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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Companies in the UK are regulated by many statutes, ranging from those dictating how much tax they need to pay, to those centred on how they treat their employees. At a corporate level, the main statute that companies should be familiar with is the Companies Act 2006. This statute sets out various duties for directors of companies.Read the <a href="https://www.mofo.com/resources/insights/220901-key-considerations-for-early-stage-companies" target="_self">full client alert</a>.

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

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Michelle Luo is an associate in the firm’s London office and a member of the Technology Transactions, Intellectual Property and Global Privacy Groups.

Michelle Si-Ting Luo

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Key Considerations for Early-Stage Companies in the Alternative Protein Industry

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Companies in the UK are regulated by many statutes, ranging from those dictating how much tax they need to pay, to those centred on how they treat their employees. At a corporate level, the main statute that companies should be familiar with is the Companies Act 2006.

Key Considerations for Early-Stage Companies in the Alternative Protein Industry

Stephanie Pong, London trainee solicitor contributed to the writing of this article.On January 1, 2021, the UK launched its very own <a target="_blank" href="https://www.gov.uk/government/publications/participating-in-the-uk-ets/participating-in-the-uk-ets">emissions trading scheme</a> (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors can trade emission allowances (also known as carbon credits). On May 19, 2021, Intercontinental Exchange, Inc. (“ICE”) hosted the scheme’s first emission allowance auctions on behalf of the UK government.The benefits of the scheme are twofold. Not only does it provide continuity from the UK’s participation in the EU’s equivalent emission trading scheme (the “EU ETS”), but it also focuses efforts to reach the UK’s <a target="_blank" href="https://www.gov.uk/government/news/uk-becomes-first-major-economy-to-pass-net-zero-emissions-law">goal</a> of reducing all greenhouse gas emissions to net-zero by 2050 as announced in June 2019, and other carbon reduction commitments.<h4>The UK ETS largely mirrors the EU ETS</h4>Similar to the EU ETS, the UK ETS works on the cap and trade principle (i.e., market participants buy or receive emission allowances within the cap and then trade those allowances with other participants), which provides economic incentives for reducing industrial pollutant production.Established through the <a target="_blank" href="https://www.legislation.gov.uk/uksi/2020/1265/contents/made">Greenhouse Gas Emissions Trading Scheme Order 2020</a>, the UK ETS currently covers the same industries as the EU ETS: 1) the power generation industry; 2) the aviation sector; and 3) other energy intensive industries. The UK government has, however, stated that it intends to expand the scope of the UK ETS to other sectors.The first auction under the UK ETS took place on May 19, 2021, on ICE, which also hosts the EU ETS. On May 10, 2021, the UK government published guidance on the supply of allowances in the UK ETS (the “Guidance”). The Guidance clarified that auctions under the UK ETS will take place every two weeks, with around 83 million allowances (divided between the fortnightly auctions) predicted to be sold this year. For the 2021 auction calendar, please follow the link <a target="_blank" href="https://www.theice.com/publicdocs/circulars/21030.pdf">here</a>. The 2022 auction calendar will be published by July 15, 2021, and the UK ETS Authority has anticipated 80 million allowances will be available for the 2022 period. The first auction saw all of the available allowances sold to 14 bidders, at a price of £43.99.The <a target="_blank" href="https://www.legislation.gov.uk/uksi/2021/484/contents/made">Auctioning Regulations</a> and <a target="_blank" href="https://www.gov.uk/government/publications/participating-in-the-uk-ets/participating-in-the-uk-ets">guidance</a> for UK ETS participants provide that the Auction Reserve Price (“ARP”) is £22 per tonne of carbon dioxide equivalent, which is the minimum price at which emission allowances can be sold at auction. The UK government will consider withdrawing the ARP later in 2021 as the scheme matures and certain amendments to the Auctioning Regulations, most notably the removal of the requirement that a natural person be established in the UK to submit, modify, or withdraw a bid under the UK ETS, have been made and came into force on <a target="_blank" href="https://www.legislation.gov.uk/uksi/2021/513/contents/made">May 19, 2021</a>. Further, the UK’s implementation of the “monitor, report, and verify requirements” under the Carbon Offsetting and Reduction Scheme for International Aviation (“CORSIA”) comes into force on May 26, 2021, and the UK government will hold further consultations this summer on proposals for implementing