K&L Gates advises healthcare and biotech clients on regulatory, transactional, and commercial matters across the product lifecycle, from R&D through to commercialization and cross-border transactions, headed by Andrew Ruskin in Washington, DC and Michael Hinckle in North Carolina.
Life sciences in United States
K&L Gates
Responsables de la pratique:
Andrew Ruskin; Michael Hinckle
Les références
‘The firm’s regulatory counsel Michael Hinckle was knowledgeable, professional, and responsive in the life sciences space.’
‘They are highly professional, have a long history of working with early-stage public companies, provide thoughtful/common-sense advice and guidance, communicate well and get the job done (strong execution) all at a reasonable hourly rate.’
‘Seamless interaction. Understands the problem as if it were their own and presents the solution in a practical way that is clear and easy to apply.’
Principaux clients
Novozymes North America
Visterra, Inc.
Novartis
Rona Therapeutics
Abpro
Arbor Biotechnologies, Inc.
Flagship Pioneering, Inc.
Gilead
Sanofi Aventis
Arnold & Porter
Arnold & Porter advises life sciences clients on regulatory, transactional, IP, public policy, and litigation matters affecting the sector. The firm handles matters involving emerging scientific fields, including immuno-oncology, cell and gene therapy, and novel diagnostics. Daniel Kracov chairs the global life sciences practice and advises clients on FDA regulatory strategy, compliance, enforcement issues, clinical research matters, and government and internal investigations relating to product and compliance issues. Jeffrey Handwerker advises on pharmaceutical pricing and contracting, as well as coverage, reimbursement, and investigations and litigation affecting life sciences and healthcare companies. Mahnu Davar focuses on regulatory and compliance matters involving pharmaceutical, biologics, and medical device products, and co-chairs the firm's life sciences and healthcare regulatory team with Allison Shuren. Kristin Hicks advises on compliance issues including anti-kickback matters involving specialty pharmacy arrangements, PBM and GPO relationships, wholesaler agreements, and patient assistance programs. Abeba Habtemariam advises pharmaceutical and medical device manufacturers on regulatory, compliance, and legislative matters. All lawyers mentioned above are based in Washington, DC.
Responsables de la pratique:
Dan Kracov; Mahnu Davar; Allison Shuren
Autres avocats clés:
Jeff Handwerker; Mahnu Davar; Kristin Hicks; Abeba Habtemariam
Cooley LLP
Cooley LLP maintains a strong presence in the life sciences and healthcare sector, with particular emphasis on transactional work for startups and late-stage companies, including those pursuing IPOs. The firm regularly advises on securities offerings, joint ventures, and M&A matters involving life sciences businesses. Reston-based Christian Plaza serves as co-chair of the firm’s life sciences and healthcare vertical, alongside Marc Recht in Boston, who advises life sciences companies on capital markets transactions, joint ventures, and corporate deals. The firm has newly appointed Kenneth Krisko in Reston as head of corporate partnering and licensing, who is involved in significant life sciences commercial agreements. The team has recently expanded its regulatory, IP litigation, and non-IP litigation capabilities in support of its life sciences and healthcare client base. This combination of transactional strength and expanded advisory platforms is shown in the firm’s continued activity across multiple areas of the sector.
Responsables de la pratique:
Christian Plaza; Marc Recht; Kenneth Krisko
Principaux clients
Abivax
Acadia Pharmaceuticals
Autolus
Bicycle Therapeutics
Biomarin Pharmaceutical
Cidara Therapeutics
CG Oncology
Illumina
Inovio
Instil Bio
Jazz Pharmaceuticals
Liquidia Technologies
Maplight Therapeutics
Travere Therapeutics
Principaux dossiers
- Advised BioNTechSE, on its $11.1 billion global co-development and co-commercialization collaboration agreement with Bristol Myers Squibb forBioNTech’s antibody candidate BNT327.
- Advised Maplight Therapeutics, on its oversubscribed $372.5 million Series D crossover financing and subsequent $258.9 million IPO.
- Advised Poseida Therapeutics, on its $1.5 billion sale to Roche.
Hogan Lovells US LLP
Hogan Lovells US LLP maintains a broad life sciences and healthcare practice spanning IP licensing, regulatory, and transactional matters. The team advises on complex licensing and collaboration agreements involving IP at all stages of the product lifecycle, including work with emerging and cutting-edge companies. The practice has also developed a focus on energy demand issues affecting life sciences businesses. Leadership of the team includes Philadelphia-based Steve Abrams, co-head of the firm’s life sciences and healthcare industry sector, who advises on capital markets offerings, collaboration and licensing transactions, and M&A matters, and Washington, DC-based Lynn Mehler, fellow co-head of the life sciences sector and head of the pharmaceuticals and biotechnology regulatory practice. The practice’s regulatory capabilities are further reflected in the medical device and technology regulatory division, co-led by Jodi Scott and John Smith; Scott advises on FDA inspections and enforcement matters from Denver, while Smith focuses on bringing device-based technologies to market, including AI-based image analysis tools, from Washington, DC. Cullen Taylor co-leads the life sciences licensing and commercial transactions team from Northern Virginia, and in Washington, DC David Fox and Komal Karnik Nigam advise on new drug approvals, regulatory compliance, and product lifecycle exclusivity issues.
Responsables de la pratique:
Steve Abrams; Lynn Mehler; Jodi Scot; John Smith; Cullen Taylor; Andrew Strong
Autres avocats clés:
Conor Larkin; Elizabeth Jungman; Maura Calsyn; David Fox; Komal Karnik Nigam; Michael Heyl; Stephen Nicolai; John Smith; Eriko Yoshimaru
Les références
‘This firm stands out for its multidisciplinary approach, high-level regulatory law with deep technical knowledge across a wide range of medical device technologies. What makes them unique is their team’s diverse expertise; they don’t just provide legal advice, but act as strategic partners who help translate complex engineering data into successful US regulatory submissions.’
‘The individuals we worked with, specifically Janice Hogan and Lina Kontos, truly stand out due to their responsiveness and the high caliber of their strategic advice.’
‘This team is the most responsive and the most practical healthcare regulatory team that I’ve worked with, across FDA, fraud and abuse, and cybersecurity/privacy related issues. Solid and trustworthy. Hogan Lovells has been my go-to for over a decade now.’
Principaux clients
Novartis
Clairity
Recordati
Bristol Myers Squibb
Hitachi
Distalmotion
Scopio Labs
BioGenCell, Ltd.
OPKO Health
Lexicon Pharmaceuticals
B. Braun Medical
Invivyd
EyePoint Pharmaceuticals
Marinus Pharmaceuticals
Pulmatrix
Abcuro
Osteal
Principaux dossiers
- Advised Novartis on multiple high-value, cross-border transactions, including its $3.1 billion acquisition of Anthos Therapeutics.
- Advised Distalmotion on securing FDA De Novo market authorization for its Dexter robotic surgical system.
- Secured a landmark defense verdict for B. Braun Medical in a high-profile ethylene oxide (EtO) litigation, successfully defending against over 100 personal injury and toxic tort lawsuits in Pennsylvania state courts and establishing crucial precedent for the medical device industry.
Latham & Watkins
Latham & Watkins maintains a comprehensive healthcare and life sciences practice spanning corporate transactions, commercial arrangements, regulatory advisory work, and litigation. The firm advises on M&A and capital markets transactions, as well as strategic alliances and joint ventures, alongside regulatory matters involving government approvals and oversight and disputes ranging from IP litigation to white-collar investigations and defense. Leadership of the practice includes Shayne Kennedy, global healthcare and life sciences industry chair, who advises on public and private securities offerings for issuers and underwriters in biotechnology, medical devices, pharmaceuticals, and healthcare from California, and John Manthei, global healthcare and life sciences practice chair, who regularly counsels clients across the medical device, pharmaceutical, biotechnology, and dietary supplement industries from Washington, DC. Arlene Lee Chow and Terra Reynolds also serve as global healthcare and life sciences industry chairs, working from New York and Chicago respectively. In Washington, DC, regulatory depth is reflected in the work of Ben Haas and William A. McConagha on FDA-related matters across the product lifecycle, while Elizabeth M. Richards focuses on FDA regulatory strategy, compliance, enforcement, and technology-driven life sciences matters. Peter N. Handrinos covers life sciences M&A and public offerings, working from Boston and New York, and Julie Scallen and Cheston Larson advise on corporate transactions from Boston and San Diego respectively. Kate Hillier bolsters the team's expertise from Silicon Valley as a 'brilliant, creative, business savvy, and fabulous' partner.
