Arnold & Porter provides regulatory, litigation, transactional and licensing support to clients that range from global pharma giants to industry bodies, frequently being called upon to handle matters opposite the FDA, CMS and DOJ. The practice is also recognized for its expertise in medicare reimbursement regulations, where they assist with coverage at a state and federal level for new testing methods, clinical services and medical devices. The group is led by a three-person team composed of Allison Shuren, a compliance lawyer who specializes in healthcare fraud and abuse claims, FDA drug licensing expert Mahnu Davar and Daniel Kracov, who represents pharma and biotech companies in FDA approval proceedings. Jeffrey Handwerker is a pharma pricing specialist, with a wealth of experience handling litigation on the subject, with Kristin Hicks maintaining a broad litigation practice that covers pricing, fraud and compliance. Abeba Habtemariam is an authority on the Federal Food, Drug, and Cosmetic Act, with a record of advising healthcare-focused software and IT companies on FDA approval for their products, in addition to representing them in FDA and DOJ enforcement actions. All lawyers named here are Washington DC-based.

Cooley LLP excels at overseeing complex transactions in the life sciences market, advising both public and private clients on M&As, IPOs and follow-on offerings and collaborations in the sector. The firm is also sought after by early stage companies and VC investors looking for financing and investment opportunities. Reston-based practice co-head Christian Plaza advises on biotech, medtech and diagnostics companies on public and private offerings, VC investments and strategic collaborations, and M&A and capital markets specialist Marc Recht, based in Boston, joined the leadership team following Kay Chandler‘s retirement at the end of 2023. Palo Alto’s Ivor Elrifi chairs the firm’s global patent prosecution group, supporting clients looking to both create and enforce patents across, among others, the therapeutics, genetics and medical devices sectors, while Div Gupta is an experienced IPO lawyer based out of New York, who also handles VC transactions and M&A. With a practice split between Seattle and Palo Alto, Kate Hillier assists clients with their licensing strategies, research collaborations and clinical trial processes.

Hogan Lovells US LLP fields a deep litigation bench with expertise in the life sciences, strengthened by the October 2023 arrivals from Dechert LLP of patent litigators Howard Levine in Washington DC and Jennifer Swan in Silicon Valley, both of whom have experience in Hatch-Waxman disputes. On the non-contentious front, the practice supports major players in the pharmaceutical sector with their patent protection strategies, and is also noted for its work navigating the FDA approvals process. Leadership of the overarching practice is split between Philadelphia-based Steve Abrams, who handles IPOs and M&As in the sector, and Washington DC’s Lynn Mehler, who guides drug and biologics developers through the FDA approvals process; FDA approvals are also the key area of focus for Randy Prebula, also based in the capital. In Denver, Jodi Scott advises medical device manufacturers on MDRs and FDA inspections, while Washington’s David Fox tackles Hatch-Waxman litigation as it relates to generic drug production. Product liability litigation is the domain of Baltimore’s Lauren Colton, who represents clients facing MDLs and class actions, while Cullen Taylor and Anishiya Abrol, based in Virginia and Washington respectively, as supporting clients with the protection of their drug and medical devices patent portfolios and licensing transactions. Houston’s Andrew Strong is well versed in assisting early stage companies with growth strategies, financing and mergers.

Latham & Watkins LLP works with a number of major players in the life sciences industry on transactions in the sector, handling both M&A and IPOs, in addition to assisting with business combinations and licensing deals. In addition to transactional expertise, the practice is adept at overseeing patent protection strategies and litigation for pharma, biotech and medical devices companies. In Washington DC, John Manthei chairs the firm’s global life sciences group, specializing in the FDA regulatory process alongside vice chair Ben Haas, while also advising on the marketing of drugs and representing clients in Administrative Procedures Act litigation. Further litigation expertise comes in the shape of New York’s Arlene Chow and Chicago-based Terra Reynolds, with the former handling patent disputes concerning small molecule drugs and biologics, and the latter focusing on white collar defence and government investigations. In Silicon Valley, Shayne Kennedy is noted for his capital markets practice, advising on public and private securities offerings by life sciences clients. Boston’s Julie Scallen oversees both M&A and private equity transactions, and Elizabeth Richards, William McConagha and Jennifer Bragg, based in the capital, assist with FDA and DEA product testing and approval procedures. Judith Hasko has left the firm.

