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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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

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Privacy Act (GIPA) became the latest state genetic data privacy law to go into effect, adding to a growing number of state laws that require special protections for genetic data. This new law, signed by California Governor Gavin Newsom on October 6, 2021, impacts direct-to-consumer (DTC) genetic testing companies as well as service providers to those companies. Read our <a href="https://www.mofo.com/resources/insights/220118-latest-genetic-data-privacy-law.html?utm_source=publication&utm_medium=email" target="_blank">client alert.</a>

Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector.

Melissa M. Crespo

Melissa Crespo

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Latest Genetic Data Privacy Law Goes into Effect

Latest Genetic Data Privacy Law Goes into Effect

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California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Priva

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>.

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FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

Is 2021 the Value-Based and Shared Savings Revolution?

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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

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

The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications.  The number of published bioinformatics patents and patent applications in the last decade has nearly doubled.  Bioinformatics patents face an uphill battle due to subject matter eligibility challenges.  Within the last five years, the majority of bioinformatics patent applications faced a Section 101 rejection. The challenges continue after prosecution, such as in <a href="https://cafc.uscourts.gov/sites/default/files/opinions-orders/20-1012.OPINION.3-11-2021_1746411.pdf" target="_blank">In re Board of Trustees of Leland Stanford Junior University</a>, where the Federal Circuit affirmed Patent Trial and Appeal Board (PTAB) decisions finding two Stanford patents directed to haplotype phasing ineligible as abstract ideas.  And more recently, the Federal Circuit ruled yet another CardioNet heart monitor patent as invalid for not citing an inventive concept in <a href="https://cafc.uscourts.gov/opinions-orders/20-2123.opinion.10-29-2021_1857410.pdf" target="_blank">CardioNet, LLC v. InfoBionic, Inc</a>. There are drafting techniques that may be used to help preemptively address subject matter eligibility concerns, such as providing as much detail as possible about the algorithm, specifying any improvements to computer functionality achieved by the claimed invention, and phrasing the title, abstract, and claims so that the application is routed to a certain art unit.  However, once a patent issues, whether it will survive subject matter eligibility challenges in court remains uncertain given the Federal Circuit’s treatment of the United States Patent and Trademark Office (USPTO) Guidance as not binding.  Going forward, we should expect to see additional efforts by the USPTO to clarify subject matter eligibility and attempt to reconcile its differences with the Federal Circuit.  The USPTO just announced its <a href="https://www.uspto.gov/patents/initiatives/patent-application-initiatives/deferred-subject-matter-eligibility-response#:~:text=The%20Deferred%20Subject%20Matter%20Eligibility,to%20traditional%20compact%20prosecution%20practice." target="_blank">Deferred Subject Matter Eligibility Response (DSMER) Pilot Program</a>, designed to evaluate the impact of deferred responses on subject matter eligibility.  The USPTO will also likely update its Guidance in the coming year, which it has historically updated every 1‑2 years but has not since October 2019.

Round Rock Research, LLC v. [Multiple Defendants]

Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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Of Counsel

A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

Jean Nguyen Ph.D.

Jean Nguyen

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Bioinformatics Patents – Subject Matter Eligibility in 2022

Bioinformatics Patents – Subject Matter Eligibility in 2022

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The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applicati

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

FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021.  The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022.  The session included presentations from Ann Oxenham (CFSAN), William Maisel (CDRH), and Donald Ashley (CDER).Below are key takeaways from some of the panels:1. CFSAN – Focus on Undeclared Allergens: Ann Oxenham highlighted the division’s 2021 accomplishments, including seizures, injunctions, and warning letters.  In particular, she emphasized warning letters issued for undeclared food allergens, which were the leading cause of class 1 food recalls in the past year.  Oxenham noted that FDA is working to improve industry compliance with regard to food allergen requirements, and is conducting inspections and sampling to check that major food allergens are properly labeled and that food facilities implement appropriate controls.In 2021, FDA issued seven <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whole-foods-market-610862-12162020">warning letters</a> to facilities that manufactured and distributed food with undeclared allergens. Oxenham noted that, “although retail establishments are generally excluded from certain requirements, they are responsible for ensuring that the labeling for food manufactured under their brand name and the labeling they perform in the store is accurate with respect to allergens.”  In 2022, CFSAN will continue its particular focus on undeclared allergens.2. CDRH – FDA Inspection Priorities: William Maisel discussed CDRH’s continued focus on fraudulent COVID-19 products and the status of FDA inspection oversight.  CDRH is currently operating at its base case scenario, with domestic surveillance inspections resuming and foreign inspections occurring if mission-critical.  Maisel noted that CDRH is prioritizing using a risk-based approach, and anticipates the use of remote regulatory assessments for medical device evaluations continuing in the future. Maisel also highlighted the increased use of the Medical Device Single Audit Program (MDSAP).  MDSAP allows a recognized third-party auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program, including the FDA.  In the past year, more than 2,000 MDSAP audit reports were used in lieu of FDA surveillance inspections, and FDA will continue to accept MDSAP audit reports as a substitute for routine agency inspections.In addition, FDA is working to harmonize and modernize the Quality System regulation, with revisions to supplant existing requirements with the specifications of ISO 13485.  Maisel noted that the proposed rule is coming soon.3. CDER – Novel cGMP Compliance Actions: Donald Ashley highlighted the novel compliance actions developed during the pandemic, including analytical testing of drugs at the border and import alerts.  Some of these measures were developed to address methanol-contaminated hand sanitizers imported into the U.S. and FDA issued the first-ever warning letters based upon analytical testing of samples collected at the border.  FDA also issued the first-ever warning letters based on 704(a)(4) records requests, as well as warning letters based on the refusal of those records requests.Ashley also noted FDA’s <a href="https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-panexcell">public notification</a> informing industry that clinical and bioanalytical studies conducted by Synchron Research Services and Panexcell Clinical Lab were not acceptable in NDAs and ANDAs because of data-integrity concerns.  Applications using studies conducted by these CROs will need to be repeated, and this has affected more than 100 drug applications.For questions on any of the topics discussed, please contact the authors or a member of <a href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html">MoFo’s FDA Regulatory + Compliance practice</a>.

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3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

mofolifesciences-litigation

FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021.  The session titled Compliance Central with FDA Center Compliance 

3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

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

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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