Responsables de la pratique:
Shayne Kennedy; John Manthei; Arlene Chow; Terra Reynolds
Autres avocats clés:
Julie Scallen; Ben Haas; Elizabeth Richards; William McConagha; Cheston Larson; Kate Hillier
Les références
‘Latham has one of the top, if not the top, healthcare life sciences practices.’
‘They have particularly deep expertise in capital markets and M&A for this industry, both on the company and bank side.’
‘They have not only the technical depth/breadth but an in-depth understanding of how companies in this space operate and what drives the capital markets cycle and M&A.’
Principaux clients
Merus
Siemens AG
Regulus Therapeutics
OrganOx
Boston Scientific
GRAIL
scPharmaceuticals
CARGO Therapeutics
Nevro Corp.
Gossamer Bio
DHL Group
HilleVax
LENSAR
Kardigan
atai Life Sciences
bluebird bio
Coherus BioSciences
Zevra Therapeutics
Ceribell
Metsera
Shoulder Innovations
Caris Life Sciences
Avidity Biosciences
Mineralys
PROCEPT BioRobotics
Revolution Medicines
Sobi
Vulcan Bio Corporation
BridgeBio Pharma
Vera Therapeutics
Abridge AI
Callio Therapeutics
Character Bioscience
Timberlyne Therapeutics
Crystalys Therapeutics
Oath Surgical
AbbVie
LEO Pharma
Immuneering Corporation
Lyra Therapeutics
MiNK Therapeutics
Rhythm Pharmaceuticals
Intera Oncology
Chugai
Nalu Medical
Evoke Pharma
George Medicines
Ollin Biosciences
Principaux dossiers
- Advised Merus in the sale to Genmab, and the public offering of 5,263,158 shares of common stock at US$57.00 per share listed on Nasdaq.
- Advised Siemens AG in its acquisition of Dotmatics.
- Advised Regulus Therapeutics, in its sale to Novartis AG, a Swiss multinational pharmaceutical corporation.
McDermott Will & Schulte
McDermott Will & Schulte fields a well-established life sciences practice advising on corporate, regulatory, IP, and litigation matters across the product lifecycle. The group handles complex domestic and cross-border transactions, patent disputes, and regulatory issues for clients ranging from early-stage companies to established global businesses. The firm demonstrates particular strength in transactional and corporate work, supported by a dedicated IP strategy, prosecution, and high-impact litigation team. Kristian Werling serves as global head of the health and life sciences practice from Chicago and represents private equity and strategic investors in a wide range of transactional matters within the sector. Washington, DC-based Michael Ryan co-heads the firm’s life sciences industry practice and advises manufacturers, healthcare providers, and drug and technology developers on sector-specific legal issues. Also in DC, James Ravitz, co-head of the life sciences industry practice and head of the FDA practice, advises on regulatory compliance, consumer protection investigations, government enforcement matters, and broader FDA regulatory issues affecting life sciences and healthcare clients.
Responsables de la pratique:
Krist Werling; Michael Ryan; James Ravitz
Autres avocats clés:
Doug Carsten
Les références
‘Service is timely and professional. Highly recommend.’
‘Doug Carsten is great.’
Ropes & Gray LLP
Ropes & Gray LLP advises life sciences and healthcare clients at every stage of the development lifecycle, with a practice spanning transactional, regulatory, IP, and enforcement matters. The firm assists clients in developing, protecting, and commercialising IP assets, advising on portfolio development, patent due diligence, freedom-to-operate assessments, and complex licensing and technology transfer arrangements. The team’s life sciences capabilities are supported by a strong corporate and commercial platform as well as an established regulatory practice. Michael Beauvais represents pharmaceutical, biotech, medical device, digital health, and healthcare services clients. Gregory Levine bolsters the team’s experience as an expert in navigating FDA challenges. Former practice co-head Kellie Combs left the firm in April 2026.
Responsables de la pratique:
Michael Beauvais
Autres avocats clés:
Gregory Levine
Les références
‘The life sciences regulatory and compliance practice group at Ropes & Gray has been an amazing team to work with.’
‘They possess exceptional knowledge of the current regulatory landscape and have been paramount in navigating the changes that are occurring with respect to the FDA’s views of drug advertising and promotion.’
‘They are always available for discussions of all things FDA and OPDP, as well as provide advice on how to apply knowledge of the current landscape to our own promotional pieces.’
Dechert
Dechert maintains a broad life sciences practice encompassing IP licensing and litigation, antitrust, product liability, capital markets financing, M&A, and data privacy matters. The firm advises clients across the pharma, tech, life sciences, and biotech sectors, handling both contentious and non-contentious work. A particular area of focus is novel innovations and therapeutics, including disputes involving small and large molecule products. The practice regularly represents clients in complex patent litigation as well as related commercial and regulatory disputes. From New York, Katherine Helm, chair of the firm’s IP practice, represents key innovator pharma and biotech companies in high-value patent and patent-adjacent litigation matters, while David Rosenthal advises on corporate and securities matter within the sector.
Responsables de la pratique:
Katherine Helm; David S. Rosenthal
Autres avocats clés:
Melanie Thill-Tayara; Mark S. Cheffo
Les références
‘Experienced team, sensitive to the needs of the client and quite innovative.’
‘Readily available.’
Principaux clients
Aquestive Therapeutics
AVEO Pharmaceuticals
Baxter Healthcare
Biogen
Citron Pharma
Eli Lilly and Company
Endo Pharmaceuticals
GlaxoSmithKline
Johnson & Johnson
Lannett Company
Merck Sharp & Dohme LLC
Padlock Therapeutics
Regeneron
Royalty Pharma
Sanofi SA
Teva Pharmaceuticals
vTv Therapeutics
Principaux dossiers
- Serves as lead counsel to GlaxoSmithKline in Zantac litigation.
- Defending a patent litigation filed by Halozyme alleging Merck Sharp & Dohme LLC’s subcutaneous pembrolizumab product infringes fifteen of Halozyme’s U.S. patents.
- Representing Johnson & Johnson in two purported indirect purchaser class actions.
DLA Piper LLP (US)
DLA Piper LLP (US) offers a broad practice covering both contentious and non-contentious matters in the sector, including advice and representation in product liability, transactional, IP and regulatory matters. Global life sciences and healthcare co-chair Emilio Ragosa heads the team from Short Hills. Loren Brown co-ordinates mass tort and multidistrict litigation from New York, including product liability disputes involving allegations of contamination and personal injury, working with Boston-based Katie Insogna, who focuses on defense in product liability litigation for pharmaceutical, life science and medical device companies. In Philadelphia, IP advisor Raymond Miller covers patent prosecution and IP strategy, while Lauren Murdza acts for clients in life sciences transactions and license agreements. Based in Washington, DC, Vernessa Pollard chairs the FDA regulatory practice, advising medical device and technology clients on regulatory compliance during product development and promotion, while Andrew Gilbert advises on strategic matters and IP from New York.
Responsables de la pratique:
Emilio Ragosa
Autres avocats clés:
Loren Brown; Katie Insogna; Ray Miller; Lauren Murdza; Vernessa Pollard; Andrew Gilbert; Sam Marll
Les références
‘The team has been outstanding through the different stages of corporate development, including initial documents, seed funding, series A and B, and negotiations with strategic partners. I find them to be definitive sources and can trust their advice completely, including on personnel matters’
‘Andy Gilbert is the primary partner, and Sam Marll was the associate, but now a new partner. They have been 100% responsive and provide clear and timely, reliable responses to all issues.’
‘Strong general knowledge of the field, multidisciplinary and with wide global presence – a true one-stop shop for a global life sciences client.’
Principaux clients
Altesa BioSciences Inc.
Bayer Corporation
Bristol-Myers Squibb Company
Cognition Therapeutics, Inc.
DexCom, Inc.
Elutia
Johnson & Johnson
Liquidia Corporation
Novo Nordisk A/S
Neurelis, Inc.
Pfizer Inc.