One client suggests that McDermott Will & Emery LLP fields ‘best trial team in the patent litigation space,’ and the practice is sought after by clients seeking both to protect their novel drugs and enforce them in the face of infringements. Beyond this, the firm is able to provide support across myriad matters, including stock and asset deals, M&As and partnerships in the industry. Jointly leading the team alongside her are Douglas Carsten, an Orange County-based specialist in life sciences patent disputes who helps clients protect pharmaceuticals, biologics and medical devices, and Silicon Valley’s William Gaede, a fellow patent litigator who specializes in antibodies, proteins and small molecules. Also in Silicon Valley, Bhanu Sadasivan litigates patent disputes concerning recombinant DNA technology. Vernessa Pollard and Anisa Mohanty departed the firm in February 2024.

Ropes & Gray LLP is particularly well versed in handling complex cross-border licensing agreements, and is also a name to note for transactions in the life sciences space. Additionally, the practice offers extensive expertise across a wide range of litigation, representing clients facing IP disputes and product liability class action, and is able to support clients seeking FDA approval for their products. The practice is headed jointly by transactional specialists Marc Rubenstein and Michael Beauvais, both of whom are based in Boston and maintain a broad transaction practice encompassing IPOs, licensing agreements and M&As in the sector, and Washington DC’s Gregory Levine, who focuses predominantly on assisting pharmaceutical, biotech and medical devices clients in navigating the FDA’s regulatory regime. Kellie Combs, also operating out of the capital, is noted for her knowledge of the Food, Drug, and Cosmetic Act and the Public Health Service Act, FDA promotional rules and the regulation of digital health systems.

With a raft of lawyers ‘whose experience is deeply rooted in the space,’ Goodwin is able to assist life sciences sector clients across the spectrum of related issues, ranging from multi-billion dollar acquisitions, to securing FDA approval for groundbreaking drugs, and obtaining patent protection for their products. 2023 saw extensive hiring at the partner level, with the October 2023 arrivals of licensing specialist David Chen in Santa Monica from Ropes & Gray LLP and capital markets expert Adam Johnson from Latham & Watkins LLP in New York underscoring the arrival in Philadelphia of a 10-strong team from Troutman Pepper in February. Mitchell Bloom leads the team alongside Kingsley Taft, with both assisting clients in securing VC funding and with eventual IPOs, with the latter also handling licensing agreements and the structuring of joint ventures; both are based in Boston.  Also in Boston, Marishka DeToy and Robert Puopolo‘s practices center on capital markets transactions in the sector. The firm’s FDA regulatory experts are Steven Tjoe and Alexander Varond, both based in Washington DC and advising on medical devices and drug development processes.

King & Spalding LLP represents clients in a range of complex disputes, including drug pricing issues under the federal 340B program, and is also a name to note for advice concerning the FDA’s regulatory procedures governing biologics and biosimilars. A number of investors in life sciences entities also regularly come to the firm for assistance in transactional matters. Leading the team is a three-person group of FDA regulatory specialists, with Mark Brown advising on both compliance and enforcement action, Nikki Reeves handling Form 483s and product recalls, and Seth Lundy, who assists medical device manufacturers design compliance programs and handle government investigations. Brian Bohnenkamp is also noted for his expertise in creating compliance programs, which he handles for both emerging and established players in the sector, while Lisa Dwyer specializes in the burgeoning digital health space, in addition to pre-market strategies. John Shakow is the name to note for issues of drug pricing, where he offers significant litigious experience. The practice was strengthened in August 2023 by the arrival from Hyman Phelps & McNamara, P.C. of Jeffrey Shapiro, an expert on the FDA’s approach to medical device regulation.

Debevoise & Plimpton LLP is equally adept at advising life sciences clients on FDA regulations governing drugs and medical devices as it is assisting major private equity investors with acquisitions in the sector. The practice offers litigation services in relation to price fixing allegations and matters tied to the opioid epidemic. Andrew Bab, Jennifer Chu and Kevin Rinker handle the firm’s transactional workload, advising on the structuring of acquisitions and assisting with licensing issues. Mark Goodman represents clients in civil litigation and white collar trials, while also advising on internal investigations, with Maura Monaghan taking the lead on product liability and mass tort litigation. In Washington DC, Paul Rubin handles FDA matters, including compliance and regulatory enforcement, and is also recommended for carrying out due diligence processes for private equity houses. All lawyers are New York-based unless otherwise specified.

