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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The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the doctrine of equivalents (DOE) to enforce claims to life science inventions has traditionally been limited. But times may be changing. For example, the <a href="https://www.mofo.com/resources/insights/190904-biologics-doctrine-of-equivalents.html" target="_blank">2019 Ajinomoto Federal Circuit</a> case makes it clear that the doctrine of equivalents can apply to sequence-based claims of life science inventions, and a recent <a href="https://cafc.uscourts.gov/sites/default/files/opinions-orders/20-2220.OPINION.9-17-2021_1836421.pdf" target="_blank">Federal Circuit case</a> (Jennewein Biotechnologie GMBH v. ITC, 2020-2220 (Fed. Cir. 2021)) found infringement under the DOE of claims directed to methods involved in producing milk oligosaccharides in bacteria. This suggests a possible uptick in reliance on the DOE the life sciences. Patent strategies should consider including narrower sequence-based claims with the DOE in mind, as we await further developments in the case law.<div id="_mcePaste" style="position: absolute;left: -10000px;top: 0px;width: 1px;height: 1px;overflow-x: hidden;overflow-y: hidden;">reliance on the DOE</div>

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Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

Transforming the U.S. Healthcare Industry with Blockchain Technology

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The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting paten

Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

With an expanding global population and finite resources, our food systems are under significant pressure. Alternative proteins are increasingly presented as the solution to relieving the pressure that our food systems are under and to improving global food security. They can provide excellent nutritional value while also helping food systems become more sustainable and environmentally friendly. Investing in and partnering with companies specialised in the production of alternative proteins is fast becoming a key trend.Read the <a href="https://www.mofo.com/resources/insights/210602-alternative-protein-industry-series" target="_self">full client alert</a>.

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Cherokee, Inc.

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Managing Partner, London

Andrew Boyd is an M&A partner based in the London office. He specializes in advising on strategic cross-border mergers and acquisitions, private equity and joint venture transactions with particular e

Andrew Boyd

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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Simon Arlington is a partner based in the Corporate Group focusing on M&A and private equity.

Simon Arlington

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Alternative Protein Industry Series

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With an expanding global population and finite resources, our food systems are under significant pressure. Alternative proteins are increasingly presented as the solution to relieving the pressure that our food systems are under and to improving global food security. They can provide excellent nutritional value while also helping food systems become more sustainable and environmentally friendly. Investing in and partnering with companies specialised in the production of alternative proteins is fast becoming a key trend.