Sanofi
Trustees of the University of Pennsylvania, The
Principaux dossiers
- Serves as co-national counsel for Sanofi in matters related to Zantac, a heartburn medication allegedly contaminated with NDMA, a possible carcinogen.
- Managed Neurelis’ neuroscience IP portfolio – securing patents for FDA-approved VALTOCO and extending LOE, defending against generic challenge at the PTAB (IPRs) and in litigation (D. Ct. DE), and articulating strategy in diligence resulting in restructured licensing/acquisition offers that added over USD$500 million to the contemplated transaction.
- Led a complex spin-out of University of Pennsylvania’s Wilson Lab into Gemma Biotherapeutics and Franklin Biolabs, negotiating multiple license agreements and sublicenses for programs underpinning a transaction exceeding USD$100 million.
Goodwin
Goodwin advises life sciences companies across the corporate lifecycle, providing guidance on fundraising, IP portfolio development, regulatory frameworks, and corporate transactions. The firm handles capital markets offerings, licensing and collaboration agreements, M&A transactions, and Hatch-Waxman litigation. Mitchell Bloom and Kingsley Taft serve as global co-chairs of the life sciences practice; both advise emerging through to mature companies on matters including venture financings, strategic alliances, IPOs, and broader corporate affairs. Marishka DeToy focuses on life sciences transactions and represents domestic and foreign issuers and underwriters in a range of offerings. Robert Puopolo regularly advises on IPOs and public offerings, while from Washington, DC Steven Tjoe works with in vitro diagnostic, laboratory developed test, digital health, and non-traditional medical device manufacturers. The recent arrival of Carl Morales from Fenwick & West LLP further strengthens the firm’s life sciences bench in New York. All lawyers mentioned above are based in Boston unless otherwise specified.
Responsables de la pratique:
Mitchell Bloom; Kingsley Taft
Autres avocats clés:
Marishka DeToy; Carl Morales; Robert Puopolo; Steven Tjoe
Les références
‘From our experience, Goodwin’s IP team has been like our own team and is deeply invested in the success of our company. As compared to other firms, they have more extensive expertise in the subject matter and provide recommendations even if against their own interests.’
‘They use technology to further save on costs to client and focus their energy on strategy.’
‘Attentive to Client needs and respectful of Client’s perspectives.’
Principaux clients
Dren Bio
SpringWorks Therapeutics
Royalty Pharma
Blueprint Medicines
Orionis Biosciences
Zealand Pharma A/C
Sionna Therapeutics
Kymera Therapeutics
Insulet Corporation
Sandoz, Inc.
Deep Apple Therapeutics
IDRx
2seventy Bio
Syneron Bio
Ollin Biosciences
Inozyme Pharma
Avadel Pharmaceuticals
Barinthus Biotherapeutics
Principaux dossiers
- Advised Blueprint Medicines in its $9.5 billion sale to Sanofi.
- Advised Ollin Biosciences on its launch with an initial $100 million in financing.
- Advised Sionna Therapeutics on its $219.2 million upsized initial public offering.
King & Spalding
King & Spalding advises pharma, biotech, and medical device companies on complex and high-stakes regulatory and enforcement matters across the product lifecycle. Based in Washington, DC, the team’s work spans clinical trials and product approvals through to post-market compliance, government investigations, and litigation. Clients regularly rely on the firm in sensitive DOJ and DEA inquiries, as well as in navigating False Claims Act litigation. Nikki Reeves, who co-chairs the government matters and regulation practice, advises life sciences companies on pre- and post-market FDA regulatory compliance and enforcement issues. John Shakow focuses on regulatory, commercial, investigative, and litigation matters relating to pharma pricing and reporting. Mark Brown, chair of the FDA and life sciences team, advises on FDA regulatory issues arising in product liability disputes and related matters. Lisa Dwyer develops regulatory, legislative, and litigation strategies for companies marketing FDA-regulated products, while Brian Bohnenkamp assists manufacturers with compliance programs and risk assessments.
Responsables de la pratique:
Nikki Reeves; John D. Shakow; Mark S. Brown
Autres avocats clés:
Lisa Dwyer; Brian Bohnenkamp
Les références
‘Strong and deep bench on the life sciences side of their practice, particularly with respect to regulatory and compliance matters.’
‘Their ex-FDA attorneys have a unique perspective when dealing with FDA inspections and observations.’
Principaux clients
AbbVie
Acadia Pharmaceuticals
Allergan, Inc.
Amarin Corporation
Amgen
Baxter International
BioMarin
Boehringer Ingelheim
Carl Zeiss Vision
Coloplast Corporation
Daiichi Sankyo Pharmaceuticals
Eli Lilly
EMD Serono
Exact Sciences
GE Healthcare
GlaxoSmithKline
Henry Schein
Immunocore
Integra LifeSciences
Invacare Corporation
Ipsen Pharmaceuticals
LEO Pharma, Inc.
LivePerson
Medtronic
Moderna
Novo Nordisk
Organon
PhRMA
Genentech
Takeda Pharmaceuticals
Teleflex, Inc.
Zimmer Biomet
Garmin International
Principaux dossiers
- Secured dismissal against CG Oncology on all claims in a lawsuit brought by ANI Pharmaceuticals.
- Advising more than 15 pharmaceutical and medical device manufacturers on strategies related to separate but related section 232 investigations launched by the Trump Administration into tariffs and exports/international trade.
- Representing Amgen before two Prescription Drug Affordability Board proceedings.
Morgan, Lewis & Bockius LLP
Morgan, Lewis & Bockius LLP provides a variety of services from bet-the-company disputes and regulatory litigation to intellectual property, marketing and licensing matters, with a particular focus on transactional matters in the life sciences sector. Alan Leeds leads the life sciences transactions practice from Princeton and is also global co-leader of the life sciences industry team, assisting clients that range from early-stage biotechnology companies to global pharma and medical device companies. In Washington, DC Michele Buenafe leads the FDA and healthcare practice, while Jacqueline Berman advises companies throughout the product supply chain on FDA regulatory and compliance requirements. Christopher Betti in Chicago and Amy Schuh and Brian Shaffer in Philadelphia also assist in co-leading the practice.
Responsables de la pratique:
Jacqueline Berman; Christopher J. Betti; Michele Buenafe; Alan B. Leeds; Amy E. Schuh; Brian W. Shaffer
Autres avocats clés:
Kathleen M. Sanzo; Michael J. Abernathy
Les références
‘Morgan Lewis is one of our go to firms when it comes to complex healthcare enforcement matters. They are trusted, they are excellent partners for our company, and they deliver positive results for us.’
Principaux dossiers
Orrick, Herrington & Sutcliffe
Orrick, Herrington & Sutcliffe guides companies, investors and innovators through the full lifecycle of discovery, development, commercialisation and strategic growth. The firm's work spans pharma, biotech, medical devices, diagnostics, digital health and emerging biotech sectors. With a wide breadth of capabilities, the team provides an integrated litigation, IP, transactional and FDA offering to clients. In Washington, DC, global co-leader of the life sciences and healthtech sector Tony Chan focuses on representing private equity and strategic clients, while Thora Johnson is a trusted cyber, privacy and healthtech regulatory advisor. Fellow global co-chair Stephen Thau provides strategic advice to life sciences and tech companies from New York, while in Los Angeles David Gindler focuses on IP litigation and licensing.
Responsables de la pratique:
Tony Chan; Thora Johnson; Stephen Thau; David Gindler
Les références
‘Incredible depth of experience and if they don’t have the experience they will find an expert quickly.’
‘Thoughtful, available, creative, trustworthy, experienced.’
‘Experienced attorneys with deep knowledge of corporate law and intellectual property protection.’
Principaux clients
Carlyle, SK Capital Partners and Beacon Parent Holdings
Genentech
Vanda Pharmaceuticals
Regeneron Pharmaceuticals
Johnson & Johnson
Hinge Bio
Bexorg
DURECT Corporation
Gilead Sciences, Inc.
Ferring Pharmaceuticals
Principaux dossiers
- Advised Genentech in an international arbitration against Novartis resolving a high-stakes dispute over commercialization rights to ophthalmology blockbuster Vabysmo®.
- Advised Vanda Pharmaceuticals on the exclusive license of imsidolimab from AnaptysBio to advance a late-stage therapy for Generalized Pustular Psoriasis.