Dechert LLP is well-placed to advise clients engaged in major cross-border transactions, including assisting with patent strategies tied to deals. On the contentious front, the firm’s litigators represent clients in patent disputes tied to a variety of drugs, and are also well versed in handling MDLs and class actions arising out of product liability claims. Boston-based patent specialist Andrea Reid advises biotech and pharmaceutical clients on the management of their IP portfolios, offering a deep understanding of the drug discovery and development processes and leading the practice alongside New York’s David Rosenthal, who advises life sciences-focused investors on IPOs, secondary offerings and licensing matters. Also based in New York, litigator Katherine Helm handles a broad spectrum of patent-related disputes, representing both plaintiffs and defendants in infringement suits and tackling commercial issues including breach of contract and antitrust litigations.

DLA Piper LLP (US) handles a range of high value disputes in the sector, helping clients defend their patents in cross-border litigation and also providing support in product liability and personal injury MDLs arising out of allegations of faulty products or drugs. Licensing and supply agreements also fall within the group’s purview, where the group acts for both suppliers and buyers of critical medical ingredients. Heading the team are Matthew Holian, a Boston-based litigator whose practice encompasses multi-jurisdictional product liability disputes, and New York’s Andrew Gilbert, who advises both public and private life sciences companies on M&As and securities law; February 2024 saw the arrival of FDA regulatory specialists Vernessa Pollard and Anisa Mohanty from McDermott Will & Emery LLP‘s Washington office, advising on pre-market strategy and post-market compliance. Loren Brown represents clients across the spectrum of litigation pertinent to life sciences clients, including patent and trade secret infringement claims, and securities class actions, and Lucas Przymusinski focusing on product liability suits tied to drugs and medical devices; both are located in New York. Boston’s Katie Insogna is recommended for her ability to handle both regulatory issues and litigation, including MDLs tied to product liability, and broader commercial litigation.

With a client base spanning pharmaceutical, medical devices and biotech companies, Mayer Brown offers a full range of contentious and advisory IP services, covering Hatch-Waxman disputes and infringement allegations, while also overseeing cross-border mergers and joint ventures and associated IP strategies. Leading the team out of New York are Lisa Ferri, who frequently appears before the PTAB and Federal Appeals Courts in complex patent trials, while also working alongside Reb Wheeler to oversee transactions in the sector, including M&A, private equity acquisitions and joint ventures.

Pairing an ‘unparalleled combination of legal and business acumen,’ Morrison Foerster is the firm of choice for several global pharmaceutical companies facing patent challenges, whether looking to gain patent coverage for their novel drugs, or to enforce existing patents via the courts. The January 2023 merger with litigation boutique Durie Tangri saw experienced patent litigators Daralyn Durie, Adam Brausa, both in San Francisco, and Los Angeles-based Kira Davis join the practice, further enhancing its ability to take on major patent disputes concerning cancer treatments, biosimilars, small molecules and more. Practice head Michael Ward maintains a practice between San Francisco and Boston, overseeing patent portfolios for both drug developers and clients active in the agriculture field, whom he advises on protection strategies and licensing for their unique plants. In Palo Alto, Catherine Polizzi and Janet Xiao assist clients with the development of their patent portfolios, as it pertains to therapies for cancer, autoimmune diseases and gene therapy, among others. Based out of Washington DC, Stacy Amin handles FDA regulatory issues, including enforcement actions.

Weil, Gotshal & Manges LLP‘s ‘responsive and dedicated’ life sciences practice melds an active transactional life practice with a patent practice that covers both patent strategy and disputes before the PTAB and Federal Circuit Courts, working together to see through collaborations and licensing agreements in the sector. The firm’s efforts are spearheaded by patent litigators Elizabeth Weiswasser and Silicon Valley’s Edward Reines, who handle matters pertaining to biologics and small molecules among a range of other complex patent issues. Derek Walter, also based in Silicon Valley, is another name to note for patent litigation in the pharmaceuticals and biotech spaces. Transactions with a substantial IP element are overseen by Jeffrey Osterman and Charan Sandhu, who also advise on joint ventures and technology transfers. Lawyers mentioned are based in New York unless otherwise specified.