Alternative Protein Industry Series

Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In addition, a number of policies implemented in response to COVID-19 are expected to have a positive impact on rare disease drug development going forward. Yet, the lasting nature of these policies, post-pandemic, remains uncertain, creating an opportunity for rare disease drug sponsors to be proactive in engaging with regulatory authorities and the patient community to advocate the retention of these positive policy developments.A quick review of the <a href="https://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm" target="_blank">FDA’s Orphan Drug Designation Database</a> for designations with a 2020 date finds that 476 Orphan Drug Designations (ODDs) were issued by FDA’s Office of Orphan Drug Product Development. This compares to 340 ODDs issued by FDA during 2019. This indicates that both product development and FDA resources remained focused on rare disease products, even during the exceptional strains 2020 brought to both groups. On August 28, 2020, FDA proceeded with the planned public meeting on “<a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-cder-standard-core-sets-clinical-outcome-assessments-and-endpoints-grant-program-0" target="_blank">CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program</a>,” an important milestone in the COA Endpoints Pilot Grant Program where grantees were able to share their development plans for the COA standard core COAs sets and receive feedback from stakeholders. The COA Endpoints Pilot Grant Program launched late in 2019 and is part of FDA’s Patient Focused Drug Development efforts. Three grants were made to enable COA standard core set development in (1) migraine, (2) acute pain in infants and young children, and (3) physical function across a range of chronic conditions. The goal of the COA standard core sets is to establish a minimum list of impacts that matter most to patients, are likely to demonstrate change, and that should be assessed during a clinical trial.Although not purposefully directed at rare disease clinical trials, FDA’s “<a href="https://www.regulations.gov/document/FDA-2020-D-1106-0002" target="_blank">Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators and Institutional Review Boards</a>” released on March 18, 2020, has in fact significantly benefited ongoing and newly initiated rare disease trials. FDA often updated the guidance throughout 2020, in April, May, July, September, and in December, each time addressing new questions and providing further clarity on trials for enrollment, remote visits, remote monitoring, and protocol modifications. Clinical trials for rare disease indications are particularly important to the rare disease patient community since there are approximately 7,000 identified rare diseases and a mere 10% have an FDA-approved treatment or therapy, meaning many patients can only access unapproved treatments through investigational studies. The policy changes made in response to the pandemic may pave the way in the future for decentralized, virtual clinical trials that are expected to significantly benefit rare disease studies where patient enrollment, engagement, and retention are exceptionally challenging. These policies allowed for integrating home health visits and telemedicine, direct-to-patient drug and supply delivery, and collection of data by portable or wearable devices. A November 12, 2020, Tuffs Center for the Study of Drug Development report found that “55% of active ongoing clinical trials have transitioned to remote and virtual execution models since early spring,” indicating that the transition to decentralized trial design is prevalent and may become the norm in coming years.FDA implemented administrative simplifications, such as permitting applicants and sponsors to submit information to the Office of Orphan Drug Product Development through email submissions rather than the recently launched online portal for ODD requests. Congress also assisted in maintaining existing rare disease programs in 2020, authorizing an extension of the <a href="https://www.fda.gov/media/90014/download" target="_blank">Rare Pediatric Disease Priority Review Voucher</a> program in December 2020, that was, as we disused in an <a href="https://lifesciences.mofo.com/topics/Bill-Proposes-Continuation-of-FDA-Rare-Pediatric-Disease-Priority-Review-Vouchers.html" target="_blank">earlier post</a>, at risk of expiring in the midst of the pandemic.FDA’s rare disease focus in 2020 extended to minimizing the impact of COVID-19 circumstances for rare disease patients. For example, FDA quickly realized the increase in demand for hydroxychloroquine as a potential treatment for COVID-19 and established a priority review process for all generic hydroxychloroquine drug applications so that lupus patients could continue to access the drug for its FDA-approved use. FDA also worked with manufacturers of rare disease drugs as part of FDA’s supply chain management efforts in response to COVID-19.Rare disease patients were uniquely impacted during the COVID-19 pandemic, with 74% of the <a href="https://rarediseases.org/wp-content/uploads/2020/05/NRD-2061-RareInsights-CV19-Report_v2-2.pdf" target="_blank">NORD survey</a> respondents reporting a medical appointment had been canceled due to the pandemic, and 29% of respondents reporting loss of a job, with 11% of those job losses also meaning a complete loss of health insurance. We are encouraged that sponsors continue drug development programs, as evidenced by the large number of ODDs in 2020, and that FDA continues to devote resources and attention to programs focused on rare disease drug development. We will monitor these areas in 2021 and remain hopeful that the clinical trial policies put into effect during the pandemic prove to be viable and accessible tools for future rare disease clinical trials.On the patent exclusivity and investment fronts, orphan diseases have increasingly been on the forefront, with focus on drugs and partnering for these indications. This reflects a major shift and a breakaway from the traditional, narrower view of the value and importance of these programs. “Five or 10 years ago the dogma was that these indications would not necessarily warrant full investment, either for clinical development or patent exclusivity,” according to Morrison & Foerster’s partner <a href="https://www.mofo.com/people/catherine-polizzi.html" target="_blank">Dr. Catherine Polizzi</a>, recognized patent law leader with over 25 years in life sciences patent practice. “I thought this was a short-sided view, and that there was tremendous opportunity in rare diseases, not to mention the important attention needed for these patients. Those who previously ignored this have very much changed course.”

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Intellectual versatility combined with incisive, pragmatic counseling and business acumen is the hallmark of Catherine’s practice.
Catherine helps emerging and established companies through the challe

Catherine M. Polizzi Ph.D.

