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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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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Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for PTE, a patent must claim a drug product, a method of using a drug product, or a method of manufacturing a drug product, and PTE is only available for the first approval of an “active ingredient.”The Federal Circuit has addressed the question of what constitutes an active ingredient[1] several times in the context of small molecules. For example, claims directed to a metabolite do not cover the active ingredient,[2] enantiomers of the same compound are different active ingredients,[3] and different salts of the same compound are considered the same active ingredient for purposes of PTE.[4] Although the Federal Circuit case law on small molecules is more developed, it is not clear how the court will apply the current case law and statutory framework to biologics including cell-based therapies and gene therapies.Recent approval of a cell therapy, YESCARTA®, provides insight into considerations from the U.S. Patent & Trademark Office (USPTO) on what constitutes the active ingredient in the context of biologics. The YESCARTA PTE application illustrates two challenges for defining the active ingredient in cell-based therapies to meet the first approval requirement.[5] One challenge is how to define the active ingredient for certain cell-based therapies, where the product differs from patient to patient. Moreover, there is the related challenge of providing a detailed enough description of the active ingredient in the PTE application to allow the USPTO to distinguish the active ingredient of the product from previously approved active ingredients.YESCARTA (Axicabtagene ciloleucel) is an immunotherapy approved to treat B-cell lymphomas. YESCARTA comprises autologous T cells (a type of immune cell that plays a crucial role in detecting and killing cancer cells) derived from an individual patient and engineered specifically to target the patient’s cancer cells. The engineered T cells comprise: (1) T cells harvested from a patient and (2) a foreign protein (i.e., a chimeric antigen receptor (CAR)) specifically targeting a cell-surface protein. The T cells vary from patient to patient, but the CAR is the same for all patients. The T cells containing the CAR are responsible for the anti-tumor activity. All of this raises the question of whether the active ingredient is the T cells and/or the CAR.In the YESCARTA PTE application, applicant Cabaret Biotech Ltd. (“Cabaret”) defined the active ingredient as the engineered T cells. After reviewing the PTE application, the USPTO issued a letter to Cabaret, stating that (a) the cells could not be the active ingredient because the cells differ from patient to patient and (b) the CAR was not an active ingredient because it was not defined in the application as filed. Aside from the challenge surrounding the question “What is the active ingredient?” the USPTO also indicated that the applicant’s description of the structure of YESCARTA was insufficient. The USPTO requested that the applicant comment on whether an earlier approved antibody that targeted the same cell-surface protein was actually the first approval for the active ingredient in YESCARTA.The USPTO never squarely addressed what it considered the active ingredient of YESCARTA to be. After multiple communications between the USPTO and Cabaret, and between the USPTO and FDA, the USPTO approved the YESCARTA PTE application. The information the USPTO finally relied upon for determining that YESCARTA was eligible for PTE was the DNA sequence encoding the CAR. It appears that, based upon the differences in sequences between the YESCARTA CAR and the previously approved antibody, the USPTO determined that YESCARTA contained a new active ingredient.Interestingly, YESCARTA is not the first cell-based product with patient-to-patient variability to receive a grant of PTE. LAVIV® (Azficel-T) is an autologous cell product used for treating moderate to severe wrinkles. In its PTE application, Fibrocell Technologies, Inc. described the active ingredient of LAVIV as an autologous cellular product composed of fibroblasts suspended in a particular cell medium, and listed the active ingredient as “fibroblast cells.”[6] Although LAVIV shares the patient-to-patient variability seen in CAR T cells, the USPTO accepted this designation without further comment.The YESCARTA PTE application illustrates the challenges in applying the active ingredient analysis developed in the small molecule realm to biologics technologies. Precisely how the USPTO views the question of what constitutes an active ingredient in cell-based therapies remains an open question that will most likely be resolved by the courts. This uncertainty, however, has not impeded the grant of PTE for these cell-based therapies. Thus, patentees should not be deterred from filing PTE applications to secure an additional patent term for biologics products, but should keep these challenges in mind when drafting the description of the active ingredient in the PTE application.Follow us to stay up to date on developments regarding PTE. [1] Title 21 of the Code of Federal Regulations defines an “active ingredient” as any component that is “intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.”[2] Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990).[3] Ortho McNeil Pharm. v. Lupin Pharm., 603 F.3d 1377 (Fed. Cir. 2010).[4] Pfizer Inc. v. Dr. Reddy Labs. Ltd., 359 F.3d 1361 (Fed. Cir. 2004).[5] U.S. Patent No. 7,741,465; received at the USPTO on December 14, 2017.[6] U.S. Patent No. 5,591,444; received at the USPTO on August 17, 2011.

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. 

