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Healthcare: life sciences in United States

Arnold & Porter

Arnold & Porter's pre-eminent life science department is nationally recognized for its strong bench of corporate attorneys, regulatory experts and patent prosecutors, who act for leading pharmaceutical companies including Pfizer, Novartis and AstraZeneca. Naturally, the team has recently been very active in assisting clients with the financing, development, authorization and supply of Covid-19 vaccines and therapies. Key names in the sizeable team include Washington DC regulatory experts Daniel Kracov, Allison Shuren, Mahnu Davar, Jeffrey Handwerker, Ariane Horn and new addition, Howard Sklamberg, who joined from Akin Gump Strauss Hauer & Feld LLP in March 2020. Also recommended in Washington DC are Murad Hussain and Kristin Hicks, who focus on regulatory and administrative issues, and are top counsel for defense against FCA claims. Patent and product liability litigation are also key areas of activity, and contacts in this regard include New York-based attorneys Anand Agneshwar, Daniel DiNapoli, James Herschlein and Daniel ReisnerVinita Kailasanath and Deborah Fishman are names to note in Silicon Valley.

Practice head(s):

Dan Kracov; Allison Shuren

Other key lawyers:

Mahnu Davar; Howard Sklamberg; Ariane Horn; Jeffrey Handwerker; Daniel Reisner; James Herschlein; Daniel DiNapoli; Murad Hussain; Kristin Hicks; Anand Agneshwar; Vinita Kailasanath; Deborah Fishman; Abeba Habtemariam

Testimonials

‘The team pulls out all the stops to defend its clients. They have one speed, and it is all-in.’

‘Anand Agneshwar is a master strategist, a brilliant trial attorney, and a fair leader. He is everything that you want in a first-chair trial lawyer. He is the best in the game.’

Key clients

AstraZeneca

Endo Pharmaceuticals Inc.

Pharmaceutical Research and Manufacturers of America (PhRMA)

Pfizer

Bristol-Myers Squibb Company

GSK

Novartis

Eisai, Inc.

Hologic

Sanofi and Regeneron

AbbVie

Sandoz Inc. and Fougera Pharmaceuticals Inc.

Bausch Health Companies

Novo Nordisk

Work highlights

  • Represented AstraZeneca in agreements for the funding and global distribution of the University of Oxford’s potential Covid-19 vaccine.
  • Advising the Pharmaceutical Research and Manufacturers of America (PhRMA) on many matters with significant implications for the pharmaceutical industry, including constitutional challenges to price control and transparency laws enacted in Oregon and California, among others.
  • Secured a complete victory for Sanofi and Regeneron in a patent suit brought by Amgen, seeking damages and a permanent injunction against the sale of Sanofi and Regeneron’s lifesaving, cholesterol-reducing drug Praluent.

Cooley LLP

Cooley LLP is a top-tier practice recognized for its strong transactional abilities, particularly in life sciences IPOs, M&A and collaboration agreements. Kay Chandler chairs the global life sciences practice from San Diego, and recently advised Neurocrine Biosciences on its $2bn strategic partnership agreement with Takeda to develop and commercialize potential therapies for psychiatric disorders. Also recommended in San Diego is corporate lawyer Barbara Borden, who has experience with M&A and public financing transactions in the life sciences sector, and Koji Fukumura, who focuses on securities litigation. Palo Alto-based Marya Postner is recommended for strategic alliances and major licensing and profit-sharing arrangements, as are Laura Berezin and Kate Hillier. Vice chair Christian Plaza and Ken Krisko advise on securities offerings and commercialization deals from Reston, Virgina. The patent practice is led by Ivor Elrifi in New York, and also includes top litigators Michelle Rhyu and Sanya Sukduang in Palo Alto and Washington DC, respectively.

Other key lawyers:

Kay Chandler; Christian Plaza; Barbara Borden; Koji Fukumura; Marya Postner; Laura Berezin; Ken Krisko; Ivor Elrifi; Michelle Rhyu; Sanya Sukduang; Kate Hillier

Key clients

Autolus Therapeutics

CSL Behring

eFFECTOR Therapeutics

Fate Therapeutics

Immatics

Jazz Pharmaceuticals

Legend Biotech

Neurocrine Biosciences

PhaseBio Pharmaceuticals

Pulmonx Corporation

RenalytixAI

Sangamo Therapeutics

Synthorx

Vir Biotechnology

Work highlights

  • Advised Neurocrine Biosciences on its $2bn strategic partnership agreement with Takeda to develop and commercialize potential therapies in Takeda’s early- to mid-stage pipeline for psychiatric disorders.
  • Advised Legend Biotech on one of the largest life sciences IPOs ever, priced at $487.3m.
  • Advised Fate on its $3.1bn global collaboration and option agreement with Janssen Biotech, Inc.

Latham & Watkins LLP

Latham & Watkins LLP is renowned for its healthcare and FDA regulatory practice, which is working alongside government bodies to develop policy and proposals for therapeutic and vaccine development for Covid-19. The practice group also benefits from the strength of the firm's corporate team, which includes Silicon Valley-based partners Brian Cuneo, Judith Hasko, Alan Mendelson and Mark Roeder, all of whom have deep experience of financing, corporate and commercial transactions in the sector. Contacts in New York include financing expert Nathan Ajiashvili, and patent litigation specialists Arlene Chow and Ernest Yakob, both of whom joined from Hogan Lovells US LLP in June 2020. The team also expanded its capabilities in Washington DC, with the lateral hire of Adam Perlman, former co-chair of patent litigation at Williams & Connolly LLP. IP litigator Michael Morin and regulatory experts John Manthei, Ben Haas and Elizabeth Richards are also recommended in the Washington DC office.

Practice head(s):

Brian Cuneo; Michael Morin; Terra Reynolds; Robbie McLaren ; John Manthei; Judith Hasko

Other key lawyers:

Alan Mendelson; Mark Roeder; Nathan Ajiashvili; Arlene Chow; Ernest Yakob; Adam Perlman; Ben Haas; Elizabeth Richards

Testimonials

‘Life Sciences team at Latham & Watkins has exceptional knowledge about FDA-related regulatory issues and provides practical and timely solutions to addressing such matters.’

‘Although a client firm may need to access one or two disciplines within Latham for a specific business transaction, one value of the firm is their fully-integrated structure. This allows Latham to bring deep expertise to the table, after careful consideration and internal dialog with other functional disciplines across their organization.’

‘Judith Hasko is simply tremendous. This was my first time working directly with her on a transaction. Not only did Judith surpass my expectations on each of those specific points, but what impressed me the most was her innate ability to maintain a calm and highly engaging demeanour balanced with a firm position to ensure her client partners secure the best long-term positions.’

‘Elizabeth Richards is highly knowledgeable in the practice area and always responds to our inquiries in a timely manner, providing well-thought-out advice at a pace commensurate with our business and our industry.’

Key clients

3OE Scientific

Abbott Laboratories

Abcam plc

Aligos Therapeutics, Inc

Amgen

Annexon, Inc.

Astellas Pharma

Atea Pharmaceuticals, Inc.

AVEO

Avidity Biosciences, Inc.

