Life sciences and healthcare companies face an increasingly complex and competitive landscape. To succeed in this environment, industry leaders and start-ups and their investors and capital providers need a strong partner that can provide creative yet practical legal and business solutions to help them navigate the unpredictable market.

Creating Value

We partner with clients to understand and advise on their business and legal objectives, delivering tailored solutions, creative strategies, innovative value-add offerings, and seamless service across practices and regions. Our lawyers handle complex transactional, regulatory, and litigation matters, providing guidance and insight into the industry as a whole.

We help our clients protect and enhance their value in this complex, unpredictable marketplace:

• Partnering with more than half of the top 50 life sciences and healthcare companies by market capitalization

• Handling numerous high-stakes, bet-the-company patent litigations, and post-grant proceedings

• Advising on high-profile government compliance, investigations, and enforcement issues, including FDA regulatory and enforcement advice

• Providing strategic counsel on nearly every type of capital markets offering

• Structuring complex cross-border transactions—from M&A to innovative strategic partnerships, to licensing and funding arrangements

• Developing and implementing compliance risk management programs in collaboration with our Life Sciences Consulting Group

• Nearly every lawyer in our premier IP practice has a technical degree in life sciences, engineering, or chemistry. The group includes PhD-level scientific advisors who have substantial experience in pharmaceutical patent litigation.

Transactional Life Sciences

Life sciences companies trust us to handle their most important matters – and we consistently deliver successful outcomes across the full spectrum of life sciences transactions. We leverage our decades of experience, deep industry knowledge, and culture of innovation and collaboration to deliver best-in-class legal advice on every matter.

• Broad-based Capital Markets Offering:

  From startups to public offerings, our highly skilled Capital Markets team provides strategic counsel on nearly every type of capital markets offering and under the laws of multiple jurisdictions. We represent issuers, underwriters, and other financial institutions in domestic and international equity and debt capital-raising transactions; establishment of U.S. and international securities exchange listings; and compliance with securities laws, securities exchange rules, and the corporate governance requirements.

• Venture Capital & Emerging Growth Companies: We advise emerging growth companies with all aspects of their business activities from formation, initial start-up advice to exit transactions, as well as the investors who help power innovation into new markets and access to new technologies and opportunities.

• Sophisticated M&A Deal Experience: Life Sciences is a significant focus of the Paul Hastings M&A Group. Our sophisticated M&A lawyers understand the complex M&A issues that are most critical to change of control transactions involving life sciences companies and are adept at devising innovative ways to get deals done on time and on budget.

• Collaborations & Licensing: We help clients identify and leverage opportunities to pursue new paths to growth through collaborative relationships and initiatives. We guide clients through their R&D and commercialization collaborations, joint ventures and other strategic alliances, enabling them to efficiently grow, commercialize, and diversify their product and service offerings to consumers.

Compliance Counseling, Investigations & Enforcement

Our diverse powerhouse team includes seasoned former in-house counsel, former federal and state prosecutors, and veteran congressional defense practitioners. We bring unmatched compliance and enforcement experience to our clients most complex challenges.

Few firms can boast the breadth of experience that Paul Hastings can. Many of the world’s leading companies in the life sciences industry and beyond have entrusted our team to represent them before global, federal, and/or state prosecutors on their largest and most challenging cases. Paul Hastings has advised on more FCPA settlements than any other firm since late 2008, and has had more FCPA monitorships than any other firm since 2004 (Global Investigations Review).

A Track Record that Speaks for Itself

Our record of helping companies successfully investigate, defend and negotiate the terms of domestic healthcare cases with U.S. Attorney’s Offices and DOJ and SEC plea and/or settlement agreements speaks for itself. We successfully managed multiple successful outcomes and represented three of the world’s Top 10 pharmaceutical companies in the successful resolution of their DOJ / SEC / FCPA matters and subsequent monitorships.

In addition to federal regulatory matters, we have a State AG Investigations team that leads corporate responses to large-scale and complex multi- and single-state investigations and enforcement actions brought by state AGs.

We also offer training and resources to satisfy regulator compliance program expectations. Our day-to-day compliance advisory work for clients across the industry means we keep our finger on the industry pulse, and our deep in-house life sciences experience means we bring a unique insider’s perspective.

FDA, Regulatory and Enforcement

Life Sciences companies face an increasingly complex and regulatory and legal environment, and they need experienced counsel to help them navigate key questions and address potential enforcement risks. Our FDA Regulatory and Enforcement lawyers leverage their experience as former executives and counsel at the FDA, pharmaceutical and medical device companies, as well as in private practice, and a collaborative operating model to deliver tailored FDA regulatory, compliance, and enforcement support.