- Advised Carlyle, SK Capital Partners and Beacon Parent Holdings on the acquisition of bluebird bio (now Genetix Biotherapeutics), a biotechnology company developing potentially curative gene therapies.
Debevoise & Plimpton LLP
Debevoise & Plimpton LLP has a global cross-border practice, with particular expertise in handling M&A and transactional matters, complex litigation, IP litigation and white-collar investigations. Co-chair of the healthcare and life sciences group Andrew Bab assists with private acquisitions, divestitures and joint ventures, including cross-border transactions for both private equity and corporate clients. Fellow co-chair Mark Goodman frequently gives advice in high-risk matters involving the interplay of civil litigation, criminal liability and fiduciary obligations, while Maura Monaghan focuses on product liability, environmental, healthcare, criminal investigations and arbitration mandates. Based in Washington, DC, chair of the FDA regulatory practice Paul Rubin represents FDA-regulated drug, device and consumer product companies on a wide range of issues, ranging from strategic regulatory counseling to complex compliance and enforcement matters. All lawyers mentioned above are based in New York unless otherwise stated.
Responsables de la pratique:
Andrew Bab; Mark Goodman; Maura Monaghan; Paul Rubin
Autres avocats clés:
Christopher Anthony; Spencer Gilbert; Kevin Rinker
Les références
‘Outstanding people with contrasting complementary skills and little or no ego so people work together constructively and collaboratively.’
‘Each is a leader in his/her own field with a wonderful ability to work with colleagues who have different skills to provide a seamless service.’
Principaux clients
The Carlyle Group
Certain Former Directors and Shareholders of Purdue Pharma, Inc.
Clayton, Dubilier & Rice
Former CEO of Sandoz, Armando Kellum
Gedeon Richter
Konica Minolta
Merck KGaA
Novartis AG
OneOncology
Sawai and Sumitomo
TPG Capital
Tractor Supply
Principaux dossiers
- Representing certain former directors and shareholders of Purdue Pharma, Inc., in defending litigation regarding prescription opioids in numerous fora across the country.
- Advised Konica Minolta in several major transactions, including the sale of subsidiary Ambry Genetics, and the sale of subsidiary Invicro.
- Secured a preliminary injunction for both Novartis AG and Novartis Pharmaceuticals Corporation against defendants MSN Laboratories Private Limited and MSN Pharmaceuticals Inc.
Fenwick & West LLP
Fenwick & West LLP advises life sciences and healthtech companies at all stages of their lifecycle on IP, transactional, and litigation matters. The firm works with clients developing therapies, diagnostics, medical devices, digital health platforms, and AI-enabled drug discovery technologies. It is particularly known for advising emerging companies on sell-side M&A transactions. Stefano Quintini, industry co-lead for life sciences and healthtech, advises on collaborations and strategic transactions, working from Silicon Valley. Alongside Quintini and based in San Francisco, Matthew Rossiter represents clients in public and private financings, strategic collaborations, and other corporate transactions. Seattle-based Melanie Mayer, also an industry co-lead, focuses on IP litigation and dispute resolution, including patent infringement and licensing disputes, reflecting the firm’s combined strength in corporate and IP-related matters within the sector.
Responsables de la pratique:
Stefano Quintini; Matthew Rossiter; Melanie L. Mayer, Ph.D.
Principaux dossiers
Foley Hoag LLP
Foley Hoag LLP guides innovators through the full product and company lifecycle, combining corporate, IP, regulatory and disputes. Working in combination with the life sciences team, the transactional team structures high-value, often cross-border collaborations and financings, while the IP team protects and leverages market‑leading assets, managing global portfolios for clients across pharma, tech, digital health and biotech. Co-chair of the life sciences industry group Amy Baker-Mandragouras advises life sciences companies on IP strategy, portfolio management, and high-stakes transactions. Alongside her, co-chair Jeffrey Quillen serves a number of emerging biotech, software and information technology companies, negotiating and drafting agreements regarding IP rights, including patent license agreements. Both lawyers mentioned above are based in Boston.
Responsables de la pratique:
Amy Baker-Mandragouras; Jeffrey Quillen
Autres avocats clés:
Stacie Aarestad; Barbara Fiacco; Jeffrey I.D. Lewis
Les références
‘The team at Foley has been our go to firm for our most important IP filings for years now. They are very strong both technically and in terms of their worldwide patent practice-related expertise. Their customer service is excellent and extremely responsive.’
Principaux clients
AbbVie, Inc., Pharmacyclics LLC, Allergan plc
Alexion Pharmaceuticals, Inc.
Alloy Therpeutics
Butterfly Network, Inc.
Geneoscopy, Inc.
Genmab A/S
La Jolla Pharma, LLC
Lantheus Holdings, Inc.
LigaChem Biosciences
Novartis Pharma AG
Regeneron Pharmaceuticals, Inc.
Biodesix
Enanta Pharmaceuticals, Inc.
Greenberg Traurig
Greenberg Traurig advises life sciences and medical tech clients on a range of transactional, regulatory, IP, and litigation matters. The firm regularly represents clients before administrative and regulatory agencies and frequently advises on FDA-related issues. Its work spans corporate transactions, regulatory compliance, and dispute resolution for companies operating in the healthcare and life sciences sectors. In Boston, David Dykeman, co-chair of the global life sciences and medical technology group, focuses on IP protection and related commercial strategy for medical device and life sciences clients. Atlanta-based Wayne Elowe, also co-chair of the group, advises multinational companies and investors on cross-border corporate and transactional matters in the life sciences and medical tech industries. In Washington, DC, Chia-Feng Lu represents tech companies in regulatory and legislative processes, while Melissa Hunter-Ensor, co-chair of the global patents and innovation strategies group and working from Boston, advises pharma, biotech, diagnostics, agricultural, and medical device companies on IP and commercial matters.
Responsables de la pratique:
David Dykeman; Wayne Elowe
Autres avocats clés:
Chia-Feng Lu; Melissa Hunter-Ensor
Les références
‘Everyone from Greenberg Traurig LLP has been courteous and professional and deliver high-quality work. Their billing usually accurately reflects the work and hours of work.’
‘Mr. Chia-Feng Lu is my lead counsel from Greenberg Traurig LLP. He provides advice to us based on his vast knowledge and experience in healthcare business, especially about pharmaceutical licensing and transactions, which is very reassuring. He works in a very proactive and collaborative manor. We could always count on him and his staff for what we need in a timely manner.’
‘This practice is distinguished by its deep understanding of the medical device industry and its ability to integrate regulatory, corporate, IP, and commercial considerations into a single, coherent legal strategy.’
Principaux dossiers
- Provided IP counselling during preparing and negotiations of an Acquisition Agreement.
- Advised OPKO Health Inc., in negotiating an agreement to sell select assets of its wholly owned subsidiary, BioReference Health, to Labcorp.
Jones Day
Jones Day advises global and emerging pharma, tech, and medical device companies on IP portfolio strategy, enforcement, and related disputes. The firm regularly assists clients with managing and protecting IP portfolios as well as handling litigation involving life sciences technologies. Anthony Insogna, chair of the firm’s global IP practice and working from San Diego, advises pharmaceutical and biotech companies, investors, and private equity firms on portfolio strategy, patent enforcement and defence, and due diligence relating to therapeutic products. In Chicago, Heather O’Shea, co-leader of the healthcare and life sciences practice group, represents companies in federal and state government enforcement actions as well as regulatory and compliance matters. Alexis Gilroy, also co-leader of the healthcare practice and based in Washington, DC, focuses on digital health and advises on transactional and regulatory issues involving telemedicine, telehealth, and mobile health technologies. The firm boosted its practice with the March 2025 hires of Silicon Valley-based Edward Reines, who leads complex competitor disputes in the life sciences and tech industries, and San Francisco-based Derek Walter, who handles litigation involving genomics science, from Weil, Gotshal & Manges LLP.
Responsables de la pratique:
Alexis S. Gilroy; Heather M. O’Shea; Anthony M. Insogna
Autres avocats clés:
Edward R. Reines; Derek C. Walter; Tom Briggs; Colleen Heisey; Tammy Weisser; Jocelyn Yu
Les références
‘The Jones Day team knows the law and industry. We don’t have to pay them to learn the law; they already know it. That makes their responses quicker and less expensive than their contemporaries. It is not unusual to have a response to a complex question within a day.’