Ayala Pharmaceuticals, Inc.

Aziyo Biologics, Inc

Berkeley Lights, Inc.

Eagle Pharmaceuticals

Eargo, Inc.

Eli Lilly

Emerja Corporation

Fractyl Laboratories

Galera Therapeutics, Inc.

GRAIL, Inc.

Harmony Biosciences Holdings, Inc.

Hemanext

Inari Medical, Inc.

Johnson & Johnson

Lyra Therapeutics, Inc.

Merck

Momenta Pharmaceuticals, Inc.

Nestlé Health Science S.A.

Orig3n

Pneumico

Puma Biotechnology Inc.

Ra Pharmaceuticals, Inc.

Revolution Medicines, Inc.

Ridgeback Biotherapeutics

Siemens Healthineers AG

SQZ Biotechnologies Company

The Ventilator Project

Zentalis Pharmaceuticals, Inc.

Work highlights

  • Advised US-headquartered Ridgeback Biotherapeutics on a collaboration with Merck to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with Covid-19.
  • Represented Astellas Pharma in its co-development and co-commercialization agreement with Adaptimmune, a biopharmaceutical company headquartered in the US and UK, to bring new stem-cell derived allogeneic T-cell therapies to people with cancer.
  • Defending Abbott Laboratories in a patent infringement lawsuit filed by FlexStent, LLC, in the Central District of California, alleging that Abbott’s Xience stents, the best-selling drug-eluting stents on the market, infringes its patent.

Goodwin

Goodwin continues to grow its life sciences practice with a number of lateral hires over the review period. Patent litigators Kristina Bieker-Brady and Sabrina Poulos joined from Morgan, Lewis & Bockius LLP and Wilson Sonsini Goodrich & Rosati in Boston and San Francisco, respectively; healthcare regulatory partner Delphine O’Rourke joined the New York office from Duane Morris LLP; and Washington DC-based transactions partner Adam Walter Bellack joined from Hogan Lovells US LLP. The firm has also established a Late Stage Drug Development consulting service focusing on IP commercialization and patent protection. In Boston, Kingsley Taft and Robert Puopolo represent life sciences clients at every stage of operation, with particular focus on licensing, collaborations and venture financings. Danielle Lauzon is sought after for corporate counsel for start-up and later stage companies. Washington DC is the hub of the FDA regulatory team, where names to note include Alexander Varond and senior associate Steven Tjoe.

Practice head(s):

Mitchell Bloom; Kingsley Taft

Other key lawyers:

Kristina Bieker-Brady; Sabrina Poulos; Delphine O’Rourke; Robert Puopolo; Danielle Lauzon; Alexander Varond; Steven Tjoe

Testimonials

‘As a firm, Goodwin clearly works very hard behind the scenes to make the client experience very good – it is frictionless and enjoyable. They hire great people who are good technical lawyers and seem to enjoy their work and look after clients. The US life sciences team is a good reflection of these qualities’

‘It’s always about the people! Rob Puopolo and his team have been wonderful partners for our company and supported a lot of activity from corporate law, fund raising, M&A, all under break-neck pace/deadlines.’

‘Rob Puopolo – good technical lawyer, great experience and runs a nice team of calm professionals.’

‘Alex Varond exudes genuine interest in my programs. He provides honest advice. When we have a disagreement on a viewpoint, his response is flexible. I trust that his effort is done with my best interests in mind. I never feel input is provided simply for “billable” hours. He’s a true professional and a pleasure to work with. He never shows up at the table without completing a prior reviews

‘The entire team, led by Rob Puopolo, is very customer-centric. This includes responsiveness, proactive solution-orientation, and teaming with other counsel in non-US jurisdictions where appropriate.’

Key clients

Moderna, Inc.

BeiGene, Ltd.

CRISPR Therapeutics AG

Fusion Pharmaceuticals Inc.

Karuna Therapeutics, Inc.

Black Diamond Therapeutics, Inc.

Immatics N.V.

MyoKardia

Blueprint Medicines

Alnylam Pharmaceuticals

Work highlights

  • Represented Moderna in connection with its $500m and $1.34bn underwritten public offerings, its proprietary mRNA-based Covid-19 vaccine candidate, and on expansion of its collaboration with Merck to develop and commercialize novel personalized messenger RNA cancer vaccines to include shared antigen mRNA cancer vaccines, including mRNA- 5671, Moderna’s mRNA KRAS cancer vaccine.
  • Represented CRISPR Therapeutics, a leading gene editing company, in connection with its November 2019 $315.2m and July 2020 $517.5m follow-on public offerings.
  • Advised long-time client MyoKardia, Inc., a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases, on the successful completion of its acquisition by Bristol Myers Squibb for approximately $13.1bn.

Hogan Lovells US LLP

Hogan Lovells US LLP 's national life sciences practice has a strong reputation for M&A, financing transactions and large-scale commercial deals. It also stands out for its dedicated regulatory offering and its experience in IP litigation and pharmaceutical and medical device product liability proceedings. Its Washington DC-based regulatory team was recently strengthened by the arrival of Jonathan Wasserman, former associate general counsel at Bristol Myers Squibb.  It is also highly commended for its Washington DC based FDA and healthcare regulatory team. Contacts in this space include Philip Katz, who leads the group's pharmaceutical work; Randy Prebula, head of medical devices; Jonathan Kahan and David Fox, who focus on FDA matters; and Anishiya Abrol, a contact for commercial and licensing transactions. The service group is jointly led by Steve Abrams and Lynn Mehler in Philadelphia and Washington DC, respectively. Asher Rubin and Adriana Tibbitts joined Sidley Austin LLP in January 2021; Suzanne Filippi left for Morgan, Lewis & Bockius LLP in April, and Adam Golden left for Freshfields Bruckhaus Deringer LLP in May.

Practice head(s):

Steve Abrams; Lynn Mehler

Other key lawyers:

Jonathan Wasserman; Philip Katz; Jonathan Kahan; Randy Prebula; Anishiya Abrol 

Testimonials

‘They are thorough and responsive. Best for complex matters.’

Key clients

Baxter International Inc.

Biom’Up SA

Celgene

Exact Sciences

Jazz Pharmaceuticals

LabCorp

Novartis

Work highlights

  • Represented NextCure as its principal outside counsel since its founding, initial growth and fundraising, all its debt and equity financings, licensing transactions, and collaborations, on to its IPO, and an initial follow-on offering.
  • Advised Lucira Health on its Emergency Use Authorization submissions for the first rapid, at-home test systems for Influenza and SARS-CoV-2 viruses.
  • Represented Daiichi Sankyo in its global development and commercialization agreement with AstraZeneca.

King & Spalding LLP

Based in Washington DC, the team at King & Spalding LLP provides comprehensive support to clients on a full range of matters, including product development, FDA premarket review, compliance and defense of government investigations. In addition, the team has strong capabilities in Hatch-Waxman cases and matters relating to market exclusivity. Seth Lundy, Nikki Reeves and Brian Bohnenkamp have experience advising on regulatory proposals and agency efforts to implement drug pricing transparency requirements. Chair of the FDA life sciences team Mark Brown advises on FDA regulatory issues that arise in product liability litigation and other disputes. John Shakow has over 20 years' experience in complex regulatory, investigation, and litigation issues related to pharmaceutical government pricing and price reporting. Lisa Dwyer and Preeya Noronha Pinto are also recommended.