CORSIA and its interaction with the UK ETS; further developments of the UK ETS are therefore expected over the coming year.Certain sectors deemed to be exposed to a significant risk of “carbon leakage” receive free allowances. “Carbon leakage” refers to businesses transferring production to other countries with less stringent emission constraints, therefore leading to an increase in total emissions. The UK ETS uses the same benchmark to calculate free allocations as the EU ETS. The UK government closed its <a target="_blank" href="https://www.gov.uk/government/consultations/uk-emissions-trading-scheme-free-allocation-review-call-for-evidence#:~:text=Within%20the%20context%20of%20the,the%20risk%20of%20carbon%20leakage">consultation</a> in April 2021, which called for evidence on how to use its free allocations effectively under the UK ETS. The UK government published an <a target="_blank" href="https://www.gov.uk/government/publications/uk-ets-allocation-table-for-operators-of-installations">allocation table</a> setting out operators of stationary installations’ entitlement to free allowances for 2021‑25 and aims to have those under the scheme year 2021 allocated by May 28, 2021; the aviation allocation table is expected in June 2021. We expect to hear further related proposals later this year.<h4>ICE UK Allowance (UKA) Futures</h4>Coinciding with the start of the first UK ETS auction, and subject to regulatory approval, ICE plans to launch the ICE UK Allowance (“UKA”) Futures contracts, with UKA Daily Futures following on May 21, 2021. ICE UKA Futures will trade on ICE Futures Europe and clear at ICE Clear Europe alongside ICE’s global environmental complex, including European Union Allowances (“EUA”), California Carbon Allowances (“CCAs”), and California Carbon Offsets (“CCOs”). By facilitating trading in allowances through futures contracts, market participants may benefit from a more liquid market, improved price discovery, and the ability to sell or procure allowance on a forward basis and otherwise hedge market exposure.<h4>The UK ETS is more ambitious than its EU counterpart</h4>Although the UK ETS largely mirrors the EU ETS, one key difference is that the UK ETS has a more ambitious emissions reduction target. The UK’s initial cap on the total amount of certain greenhouse gases that can be emitted by the installations covered by the system (i.e., allowances) is 5% lower under the UK ETS than the UK’s share cap under the EU ETS. As the UK ETS has a smaller market than the EU ETS, a lower cap will help maintain market stability by limiting price spikes and aggressive price fluctuations. Further, the threshold for triggering the UK ETS cost containment mechanism, which would allow the UK government to intervene should price spikes occur, was set at £44.74 a tonne by the UK government on <a target="_blank" href="https://www.gov.uk/government/publications/uk-emissions-trading-scheme-markets/uk-emissions-trading-scheme-markets#cost-containment-mechanism">May 10, 2021</a>. This is a lower threshold than that under the EU ETS. Future contracts traded as high as £50.23 a tonne on the first day, however this settled back to £45.75 after the first auction. The high prices were driven by high levels of interest in the first auction, and by a small number of bidders. The initial volatility is expected to settle over time, however there remain concerns that the UK government may need to step in within the first few weeks of the UK ETS’s launch.New entrants to the UK ETS will need to ensure that they are accurately recorded on the new UK ETS registry. Further, a new permit system is expected to replace the current permit system, which was set up and managed in accordance with the EU ETS, in the near future.Enforcement of obligations under the UK ETS will be carried out by the relevant UK environmental regulators with civil penalties of £100 per tonne for exceeding emission allowances, which is a slight increase from the €100 fine under the EU ETS.<h4>The UK and EU ETSs will likely remain largely parallel</h4>The EU-UK Trade and Co-operation Agreement (the “Agreement”) does not provide much wriggle room for the UK ETS to diverge significantly from the EU ETS. Under the Agreement, the EU and UK agreed that they are both committed to cooperate on carbon pricing. “Serious consideration” will be given to linking up the UK and EU schemes, similar to how the EU and Swiss schemes were <a target="_blank" href="https://www.bafu.admin.ch/bafu/en/home/topics/climate/info-specialists/reduction-measures/ets/linking-swiss-eu.html#:~:text=Under%20the%20Agreement%2C%20flights%20from,covered%20by%20the%20EU%20ETS.