‘Tom Briggs treats my client as his most important even though I know I am not. He responds almost immediately, and I have never had to wait for anything. We’ve dealt with tough adversaries, and Tom handles them calmly and in such a way that the right answer always results.
‘Colleen Heisey knows the law and regulations. She knows how to get me the best result while minimizing regulatory risk.’
‘There is deep expertise in the Life Sciences patent prosecution team that can handle a large docket and complex technologies. Their office in Europe streamlines European patent filings and responses that can focus on issues to address EP patent law.’
‘The Life Sciences patent prosecution team, particularly Tammy Weisser and Jocelyn Yu, are responsive and understand complex technologies and the business needs.’
‘The team at Jones Day is very strong and very collaborative. They know the material very well and are always very helpful and value added in their services.’
Kirkland & Ellis LLP
Kirkland & Ellis LLP structures every kind of deal in the healthcare and life sciences industries, from large transactional mandates to day-to-day regulatory matters for clients in various areas, such as clinical research, sales and marketing, compliance and market exclusivities. Bringing a breadth of expertise to the New York-based team, Devora Allon has a particular focus on antitrust, product liability and other commercial disputes, while Jay Lefkowitz also specialises in antitrust and product liability, but concentrates on litigation against the FDA and False Claims Act matters. Alongside them, Jeanna Wacker covers patent litigation for clients in the pharma, biotech, chemical and medical device industries, representing both plaintiffs and defendants at all stages of litigation.
Autres avocats clés:
Devora Allon; Jeanna Wacker; Jay Lefkowitz
Les références
‘The firm is consistently accessible and responsive.’
‘The Kirkland team are market leaders in M&A within the drug development/life sciences space. They are the go-to firm for such transactions.’
Principaux dossiers
- Representing Gilead Sciences, Inc. in a qui tam action.
- Representing Sun Pharma and its Ranbaxy subsidiaries in a putative class action antitrust lawsuit seeking upward of $10 billion in damages.
- Awarded summary judgment on all claims in a sweeping False Claims Act (FCA) case alleging a nationwide, 15-year scheme to promote Botox off-label and with kickbacks.
Morrison Foerster
Morrison Foerster fields a cross-disciplinary life sciences team advising on IP, licensing and commercial agreements, startup ventures, and litigation matters. The firm is regularly instructed by emerging biotech companies and provides strategic patent counsel to support the development of new therapies and technologies. Daralyn Durie serves alongside Michael Ward as co-chairs of the life sciences group. Based in San Francisco, Durie litigates patent infringement trials for pharma clients, while Ward focuses on IP issues relating to plants and plant products, advising on plant and plant utility patents, licensing agreements for plant IP, and related litigation in US state and federal courts, working between San Francisco and Boston. Palo Alto-based Catherine Polizzi advises a range of clients from emerging startups to larger companies on protecting therapies, drugs, and technologies as they move from development to commercialization, and has also been involved in acquisitions within the life sciences sector.
Norton Rose Fulbright
Norton Rose Fulbright advises a broad range of clients in the life sciences sector, including pharma and medical device companies, bioscience and biotech businesses, retail pharmacies, wholesale distributors, food tech companies, and investors such as venture capital and private equity firms. The firm focuses on litigation affecting participants across the sector, but also handles regulatory and commercial matters. D’Lesli Davis, head of life sciences and healthcare, serves as lead trial counsel for pharma and medical device clients in mass tort cases, including multidistrict litigation and consolidated proceedings in state and federal courts. Jonathan Skidmore, global co-head of life sciences and healthcare, focuses on matters involving pharma products, medical products, and device liability, with substantial experience representing clients in complex mass tort litigation. Both lawyers mentioned above are based in Dallas.
Responsables de la pratique:
D’Lesli M. Davis; Jonathan Skidmore
Principaux clients
Alcon Inc.
Sanctum Therapeutics Corporation
Takeda Pharmaceutical Company, Ltd.
Eli Lilly and Company
Cincinnati Children’s Hospital Medical Center
McKesson Corporation
Bausch Health US, LLC
Salix Pharmaceuticals, Inc
Hikma Pharmaceuticals PLC
Johnson & Johnson
Principaux dossiers
- Advised Alcon Inc. in its merger agreement to acquire LENSAR, Inc.
- Advised Sanctum Therapeutics Corp. in its merger with Adnexus Biotechnologies Inc.
- Overseeing the management, expansion, and prosecution of the complete patent portfolio for Cincinnati Children’s Hospital Medical Center’s Center for Stem Cell & Organoid Medicine (CuSTOM) Division.
Paul Hastings LLP
Paul Hastings LLP focuses on compliance, investigations, enforcement, governance, and regulatory challenges at each phase of the product life cycle. With expertise covering pharma, medical devices, rare disease treatments, biotech and diagnostics, the team consistently handles complex life sciences mandates of national and international significance. Gary Giampetruzzi leads the practice across a range of regulatory and compliance matters, as well as highly sensitive investigations and precedent-setting enforcement actions, working from New York. Alongside him, Houston-based S. Joy Dowdle regularly advises life sciences companies of all sizes in the design, enhancement, and implementation of their anti-bribery compliance programs.
Responsables de la pratique:
Gary Giampetruzzi
Autres avocats clés:
S. Joy Dowdle
Skadden, Arps, Slate, Meagher & Flom LLP
Skadden, Arps, Slate, Meagher & Flom LLP advises life sciences clients on a range of corporate, regulatory, and enforcement matters. The firm’s multidisciplinary team handles high-value M&A transactions, licensing and collaboration agreements, and intellectual property acquisition and enforcement. The practice also advises on FDA regulatory compliance, government and internal investigations, compliance program development, and tax structuring issues affecting life sciences businesses. Working from Boston, Maya Florence advises clients on regulatory compliance, government enforcement matters, and complex transactions in the sector, and also represents companies in litigation involving significant commercial and regulatory issues.
Responsables de la pratique:
Maya Florence
WilmerHale
WilmerHale blends transactional, regulatory and litigation expertise to serve clients from various industries such as biotech, pharma, diagnostics and medical devices, as well as financial institutions, and leading academic institutions. The firm advises companies navigating complex scientific innovation and regulatory scrutiny, including emerging technologies such as gene therapies, biologics, and AI-driven discovery, development and diagnostic products. Judith Hasko serves as co-chair of the life sciences practice from Palo Alto, focusing on the structuring and negotiation of strategic, intellectual property and tech-based commercial transactions. Alongside her, co-chair Stuart Falber in Boston serves as counsel for a broad range of life sciences clients, including newly public and mature public companies.
Responsables de la pratique:
Stuart Falber; Judith Hasko
Autres avocats clés:
Steve Barrett; Cynthia Mazareas
Principaux clients
Sonoma Biotherapeutics
Exelixis
Bridgebio
Character Biosciences
Curis, Inc.
Roche
Molecular
CytomX
Shape Therapeutics
Pliant Therapeutics
Terns Pharmaceuticals
Principaux dossiers
- Advising longtime client Thermo Fisher Scientific.
- Represented Ratio Therapeutics Inc, a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, in its exclusive worldwide license and collaboration agreement for the development of a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer.
- Represented Roche in its exclusive collaboration and licensing agreement with Zealand Pharma.
Winston Taylor
Winston Taylor advises life sciences clients across IP, transactional, regulatory, and litigation matters spanning the product lifecycle. The firm represents clients in complex IP and product liability disputes, including cases involving scientific and technical subject matter. Its practice also encompasses corporate transactions, regulatory advisory work, investigations, and capital markets issues affecting companies operating in the sector. The team handles disputes relating to innovative products as they move from development through to commercialisation. Based in Washington, DC, T. Reed Stephens, co-chair of the healthcare and life sciences industry group, advises a range of healthcare clients including medical device manufacturers, health systems, and managed-care organisations. His work reflects the firm’s broader involvement in regulatory, litigation, and commercial matters affecting life sciences and healthcare businesses.
Responsables de la pratique:
T. Reed Stephens; Justin Levy
Principaux clients
Abbott Laboratories
Alphatec
Biora Therapeutics, Inc.
Corning
Denali Capital Acquisition Corporation/Semnur Pharmaceuticals
Hikma Pharmaceuticals USA
Intuitive Surgical, Inc.