Practice head(s):

Mark Brown; Seth Lundy; Nikki Reeves

Other key lawyers:

Brian Bohnenkamp; John Shakow; Lisa Dwyer; Preeya Noronha Pinto

Key clients

AbbVie

Allergan, Inc.

Amarin Corporation

Baxter International

Bristol Myers Squibb

Eli Lilly

EMD Serono

Exact Sciences

GlaxoSmithKline

Hillrom

Integra LifeSciences

Invacare Corporation

LEO Pharma, Inc.

Medtronic

Novo Nordisk Pharmaceuticals

PhRMA

Promega

SmileDirectClub

Takeda Pharmaceuticals

Teleflex, Inc.

Urogen

Zimmer Biomet

Work highlights

  • Representing Bristol Myers Squibb in a government investigation of the company’s price reporting calculations and reporting of the average manufacturer price in connection with a certain kind of inventory management fee paid to wholesalers and distributors.
  • Successfully represented the plaintiffs, Galderma Laboratories, in a Hatch-Waxman patent litigation regarding Oracea®, Galderma’s successful pharmaceutical treatment for rosacea, against Amneal Pharmaceuticals.
  • Assisted Ventec in its partnership with General Motors to increase its ventilator output capacity due to the Covid-19 pandemic needs, advising on federal regulatory and government contracting aspects.

Morgan, Lewis & Bockius LLP

Morgan, Lewis & Bockius LLP demonstrates significant strength and capability in FDA and other healthcare regulations, as well as in IP matters. It is regularly engaged in cross-border licensing and collaboration agreements, capital markets transactions and M&A deals. The firm also introduced several applications in response to Covid-19, among them ML ClientSite and ML Parallex, to facilitate better remote client engagement and reduce costs. Washington DC-based Kathleen Sanzo leads the firm's FDA practice; while key figures for transactional IP and patent infringement work are Jeffry Mann in Boston, Princeton-based Alan Leeds, Michael Abernathy in Chicago and Benjamin Pensak in the San Francisco office. Michele Buenafe is highly recommended for digital health and med-tech issues, such as those relating to AI and mobile medical apps.

Practice head(s):

Kathleen Sanzo; Michael Abernathy; Alan Leeds; Troy Brown; Gargi Talukder

Other key lawyers:

Jeffry Mann; Michele Buenafe; Benjamin Pensak

Testimonials

‘They are incredibly responsive and give practical, thorough, thoughtful counsel.’

Key clients

Velos Bio

Eli Lilly

Innovent Biologics

Hansoh Pharmaceutical

PTC Therapeutics

Amneal Pharmaceuticals

Celgene

Engage Therapeutics

Bristol Myers Squibb

Alfred E. Mann Foundation for Scientific Research

Baxalta (affiliate of Takeda Pharmaceuticals)

Work highlights

  • Represented VelosBio in its Series B preferred stock financing led by Matrix Capital Management and Surveyor Capital.
  • Represented Eli Lilly and Co. in its agreement with AbCellera to co-develop antibody products for the treatment and prevention of Covid-19.
  • Represented Innovent Biologics Inc. in its $2.1bn strategic research and development collaboration with Roche.

Ropes & Gray LLP

Ropes & Gray LLP is a go-to name for licensing and collaboration agreements, strategic partnerships, M&A and financings in the life sciences sector. It also handles FDA compliance, contentious regulatory proceedings and patent disputes. July 2020 saw the launch of the firm's life sciences consulting service, R&G Insights Lab, which assists with corporate and investment strategy, internal policies procedures and governance, and risk management. Key contacts in the Boston office include Michael Beauvais and Marc Rubenstein, one of the leading figures for commercialization strategies. Other recommended attorneys include Washington DC-based regulatory experts Gregory Levine and Kellie Combes; and Megan Baca in Silicon Valley, who is particularly active in digital health.

Practice head(s):

Michael Beauvais; Gregory Levine

Other key lawyers:

Zach Coseglia; Marc Rubenstein; Kellie Combes; Megan Baca

Testimonials

‘Ropes & Gray’s life sciences practice is my go to for complex, sophisticated deals and issues that no one has seen before in the market. The team has a deep bench of transactional, IP and regulatory attorneys to pull from in all of the key jurisdictions and is able to handle adeptly and efficiently transactions that are multi-faceted.’

‘The life sciences team, including Michael Beauvais, Abigail Gregor, Melissa Rones, Marc Rubenstein, Mark Bellomy, Al Cacozza and others brings vast experience in the life sciences industry. They have helped guide multi-billion transactions for us that involve M&A, licensing, and regulatory issues with ease. I am always impressed by their professionalism and their ability to work together as a team to tackle these difficult and unique transactions.’

Key clients

Gilead Sciences

Blackstone Life Sciences

Sarepta Therapeutics

Beam Therapeutics

Bain Capital

Regeneron Pharmaceuticals, Inc.

Wright Medical Technology, Inc.

Novavax, Inc.

Pfizer, Inc.

Takeda Pharmaceuticals

Work highlights

  • Representing long-time client Novavax, Inc. in its $167m acquisition of Praha Vaccines, which will enable the company to produce 100 million doses of its anticipated Covid-19 vaccine by early 2021.
  • Represented Gilead Sciences in its $1.74bn exclusive option to acquire Pionyr Immunotherapeutics Inc., a California-based privately held company developing cancer immunotherapies, and pending $1.55bn exclusive option to acquire Tizona Therapeutics, Inc., a California-based privately held clinical-stage immunotherapy company.
  • Advised Blackstone, including Blackstone Life Sciences and its credit platform GSO Capital Partners, on a $2bn strategic financing collaboration with Alnylam, one of the largest-ever private financings of a biotech company.

Weil, Gotshal & Manges LLP

Weil, Gotshal & Manges LLP has a significant presence in top-end life science transactions and litigation. Among its recent standout work, the team advised Eli Lilly on its negotiation with Gates Foundation to make its antibody therapies available and supplied to lower-income countries. Co-head and leading patent litigator Edward Reines acted alongside Derek Walter (both in Silicon Valley) in securing a complete, $24m verdict for Bio-Rad Laboratories and the University of Chicago in a patent infringement suit brought against 10X Genomics concerning certain genetic testing methods. In New York, co-head and fellow patent litigator Elizabeth Weiswasser represents leading clients in business-critical litigation concerning biologics, pharmaceuticals, chemicals and medical devices. Jeffrey Osterman focuses on commercial and technology transactions in the healthcare space.

