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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The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance and Enforcement Group for a 2024 preview, and here is what our team of former government officials from the U.S. Department of Justice (DOJ), Food and Drug Administration (FDA), and Department of Health and Human Services (HHS), former in-house compliance counsel, privacy lawyers, and veteran defense attorneys have offered up.Read the full <a href="https://www.mofo.com/resources/insights/240109-2024-regulatory-compliance-and-enforcement-predictions" target="_blank">client alert</a>.

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

Adam L. Braverman

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

Adam Braverman

Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. 

Nathaniel Mendell

Nathaniel R. Mendell

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

Brigid DeCoursey Bondoc

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

Brigid Bondoc

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The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier.

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe harbors for information sharing in the healthcare industry, and suggested that DOJ’s increased scrutiny of information sharing will extend to other industries. Mekki explained that the DOJ was working with the Federal Trade Commission (FTC) to withdraw all three policy statements, each of which was jointly issued by the agencies, and they followed through with that promise on February 3, 2023.Read the <a href="https://www.mofo.com/resources/insights/230206-doj-increase-antitrust-scrutiny-information-sharing" target="_self">full client alert</a>.

DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

Co-chair Global Antitrust Law Practice Group

Alex Okuliar is Co-Chair of Morrison Foerster’s Global Antitrust Law Practice Group. He is the former Deputy Assistant Attorney General for Civil Antitrust Enforcement at the U.S. Department of Justice and a former advisor at the Federal Trade Commission.

Alexander Okuliar


Lisa M. Phelan, former Chief of the National Criminal Enforcement and Washington Criminal I Sections of the Antitrust Division of the U.S. Department of Justice (DOJ), is a partner and Co-Chair of Mo

Lisa Phelan

Lisa M. Phelan

Joseph Folio is a trial lawyer and partner in Morrison Foerster’s Global Antitrust Law, Crisis Management, and Privacy + Data Security Groups, with more than a dozen years of experience leading complex government investigations and high-profile litigation.

Joseph Charles Folio III

Joseph Folio III

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Margaret Webb is a Litigation associate in the firm’s San Francisco office. Her practice focuses on complex commercial disputes, as well as civil, criminal, and internal investigations.
Margaret repre

Margaret A. Webb

Margaret Webb

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DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements

On July 9, 2021, President Biden enacted a sweeping <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</a> creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a <a target="_blank" href="https://www.mofo.com/resources/insights/210714-president-biden-executive-order-antitrust.html">recent client alert</a> that provides a comprehensive summary of the efforts to change both the substance and the approach of the federal government to U.S. competition policy. Among the many initiatives addressed to more than a dozen federal agencies, the executive order seeks to combat increased market concentration and rising prices in prescription drugs and devices, health insurance, and hospital markets.The executive order’s healthcare initiatives instruct federal agencies to undertake projects as varied as standardizing healthcare options in the national Health Insurance Marketplace to proposing a rule to permit over-the-counter sales of hearing aids. It also encourages the Department of Justice (DOJ) and the Federal Trade Commission (FTC) to review and consider revising their merger guidelines to better address increased costs and inadequate options caused by hospital mergers, particularly in rural areas, and instructs the Department of Health and Human Services (HHS) to implement the price transparency initiatives required by the No Surprises Act. However, the focus of the executive order’s directives for the healthcare industry are designed to address drug‑pricing concerns. The most significant new proposal directs FTC to consider exercising its statutory rulemaking authority to address “unfair anticompetitive conduct or agreements in the prescription drug industries, such as agreements to delay the market entry of generic drugs or biosimilars.”  President Biden also commits his administration to lowering prescription drug prices through “aggressive legislative reforms” such as allowing Medicare to negotiate drug prices, imposing inflation caps, and supporting a public health insurance option.Other new policies include directing HHS to submit a plan within 45 days to combat excessive pricing, enhance domestic pharmaceutical supply chains, and address the “recurrent problem of price gouging,” as well as directing the FDA commissioner to write a letter to the Patent and Trademark office within 45 days outlining any concerns regarding whether the patent system unjustifiably delays generic and biosimilar competition.Many provisions in the executive order relating to drug pricing direct HHS and FDA to continue existing policy, including:<ul><li>Directing HHS to continue increasing the transparency, efficiency, and predictability of the approval framework for generic drug and biosimilars, in order to promote competition and lower prices for those products by continuing to implement the FDA’s Drug Competition Action Plan of 2017 and Biosimilar Action Plan of 2018;</li><li>Clarifying the standards for interchangeability of biosimilars;</li><li>Improving the understanding of biosimilar and interchangeable products among healthcare providers, patients, and caregivers;</li><li>Continuing to update the FDA’s biologics regulations to clarify existing requirements and procedures related to the review and submission of Biologics License Applications by advancing the “Biologics Regulation Modernization” rulemaking; </li><li>Working with the FTC to identify and address false, misleading, or otherwise deceptive statements about generic drug and biosimilar products and their safety or effectiveness;</li><li>Continuing to implement the CREATES Act of 2019 by issuing Covered Product Authorizations promptly and issuing guidance for industry; and</li><li>Requiring the administrator of the Centers for Medicare and Medicaid Services (CMS) to “prepare for Medicare and Medicaid coverage of interchangeable biological products, and for payment models to support increased utilization of generic drugs and biosimilars.”</li></ul>Notably, the executive order also directs HHS to continue implementing the controversial Importation of Prescription Drugs rule, which was finalized in President Trump’s last months in office. The rule is subject to litigation in federal court that the Biden administration has continued defending. Just a few days before issuance of the executive order, the Biden administration pulled two other Trump-era proposals to allow the reimportation of insulin and broad personal importation from anywhere. FDA reportedly said it pulled the proposals because it had not received any proposals in response to the request for proposals, but was considering other options.Last week CMS also submitted to the Office of Management and Budget (OMB) a new, economically significant proposed rule called “Most Favored Nation (MFN) Model,” which likely is the newest proposal of the rule President Trump issued to tie Medicare Part B drug prices to those paid in other wealthy countries. The previous rule was issued in the final days of the Trump administration without notice and comment and was enjoined by a federal court in Baltimore for violating the Administrative Procedure Act. While the newest MFN proposal from CMS may be a negotiating tool to prompt action from Congress, it could be a sign that President Biden is continuing some of the most aggressive and controversial of the Trump administration’s drug pricing initiatives.These recent actions on drug importation and the MFN proposal, combined with the proposals in the Executive Order on Promoting Competition in the American Economy, demonstrate the Biden administration intends to keep the pressure on drug pricing.

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BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives

Is 2021 the Value-Based and Shared Savings Revolution?

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On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the admini

BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives

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.

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.

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.

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

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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

The U.S. antitrust agencies – the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) – have recognized a need for “unprecedented cooperation between federal, state, and local governments and among private businesses to protect Americans’ health and safety” during the COVID-19 crisis. To facilitate this necessary cooperation and clear the antitrust path for collaborative efforts among private businesses, including competitors, the agencies announced three joint steps.Read our <a href="https://www.mofo.com/resources/insights/200325-federal-antitrust-agencies.html?utm_source=publication&utm_medium=email" target="_blank">client alert.</a>

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Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis

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The U.S. antitrust agencies – the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) – have recognized a need for “unpreceden

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