THC) limits for customers age 21 and older; possible THC limits (10–15%) for customers between 18 and 21 years old.</li><li>No import of cannabis for recreational use for the time being.</li><li>Prohibition of advertising for cannabis products.</li></ul>It must also be pointed out that the legalization efforts of the German government still face a number of key challenges that need to be overcome. While the reform has the necessary political majorities in Germany to be passed in parliament in the future, the EU in particular could delay the project. The European Commission (EU Commission) is now being consulted by the German government to check whether the German plan is compatible with EU law. If the EU gives the green light, a draft law will be formulated. However, if the Commission were to make it clear that the German model was not compatible with EU law, the legalization on the basis of the Key Point Paper would be off the table.This article will take a closer look at the content of the Key Points Paper and the legal challenges cannabis reform faces on the international level and will also give an outlook on how the legislative procedure will continue in the future.BackgroundIn Germany, cannabis is subject to the rules of the GNA. Thus, any act of import, possession, or sale is prohibited by law, if not exempted. In 2017, medical cannabis was exempted from the general prohibitions of the GNA, so that pharmacies were allowed to dispense medical cannabis to patients with prescriptions. However, only three licenses to cultivate medical cannabis in Germany were issued, and the amount to be produced was capped at 10,400 kilograms over four years. Thus, to satisfy the increasing demand, the imports grew to 5,700 kilograms in 2021 over previous years. It is expected that over a million German patients will have access to medical cannabis by 2024, and the German medical market alone will be worth USD 8 billion by 2028.On the other hand, the black market for recreational cannabis is estimated to amount to USD 13.1 billion in 2020 and is expected to grow to USD 16.6 billion by 2025. The upcoming legislation legalizing recreational use of cannabis is intended, among other things, to disrupt the black market and to protect the health of children and minors.The Key Points PaperThe Key Points Paper provides a first glimpse on how the legislature is likely to deal with the following issues:1. Basic principlesAccording to the Key Points Paper, cannabis will no longer be subject to the GNA. The purchase and possession of 20–30 grams of cannabis will be decriminalized for adults. Private cultivation will be legal, but only for up to three plants per person.2. DistributionDistribution of cannabis will be possible through licensed shops and, most probably, pharmacies. Online distribution, on the other hand, will not be permissible at first. However, the Paper indicates that sales in online stores could be allowed over time.Shop licenses from the German authorities will likely have several requirements. Shop owners must be proven to be competent and reliable. Shop locations must guarantee to have minimum space and must not be located close to schools and childcare facilities. The sales personnel will need to be trained in the handling of cannabis, addiction prevention, protection of minors, etc. Advice must be offered for every purchase, and the risks of consumption must be pointed out.Also, cannabis products for smoking and inhalation and for intake in the form of capsules, sprays, or drops will be allowed. So-called edibles, such as cookies or sweets containing cannabis, will likely not be allowed for the time being. The same applies for synthetically produced cannabinoids.In addition to the existing sales tax, companies selling cannabis will also be taxed with a new cannabis tax (Cannabissteuer), depending on the THC content. A higher THC amount will lead to a higher cannabis tax rate. The goal of the tax will be to bring the price of legal cannabis in line with the price on the black market. This would likely mean a price of EUR 10–15 per gram for the consumer.3. Partial THC limitsThere will be no general limit of the THC amount contained in cannabis sold to customers over 21. Only cannabis that is to be sold to 18–21-year-olds may have a restriction on the THC amount (possibly around 10%).This approach is good news for the industry. In a leak of the Key Points Paper from last week, the Ministry of Health had still envisioned a THC cap of no more than 15% in general but has changed its position following criticism from politicians and various stakeholders of the German cannabis industry.4. Import is a critical topicThe Key Points Paper explains that, at least for an initial phase, the German cannabis demand may only be met by cannabis cultivated in Germany. Imports from other countries will not be feasible as this may cause foreign trade issues with the EU and violate international law.Regardless of the origin, strict government control is required at all stages to prevent illegally sourced cannabis from the black market from entering the legal supply chain—and vice versa. The entire supply and trade chain (cultivation, processing, transport, wholesale, retail trade) will be subjected to a control system (track and trace) that includes documentation of the individual steps in the chain. As recreational cannabis will not fall under the GNA, it is clear, however, that strict quality standards like the Good Manufacturing Practice (GMP) and the Good Distribution Practice (GDP), as applied to medical cannabis, are not required be followed.5. Total prohibition of advertising and brandingLast but not least, the Paper suggests that advertisements will not only be restricted, but generally prohibited. Even the branding of products must be neutral and should not contain any advertising. This approach follows the Dutch way of cannabis regulation. It remains to be seen if it will make its way into the legislative proposal in strict form.Key ChallengesInternationally, Germany has committed itself to prevent commercial cannabis activities outside of scientific and medical purposes in three international treaties: the Single Convention on Narcotic Drugs of 1961, the Convention on Psychotropic Substances of 1971, and the Convention Against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. To avoid the violation of these treaties, withdrawal and re-entry under the condition of allowing recreational use was previously discussed. Now the federal government plans to send an “interpretive statement” to the other states first.On the EU level, the Schengen Implementation Convention and Council Framework Decision 2004/757/JHA of October 25, 2004, force the member states to prevent all commercial activities involving cannabis outside of scientific and medical purposes. Next to that, the EU itself is a contracting party in the Convention Against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.The German government is aware of this EU legal problem and is counting on close cooperation with the EU Commission. The EU Commission has yet to submit its assessment of the German plan. If the Commission gives the green light, a draft law will be formulated.The outcome of the EU Commission’s consultation is difficult to predict. On one hand, Germany is not the first country in the EU to liberalize its cannabis policy. In the case of other EU member states, like The Netherlands or Portugal, the EU Commission has never taken sanctions before (e.g., an infringement case before the European Court of Justice). On the other hand, the German proposal in the Key Points Paper goes beyond any legalization efforts in other EU member states, which have only decriminalized possession and private cultivation.It therefore remains to be seen how strictly the EU Commission will interpret the existing legal framework. In any case, one thing is certain: if the EU Commission is against the German government’s legalization plan outlined in the Key Points Paper, no German draft law will be formulated on the basis of the Key Points Paper. This was explicitly stated by the German Minister of Health Karl Lauterbach at a press conference on October 26, 2022.OutlookThe Key Points Paper is the first step toward the legalization of cannabis in Germany. If the EU Commission green-lights the approach, the Ministry of Health plans to publish a first draft law by the beginning of 2023. However, it is currently unclear whether a response from the EU Commission will be received before the end of the year.It must also be reiterated that the key points proposed by the Ministry of Health are not set in stone and that the Ministry of Health will take into account feedback of industry stakeholders as well as of the various political camps. The German government has already indicated its readiness to defer from this proposal by taking a much more liberal approach with the current version of the Key Points Paper, compared to a leaked version of the Paper last week that met with lots of criticism (e.g., insisting on a higher amount for personal use, no general THC cap, etc.). Yet, all government parties expressed their intention to get this reform done, since it was one major promise when this government came into office last year. Despite the difficulties at the international level, as of now, the law is expected to come into force in 2024.

Germany: Ministry of Health Grants First Glimpse on the Upcoming Cannabis Legalization and Seeks Green Light from the European Commission

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