Practice head(s):

Edward Reines; Elizabeth Weiswasser; Michael Epstein

Other key lawyers:

Derek Walter; Jeffrey Osterman

Key clients

Sanofi

Johnson & Johnson

AbbVie

Eli Lilly

Guardant Health

Illumina

Bio-Rad Laboratories

Pacific Biosciences

Regeneron Pharmaceuticals

Quest Diagnostics

Work highlights

  • Representing Illumina in numerous patent litigations related to prenatal testing methods for the early diagnosis of fetal abnormalities, delivering a preliminary injunction at the district court level and a pair of appellate victories at the Federal Circuit, one of which broke new ground in Section 101 jurisprudence.
  • Advising Allergan on the antitrust aspects of Allergan’s blockbuster $63bn acquisition by AbbVie, which featured a highly complex and in-depth ten month review and overcame significant public opposition in the US to secure antitrust clearances and close the transaction.
  • Lead counsel to Sanofi in IPR proceedings and litigation in the US District Court for the District of New Jersey asserting seven patents directed to Sanofi’s multibillion-dollar LANTUS SOLOSTAR franchise, an insulin biologic delivered in an innovative pre-filled injection device, which is one of Sanofi’s most important and successful drug products and devices.

Dechert LLP

Dechert LLP is active across all areas of the life sciences market, leveraging a strong corporate team advising on capital markets transactions, M&A and commercialization deals. The team is recognized for its strengths in finance and its experience assisting pharmaceutical companies with fundraising for Covid-19 treatments. Of recent note, the team represented a US-based financial services client in BioNTech's $325m Series B financing round—one of the single largest private funding rounds for a biotech company in European history. Los Angeles-based Kimberly Branscome and Jay Bhimani joined from Kirkland & Ellis LLP, strengthening the product liability and mass torts practice. Co-chairs Andrea Reid and David Rosenthal are based in Boston and New York, respectively; product liability co-chair Mark Cheffo, patent litigator Katherine Helm and patent prosecutor Carl Morales are contacts in New York.

Practice head(s):

Andrea Reid; David Rosenthal; Mélanie Thill-Tayara; Mark Cheffo

Other key lawyers:

Kimberly Branscome; Jay Bhimani; Katherine Helm; Carl Morales; David Schulman; David Rosenthal

Testimonials

‘The team has a huge knowledge of the patent space and what sets them apart is the strategic view they can provide about putting together an integrated and comprehensive patent plan that maximises protection and cover.’

‘Andrea Reid has deep expertise in patent and patent strategy, collaborative approach to working with us and other patent houses we use, makes it feel like and in house patent team. Always makes time to consult and advise the team based on wide and deep rooted experience. Paul Fleming – deeply committed, rooted in strong scientific experience from a career in industry and training at MIT.’

‘Dechert and Andrea Reid do a really good job providing both strategic and tactical support to enabling growing companies build the right IP strategies in their business plans.’

‘Andrea is unique in this business. She understands the science well, she can support IP and business strategies not only for company internal activities abut also in financing and partnering discussions. She does this in an impeccable and productive manner.’

‘Dechert really is a team – amazing and seamless ability to bring deep expertise to bear, while also having a key relationship manager. They get client service right.’

‘Andrea Reid is an exemplary lawyer and leading light in IP thinking. Further, she is an amazing manager and developer of talent, as evidenced by the amazing associates and young partners she has groomed.’

Key clients

AbbVie

Antares Pharma Inc.

Aquestive Therapeutics

ArchiMed

Arrakis Therapeutics

Bayer

Bicycle Therapeutics

BioAtla

BioNTech

Cano Health

Centrexion Therapeutics

Cerberus Capital Management

Citron Pharma

CVS Health

Dicerna Pharmaceuticals

Diffusion Pharmaceuticals

Disc Medicine

DuPont Nutrition & Biosciences

Eli Lilly and Company

Endo Pharmaceuticals

Ferring Pharmaceuticals

Fresenius Medical Care

GlaxoSmithKline

Johnson & Johnson

Kymera Therapeutics

Kleo Pharmaceuticals

Lannett Company, Inc.

Merck KGaA

Navitor Pharmaceuticals

Norgine B.V.

OraSure Technologies Inc.

Oxford Biodynamics

PDL BioPharma, Inc.

Pfizer

PIC Therapeutics

Purdue Pharma

Quest Diagnostics Inc.

Roche

Royalty Pharma

Sunovion Pharmaceutical Inc.

Valneva

Zyla Life Sciences

Zynerba Pharmaceuticals, Inc.

Work highlights

  • Lead counsel for Pfizer in defending claims by thousands of plaintiffs alleging Pfizer’s statin medication, Lipitor, caused them to develop type-2 diabetes.
  • Counsel to Royalty Pharma on IP issues in connection to its $575m acquisition of the residual royalty interest in Vertex Pharmaceuticals, Inc.’s cystic fibrosis treatments owned by the Cystic Fibrosis Foundation; and $255m acquisition from Agios Pharmaceuticals of sales-based royalty rights on worldwide net sales of Bristol Myers Squibb’s IDHIFA® (enasidenib).
  • Advising Valneva on its collaboration with Pfizer to develop and commercialize Valneva’s Lyme disease vaccine candidate VLA15, which is currently in Phase 2 clinical studies.

DLA Piper LLP (US)

DLA Piper LLP (US) is a recognized name for IP matters in the life sciences sector, leveraging a global footprint and depth of experience in the management of patent portfolios, post-grant reviews and ANDA litigation, alongside a strong patent infringement practice. Boston-based practice co-head Matthew Holian manages a busy litigation practice, covering mass torts and product liability, and is also active in regulatory and enforcement matters. Fellow co-head Andrew Gilbert, based in Short Hills, is a contact on the transactional side, with deep experience in M&A, public and private offerings, and investment deals. Lisa Haile in San Diego is a name to note for patent protection, as are New York-based Loren Brown and Lucas Przymusinski, who are experienced in defending pharmaceutical product liability actions. Katie Insogna made partner in the Boston office in April 2020.

Practice head(s):

Matthew Holian; Andrew Gilbert

Other key lawyers:

Lisa Haile; Loren Brown; Lucas Przymusinski; Katie Insogna

Testimonials

‘Amazing depth of knowledge on all things IP law and life sciences. All the partners I worked with were some of the best. I felt like I had the A-Team all the time. ‘

‘The DLA team has a deep understanding of the biotech/pharma industry as well as the unique issues/challenges associated with industry/academic partnerships which represent the majority of our engagements with DLA. The team is incredibly responsive and has delivered high quality results/product 100% of the time.’

‘Subject-matter experts + a pragmatic, efficient approach that is perfect for in-house attorneys trying to navigate external legal risk while advising the business through a risk-based approach that allows the business to continue as much as possible.’

‘DLA Piper LLP (US) has an in depth knowledge of the healthcare sector and is a leader in this field. It has been a pleasure working with DLA. All of the lawyers could not have been more engaged and their advice on complex healthcare topics was outstanding. They worked with highest efficiency on different healthcare questions across the globe, always exceeding the clients expectations.’

‘Lisa Haile: Lisa is very strong technically and a creative strategist. She is well versed in patent prosecution concerns arising in the life sciences sector and draws on extensive technical expertise in areas such as cell and molecular biology, regenerative medicine and immunology, to advise on matters ranging from due diligence, patentability, portfolio management and licensing.’

Key clients

Pfizer

Bayer

Medtronic

Liquidia Technologies, Inc.

Immunomedics, Inc.

