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.
Life sciences in United States
Arnold & Porter
Praxisleiter:
Allison Shuren; Mahnu Davar; Daniel Kracov
Kernmandanten
Pharmaceutical Research and Manufacturers of America (PhRMA)
Enzyvant
Pfizer Inc.
Hologic, Inc.
Sanofi S.A.
Regeneron Pharmaceuticals, Inc.
Provention Bio
Highlight-Mandate
- Advising Enzyvant in connection with manufacturing, supply, procurement, and launch activities for RETHYMIC.
- Advised Sanofi on a co-promotion agreement with Provention for the latter’s lead investigational drug candidate, teplizumab, for the delay of clinical type 1 diabetes in at-risk individuals.
Cooley LLP
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.
Praxisleiter:
Christian Plaza; Mark Recht
Kernmandanten
Acrivon Therapeutics
Arvinas
Autolus Therapeutics plc
Cellares
Horizon Therapeutics
Immatics
Locanabio
MindMed
Moderna TX
Myovant Sciences
Neurocrine Biosciences
OKYO Pharma
Quell Therapeutics
RefleXion Medical
SCYNEXIS
Syndax
Turnstone Biologics, Inc.
Highlight-Mandate
- Advised Horizon Therapeutics on its agreement to be acquired by Amgen for $27.8bn.
- Advised MapLight Therapeutics on its oversubscribed $225mn Series C financing.
- Advised Autolus Therapeutics plc on its $150mn follow-on offering of 75,000,000 American Depositary Shares at a public offering price of $2 per ADS.
Hogan Lovells US LLP
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.
Praxisleiter:
Steve Abrams; Lynn Mehler; Randy Prebula; Lauren Colton; Cullen Taylor; Jodi Scott; Andrew Strong; Anishiya Abrol
Referenzen
‘The Hogan Lovells Philadelphia Life Science Team has delivered high touch, tremendous customer service. They are always available and meet all key deadlines. In addition, they are very strategic in their approach.’
‘Very dependable and reliable team. Always available and the two partners on the account are always the service providers, no bait and switch. Always keep the big picture in mind.’
Kernmandanten
Bristol Myers Squibb
Danco Laboratories
Jazz Pharmaceuticals
Labcorp
Novartis
Pfizer
Salarius Pharmaceuticals, Inc
Gilead Sciences
OptiNose Inc.
Daiichi Sankyo
Highlight-Mandate
- Represented Danco Laboratories, manufacturer of Mifeprex, a drug approved to terminate pregnancy, in a lawsuit seeking to revoke FDA’s approval of the drug.
- Advised Daiichi Sankyo Company, Limited on its multibillion dollar global collaboration with Merck to develop and commercialize three of its DXd antibody-drug conjugates (ADCs).
- Advised Tevogen on patent prosecution and intellectual property strategy, and most recently on its combination with publicly traded special purpose acquisition company Semper Paratus Acquisition Corporation.
Latham & Watkins LLP
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.
Praxisleiter:
Arlene Chow; Terra Reynolds; Shayne Kennedy; John Manthei; Ben Haas
Weitere Kernanwälte:
Julie Scallen; Elizabeth Richards; Cheston Larson; William McConagha; Jennifer Bragg
Referenzen
‘I saw Arlene Chow make two different arguments in front of the PTAB and was blown away by her knowledge of the record and her ability to respond succinctly and persuasively in front of the board.’
Kernmandanten
Prometheus Biosciences
Swedish Orphan Biovitrum AB
Ironwood Pharmaceuticals
AcuFocus
Pionyr Immunotherapeutics
Relievant Medsystems, Inc.
Inari Medical, Inc.
AEON Biopharma
Sonoma Biotherapeutics
CytomX
Shape Therapeutics
Erasca, Inc.
Ascendis Pharma A/S
AbbVie
Johnson & Johnson Surgical Vision, Inc.
AMO Development, LLC
AMO Manufacturing USA, LLC
AMO Sales and Service, Inc.
Merck Animal Health
Kansas State University Research Foundation
Amgen
Highlight-Mandate
- Advised Prometheus Biosciences on its sale to Merck for $10.8bn.
- Advised AEON Biopharma, a clinical-stage biopharmaceutical company developing a proprietary botulinum toxin for the treatment of multiple conditions, in a business combination with Priveterra Acquisition Corp.
- Advised Sonoma Biotherapeutics on its collaboration with Regeneron Pharmaceuticals to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell therapies for autoimmune diseases.
McDermott Will & Emery LLP
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.
Praxisleiter:
Douglas Carsten; William Gaede
Weitere Kernanwälte:
Bhanu Sadasivan
Referenzen
‘In my opinion, the best trial team in the patent litigation space is fielded by MWE. Bill Gaede and Bhanu Sadasivan and their colleagues are a formidable team which understands complex technology and complex patent law. The combination of experience, diversity, and a genuine desire to win renders the MWE team a top choice when selecting counsel.’
‘Bill Gaede is a true trial attorney who understands his case fully and registers immediate credibility with a judge and jury. Bhanu Sadasivan knows the law and the technology inside and out, and radiates a sincerity which makes her arguments resonate.’
‘It’s all about the people. They seem genuinely invested in me as a person and the success of my company.’
Kernmandanten
Amgen Inc.
QuidelOrtho Corporation
Natera Inc.
Heron Therapeutics
Turn Biotechnologies, Inc.
Aurinia Pharmaceuticals
Delpor, Inc.
