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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<a href="http://lifesciences.mofo.com/topics/2019-FDA-enforcement-related-litigation-trends.html" title="2019 FDA Enforcement and Related Litigation Trends (Part 1)" target="_blank">Yesterday</a>, we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent DecreesFDA published press releases about six consent decrees in 2019.  As discusssed in Part One, compounding facilities were a focus of FDA enforcement in 2019, and this focus included entering consent decrees, with four of the six consent decrees in 2019 entered against compounding facilities.On February 6, 2019, the U.S. District Court for the Western District of Pennsylvania entered a consent decree between the United States and Ranier’s Rx Laboratory Inc., and owner Francis H. Ranier for manufacturing purportedly sterile drug products in insanitary conditions.  When announcing the consent decree, then-Commissioner Gottlieb stated, “We continue to see concerning activity when it comes to some compounded drugs, including problems related to the conditions under which compounded sterile medicines are made, which can raise significant risks to patients.  This is an area of intense focus for FDA.  We’re committed to making sure that compounded drugs are made under appropriate production standards and, when necessary, taking enforcement actions against compounders who fail to produce sterile drugs in compliance with the law.”   On March 12, 2019, the U.S. District Court for the Northern District of Texas entered a consent decree against Guardian Pharmacy Services and owner Jack Munn.  When announcing the consent decree, Commissioner Gottlieb again confirmed FDA’s enforcement focus on compounding facilities, stating, “Although compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA approved drug product, compounded drugs can also pose unique risks.  They’re not FDA approved and do not undergo premarket review for safety, effectiveness or quality.  All drug compounders must comply with certain requirements, which can include current good manufacturing practice requirements, to avoid product quality problems and potential patient harm.”  According to the complaint, Guardian manufactured and distributed purportedly sterile drug products that were manufactured under insanitary conditions.  Additionally, Guardian’s labels were false or misleading and did not include adequate directions for patient use. On May 22, 2019, the U.S. District Court for the Southern District of Texas entered a consent decree against Pharm D Solutions, LLC, and owners Luis R. De Leon and Juan C. De Leon.  When announcing the consent decree, Acting Commissioner Sharpless stated, “We understand that compounded drugs can be important for patients whose medical needs cannot be met by FDA-approved drug products, and we’re continuing efforts to advance policies to help further improve the quality of compounded products. . . .  These drugs are not approved by the FDA and have not been evaluated for safety or efficacy, so when they’re not appropriately compounded, they have the potential to cause patients harm.  We’ll continue taking enforcement actions, like the one we’re taking today, to ensure that these companies and products do not put patient health at risk.”  According to the complaint, Pharm D Solutions manufactured and distributed drugs that were made under insanitary conditions, had strengths different from what they were represented to possess, and did not include adequate directions for use. Also on May 22, 2019, the U.S. District Court for the Northern District of Illinois entered a consent decree against PharMedium Services and president and vice president Scott Aladeen and Warren Horton for violations at multiple facilities including manufacturing drugs under insanitary conditions and failing to include adequate directions for use.  When announcing the consent decree, Acting Commissioner Sharpless stated, “We will continue to take appropriate actions when compounding pharmacies and outsourcing facilities produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm to patients.”The other two consent decrees were entered on July 18, 2019 and September 3, 2019, respectively, against an Arkansas food and medical product grocery warehouse, J and L Grocery, LLC, for insanitary conditions, and Tennessee drug, dietary supplement, and device distributors Basic Reset and Biogenyx, for distributing unapproved drugs and devices, failing to comply with CGMPs for dietary supplements, and distributing dietary supplements with incomplete labeling. Check back tomorrow for Part Three of our series, where we’ll take a look at some of the Department of Justice enforcement trends in 2019.

