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

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

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

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

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

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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

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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

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated <a target="_blank" href="https://aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_Plan_9-9-2021.pdf">report</a> to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued in response to President Biden’s <a target="_blank" href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/">Executive Order on Promoting Competition in the American Economy</a>—contains a range of approaches for effecting reforms aimed at reducing the price of prescription drugs. Among these proposed reforms are administrative actions that will be undertaken by the Food and Drug Administration to “address potential barriers to biosimilar and generic drug development and market entry to spur competition so that consumers can access the medicines they need at affordable prices.” HHS Report at 19.For both the biosimilar and generic drug marketing pathways, HHS emphasized the importance of labeling carve-outs—so-called “skinny” labels—under 21 U.S.C § 355(j)(2)(A)(viii) as a way to “decrease[] costs to patients and to the federal government, including reducing spending on Medicare and Medicaid.” HHS Report at 21. HHS’s emphasis appears driven in part by a recent case before the Federal Circuit, GlaxoSmithKline v. Teva Pharmaceuticals USA, Inc., addressing patent-infringement liability for generic drug manufacturers that employ skinny labeling practices. 976 F.3d 1347 (Fed. Cir. 2020), aff’d in part and vacated in part, 7 F.4th 1320 (Fed. Cir. 2021); HHS Report at 21 (“Recent litigation has raised some questions about the practice of carving out patent-protected indications for generic drugs, which may discourage the use of carve-outs and thus delay the approval of some generic drugs.”).The patent at issue in GlaxoSmithKline covered the use of Coreg® (carvedilol) to treat congestive heart failure. Teva’s label for its generic carvedilol product omitted this patented indication when FDA first approved it but retained indications for two other approved uses: treatment of post-MI LVD (left ventricular dysfunction following post-myocardial infarction) and hypertension. During this time, however, Teva also marketed carvedilol as therapeutically equivalent to Coreg®, and there was evidence that post-MI LVD patients were also being treated with carvedilol for congestive heart failure. Beginning in 2011, Teva maintained the carve-out but added language elsewhere in the carvedilol label stating that it could be used to treat congestive heart failure. The jury found Teva liable for induced infringement, but the district court granted Teva judgment as a matter of law reversing the verdict. GSK appealed, and, last year, the Federal Circuit reversed the district court’s judgment, holding that the jury’s finding of induced infringement was supported by substantial evidence. GlaxoSmithKline, 976 F.3d 1347 (Fed. Cir. 2020). Teva subsequently requested rehearing, but the same three-judge panel <a target="_blank" href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1976.OPINION.8-5-2021_1814836.pdf">affirmed </a>its prior judgment on August 5, 2021, again holding that substantial evidence supported the jury’s verdict that Teva was liable for inducing infringement.[1]The panel reiterated that its decision was limited to the particular factual circumstances presented. The panel emphasized, for example, that “GSK presented evidence that doctors read and consider labels, that Teva’s marketing materials guided doctors to the label and to its website promoting the patented use, that Teva issued press releases encouraging doctors to prescribe carvedilol for the patented use, that Teva’s own employees expected doctors to prescribe carvedilol during the partial label period for the patented uses, and expert testimony that Teva’s actions encouraged doctors to do so.” 7 F.4th at 1338. But the decision raised concerns among generic manufacturers that skinny labeling would not sufficiently shield them from liability and appears to have piqued HHS’s interest. In fact, Teva filed a <a target="_blank" href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltfbd4dcd9d59ab6e0/627317894d9f89297129022b/1429000-1429343-petition.pdf">petition</a> for en banc rehearing on October 7, 2021, in which it urged the full court to reject the panel’s decision because it would “throw inducement doctrine into disarray” and have a “seismic” effect on skinny-label cases.Given how recently GlaxoSmithKline was decided and the uncertainty about how the court will rule en banc, the scope of its impact on skinny labeling practices remains to be seen. The handful of opinions citing it so far have not expanded its application. See Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC, 503 F. Supp. 3d 156, 2020 U.S. Dist. LEXIS 223968 (D. Del. Nov. 30, 2020) (jury could reasonably infer lack of intent to induce infringement from “removal of field restrictions from [generic] labelling”); Niazi Licensing Corp. v. St. Jude Med. S.C., Inc., 2021 U.S. Dist. LEXIS 54618 (D. Minn. Mar. 23, 2021) (distinguishing GlaxoSmithKline in finding insufficient evidence of intent to induce infringement by generic manufacturer); United Food & Commer. Workers Local 1776 v. Takeda Pharm. Co., 2021 U.S. App. LEXIS 25572 (2d. Cir. Aug. 25, 2021) (citing GlaxoSmithKline solely for general proposition that a generic manufacturer may carve out patented uses). Nevertheless, and although the Court observed that “the FDA is not the arbiter of patent infringement issues,” the HHS Report concludes that HHS is “committed to taking steps as appropriate to ensure these critical [skinny label] practices remain available for generic drugs and biosimilars.”Check back to the <a target="_blank" href="https://lifesciences.mofo.com/">MoFo Life Sciences Blog</a> for updates on any specific actions HHS and/or FDA take to address skinny labeling. [1] Teva requested en banc rehearing, but the Federal Circuit interpreted its request as seeking panel rehearing. For a quick overview of this procedural quirk, see this <a target="_blank" href="https://federalcircuitry.mofo.com/topics/Know-Your-En-Banc-Petition-ProcessHow-An-En-Banc-Petition-In-GlaxoSmithKline-v-Teva-Led-To-A-New-Panel-Argument-Without-Apparent-En-Banc-Action.html">recent post </a>from MoFo’s Federal Circuitry blog.