Premier, Inc.
Alnylam Pharmaceuticals
United Therapeutics Corporation
Komipharm International Co., Ltd.
Next Caller Inc.
CRISPR Therapeutics, Inc.
InferVision Medical Technology
Charles River Laboratories, Inc.
Gastro Health
Cordis
Cogent Biosciences
Specifica Inc.
Citius Pharmaceuticals
Highlight-Mandate
- Represented United Therapeutics in its patent infringement suit against Liquidia Technologies.
- Served as IP counsel to QuidelOrtho Corporation, a NASDAQ-listed public company that manufactures and commercializes diagnostic testing solutions for infectious diseases.
- Served as IP counsel for Heron Therapeutics, Inc. a NASDAQ-listed public company providing a technology solution for delivery of pharmaceuticals.
Ropes & Gray LLP
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.
Praxisleiter:
Marc Rubenstein; Michael Beauvais; Gregory Levine
Kernmandanten
Abata Therapeutics, Inc.
Alexion Pharmaceuticals
Bain Capital
Blackstone Life Sciences
Forma Beauty Brands
Galderma Laboratories
Ginkgo Bioworks, Inc.
HotSpot Therapeutics
HUTCHMED (China) Limited
ImmunoGen, Inc.
Ionis Pharmaceuticals, Inc.
Jounce Therapeutics, Inc.
Karl Storz
Medical Information Working Group
Metsera, Inc.
NeoGenomics Inc.
Novavax, Inc.
Novo Nordisk
OPKO Health, Inc.
Paratek Pharmaceuticals Inc.
Pfizer Inc.
Sigilon Therapeutics, Inc.
Takeda Pharmaceuticals
Tempus Labs, Inc.
TRex Bio, Inc.
uniQure
Verrica Pharmaceuticals
Vira Health
Highlight-Mandate
- Advised ImmunoGen in its sale to AbbVie for $10.1bn.
- Advised Pfizer on a partnership with Flagship Pioneering to develop 10 single-asset programs by leveraging Flagship’s ecosystem of more than 40 human health companies and multiple biotechnology platforms for up to $7bn.
- Advised Novo Nordisk in a collaboration and license agreement with Valo Health for up to $2.7bn.
Goodwin
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.
Praxisleiter:
Mitchell Bloom; Kingsley Taft
Weitere Kernanwälte:
Robert Puopolo; Alexander Varond; Steven Tjoe; Marishka DeToy; David Chen; Adam Johnson
Referenzen
‘Deep industry experience in drug development, specifically in interfacing with the FDA and relevant regulatory guidance.’
‘We’ve recently moved our work to Goodwin and couldn’t be happier. They have a full suite of knowledge attorneys across practice groups relevant to the life sciences team (e.g., regulatory, healthcare fraud and abuse, reimbursement, clinical, promotional) and capital markets and M&A teams whose experience is deeply rooted in the space.’
Kernmandanten
Alentis Therapeutics
argenx SE
Avadel Pharmaceuticals
Better Therapeutics
Biomea Fusion
Entrada Therapeutics
Fulcrum Therapeutics
Globus Medical
Guggenheim Securities
Inversago Pharma
KBP Biosciences
Nimbus Therapeutics
ReNAgade Therapeutics
Royalty Pharma
Seagen Inc.
TELA Bio, Inc.
Versanis
Highlight-Mandate
- Advised argenx SE on the closing of its upsized $1.27bn global offering.
- Advised Inversago Pharma, Inc. on its acquisition by Novo Nordisk A/S for up to $1.075bn.
- Advised Nimbus Therapeutics, LLC on its sale to Takeda of Nimbus Lakshmi, Inc. and its tyrosine kinase 2 (Tyk2) inhibitor program for $4bn up front and up to $2bn in commercial-related milestone payments.
King & Spalding LLP
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.
Praxisleiter:
Mark Brown; Nikki Reeves; Seth Lundy
Referenzen
‘The life sciences practice at King & Spalding is a highly experienced, business-savvy team of delightfully genuine and personable attorneys.’
‘Seth Lundy is a consummate all-around life sciences commercialization and compliance leader and partner.’
‘This team is very strong and plays off each other to advise its clients for solutions that work for the business. They clearly lay out risks and levels of risk so that you can make well-advised decisions as a business.’
Kernmandanten
AbbVie
Acadia Pharmaceuticals
Allergan, Inc.
Amarin Corporation
Amgen
Baxter International
BioMarin
Boehringer Ingelheim
Bristol-Myers Squibb
Coloplast Corporation
Daiichi Pharmaceuticals
Eli Lilly
EMD Serono
Exact Sciences
Garmin International, Inc.
GSK
HeartFlow, Inc.
Henry Schein
Hope Medical Enterprises, Inc. (Hope Pharmaceuticals)
Imperative Care
Integra LifeSciences
Invacare Corporation
Kiyatec
LEO Pharma, Inc.
LivePerson
Medtronic
Novo Nordisk
PhRMA
Takeda Pharmaceuticals
Teleflex, Inc.
Urogen
Zimmer Biomet
Highlight-Mandate
- Advised HeartFlow Holding, Inc. on its $215m Series F and Series F-1 preferred stock financing, which was led by Bain Capital Life Sciences.
- Represented Eisai in connection with a restructuring of its collaboration with US-based Biogen.
- Represented Novo Nordisk before the Third Circuit concerning manufacturers’ obligations to sell drugs to hospitals at a discount under the federal 340B pricing program.
