Life Sciences and Healthcare
About
Given our extensive experience worldwide, including in the US, UK and EU, we understand the business and legal intricacies that life sciences and healthcare companies face. We have successfully advised our clients on the full spectrum of legal challenges and have helped them leverage opportunities in these dynamic industries. Our clients include traditional Big Pharma companies, biotechnology and tech companies, medical device manufacturers, healthcare entities, and venture capital and private equity funds.
We advise many of the leading global players in the life sciences and healthcare sectors on their disputes, transactions, including M&A and major investments and financings, and antitrust matters. Our team has extensive experience in the following areas:
- Pharmaceuticals: We guide pharmaceutical companies through every stage of product development, ensuring regulatory compliance while maximizing commercial success. Our lawyers have won some of the biggest pharmaceutical cases in history, successfully handling high-profile patent cases and advising on the full spectrum of IP-related work. We have significant experience in Hatch-Waxman litigation, representing clients in disputes that have shaped the pharmaceutical landscape.
- Biotechnology: Our lawyers craft innovative legal strategies that drive growth and facilitate breakthrough discoveries such as gene therapy, personalized medicine and bioinformatics. We work with our clients to ensure they comply with regulatory standards and support innovation in biotechnology.
- Biologics and biosimilars: We represent clients in cutting-edge litigation and provide strategic advice on regulatory compliance, IP protection and market entry strategies.
- Medical devices: Our team advises medical device companies on navigating the regulatory and commercial hurdles they face, helping them bring cutting-edge technologies to market, including medical device software, and achieve sustained growth.
- Healthcare: We provide comprehensive legal advice to healthcare providers, payers and service organizations. Our lawyers help them navigate complex regulatory landscapes and optimize operational efficiencies.
- Technological advancements: We advise clients on the latest technological advancements, including digital health, telemedicine and AI, in the pharma, MedTech and healthcare industries. Given the profound and growing impact of AI, we counsel clients on leveraging AI technologies to enhance drug discovery, diagnostics and patient care, and on navigating the related regulatory and ethical considerations and liability issues. Our team advises on intellectual property protection for AI innovations, data privacy and regulatory issues, and the integration of AI into healthcare systems and products.
- Animal health: We counsel clients in the growing field of animal health, advising on regulatory and commercial challenges and helping them leverage opportunities.
- Drug pricing: Legislators, enforcement agencies and private plaintiffs have been increasingly focused on the pricing of pharmaceutical products. Federal legislation and the complex web of state drug pricing laws have generated new and challenging competition questions for companies at every level of the pharmaceutical distribution chain. Our team is adept at navigating these complexities. We have successfully represented clients in investigations and litigation related to drug pricing and have crafted innovative legal strategies to address our clients’ challenges.
- Private equity: We have a strong focus on representing private equity firms and their portfolio companies in the life sciences and healthcare sectors. Our team provides comprehensive legal services, including transaction structuring, due diligence, regulatory compliance and exit strategies, ensuring that our private equity clients can maximize their investments and achieve their business objectives
- Capital Markets/Emerging companies: Our Capital Markets Practice has a market-leading presence in all the major financial centers in the Americas, EMEA and APAC. We advise issuers, banks and investors on their equity and debt-related financing needs. Our comprehensive offering, combined with our deep US/English law bench and global network, make us a first choice for complex cross-border capital markets matters.
In addition to traditional drug development and commercialization, we offer robust support to life sciences companies in various legal areas in the US, Europe and Asia-Pacific:
- M&A: We advise companies in the life sciences and healthcare sectors throughout their entire life cycle and provide comprehensive legal advice, including on issues related to structure, governance and operating documents, M&A, initial IP protection, early-stage equity and debt financings, strategic acquisitions and dispositions, licensing and distribution, IPO and public capital-raising in the public markets, disposition and go-private transactions. We understand the economic, market, regulatory, enforcement, and political climates in which healthcare companies operate and our global team can provide integrated solutions for our clients’ legal and business needs.
- Antitrust/Competition litigation: Our team closely tracks developments in competition and pharmaceutical policies, focusing on potential investigations and litigation. We have successfully defended antitrust challenges to life-science patent settlements (reverse-payment cases), product innovation strategies (product-hopping cases), cartel claims and a range of distribution practices. Our Antitrust lawyers have extensive experience handling pharmaceutical antitrust cases and have secured significant victories, including in the areas of biologics and biosimilars.
- Commercial litigation: We handle disputes related to contracts, intellectual property, regulatory compliance and partnership disagreements. Our deep understanding of FDA regulations and pharmaceutical licensing enables us to provide strategic counsel to our clients to protect their interests and achieve favorable outcomes through negotiation, mediation or litigation
- White collar and investigations: We advise clients on white collar disputes related to the life sciences and healthcare industry, focusing on regulatory compliance, fraud, insider trading, bribery and corruption cases. Our team counsels clients on how to strategically navigate the industry’s complex legal landscape, protect their reputations and mitigate risks. We’re adept at managing investigations, dismantling government actions and negotiating favorable settlements for our clients while safeguarding their interests.
