Global Life Sciences
Litigation
Advising on the full scope of litigation and dispute matters, we can offer you a holistic legal approach that will smooth your path as you navigate industry changes, technological advances, market demands and policy hurdles.
Services
Innovation in the life sciences industry is driven by cutting-edge research, complex regulatory pathways, and substantial investment in intellectual property. Sidley’s Global Life Sciences (GLS) IP Litigation team is a trusted partner to life sciences companies seeking to protect and enforce their most valuable assets in high-stakes patent, trade secret, and related disputes. With approximately 40 IP litigators, including many with advanced scientific degrees and deep trial experience, we represent clients of all sizes — from emerging biotechs to global pharmaceutical and medical device manufacturers — in critical IP battles that define markets, shape pipelines, and safeguard innovation.
We bring value to our clients in the following ways:
- Industry Insight and Technical Depth: Sidley’s IP litigators bring multidisciplinary training and sector-specific understanding to every engagement. Many members of our team have backgrounds in molecular biology, chemistry, pharmacology, biomedical engineering, or related fields — allowing us to litigate complex matters involving biologics, biosimilars, small molecule drugs, diagnostics, drug delivery systems, medical devices, and digital therapeutics with unmatched fluency.
We routinely represent life sciences clients in litigation related to:
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- Trial-Tested, Strategy-Driven: Our first-chair trial lawyers have successfully litigated some of the most closely watched IP disputes in the life sciences industry in district courts, the Federal Circuit, and the U.S. Supreme Court. We tailor our approach to each client’s business goals — whether securing a preliminary injunction to block generic entry, protecting a billion-dollar asset from biosimilar challenge, persuading juries to compensate innovative medical device companies for patent infringement by competitors, or resolving co-development disputes involving IP rights.
We have acted as counsel in over 300 Federal Circuit appeals and nearly 500 Patent Trial and Appeal Board (PTAB) proceedings, regularly securing favorable outcomes in inter partes review (IPR) and post-grant review (PGR) matters involving complex pharmaceutical, biotechnology, and medical device patents. - Appellate Experience: Sidley has one of the preeminent appellate practices in the country with lawyers who have in-depth experience in complex intellectual property law. Our patent and IP appellate team includes former Federal Circuit and U.S. Supreme Court clerks, experienced litigators, and appellate specialists who are conversant with virtually every area of technology. In the Federal Circuit, Sidley’s appellate lawyers have represented clients in cases involving such diverse technologies as recombinant DNA, surgical robotics, remote cardiac monitoring, and chemotherapy drugs. Sidley lawyers have also handled IP disputes and appeals in a number of other federal courts of appeal
- Recognition Across the Industry: Sidley’s IP litigators are consistently recognized as leaders in life sciences disputes by Chambers USA, LMG Life Sciences, IAM Patent 1000, Benchmark Litigation, and Managing IP. For seven consecutive years, Sidley has earned first-tier national rankings for IP Litigation and Patent Litigation in Best Lawyers® “Best Law Firms.”
Clients value our combination of courtroom experience, strategic insight, and technical depth. As Chambers USA recently noted, our team is “extremely smart, encyclopedic in their knowledge of patent law and excellent litigators,” with “a tremendous level of technical expertise, which is a critical skill in patent litigation.”
Contact
Ching-Lee Fukuda
Learn more about our IP Litigation practice.
For the last two decades, False Claims Act enforcement has been one of the most significant legal risks facing healthcare and life sciences companies. Throughout that time, Sidley has been at the forefront of the defense of Department of Justice (DOJ) investigations and qui tam litigation. Our Chambers Band 1-ranked False Claims Act team has defended such actions on behalf of pharmaceutical, medical device, and medtech companies, laboratories, pharmacies, hospitals and health systems, specialty healthcare providers, and industry investors, among others. While we have assisted clients to steer high-profile, bet-the-company DOJ investigations to resolution and have successfully defended whistleblower suits in courts across the country, our team has brought many more matters to resolution without any settlement or litigation.