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2019 FDA Enforcement and Related Litigation Trends (Part 2)

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Yesterday, we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our 

2019 FDA Enforcement and Related Litigation Trends (Part 2)

The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April.  For the bulk of the year, FDA was led by Acting Commissioner, Ned Sharpless, until Brett Giroir took over in November, and ultimately, Stephen Hahn was sworn in as the 24th Commissioner of Food and Drugs on December 17, 2019.  In this three-part series, we’ll take a look back at FDA’s enforcement actions over the past year, discuss trends and focuses, and look forward to what we might be able to expect from FDA in 2020. The BasicsFDA conducted a total of 18,034 inspections in FY 2019, 14,377 of those being domestic inspections.  This is a decrease from FY 2018, when there were 21,343 inspections, with 17,330 being domestic inspections. The following shows the breakdown of the different kinds of firms undergoing inspections:As has been the case in previous years, the majority of inspections resulted in a classification of No Action Indicated (NAI). FDA issued a total of 15,015 Warning Letters in FY 2019, which is a slight increase over 2018, but still below the total for 2017.In FY 2019, 14,929 Warning Letters were sent to domestic firms, and 88 were sent to foreign firms.  In FY 2018, 14,358 Warning Letters were sent to domestic firms, and 131 Warning Letters were sent to foreign firms.  The following shows the Warning Letters sent broken down by product type, comparing 2019 to 2018:FDA continued its trend of increasing the number of import alerts, publishing 98 import alerts in 2019, a significant increase over 2018, when 23 import alerts were published, and 2017, when 10 import alerts were published.  The increased number of import alerts corresponds with a decreased number of injunctions and seizures – while in 2017 there were 10 injunctions and two seizures, and in 2018 there were seven injunctions and one seizure, in 2019, there was one injunction and zero seizures – showing FDA’s preference for earlier preventive measures over later involvement.  Specific Trends in 2019Enforcement Specific to Drug Manufacturers An analysis of 483s provided to drug manufacturers in FY 2019 shows that manufacturers continue to struggle with the same themes.  §211.22(d), “Procedures applicable to the quality unit shall be in writing and shall be followed,” was the most frequently cited regulation in 483s sent to drug manufacturers in FY 2019; it was the second most frequently cited regulation in FY 2018.  The frequency of the appearance of this regulation may be explained by FDA’s focus on over-the-counter manufacturers, which often lack formalized quality units.  While the frequency of §211.113(b), “Control of microbiological contamination” dropped consistently from FY 2015 through FY 2018, it increased significantly in FY 2019.  Additionally, §211.160(b), “Lab controls should include scientifically sound specifications” fell from first place in FY 2018 to fourth place in FY 2019. A total of 81 Warning Letters were issued to finished product manufacturers in FY 2019, the highest number since FY 2015.  Warning Letters issued to API manufacturers, however, continued to drop after peaking in FY 2017.  The highest number of Warning Letters were issued to domestic firms, followed by firms in India and China.  The most frequently cited regulation in the Warning Letters issued to drug manufacturers was §211.22, “Responsibilities of the quality control unit” (41 Warning Letters), followed by §211.100, “Written procedures; deviations” (31 Warning Letters).  As mentioned above, FDA continued to focus on over-the-counter drug manufacturers, and Warning Letters to these firms in FY 2019 focused on four main themes: documented adherence to relevant regulations and standards; establishment and suitability of analytical and microbial testing and validation methods; nonconformance management; and the roles, responsibilities, and authority of the quality unit. Homeopathic MedicineOn October 24, 2019, Acting Commissioner Ned Sharpless announced that the Agency was withdrawing Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May Be Marketed.”  In his announcement Sharpless noted that, “Since the issuance of CPG 400.400 in 1988, the FDA has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described in CPG 400.400.  However, CPG 400.400 is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking.”  By withdrawing CPG 400.400, FDA ended its previous exercise of enforcement discretion for the marketing of homeopathic drugs without FDA approval.  In the announcement, Sharpless also noted that FDA had issued more than ten Warning Letters to companies for violations concerning homeopathic products, including to four companies that had manufactured and packaged eye drops in non-sterile conditions.  With the withdrawal of CPG 400.400, FDA also revised its 2017 draft guidance to expand upon the details of FDA’s risk-based enforcement policy, and asked for public input on the revised draft.  The comment period closes on January 23, 2020, and as such, it is likely that we will see continuing trends of enforcement against unproved homeopathic drugs in 2020. Stem CellsAs we head into the last year of FDA’s three-year period of enforcement discretion towards certain regenerative medicine products, which ends in November 2020, it is important to look back at FDA’s related activities in 2019.  Early in the year, on January 15, 2019, Commissioner Gottlieb reinforced the Agency’s focus on stem cell and gene therapies in a statement that noted that FDA anticipates that by 2020, it will receive more than 200 investigational new drug applications per year, building on the more than 800 active investigational new drug applications already on file with FDA.  