- Intellectual property and technology licensing: Our lawyers have significant experience protecting and leveraging our clients’ IP assets through strategic licensing transactions.
- Strategic alliances and collaborations: We have substantial experience structuring complex partnerships that drive innovation and growth. Our lawyers also have extensive experience helping life sciences and healthcare companies navigate public offerings, private placements and other financing transactions. We provide strategic advice on securities regulation, compliance and capital-raising, ensuring that our clients can access the funding needed to drive innovation and growth.
- Trade, national security and sanctions: Our lawyers help our clients navigate trade, national security and sanctions issues related to supply chains.
- Data privacy: We advise our clients on how to address data privacy concerns, particularly around sensitive medical data.
- Strategic financing transactions: Our Capital Markets team handles the entire scope of securities products (debt, equity, high yield and structured finance and derivatives).
- Public company advisory: Our public company clients face evolving regulatory requirements, legal obligations and corporate governance challenges. We advise US and non-US public companies on their day-to-day affairs, crisis and all aspects of their compliance with the US securities laws, and the listing requirements of the major US exchanges, among other issues. Our Public Company Advisory Group keeps clients informed of the recent and pending developments and strategic trends in securities, corporate governance and executive compensation advisory.
We also have significant experience handling matters related to the Foreign Corrupt Practices Act, False Claims Act, international arbitration, tax, Securities Exchange Commission, environmental and international trade.
View more information on Cartel investigations
View more information on Merger control
View more information on Antitrust litigation & class actions
View more information on Drug Pricing
View more information on Due process
View more information on European state aid
View more information on Competition compliance
View more information on Antitrust/Competition
View all lawyers in Life Sciences and Healthcare
AWARDS & RECOGNITION
Shortlisted for Antitrust Firm of the Year and FDA Litigation & Enforcement Firm of the Year
LMG Life Science Awards 2024 Americas
Antitrust Attorney of the Year—Eric Grannon
LMG Life Science Awards 2024 Americas
Experience
Bystolic antitrust litigation
We successfully argued, on behalf of the defendants (innovator and generic), the motion to dismiss reverse-payment, "pay for delay" complaints filed by plaintiffs (direct-purchaser, end-payor and opt-out) concerning six separate settlements of pharmaceutical patent litigation. We also defeated the plaintiffs’ appeal of the district court’s ruling to dismiss their complaints with prejudice before the US Court of Appeals for the Second Circuit.
TSRA licenses for American pharmaceutical company
We advised an American pharmaceutical company that produces medicines and vaccinations for pets and livestock on general export controls and sanctions regarding Russia, China and Belarus. We obtained TSRA licenses for medicine and medical devices for export to Iran and Sudan.
Servier patent litigation
We represented French pharmaceutical company Servier in its challenge of the European Commission’s decision on patent settlement agreements in pharmaceutical markets. The General Court partially annulled the decision, notably overturning all findings of abuse of dominance under Article 102 and reducing the fine by more than €100 million.
Pfizer competition litigation
We have been advising Pfizer for more than 20 years. Notably, we successfully represented Pfizer in an appeal of the Competition & Markets Authority (CMA)’s decision on excessive pricing before the Competition Appeal Tribunal (CAT). Initially, the CMA imposed a fine of £84.2 million on Pfizer (a record amount in the UK) in December 2016. On appeal, the UK CAT annulled the decision in June 2018 and reverted the case back to the CMA. The UK Court of Appeal upheld the CAT's findings in March 2020. The CMA then reimposed a lower fine of £63.3 million on Pfizer in August 2022. An appeal of this decision is pending.
Delta Med S.p.A. acquisition
We’re advising Delta Med S.p.A., a portfolio company of White Bridge Investments S.p.A. specializing in the development and production of medical devices with a particular focus on the segment of vascular accesses, in the acquisition of D.B.M. S.r.l., an Italian company active in the medical device industry.
Top biotech company compliance program
We represented a top biotech company in upgrading its compliance program to meet the gold standard, including providing guidance on how to enhance training, increase hotline and other reporting of potential compliance issues, refine monitoring and strictly enforce controls on sales interactions with physicians that could potentially implicate the Anti-Kickback Statute and False Claims Act.
Leading medical device company acquisition
We represented a leading medical device company in a US$1 billion acquisition. We evaluated and recommended upgrades for the target entity’s global compliance program. This work focused on complying with the Foreign Corrupt Practices Act and due diligence in the four continents in which the target entity conducted business. It also involved specific policy and procedure recommendations for the use of sales distributors, interviews and forensic accounting audits in Asia-Pacific, Europe, Latin America and the US.
Neopharmed Gentili note issuance and financing
We’re advising Neopharmed Gentili, a portfolio company of Ardian and NB Renaissance and a leading Italian primary care pharmaceutical company, in the issuance of €750 million senior secured fixed and floating rate notes and entry into a new €130 million revolving credit facility.