Our work in this dynamic space is shaped by the following attributes:
- A Multidisciplinary, Industry-Integrated Approach. Sidley is uniquely positioned to manage the complexity of FCA litigation in the healthcare and life sciences industry. Our lawyers collaborate seamlessly with our destination healthcare and FDA regulatory teams, enabling us to assess issues holistically and develop cohesive strategies grounded in deep subject-matter knowledge.
We also rely on a deep government enforcement bench that includes several former high-level government officials, including a former Assistant Attorney General and Deputy Assistant Attorney General for the Criminal Division of DOJ; former U.S. Attorneys and former Assistant U.S. Attorneys; a former Acting Chief Counsel of the FDA; and a former Head of the FDA’s Special Prosecution Task Force. Our team has excellent working relationships with the senior lawyers at DOJ handling these matters, including Sidley alumni. - Litigation Excellence. Sidley brings decades of experience handling complex FCA disputes in every federal circuit and in state courts across the country. In these cases, we have dealt with virtually every legal issue that can arise — from constitutional issues to jurisdictional issues to pleadings issues, and the full array of substantive issues. Our clients have prevailed on the vast majority of dispositive motions we have filed.
We also have a strong record defending companies in FCA matters brought under state and local statutes, where collaboration between DOJ, state attorneys general, and private relators is increasingly common. In addition, we regularly handle related litigation, including retaliation claims, exclusion and debarment proceedings, and overlapping product liability and securities matters. - Sophisticated Thought Leadership. We bring our depth of experience and breadth of resources from the firm’s myriad legal disciplines to analyze emerging issues within this dynamic area of law on our industry-leading blog, Original Source: The Sidley Austin False Claims Act Blog. We also are frequent authors and presenters on cutting-edge FCA topics.
Representative Matters
- A major dialysis provider in connection with a government investigation of civil FCA claims arising from a qui tam suit filed by a former senior executive. Despite the sweeping nature of the allegations, the matter was resolved on favorable terms and without a Corporate Integrity Agreement.
- HealthcarePartners Inc. in defense of a Department of Justice, Civil Frauds investigation and resolution of claims related to alleged Medicare Advantage “upcoding.”
- Novo Nordisk Inc. in qui tam litigation, United States of America ex rel. Siegel v. Novo Nordisk Inc., against the relator and State of Washington asserting FCA claims based on alleged off-label promotion and violations of the Anti-Kickback Statute in connection with physician arrangements and a patient support program. Sidley has obtained a dismissal of the nationwide claims and the parties continue to litigate the claims arising from conduct in the state of Washington.
- Incyte Corporation in a civil qui tam action, United States of America ex rel. Dillon v. Incyte Corporation, involving its charitable donations to patient assistance foundations. After an intensive DOJ investigation, the government declined to intervene in the qui tam action. The matter was resolved very favorably for the company without any admission of liability or a Corporate Integrity Agreement.
- Novo Nordisk Inc. in qui tam litigation, United States of America ex rel. Daniel v. Novo Nordisk Inc., asserting FCA claims based on alleged off-label promotion and violations of the Anti-Kickback Statute in connection with the promotion of the company’s GLP-1 products.
- Envision Healthcare, a national emergency medicine provider, in qui tam litigation, United States ex rel. Hernandez v. Envision Healthcare, asserting claims based on alleged upcoding, use of medical scribes, and billing for midlevel practitioners.
- Kindred, a skilled nursing facility provider, in defense of qui tam litigation based on allegedly fraudulently inflated RUG scores.
- Janssen Biotech in defending against False Claim Act claims based on allegations of fraud on the Patent Office in United States ex rel. Silbersher v. Janssen Biotech, Inc.
- A large private equity firm in defense of a Department of Justice, Civil Frauds investigation of FCA liability arising from alleged conduct by a healthcare portfolio company.
- Jazz Pharmaceuticals in defense of qui tam litigation, United States ex rel. Sorghi v. Jazz Pharmaceuticals, against the relator in the District of Massachusetts based on alleged fraud on the Patent & Trademark Office and FDA in connection with a particular method of use patent.