&text=An%20electronic%20link%20between%20the,the%20registries%20since%20September%202020.">linked</a> in 2020. At present, aircraft operators, for instance, must comply with the UK ETS for flights from the UK to EEA countries, and the EU ETS for flights from EEA countries to the UK. Divergence of scheme rules will only make it more complex for market players to ensure compliance. Regardless, it is unlikely that the UK ETS will become substantially different, or less stringent, compared to the EU ETS, given the UK’s ambitious net zero 2050 target and 68% emission cuts by 2030, versus the EU’s 55% target.The approach to carbon pricing was addressed in a <a target="_blank" href="https://commonslibrary.parliament.uk/research-briefings/cbp-9212/">briefing paper</a> published by the House of Commons on May 4, 2021, which indicates the government’s preference to link the UK ETS with the EU ETS to ensure market liquidity and price visibility and to reduce the risk of carbon leakage. However, for this to be achievable, the two schemes must be closely aligned including both adopting net-zero targets. A risk of linking is that it may limit the policy autonomy that the UK has over its scheme in relation to governance arrangements and the proposed expansion of the UK ETS to other sectors. Alternatives suggested in the paper include having a standalone UK ETS or implementing a carbon tax.<h4>Emission Trade Schemes around the world</h4>United StatesIn contrast to the UK and EU, the United States lacks a nationalized carbon market. Rather, carbon trading in the United States takes place across a variety of fractured markets, with some being driven by voluntary private trading, and others by various government regulations.Market drivers from the federal level include the recently updated <a target="_blank" href="https://home.treasury.gov/news/press-releases/sm1227">45Q tax credit</a> for certain forms of carbon sequestration, and several programs <a target="_blank" href="https://www.epa.gov/emissions-trading-resources">administered</a> by the U.S. Environmental Protection Agency.A minority of states have also constructed state-level exchanges. These include the <a target="_blank" href="https://ww2.arb.ca.gov/our-work/programs/cap-and-trade-program">Cap-and-Trade Program</a> in California, and the <a target="_blank" href="https://www.rggi.org/program-overview-and-design/elements">Regional Greenhouse Gas Initiative (RGGI)</a>, which is a cooperative effort between eleven eastern states (Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Virginia).On the private side, organizations such as <a target="_blank" href="https://verra.org/">Verra</a> and the <a target="_blank" href="https://americancarbonregistry.org/">American Carbon Registry</a> operate their own voluntary registries. These private organizations also interact with the various regulatory markets by providing standards and quantifying and verifying carbon valuations. For instance, Verra helps administer California’s Cap-and-Trade Program.AsiaKorea has the second largest in scale emission trade scheme (“ETS”), after the EU ETS, which was launched in 2015 and is also based on the cap and trade principle. This year, the scheme entered into its final phase (2021-2025), which further reduces the proportion of free allocations.China, the world’s largest emitter of greenhouse gases, <a target="_blank" href="https://www.forbes.com/sites/scottcarpenter/2021/03/02/toothless-at-first-chinas-carbon-market-could-be-fearsome/?sh=538e0e062af1">launched</a> its national ETS on February 1, 2021. China’s ETS covers the power generation sector in its initial phase. Since August 2017, China has operated seven regional ETSs that will gradually transition into a single national scheme.Similar to the United States, Japan does not have a nationalized carbon market; however, it was a pioneer in that the Tokyo metropolitan government launched the Tokyo ETS in 2010, which notably targets office buildings, educational institutions, and commercial buildings, as well as factories and other industrial/energy sector facilities. The Tokyo ETS is linked to the Saitama ETS, which was established in 2011 by the Saitama Prefecture.Latin AmericaLatin American countries including Chile, Mexico, Argentina, and Columbia have taken a different approach of introducing carbon taxes and other carbon pricing mechanisms to tackle the climate crisis. However, the efficacy of these solutions is debatable, especially given their very low carbon tax rates, which may fail to discourage carbon-intensive activities.<h4>Concluding Remarks</h4>It is clear that countries across the globe recognize the need to take extensive action to tackle the climate crisis, in particular by reducing their respective greenhouse gas emissions. A popular and effective solution that has emerged over the last 5-10 years is the emission trade scheme. However, such schemes have proved to be costly and highly complex to implement, often requiring a pilot phase.The UK ETS represents a promising test as to how a new emission trade scheme can begin to grow and develop, using established emission trade schemes (such as the EU ETS) as models. As we look to the future, more countries might begin to adopt nationalized carbon markets and schemes in order to meet their carbon reduction commitments, and we may even see major emission trade schemes linking up to unify humanity’s attempt to reverse climate change.Visit our <a href="https://www.mofo.com/capabilities/environmental-social-governance.html" target="_blank">Environmental, Social, and Governance (ESG)</a> resource center and follow our Life Sciences blog to stay informed about any progress on this matter.