Catherine Polizzi

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Rare Disease: Sustained Progress in Development Regardless of the Pandemic

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Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare dis

Rare Disease: Sustained Progress in Development Regardless of the Pandemic

Nina Schäfer and Jin Ito contributed to this article.On November 25, 2020, the European Commission (the “Commission”) published its “<a href="https://ec.europa.eu/health/human-use/strategy_en" target="_blank">Pharmaceutical Strategy for Europe</a>” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system.  The strategy aims to achieve various goals through legislative and non-legislative actions, namely ensuring access to affordable medicines for patients and addressing unmet medical needs while supporting the competitiveness, innovation and sustainability of the EU’s pharmaceutical sector. It was accompanied by the Commission’s “Intellectual Property Action Plan” published on the same day.  Here are some notable cornerstones of the initiative (see also the <a href="https://ec.europa.eu/commission/presscorner/detail/en/fs_20_2201" target="_blank">Fact Sheet</a> published by the Commission):<ul><li>Streamline procedures and costs for regulatory approval</li><li>Achieve strategic autonomy</li><li> Fuel competition by generics and biosimilars </li><li>Facilitate R&D through efficient access to health data</li><li> Introduce a Unitary Supplementary Protection Certificate </li><li>Simplify reimbursement decisions</li></ul><h4>Regulatory Approval</h4>The Commission acknowledges that regulatory efficiency is one of the key factors to achieving the goals outlined above. To enhance regulatory efficiency, the Commission plans to:<ol><li>Evaluate procedures to explore new approaches to assessing and assembling scientific evidence regarding the safety and efficacy of medicines, e.g., create innovative and pragmatic trial designs and bring EU approval times on par with other parts of the world; </li><li>Consider how digital technology and artificial intelligence can be leveraged to support regulatory decision-making and boost efficiency; and  </li><li>Implement a regulatory framework that further advances the digital transformation of the healthcare system.</li></ol>Rightfully, the Commission emphasizes that the success of such an endeavor will largely depend on collaboration of all stakeholders involved. A study on the current situation involving authorization and monitoring of medicines for human use will be published in 2021 and shall serve as a basis for sparking the collaboration.<h4>Strategic Autonomy</h4>In light of challenges witnessed during the COVID-19 pandemic, the Commission will also pursue measures aimed at achieving greater strategic autonomy. Shortages of medicine have been a serious concern in recent years and have only worsened during the pandemic. To combat the impact the shortages have on patients, the Commission is evaluating revisions of the current legislation to potentially include stronger obligations to ensure the supply of medicines, earlier notification of shortages, enhanced transparency along the supply chain and a stronger coordination role for the European Medicines Agency (EMA).To further tackle the issue, the Commission is committed to:<ol><li>Identify precise causes and drivers for potential vulnerabilities through a structured dialogue with all actors involved; and</li><li>Encourage joint procurement by all EU Member States of critical medicines.</li></ol><h4>Generics and Biosimilars</h4>The Commission highlights the importance of generics and biosimilars when it comes to reducing costs for the healthcare system and providing accessible and affordable treatment to a large number of patients. The Commission therefore intends to support greater generics and biosimilar competition through at least two measures:<ol><li>As outlined in the “<a target="_blank" href="https://ec.europa.eu/health/human-use/strategy_en">Pharmaceutical Strategy for Europe</a>” and the “Intellectual Property Action Plan,” the Commission intends to strengthen and harmonize the so-called “Bolar Exemption.” The Bolar Exemption allows third parties to use a patented invention—for a limited time before the patent expires—for research and testing purposes to obtain market authorization, allowing for a more timely entry to market. Currently, Article 10(6) of EU Directive 2001/82/EC (as amended by EU Directive 2004/24/EC) only provides for certain minimum standards, specifically with respect to generics. Some of the EU Member States, however, adopted more permissive rules leading to a fragmented landscape. For instance, the Directive addresses only use to generate data for regulatory approval in an EU or EEA country. Germany and France, however, permit the support of regulatory approval in non-EU and non-EEA countries. In Germany, the Bolar Exemption is not limited to generics but also applies to innovative products. </li><li>In addition, the Commission plans to revisit current enforcement of EU competition rules. A <a href="https://ec.europa.eu/competition/sectors/pharmaceuticals/report2019/index.html" target="_blank">report</a> on competition enforcement in the pharmaceutical sector has shown that originator companies sometimes try to hinder the market entry or market expansion of cheaper generics and biosimilars (e.g., so-called “pay-for-delay,” i.e., originator companies paying generics companies a share of their profits for a delayed entry to market). The Commission indicated that such behaviors may come under stricter competition law scrutiny.