On April 3, 2019, then-Commissioner Gottlieb released another statement, this one focused on firms illegally manufacturing, selling, and promoting stem cell therapy products.  He noted specifically that contrary to certain industry belief, products originating from the same person they are given back to are still subject to FDA regulation.  In his statement, Commissioner Gottlieb stated that as the Agency comes to the end of the period of enforcement discretion, it may “take additional steps to delineate an efficient development path for promising products that pose lower risk to patients and that are being developed by sponsors who’ve engaged the regulatory process in a responsible manner by filing INDs,” but for products with significant potential risks and that are being developed by sponsors who have not engaged in the regulatory process, the FDA plans to step up its oversight.  The same day, FDA issued twenty-one enforcement letters to manufacturers and health care providers offering unapproved stem cell products.  As we approach November 2020, we expect to see this enforcement trend to continue. CompoundingIn 2019, FDA continued to focus on improving the quality of compounded drugs.  Days before stepping down, Commissioner Gottlieb released a statement on new 2019 efforts to improve the quality of compounded drugs, in which he shared FDA’s 2019 compounding priorities.  Commissioner Gottlieb noted that the Agency would focus on compliance with good manufacturing practice requirements by outsourcing facilities, helping compounders identify insanitary conditions, and performing risk-based inspection and other enforcement efforts to identify compounders producing drugs under substandard conditions.  Additionally, Commissioner Gottlieb stated that the Agency would focus on the inappropriate use of bulk drug substances in compounding, including developing the 503A and 503B lists of appropriate bulk drug substances, and compounding performed by hospitals and health systems.  As noted below, FDA’s stated priority of enforcement against inappropriate compounding conditions held true, with at least four permanent injunctions entered against compounding companies operating under conditions identified as risks to public health and safety in 2019. Dietary SupplementsOn February 11, 2019, Commissioner Gottlieb released “a plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”  Commissioner Gottlieb noted that while scientific advancement has led to new opportunities for consumers to improve their health, there has also been an increase in the number of adulterated and misbranded products “including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks.”  On the same day, FDA issued twelve Warning Letters and five online advisory letters to companies illegally marketing unapproved drugs claiming to prevent, treat, or cure Alzheimer’s disease and other serious health conditions.  In his statement, Commissioner Gottlieb also highlighted actions taken against dietary supplement manufacturers claiming to prevent, treat, or cure other serious conditions such as cancer and opioid addiction.  One month later, on March 11, 2019, FDA issued a Warning Letter to Nutra Pharma Corp., noting its distribution of new unapproved drugs claiming treatment of cancer, arthritis, and opioid addiction. Throughout 2019, FDA took a particular interest in athletic performance enhancing dietary supplements and probiotic dietary supplements.  For example, on March 13, 2019, six people and two Florida corporations were charged in an indictment for their roles in a scheme to distribute hundreds of thousands illegal products, including anabolic steroids, claiming that the products were high-quality, legal dietary supplements.  Additionally, at the May 14, 2019 Dietary Supplement Regulatory Summit, FDA speakers focused on probiotic labeling, specifically, controversy over the listing of the quantity of colony-forming-units (CFUs) to indicate strength and effectiveness. On May 16, 2019, Steven Tave, FDA Director of the Office of Dietary Supplement Programs, highlighted significant non-compliance by the supplement industry with the FDA’s requirement for Premarket Notification for New Dietary Ingredients (NDIs), estimating that the number of premarket notifications for supplements containing new dietary ingredients submitted is less than 25% of where the Agency expects it should be.  It appears as though FDA will continue more aggressively enforcing the NDI notification requirement in 2020. Electronic Nicotine Delivery SystemsThroughout 2019, FDA stepped up its highly publicized enforcement of Electronic Nicotine Delivery Systems (ENDS) manufacturers and distributors, especially related to marketing practices directed towards children.  On September 9, 2019, FDA issued a Warning Letter to JUUL Labs Inc. for selling and distributing modified-risk tobacco products without an FDA order that permits such sale or distribution.  The Warning Letter highlighted FDA’s concern about JUUL’s claims that their products are safer than cigarettes, and that these claims were made directly to children in school: “Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL’s products, and evidence that ENDS products contribute to youth use of, and addiction to, nicotine, to which youth are especially vulnerable.”  Just a few days ago, FDA released its “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” guidance document, indicating that FDA intends to prioritize enforcement against flavored, cartridge-based ENDS products, and products that are either targeted to minors or for which the manufacturer has failed to take adequate measures to prevent minors’ access to the products.  With the release of this document, it is clear that FDA will continue to take enforcement actions against ENDS manufacturers and distributors in 2020. Come back tomorrow for Part Two of our 2019 FDA recap, where we will review last year’s six Consent Decrees.