• We have experience working on the development and commercialization of a broad range of FDA-regulated product types and technologies, spanning biologics, drugs, and devices, digital health tools, and diagnostic technologies. Our team provides compliance and enforcement support for all aspects of the product lifecycle. Because of our team's unique backgrounds, we have a keen understanding of the FDA’s priorities and our clients’ needs, enabling us to guide companies successfully through the constantly changing regulatory and enforcement landscape.

• We advise medical product companies on engagement with regulators, including related to product development, product quality issues, and product jurisdiction; as appropriate, we also coordinate with products liability and other counsel to reduce legal exposure, and develop coordinated approaches for addressing concerns from multiple global health authorities.

• Our team defends clients in civil and criminal investigations by the DOJ into alleged violations of the Federal Food, Drug, and Cosmetic Act, Title 18, and related federal statutes. We handle DOJ actions related to FDA enforcement, including injunctions, product seizures, and consent decrees.

• We support a variety of life sciences transactions, from license and supply arrangements to clinical trial agreements, outsourcing arrangements; we conduct investment due diligence for FDA-related issues, including acquisitions of pharmaceutical and medical device companies, manufacturing sites, and products.

Life Sciences and Healthcare Consulting Group

Our first-of-its-kind consulting group has deep experience working both independently and arm-in-arm with our top-tier legal colleagues to design, build, implement, and operate effective compliance risk management programs—as well as the organizational constructs and resource models that support those programs across the enterprise.

Whether the context in which we work together is reactive (i.e., an investigation or government action) or proactive (i.e., borne out of a desire to enhance your risk management program), we have the experience necessary to tailor our approach to your unique needs.

Intellectual Property Litigation

The Paul Hastings Life Sciences Intellectual Property (IP) Practice has a long track record of success in high-stakes, bet-the-company cases in the district courts as well as groundbreaking victories in Patent Trial and Appeal Board (PTAB) proceedings. Our deep and diverse bench of award-winning first-chair attorneys excel at collaborating, and provide a one-stop shop for complex IP disputes requiring strategic coordination across multiple forums.

• Deep Bench of Trial-Tested Biotech and Pharma Patent Litigators. We are a go-to firm when the patents or trade secrets protecting a client’s primary revenue-driving drug products are on the line, having substantial experience in the nuances of Hatch-Waxman and biotech patent litigation, including strategies to win cases in federal district court while navigating intersecting regulatory issues involving the FDA. We also have substantial experience in biosimilars patent litigation practice under the BPCIA, providing key strategic advice and representing both reference product sponsors and biosimilar applicants companies in litigation and related PTAB proceedings.

• Substantial Experience Handling Parallel Proceedings Before PTAB. Our Patent Office practice has extensive experience with post-grant challenges, including post-grant review and IPR proceedings, resulting in a strategic and cost-efficient defense to litigation. We have been involved in more than 500 post-grant proceedings and, significantly, are undefeated at the PTAB in Life Sciences matters. Managing both district court and Patent Office proceedings, we are able to develop efficient, coordinated strategies that take account of the differences between the two venues, while maintaining consistency in positions and taking the approach most likely to protect key patents through all proceedings.

• Deeply Diverse Team of Legal Professionals and Ph.D.-Level Attorneys and Scientific Advisors. Beyond trial talent, nearly all our Life Sciences IP attorneys hold technical degrees, including advanced degrees in biotechnology, life sciences, chemistry, and materials science, and many have hands-on experience from working at leading international research institutions and large life sciences companies. We recognize the importance of learning and mastering the specific technology at issue in any case from the outset and have a team of lawyers with the technical acumen to do so.

Data Privacy & Cybersecurity

Our team advises on unique data governance issues, Internet of Things (IoT) development and rollout, proactive privacy and cybersecurity assessments, and related litigation & investigations across the industry. Our core offerings include:

• Regulatory Advice & Counseling

• Global Data Privacy Compliance & Enforcement

• HIPAA Compliance & Enforcement

• Data Breach Incident Response & Crisis Management

Recognition for Our Practice

• Named IPR Team of the Year by LMG Life Sciences.

• Ranked by Managing Intellectual Property’s IP Stars as Tier 1 in Life Sciences.

• The firm was named Life Sciences Litigation Firm of the Year by Managing Intellectual Property.

• The firm was shortlisted by Benchmark Litigation for "California - Intellectual Property Litigation Firm of the Year"

• Recognized as Life Sciences Practice Group of the Year by Law360.

• Recognized as Most Valuable Players – Life Sciences and IP by Law360.

• Ranked in consecutive editions of Global Investigations Review GIR 100, for handling sophisticated cross-border government-led and internal investigations.

• Recognized as a top firm for Healthcare: Life Sciences, Legal 500 U.S.

• "The team is known as an international firm with a strong U.S. footprint and sector expertise in life sciences and frequently called upon for strategically significant cross-border transactions." Chambers US