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Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

David concentrates on structured transactions involving commodities and derivatives. He also has extensive experience with mergers, acquisitions, and corporate reorganizations. David works closely wit

David Kaufman

David concentrates on structured transactions involving commodities and derivatives. He also has extensive experience with mergers, acquisitions, and corporate reorganizations. David works closely with the firm’s financial institution and end-user clients in the commodity, equity, fixed income, and credit derivative markets, often assisting clients in developing and structuring products.

David H. Kaufman

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UK’s new emissions trading scheme hosts first auctions

UK Plans for Robust Life Sciences Regulation Post-Brexit

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Stephanie Pong, London trainee solicitor contributed to the writing of this article.
On January 1, 2021, the UK launched its very own emissions trading scheme (

UK’s new emissions trading scheme hosts first auctions

On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program. Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD.After key definitions and concept overviews by the McKinsey team, Bethany Hills set the foundation of the FDA’s evolution in regard to SaMD in the United States and provided insights into the specific pathways impacting digital therapeutics. The FDA has not specifically defined SaMD, instead relying in the guidance documents on the definition provided by the International Medical Device Regulators Forum (IMDRF), which define the term as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. In essence, the software must act on its own, and have indications or be intended for the diagnosis, treatment, prevention, or monitoring of a condition. Medical devices in the United States are assigned one of three regulatory classes based on the risk and safety and effectiveness of the device. Most SaMD would fall under Class I or II, which then determines the type of submission required for authorization to market, including the 510(k) and De Novo pathways. Most devices are cleared under the 510(k) pathway; however, that trend is changing more recently, with many de novo submissions and authorizations involving SaMD. Areas to keep a close eye on include FDA’s finalization of its Clinical Decision Support Software Guidance, currently in draft form, and the Pre-Certification Pilot Program that could significantly impact SaMD if implemented outside the pilot program, by providing a faster, more efficient pathway to FDA authorization. The FDA does not make reimbursement-related decisions, however, a recent <a target="_blank" href="https://www.federalregister.gov/documents/2021/01/14/2021-00707/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and">CMS Final Rule</a> creates the Medicare Coverage of Innovative Technology (MCIT) pathway that will result in four years of national Medicare coverage starting on the date of the FDA’s market authorization of a device holding a Breakthrough Device Designation.  Providing the European perspective, Wolfgang took the stage to discuss the EU’s current regulatory landscape, and reimbursement for Digital Health Apps in Germany. The EU Medical Device Directive (MDD) will soon be replaced, effective May 26, 2021, by the EU Medical Device Regulation (MDR), directly applicable across the EU and significantly stricter for medical device software (MDSW) in three areas: prediction and prognosis applications, impact on the Class I categorization, and enhanced quality and safety requirements. After a review of the MDSW classifications and key changes to the Quality Management Systems, including more stringent requirements for Post-Market Surveillance activities, additional responsibilities along the supply chain, and stricter timeframes for document retention and incident reporting, the discussion turned to Unique Device Identification, which aims to enhance the effectiveness of post-market safety-related activities and traceability. Finally, the discussion focused on the application requirements for low risk apps (Class I or IIa) to receive reimbursement in Germany per the regulation on the Eligibility of Digital Health Applications for Reimbursement by the State Health Schemes (DiGAV), including certain interoperability requirements with the Electronic Patient File system, data protection requirements, and positive healthcare effects to be shown.Below are some highlights from the Q&A:1. Are there exceptions for software developed in a research setting/environment?a. In the United States, a software product can be used in a research and development setting without requiring the FDA’s authorization. However, there are nuances if the research setting involves human subjects.b. In the EU, the MDR generally applies to SaMD that is made available to others, including in a research setting. Yet, one important exception allows for the in-house development and use of SaMD in health institutions with only limited regulation (Article 5(5) MDR). The requirements to fulfill in order to benefit from this exception are rather strict. Most notably, they include that the specific needs for the targeted treatment cannot be met by any equivalent device on the market and that the SaMD is not transferred to another legal