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Associate

Dr. Kate You is a member of the firm’s Patent  Group and focuses her practice on patent prosecution and counseling, including  domestic and international patent preparation and prosecution, and litiga

Yuying (Kate) You Ph.D.

Yuying (Kate) You

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PATENT TERM EXTENSION FOR BIOLOGICS

Transforming the U.S. Healthcare Industry with Blockchain Technology

mofolifesciences-biotech

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent t

PATENT TERM EXTENSION FOR BIOLOGICS

On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since 2014, and the second largest in FCA history. Though $2.8 billion in recoveries are the result of the civil portion of the settlement with Purdue Pharma, the government still collected $2.8 billion from other FCA defendants. This number is in line with recent annual trends and marks an increase from the $2.2 billion collected in fiscal year 2020.  Read full <a target="_blank" href="https://protect-us.mimecast.com/s/j0jCCn5N7lH7m5jJRUJQTzI?domain=www2.mofo.com">client alert.</a>

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Brian Kidd is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice. 

Brian K. Kidd

Brian K. Kidd is former Chief of the Market Integrity and Major Frauds (MIMF) Unit of the Criminal Division’s Fraud Section at the United States Department of Justice (DOJ) and a partner in Morrison & Foerster’s Investigations + White Collar Defense Practice Group. At DOJ, Brian supervised a team of roughly 40 federal prosecutors and oversaw virtually all major fraud cases, with a special focus on investigating and prosecuting complex securities, commodities, and other major corporate fraud cases.

Brian Kidd

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Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense practice. Adam formerly served as an Associate Deputy Attorney General for the U.S. Department of Justice (DOJ) and as the U.S. Attorney for the Southern District of California. 

Adam L. Braverman

Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense group. He represents companies and their executives in internal and government investigations, white collar criminal defense matters, and parallel civil litigation related to allegations of bribery, government procurement fraud, COVID-19 and CARES Act fraud, anti-money laundering violations, and matters involving organized crime.

Adam Braverman

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Demme Doufekias is a trial attorney whose practice focuses on matters involving complex government and internal investigations.

Demme Doufekias

Demme Doufekias represents corporations and individuals in enforcement proceedings and criminal investigations conducted by the U.S. Department of Justice, U.S. attorney’s offices, and other federal enforcement agencies. She also tries civil and criminal cases in federal and state court. Her practice focuses on health care enforcement issues, the Foreign Corrupt Practices Act, and the False Claims Act.What do you like best about your work? Strategy. Investigations and trial work demand a focus on the end game, even as the facts are changing and evolving. You have to be thinking about how multiple scenarios might play out, strategizing ten steps down the road on each one, and staying flexible enough to swap your thinking for something different, depending on how the case develops.What has been the key to your success? Working with smart people who respect collaborative thinking and challenge the whole team to do its best work.What is your favorite thing about your city? How open Washington, D.C. feels because buildings cannot be built higher than the top of the Capitol Building.

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DOJ Releases False Claims Act Statistics for Fiscal Year 2021

DOJ Releases False Claims Act Statistics for Fiscal Year 2021

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On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments

Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets.Digital Transformation in the Life Sciences<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt05435bfbc3932ff8/6273179623c6cf2a1c3af5cf/mofolifesciences-digital-transformation-life-sciences-themes.jpg?format=auto&quality=60" width="650" height="366" type="asset" sys-style-type="download"> The Digital Health sector had a record-breaking year across the board, with investment and M&A at an all-time high and funding for digital therapeutics and mental health tech more than doubled in the last year. Discussion topics included:<ul><li>Best practices for digital health partnerships <ul><li>How to attract the right partners whether you are a startup or a more established digital health company</li><li>Defining your value proposition</li><li>How to partner with payors and other research organizations</li></ul></li><li>Keeping up momentum <ul><li>Access and consumer adoption</li><li>Focusing on personalization</li><li>Reimbursement challenges</li><li>Working with providers</li></ul></li></ul>View the recording <a href="https://www.youtube.com/watch?v=vOMifzAICH8&t=2s" target="_blank">here</a>. Future of Drug Discovery and Diagnostics<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blta22f4b1dbaf8de84/627317964886af2aa2be10fa/mofolifesciences-future-drug-discovery-diagnostics.jpg?format=auto&quality=60" type="asset" sys-style-type="download"> The life sciences industry has experienced tremendous change over the last decade and innovation is moving at a rapid rate, fueled not only by new technologies, but also by strategic collaborations to advance next-gen therapeutics and diagnostics in ways we have not seen before. Discussion topics included:<ul><li>How companies are sourcing deals to expand R&D and product pipelines</li><li>The role of food to influence drug discovery and diagnostics and produce more positive outcomes for patients</li><li>How companies are assessing new technologies to treat disease and the tools of the    future that will lead to effective treatments and diagnostics</li><li>Challenges for startups in drug discovery, including financing and finding the right      talent in a competitive market</li></ul>View the recording <a href="https://www.youtube.com/watch?v=mtLiRhsW3_w&t=4s" target="_blank">here</a>.

