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

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

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

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

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

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Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

April 2025 Update on Regulation of New Genomic Techniques in the EU

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of two doses taken three weeks apart, and is indicated for use in individuals 16 years of age and older.The official authorization follows <a target="_blank" href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement#event-information">Thursday’s meeting</a> of FDA’s Vaccines and Related Biological Products Advisory Committee to review and discuss information about the vaccine. The external advisory panel voted to recommend that FDA grant authorization, agreeing that the benefits of the vaccine outweigh its risks for use. While it did not ultimately have to follow the Committee’s recommendation, FDA <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19">officially did so</a> on Friday.<h4>Emergency Use Authorization</h4>An EUA grants FDA “authorization,” which is not the same as FDA “approval.” Vaccines are typically approved though a biologics license application, which can require years of clinical testing and back-and-forth with regulatory authorities. FDA uses this pathway to ensure that products meet a certain standard of safety and effectiveness. The EUA application and review are an abbreviated authorization process that only requires a showing that the product’s benefits outweigh its risks.EUAs have already issued for a variety of products like test kits, face masks, ventilators, and other drugs and devices used during the COVID-19 pandemic. Although the EUA process is not new, this is the first time that FDA is authorizing a vaccine product through the expedited EUA pathway. Drug and biologic products pose greater risks than diagnostics and PPE, and require clinical data to evaluate safety and effectiveness. While authorization was granted for the vaccine, a recurring issue in Thursday’s committee meeting was the additional information and data FDA may want from Pfizer as the vaccine moves from authorization to full approval through a BLA.<h4>The First of Its Kind</h4>In addition to being the first vaccine to be granted EUA, the Pfizer/BioNTech vaccine is also the first mRNA vaccine ever to be made available for mass inoculation. Unlike most vaccines, which use weakened or inactivated pathogens to trigger an immune response in the recipient, the Pfizer/BioNTech COVID-19 vaccine contains temporary genetic material (mRNA) that codes for the spike protein found on the surface of the novel coronavirus. Once the vaccine is administered, cells in the recipient’s body take up the mRNA and temporarily produce and display this same spike protein on their surfaces until the mRNA is degraded. The body’s immune system recognizes the spike protein as foreign and starts making antibodies. Thus, if the vaccine recipient were exposed to the coronavirus in future, the body would already know how to mount the appropriate immune response before the recipient developed symptoms.Though this is the first time an mRNA vaccine has been authorized for use on the general public, FDA has emphasized that these vaccines will be held to the same <a target="_blank" href="https://www.fda.gov/media/139638/download">standards</a> of safety and efficacy as any other type of vaccine. To that end, in the <a target="_blank" href="https://www.fda.gov/media/144245/download">briefing</a> document provided ahead of the December 10 meeting, VRBPAC reported an extensive body of data relating to Pfizer/BioNTech’s ongoing phase-3 randomized, double-blinded, and placebo-controlled trial of the vaccine in approximately 44,000 participants. These data played a key role in informing the committee’s decision to recommend authorization of the vaccine.<h4>Risk-Benefit Analysis</h4>There was significant discussion in Thursday’s Advisory Committee meeting around potentially contraindicated populations in light of two adverse events in vaccine recipients with known allergies to medications. It appears that FDA has worked with Pfizer to draft suitable warning language and contraindications for that population. The CDC stated on a conference call Sunday that people with a history of severe allergic reactions can still take the Pfizer/BioNTech vaccine, but recommends that they discuss the risks of doing so with a doctor and be monitored for 30 minutes following administration.The Committee also focused on the indicated age group for the vaccine. Younger populations are known to contract COVID-19 at lower rates and to not experience symptoms as severely as other groups, limiting the benefit of approving the vaccine for those groups. FDA ultimately authorized the vaccine for use by people aged 16 years and older. Since the authorization, CDC’s Advisory Committee on Immunization Practices (ACIP) has also recommended the vaccine for use in this population.<h4>Distribution Roadmap</h4>Although the vaccine has been authorized for use in the U.S., safety monitoring is an ongoing concern. FDA has, in the case of hydroxychloroquine, revoked an EUA following serious adverse events and questionable efficacy data. As a condition of authorization, Pfizer must report serious adverse events associated with the vaccine to the Vaccine Adverse Event Reporting System.The vaccine will likely be distributed according to <a target="_blank" href="https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm?s_cid=mm6949e1_w">CDC’s guidance</a> that health care personnel and long-term care facility residents be vaccinated in the initial phase. While not included in the initial phase, ACIP also identified older individuals and those with underlying medical conditions as potential future priority groups. To prepare for the vaccine rollout, CDC has compiled <a target="_blank" href="https://www.cdc.gov/vaccines/covid-19/index.html">clinical information</a> and <a target="_blank" href="https://www.cdc.gov/vaccines/ed/index.html">training resources</a> and recommended that all health care personnel administering vaccines receive comprehensive competency-based training on vaccine policies and procedures.VRBPAC will hold another <a target="_blank" href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement">meeting this week</a> to discuss the EUA application for a second COVID-19 vaccine submitted by Moderna, Inc. Stay up-to-date with the latest legal and regulatory COVID-19 developments at MoFo’s <a target="_blank" href="https://lifesciences.mofo.com/">Life Sciences</a> blog.