2019 FDA Enforcement and Related Litigation Trends (Part 1)

The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April.  For th

2019 FDA Enforcement and Related Litigation Trends (Part 1)

Are companies keeping up with technological advances, and what are they doing specifically to contribute to society and provide value? What are the future prospects, and what kind of opportunities are being created for progress, including in the digital and scientific arenas?As Japanese companies play an increasingly active role in developing processes to further realize the potential of IoT, big data, and artificial intelligence (AI) technology across a range of sectors, the Hitachi Social Innovation Forum 2019, held in Tokyo on October 17–18, 2019, was a good opportunity to reflect on and discuss these questions.One of the key challenges that speakers highlighted at the Forum relates to data “preparation” or processing. Within the entire process of data collection, preparation, and analytics, preparation is by far the most time-consuming task. This is primarily because data itself, without a framework, lacks any kind of organization and comes in myriad forms. At the same time, this presents a great opportunity for the creation of new platforms, and, more generally, the development of innovative digital infrastructures, capable of efficiently processing such data. Increasingly, speakers noted, the competitive advantage that a number of companies in this field are able to offer relates to the provision of integrated solutions within a single platform.In the life sciences industry specifically, one such platform was discussed at a digital innovation session regarding lessons learned from the American Heart Association’s (AHA) Precision Medicine Platform. The platform includes a vast array of curated and distributed datasets, which are centrally accessible to researchers who can analyze and share these securely with other researchers. Jennifer Hall, chief of the Institute for Precision Cardiovascular Medicine at the AHA, explained that one of the main reasons for initiating this platform related to the difficulties for researchers engaging in medical research stemming from a variety of obstacles, such as the need to assemble the necessary equipment, create a security process, find datasets, and have sufficient audit controls in place. The purpose of the Precision Medicine Platform was to facilitate the entire process for researchers by letting them have access to rich and varied sources of data, with the underlying infrastructure already designed to take into account necessary compliance requirements (e.g., with the Health Insurance Portability and Accountability Act). The result is that researchers are capable of having their own private cloud environment that they can customize and are provided with an enhanced infrastructure and tools to work with.Hall went on to discuss a user case in which a researcher was able, through the support of the Precision Medicine Platform, to apply AI to help patients in need of coronary stents. An algorithm was developed to sort through a large amount of x-ray images to identify those images that were easiest to read, as opposed to those that would require the assistance of a radiologist. This was cited as a strong example of how data optimization can help create new solutions that can positively affect people’s lives.Many people see AI as one of the most promising fields for rapid scientific development; for instance, scientists are currently developing algorithms capable of <a target="_blank" href="https://www.fiercebiotech.com/biotech/deep-genomics-reveals-its-program-first-ai-discovered-drug-candidate">scanning patient mutations and automatically identifying potential drug targets</a>. Continued progress in the field of digital infrastructure, such as the Precision Medicine Platform, can help support these developments by sharing results seamlessly and making them easily accessible to others.The author would like to thank Letian Ge for his participation at this event.