Debevoise & Plimpton LLP
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.
Praxisleiter:
Andrew Bab; Jennifer Chu; Mark Goodman; Maura Monaghan; Kevin Rinker; Paul Rubin
Referenzen
‘Paul Rubin is an outstanding thought leader in matters involving FDA and FTC regulation, particularly with respect to the regulation of food, dietary supplements and drugs.’
‘Andrew Bab is very responsive; we appreciated this in a transaction with a very limited timeline.’
Kernmandanten
Abingsworth
Armando Kellum
Blackstone
Carlyle
Certain former directors and shareholders of Purdue Pharma, Inc.
Clayton Dubilier & Rice
Deutsche Bank
Gedeon Richter
GSK
J.P. Morgan Securities
JAB Holdings
Johnson & Johnson
Lannett
Merck KGaA
Resonetics
TPG Capital
Highlight-Mandate
- Advised TPG Capital, alongside AmeriSourceBergen Corporation, on the acquisition of OneOncology from General Atlantic for $2.1bn.
- Represented certain former directors and shareholders of Purdue Pharma, Inc. in defending litigation regarding prescription opioids in numerous fora across the country, and in efforts to negotiate a global settlement in bankruptcy court.
- Advised Carlyle and its life sciences franchise Abingworth, along with their recently formed development company Launch Therapeutics, in their investment of up to $170m in Opthea Limited.
Dechert LLP
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.
Praxisleiter:
Andrea Reid; David Rosenthal
Referenzen
‘The collective discipline, first-hand knowledge of particular issues and the patience to explain complex issues is what makes the team invaluable.’
Kernmandanten
4E Therapeutics
AbbVie/Allergan
Aldeyra Therapeutics
argenx SE
Atlas Ventures
Bicycle Therapeutics
Biogen
Cerus Endovascular
Chiesi Farmaceutici S.p.A.
Dana-Farber Cancer Institute
Diffusion Pharmaceuticals
Eli Lilly and Company
Endo Pharmaceuticals
Forbion Capital Partners
GlaxoSmithKline
Homology Medicines
Ikena Oncology
Ipsen
Johnson & Johnson
Longwood Fund
Moderna Therapeutics
Nimbus Therapeutics
Sanofi SA
Solu Therapeutics
Quest Diagnostics
Highlight-Mandate
- Advised Nimbus Therapeutics’ on patent issues relating to highly selective, allosteric TYK2 inhibitor portfolio to address multiple immune-mediated diseases.
- Represented GSK as lead counsel in connection with multidistrict and state court litigation alleging that Zantac, a type of heartburn medication, causes cancer as a result of the formation of the chemical NDMA.
- Advised Chiesi Farmaceutici S.p.A. in its definitive agreement to acquire Amryt Pharma Plc in an all-cash transaction valued at US$1.48bn.
DLA Piper LLP (US)
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.
Praxisleiter:
Matthew Holian; Andrew Gilbert; Vernessa Pollard
Weitere Kernanwälte:
Loren Brown; Lauren Murdza; Katie Insogna; Lucas Przymusinski; Anisa Mohanty
Kernmandanten
Pfizer Inc.
Johnson & Johnson
ResMed, Inc.
Bayer Corporation
Bristol-Myers Squibb Company
Biogen Inc.
Novo Nordisk A/S
Pharmaceutical Research and Manufacturers of America (PhRMA)
Qatar Pharma for Pharmaceutical Industries WLL
Adamas Pharmaceuticals, Inc.
Highlight-Mandate
- Advised Sanofi on litigation and regulatory issues relating to Zantac, a common heartburn medication that allegedly contains or is contaminated with NDMA, a possible carcinogen.
- Represented Taiho Oncology Inc. and Taiho Pharmaceutical Corp in several patent infringement cases related to Lonsurf™, an oral combination therapy used for treating adult patients with metastatic colorectal cancer.
- Advised Axsome Therapeutics, Inc. in the closing of its previously announced underwritten public offering of 3,000,000 shares of its common stock at the public offering price of US$75.00 per shareand on entering into an exclusive license agreement with Pharmanovia to commercialize and further develop Sunosi.
Mayer Brown
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.
Praxisleiter:
Lisa Ferri; Reb Wheeler
Kernmandanten
Gilead Sciences
Roivant Sciences
Takeda Pharmaceutical Company Limited
Galderma Laboratories, L.P.
Sanofi
Regeneron
GSK
Gerber Products Company
bioMérieux SA
Nestlé Health Science
Morrison Foerster
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.
Praxisleiter:
Michael Ward
Weitere Kernanwälte:
Stacy Amin; Catherine Polizzi; Janet Xiao; Daralyn Durie; Kira Davis; Adam Brausa
Referenzen
‘I’ve interacted with three attorneys at MoFo and have been impressed with their knowledge and expertise. They are thorough and helpful, and most of all, they are very quick in their response times.’
‘Each individual is highly competent. The team is incredibly responsive. They really care about the client and go out of their way to provide comprehensive, business-relevant answers.’
‘I use the IP prosecution team. It is a very diverse team, which is incredibly unique in this area of law.’
Kernmandanten
10x Genomics
9amHealth
Ally Bridge Group
Alpine Immune Sciences
Arcellx
Avadel Pharmaceuticals
Bard
Bayer
BeiGene
Biopharmaceutical Research Company
Bristol-Myers Squibb (Celgene Corporation, Juno Therapeutics, Abraxis Biosciences)
Carlsmed, Inc.