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Fitz Collings is an IP litigator who puts science first to develop innovative litigation strategies for life sciences and technology companies.
Fitz counsels some of the largest pharmaceutical, biotec

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Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices

The EU General Court’s Ruling on Pay for Delay

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Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report

Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices

<div><h4>Summary</h4></div><ul><li>The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe.</li><li>A study recently published by the European Commission (“Commission”) now calls for targeted policy action regarding plants derived from targeted cis- and mutagenesis, with an inception impact assessment expected in the third quarter of 2021, as the study revealed that: <ul><li>The current European legislation regarding genetically modified organisms (GMOs) is no longer fit for its purpose with respect to plants derived from targeted cis- and mutagenesis.</li><li>Scientific review did not uncover any new hazards linked to targeted cis- and mutagenesis compared to conventional breeding methods or random mutagenesis.</li><li>In particular, in the agri-food sector, use of NGTs is likely to result in plants more resilient to diseases and climate change effects that have the potential to contribute to a more sustainable agri-food system and thus benefit society.</li><li>Only 21% of EU consumers have ever heard of “gene-editing” but general perception of such technologies is still negative.</li><li>Disparities between public perception and limited public knowledge about NGTs could hamper NGTs market uptake. </li><li>Different regulatory oversight for NGTs in other countries could lead to trade limitations and disruptions, and put EU operators at a competitive disadvantage.</li></ul></li><li>A basic problem identified by the study is the lack of reliable methods to detect such NGT products. To ensure a level playing field for all stakeholders involved, such methods must be able to distinguish between regulated and unregulated products, which is, however, a challenge from a scientific point of view. Alternatively, the study suggests a document-based traceability system, which would, however, involve additional costs and could affect the international competitiveness of EU operators.</li><li>The study suggests that a more flexible approach to assessment of risk of NGTs should be undertaken on a case-by-case basis, rather than the restrictive regulatory framework that is currently in place.</li></ul>With respect to other organisms than plants (microorganisms and animals) and other NGTs than cis- and mutagenesis (e.g., epigenetic editing), however, the study observes substantial knowledge gaps. While the Commission intends to build further knowledge, at this stage other organisms and other NGTs will remain subject to the current GMO legal framework.<a target="_blank" href="https://www.mofo.com/resources/insights/210525-novel-genomic-techniques.html?utm_source=publication&utm_medium=email">Read our alert</a>

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16

Fourth Circuit’s Decision Revitalizes First Amendment Challenge to the TCPA

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Summary


The decision of the Court of      Justice of the European Union (CJEU) in case C-528/16 essentially banning      novel genomic techniques (NGTs), in 