entity.2. Is there different regulatory treatment if the use of the medical device is for healthcare providers only vs. patients?a. In the United States, the answer depends on the category of the SaMD. For example,<a href="https://www.fda.gov/media/109618/download" target="_blank"> Clinical Decision Support</a> software has different standards applied for provider users v. patient users.b. The MDR in the EU does not expressly distinguish between groups of end-users; however, some regulatory requirements can make differentiated measures necessary. For example, instructions for use under certain circumstances may be delivered to professionals in electronic form while non-professional users can demand a printed version. Additionally, member states of the EU can decide that the instructions must be delivered in a certain language. In this regard, Germany requires documents to be in German for non-professional users but deems English instructions sufficient for professional users.3. What are some of the reimbursement options for SaMD companies?a. Reimbursement options and pathways seem elusive for SaMD companies, although there does seem to be an evolving path for the category of digital therapeutics.b. In the EU, reimbursement options for SaMD are not harmonized, i.e., each member state has established its own rules on the matter. This means, that the requirements to qualify for reimbursement differ significantly from country to country. Since the COVID-19 pandemic has seriously boosted the acceptance and demand for digital health products, some member states are currently revisiting their frameworks for reimbursement for SaMD. Germany, for instance, has enacted the DiGAV under which certain low risk apps (Class I or IIa) can receive reimbursement (see above and <a href="https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf;jsessionid=04D2120BC0B889420CDDF02A652FA0D2.2_cid354?__blob=publicationFile&v=2" target="_blank">here</a>).4. What are the implications of GDPR on SaMD regulation in Europe? Among other issues to consider, the GDPR sets up restrictions for transfers of personal data from within the European Union to a country outside the EU. Please note that the meaning of “transfer” is understood quite broadly, and includes situations in which personal data becomes accessible to a third party, even if such third party does not actually access the data. Cross-border data transfers require a so-called transfer mechanism, which can usually be an adequacy decision by the European Commission for a particular country, EU model clauses, or binding corporate rules. Following the judgment of the European Court of Justice in the case “Schrems II,” in which the Court invalidated the EU-U.S. Privacy Shield, transfers to the United States have become particularly onerous to facilitate. Furthermore, EU member states may have introduced additional restrictions for transfers in the context of SaMD. For example, in Germany under the DiGAV, data transfers to the United States or any other non-EU country without an adequacy decision by the EU Commission is generally impossible. However, the German Federal Institute for Drugs and Medical Devices has issued guidance explaining under which circumstances it may be possible to use EU subsidiaries with parent companies in non-EU countries. More information is available <a href="https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/Data_Processing_outside_of_Germany_FAQ.pdf?__blob=publicationFile&v=3" target="_blank">here</a>. Please note, however, that this topic is hotly debated and far from settled.5. How critical is HIPAA for companies in the U.S. market? HIPAA is a critical set of federal standards for privacy and security of protected health information. However, HIPAA is only one piece of the patchwork of privacy and security laws in the United States spanning federal and state requirements that could be applicable to SaMD.Related posts <a target="_blank" href="https://lifesciences.mofo.com/topics/Progress-and-Concerns-of-FDAs-Plan-for-Regulatory-Oversight-of-Artificial-IntelligenceMachine-Learning-AIML-Based-Software-as-Medical-Devices-SaMDs.html">FDA’s Plan for AI/ML-Based Software as Medical Devices: Progress and Concerns</a><a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-Clinical-Decision-Support-Software-vs-EUs-Medical-Device-Regulation.html">FDA Clinical Decision Support Software Vs. EU’s Medical Device Regulation</a>  MoFo Life Sciences also features a six-part blog series discussing software as a medical device in Europe and the current regulatory landscape in more detail. Catch-up on parts 1-5 below and subscribe to our blog to receive the latest updates. <ul><li><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html">New regulatory regime about to enter into force</a></li><li><a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html" target="_blank">A more detailed approach to the “intended purpose” </a> </li><li><a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html" target="_blank">Risk class re-categorization</a></li><li><a href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force-Part-4-of-6.html" target="_blank">Additional quality assurance and documentation requirements for MDSW</a></li><li><a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe--New-Regulatory-Regime-About-To-Enter-Into-Force--Part-5-of-6.html" target="_blank">Introduction of a Unique Device Identification requirement for MDSW</a></li></ul>