CG Oncology, Inc.
Chugai Pharmaceutical
Cornell University
Crinetics Pharmaceuticals
CSPC Pharmaceutical Group Limited
Dewpoint Therapeutics
DNA Genotek/OraSure Technologies, Inc
Driscoll’s
Dynavax Technologies
Eureka Therapeutics, Inc.
Evolve Biosystems
Foundation for Food & Agriculture Research
Geneos Therapeutics, Inc
General Catalyst
Genentech
Glenmark Pharmaceuticals
ImmuneBridge
insitro
Johnson & Johnson
Lyndra Therapeutics
Maze Therapeutics
McKesson Corporation
NKGen Biotech
Novartis
Nuvation Bio Inc.
MyChem
NextSense, Inc
Onc.AI
Ono Pharmaceutical
Orbimed Advisors
Pillar Biosciences
Pliant Therapeutics
Rakuten Medical
RheumaGen
Sama Therapeutics
Sandoz
Santen Pharmaceutical
Seagen
Sequlite Genomics
Shoreline Biosciences
SNIPR Biome
Spark Therapeutics
Theonys, Inc
Triastek, Inc.
Trio Pharmaceuticals, Inc
TRIO Pharmaceuticals
Volastra Therapeutics
Highlight-Mandate
- Advised Seagen on its patent strategy for monoclonal antibody-based therapies for the treatment of cancer.
- Representing Bristol-Myers Squibb and its subsidiaries Celgene and Juno Therapeutics on patent issues.
- Represented Evolve Biosystems and the Regents of the University of California in their litigation against Abbott Laboratories in the Northern District of Illinois.
Weil, Gotshal & Manges LLP
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.
Praxisleiter:
Elizabeth Weiswasser; Edward Reines
Referenzen
‘Creative and innovative in their approach. Know the company well and understand our products and technology. Responsive and dedicated.’
Kernmandanten
CareDx
Invitae
Regeneron
Synthego
NanoString
Sanofi
BeiGene
Daiichi Sankyo
Elanco Animal Health
Johnson & Johnson
Torrent Pharmaceuticals
Abbott Laboratories
Bausch + Lomb
Eli Lilly
Quest Diagnostics
Highlight-Mandate
- Secured an important decision from the PTAB in favor of Regeneron, protecting the client’s novel biologic to treat macular degeneration and other serious eye diseases.
- Secured the invalidation of two Agilent patents before the PTAB that were asserted against Synthego, a CRISPR-focused synthetic biology company.
- Represented Invitae in bringing two parallel infringement suits against Natera relating to DNA sequencing technology.
WilmerHale
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.
Praxisleiter:
Stuart Falber; Lisa Pirozzolo
Weitere Kernanwälte:
Amy Wigmore
Referenzen
‘Our WilmerHale team is made up of top notch associates that provide spot on and good, practical advice and solutions. They are extremely hardworking and happy to stand shoulder to shoulder with us.’
‘The partners I’ve worked with are more than up to the challenge and are adept at quickly working through complex contractual issues.’
Kernmandanten
Revvity
Bristol Myers-Squibb Company
PTC Therapeutics
AVEO Oncology
Exelixis, Inc.
Cybrexa Therapeutics
Quest Diagnostics
Verve Therapeutics
Becton, Dickinson and Company
Akouos, Inc.
Roche Diagnostics
Apellis Pharmaceuticals
Braintree Laboratories
IVERIC Bio
Nuvalent, Inc.
Carisma Therapeutics
Voyager Therapeutics
Flare Therapeutics
Astria Therapeutics
Decibel Therapeutics
Georgiamune, Inc.
Highlight-Mandate
- Represented Revvity in its agreement to divest its Applied, Food and Enterprise Services businesses to New Mountain Capital for $2.45bn in cash.
- Represented Gilead Sciences when a federal jury sided with the pharmaceutical company against the US Government in a precedent-setting patent infringement trial centered on two HIV-prevention drugs that had been developed by Gilead: Truvada and Descovy.
- Represented PTC Therapeutics, Inc. in its agreement with Royalty Pharma plc. to monetize PTC’s remaining interests in its Evrysdi royalty stream for up to $1.5bn.
Fenwick & West LLP
Fenwick & West LLP advises a client base consisting of emerging companies and internationally established businesses active in immuno-oncology, diagnostics and digital health, among a multitude of other areas. The practice assists clients with a range of issues, including patent and Hatch-Waxman disputes, due diligence in the lead up to acquisitions and financings in the life sciences industry, and issuer-side IPOs. Leadership of the team is shared between San Francisco-based Matthew Rossiter, who advises on corporate structuring and IP protection strategies, Seattle’s Melanie Mayer, a specialist in patent and licensing disputes, and Stefano Quintini, based in Silicon Valley and overseeing collaboration agreements and joint ventures. New York-based Carl Morales is well versed in developing patent portfolios for clients with FDA-approved drugs.
Praxisleiter:
Matthew Rossiter; Melanie Mayer; Stefano Quintini
Referenzen
‘Carl Morales is a knowledgeable, commercial, responsive and thoughtful partner who we reach out to for our IP questions/concerns. Great partner to collaborate with on our transactions.’
Kernmandanten
Amyndas Pharmaceuticals
Chinook Therapeutics, Inc.
Day One Biopharmaceuticals
Graybug Vision
Meril Life Sciences
Morphic Holding, Inc.