Pharmaceutical companies, academic institutions and investors come to WilmerHale for advice on critical transactions, including M&A, joint ventures and strategic alliances, in addition to being entrusted with complex patent disputes. Stuart Falber is sought after by a range of established players and new market entrants, including VC investors, for IPOs, spinoffs and licensing deals, leading the team alongside Lisa Pirozzolo, who represents clients in patent infringement and contractual litigation; both are based in Boston. In Washington DC, Amy Wigmore brings further litigious experience, handling a range of matters under the Hatch-Waxman Act and concerning biosimilars. Judith Hasko joined in Palo from Latham & Watkins LLP in June 2024, bringing significant experience.

Tackling both transactions and disputes in the life sciences sector, Gibson, Dunn & Crutcher LLP is sought out by clients engaged in Hatch-Waxman and product liability litigation, in addition to those both seeking financing or seeing through M&A. Taking the lead on corporate and transactional matters is Ryan Murr, who counsels pharmaceutical, biotech and diagnostics companies on business combinations and securities transactions out of San Francisco, while New York-based Jane Love spearheads the practice’s efforts on the IP front, where she represents clients in litigation concerning biologics and small molecule therapies.

Greenberg Traurig LLP boasts ‘very deep expertise’ in life sciences mandates, with particular expertise in overseeing IP-heavy transactions, where the practice helps clients shape their patent strategies and develop their portfolios, covering novel products in the pharmaceutical, medical devices and biotech markets. The practice is overseen by Boston-based David Dykeman, a specialist in securing patents for clients’ new products and in the strategic management of their portfolios, and Atlanta’s Wayne Elowe, who oversees transactions including M&A and licensing deals, in addition to assisting with specific asset purchases. Melissa Hunter-Ensor, also based in Boston, maintains a broad patent practice that encompasses both portfolio management and litigation.

Kirkland & Ellis LLP‘s life sciences work brings together a number of the firm’s departments, together handling antitrust proceedings in the sector, while also representing pharmaceutical companies in product liability and personal injury litigation. Such disputes are the domain of Jay Lefkowitz, who also handles False Claims Act and shareholder litigation before Circuit Courts of Appeal and the Supreme Court. Further antitrust litigation experience comes in the form of Devora Allon, who also handles a broad range of commercial litigation. Patent litigation covering pharmaceuticals, medical devices and biotechnology is handled by Jeanna Wacker, and she is also consulted on the IP aspects of corporate and asset transactions. All lawyers mentioned are based in New York.

In addition to advising clients in the pharmaceuticals and medical devices clients, Norton Rose Fulbright also advises a number of retail pharmacies and drug distributors, supporting them in the event of data breaches and also providing data security compliance support, with New York-based David Kessler taking the lead on such matters. The practice also takes on a range of contentious work, including antitrust litigation and patent disputes before the ITC. D’Lesli Davis, a Dallas and New York-based litigator who represents clients facing mass tort and MDL cases, leads the group alongside Jonathan Skidmore, who handles disputes revolving around pharmaceutical and medical products and devices liability.

Fielding a ‘very strong team across the board,’ Orrick, Herrington & Sutcliffe LLP advises across a range of issues in the life sciences, including disputes concerning patents and licensing and royalty deals, while also advising issuers, underwriters and investors on IPOs in the sector. Leading the team alongside each other are Stephen Thau, a New York and Silicon Valley-based specialist in life sciences M&A, licensing deals and strategic alliances, and Thora Johnson, who helps clients navigate regulatory challenges arising out of privacy issues and HIPAA, among others. ‘True advocate’ David Gindler is a patent litigation expert, tackling infringement and validity claims, while also assisting with the structuring of IP license agreements.

Proskauer Rose LLP‘s life sciences practice is particularly adept at handling multi-faceted patent disputes concerning biologics, medical devices and pharmaceutical developments, and 2023 saw the team expand with the arrivals of Erik Milch in Washington DC and Joseph Drayton in New York from Cooley LLP in July and October respectively, while Morrison Foerster‘s Grant Esposito and David Fioccola also joined the New York office in October. The team is led by Boston’s ‘excellent patent lawyer’ Fangli Chen, whose litigious experience encompasses immunotherapy, gene therapy and editing and vaccines, managing partner and transactions specialist Daryn Grossman in New York, and Siegmund Gutman, who represents clients in patent disputes concerning biologics and in Hatch-Waxman disputes out of Los Angeles.