Monsanto
Picard Medical, Inc.
R. F. Lafferty & Co., Inc.
Voyager Acquisition Corporation/VERAXA Biotech AG
Principaux dossiers
- Representing Abbott, in state and federal proceedings involving numerous product liability lawsuits.
- Representing Hikma Pharmaceuticals before the U.S. Supreme Court, challenging a Federal Circuit decision that threatens the viability of “skinny labels” in the pharmaceutical industry.
- Represented Denali Capital Acquisition Corp. in its high-profile business combination with Semnur Pharmaceuticals, Inc.
Baker Botts L.L.P.
Baker Botts L.L.P. advises life sciences clients on the IP, litigation, and corporate transactional matters associated with bringing pharmaceutical products, medical devices, and research tools to market. The firm also supports clients on business development initiatives and corporate transactions within the sector, including identifying and evaluating potential investment targets, mergers, and acquisitions. Steve Lendaris, firmwide life sciences sector chair and based in New York, advises on a range of biotechnology-related IP matters, including evaluating third-party patents ahead of product launches and developing patent filing strategies for new therapeutic approaches.
Responsables de la pratique:
Steve Lendaris
Autres avocats clés:
Matthew Avery; Sandra Lee
Les références
‘The Baker Botts team has been very responsive to our needs. They have taken complex problems (e.g. IP) and worked through them to provide solid guidance and solutions.’
‘Their ability to quickly understand/comprehend complex problems and offer thoughtful solutions.’
‘Their proactive nature – providing unsolicited recommendations for problems and issues that need to be addressed.’
Principaux clients
Agni Bio, Inc.
Alga Biosciences
Antipodean Pharmaceuticals, Inc. and MitoQ Ltd
Assertio Holdings, Inc.
Columbia University
Editas Medicine
Eikon Therapeutics, Inc.
FUJIFILM Cellular Dynamics, Inc. (FCDI)
Genentech / Roche
GRAIL, Inc.
Kanvas Biosciences
Lazarus3D, Inc.
Memorial Sloan Kettering Cancer Center
Merck & Co., Inc.
National Associate of Boards of Pharmacy
Novartis International AG / Novartis Pharmaceuticals
Octagos Acquisition, LLC / Octagos Health, Inc.
OncoNano Medicine, Inc.
Penumbra, Inc
Pharmacosmos A/S
Philips Respironics
Professional Disposables International. (PDI)
Royalty Pharma
Shenzhen Smoore Technology Co., Ltd.
Somnair, Inc
Spotitearly
Sun Pharmaceuticals and Taro Pharmaceuticals
Takasago International Corporation
UnitedHealth Group Incorporated / UnitedHealthCare, Inc. / Optum, Inc.
University of Pennsylvania
University of Pittsburgh
Vision Service Plan (“VSP”)
Wave Life Sciences
Principaux dossiers
- Handles a wide variety of diligence and prosecution matters for Genentech, a leading biotechnology company and member of the Roche family of companies.
- Represents Sun Pharmaceuticals and Taro Pharmaceuticals in two major antitrust matters.
- Serves as lead M&A antitrust counsel for UnitedHealth Group, advising on major transactions across its enterprise, including health plans, care delivery, PBM services, and healthcare technology.
Duane Morris LLP
Duane Morris LLP advises biotech, biopharma, and pharma companies on matters relating to the development and commercialization of therapeutics, including funding, research and development, clinical trials, and market entry. The firm also represents medical device manufacturers as well as companies in the agriculture and animal health sectors. Its life sciences and medical technologies industry group handles IP, regulatory, and transactional matters affecting product development and commercialization. Dana Ash is a team lead within the group, alongside Frederick Ball in Boston who advises developers, sponsors, manufacturers, CDMOs, contract service providers, food companies, and pharmacies operating in regulated sectors. Michael Harrington represents early and growth-stage companies in tech, life sciences, healthcare, and cleantech industries, while Vicki Norton in San Diego focuses on strategies to counter patent claims and conducts IP due diligence for transactions. Shannon Hampton Sutherland and Miami-based Driscoll Ugarte also serve as team leads within the group. All lawyers mentioned above are based in Philadelphia unless otherwise stated.
Responsables de la pratique:
Dana J. Ash; Frederick R. Ball; Michael S. Harrington; Vicki G. Norton; Shannon Hampton Sutherland; Driscoll R. Ugarte
Autres avocats clés:
Sima Kulkarni
Les références
‘Well-rounded, well-informed, well-educated team. More available to respond and answer matter concerns than other firms’
‘Sima Kulkarni is an exceptional IP attorney, ready to go beyond the expected in client relations and delivery.’
‘Duane Morris assigns a primary contact for each client and then brings in attorneys specializing in certain areas of the law as needed – ensuring the highest quality advice is provided to their clients. Having a primary contact assigned from Duane Morris results in exceptional and efficient client service.’
Principaux clients
Monogram Technologies
Calez Capital
Allele Biotechnology
Ocunexus/Inflammx
Eurofins NSC US, Inc.
Annovis Bio
Rijk Zwaan
International AIDS Vaccine Initiative
Altimmune, Inc.
Action Medical Technologies, LLC
Principaux dossiers
- Represented a leading orthopedic robotics company in its acquisition by a major medical device manufacturer.
- Sued Creative Biolabs Inc. among other co-defendants alleging patent infringement, unfair competition, false advertising, and trademark infringement.
- Handled company side diligence support for InflammX’s option agreement with Bausch & Lomb.
Freshfields
Freshfields advises life sciences clients across biopharma, medical devices, digital health, and health IT on strategic transactions and contentious matters. Kristen Riemenschneider heads the team from Washington DC. Adam Golden and Vinita Kailasanath have departed the firm.
Responsables de la pratique:
Kristen Riemenschneider
Principaux clients
Acelyrin
AstraZeneca
Basilea
Camurus
CK Life Sciences
Cullinan Therapeutics
Johnson & Johnson
Merck
Novartis
Sanofi
SERB Pharmaceuticals
Standard BioTools Inc.
Strava Inc.
Sumitomo
Principaux dossiers
- Advised Merck on its $10bn acquisition of Verona plc.
- Advised Sanofi on its acquisition of Vigil Neurosciences.
- Advised Novartis on its strategic collaboration with Monte Rosa Therapeutics regarding the development of novel degraders for immune-mediated diseases.
Gibson, Dunn & Crutcher LLP
Gibson, Dunn & Crutcher LLP fields a broad life sciences practice advising biotech, pharma, medical device, and diagnostics companies on transactional and IP matters. The firm handles mergers and acquisitions, capital markets transactions, debt financings, and private equity investments, alongside a strong focus on patent litigation. Ryan Murr, co-chair of the life sciences practice, advises public and private life sciences companies and investors on securities offerings and business combination transactions, working from San Francisco. Jane Love, also co-chair and based in New York, represents pharma and biotech companies in high-value patent litigation, including global disputes.
Responsables de la pratique:
Ryan Murr; Jane M. Love
Autres avocats clés:
Branden Berns; Karen Spindler; Eric J. Stock
Principaux clients
Sun Pharmaceutical Industries, Inc.
Advanced Accelerator Applications USA, Inc. (ADACAP)
Novartis
UnitedHealth Group and its subsidiaries, OptumRx, Inc.
Merck & Co., Inc.
Amgen, Inc.
AbbVie, Inc.
89bio, Ltd.
Royalty Pharma
Alcon, Inc.
Arrowhead Pharmaceuticals, Inc.
Jade Biosciences, Inc.
USWM, LLC
Cogent Biosciences, Inc.
Principaux dossiers
- Advised 89bio, on its sale to Roche Holdings.
- Enabled Sun Pharma’s product launch and clarified standards in disputes concerning innovative therapies.
- Represents Advanced Accelerator Applications in patent matters involving Lutathera.
Leech Tishman
Leech Tishman offers guidance in healthcare transactions, regulatory compliance and strategy, crisis response, and disputes, with clients ranging from large publicly traded entities to cutting-edge early-stage startups driving complex multimillion-dollar deals. Harry Nelson serves as outside counsel to numerous large healthcare organisations and chairs the healthcare practice group. Working from Los Angeles, Chicago and Pittsburgh, he leads clients through risk identification, provides strategies and practical solutions for compliance, and regularly assists clients in managing crises in healthcare settings.