The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16

The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.:(1)  Engaged in “fraud-on-the-FDA” when obtaining clearance for several devices used in spinal fusion surgeries; (2)  Engaged in unlawful marketing of the devices for off-label and contraindicated use; and (3)  Paid illegal kickbacks to physicians to induce physicians to order such devices in violation of the federal Anti-Kickback Statute.The Ninth Circuit reversed the district court, in part, for the fraud-on-the-FDA allegation, and affirmed the district court’s dismissal of the unlawful marketing and kickback allegations. We discuss each of these allegations in turn.With regard to the fraud-on-the-FDA allegation, the relator alleges that Medtronic defrauded the FDA into granting it Class II clearance for the devices. The Ninth Circuit accepted the relator’s grouping of the devices into two categories: (1) “Contraindicated-only Devices,” devices that cannot be used for their intended use in the thoracolumbar spine in their clearance application, but rather can only be used in the cervical area of the spine; and (2) “Extra-use Devices,” devices that could be used for their stated intended use in the thoracolumbar spine, but are used for a contraindicated use in the cervical spine.In its decision, the Ninth Circuit dismissed the relator’s fraud-on-the-FDA allegation with regard to the Extra-use Devices; however, for the Contraindicated-only Devices, the Ninth Circuit reversed the district court, giving credence to the relator’s theory that such devices were not properly cleared by FDA for any use, and that if Medtronic properly disclosed that the devices’ intended use was in the cervical spine, then FDA would have required Class III approval, rather than Class II clearance based on a predicate device. The relator advanced this argument in an attempt to show that the fundamental requirement for Medicare or Medicaid reimbursement of a device—that there be an appropriate FDA clearance or approval in place—had not occurred in this case. We note that Medtronic countered this relator’s allegation by stating that a False Claims Act action is an improper vehicle to bring a fraud-on-the-FDA claim and plans to continue to defend itself against this remaining claim that was not dismissed by the Ninth Circuit.With regard to unlawful marketing claim for contraindicated use, the relator alleges that Medtronic marketed the devices without FDA approval or clearance for use in the cervical spine, which would be an off-label and contraindicated use, and thus a misbranding and adulteration violation of the FDCA. The Ninth Circuit affirmed the district court in dismissing the relator’s claims, more firmly establishing the standard that off-label promotion is not an inherent False Claims Act violation, particularly if the device has appropriate FDA clearance or approval and is “reasonable and necessary” under the CMS rules.In the decision, the Ninth Circuit specifically noted the well-rooted idea that a physician may use a device for an off-label purpose so long as such use is medically necessary and reasonable. The court went on to state: “As long as a doctor finds an off-label use to be medically reasonable and necessary, then the off-label use is permitted, even if the particular use is contraindicated on the label.” The court’s reasoning is in line with the concept that FDA does not regulate or interfere with the practice of medicine. Accordingly, whether a device is used off-label has no bearing on whether a federal healthcare program reimburses for such device; rather, the device must have FDA approval/clearance and be “reasonable and necessary” to be eligible for Medicare coverage, as well as meet any other pertinent regulations.Lastly, with regard to the relator’s allegations of Anti-Kickback violations, the Ninth Circuit dismissed the relator’s claims. The relator alleged that Medtronic paid illegal kickbacks to healthcare providers through the use of improper rebate agreements with hospitals and through paying physicians for food, travel, and promotional costs related to business development events.  The Ninth Circuit affirmed the district court in dismissing these two anti-kickback allegations. First, the Ninth Circuit found that the relator did not identify how the rebate agreement violated the Anti-Kickback statute, particularly in light of the fact that medical device companies may provide rebates if such rebates are properly disclosed and reflected in charges to federal healthcare programs, in accordance with existing safe harbor provisions. Second, the Ninth Circuit found that the relator identified only general allegations related to improper physician remuneration; the relator did not identify any physicians or categories of physicians who received payment in connection with these types of events or connect such physicians or groups of physicians to the purchase or use of the subject devices.This decision, therefore, only leaves open one important claim, the “fraud-on-the-FDA” claim. Our team will be monitoring this issue going forward to better understand how the courts are interpreting this important claim, where private litigants seek to enforce or prosecute issues under the FDCA.

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Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtr

Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts.[1] In two recent rulings – “Lundbeck”[2] and “Paroxetine”[3] – the European Court of Justice (ECJ) dealt with settlement agreements between originator companies and generic companies aimed at delaying the introduction of generic drugs to the market, so-called “pay-for-delay” or “reverse patent settlement” agreements. In these agreements, the generic companies usually commit to refrain from entering the market for a relevant medicine protected by a (possibly contestable) patent that the originator company holds while the originator company is obliged to pay a certain compensation. The recent ECJ judgments indicate that most of the “pay-for-delay” agreements likely constitute anti-competitive agreements by object and hence violate EU antitrust laws.<h4>Facts/Background</h4>The ECJ provided fundamental guidance regarding questions on “pay-for-delay” agreements in its preliminary ruling in “Paroxetine” on January 30, 2020. In this case, the British Competition Appeal Tribunal (“CAT”) referred various questions to the ECJ for a preliminary ruling. The background for the legal proceedings were settlement agreements with respect to patent disputes between GlaxoSmithKline (the holder of a patent for the paroxetine anti-depressant) and certain generics companies, in which the generics companies agreed to refrain from entering the market with their own generic medicines for a certain period of time and GlaxoSmithKline promised payments in return.In its “Lundbeck” decisions of March 25, 2021, the ECJ applied the principles established in “Paroxetine” to a fine decision of the EC. The ECJ confirmed the previous EC decision including the ruling of the General Court to fine Lundbeck (originator company of the citalopram anti-depressant) and producers of generic medicines for their anti-competitive settlement agreements. After the original compound patent expired in 2002, Lundbeck (still holding a number of secondary patents) and several generic companies entered into “pay-for-delay” agreements. The generic companies committed not to enter the citalopram market and Lundbeck made in return significant payments and also purchased their stocks of generic products. Those agreements led to investigations concluded by the EC’s decision of June 19, 2013[4] to fine Lundbeck and the generic companies. Their appeals before the General Court were dismissed by various judgments of September 8, 2016. Finally, the ECJ dismissed the appeals against the Court’s decisions.<h4>The ECJ Decisions</h4>The ECJ’s decisions mainly focus on the standards of the European cartel ban (Article 101 TFEU) and the rules on abuse of dominance (Article 102 TFEU, see particularly “Paroxetine”) applying to “pay-for-delay” agreements. They particularly provide clarity in which cases generic manufacturers could be considered as potential competitors and in which cases “pay-for-delay” agreements constitute a restriction of competition “by object” (or effect). While the preliminary ruling in “Paroxetine” provides the guidelines to assess “pay-for-delay” agreements in general, the ECJ confirmed and applied those guidelines to a specific fine decision in “Lundbeck.”Potential CompetitorsThe “pay-for-delay” agreements are only anti-competitive if the companies involved are at least “potential competitors.” According to the ECJ in its “Paroxetine” ruling, the relevant potential competition between the originator companies and the generic companies needs to be assessed with “regard to the structure of the market and the economic and legal context within which it operates.” To establish potential competition, the ECJ emphasized that there is no need for certainty that the generic company will in fact enter the market, but the generic companies must have “real and concrete possibilities of entering the market at the relevant time.” More precisely, according to the ECJ, this means that a potential competitor must have taken sufficient preparatory steps to enter the market at the time of the conclusion of the “pay-for-delay” agreement and must show a firm intention as well as an inherent ability to enter the market. Moreover, there shall be no “insurmountable barriers” for entering the market, but the ECJ clarified that the existence of a patent alone cannot be regarded as such an “insurmountable barrier” as long as the potential competitor shows a readiness to challenge the validity of that patent. According to the ECJ, it is not required to assess the “strength of the patent” or how likely it is that a court would find that the patent is valid and has been infringed. Restriction of Competition by ObjectRegarding the question when there is a “restriction of competition by object,” the ECJ pointed out that the agreements must reveal a sufficient degree of harm to competition, considering the agreement’s content, objectives, and economic and legal context. According to the ECJ, such a harm to competition is strongly indicated when the agreed transfers of value cannot have any explanation other than the commercial interest of the parties not to engage in competition on the merits. For this purpose, it is crucial to assess whether the net gain arising from the payments in question is high enough to act as an incentive to the generic companies to refrain from entering the market. However, the net gain is not required to be higher than the profits the generic company would have made if it were successful in the patent proceedings. As with the assessment of a “potential competition,” it is not necessary to assess the strength of the respective patents or of the party’s prospects of success in a patent process, if the transfer of value is significant enough.Abuse of DominanceIn its “Paroxetine” decisions, the ECJ also specified the conditions under which a “pay-for-delay” agreement constitutes an abuse of a dominant market position (Article 102 TFEU). According to the ECJ, the definition of the relevant product market must take the generic versions of the medicine into account, although the generic companies would not be able to legally enter the market. The ECJ further clarified that the exercise of an IP right, including the conclusion of patent settlement agreements, is not per se abusive, but that negative effects for competition arise if this exercise prevents access to the market. Finally, the ECJ pointed out that adverse effects on the market might be counterbalanced by efficiency advantages that also benefit consumers.<h4>Conclusion and Outlook</h4>After the EC and the General Court established the first principles for the assessment of “pay-for-delay” agreements in the pharmaceutical sector under EU antitrust law, the two ECJ rulings provided now more clarity and final guidance on this topic for various issues. This particularly concerns the qualification of the companies involved as “potential competitors,” the relevant test for assessing whether there is a “restriction of competition by object,” and the (non‑)relevance of the likelihood of success in patent proceedings. There are still some open questions, particularly regarding the defense of the companies involved with respect to potential pro-competitive effects or efficiencies. But this could also have been deliberately left open as, in general, the ECJ seems to put “pay-for-delay” agreements under close scrutiny. And while it does not generally prohibit those agreements, they are subject to a critical assessment resulting in “tough (antitrust) times” for any “pay-for-delay” agreements. [1] See prior client alert.[2] Judgments of the ECJ of March 25, 2021 in Cases C-586/16 P, C-588/16 P, C-591/16 P, C-601/16 P, C-611/16 P, and C-614/16 P.[3] Judgment of the ECJ of January 30, 2020 in Case 307/18.[4] EC Decision of June 19, 2013, Case AT.39226 – Lundbeck. in Cases T-460/13, T-467/13,, T-469/13, T-470/13, T-471/13, and T-472/13.