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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Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on reg

Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap

The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain vaccine doses as the pharmaceutical industry slows down deliveries due to manufacturing issues. Yet, time is of the essence when it comes to vaccine rollouts, particularly amid a surge in cases due in part to the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.Against this backdrop, it comes as no surprise that certain political voices in Germany are calling for state intervention in the vaccine manufacturing process (see, i.e., the coverage by Central German Broadcasting, in German language). However, the idea that the state could take over production of highly complex vaccines or allow third parties to manufacture their competitors’ proprietary pharmaceuticals faces factual and legal challenges. In this article, we discuss whether German law provides the necessary means for state intervention in vaccine production and what stakeholders should bear in mind.<h4>What would be the basis for state intervention in Germany?</h4>The German legislator amended the German Infection Protection Act (Infektionsschutzgesetz – “GIPA”) at a very early stage of the pandemic, among other things to allow quicker decision‑making processes that will reduce requirements for participation of the German Federal Parliament (Bundestag). It thereby authorized the German Ministry of Health (Bundesministerium für Gesundheit – the “Ministry of Health”) to autonomously[1] take “measures to ensure the supply of medicinal products, including vaccines,” in an epidemic situation of national importance (sec. 5 (2) no. 4 GIPA).The authorizations vested in the Ministry of Health are comprehensive. In the case that the German Federal Parliament declares an “epidemic situation of national importance,” the Ministry of Health can issue statutory decrees, e.g., to:<ul><li>Allow exceptions from provisions of the German Medicines Act (“GMA”) with respect to manufacturing, labeling, approval, clinical testing, use, prescribing and dispensing, import and export, and transfer and liability; </li><li>Order the securing and the use of vaccines; or</li><li>Maintain, convert, open, or close production facilities or individual operating sites of enterprises producing the abovementioned products.</li></ul>The aforementioned list in sec. 5 (2) no. 4 GIPA is exemplary and not exhaustive. Other measures are thinkable, too. In light of the extremely broad competences given to the Ministry of Health, such order could even encompass the manufacturing of vaccines by a new third‑party manufacturer to ensure continuous vaccine supply to the German population.<h4>What are the requirements for such an order?</h4>As the COVID-19 pandemic was already declared an “epidemic situation of national importance” in Germany on March 25, 2020, the only further requirement that would have to be fulfilled is that any of the listed measures would have to be proportionate to reach the purpose of ensuring the supply of the population with medicinal products as part of the maintenance of healthcare. The proportionally test involves three prongs. The question is whether the individual measure is suitable and necessary, as well as appropriate to reach this purpose.[2]The suitability for the intended purpose already faces serious doubts, as it requires that the envisaged measure can at least facilitate such purpose, i.e., accelerate the production of vaccines as part of the maintenance of healthcare. The production of vaccines is an extremely complex process that cannot simply be assigned to any new third party. From a practical point of view, the transfer of vaccine production is highly complex and by no means a fast process. In an interview with the German newspaper Rheinische Post, Dr. Hans-Georg Feldmeier, the chair of the German Pharmaceutical Industry Association (“BPI”), states in this context: “[. . . ] out‑licensing to other manufacturers, regardless of the legal implications, according to our estimations would take at least 12 months or longer for vaccines to become available from this [third-party] manufacturing.” Against this backdrop, it is indeed questionable whether Germany can reach an acceleration in overall production capacity of vaccines by trying to integrate third parties into the process.Even if the answer to this question would be yes, however, the next challenge will be to show the necessity of these measures. This may be difficult as there are likely equally effective options available to the Ministry of Health with fewer limitations of the fundamental rights of the stakeholders involved. First, when looking at the examples of Israel, the United States, and the UK, it is obvious that there are ways to carry out vaccination programs more effectively, short of direct government intervention into vaccine production. Second, it remains possible that simply undertaking higher spending for vaccine purchases now or funding of the establishment of additional production capacities would also be a viable path to resolve the problem. The EU and Germany have applied restrictive policies of vaccine purchases while others were willing to spend significantly more for early shipments (see <a target="_blank" href="https://www.bmj.com/content/372/bmj.n281">here</a>). Third, options to incentivize voluntary cooperation between vaccine developers and candidates for third-party manufacturing as a long-term plan should also be looked at and may be an alternative to unilateral government orders.Regarding the appropriateness of the described measures, it is clear that the vaccine proprietor will suffer extensive interferences with their fundamental rights (i.e., property rights) if they are ordered to enable a new third party to help with the production. For such interferences to be appropriate, the achievement of the pursued purpose of the measure must be highly likely. Yet, it is questionable whether an order by the Ministry of Health could effectively reach the purpose of swiftly ramping up production capacities by involving new third‑party manufacturers. This is because the latter will need to have access to the specific composition and formula of the vaccines. Albeit, this information is part of the dossier that must be filed with the competent authority in the marketing authorization process. This part of the dossier is subject to confidentiality requirements, the so-called data exclusivity. Whether the Ministry of Health could legally base a demand for disclosure of such information simply on sec. 5 (2) no. 4 GIPA may be doubtful. However, even if a general provision like sec. 5 (2) no. 4 GIPA the Ministry of Health could justify such a severe interference with the vaccine proprietors constitutionally protected property rights, the Ministry of Health would face additional factual hurdles. In particular, with regard to the newly developed mRNA-vaccines, specific manufacturing know-how may be required. If such manufacturing know-how was not disclosed as part of the marketing authorization application dossier (e.g., because it has never been put to writing), it is again questionable if sec. 5 (2) no. 4 GIPA will be able to justify a request for disclosure of such confidential information from the vaccine proprietor.