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MoForum Recap: Transformation Across the Industry

2022 Life Sciences MOFORUM Starts This Week

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Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and

MoForum Recap: Transformation Across the Industry

Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy. We welcomed 100+ participants over the three-day virtual program to hear from leaders from across the biotechnology, digital health, and healthcare ecosystems on what is driving the industry forward and the challenges and opportunities for new innovation across the sector.Recordings from Day 1 and Day 2 of our program are now available.Digital Transformation in the Life SciencesModerated by: Brigid Bondoc, Of Counsel, FDA Regulatory and Compliance practicePanelists:<ul><li>Melinda Decker, Digital Health Advisor and former Chief Commercial Officer, Mymee</li><li>Chris Bergstrom, President, Amalgam Rx</li><li>Laura Taraboanta, Sr. Manager, Head of Clinical Innovations, Click Therapeutics</li><li>Shaheen Lakhan, Chief Medical Officer, Click Therapeutics</li></ul> <div class="media-wrap embed-responsive embed-responsive-16by9"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" frameborder="0" title="2022 Life Sciences MoForum: Day One YouTube video" src="https://www.youtube-nocookie.com/embed/vOMifzAICH8" height="315" width="560" style="width: 560%; height: 315;" title="iframe"></iframe></div> The Future of Drug Discovery and DiagnosticsModerated by: Matthew Karlyn, Partner, Life Sciences Transactions & Licensing practicePanelists:<ul><li>Scott Carter, Assistant General Counsel, BeiGene</li><li>Michelle Egger, Co-founder & CEO, BIOMILQ</li><li>Daniel Oliver, Co-founder & CEO, Rejuvenate Bio</li><li>William W. Li, M.D., President and Medical Director, The Angiogenesis Foundation</li></ul> <div class="media-wrap embed-responsive embed-responsive-16by9"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" frameborder="0" title="2022 Life Sciences MoForum: Day Two YouTube video" src="https://www.youtube-nocookie.com/embed/mtLiRhsW3_w" height="315" width="560" style="width: 560%; height: 315;" title="iframe"></iframe></div>

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RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY

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Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Inno

RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY

In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access.  This policy change will be effected by the drug’s manufacturers making modifications to their Risk Evaluation and Mitigation Strategy (REMS), a program to restrict distribution of drugs that, in FDA’s judgment, is necessary for the safe and effective administration of such drugs.  The FDA announcement stated that it had ordered the drug’s manufacturers to modify their shared-system REMS to remove the requirement that mifepristone be dispensed only in certain certified in-person healthcare settings and allow for certified pharmacies to dispense the drug.  While the FDA’s announcement was met with much breathless commentary by proponents and opponents of the new policy, implementation is most likely at least a year away, and conflicts with many state laws may preserve the status quo until resolved by a court, effectively preventing mail order delivery of the drug or telemedicine prescribing of the drug in states that currently prohibit such practices.Although many other drugs approved by FDA are subject to REMS, mifepristone is the only drug that FDA requires in-person dispensing.  FDA approved MIFEPREX (mifepristone) for early nonsurgical abortion in 2000, before amendments to the Federal Food, Drug, and Cosmetic Act authorized REMS designation.  Yet, FDA tightly regulated distribution of the drug, requiring in-person administration of mifepristone at a health care facility by a specially trained physician with an in-person signature requirement.  With the accumulation of scientific evidence of the drug’s safety over time, including its use since the 1980s in Europe, FDA and the manufacturers of mifepristone have gradually made changes to the REMS to reduce barriers to access, including prescribing by non-physicians, allowing patients to take the medication at home, and extending the gestational period during which the medication is approved for use from seven weeks to ten weeks.  The COVID-19 pandemic, which has placed unprecedented burdens on the health care system and made in-person appointments more risky for patients and providers, likely created the conditions for a change in the in-person dispensing and signature policy at the federal level.  The American College of Obstetricians and Gynecologists and others sued FDA to eliminate these in-person requirements during the public health emergency and were successful in the trial court.  FDA’s announcement mooted the case on appeal.As of June 16, 2021, at least nineteen (19) states prohibited telemedicine abortion, either expressly or impliedly, by requiring the prescribing clinician to be physically present with the patient.[1]  Moreover, there are also twenty-six (26) states that require patients to receive an ultrasound before an abortion and another twelve (12) that have in-person counseling requirements.[2]  In other words, the option for a telehealth protocol for medication abortion  is currently available in only 22 states and DC.  This acutely demonstrates the conflict that can arise between the traditional domain of the states with respect to regulation of the healthcare professions (including medicine and pharmacy) and the execution of federal health care policies. Some argue that REMS should preempt the state laws  in this particular situation because FDA’s modification to the REMS for mifepristone considered factors that place the state laws in direct contradiction.  Others argue that the REMS would not preempt more stringent state laws that would prohibit a provider from prescribing the drug via a telemedicine setting.  Another potential outcome is that a court could allow an alternative approach, such as allowing states to impose telemedicine restrictions but preempting state restrictions on distribution of the medication (e.g. via the mail) or declaring such restrictions a burden on interstate commerce.  A compromise along those lines would mean that the need for an in-person visit would hinder initial access for rural populations; however, a patient’s local pharmacy could then dispense the medication or a mail-order pharmacy could deliver the medication to a patient’s home.Although the consumer uptake of telemedicine continues to increase at a rapid pace during the public health emergency, it remains to be seen whether the modification of the REMS for mifepristone will result in wider access to the drug through telemedicine.  Setting aside the deep rifts in public opinion on the issue of abortion, another likely reason that companies have yet to undertake offering mail order mifepristone is likely due to the national scope of their businesses.  State-by-state regulatory hurdles, which require different processes and procedures, create operational hurdles that are time consuming and burdensome to overcome.  Without federal legislation legalizing the use of telemedicine to prescribe mifepristone, or a court decision that clarifies the roles of the states and federal government respectively, the nationwide patchwork of requirements will likely remain barriers to businesses who would otherwise enter this market.<a href="file:///C:/Users/cxm41/AppData/Roaming/OpenText/DM/Temp/NEW_YORK-%232322920-v2-JURISDICTIONAL_CONFLICT_OVER_ABORTION.docx#_ftnref1">[1]</a> Kaiser Family Foundation, Medication Abortion and Telemedicine: Innovations and Barriers During the COVID-19 Emergency (June 16, 2021), <a href="https://www.kff.org/policy-watch/medication-abortion-telemedicine-innovations-and-barriers-during-the-covid-19-emergency/">https://www.kff.org/policy-watch/medication-abortion-telemedicine-innovations-and-barriers-during-the-covid-19-emergency/</a>.<a href="file:///C:/Users/cxm41/AppData/Roaming/OpenText/DM/Temp/NEW_YORK-%232322920-v2-JURISDICTIONAL_CONFLICT_OVER_ABORTION.docx#_ftnref2">[2]</a> Id.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use