Novo Nordisk
Pharmakon Advisors LP
Royalty Pharma
UCB
Highlight-Mandate
- Represented Novo Nordisk in Hatch-Waxman litigation to protect its most high-profile products, including Ozempic.
- Represented Chinook Therapeutics, Inc. in its acquisition by Novartis for $3.5bn.
- Represented Meril Life Sciences in a suit filed by Edwards Lifesciences for patent infringement.
Foley Hoag LLP
Foley Hoag LLP handles a broad range of mandates, advising pharmaceutical companies and academic institutions on the financing of growth stage companies and IP protection and litigation strategies. The team is also able to provide support regarding the FDA regulatory process, in addition to Medicare and Medicaid reimbursement issues. Boston’s Jeffrey Quillen took on sole leadership of the practice following Hemmie Chang‘s departure in September 2023, representing a number of emerging biotech clients as it relates to patent licensing and collaboration agreements. Universities and non-profits come to New York-based John Gourary and Rachel Beller for advice on monetizing their pharmaceutical royalties, with Boston-based Amy Baker-Mandragouras, who arrived from Cooley LLP with her team in July 2023, assisting clients on the development of the patent portfolios.
Praxisleiter:
Jeffrey Quillen
Weitere Kernanwälte:
John Gourary; Rachel Beller; Amy Mandragouras; Carmen DeMatteis; Jeongseok Yu; Beth Neitzel
Referenzen
‘They just care. It is amazing how much time, effort, and energy they spend thinking about our business. They are hyper responsive when needed.’
‘Jeffrey Quillen is not only brilliant, but responsive, creative, and kind as well. He is simply a joy to work with.’
Kernmandanten
10x Genomics
AbbVie, Inc.
Amgen Inc.
AstraZeneca Pharmaceuticals
Becton, Dickinson
Biodesix
Biogen Inc.
Dana-Farber Cancer Institute
Gilead Sciences, Inc.
Ginkgo Bioworks
Harvard University
Horizon Therapeutics
La Jolla Pharmaceuticals
Massachusetts Institute of Technology
Myriad Genetics, Inc.
Novo Nordisk A/S
Organogenesis Inc.
Roche Diagnostics
Thermo Fisher Scientific
University of California
Gibson, Dunn & Crutcher LLP
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.
Praxisleiter:
Ryan Murr; Jane Love
Kernmandanten
Guardant Health
Gilead Sciences
Dental Monitoring SAS
Merck & Co., Inc.
Cullgen Inc.
GE Healthcare
CTI BioPharma Inc.
Elliott Investment Management L.P.
Heska Corporation
Tenet Healthcare Corporation
Royalty Pharma
Lincoln International
MoonLake Immunotherapeutics
BioCryst Pharmaceuticals, Inc.
Mirum Pharmaceuticals, Inc.
Sutro Biopharma, Inc.
Dianthus Therapeutics, Inc.
89bio, Ltd.
Apogee Therapeutics, Inc.
Arrowhead Pharmaceuticals, Inc.
Cogent BioSciences, Inc.
Ultragenyx Pharmaceutical Inc.
Spyre Therapeutics, Inc.
Neurogene
Spectrum Pharmaceuticals
Concentra Biosciences
Highlight-Mandate
- Advised Elliott Investment Management on the $7.1bn acquisition by a private investment consortium of Syneos Health.
- Advised Cullgen on a $1.9bn strategic collaboration and option agreement to advance innovative targeted protein degraders with Astellas Pharma.
- Advised Merck on its $1.35bn acquisition of Imago BioSciences, Inc.
Greenberg Traurig LLP
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.
Praxisleiter:
David Dykeman; Wayne Elowe
Referenzen
‘Our GT team has very deep expertise, not just in life sciences but in the specific area we work in.’
‘The Greenberg Traurig team provides excellent patent prosecution services in all areas of the life sciences to my institution. They fully understand our business and its complex needs, and I can always be sure that someone from GT will fully grasp any invention disclosed to them.’
Kernmandanten
Moderna, Inc.
Provention Bio, Inc.
Huadong Medicine Co.
Teva Pharmaceuticals
AnnJi Pharmaceutical
Aspira Women’s Health
Embecta Corp.
Exactech, Inc.
Elios Vision
Redhill Biopharma
Highlight-Mandate
- Represented Moderna, Inc. in defending its COVID-19 vaccine against patent infringement claims brought by Promosome.
- Assisted Provention Bio, Inc. with the IP aspects of two public stock offerings and a private placement.
- Represented Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. in the global expansion of the strategic alliance for SCO-094, a GLP-1R and GIPR dual agonist with SCOHIA PHARMA, Inc.
Kirkland & Ellis LLP
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.
Weitere Kernanwälte:
Jay Lefkowitz; Devora Allon; Jeanna Wacker
Referenzen
‘Overall, excellent.’
‘The breadth and depth of the healthcare litigators is breathtaking. The range of cases they work on, from Hatch-Waxman to reverse payment cases to complex commercial and IP disputes to regulatory investigations and litigation, is unparalleled. They are the go-to firm for bet-the-company litigation in the life sciences space.’
Kernmandanten
Abbott Laboratories
AbbVie, Inc.
Allergan plc
Eli Lilly & Company
Gilead Sciences
Glenmark Pharmaceuticals
Impax Laboratories
Ranbaxy Pharmaceuticals
Lupin Pharmaceuticals
Teva Pharmaceuticals
Torrent Pharmaceuticals
Upsher-Smith Laboratories
Advanced Bionics/Sonova Group
Alcon
Biederman Technologies GmbH & Co. KG
Boehringer Ingelheim USA
Bristol-Myers Squibb
Finch Therapeutics
Microspherix LLC
Moderna, Inc.
GSK
Haleon plc
Johnson & Johnson
Norton Rose Fulbright
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.
Praxisleiter:
D’Lesli Davis; Jonathan Skidmore
Kernmandanten
McKesson
Takeda
Bausch Health US, LLC/Bausch Health Americas, Inc./Oceanside Pharmaceuticals, Inc.
CVS Pharmacy, Inc.
Bausch Health
Glenmark Pharmaceuticals Inc., USA/Glenmark Pharmaceuticals Ltd.
Attends Healthcare Products
3M Company
MEKONOS, Inc.
Highlight-Mandate
- Represented McKesson in the Sartan MDL, a multi-district litigation against all levels of the supply chain.
- Represented CVS Pharmacy, Inc. over claims regarding the alleged illegal sale of homeopathic drug products in violation of the Federal Food, Drug & Cosmetic Act.
- Represented Bausch Health in the Generic Pharmaceuticals Pricing Antitrust litigation.
O'Melveny & Myers LLP
O'Melveny & Myers LLP‘s life science team advises on a range of matters pertaining to the life sciences, including regulatory challenges, class actions and IP litigation and transactions, with the firm maintaining particularly strong ties to the Chinese market and overseeing a range of cross-border deals. Steve Brody is a Washington DC-based specialist in product liability and mass tort claims concerning medical device marketing, false claims and more, while New York’s Lisa Pensabene takes the lead on IP litigation, offering a ‘strong grasp on patent law’ in disputes concerning cancer, HIV and neurological treatments. Government investigations and False Claims Act matters fall under the remit of Ross Galin, also based in New York and providing advice on criminal proceedings. Operating out of Los Angeles, Richard Goetz‘s litigation practice encompasses false advertising, improper labelling, personal injury and defective manufacturing claims. Hassen Sayeed is a patent litigator specializing in Hatch-Waxman and BPCI Act disputes.
Praxisleiter:
Steve Brody; Lisa Pensabene; Ross Galin; Rich Goetz
Referenzen
‘They really understand the science and dig into the details. They were able to uncover new arguments and strategies based on their approach and understanding.’
‘Lisa Pensabene is a client-focused lawyer with the chops for litigation. She ensures her clients are informed and involved with shaping case direction and strategy. These strengths pair nicely with her strong grasp on patent law and ability to simplify difficult issues.’
Kernmandanten
AbbVie
Acotec Scientific Holdings Limited
Allergan Sales, LLC, Allergan, Inc./Duke University
AstraZeneca Pharmaceutical Co., Ltd.
C.R. Bard
Endo Pharmaceuticals, Inc.
Johnson & Johnson and related companies
Myriad Genetics
Novartis Pharmaceuticals
Servier Pharmaceuticals
Willow Innovations, Inc.
Highlight-Mandate
- Represented C.R. Bard against competitor AngioDynamics, which accused Bard of violating the Sherman Act.
- Secured a $39m jury award for Duke University and Allergan in a patent infringement case brought against defendant Sandoz concerning a patent covering the hair growth drug Latisse.
- Represented Myriad Genetics, Inc. in a successful challenge to the Revised Prenatal Screening Program administered by the California Department of Public Health (CDPH) that permanently enjoins CDPH regulations that barred all but four laboratories from providing the tests for pregnant women that look for genetic disorders.
Orrick, Herrington & Sutcliffe LLP
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.
Praxisleiter:
Stephen Thau; Thora Johnson
Referenzen
‘Orrick has a very strong team across the board, with a deep bench. They also have excellent partners in other specialty areas outside of IP (appellate practice, arbitration practice).’
‘David Gindler is a true advocate and dives in deep on issues. He is incredibly thoughtful and creative.’
‘We use Orrick for our health privacy compliance efforts. They have demonstrated a strong subject matter expertise while helping assess the practical risks we face.’
Kernmandanten
Genentech, Inc.
Miltenyi Biomedicine
Ipsen
SFJ Pharmaceuticals
BioAtla
Corteva Agriscience
Catalyst Biosciences
Gilead Sciences, Inc.
ANI Pharmaceuticals
Johnson & Johnson
Highlight-Mandate
- Represented Genentech in a dispute worth over $200m dollars with competitor Novartis, in which Novartis seeks to avoid paying royalties owed on Novartis’ drugs, Cosentyx and Ilaris.
- Represented Gilead in a matter involving a patent infringement verdict of over $1.2bn dollars against its cancer therapy.
- Advised Ipsen on its acquisition of Albireo Pharma Inc.
Proskauer Rose LLP
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, and managing partner and transactions specialist Daryn Grossman in New York. Siegmund Gutman has left the firm.
Praxisleiter:
Fangli Chen; Daryn Grossman
Weitere Kernanwälte:
Erik Milch; Joseph Drayton; Grant Esposito; David Fioccola
Referenzen
‘The Proskauer life sciences practice is unique in the close partnership they form with their clients. Project teams are diverse and appropriately staffed both in number and level to provide excellent legal services.’
‘Special call out for Fangli Chen in her management of the team and her proactive approach.’
‘The patent team at Proskauer provides insightful, strategic and yet pragmatic advice to its client. Its practice on life sciences is particularly strong, covering both biotech and pharmaceuticals. It is my go-to firm when I need strategic advice to handle complex IP issues.’
Kernmandanten
Amgen
SoClean
Gilead Science, Inc.
Bayer/Monsanto
NuVasive, Inc.
Biocon
Bachem
Sanofi Pasteur
Alvogen
Takeda Pharmaceutical Company
Versicolor
BlueRock Therapeutics
Church & Dwight
Akebia
Translate Bio
Various Life Sciences
Beam Therapeutics
Highlight-Mandate
- Represented Gilead Sciences, Inc. in a $3.6bn antitrust lawsuit where it was alleged that the pharmaceutical company had engaged in an anticompetitive “pay-for-delay” patent settlement regarding two HIV medications.
- Represented Amgen in a patent case related to a biosimilar akin to Johnson & Johnson’s Stelara.
- Advised Translate Bio on their global patent portfolio, encompassing diverse platform technologies and programs, including developing a patent protection strategy for their lipid nanoparticle.
Skadden, Arps, Slate, Meagher & Flom LLP
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.
Praxisleiter:
Paul Schnell
Weitere Kernanwälte:
Graham Robinson
Kernmandanten
Agenus
Alcon
Alnylam Pharmaceuticals
Array BioPharma
BELLUS Health Inc.
Biogen
Centene Corporation
CTI BioPharma
Endo International plc
Exact Sciences Corporation
Exelixis
Genomic Health
Intercept Pharmaceuticals
IVERIC bio
Mirati Therapeutics
NeoGenomics
POINT Biopharma Global
Purdue Pharma
Theravance Biopharma
Vertex Pharmaceuticals
vTv Therapeutics
Highlight-Mandate
- Represented Agenus Inc. in resolving an action brought against Recepta Biopharma S.A. in the U.S. District Court for the District of Massachusetts stemming from a dispute arising under a collaboration agreement.
- Represented Alnylam Pharmaceuticals, Inc. in its $2.8bn partnership with Roche to develop and commercialize Alnylam’s investigational RNA interference therapeutic zilebesiran for hypertension.
- Represented Purdue Pharma L.P. in connection with its resolution of US Department of Justice civil and criminal investigations concerning the sale and marketing of opioid products.
Winston & Strawn LLP
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.
Praxisleiter:
Reed Stephens
Kernmandanten
Abbott Laboratories
Alphatec Holdings
Bayer
Cresco Labs
Corning Incorporated
Estrella Biopharma, Inc.
Fresenius Kabi USA
Hikma Pharmaceuticals
Intuitive Surgical
Lupin Limited
MSN Laboratories
Novartis Pharma AG
Otsuka America Pharmaceutical
Pfizer
Polpharma
Sandoz Inc.
Sun Pharmaceutical Industries, Ltd.
Teva North America
Highlight-Mandate
- Represented Corning in a month-long patent infringement and trade secrets trial related to cell-culturing technology.
- Representing Hikma Pharmaceuticals in opioid litigation brought by the state of Arkansas by successfully arguing failure to state a claim against our client.
- Represented a MIT professor against false research misconduct charges, publicly clearing his name in connection with an internal investigation that lasted more than three years.
Akin
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.
Praxisleiter:
Nathan Brown
Referenzen
‘Nathan Brown has an impressive understanding of historical and current FDA enforcement and oversight approaches.’
Kernmandanten
AdvaMed
Centrient Pharmaceuticals
U.S. Pharmacopeia
Leukemia & Lymphoma Society
Freshfields Bruckhaus Deringer
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.
Praxisleiter:
Adam Golden
Weitere Kernanwälte:
Vinita Kailasanath; Kristen Riemenschneider; Jeff Jay
Kernmandanten
Roivant Sciences Ltd.
Novartis
SERB Pharmaceuticals
PhenomeX Inc.
Basilea Pharmaceutica International Ltd
Agilent Technologies
AstraZeneca
Apyx Medical Corporation
AbbVie
Moderna
Capsida Biotherapeutics
Bausch + Lomb
BioCryst
Inscripta
Highlight-Mandate
- Advised Roivant Sciences on the $7.2bn sale of Telavant.
- Advised Novartis on the separation and spin-off of Sandoz.
- Advised AbbVie on its global exclusive strategic collaboration and option to license agreement with HotSpot Therapeutics.
Haynes and Boone, L.L.P.
Patent prosecution, IP due diligence and litigation form the core of Haynes and Boone, L.L.P.‘s life sciences practice, which helps clients active in sectors ranging from large and small molecule therapeutics to immunology protect their IP via post-grant proceedings at the USPTO and in disputes before federal courts. Heading the team are Washington DC’s Jeffrey Wolfson and Vincent Shier, both of whom have experience in managing clients’ IP portfolios and advocating for them before the USPTO, and Benjamin Pelletier, based in San Francisco and advising on the management of IP portfolios containing large molecule treatments. Dallas-based Jamie Raju is particularly well versed in supporting clients looking to protect innovative products that utilize AI in relation to diagnostics, treatment planning and disease management.
Praxisleiter:
Jeffrey Wolfson; Vincent Shier; Benjamin Pelletier
Kernmandanten
TeneoBio, Inc.
GRAIL, LLC
Reset Pharmaceuticals, Inc.
Strides Pharma Inc.
Eutilex Co., Ltd.
Carbfix hf.
Orthofix/SeaSpine
Conformis
Highlight-Mandate
- Represented Orthofix in two patent-infringement cases in the Eastern District of Texas.
- Represented Strides Pharma Science Limited in ongoing transaction work related to the $24m acquisition of Endo International’s manufacturing facility in New York and various Abbreviated New Drug Applications.
- Advised TeneoBio on all IP-related aspects of its acquisition by Amgen in 2021 and continued managing the legacy TeneoBio patent portfolio.
Jones Day
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.
Praxisleiter:
Alexis Gilroy; Heather O’Shea
Referenzen
‘The team works seamlessly together to update and inform each other to ensure alignment on global strategy. The team is incredibly responsive, creative in approach, and expert in substantive legal contributions.’
Kernmandanten
Celgene
Labcorp
Bristol-Myers Squibb
DePuy Synthes
Sumitomo Pharma Co. Ltd.
Astellas Pharma Inc.
Loeb & Loeb LLP
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.
Praxisleiter:
Fran Stoller; Mark Waddell; Jim Czaban; Mitchell Nussbaum
Referenzen
‘Outstanding SEC filing, FDA regulatory, and IP expertise.’
Kernmandanten
Genentech, Inc./InterMune, Inc.
JATT Acquisition Corp.
Rosemont Pharmaceuticals Ltd.
Swiftmerge Acquisition Corp.
Health Sciences Acquisitions Corporation 2
QVC/Home Shopping Network
ThinkEquity
Maxim Group LLC
MAIA Biotechnology, Inc.
Liminatus Pharma LLC
Redwoods Acquisition Corp.
Highlight-Mandate
- Represented Liminatus Pharma LLC in its merger with Iris Acquisition Corp.
- Advised Rosemont Pharmaceuticals on FDA issues regarding prescription drug product development strategies.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. handles a wide range of matters for life sciences clients, including public offerings, strategic patent advice and litigation. The practice’s leadership team is located in Boston and consists of Jonathan Kravetz and William Whelan, who handle a variety of financing structures and IPOs, and both are well-equipped to advise on venture capital investments, advising both investors and investees. Lewis Geffen leads on licensing transactions, supporting pharmaceutical, biotech and medical devices companies looking to fund drug research, while Thomas Wintner is the key contact for contentious matters, handling patent and trade secrets disputes concerning inter alia drugs, drug delivery systems and vaccines. Siegmund Gutman, who represents clients in patent disputes concerning biologics and in Hatch-Waxman disputes out of Los Angeles, joined the firm in May 2024 from Proskauer Rose LLP.
Praxisleiter:
Jonathan Kravetz; William Whelan; Lewis Geffen; Thomas Wintner; Siegmund Gutman
Weitere Kernanwälte:
Cheryl Reicin
Reed Smith LLP
Reed Smith LLP handles the full spectrum of regulatory issues in the life sciences sector, with notable expertise in assisting clients looking to enter the digital healthcare arena, in addition to advising on FDA rules concerning clinical trials and marketing. June 2023 saw the firm strengthen its position at the intersection of transactional and regulatory issues with the arrival of Brian Bewley from Manatt, Phelps & Phillips, LLP, adding to Nancy Halstead‘s expertise in regulations governing the use of technology in the life sciences and healthcare industries. Scot Hasselman spearheads the firm’s life sciences team, having built up a practice covering government investigations, transactions and licensing deals.
Praxisleiter:
Scot Hasselman
Weitere Kernanwälte:
Nancy Halstead; Rebecca McKnight; Katie Pawlitz; Brian Bewley
Referenzen
‘Incredibly customer-focused, timely, detailed work. No project too small, they never pass off work to staff I don’t know, I always work with the same team, which is wonderful. I feel like they care about my organization’s needs. Reed Smith works very well together internally and that shows.’
Sheppard, Mullin, Richter & Hampton LLP
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.
Praxisleiter:
Jeffrey Fessler; Scott Liebman
Referenzen
‘Sheppard Mullin has been a reliable partner for our company. We can always rely on SM to provide excellent legal service, no matter what the legal issues are. SM’s client service is something that we greatly treasure and appreciate. SM’s key strength is its broad legal expertise and excellent attorneys.’
‘Sheppard Mullin teams have always been flexible and business oriented. We receive practical advice that does not require reading a long memo, but can apply it to our business the same day. Highly recommend.’
‘They are very knowledgeable about companies like ours.’
Kernmandanten
Pacira Biosciences Inc.
Gilead Sciences, Inc./Kite Pharma
Global Blood Therapeutics, Inc.
Edwards Lifesciences Corporation
Unicycive Therapeutics
AIS Healthcare
Ladenburg Thalmann
Hillstream BioPharma
Aditxt, Inc.
Hepion Pharmaceuticals, Inc.
Highlight-Mandate
- Represented Pacira against three compounding pharmacies in federal Lanham Act cases concerning false and misleading advertisement and marketing materials.
- Advised Gilead Sciences, Inc. on the management of its patent portfolio.
- Represented Global Blood Therapeutics in connection with its patent portfolio in relation to Oxbryta, a drug aimed at treating haemolytic anaemia in sickle cell patients.
White & Case LLP
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.
Praxisleiter:
Peter Carney
Referenzen
‘This practice has strong experience.’
Kernmandanten
AbbVie
Apollomics
Azurity Pharmaceuticals
Bayer
Elevance Health
Hikma Pharmaceuticals
Indivior
Johnson & Johnson (Jansen Pharmaceutical)
Kite Pharmaceuticals
Myriad Genetics
Pfizer
Samsung Bioepsis
Vertex
Vizgen