Iovance Biotherapeutics, Inc.

NuVasive

Sanofi

Biogen

Work highlights

  • Achieved a significant victory for Pfizer Inc., effectively ending the more than 800-plaintiff product liability MDL in which plaintiffs claimed that erectile dysfunction medications, including Viagra, is associated with the progression of melanoma.
  • Represented Liquidia Technologies, Inc., a late-stage clinical biopharmaceutical company, in its acquisition of RareGen, LLC, a provider of strategy, investment, and commercialization services for pharmaceutical companies and a portfolio company of healthcare investment firm PBM Capital.
  • Global coordinating counsel for Bayer in mass tort litigation involving Essure, a permanently implantable contraceptive device for women that Bayer discontinued in 2018.

Mayer Brown

Fielding a sizeable group of attorneys with backgrounds in medicine, pharmacy and biochemistry, the team at Mayer Brown is a well-known name among start-ups, leading pharmaceutical and biotech companies, funds and investors in life sciences. Recently, it has been especially active in consulting clients on the impact of the Covid-19 pandemic through various online platforms. Global life sciences co-chair Reb Wheeler and Lisa Ferri jointly lead the IP department, specializing in M&A and large-scale commercial transactions. Ferri also handles a significant amount of patent litigation work. Also recommended are David Bakst, who handles equity financing transactions; Henninger Bullock, who focuses on product liability; IP specialist Brian Nolan; and David Carpenter, a contact for general corporate and commercial matters. All named attorneys are based in New York.

Practice head(s):

Lisa Ferri; Reb Wheeler

Other key lawyers:

David Bakst; Henninger Bullock; Brian Nolan; David Carpenter

Key clients

AbbVie

Adaptimmune Therapeutics

Anchiano Therapeutics

Baxter

BiomX Ltd

Brickell Biotech, Inc

Bristol-Myers Squibb

Gilead Sciences Inc.

Glaxo Group Ltd., GSK

GW Pharmaceuticals

Medtronic Inc.

MeMed

Merck & Co.

Nestlé Health Science

Novartis AG

St. Jude Medical, Inc.

Takeda

Work highlights

  • Assisted Nestlé Health Science with expanding its footprint in the pharmaceutical sector with its acquisition of drugs, Zenpep and Viokace, from Irish drug maker, Allergan plc, and $2.6bn acquisition of NASDAQ-listed Aimmune Therapeutics, Inc., a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies.
  • Advised MeMed Ltd., an Israel-based diagnostic solutions developer, on a strategic licensing agreement with Italy-based DiaSorin S.p.A., a global leader in the In Vitro Diagnostic (IVD) field, to develop and commercialize a novel host immune response-based diagnostics solution to differentiate accurately between bacterial and viral infections.
  • Representing Gilead Sciences, Inc. in a Hatch-Waxman patent litigation filed in the US District Court for the District of Delaware against 11 different defendants groups, concerning an intravenous solution of regadenoson, marketed under the trade name Lexiscan®.

McDermott Will & Emery LLP

McDermott Will & Emery LLP's life sciences team has a solid on-the-ground presence in Boston, New York, Washington DC, Chicago and Silicon Valley, and is active across the spectrum of transactional healthcare, life sciences and digital health matters. The practice has substantially bolstered its offering in IP litigation and FDA regulations with the 2020 hires of April Weisbruch and Brian Malkin in Washington DC; patent litigators Ralph Gaskins and Jackie Toney in Atlanta, and Michael Siekman and Jenny Chen in Boston. Indeed, the group is now especially well placed to handle patent prosecution, Hatch-Waxman matters, licensing and post-grant proceedings. The New York office added former Kirkland & Ellis LLP attorneys Warren Haskel, Dmitriy Tishyevich and Joshua Simon in March 2020 to its growing team of healthcare litigators. Practice co-heads Stephen Bernstein and Kristian Werling are based in Boston and Chicago, respectively. William Gaede in Silicon Valley chairs the global IP practice.

Practice head(s):

Stephen Bernstein; Kristian Werling; William Gaede

Other key lawyers:

April Weisbruch; Brian Malkin; Ralph Gaskins; Jackie Toney; Michael Siekman; Jenny Chen; Warren Haskel; Dmitriy Tishyevich; Joshua Simon

Testimonials

‘The MWE team has a deep understanding of biotechnology and healthcare technology and the law. The team also had a good understanding of the murky caselaw related to the legal matter.’

‘The pragmatic business advice and appropriate staffing for the case were several highlights from the MWE team.’

Key clients

Amgen

Novartis

Quidel

Bausch

Baxter

Biogen

Ampersand Capital Partners

Merck KgA

Work highlights

  • Representing Amgen in its long-fought battle with Sanofi and Regeneron Pharmaceuticals over the new generation of blockbuster drugs proven to lower LDL cholesterol.
  • Defending Novartis in a patent infringement brought by Plexxikon, a subsidiary of Daiichi Sankyo, in the Northern District of California, regarding Novartis’s melanoma drug, Tafinlar®, which is accused of infringing two of Plexxikon’s patents.
  • Represented Baxter Healthcare Corporation in acquiring exclusive global rights to manufacture and sell Cardene® IV (nicardipine hycrocholoride) Premixed Injection from Chiesi USA, Inc., a specialty pharmaceutical company focused on commercialization of products for the hospital, rare disease and target office-based specialties.

Morrison & Foerster LLP

Morrison & Foerster LLP is active in all segments of the life sciences market, showcasing key strengths in contentious proceedings including patent invalidation actions, infringement and product liability litigation. Of recent note, the firm has been advising pharmaceutical clients and developers on an array of matters concerning Covid-19, ranging from clinical trials, funding for vaccine development, FDA approval and assisting with agreements to ensure supply in developing countries. Global chair of life sciences Michael Ward (San Francisco) is a recognized figure in patent litigation, and is highlighted for his niche experience in agriculture IP. Catherine Polizzi (Palo Alto) focuses on portfolio development and commercialization breakthrough therapies, as does patent specialist Janet Xiao. Bethany Hills (New York) has a wealth of experience in FDA regulations and compliance.

Practice head(s):

Catherine Polizzi; Michael Ward

Other key lawyers:

Janet Xiao; Bethany Hills

Testimonials

‘MoFo has made an exceptional effort in relationship building to get to know our company’s risk profile and corporate strategy. This is an immense help to me, because any feedback and deliverables provided don’t require extensive analysis on my end to determine if it fits within our internal objectives; ultimately saving me a lot of time.’

Key clients

Krystal Biotech

BGI Genomics

Pliant Therapeutics, Inc.

Nevro Corp.

Washington University in St. Louis (WashU)

Survivor Corps.

Adicet Bio, Inc.

Santen Pharmaceutical

Work highlights

  • Successfully secured an emergency use authorization for a Covid-19 diagnostic test for new client BGI Genomics, the first-ever FDA approval received by BGI Genomics.
  • Represented Krystal Biotech, Inc., a gene therapy company developing a new class of medicines to treat diseases caused by gene or protein dysfunction, in a $125m underwritten public offering.
  • Represented Washington University in a breach of royalty contract against University of Wisconsin and its Wisconsin Alumni Research Foundation involving kidney disease treatment patent.