Responsables de la pratique:
Harry Nelson
Principaux clients
Healthy America El Segundo CA LLC/Love.Life
Ehab Yacoub, MD Inc. DBA Brain Health USA
Minicircle, Inc.
SkinSpirit Essential, LLC
CanyonMD Billing, LLC
Brigade Health LLC
Food Allergy Institute/Translational
Pulmonary and Immunology Research Center
Mainspring Recovery
DC Delis, Clinical Psychologist, Inc.
Kimia Wellness
Principaux dossiers
- Advised Love.Life on the structuring and operational build-out of a leading-edge, first-of-its-kind integrated luxury wellness, longevity, medical, and fitness center.
- Advised Brain Health USA, a behavioural telehealth provider, on health facility acquisitions, establishment of residency programs, and institution of regulatory compliance programs.
- Advised Minicircle, a biotech and gene therapy company, on FDA and international compliance for manufacturing, distribution, and research and development, as well as on strategic business partnerships.
Mayer Brown
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. advises clients across the life sciences sector, including emerging biotech companies, global pharma businesses, investors, academic institutions, and government entities. The firm handles corporate transactions, IP matters, regulatory strategy, and litigation affecting companies operating in the sector. In Boston, William Hicks, co-chair of the life sciences practice, represents issuers, investors, and investment banks in IPOs, cross-over investments, alternative public offerings, reverse mergers, and Form 10 transactions. Los Angeles-based Siegmund Gutman chairs the life sciences litigation practice and focuses on disputes involving biologic drug patents, other life sciences innovations, and Hatch-Waxman matters.
Responsables de la pratique:
William Hicks; Siegmund Gutman
Autres avocats clés:
John Rudy; Cheryl Reicin
Principaux clients
QIAGEN N.V.
Leerink Partners
Standard BioTools
Myriad Genetics
Fulgent Genetics
Amgen
Eli Lilly
Sanofi
Gilead Sciences
Breakout Ventures
Principaux dossiers
- Represents Eli Lilly in high-stakes intellectual property matters.
- Representing Amgen in a series of high-profile cases under the Biologics Price Competition and Innovation Act.
- Represented the underwriters in the $285M initial public offering (IPO) of LB Pharmaceuticals Inc.
O'Melveny
O'Melveny advises life sciences firms on patent litigation matters, with a particular focus on disputes involving pharma, medical device, life sciences, and chemicals companies. The firm regularly represents clients in Hatch-Waxman litigation, BPCIA matters, and pre-suit investigations relating to complex scientific technologies. Lisa Pensabene, co-chair of the life sciences practice, acts as first-chair trial lawyer in patent litigation for pharmaceutical and chemical companies, including bench and jury trials and appellate arguments. Hassen Sayeed co-heads the life sciences IP litigation practice and represents pharmaceutical and biotechnology clients in patent infringement and enforcement litigation. Both lawyers mentioned above are based in New York.
Responsables de la pratique:
Lisa Pensabene
Autres avocats clés:
Hassen Sayeed; Rob Shaffer
Principaux dossiers
Proskauer Rose LLP
Proskauer Rose LLP fields a multidisciplinary life sciences group advising biologics, pharma, biotech, and medical device clients on IP and transactional matters. The firm handles patent litigation, contested patent office proceedings, patent prosecution, and patent-related transactions including licenses and assignments. In Boston, Fangli Chen, chair of the life sciences patent practice, advises biotech and pharma companies on the strategic development of complex IP portfolios across the innovation lifecycle. New York-based Daryn Grossman, chair of the life sciences group, focuses on technology and IP transactions, including strategic alliances, licensing arrangements, technology development, and outsourcing agreements. Christine Espino departed the firm.
Responsables de la pratique:
Fangli Chen; Daryn Grossman
Autres avocats clés:
Colin Cabral
Principaux clients
Sixth Street – Essential Pharma
Oramed Pharmaceuticals Inc. – Scilex Holding Company
Akebia
Takeda Pharmaceutical Company
Various Life Sciences Companies
Globus Medical, Inc.
NuVasive
Medela LLC
AbbVie
Sandoz
SoClean, Inc.
Proneuron
Lupin Pharmaceuticals
Sidley Austin LLP
Sidley Austin LLP advises clients across the life sciences sector, including biotech, biopharma, medical device, diagnostics, and pharma companies. The firm handles transactional, regulatory, compliance, and enforcement matters arising throughout the product lifecycle. Sharon Flanagan leads the firm’s global life sciences practice from San Francisco and represents companies in public and private M&A, joint ventures, minority and controlling investments, and securities offerings. Torrey Cope focuses on FDA regulatory matters from Washington, DC, advising pharma, biotech, and medical tech companies on regulatory strategy and product development issues.
Responsables de la pratique:
Sharon R. Flanagan
Autres avocats clés:
Torrey Cope
Les références
‘Strong knowledge, great availability. lot of experience.’
Principaux clients
EpimAb Biotherapeutics
Supira Medical, Inc.
Outset Medical, Inc.
Contego Medical, Inc.
Morgan Stanley
Stryker
Hoffmann-La Roche, Inc.
DaVita Inc.
Genentech
Nektar Therapeutics
Principaux dossiers
- Represented Stryker, in its approximately US$4.9 billion acquisition of Inari Medical, Inc.
- Representing Roche, in its acquisition of 89bio.
- Represented Roche in its approximately US$1.5 billion acquisition of biopharmaceutical company, Poseida Therapeutics, Inc.
Weil, Gotshal & Manges LLP
Weil, Gotshal & Manges LLP advises biotech, pharma, and medical device companies on a range of corporate, IP, regulatory, and litigation matters. The firm assists clients with mergers and acquisitions, strategic alliances, licensing agreements, and collaborations aimed at expanding life sciences businesses. It also represents companies in disputes involving patents, trade secrets, trademarks, and commercial matters, alongside litigation relating to shareholder issues, product liability, antitrust, and government investigations. Recently hired from Latham & Watkins, Doug Lumish and Jeff Homrig co-head the firm’s IP, technology and science litigation practice. Based in San Francisco and Silicon Valley, Lumish handles patent, trade secret, contract, licensing, and fraud disputes involving technology and life sciences companies, while Homrig, working from Dallas and Houston, represents life sciences companies in complex patent and trade secret litigation, reflecting the firm’s focus on high-stakes IP disputes in the sector. Bolstering the team's expertise is the 'wonderful' Gabe Gross, who specialises in IP and commercial litigation matters and works between the San Francisco and Silicon Valley offices.
Responsables de la pratique:
Doug Lumish; Jeff Homrig
Autres avocats clés:
Gabe Gross; Gaby LaHatte
Les références
‘We worked primarily with Gabe Gross and he’s been wonderful. He’s likely one of the best negotiators I’ve ever encountered, as well as a great human being in general. It was always a pleasure working with him.’
Principaux clients
Regeneron Pharmaceuticals
CareDx
Edwards Lifesciences Corporation
Veracity-Health, Inc. and its Co-Founder
North American Science Associates
Sanofi, S.A.
GoodRx, Inc.
Chemed Corporation
Lunan Pharmaceuticals
Dental Monitoring
Torrent Pharmaceuticals
Suven Pharmaceuticals
Iodine Software, LLC
Goldman Sachs Alternatives
Halozyme Therapeutics, Inc.
Principaux dossiers
- Won a significant antitrust plaintiff jury verdict for client Regeneron Pharmaceuticals, Inc. in Delaware federal court.
- Won a major victory for CareDx by successfully persuading the Delaware District Court to grant CareDx’s post-trial motion for judgment as a matter of law.
- Secured a complete appellate victory for Edwards Lifesciences in a patent infringement suit targeting the company’s transcatheter aortic valve replacement devices.
Akin
Akin advises clients in the medical device, diagnostics, pharma, biotech, AI, and food and dietary supplement sectors. The firm combines experience in FDA regulatory matters with CMS coverage and reimbursement issues, and has a focus on digital health and AI in healthcare. Based in Washington, DC, Nathan Brown leads the FDA practice while Kelly Cleary advises on healthcare regulatory, policy, and enforcement matters.