Is 2021 the Value-Based and Shared Savings Revolution?

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In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the deliver

FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use

Morrison & Foerster kicked off its virtual <a target="_blank" href="file://BTUsers.mofo.com/USERS/PEOPLE/KTMhttps:/www.mofo.com/resources/events/220125-life-sciences-moforum-2022.html4/My%20Documents/Chambers">2022 Life Sciences MOFORUM</a> – Growth, Innovation, and Strategy on January 25, 2022. With three days of programming planned, the series started with a discussion on the “Digital Transformation in Life Sciences,” featuring digital health advisor Melinda Decker, Chris Bergstrom of Amalgam Rx, and Shaheen Lakhan and Laura Taraboanta of Click Therapeutics. The conversation focused on best practices for engaging in partnerships, how to scale digital health solutions, and predictions and trends for the digital health sector going forward.The program continues on Wednesday, January 26 with “The Future of Drug Discovery and Diagnostics.” Featuring industry leaders including Scott Carter of Beigene, Michelle Egger of BIOMILQ, and Daniel Oliver of Rejuvenate Bio, the panel also includes Dr. William Li, President and Medical Director at The Angiogenesis Foundation and an internationally renowned physician, scientist, and author of the New York Times bestseller, “Eat to Beat Disease.” Continuing the theme of transformation, this discussion will focus on the rapid pace of innovation across the industry and how advancements in next-gen therapies and diagnostics are leading to new business models and changing the life sciences landscape.Finally, on Thursday, January 27, we will conclude our program with a keynote fireside chat featuring Shannon Klinger, Chief Legal Officer of Moderna, who will share her perspective on how the industry has shifted over the last few years, its response to the pandemic, and the challenges facing life sciences innovators today and in the future.Subscribe to MoFo Life Sciences for updates from the MOFORUM sessions and invitations to future events.Complimentary Masterclass InvitationMoFo Life Sciences subscribers are invited to register for Dr. William Li’s upcoming masterclass where he shared his wealth of knowledge and research that has impacted more than 50 million lives. As a true pioneer in food as medicine, Dr. Li has discover more than 200 foods that activate the body’s hardwired health defense systems: angiogenesis, regeneration, microbiome, DNA protection, and immunity. During this 60-minute masterclass, Dr. Li will break down each of the health defense systems to help you understand the basis of how they function and then share specific foods that you can use to activate each one.