</li></ol><h4>Access to Health Data</h4>The Commission acknowledges that the limited options to use health data for R&D are detrimental to both patients and the industry. To enable industry and regulators to access such health data from across the EU, the Commission plans to take the following steps:<ol><li>Adopt a legislative proposal for a European Health Data Space by the fourth quarter of 2021; and</li><li>Establish an interoperable data access infrastructure, to be completed in 2025, which will improve the cross-border analysis of health data, while also protecting individuals’ rights to privacy and data protection.</li></ol>The planned legislation on the European Health Data Space is in line with the European Data Strategy of the Commission from February 2020. The data strategy is aimed at the creation of a single data market for the EU and the establishment of European Data Spaces in strategic sectors and domains of public interest. One of these is the health sector.In addition to these measures, the Commission intends to:<ol><li>Revise the pharmaceutical legislation to adapt to innovative products, scientific developments (e.g., genomics or personalized medicine) and technological change (e.g., data analytics and digital tools); and </li><li>Support projects that combine the use of high performance computing and artificial intelligence with EU health data to develop pharmaceutical innovations.</li></ol><h4>Unitary Supplementary Protection Certificate</h4>In its Intellectual Property Action Plan, the Commission also looks at the protection of the fruits of pharmaceutical research and development. There the Commission revealed its plans to potentially overhaul the system for Supplementary Protection Certificates (SPCs).SPCs are granted for patented medicinal and plant protection products and offer an additional period of IP protection to counter-balance their often lengthy clinical trials and market authorization processes. They are currently regulated under Regulation (EC) No. 469/2009.A <a href="https://ec.europa.eu/docsroom/documents/43847" target="_blank">study</a> evaluating the current SPC system showed that its efficiency is suffering from its fragmented implementation across EU Member States, leading to high costs and administrative burdens on applicants, hampering innovation and ultimately harming the patients. It also found the system lacking in transparency, with no EU-wide information system and published information oftentimes not being comprehensive, up-to-date or available in foreign languages. To address these pitfalls, the Commission indicated the possibility of a unified grant mechanism and/or the creation of a unitary SPC title by the first quarter of 2022.In the same vein, the Commission also stresses the importance of a unitary patent system and called on EU Member States to ensure its rapid rollout. Information on recent developments regarding the unitary patent system can be found <a href="https://www.unified-patent-court.org/" target="_blank">here</a>.<h4>Reimbursement</h4>There are still differences in access to new medicines and therapies among EU Member States. Since companies are not obligated to offer their products in every EU Member State, different pricing and reimbursement policies are often the deciding factor why products reach some markets and not others. The Commission thus wants to work towards enabling EU Member States to make better and more consistent reimbursement decisions. Key issues identified by the Commission are:<ol><li>Lack of transparency, especially regarding R&D costs, which play an important role when determining the reimbursement price;</li><li>Lack of consensus on cost principles among EU Member States; and</li><li>Lack of uniform principles to evaluate the efficacy of health technologies.</li></ol>To address these issues, the Commission aims to assemble and lead a group of national pricing and reimbursement authorities and healthcare payers to share information among themselves on pricing, payment and procurement policies. Furthermore, the Commission will engage with EU Member States in implementing non-legislative measures designed to increase transparency, such as the introduction of guidelines on costing methods for determining R&D costs. With respect to the evaluation of the efficacy of health technologies, the Commission already issued a <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52018PC0051" target="_blank">proposal </a>in 2018 that is intended to help standardize the health technology assessment process in the EU. It is expected to be adopted in 2021.<h4>Outlook</h4>The pharmaceutical strategy was <a href="https://www.consilium.europa.eu/en/meetings/epsco/2020/12/02/" target="_blank">discussed</a> on a political level at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council Meeting on December 2, 2020. The Ministers expressed their overall support for the strategy and stated that they hoped the Member States would be fully involved in all future discussions and actions related to the implementation of the strategy.The first proposals will be implemented in the coming months, with a revision of the legislation on rare diseases and children being one of the first. The Commission states on its <a href="https://ec.europa.eu/health/human-use/strategy_en" target="_blank">website</a> that the implementation of the strategy will span the mandate of this Commission and will notably see a proposal for revision of pharmaceutical legislation in 2022.We will post further updates as the implementation of the Commission’s pharmaceutical strategy for Europe progresses.

