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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Is Your Claim Open or Closed? Claim Construction Takes on a New Meaning in Eye Therapies, LLC v. Slayback Pharma, LLC

Need to FAST Track Your Patent? The USPTO increases the Annual Limit to 20,000

What Makes a Good Cell and Gene Therapy Application?

A Tip for Improving Your “Improved” Jepson Claim: Include Written Description Support

USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

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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 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

Biotech

Healthcare

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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.

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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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2022 Life Sciences MOFORUM Starts This Week

2022 Life Sciences MOFORUM Starts This Week

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Morrison & Foerster kicked off its virtual 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy on January 25, 2022. With three days of programming pla

United States

Digital Health

Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product approvals, and post-approval monitoring of drugs.“Overall, the draft guidance aligns with other steps FDA has undertaken, including the ongoing Complex Innovative Trial Design Pilot Meeting Program, which is intended to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs,” the authors wrote. “Such innovative trial designs offer the prospect of greater efficiency and smaller cohorts of participants by sharing control arms and studying multiple agents in the course of the same study.”They added: “The goals of this draft guidance also appear to align with the industry guidance FDA issued for sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19 in which FDA has discussed how novel study design models can help researchers “do more with less” through more judicious use of human subjects in research and greater use or re-use of existing data sources. For instance, in the COVID-19 master protocol guidance, the agency has endorsed adoption of more complex research models that either share control arms, draw more heavily on existing data, or use data iteratively to refine the study on an ongoing basis, such as via Bayesian models in which results in one stage of a study can influence what variables or interventions are examined in the next. Master protocols are research plans that govern studies designed to examine multiple therapies, multiple diseases, or both, in the context of a single research study. In its guidance on the use of master protocols, the agency has articulated the potential public health benefits that could accrue from more flexible research designs, while emphasizing that with complexity can come increased risk of confusion or error. As the FDA has indicated its receptiveness to innovative research modalities, it has also made clear that its underlying high standards for scientific rigor remain unchanged.”Read the <a href="https://www.clinicalleader.com/doc/fda-releases-draft-guidance-on-use-of-real-world-evidence-for-drug-biological-products-0001" target="_blank">full article</a>.

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its lates

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

Regulatory

Cell + Gene Therapy

Starting February 1, 2022, the U.S. Patent and Trademark Office (USPTO) will begin inviting selected applicants to participate in a <a href="https://www.uspto.gov/patents/initiatives/patent-application-initiatives/deferred-subject-matter-eligibility-response" target="_blank">pilot program</a> to defer subject matter eligibility examination until final disposition of the application or all other rejections have been addressed. The theory behind the program appears to be that satisfaction of other patentability conditions (e.g., novelty, non-obviousness, and written description) may resolve subject matter eligibility issues as well. Continuation and divisional applications, reissue applications, and applications accorded special status (such as Fast- Track applications) are not eligible for the program. Applications must raise both subject matter eligibility rejections and non-subject matter eligibility rejections to be eligible. Participating examiners may invite the applicant of a prospective pilot application to participate in the pilot program by including a form paragraph in the first Office action on the merits. An applicant can then elect to accept the invitation and participate in the program or decline. To accept the invitation, the applicant must file form PTO/SB/456. Once in the program, the Examiner will assess all bases of patentability, including subject matter eligibility, in each office action. In response, the applicant is able to defer presenting arguments, evidence, or amendments in response to the subject matter eligibility rejection(s) until the earlier of final disposition of the application or the withdrawal or obviation of all other outstanding rejections. “Final disposition” of the application is the first of (1) mailing of a notice of allowance, (2) mailing of a final Office action, (3) filing of a notice of appeal, (4) filing of a request for continued examination (RCE), or (5) abandonment of the application.It will be interesting to see how many applicants elect to enter the program and whether it meaningfully impacts patent quality or time to issuance. The program still requires examiners to evaluate subject matter eligibility early on in prosecution. However, applicants may benefit from the program by avoiding wasted time and effort wading into arguments in the sometimes murky area of subject matter eligibility. Instead, applicants can focus their prosecution efforts on more straightforward novelty and non-obviousness analyses, which may also resolve the subject matter eligibility issue.Read more about the program <a href="https://www.federalregister.gov/documents/2022/01/06/2021-28473/deferred-subject-matter-eligibility-response-pilot-program" target="_blank">here</a>.

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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USPTO Launches Program to Defer Subject Matter Eligibility Responses

USPTO Launches Program to Defer Subject Matter Eligibility Responses

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Starting February 1, 2022, the U.S. Patent and Trademark Office (USPTO) will begin inviting selected applicants to participate in a pilot program to defer subje

Intellectual Property

Bioinformatics

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

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Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