- Multiple molecular testing laboratories, in defense of FCA enforcement actions related to alleged violations of the “Medicare 14-Day Rule.”
- One of the largest clinical laboratory services companies in connection with qui tam suits brought in federal and state courts alleging payment of improper kickbacks and violation of state “usual and customary charge” requirements for Medicaid.
- A healthcare provider management services organization in a False Claims Act investigation related to the medical necessity of certain procedures for which the client provided oversight and billing services.
- Novo Nordisk Inc., in defense of a Department of Justice, Civil Frauds investigation and resolution of claims related to False Claims Act concerns arising from alleged failure to comply with an FDA-mandated REMS program, off-label promotion, and kickbacks.
- Numerous pharmaceutical companies in DOJ False Claims Act investigations focused on promotional speaker programs.
- Bayer Corporation in joint criminal and civil investigation by the U.S. Attorney’s Office for the Eastern District of New York and Main Justice’s Consumer Protection Branch and Civil Fraud Section regarding the alleged off-label promotion of pharmaceutical products. Government declined to proceed with enforcement action and persuaded relator to dismiss the qui tam complaint.
- A pharmacy provider in connection with a DOJ False Claims Act investigation related to alleged violations of the AKS in connection with the provision of patient financial hardship waivers and other billing issues and in connection with the pharmacy’s adherence programs funded by pharmaceutical manufacturers.
- Pharmacies in United States ex rel. Proctor v. Safeway, Inc. and U.S. ex rel. Schutte v. SuperValu, Inc., Nos. 21-1326, 22-111 (S. Ct.), before the Supreme Court to resolve the question whether and when a defendant’s contemporaneous subjective understanding or beliefs about the lawfulness of its conduct are relevant to whether it ‘knowingly’ violated the False Claims Act.
- Kimberly-Clark in civil qui tam actions filed in California, Texas, and Georgia in which the relator alleges that Kimberly-Clark’s surgical gowns and other healthcare products did not meet industry standards. The DOJ has declined to intervene.
- Walgreens in two qui tam false claims act cases. One in the Central District of California alleges that Walgreens improperly delayed dispensing “time-sensitive” medications. The matter in the Eastern District of Pennsylvania involves allegations that Walgreens dispensed drugs that did not comply with certain package safety requirements.
- Bayer Corporation in a qui tam lawsuit in which the court dismissed the relator’s second amended complaint with prejudice for failure to plead fraud with particularity.
- Ista Pharmaceuticals, Inc. in criminal and civil qui tam investigations involving off-label promotion and kickbacks brought by DOJ’s Consumer Protection Branch and Civil Fraud Section and the U.S. Attorney’s Office for the Western District of New York.
- Bayer Corporation in a qui tam lawsuit in which the court dismissed the relator’s complaint under the False Claims Act with prejudice, agreeing with Sidley that the complaint was based upon publicly disclosed information and relator — a corporation formed for the sole purpose of filing this lawsuit — was not an original source of the information.
- Represented Bayer Corporation in a qui tam action, United States of America ex rel. Simpson v. Bayer Corporation, et al., involving U.S. Department of Defense contracts and Bayer’s cholesterol-lowering drug Baycol. After an extensive investigation by DOJ, successfully convinced DOJ to decline to intervene in the matter.
- DaVita in connection with a government investigation of criminal and civil FCA claims related to the Company’s physician joint venture practices. Also in connection with that matter Sidley negotiated DaVita’s Corporate Integrity Agreement.
Contacts
Jaime Jones
Kristin Graham Koehler
Learn more about False Claims Act practice.
Lawyers in Sidley’s Global Life Sciences (GLS) Administrative Proceedings and Regulatory Litigation practice have significant experience handling client disputes with the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the U.S. Drug Enforcement Administration (DEA), and other federal and state life-sciences regulators. Many of our lawyers formerly held senior government positions, including within these very agencies, giving us insight into the internal dynamics, strategic priorities, and decision-making processes of the regulators our clients face.