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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The European Commission’s New Pharmaceutical Strategy for Europe

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

mofolifesciences-eu

Nina Schäfer and Jin Ito contributed to this article.
On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy fo

The European Commission’s New Pharmaceutical Strategy for Europe

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights.At the outset, it is important to recognize that the patent term of a biologic product is distinct from the FDA’s regulatory market exclusivity period for the same product; these two public policies are governed by entirely separate laws and regulations. Patent term and the FDA’s exclusivity programs run concurrently and in parallel. As such, pediatric exclusivities (or other FDA exclusivities) do not formally extend the term of any patent rights. However, both of these legal frameworks have the same effect of extending the biologic product’s market monopoly and preventing competitors from introducing biosimilar products into the marketplace. In the event that certain patents rights are invalidated prior to the expiration of the full patent term, FDA exclusivities provide an additional safeguard against competitors seeking to enter the market. Thus, Sponsors should consider using both patent rights and FDA exclusivities to recoup research and development investments.Biologics are eligible to participate in the FDA’s pediatric exclusivity program.[i] Under Section 351 of the Public Health Service Act, in order to receive six months of pediatric exclusivity in addition to the 12-year exclusivity period granted under the Biologics Price Competition and Innovation Act,[ii] the FDA must issue a Written Request for the Sponsor to conduct specific pediatric studies for a given biological product.[iii] The Sponsor may choose (but is not required) to conduct the pediatric studies outlined in the Written Request, at its own expense, in exchange for an additional six months of exclusivity for its biological product. The exclusivity grant is based on whether the applicant complied with the terms of the Written Request and is not conditioned on approval of a pediatric indication.[iv] Any unauthorized deviation from the Written Request may result in non-compliance and can jeopardize the Sponsor’s ability to earn pediatric exclusivity. The FDA maintains discretion over issuing Written Requests for pediatric studies, and thereby controls the Sponsor’s ability to obtain multiple pediatric exclusivities. The FDA may issue multiple Written Requests, which are each eligible for an additional six-month exclusivity period, provided that the Sponsor appropriately complies with each Written Request.[v] Examples of previous Written Requests for biologics can be found on the FDA’s <a target="_blank" href="https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request">List of Determinations Including Written Request</a> web page (see, e.g., ipilimumab and tocilizumab). It appears that the FDA has not yet issued multiple Written Requests for a single biologic. In fact, it appears rare for the FDA to issue multiple Written Requests for the same drug. In a previous Guidance, the FDA explained that a Sponsor of a new drug under Section 505A of the Federal Food, Drug, and Cosmetic Act (FDCA) may submit a detailed proposal to the FDA for a Written Request, which is equally applicable to the holder of an approved Biologics License Application under Section 351 of the Public Health Service Act.[vi] The proposal for a Written Request should substantially follow the template that the FDA has previously used for a Written Request (see, e.g., <a target="_blank" href="https://www.fda.gov/media/106997/download">ipilimumab</a> and <a target="_blank" href="https://www.fda.gov/media/115367/download">tocilizumab</a>). The proposal should contain sufficient information to execute the studies such as the objective of the study, trial design, number and kinds of patients and other relevant patient characteristics, inclusion and exclusion criteria for the study, drug dosing for the treatment arm, statistical information for analyzing the results, and other pertinent information.