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Reflecting on the Challenges and Opportunities of Data at the Hitachi Social Innovation Forum 2019

Are companies keeping up with technological advances, and what are they doing specifically to contribute to society and provide value? What are the future prosp

Reflecting on the Challenges and Opportunities of Data at the Hitachi Social Innovation Forum 2019

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published 20 years of reports submitted through the ASR Program that had not previously been disclosed to the public, leaving manufacturers with potentially massive amounts of data to sort through regarding their products.Background of the ASR ProgramCreated in 1997, the ASR Program was designed to give FDA more time to review and act on “new safety signals and less understood risks” by relieving FDA of the obligation to review well-known and well-understood adverse events. Under the ASR Program, manufacturers could request an exemption from the burden of submitting individual reports and instead submit quarterly summary reports for common adverse events. Since the ASR program’s inception, FDA has granted 108 exemptions for specific, well-known adverse events associated with medical devices, such as adverse events those described in the labeling of the device.FDA Ends ASR Program to Increase TransparencyThe ASR Program caused some concern among the public because very few of the reports submitted to the FDA through this program were accessible to the public. In 2017, FDA took steps to make the ASR program more transparent by requiring manufacturers to submit dual reports. Along with their ASR reports, FDA asked manufacturers to submit a “companion” MDR that would be available to the public through the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database holds mandatory reports (submitted by manufacturers, importers, and device user facilities) and voluntary reports (submitted by healthcare professionals, patients, and consumers) that the entire public can access. In 2018, FDA also began to slowly phase out the ASR Program when it launched the Voluntary Malfunction Summary Reporting (VMSR) Program.The VMSR Program was also designed to reduce FDA’s monitoring burden. Under the VMSR Program, manufacturers of specific medical devices can report certain malfunctions on a quarterly basis in a summary format rather than through individual reports. When FDA ended the ASR Program, only 13 companies still had VMSR exemptions. These included manufacturers of dental implants, implantable cardiac defibrillators, and pacemaker electrodes. In an effort to increase transparency regarding safety of medical devices, FDA decided to end the ASR Program and release 20 years of reports that were filed under the ASR Program.Further Steps Taken by FDA to Improve TransparencyFDA has also been working to make the MAUDE system more user-friendly and to modernize the Medical Device Programs Information Technology Systems. Since 2012, FDA has been working on the National Evaluation System for health Technology (NEST). This active surveillance system uses real-world data to quickly find and address safety signals once devices are on the market. NEST is designed as a counterpart to the MDR Program, with the intent of removing the human error that can come through reports. These actions demonstrate FDA’s commitment to making records more transparent and giving the public a more open view into its regulatory activities.ImplicationsMedical device manufacturers should monitor FDA’s push for transparency and the potential impact transparency may have on their businesses. With the release of 20 years’ worth of ASR Program data, 6 million previously undisclosed adverse event reports are open now to public scrutiny. Morrison & Foerster’s new FDA practice and our product liability lawyers can help you assess the potential impact of these reports on your company. [1] Shuren, Dr. Jeffery E. “Statement on agency’s efforts to increase transparency in medical device reporting.” U.S. Food & Drug Administration, 21 June 2019, <a href="https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting" target="_blank">https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting</a>

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

Julie Park

Julie Park | Product Liability Lawyer

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

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Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