<h4>What impact does patent protection have in this respect?</h4>In context of state intervention relating to vaccine manufacturing, patent law exemptions are often praised as salvation. And indeed, as previously <a target="_blank" href="https://www.mofo.com/resources/insights/200414-patent-exceptions-cure-covid-19.html">reported</a>, sec. 5 (5) GIPA[3] authorizes the Ministry of Health to issue administrative orders to use patented technology relating to COVID-19-relevant pharmaceuticals and medical devices. Of course, these instruments will likely be necessary means to circumvent vaccine proprietor’s patent protection relating to the general technology underlying their vaccine (e.g., a type of general mRNA‑related technology). Yet, with respect to the COVID-19 vaccine’s specific features, sec. 5 (5) GIPA orders may not be necessary, at least, if the respective patents are still in the application stage. This is because patent applications do not exclude third parties from using their relevant discoveries and until publication do not even trigger compensation claims.<h4>Will the affected party be compensated?</h4>The Ministry of Health is required to provide for a compensation to be paid to the affected party for any measure that results in expropriation or expropriation-like interference with the affected party’s rights. Such compensation is to be obtained directly from the government and not from third parties authorized by the Ministry of Health or its subordinates to produce or sell the vaccine. The Ministry of Health must lay down the type and scope of such compensation in the underlying statutory decree. Above all, however, the compensation will need to be appropriate. It will be subject to discussion what “appropriate” in this context means. As a statutory decree ordering the manufacturing of a vaccine proprietor’s product by a third party (even if not or not yet protected by patent right) is very similar to the order of a compulsory license to a pharmaceutical patent, it seems worth thinking about adapting the established case law of the German Federal Patent Court (Bundespatentgericht) on drawing upon the concept of an average license fee.  <h4>Who will be liable for damages caused by the vaccine?</h4>If third-party manufacturers operating under an order of a state authority cause harm to others, the question of liability arises. So far, no case law directly relevant to the constellation described herein exists, but it is likely that the competent German Civil Courts will assess damage claims based on the assumption that these manufacturers are so-called “administrative assistants.” In this scenario, if manufacturers cause damages following the Ministry of Health’s order, they cannot be held liable personally; instead, claims must be brought directly against the Ministry of Health (sec. 823 (1) of the German Civil Code and Article 34 of the German Basic Law).<h4>How can an order based on a sec. 5 (4)no. 4 GIPA statutory decree be challenged?</h4>Challenges against an order that is based on the Ministry of Health’s statutory decree issued in accordance with sec. 5 (2) no. 4 GIPA must be brought before the German Administrative Courts. In order to reach a suspending effect, the affected party will need to file for a specific order for interim relief as sec. 5 (4) sentence 5 GIPA provides for the immediate enforceability of any measure ordered by the Ministry of Health. Challenges of the inadequacy of compensation must be brought before the German Civil Courts.<h4>Outlook</h4>It seems as though sec. 5 (2) no. 4 GIPA can pave the way for the Ministry of Health to procure production of COVID-19 vaccines by new third-party manufacturers. However, at a closer look, the complexity and duration of the transfer of production as well as the available alternative means to accelerate the production and availability of vaccines cast serious doubts as to the likelihood and legality of such measures. Yet, as it has always been the case with state intervention, the mere existence of the possibility of a sovereign to intervene can be a persuasive means to leverage market players into increasing their capacities for delivery. If the pandemic has shown one thing so far, it is that cooperation is a key factor in successfully combating the virus and that the stakeholders in the pharma industry are principally willing to work together to deliver on their promises. Thus, it can be expected that an incentive-based strategy would likely lead to increased level of cooperation among key players and subsequently to a higher availability of vaccines while simultaneously protecting the rights of the stakeholders. Either way, now may be a good time for pharmaceutical manufacturers to hold prospective vaccine production capacities out and to brace themselves for potential negotiations and engagement in the production of vaccines, either based on a state order or on licensing deals with vaccine proprietor’s or current manufacturers of COVID-19 vaccines.    [1] Due to the impact on commerce, these statutory decrees are issued in consultation with the Federal Ministry of Health for Economic Affairs and Energy (Bundesministerium für Wirtschaft und Energie).[2] It must be noted that sec. 5 (2) no. 4 GIPA has already been used by the Ministry of Health to enact a number of administrative decrees during the pandemic, which, e.g., allow for facilitated procurement of medicinal products or order hospital pharmacies to stockpile such products for intensive medical care.[3] In conjunction with Section 13 of the German Patent Act (Patentgesetz).