[vii] The FDA will then evaluate the proposal and decide whether to issue a formal Written Request based on the information submitted. In addition, the FDA maintains a <a target="_blank" href="https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently">FAQ web page</a> dedicated to qualifying for pediatric exclusivity under Section 505A of the FDCA. To qualify for pediatric exclusivity, the pediatric studies conducted to satisfy the requirements of the Pediatric Research Equity Act (PREA) must also satisfy all of the requirements for pediatric exclusivity under Section 505A of the FDCA.[viii]Fulfilling the Written Request for pediatric exclusivity is separate from meeting the Sponsor’s PREA obligations or any other requirements to perform phase 4 post-market surveillance studies.[ix] PREA requires that all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration contain an assessment of the safety and effectiveness of the product for the claimed indication(s) in pediatric patients, unless this requirement is waived, deferred, or inapplicable.[x] In terms of scope, PREA is more limited and requires a pediatric assessment of those indications included in the pending biologics license application (BLA), which addresses the safety and effectiveness of the claimed indications with respect to the drug or biological product. The FDA’s authority to issue a Written Request for pediatric exclusivity extends to the use of an active moiety for all indications that occur in the pediatric population, regardless of whether the indications have been previously approved in adults or approval for those indications is being sought in adults.[xi] The FDA has previously advised that an applicant seeking to qualify for pediatric exclusivity should obtain a Written Request for studies from FDA before submitting the pediatric studies to satisfy PREA.[xii]  [i] See 42 U.S.C. § 262(m) (Section 351 of the Public Health Service Act). Notice that under § 262(m)(1), the rules for submitting pediatric studies are the same for both drugs and biologics under § 505A of the Federal Food, Drug, and Cosmetic Act (FDCA) (codified as 21 U.S.C. § 355a). More precisely, § 262(m)(1) carves out the exclusivity benefits in §§ 505A (b)-(c) for drugs, which are then re-inserted as §§ 262(m)(2)-(3) as applicable to biologics given the different exclusivity periods.[ii] See 42 U.S.C. § 262(k). [iii] See 42 U.S.C. § 262(m) (Section 351 of the Public Health Service Act). Under both §§ 262(m)(2) and m(3), the Secretary makes a written request to the applicant to perform additional pediatric studies, and the applicant accepts that request (at its own expense), the applicant is rewarded another six months of exclusivity. Note that under 21 U.S.C § 355a(h) (carried over into 42 U.S.C. § 262(m)(1) for biologics), pediatric exclusivity shall only be granted for a study or studies that are the subject of a Written Request from the FDA and prior to nine months from expiration.[iv] See <a target="_blank" href="https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently">https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently</a>.[v] See Guidance for Industry, Qualifying for Pediatric Exclusivity Under Section 505(A) of the Federal Food, Drug, and Cosmetic Act (June 1998, revised Sept. 1999). [vi] See id. (listing specific requirements for a Proposed Pediatric Study Request).[vii] See id.[viii] See Sections 505A(d) and 505A(h) of the FDCA (codified as 21 U.S.C. §§ 355a(d) and (h), respectively).[ix] See Section 505B of the FDCA (codified as 21 U.S.C. § 355c). PREA also authorized the FDA to waive the required assessments when the drug or biological product (1) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients and (2) is not likely to be used in a substantial number of pediatric patients.[x] See id.[xi] See Section 505A(a) of the FDCA, codified as 21 U.S.C. § 355a(b)(1).[xii] <a target="_blank" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-comply-pediatric-research-equity-act">See Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act (Sept. 2005)</a>.