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Dr. Garreth McCrudden is a member of the Intellectual Property Group and focuses his work on patent prosecution and portfolio management for clients in the chemical and pharmaceutical fields.
Prior to

Garreth W. McCrudden, D.Phil.

Garreth McCrudden

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FDA Authorizes First COVID-19 Vaccine

Using Waivers to Curb COVID-19 Legal Exposure

Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccin

FDA Authorizes First COVID-19 Vaccine

Session 2 of the GSAS Harvard Biotech Club and Morrison & Foerster course on <a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Legal Topics for Scientists, Entrepreneurs, and Start Ups</a> was led by <a target="_blank" href="https://www.mofo.com/capabilities/technology-transactions.html">Transactions and Licensing</a> partner Matt Karlyn and focused on how to navigate commercial life sciences transactions and licensing issues in a COVID-19 and post-COVID-19 world.Matt discussed three key aspects, the commercial aspects of AI and COVID-19, the critical aspects of cloud transactions, and the collaborations in a COVID-19 world. Maryam attended the session and shared that "The MoFo course offers an innovative and novel approach for acquiring the knowledge that is essential to successfully form or run a start-up. Several crucial topics are covered during the sessions including IP due diligence, licensing and patentability issues. The course also includes some of the top challenges in the industry transactions including the role of artificial intelligence in a COVID-19 world where you get to stay abreast of the latest developments in the health-care industry."<a target="_blank" href="https://www.mofo.com/capabilities/emerging-companies-venture-capital.html">Emerging Companies + Venture Capital</a> partner Jim Krenn followed in session 3 providing current and future entrepreneurs with the fundamentals of raising angel investments including the deal process, the different deal structures, and the general solicitation and equity crowdfunding. Jim commented that "angel investments are often the first type of outside capital that companies raise. We hope that by walking prospective entrepreneurs through the process, most common structures, key terms and related considerations around these investments, they can be better prepared to raise funds from angel investors to position their companies for future success."This week, we’ll turn to MoFo partner and head of our <a target="_blank" href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html">FDA Regulatory + Life Sciences Compliance</a> practice Bethany Hills to lead session 4 on COVID-19: FDA and Compliance Issues with Testing, Vaccines, and Therapies.

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Co-Chair of Emerging Companies + Venture Capital Practice

Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.

Jim Krenn

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Matt Karlyn has 23 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensi

Matt Karlyn

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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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Navigating Transaction and Licensing Issues in a COVID-19 World and Raising Angel Investments

GSAS Harvard Biotech Club and Morrison & Foerster’s Patent Course Off to a Roaring Start!

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Session 2 of the GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups was led by Transactions a

Navigating Transaction and Licensing Issues in a COVID-19 World and Raising Angel Investments