Transforming the U.S. Healthcare Industry with Blockchain Technology

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

Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

Litigation

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of focus and continued priority for 2022.Below are three key areas of focus:<ol><li>COVID Fraud. Misconduct related to the pandemic and COVID-19 was and remains a top priority. The Consumer Protection Branch will continue its collaboration with the Federal Trade Commission (FTC) to address COVID fraud and prevent fake and unapproved treatments and cures from reaching consumers. Rao noted that the FTC is referring an increasing number of civil penalty actions to the Consumer Protection Branch, and DOJ will continue to pursue civil and criminal penalties where applicable.</li><li>Opioids. The opioid epidemic remains a key area of focus for the Consumer Protection Branch. Rao pointed to examples of recent enforcement action, including Walmart and Purdue, and noted that the Consumer Protection Branch continues to pursue injunctive and civil penalty actions against local pharmacies, pharmacists, and prescribers in addition to manufacturers. Rao reiterated that it is important for manufacturers creating a product that can be used to manufacture a controlled substance to know their customers.</li><li>Clinical Trial Fraud. Rao highlighted two recent cases in Southern Florida, Unlimited Medical Research and Tellus Clinical Research, both of which involved clinical trial fraud schemes involving fabricated data and falsifying data and medical records. The Consumer Protection Branch expects to bring further actions in the coming months.  The increase in use of remote clinical trial monitoring during the pandemic may contribute to an increase in clinical trial fraud enforcement actions going forward.</li></ol>For questions on any of the topics discussed, please contact the authors or a member of MoFo’s <a href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html" target="_blank">FDA Regulatory + Compliance practice</a>.

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Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

Privacy Litigation 2020 Year in Review: BIPA Litigation

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FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Departme

Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

COVID-19

On September 30, 2021, the U.S. Food and Drug Administration (FDA) <a target="_blank" href="https://www.federalregister.gov/documents/2021/09/30/2021-21324/interpreting-sameness-of-gene-therapy-products-under-the-orphan-drug-regulations-guidance-for">announced</a> final guidance titled “<a target="_blank" href="https://www.fda.gov/media/134731/download">Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations</a>.”  The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria that help determine sameness of human gene therapy products for orphan drug designation and exclusivity purposes.  In the Federal Register notice announcing the final guidance, FDA noted that it received comments on the draft guidance that “generally supported the approach described in the guidance.”  FDA considered these comments and requests for additional clarification when finalizing the guidance, “adding clarification and examples, as feasible.”<h4>Background</h4>The Orphan Drug Act (ODA) seeks to incentivize the development of drugs for rare diseases, defined in the ODA as those affecting fewer than 200,000 people in the United States.  The incentives include a 25% tax credit on applicable research and development expenditures, waived user fees when submitting applications to FDA, and the potential for a seven-year period of orphan drug exclusivity for the approved indication.  Manufacturers must request and be granted designation before they are eligible for any incentives. When FDA grants marketing approval for a designated orphan drug for a use or indication within the designation disease or condition, FDA will determine if the drug is eligible for orphan drug exclusivity.  Orphan drug exclusivity is product and indication specific, meaning FDA cannot approve a drug containing the same active moiety for the same intended use or indication during the period of marketing exclusivity. FDA uses different criteria in determining sameness for macromolecule and small molecule drugs [1]. The FDA defines “same drug” for macromolecule drugs as “a drug that contains the same principal molecular structural features (but not necessarily all of the same structural features) and is intended for the same use as a previously approved drug, except that, if the subsequent drug can be shown to be clinically superior, it will not be considered to be the same drug." [2]If a sponsor requests orphan drug designation for a drug that is the same as a drug already approved for the same use or indication, the sponsor must provide a plausible hypothesis that its drug is clinically superior to the already approved drug.  Designation as clinically superior is based on greater efficacy, safety, or a major contribution to patient care.  In order to receive the seven-year market exclusivity, a sponsor must demonstrate that its product is actually clinically superior.<h4>Interpreting Sameness of Gene Therapy Products</h4>Human gene therapy products may qualify for orphan drug designation if they are intended for the treatment of a rare disease or condition and the sponsor sufficiently establishes a basis for expecting the drug to be effective in treating the rare disease.  The existing regulations do not describe how the “same drug” definition applies specifically to gene therapy products for orphan drug designation and exclusivity.  Mirroring the January 2020 draft guidance, FDA’s final guidance provides some insight into the current interpretation of how the “sameness” criteria applies to gene therapies.Assuming that two gene therapy products are intended for the same use or indication, FDA will consider the “principal molecular structural features” of the gene therapy products when determining “sameness.”  In the final guidance, FDA states its intention to generally “consider certain key features such as transgenes and vectors used in gene therapy products to be ‘principal molecular structural features’ under this regulation.”  However, FDA does not intend to classify two gene therapy products as different based solely on minor differences in the transgenes and/or vectors, and will determine whether differences are minor differences on a case-by-case basis.For two gene therapy products intended for the same use or indication, if the products express different transgenes, FDA generally intends to consider them to be different drugs because they will not contain the same principal molecular structural features.  This would be the case regardless of whether the two gene therapy products at issue have or use the same vector.  FDA also intends to consider vectors from a different viral group to be different for purposes of determining “sameness.”  Additionally, FDA clarified in the final guidance that it will consider two gene therapy products from the same viral group to be different “when the differences between the vectors impact factors such as tropism, immune response avoidance, or potential insertional mutagenesis.”  FDA intends to determine whether variants of a vector from the same viral group are the same or different on a case-by-case basis.In a case where two gene therapy products express the same transgene and have/use the same vector, FDA may also consider additional features of the final product when determining “sameness,” such as regulatory elements (e.g., promoters or enhancers).  In these instances, FDA generally intends to determine “sameness” of gene therapy products on a case-by-case basis.[1] 21 CFR 316.3(b)(14).[2] 21 CFR 316.3(b)(14)(ii).

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FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

The EU General Court’s Ruling on Pay for Delay

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On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orp

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products