Pediatric Exclusivity for Biologics

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distincti

Pediatric Exclusivity for Biologics

On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human Genetic Resources Regulations (the “Regulations”) and its draft Biosecurity Law, and sends a strong signal that China’s legislature is determined to strengthen the penalties and punishments for the protection of China’s biosecurity. The Draft has been published for public comments, which may be submitted by August 16, 2020.China’s current Criminal Law includes a number of crimes for violation of other laws and aimed for the prevention and control of infectious diseases and bioterrorism, e.g., certain crimes in violation of China’s Law on Prevention and Treatment of Infectious Diseases and causing the spread of, or a serious risk of spreading, a Category A infectious disease determined by that law, crimes for causing the spread of bacterial or viral agents for infectious diseases resulting in serious consequences, and crimes for violating health and quarantine regulations at the national border. The current Criminal Law also includes a number of crimes aimed at the prevention and control of biological invasions and for biological resource conservation, e.g., crimes for violation of certain national regulations on animal and plant epidemic prevention and quarantine. The current Criminal Law, however, lacks provisions on misuse of biotechnology, illegal use of human genetic resources (HGR), and other acts resulting in the destruction of ecological environment or biological resources. This is in part due to the slow legislation in other areas of law, because the Criminal Law, in the context of biosecurity, rather than defining crimes from scratch, typically provides for penalties and punishments against serious violations of other laws or regulations. The legislative progress in China’s Biosecurity Law provides the motivation for speeding up the corresponding legislative update to China’s Criminal Law.The Draft proposed to add the following provisions to the crimes in connection with the collection and supply of blood and the production and supply of blood products:Any person committing any of the following acts, in violation of relevant State regulations and endangering public health or social public interest, shall be sentenced to, in cases of serious circumstances, not more than 3 years of fixed-term imprisonment or criminal detention or control, and/or a fine, and, in cases of especially serious circumstances, imprisonment of not less than 3 years but not more than 7 years, and a fine: (i) illegally collecting China’s human genetic resources; (ii) illegally transporting, mailing or carrying China’s human genetic resources materials abroad; and (iii) supplying or providing open access to China’s human genetic resources information to foreign organizations or individuals or institutions established or actually controlled thereby.Although proposed to be added to the existing provisions related to blood and blood products, the new provisions related to HGR have far broader implications than curbing mishandling of blood products. Human genetic resources, as defined in the Regulations and the draft Biosecurity Law, include not only HGR materials, of which blood is but one example, but also the data and other information generated from the utilization of those materials, which is broad enough to cover medical images and laboratory test results. Both the Regulations and the draft Biosecurity Law, which is intended to codify significant portions of the Regulations, prohibit foreign organizations and individuals and institutions established or actually controlled thereby (collectively, “Foreign Persons”) from collecting or preserving China’s HGR within China, or providing China’s HGR abroad. Therefore, Foreign Persons are subject to the punishments provided for in items (i) and (ii) of the newly proposed HGR-related Criminal Law provisions.The Draft also includes punishments of up to seven years of imprisonment and a fine against the implant of genetically edited embryos or cloned embryos into humans or animals in violation of relevant State regulations, as crimes of illegal medical practice. This is an obvious countermeasure taken by the legislators in light of the gene-edited babies scandal that broke out in China in 2018.The inclusion of HGR-related crimes in the Draft is hardly surprising. Both the Regulations and the draft Biosecurity Law state that any violation thereof that constitutes a crime shall be prosecuted according to the law, and in the absence of the corresponding crimes in the Criminal Law, those provisions have so far been toothless when it comes to HGR. Foreign Persons should pay special attention to the Criminal Law’s legislative progress, because in addition to the economic consequences that they may have to bear for violating the Regulations and the Biosecurity Law, they may face criminal prosecution for the same violations in the event the circumstances are serious, which the courts in China will have considerable discretion to determine when imposing sentences.For a summary and analysis of the Regulations, please refer to this <a href="https://lifesciences.mofo.com/topics/China-regulations-on-human-genetic-resources-foreign-persons.html" target="_blank">author’s article</a>, and for a summary and analysis of select provisions of the draft Biosecurity Law, please refer to this <a href="https://lifesciences.mofo.com/topics/Chinas-Biosecurity-Law-will-cover-Human-Genetic-Resources.html" target="_blank">author’s article</a>.