We partner with healthcare and life sciences companies to design and execute strategies that both protect our clients’ business objectives and account for the sensitive realities of challenging the government. Our multidisciplinary teams of regulatory and litigation lawyers deliver integrated advice to clients contemplating legal action against federal agencies. We assist clients by:
- Managing Pre-Litigation Engagement: Leading high-stakes, pre-litigation meetings with agencies — including “last clear chance” discussions — to advocate for resolution and preserve litigation options.
- Designing and Executing Agency Engagement Strategies: Our lawyers have deep experience navigating the internal rules and procedures that life-sciences regulators have created for disputes arising from their decisions. Often, engagement at the agency level can air and resolve disputes without the need for litigation. At the same time, exhausting these procedures can be mandatory and a prerequisite for bringing a dispute to court.
- Building Robust Arguments: Agency disputes often turn on a mix of policy and legal arguments, and our lawyers have the experience and subject-matter knowledge to develop both. We craft arguments that address both the public health and other policy concerns that motivate regulators, as well as the intricacies of each agency’s organic act(s), the Administrative Procedure Act, and our clients’ constitutional rights.
- Evaluating Litigation Risk and Value: Handicapping legal arguments according to their likelihood of success — both with the agency and in court — is a crucial part of our practice. Realistic evaluations of the law, regulators’ institutional imperatives, and other extrinsic considerations helps our clients to recognize and achieve favorable outcomes for their mission-critical disputes.
- Advising Internal Stakeholders: We routinely support internal client discussions regarding concerns about “suing the regulator,” the potential for positive or negative media coverage, investor relations, and relationships with key opinion leaders and other important stakeholders. We help our clients pursue agency engagement or litigation while preserving institutional relationships.
- Selecting Optimal Litigation Strategies: When agency engagement has reached a standstill or litigation is the most viable pathway to resolution, we develop comprehensive strategies that account for the government’s anticipated justiciability challenges and the best venue for litigation, accounting for the relative experience of different courts in reviewing agency actions and related constitutional issues, and the possibility of home-field advantage for the agency or the client.
Contacts
Learn more about our Regulatory Litigation practice.
Healthcare and life sciences companies are regularly targeted by shareholder suits following clinical trial setbacks, regulatory scrutiny, product liability verdicts, or other events in connection with a stock price decline. Sidley’s Global Life Sciences (GLS) platform combines deep sector fluency with elite litigation experience to defend companies, boards, and executives in their most high-profile and sensitive matters. We understand the industry and help our clients navigate thorny issues involving massive damages, business risk, and reputational impact.
- Sidley’s GLS Shareholder Litigation team offers:
- Crisis-Tested Counsel: From product recalls and whistleblower reports to earnings misses and enforcement actions, we manage the fallout. Sidley is known for coordinated, cross-disciplinary defense across securities class actions, derivative suits, internal investigations, and parallel regulatory inquiries.
- Deep Industry Experience: We have successfully defended pharmaceutical, biotech, diagnostics, and medtech clients in litigation arising from clinical trial disclosures, manufacturing issues, underlying product liability litigation, market-moving regulatory decisions, and M&A activity. Where appropriate, our litigation strategy is informed by close collaboration with Sidley’s FDA and healthcare regulatory teams.
- Regulatory and Litigation Integration: We help clients navigate SEC, DOJ, FDA and HHS/CMS scrutiny tied to shareholder claims—particularly where disclosure, compliance, and financial reporting intersect. Our team advises on risk mitigation, government cooperation, and D&O insurer alignment.
- Board-Level Perspective: Sidley lawyers are trusted advisors to boards and special committees navigating fiduciary claims, shareholder demands, books-and-records requests, and governance challenges on issues of critical importance to the functioning of the board and the business. We assist boards in their highest-profile crisis situations, as well as in navigating challenges that never hit the press. And we have prevailed in cutting-edge litigation on director independence, forum selection, and demand futility.
- Recognized Excellence: Sidley is consistently ranked by Chambers USA, LMG Life Sciences, Benchmark Litigation, and U.S. News – Best Lawyers for securities litigation and corporate governance defense. Clients praise our team as "the standard by which [they] compare others."
Contacts
Learn more about our Securities and Shareholder Litigation practice.