China’s new administrative regulations on human genetic resources as applied to foreign persons

mofolifesciences-regulatory

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision in Mayo Collaborative Services v. Prometheus Laboratories.[1]  This decision, along with subsequent court decisions, has rendered certain subject matter patent ineligible under 35 U.S.C. §101 if it exploits laws of nature or natural phenomena, cornerstones of the diagnostic industry.  Although novel diagnostic agents should be patent eligible, uncertainty remains about certain diagnostic-based method claims that rely on a correlation between a diagnostic biomarker and a disease or indication. A recent draft bill released by bipartisan members of Congress offers promise of legislative action that may restore broad patent eligibility to diagnostics.<a href="https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html" target="_blank">[5/24 Blog Post]</a>  Until then, recent decisions by the Federal Circuit, including Vanda Pharmaceuticals Inc. vs. West-Ward Pharmaceuticals International [3] and Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA,[4] have provided some clarity on the reach of patent eligible subject matter to diagnostic method claims.  Although these decisions may open the door to issuance and validity of a patent to diagnostic methods, the Court’s decision in Cleveland Clinic Foundation v. True Health Diagnostics[5] underscores the reality that certain diagnostic-type claims may not provide adequate protection against potential infringers.  For this reason, companies should work with patent counsel to ensure that they secure patent-eligible claims to diagnostic methods and related treatments that are of defendable commercial value.Subject Matter Eligibility of Diagnostic Claims Under 35 § USC 101As part of its landmark Alice Corp. v. CLS Bank International decision, the Supreme Court articulated a two-step framework for determining whether claims are patent eligible.[6]  In the first step, it must be determined whether a claim is directed to a judicial exception (a law of nature, a natural phenomenon, or an abstract idea).  If so, it must then be determined whether the elements of the claim, individually or as a whole, “transform the nature of the claim into a patent-eligible application.”[7]  As Mayo explained, adding “conventional steps, specified at a high level of generality” to a law of nature does not make a claim patentable.  However, subject matter that includes “additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations” may be patent eligible.[8]After a long line of decisions finding many diagnostic-based claims to be patent ineligible under Section 101, the Federal Circuit has recently found certain types of diagnostic method claims to be patent eligible.  In Vanda Pharmaceuticals, the claim at issue was directed to the identification of a genetic variant that renders individuals poor metabolizers of a compound used to treat schizophrenia, and administering specific and different amounts of the compound to individuals, depending on whether they harbored the genetic variant.  Similarly, in Endo Pharmaceuticals, the claims were directed to treating pain in a renally impaired patient with a compound, wherein the creatinine clearance rate of the patient was measured, and a lower dosage of the compound was administered to the patient, depending on the patient’s rate of creatinine clearance.  The Court found the claims at issue in these two cases to be patent eligible, as being directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.”[9]This is contrast to the recent Federal Circuit decision in Athena Diagnostics vs. Mayo Collaborative Services.[10]  There, a claim reciting a method of diagnosing disorders related to muscle specific tyrosine kinase (MuSK) that only included a step of detecting autoantibodies to an epitope of MuSK was deemed to be patent ineligible because it did not sufficiently transform a law of nature into a patent-eligible application of the law, as required by the original Mayo decision.In response to the Federal Circuit’s evolving jurisprudence, the PTO published revised subject matter eligibility guidelines in January 2019.[11]  The new guidelines explain that a “claim that recites a judicial exception is not ‘directed to’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception.”  To this end, the PTO guidelines explain that a claim reciting a practical application of a judicial exception is patent eligible at step one of the Alice/Mayo test.  In this way, both the revised PTO guidelines and the Federal Circuit decisions have provided some clarity that is in line with the initial guidance provided by Mayo.While the courts have clarified how patent applicants may overcome the subject matter eligibility hurdle to secure patents to diagnostic-type claims, integrating a “practical application” into a diagnostic method claim may require reciting a series of steps to apply a natural correlation involving a biomarker, such as detecting the biomarker in a sample, diagnosing a patient as having a disease or condition related to the biomarker, and treating the patient with an appropriate therapeutic.  