Paul Hastings LLP

Paul Hastings LLP substantially expanded its service offering with the launch of an FDA practice—marked by the arrivals of Nathan Sheers and Peter Lindsay from Sidley Austin LLP—and the establishment of a life sciences consulting group led by BJ D’Avella, which focuses on commercial strategies, R&D operations and compliance. FDA regulatory and compliance work is a core focus, and contacts in this regard include global chair Gary Giampetruzzi, and Houston-based Jane Yoon and Joy Dowdle. On the IP litigation front, Bruce Wexler and Eric Dittmann recently represented Boehringer Ingelheim in connection with two inter partes reviews before the PTAB resulting in the invalidation of all claims of a key patent covering the most widely used indication for AbbVie’s immunosuppressive drug Humira®. All partners are based in New York.

Practice head(s):

Gary Giampetruzzi

Other key lawyers:

Nathan Sheers; Peter Lindsay; BJ D’Avella; Jane Yoon; Joy Dowdle; Bruce Wexler; Eric Dittmann

Testimonials

‘Broad spectrum of experience with variety of innovator-pharma clients. Established trust and credibility by Judges and creative thinking to propose options for the solution’

Key clients

GlaxoSmithKline

Johnson & Johnson

Merck & Co

Alexion Pharmaceuticals

Boehringer Ingelheim

Mitsubishi Tanabe Pharma Corporation

Actelion Pharmaceuticals

Spectrum Pharmaceuticals

Sucampo Pharmaceuticals, Inc.

Sorrento Therapeutics, Inc.

Redmile Group

Care DX, Inc.

Work highlights

  • Represented Alexion Pharmaceuticals before the DOJ and SEC in a high-profile and long-running FCPA case, recently reaching a resolution involving no independent monitor and no compliance obligations whatsoever.
  • Representing Mitsubishi Tanabe Pharma Corporation in several significant matters, including an unprecedented trial via Zoom—the first Zoom Hatch-Waxman Act trial in a key venue (DNJ).
  • Representing Sorrento Therapeutics, a clinical-stage and commercial biopharma company, in numerous matters, including in multiple financing transactions in 2019 and 2020 totaling $615m.

Covington & Burling LLP

At Covington & Burling LLP, section head John Hurvitz has acted as transactional counsel to both established and emerging pharmaceutical, biotech, med-tech, diagnostics, animal health and health services companies. Hurvitz is also experienced in food and drug regulatory compliance and in IP issues within the life sciences industry. Richard Kingham has represented pharmaceutical manufacturers in administrative proceedings, criminal prosecutions and congressional hearings. Named attorneys are based in Washington DC.

Debevoise & Plimpton LLP

Debevoise & Plimpton LLP fields a multidisciplinary team with expertise in corporate and commercial transactions, litigation and intellectual property. The group has particular experience of matters in the pharmaceutical sector, but also has notable depth of experience in healthcare M&A and investments, often acting for private equity firms involved in this sector. FCA litigation is another area of strength, as are FDA and FTC regulatory matters; Washington DC-based Paul Rubin is a contact in this space. In New York, Andrew Bab and Kevin Rinker are recommended private equity financing deals and acquisitions, while Mark Goodman and Maura Monaghan stand out for commercial litigation.

Practice head(s):

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

Testimonials

‘Outstanding overall quality of lawyers.’

‘Mark Goodman is simply outstanding. He is a true professional and extremely dedicated. He is responsive, a quick study, very practical and a pleasure to work with.’

Key clients

Adare Pharmaceuticals

Allergan

Armando Kellum, former CEO of Sandoz

The Blackstone Group

Certain former directors and shareholders of Purdue Pharma, Inc.

Clayton, Dubilier & Rice, LLC

Glaxosmithkline

Hospital Corporation of America and subsidiaries

JAB Holdings

J.P. Morgan Securities

Manna Pro

Memorial Sloan Kettering Cancer Center

Merck KGaA

Morgan Stanley

Pathway Vet Alliance

Precision Medicine

TPG Capital

Work highlights

  • Representing former directors and shareholders of Purdue Pharma, Inc., regarding prescription opioid litigation across the country, including a federal multi-district litigation and actions brought by states attorneys general.
  • Acting for Guggenheim Securities, LLC and Morgan Stanley & Co. LLC as financial advisors to Pfizer Inc. in connection with Pfizer’s $11.4bn acquisition of Array BioPharma Inc.
  • Advised Johnson & Johnson on its strategic acquisition of Zarbee’s, Inc., a privately held company that is a leader in naturally based healthcare products.

Kirkland & Ellis LLP

Kirkland & Ellis LLP represents market-leading pharmaceutical companies,  biotechnology companies and start-ups, as well as private equity and venture capital investors in all core segments of the pharmaceutical and life sciences industries. Jointly led by James Hurst in Chicago and New York-based trial and appellate lawyer Jay Lefkowitz, the litigation group works in tandem with IP litigators Patricia Carson and Leora Ben-Ami to handle patent infringement matters, antitrust actions brought by both government and private plaintiffs and large-scale product liability cases and class actions. The practice group also has experience advising on joint ventures and equity investments, development agreements, and university and government license arrangements.

Practice head(s):

Jay Lefkowitz; James Hurst

Other key lawyers:

Patricia Carson; Leora Ben-Ami

Key clients

Abbott Laboratories

Abbvie Inc.

Allergan plc

Arya Sciences Acquisition Corp. II

Association for Accessible Medicines

Bristol-Myers Squibb

Work highlights

  • Successfully defended AbbVie in an unprecedented, antitrust case regarding AbbVie’s Humira; plaintiffs had sued AbbVie under Section 2 of the Sherman Act, alleging that AbbVie created an illegal monopoly for Humira by erecting a patent thicket of more than 100 patents to block biosimilars.
  • Acting for Allergan in various state and federal governmental investigations, congressional inquiries, and civil suits in multiple courts related to its sale and marketing of opioid pain killers (In re Opioid Painkiller Litigation).
  • Advised Arya Sciences Acquisition Corp. II, a special purpose acquisition company (SPAC) sponsored by Perceptive Advisors, on its business combination with Cerevel Therapeutics, Inc.

Norton Rose Fulbright

Norton Rose Fulbright is recognized for its strong litigation practice, with an established track record of successfully defending pharmaceutical clients in multi-jurisdictional product liability claims and patent litigation. The antitrust team, headed by Robin Adelstein in New York, plays a key role in the firm's service offering. It is routinely involved in government investigations and enforcement actions, and also has extensive experience coordinating national competition strategies. Austin-based Stacey Martinez and Gina ShishimaD’Lesli Davis in Dallas, San Antonio-based Saul Perloff and Jeffrey Lewis in New York are recommended for product liability and torts, as well as transactional and contentious patent matters. Carol Poindexter in Washington DC is the key attorney for regulatory compliance issues.

Practice head(s):

Debbi Johnstone; Jonathan Skidmore

Other key lawyers:

Saul Perloff; Robin Adelstein; Stacey Martinez; Gina Shishima; D’Lesli Davis; Carol Poindexter; Jeffrey Lewis

Testimonials

‘The in-depth knowledge of the business is a major strength. The lawyers also are very skilled at communicating with senior leadership (e.g., CEOs) and addressing the key topics for the company.’

‘Saul Perloff knows the business and the law. He hones in on the key issues and risks of a dispute and provides clarity to the business. The life sciences industry is quite complex and constantly changing. Saul and his team stay current and also anticipate upcoming changes.’

Key clients

Bausch Health Companies, Inc.

Valeant Pharmaceuticals North America LLC (now known as Bausch Health US, LLC) and Valeant Pharmaceuticals International (now known as Bausch Health Americas, Inc.)

Oceanside Pharmaceuticals, Inc. (subsidiary of Bausch Health Companies, Inc.)

Mission Pharmacal

Gilead Sciences

Boehringer Ingelheim

Abbott Laboratories

Standard Homeopathic Company

Hyland’s Inc.

Provepharm, Inc.

Alfasigma USA, Inc.

Arbor Pharmaceuticals

QuVa Pharma, Inc.

Pharmaceuticals Strategies Group

Loopback Analytics

Sani-Tech West, Inc.

Work highlights

  • Defending Bausch + Lomb Incorporated (a subsidiary of Bausch Health) in In re: Disposable Contact Lens Antitrust Litigation, an antitrust conspiracy case in which the plaintiffs allege that the major manufacturers of disposable contact lenses engaged in a horizontal price fixing conspiracy and a vertical price fixing conspiracy in violation of US and state antitrust laws.
  • Representing Bausch Health in what has been described as the largest antitrust conspiracy ever in the United States in In re: Generic Pharmaceuticals Pricing Antitrust Litigation, in which plaintiffs allege horizontal price fixing, market allocation and bid rigging among and between manufacturers and sellers of generic pharmaceuticals in putative antitrust class actions that have been consolidated in multi-district litigation.
  • Advised Pharmaceutical Strategies Group (PSG), the largest independent pharmacy benefit consulting firm in the US, on its sale of PSG’s 340B Link business to Omnicell, Inc., a leading provider of medication management solutions and adherence tools for health systems and pharmacies.

O'Melveny & Myers LLP

O'Melveny & Myers LLP's life sciences department has strong ties to pharmaceutical, medical devices and diagnostics companies, and also maintains a strong portfolio of venture capital firms. IP litigation and class actions are a key area of focus; contacts in this regard include Lisa Pensabene in New York and Richard Goetz in Los Angeles, who specialize in business-critical patent litigation in the pharmaceutical and chemical industries and mass torts, respectively. On the transactional side, San Francisco-based Scott Elliott advises on a range of corporate issues, from incorporation to venture funding, to eventual sale or IPO. Also recommended is patent and med-tech litigator Hassen Sayeed, who has experience in cases arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.

Practice head(s):

Lisa Pensabene; Ross Galin; Scott Elliott

Other key lawyers:

Hassen Sayeed

Key clients

Amgen, Inc.

AstraZeneca

AbbVie

Endo Pharmaceuticals

JHL Biotech Inc.

Johnson & Johnson

Novartis Pharmaceuticals Corporation

Progenics Pharmaceuticals, Inc.

Samsung Bioepis

ViiV Healthcare

Work highlights

  • Nationwide coordinating counsel and lead trial counsel for Johnson & Johnson and Janssen Pharmaceuticals, Inc. in confronting claims seeking to hold them liable for the country’s opioid-abuse epidemic.
  • Represented Onyx Therapeutics, Inc. (an Amgen Inc. company) in Hatch-Waxman litigation enforcing patents relating to multiple myeloma drug Kyprolis®.
  • Advised Progenics, an oncology company focused on fighting cancer, on its definitive merger agreement with Lantheus Holdings, Inc. in an all-stock transaction.

Proskauer Rose LLP

Proskauer Rose LLP counsels mature pharmaceutical and biotech companies, early-stage medical technology developers, investors and research institutions on corporate and commercial activities, FDA regulations and patent litigation. It also demonstrates expertise in areas including immunology, oncology and neurology, and a strong background acting in cases concerning biosimilars and post-grant challenges. Siegmund Gutman in Los Angeles assists biologics, pharmaceutical, biotechnology and medical device clients in developing and executing market exclusivity, including patent office and FDA regulatory strategies. Gutman also has experience in biologic drug patent and Hatch-Waxman cases. In Boston, Steven Bauer and Fangli Chen focus on patent infringement and patent portfolio developments. Robert Cantone in New York leads on transactional matters.

Practice head(s):

Siegmund Gutman; Fangli Chen

Other key lawyers:

Steve Bauer; Robert Cantone

Key clients

Amgen

Johnson & Johnson

Bayer/Monsanto

Absorption Pharmaceuticals

Gilead Sciences

Akebia

Shire/Takeda

Kiniksa Pharmaceuticals

Translate Bio

Various Life Sciences Companies (Fangli Chen)

Zion Pharma

BeiGene Ltd.

Work highlights

  • Representing Amgen, in a high-profile patent matter brought under the Biologics Price Competition and Innovation Act (BPCIA) concerning Amgen’s development and commercialization of a biosimilar to Genentech’s Avastin, a monoclonal antibody cancer therapy.
  • Acting for Shire, a global specialty biopharmaceutical company, in developing patent portfolios that provide protection for more than 20 programs and products including their biggest lead biologic products, Elaprase and Cinryze.
  • Representing Sanofi Pasteur before the Patent Trial and Appeal Board in challenging the patentability of a patent owned by Pfizer through inter partes (IPR) review.

Sidley Austin LLP

Sidley Austin LLP is recognized in this space for its strengths in regulatory, litigation and transactional matters. Coleen Klasmeier in Washington DC has served as regulatory counsel to a wide range of life sciences companies in regulatory and congressional investigations, as well as in civil litigation and appeals. Asher Rubin and Adriana Tibbitts joined from Hogan Lovells US LLP in January 2021.

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden, Arps, Slate, Meagher & Flom LLP combines strong transactional capabilities with broad regulatory, compliance and litigation experience, representing domestic and international pharmaceutical companies and  financial institutions in M&A and financing deals and bet-the-company IP litigation. Key figures for transactional mandates are Graham Robinson in Boston and Paul Schnell in New York, while names to note for litigation are Washington DC-based John Beisner and Jessica Miller, who stands out in product liability cases.

Practice head(s):

Graham Robinson; Paul Schnell

Other key lawyers:

John Beisner; Jessica Miller

WilmerHale

The Boston-based life sciences practice at WilmerHale has notable strengths in the corporate transactions space, advising on private financings, IPOs and M&A deals on behalf of biotechnology, pharmaceutical, diagnostic and medical device companies. Steven Barrett and Stuart Falber have over thirty years' combined experienced representing start-ups and leading biotech companies and investors in a myriad of M&A, financings and licensing deals with academic institutions and pharmaceutical companies. Patent litigation is another core area of activity. Contacts in this space include Robert Gunther and Lisa Pirozzolo, who are representing Genentech in a biosimilar patent litigation and related IPR matters involving its drug Herceptin, which has been approved to treat certain types of breast and gastric cancer.