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Counsel

Jens is a counsel at Morrison Foerster’s German office in Berlin. He advises clients in all areas of European and German competition law, including merger control filings, cartel authority investiga

Jens Hackl

Jens Hackl is a counsel at Morrison Foerster’s German office in Berlin. He advises clients in all areas of European and German competition law, including merger control filings, cartel authority investigations, cartel damage claims, distribution cartel law, antitrust compliance programs and unfair competition law. Jens has particular industry-specific experience in the areas of media, technology, telecommunication, transport and aviation. In addition, he advises in the fields of state aid and public procurement law.

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Managing Partner, Berlin

Andreas is managing partner of Morrison & Foerster’s German office in Berlin and a member of the firm’s worldwide board of directors. He heads the German antitrust and regulatory practice from our Ber

Andreas Grünwald

Andreas Grünwald is a partner in the Global Antitrust Law Practice Group, and head of Morrison & Foerster’s German antitrust practice. He covers a wide range of antitrust and regulatory matters, with a particular focus on the telecommunications, media and technology (TMT) sector. Based in our Berlin and Brussels offices, Mr. Grünwald provides antitrust advice on M&A strategy, represents public and private corporations in merger control proceedings before the German Federal Cartel Office and the European Commission, and he has notable experience in coordinating multi-jurisdictional merger filings involving European, U.S., and Asian authorities. He also advises on other transactional matters such as sector-specific permit requirements as they often arise in regulated industries.

Pay-for-Delay has a tough (antitrust) time at EU Top Court

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the Eu

Pay-for-Delay has a tough (antitrust) time at EU Top Court

While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly, March 31, 2021, remains the deadline for reporting for 2020. Despite not extending any deadline, CMS is sensitive to the fact that COVID-19 may have impacted an organization’s reporting processes. Specifically, CMS recommends using “COVID-19 Impact” in an applicable manufacturer’s assumptions statement and explaining the circumstances surrounding the data, including, if applicable, references to any related help desk ticket numbers. Separately, we note that the 2020 reporting year marks the eighth year that CMS has collected open payments data. Accordingly, CMS has amassed a vast data set of payments occurring within the healthcare industry. This large data set is a tool for other agencies to enforce healthcare regulations. In particular, we expect that the Department of Justice (DOJ) will use data analytics to analyze the open payments data and use the results of such analytics to identify potential Anti-Kickback Statute violations and pursue False Claims Act litigation.As a consequence, improper reporting, or the failure to report open payments data, could lead to allegations of a false claim against a drug or medical device manufacturer and the recipient of such payment in addition to any penalties levied under the Sunshine Act regulations. Under the Sunshine Act, an applicable manufacturer that fails to report payments information is potentially subject to a civil monetary penalties for each payment or other transfer of value or ownership or investment interest that it did not report timely, accurately, or completely. If the failure to report timely, accurately, or completely is a knowing violation, those penalties increase tenfold.While generally there has been little enforcement in this area to date, in October 2020, DOJ announced a <a target="_blank" href="https://www.justice.gov/opa/press-release/file/1332261/download">settlement</a> over $9 million dollars with Medtronic based on allegations that Medtronic violated the False Claims Act by paying kickbacks to a neurosurgeon and failing to accurately report the direct and indirect payments made to the neurosurgeon. This was the first major settlement related to the Sunshine Act’s reporting obligations. We expect litigation in this space to increase as DOJ runs more sophisticated analyses against the open payments data set. Stay up-to-date with the latest legal and regulatory COVID-19 developments by subscribing to our MoFo’s <a target="_blank" href="https://lifesciences.mofo.com/">Life Sciences</a> blog.