Under the leadership of Washington DC’s Paul Schnell, Skadden, Arps, Slate, Meagher & Flom LLP offers a range of services to life sciences companies, including assisting target companies in their acquisitions by major life sciences players, cross-border licensing agreements, and disputes tied to a variety of sector-specific and broader commercial issues. Boston-based Graham Robinson advises both public and private companies on transactions in the sector, often representing target companies.

Winston & Strawn LLP advises a diverse client base consisting of pharmaceuticals, biologics and medical devices producers on matters ranging from patent, product liability and broader commercial litigation, to M&As and private equity investments in the sector. Leading the team is Washington DC’s Reed Stephens, a specialist in FCA and Anti-Kickback proceedings, and with further expertise in Medicare and Medicaid reimbursement proceedings. Chicago-based George Lombardi offers extensive experience litigating patent disputes. May 2023 saw the practice reinforced by the arrival of a three-partner group from Reed Smith LLP, with government contracts lawyers Lawrence Block, Elizabeth Leavy and Lawrence Sher arriving in the capital.

Akin brings an in-depth understanding of FDA regulatory regimes to bear for clients in the pharmaceutical sector, with particular expertise in rules governing the burgeoning area of digital health, where the practice assists with the integration of AI into diagnostics and treatment planning systems. Practice head Nathan Brown brings ‘an impressive understanding of historical and current FDA enforcement and oversight approaches’ to the table, representing drug, medical devices and diagnostics developers seeking FDA clearance for new products and advising on FDA-compliant marketing strategies; he is based in Washington DC. In New York, Craig Bleifer handles issues ranging from clinical trials to product labelling, with further expertise on the FCA.

Freshfields Bruckhaus Deringer LLP represents life sciences clients on both the target and buyer side of transactions in the sector, and is also adept at overseeing licensing agreements and asset acquisitions between pharmaceutical companies. The practice also handles litigious matters, including government investigations into off-label marketing and fraud allegations, and defense of clients facing securities suits. New York’s Adam Golden heads the team, overseeing M&A, VC investments and licensing and cooperation agreements and advising on the IP aspects of such deals. Out of Silicon Valley, Vinita Kailasanath assists with transactions at the intersection of life sciences and technology, while Washington DC-based Kristen Riemenschneider represents biopharmaceutical clients in their transactional matters, including those where liaising with government bodies is required.

Jones Day makes ‘substantive legal contributions’ to clients’ efforts in the life sciences field, managing several high value mergers in the sector, while also providing support and representation in relation to clients’ IP portfolios and issues under federal drug pricing statutes. The firm is also sought after for advice in relation to digital health and telemedicine, with practice co-head Alexis Gilroy, who splits time between Washington DC and Atlanta, advising on the structuring of telehealth services and assisting with transactions in the sector. Leading the team alongside her is Chicago-based Heather O’Shea, whose practice spans regulatory compliance issues and litigation arising out of healthcare fraud allegations under the FCA and Anti-Kickback Statute.

Loeb & Loeb LLP combines expertise in FDA regulatory issues with a specialization in patent litigation, advising clients on the marketing and commercialization of their drugs and representing them in patent disputes, including those falling under Hatch-Waxman. Washington DC-based Jim Czaban takes the lead on FDA compliance across the life cycle of medical products and representing them in enforcement actions. Mitchell Nussbaum handles a range of corporate and capital markets matters, with Fran Stoller on research collaborations, licensing agreements and securities law. Mark Waddell represents clients in Hatch-Waxman and biosimilars litigation, as does Kathleen Gersh, who also advises on FDA regulation. Unless otherwise specified, all lawyers are New York-based.

Sheppard, Mullin, Richter & Hampton LLP‘s ‘flexible and business oriented’ practice assists clients with the management of their patent portfolios, advising on patent prosecution strategies and representing them in court where infringements occur, while also supporting clients in negotiations with the FDA over labelling issues and approvals for novel drugs. Based in New York, the practice leadership consists of Jeffrey Fessler, who focuses on life sciences transactions, and Scott Liebman, who accompanies pharmaceutical, biotech and medical devices clients through FDA procedures. Former team co-head Allison Fulton took up an in house post in February 2023.

Marshalling its ‘strong experience’ in the life sciences sector, White & Case LLP handles large transactions and associated antitrust matters, with additional experience in IP litigation, covering Hatch-Waxman and BPCIA disputes. Peter Carney heads the group, specializing in both civil and criminal antitrust defense, cartel investigations in the US and a range of other countries, and negotiating patent settlement agreements.