Such multi-step processes may be carried out by multiple entities.  It’s easy to imagine that the first step would be carried out by a diagnostic company, while the latter two steps would be carried out by a physician.Thus, even if the patent eligibility hurdle is overcome, these same applicants may face an additional obstacle when they seek to enforce their patents against multiple potential infringers.  Specifically, patent owners may be required to prove induced infringement, which has additional evidentiary burdens beyond those required to prove direct infringement by a single actor.Proving Infringement by Multiple ActorsWhere multiple actors are alleged to infringe different steps of a patent claim, plaintiffs commonly must assert a theory of induced infringement.  That is, a plaintiff alleges that a defendant infringed some steps of a claim and induced another actor to infringe the other steps of the claim, or the defendant induced another actor to infringe all steps of the claim.  To prevail on a claim of induced infringement, however, a plaintiff must prove that the defendant had the specific intent to induce another party to infringe.  Additionally, induced infringement must be predicated on direct infringement.[12]  When multiple parties carry out different steps of a method, direct infringement is shown by a single defendant controlling or directing the actions of the other defendant(s), such that all actions are attributable to a single defendant.[13]  Directing or controlling another’s actions is demonstrated by (1) conditioning participation in an activity or receipt of a benefit upon performance of a step or steps of a claimed method and (2) establishing the manner or timing of that performance.[14]  Recent Federal Circuit cases highlight the potential difficulty of proving induced infringement of a multi-step method claim.  In Cleveland Clinic, the Cleveland Clinic Foundation (“CCF”) owned a method of treatment patent reciting multiple steps that were alleged to be separately carried out by True Health, a diagnostic company, and physicians. CCF sued True Health on an induced infringement theory, but lost as a result of not being able to provide factual support showing that True Health specifically intended to induce the physicians to infringe the patent at issue by diagnosing and treating patients.[15] In contrast, in the Eli Lilly and Co. v. Teva Parenteral Medicines case, the method claim included a step of administering a pretreatment and another step of administering a treatment. There, the plaintiff was able to show that the defendant induced infringement, as its product labeling instructed physicians to condition a patient’s receipt of treatment on the patient self-administering the pretreatment at specific doses and times.[16]  Vanda was also able to prove induced infringement of its multi-step method claim against the generic manufacturer West-Ward based on general language on West-Ward’s product label that the dose of the drug should be reduced in half if the patient is a poor metabolizer.[17]  A difference between Cleveland Clinic and cases in which induced infringement was found is the development of the factual record supporting the inducing activity, particularly as highlighted by language on a product label. ConclusionClients seeking patents related to personalized medicine should pursue claims that both comply with patent eligibility requirements and mitigate evidentiary burdens for finding induced infringement.  Drafting claims that capture a practical application of a natural correlation, but in a form that would be infringed by a single actor, may reduce the factual inquiries necessary to prove infringement, as compared to claims requiring multiple actors.  Further, a patent strategy should coordinate the language of patent claims to what may be on a product label, particularly because many potential infringers, including generic manufacturers, may practically implement similar instructions on their product label.[1] Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).[<a target="_blank" href="https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html">5/24 Blog Post</a>] <a href="https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html" target="_blank">https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html</a>[3] Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018).[4] Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals Inc., 919 F.3d 1347 (Fed. Cir. 2019).[5] Cleveland Clinic Foundation v. True Health Diagnostics LLC,  859 F.3d 1352 (Fed. Cir. 2017)[6] Alice Corp. Ptd. Ltd. V. CLS Bank Int’l, 573 U.S. 208, 217-18 (2014).[7] Id. at 217.[8] Mayo at 82.[9] Endo at 1354.[10] Athena Diagnostics, Inc. v Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019).[11] https://federalregister.gov/d/2018-28282[12] Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915, 920-21 (2014).[13] Id.[14] Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357, 1364-79 (Fed. Cir. 2017).[15] Cleveland Clinic at 1364.[16] Eli Lilly at 1369.[17] Vanda at 1130-31.

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allow

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims