Leading Associates

Life sciences in United States

Arnold & Porter

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.

Responsables de la pratique:

Allison Shuren; Mahnu Davar; Daniel Kracov


Principaux clients

Pharmaceutical Research and Manufacturers of America (PhRMA)


Enzyvant


Pfizer Inc.


Hologic, Inc.


Sanofi S.A.


Regeneron Pharmaceuticals, Inc.


Provention Bio


Principaux dossiers


  • 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.

Responsables de la pratique:

Christian Plaza; Mark Recht


Autres avocats clés:

Ivor Elrifi; Div Gupta; Kate Hillier


Principaux clients

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.


Principaux dossiers


  • 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.

Responsables de la pratique:

Steve Abrams; Lynn Mehler; Randy Prebula; Lauren Colton; Cullen Taylor; Jodi Scott; Andrew Strong; Anishiya Abrol


Autres avocats clés:

David Fox; Howard Levine; Jennifer Swan


Les références

‘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.’

Principaux clients

Bristol Myers Squibb


Danco Laboratories


Jazz Pharmaceuticals


Labcorp


Novartis


Pfizer


Salarius Pharmaceuticals, Inc


Gilead Sciences


OptiNose Inc.


Daiichi Sankyo


Principaux dossiers


  • 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.

Responsables de la pratique:

Arlene Chow; Terra Reynolds; Shayne Kennedy; John Manthei; Ben Haas


Autres avocats clés:

Julie Scallen; Elizabeth Richards; Cheston Larson; William McConagha; Jennifer Bragg


Les références

‘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.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Douglas Carsten; William Gaede


Autres avocats clés:

Bhanu Sadasivan


Les références

‘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.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Marc Rubenstein; Michael Beauvais; Gregory Levine


Autres avocats clés:

Kellie Combs


Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Mitchell Bloom; Kingsley Taft


Autres avocats clés:

Robert Puopolo; Alexander Varond; Steven Tjoe; Marishka DeToy; David Chen; Adam Johnson


Les références

‘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.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Mark Brown; Nikki Reeves; Seth Lundy


Les références

‘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.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Andrew Bab; Jennifer Chu; Mark Goodman; Maura Monaghan; Kevin Rinker; Paul Rubin


Les références

‘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.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Andrea Reid; David Rosenthal


Autres avocats clés:

Katherine Helm


Les références

‘The collective discipline, first-hand knowledge of particular issues and the patience to explain complex issues is what makes the team invaluable.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Matthew Holian; Andrew Gilbert; Vernessa Pollard


Autres avocats clés:

Loren Brown; Lauren Murdza; Katie Insogna; Lucas Przymusinski; Anisa Mohanty


Principaux clients

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.


Principaux dossiers


  • 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.

Responsables de la pratique:

Lisa Ferri; Reb Wheeler


Principaux clients

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.

Responsables de la pratique:

Michael Ward


Les références

‘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.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Elizabeth Weiswasser; Edward Reines


Les références

‘Creative and innovative in their approach. Know the company well and understand our products and technology. Responsive and dedicated.’

Principaux clients

CareDx


Invitae


Regeneron


Synthego


NanoString


Sanofi


BeiGene


Daiichi Sankyo


Elanco Animal Health


Johnson & Johnson


Torrent Pharmaceuticals


Abbott Laboratories


Bausch + Lomb


Eli Lilly


Quest Diagnostics


Principaux dossiers


  • 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.

Responsables de la pratique:

Stuart Falber; Lisa Pirozzolo


Autres avocats clés:

Amy Wigmore


Les références

‘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.’

Principaux clients

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.


Principaux dossiers


  • 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.

Responsables de la pratique:

Matthew Rossiter; Melanie Mayer; Stefano Quintini


Autres avocats clés:

Carl Morales


Les références

‘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.’

Principaux clients

Amyndas Pharmaceuticals


Chinook Therapeutics, Inc.


Day One Biopharmaceuticals


Graybug Vision


Meril Life Sciences


Morphic Holding, Inc.


Novo Nordisk


Pharmakon Advisors LP


Royalty Pharma


UCB


Principaux dossiers


  • 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.

Responsables de la pratique:

Jeffrey Quillen


Autres avocats clés:

John Gourary; Rachel Beller; Amy Mandragouras; Carmen DeMatteis; Jeongseok Yu; Beth Neitzel


Les références

‘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.’

Principaux clients

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.

Responsables de la pratique:

Ryan Murr; Jane Love


Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

David Dykeman; Wayne Elowe


Les références

‘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.’

Principaux clients

Moderna, Inc.


Provention Bio, Inc.


Huadong Medicine Co.


Teva Pharmaceuticals


AnnJi Pharmaceutical


Aspira Women’s Health


Embecta Corp.


Exactech, Inc.


Elios Vision


Redhill Biopharma


Principaux dossiers


  • 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.

Autres avocats clés:

Jay Lefkowitz; Devora Allon; Jeanna Wacker


Les références

‘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.’

Principaux clients

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.

Responsables de la pratique:

D’Lesli Davis; Jonathan Skidmore


Autres avocats clés:

David Kessler


Principaux clients

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.


Principaux dossiers


  • 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.

Responsables de la pratique:

Steve Brody; Lisa Pensabene; Ross Galin; Rich Goetz


Autres avocats clés:

Hassen Sayeed; Rob Shaffer


Les références

‘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.’

Principaux clients

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.


Principaux dossiers


  • 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.

Responsables de la pratique:

Stephen Thau; Thora Johnson


Autres avocats clés:

David Gindler


Les références

‘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.’

Principaux clients

Genentech, Inc.


Miltenyi Biomedicine


Ipsen


SFJ Pharmaceuticals


BioAtla


Corteva Agriscience


Catalyst Biosciences


Gilead Sciences, Inc.


ANI Pharmaceuticals


Johnson & Johnson


Principaux dossiers


  • 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.

Responsables de la pratique:

Fangli Chen; Daryn Grossman


Autres avocats clés:

Erik Milch; Joseph Drayton; Grant Esposito; David Fioccola


Les références

‘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.’

Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Paul Schnell


Autres avocats clés:

Graham Robinson


Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Reed Stephens


Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Nathan Brown


Autres avocats clés:

Craig Bleifer


Les références

‘Nathan Brown has an impressive understanding of historical and current FDA enforcement and oversight approaches.’ 

Principaux clients

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.

Responsables de la pratique:

Adam Golden


Autres avocats clés:

Vinita Kailasanath; Kristen Riemenschneider; Jeff Jay


Principaux clients

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


Principaux dossiers


  • 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.

Responsables de la pratique:

Jeffrey Wolfson; Vincent Shier; Benjamin Pelletier


Autres avocats clés:

Jamie Raju


Principaux clients

TeneoBio, Inc.


GRAIL, LLC


Reset Pharmaceuticals, Inc.


Strides Pharma Inc.


Eutilex Co., Ltd.


Carbfix hf.


Orthofix/SeaSpine


Conformis


Principaux dossiers


  • 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.

Responsables de la pratique:

Alexis Gilroy; Heather O’Shea


Autres avocats clés:

Colleen Heisey


Les références

‘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.’

Principaux clients

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.

Responsables de la pratique:

Fran Stoller; Mark Waddell; Jim Czaban; Mitchell Nussbaum


Autres avocats clés:

Kathleen Gersh


Les références

‘Outstanding SEC filing, FDA regulatory, and IP expertise.’

Principaux clients

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.


Principaux dossiers


  • 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.

Responsables de la pratique:

Jonathan Kravetz; William Whelan; Lewis Geffen; Thomas Wintner; Siegmund Gutman


Autres avocats clés:

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.

Responsables de la pratique:

Scot Hasselman


Autres avocats clés:

Nancy Halstead; Rebecca McKnight; Katie Pawlitz; Brian Bewley


Les références

‘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.

Responsables de la pratique:

Jeffrey Fessler; Scott Liebman


Autres avocats clés:

Dominick DiSabatino; Alexandra Kitson


Les références

‘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.’

Principaux clients

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.


Principaux dossiers


  • 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.

Responsables de la pratique:

Peter Carney


Les références

‘This practice has strong experience.’

Principaux clients

AbbVie


Apollomics


Azurity Pharmaceuticals


Bayer


Elevance Health


Hikma Pharmaceuticals


Indivior


Johnson & Johnson (Jansen Pharmaceutical)


Kite Pharmaceuticals


Myriad Genetics


Pfizer


Samsung Bioepsis


Vertex


Vizgen