Responsables de la pratique:
Nate Brown
Autres avocats clés:
Kelly Cleary
Les références
‘Nate Brown is a creative legal thought partner; sophisticated business advisor; is deeply plugged into regulatory and legislative initiatives and developments; broad industry perspective; incredibly strategic with regulatory and legal solutions.’
Principaux clients
AdvaMed
Precision Diagnostics, LLC
Simtra BioPharma Solutions
Apollo Laboratories Services, LLC
Siemens Corporation
Johnson & Johnson
LabCorp (Laboratory Corporation of America)
Solvd
Opella
United States Pharmacopeial Convention
Resmed Corp.
Principaux dossiers
- Acting as outside regulatory counsel to AdvaMed.
- Represented Apollo Laboratories Services, LLC, and all other individual and corporate defendants in a FCA qui tam action.
- Represented Precision Diagnostics, LLC (Precision) with respect to several FCA private whistleblower lawsuits filed against Precision, a clinical laboratory.
BakerHostetler
BakerHostetler advises clients on developments in genetics, research design, big data analytics, mobile health technologies, and cloud computing, covering litigation against government agencies and competitors, patent portfolio management, and negotiations of mergers and development contracts. Stephanie Lodise co-leads the IP life sciences and advanced materials team from Philadelphia. Based in Denver, Winston Kirton co-leads the FDA practice, while in Washington, DC Timothy Worrall advises on domestic and international patent portfolios.
Responsables de la pratique:
Stephanie A. Lodise; Timothy A. Worrall; Winston S. Kirton
Principaux clients
Alevian, Inc.
Dragonfly Endoscopy
Outsourcing Facility Association
Nationwide Medical, Inc.
Johnson & Johnson
Xencor
FarmaKeio Outsourcing LLC and North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Principaux dossiers
- Represents the Outsourcing Facilities Association in multiple lawsuits against HHS and the FDA to challenge regulatory delays and decisions impacting drug compounding and shortage lists.
- Represents several pharmacy compounders in litigation initiated by Eli Lilly & Co. and Novo Nordisk.
- Provide sophisticated patent analysis, including patentability, freedom to operate, and patent application preparation for Alevian, and its lead candidate GDF-11 and therapeutic antibody strategy in treatment of stroke.
Husch Blackwell LLP
Husch Blackwell LLP advises life sciences companies ranging from startups to established investors, including pharmaceutical businesses, medical device manufacturers, biotechnology programs, and digital health providers. The firm assists clients across the business lifecycle, including company formation, financing, research, clinical trials, and exit planning. Bryan Stewart heads the practice and advises on IP strategy and portfolio management for medical device and life sciences clients.
Responsables de la pratique:
Bryan Stewart
Autres avocats clés:
Stephen Gardner; Don Mizerk
Principaux clients
Colorado State University
Michigan State University
Motion Control
Nanjing Delova Biotech Co
Nanjing Noratech Pharmaceutical Co
North Dakota State University Research Foundation
NUtech Ventures (University of Nebraska – Lincoln)
Onego Bio Inc.
Psilera, Inc.
Rutgers University
Skysong Innovations
TWi Pharmaceuticals
UNeMed Corp
University of California, Los Angeles
University of Maryland – College Park
University of South Florida
Virginia Commonwealth University
WiCell Research Institute, Inc.
Wisconsin Alumni Research Foundation (WARF)
WiSys Technology Foundation
Xiamen LP Pharmaceutical Co.
Principaux dossiers
- Represented Psilera in connection with the sale of a subset of chemical compounds and molecules to a Netherlands strategic party.
Loeb & Loeb LLP
Lowenstein Sandler LLP
Lowenstein Sandler LLP advises life sciences clients on product commercialization and corporate transactions. The team represents emerging, development-stage, and clinical-stage companies, as well as investors, investment banks, and global pharma, biotech, and medical device businesses. Its work includes product acquisitions and divestitures, strategic collaborations, M&A, private financings, and public offerings. In New Jersey, Michael Lerner chairs the life sciences practice and advises public and private healthcare companies and their investors, while Robert Paradiso chairs the life sciences and chemical patents practice and focuses on patent prosecution, litigation, freedom-to-operate issues, and technology transfer. New York-based James Shehan advises life sciences companies on regulatory and commercial matters relating to product development, compliance, and strategic transactions.
Responsables de la pratique:
Michael J. Lerner; Robert J. Paradiso; James C. Shehan
Autres avocats clés:
Irina Ishak
Les références
‘The entire team did a terrific job guiding us through potential pitfalls and working with opposing counsel in a collaborative way to get the transaction completed. It was probably the most complicated transaction we have worked on, and we were glad to have Lowenstein with us.’
‘This practice combines sophisticated legal and transactional experience with a true understanding of the business and what it’s like to build and run a company.’
‘They understand the business and science of life sciences. They have real-world experience which they apply to the legal expertise required to properly advise our business.’
Principaux clients
Crown Laboratories, Inc.
Goldeneye 1995, LLC
Jefferies LLC
Kintara Therapeutics, Inc.
Radiance Biopharma, Inc.
Relmada Therapeutics, Inc. (NASDAQ: RLMD)
Sonnet BioTherapeutics, Inc. (NASDAQ: SONN)
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)
Principaux dossiers
- Representing Sonnet BioTherapeutics, Inc. in Agreement to Launch $888M HYPE Cryptocurrency Treasury Reserve Strategy.
- Represented Crown Laboratories, Inc., in its acquisition of Revance Therapeutics, Inc. (NASDAQ: RVNC).
- Represented Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), in multiple significant transactions during the current reporting period, including a $150 million at-the-market offering.
Reed Smith LLP
Reed Smith LLP advises life sciences clients on FDA regulatory matters and broader regulatory issues arising in complex transactions. The firm provides guidance on regulatory strategy and market entry for companies developing healthcare technologies. Scot Hasselman, co-chair of the life sciences health industry group and based in Washington, DC, advises healthcare companies and investors on regulatory, transactional, and litigation matters. In New York, Cori Annapolen Goldberg focuses on FDA regulatory issues affecting food, drug, dietary supplement, biologic, medical device, and HCT/P industries across the supply chain.
Responsables de la pratique:
Scot Hasselman
Autres avocats clés:
Cori Annapolen Goldberg
Les références
‘They are extremely practical and understand the business of our company well.’
‘Very good healthcare life sciences practice at Reed Smith; we enjoy working with them.’
‘We have worked with Cori Goldberg on healthcare regulatory matters, and found Cori to be great to work with and have strong knowledge of her practice area.’
Sheppard
Sheppard advises pharma, biotech, and medical device companies on IP, corporate finance, and FDA regulatory matters across the product lifecycle. The firm works with clients developing technologies such as gene and cell therapies, CAR-T treatments, immunotherapies, antibody-drug conjugates, and other biologics. In New York, Jeffrey Fessler co-leads the life sciences team and focuses his practice on the biotechnology industry, while Scott Liebman also co-leads the team and heads the FDA regulatory and compliance practice, advising manufacturers on regulatory strategy. Fellow co-leader Lorna Tanner advises on IP protection and portfolio strategy from San Francisco.
Responsables de la pratique:
Jeffrey Fessler; Scott Liebman; Lorna Tanner
Principaux clients
Pacira Biosciences Inc.
Tharimmune, Inc.
Structure Therapeutics
DNA Holdings Venture, Inc.
Cytokinetics
Gilead Sciences, Inc.
California Institute of Technology
TJ Biopharma
Amarin Pharmaceuticals Ireland Limited
Kite Pharma
Achieve Life Sciences
Vir Biotechnology (Vir)
ShiraTronics
Grail
Unicycive Therapeutics, Inc.
Cardiff Oncology, Inc.
Celularity Inc.
LaNova Medicines
Sanara MedTech, Inc.
TriSalus Life Sciences
Aditxt, Inc.
Principaux dossiers
- Obtained multiple federal rulings in favor of Pacira, supporting its claims against competitors that involve issues of first impression under the Lanham Act and Federal Food, Drug, and Cosmetic Act (FDCA).
- Represented Tharimmune, Inc. (NASDAQ: THAR), in its approximately $540 million private placement.
- Advised DNA Holdings Venture, Inc., as the strategic advisor and investor to Predictive Oncology Inc.’s (Nasdaq: POAI) major private placement transactions totaling $344.4 million.