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Counsel

Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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COVID-19: State Intervention in Times of Vaccine Shortages

Using Waivers to Curb COVID-19 Legal Exposure

The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availabil

COVID-19: State Intervention in Times of Vaccine Shortages

Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021 (the Act). The purpose of the Act is to create a structure for the UK Government to legislate for updates or amendments to our existing laws on human and veterinary medicine, clinical trials, and medical devices. Now that the Brexit transition period has come to an end, the Government views the Act as essential in ensuring that the UK retains its position as a world leader in the life sciences industry and is able to take advantage of innovative medicines and technologies more quickly.During its passage through Parliament, the Act was subject to a number of amendments, including the introduction of: (i) an independent Commissioner for Public Safety, and an overarching objective focused on safeguarding public health; and (ii) public consultations in relation to proposed regulations, and requirements for the Medicines and Healthcare products Regulatory Agency (the MHRA) to lay periodic reports before Parliament. These amendments were made to address concerns in the House of Lords surrounding the wide-reaching powers delegated to the MHRA under the Act.One aspect of the Act that remains largely unchanged, however, is the introduction of new enforcement powers for the MHRA. With these new powers, the MHRA can impose either civil or criminal sanctions for breaches of the Act or any secondary legislation made pursuant to it. These offences can be committed by corporates as well as individuals, including company directors. For more information on the offences themselves and the ways in which the resulting penalties can be defended or avoided, see <a target="_blank" href="https://www.mofo.com/resources/insights/201113-uk-life-sciences-regulation-post-brexit.html">our previous alert</a>.Now that the Act has become law, the MHRA must prepare and publish guidance as to the civil sanctions that can be imposed. In particular, the guidance should provide further information regarding monetary penalties and the MHRA’s power to accept enforcement undertakings in place of criminal conviction or the imposition of a fine.  With the objective of the Act being the safeguard of public health and safety it is, however, likely that financial sanctions will be onerous and tolerance for corporates without robust procedures in place will be low.Although the Act now allows the UK the flexibility to respond quickly to medical advances and developments in medical technology, we note that the UK-EU Trade and Cooperation Agreement does not provide for the mutual recognition of regulatory regimes. It will, therefore, be interesting to see how the UK Government and the MHRA seek to balance a new, robust and evolving regulatory regime with the need to remain commercially viable for multinational pharmaceutical companies, medical devices manufacturers and other affected parties that currently operate in both markets. Stephanie Pong, London Trainee Solicitor, contributed to the drafting of this alert.

Of Counsel

Jenny Galloway advises corporate clients and senior executives on a range of complex dispute resolution matters, including general commercial and corporate litigation, investigations and contentious regulatory matters. 

Jenny Galloway

Life Sciences Regulatory Framework Becomes Law Post-Brexit

Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 Febru

Life Sciences Regulatory Framework Becomes Law Post-Brexit

MoFo & GSAS Harvard Biotech Club’s new course, “<a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Legal Topics for Scientists, Entrepreneurs, and Start Ups</a>,” started on November 11, with more than 100 life sciences graduate students, post-docs, and industry professionals. The<a target="_blank" href="https://www.linkedin.com/company/harvard-biotech-club/"> Harvard Biotech Club</a> is a student organization that seeks to bridge the gap between industry and academia. MoFo partners Anita Choi, Andrew Boyd, and Fredo Silva kicked off the course with the first class, “Corporate Due Diligence for Investors and Start-Ups.”Anushree Gulvady who is participating in the course noted that "the MoFo course comes straight from a team of exceptional lawyers and has been immensely informative & enjoyable. As a scientist, I have benefitted a lot from this deep dive into the fundamentals of IP, including patentability, infringement, and due diligence analyses- all integral to biotech start-ups.” Andrew Boyd observed that “it was fantastic to see the level of interest and engagement of the students and be able to share some insights on how our global corporate and IP teams work together to identify and solve diligence issues we see on M&A and investment deals.” Fredo Silva commented that, “until it first happens to them, many companies never really consider the level of scrutiny that comes with the business, technical and legal due diligence in a significant financing raise. By helping prospective entrepreneurs understand how diligence works, we hope they can better operate their business at the early stages to ensure a smooth diligence process later.”Anita Choi added that “IP due diligence often plays a critical role in technology transactions. But the scope of diligence may vary depending on the deal and circumstances. We appreciate the opportunity to share our insights and thoughts on the diligence process. We draw from our group’s extensive experience in helping investors mitigate potential IP risks in their deals, as well as companies navigating the diligence process to get the investment needed to take their company to the next stage of growth.”Upcoming sessions will include classes on “Commercial Life Sciences Transactions and Licensing Issues in a COVID-19 and post-COVID-19 World”; “Raising Angel Investment”; “FDA and Compliance Issues with Testing, Vaccines and Therapies”; “Considerations for ANDA and BPCIA Litigation”; and “The PCT Application Process and International Patent Prosecution.”<a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Learn more about the course</a>.

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

Alfredo Silva is a partner in the Transactions Department, co-chair of the firm's Social Enterprise and Impact Investing Group, and a member of the ESG Strategy Committee.

Alfredo B. D. Silva

Alfredo Silva is co-chair of the firms Social Enterprise + Impact Investing practice and member of the firm’s Pro Bono Committee. He represents public and private companies and investors in a broad range of corporate and securities law matters, as well as nonprofit organizations on entity formation, fiduciary issues, and structuring.

Anita Choi has decades of experience providing strategic advice to companies and investors in the Life Sciences and Food + Agriculture industries. She has helped start-up companies build IP portfolios around their core technologies, and counseled them on issues related to patents versus trade secrets.

Anita Choi

Anita Choi’s practice focuses on patent prosecution, portfolio management, IP due diligence, and IP litigation support. Her clients range from early-stage start-up enterprises to established domestic and international companies. She is well-versed in building and managing worldwide patent portfolios across many sectors and technologies, including small-molecule pharmaceuticals, medical devices, diagnostics, industrial chemicals and advanced materials, food and agtech.

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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.