Practice head(s):

Stuart Falber; Lisa Pirozzolo

Other key lawyers:

Steven Barrett; Robert Gunther

Testimonials

‘Broad scope of subject matter expertise and experience, coupled with outstanding litigators and strategists.’

‘The people I work with strive to understand our business, including our needs and goals beyond the litigation or project at hand. They then look to take a holistic approach to the relationship.’

Key clients

Akebia Therapeutics

Apellis Pharmaceuticals

Astellas US

Biogen

Bristol-Myers Squibb Company

CSL Behring

Cue Health

Danaher Corporation

Disarm Therapeutics

Editas Medicine

Emergent BioSolutions

Genentech

Gilead Sciences

GlaxoSmithKline

Medtronic

Moderna

Repare Therapeutics

Roche Molecular Systems

Sloan Kettering Institute for Cancer Research

Thermo Fisher Scientific

Work highlights

  • Represented Repare Therapeutics Inc., a precision oncology company., in its global research collaboration agreement valued at up to $3bn with Bristol Myers Squibb.
  • Represented Potenza Therapeutics, Inc., a preclinical-stage biotechnology company focused on building a portfolio of oncology programs, in its acquisition by Astellas Pharma Inc., a Japanese global pharmaceutical research and development company.
  • Represented Voyager Therapeutics, Inc. in a strategic collaboration with Neurocrine Biosciences, Inc. focused on the development and commercialization of Voyager’s gene therapy programs for Parkinson’s disease and Friedreich’s ataxia.

Baker Botts L.L.P.

Supported by the firm's nationwide corporate group, the team at Baker Botts L.L.P. is recognized in particular for its handling of the IP aspects of life sciences, advising on commercialization through to patent enforcement. New York-based practice head Steve Lendaris' practice encompasses a broad range of biotechnology-related issues, with recent highlights including matters relating to therapeutic antibody development and manufacturing to novel strategies for nucleic acid sequencing. In Austin, Stephen Hash and Margaret Sampson specialize in patent litigation, commercialization and licensing. Stephen Weissman and Michael Perry in Washington DC are the main attorneys for antitrust and regulatory work.

Practice head(s):

Steve Lendaris

Other key lawyers:

Stephen Hash; Margaret Sampson; Stephen Weissman; Michael Perry

Key clients

Oxford Nanopore Technologies

Genentech

Editas Medicine

PACT Pharma

Natera

Horizon Pharma and Nuvo Pharmaceuticals

Assertio

Grail

Work highlights

  • Won a landmark patent jury trial for Oxford Nanopore, the developer of a revolutionary sequencing platform that is a fundamental change in the way DNA is sequenced.
  • Assisting Editas Medicine with its ground-breaking developments in the gene editing field into patent applications as well as directing the prosecution of those applications domestically and abroad.
  • Advise GRAIL, a start-up focused on developing a blood test to detect cancer early before symptoms appear, on corporate, privacy, real estate and IP matters.

Duane Morris LLP

Duane Morris LLP is recommended for its expertise in M&A, patents, and commercial licensing and collaboration agreements, acting for domestic companies in addition to a strong roster of clients in the Asia-Pacific region. Leaders in the litigation team include patents specialist Vicki Norton in San Diego, who handles patent counseling involving diagnostics, biopharmaceuticals and nanotechnology; and Dana Ash in Philadelphia, who is experienced in defending clients in product liability claims in medical devices and biologics segments. Patrick Gallagher co-chairs the group from Boca Raton, and specializes in IP and regulatory issues. He is joined by Boston-based Jonathan Lourie and Frederick Ball, both of whom handle corporate transactions and commercialization deals.

Practice head(s):

Patrick Gallagher; Vicki Norton; Dana Ash; Jonathan Lourie; Frederick Ball; Driscoll Ugarte; Shannon Hampton Sutherland

Testimonials

‘They understand client’s needs and work very closely to address those. Team has subject knowledge and applies it effectively in strategizing pre-litigation and litigation matters.’

‘They suggest different strategies and ideas for defenses. Also, innovative ways for settlement terms. Billing is also great and adjusts according to client’s needs.’

‘Rick Ball is the individual who stands out. He gels with client’s team very well, understands their needs, flexible, innovative, strategizes properly.’

Key clients

Allele Biotechnology

Altimmune, Inc.

Immunome, Inc.

TheraCour Pharma, Inc.

Aurigene Discovery Technologies Limited

Soligenix, Inc.

PeriphaGen, Inc.

B. Riley FBR, Inc.

Work highlights

  • Represented B. Riley FBR, Inc., as sales agent in a $4.6m at the market equity offering of common stock for Hepion Pharmaceuticals, Inc, a developer of targeted therapies for liver disease arising from chronic hepatitis, non-alcoholic steatohepatitis, fibrosis, and liver cancer.
  • Represented Soligenix, Inc.  in an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu.
  • Represented Immunome, Inc., a biotechnology company developing first-in-class antibodies as cancer therapeutics by harnessing the human immune response, in a Collaboration and License Agreement with pH Pharma Co. Ltd., a clinical-stage biopharmaceutical company advancing a diverse pipeline which includes therapeutic candidates for oncology, ophthalmology and NASH.

Fenwick & West LLP

Fenwick & West LLP leverages a strong nationwide multi-disciplinary team led by Melanie Mayer (Seattle), Stefano Quintini (Mountain View) and Matthew Rossiter (San Francisco), who together have a wealth of experience assisting early- and late-stage companies in patent infringement suits, and commercialization through licensing, joint ventures and collaboration agreements. San Francisco-based Jake Handy, Effie Toshav and Robert Freedman act for life sciences clients in the full spectrum of transactional and capital market issues. In New York, James Trainor, Jeffrey Oelke and Robert Counihan are recommended for patent and commercial litigation.

Practice head(s):

Melanie Mayer; Matthew Rossiter; Stefano Quintini

Other key lawyers:

Jake Handy; Robert Freedman; Effie Toshav; James Trainor; Jeffrey Oelke

Key clients

Arcutis Biotherapeutics

Audentes Therapeutics

BioAge Labs, Inc.

Corvidia Therapeutics

Graybug Vision

Passage Bio, Inc.

Seattle Genetics, Inc.

Second Genome

Work highlights

  • Advised Audentes Therapeutics, Inc., an AAV-based (adeno-associated virus) genetic medicines company, on its acquisition by Astellas Pharma Inc., a Japanese multinational pharma company.
  • Advised Second Genome, a biotechnology start-up providing microbial profiling services designed to improved health, in an innovative strategic collaboration with Gilead Sciences.
  • Representing Novo Nordisk Healthcare AG before the USPTO in an IPR in which a petitioner challenged Novo Nordisk’s patent concerning a virus filtration process used for the company’s hemophilia Factor VIIa drug.

Gibson, Dunn & Crutcher LLP

Gibson, Dunn & Crutcher LLP represents biotechnology, pharmaceutical and medical device companies in patent and product liability litigation, FDA investigations and enforcement actions, as well as in corporate transactions and financings. It also has experience advising diagnostic companies, healthcare IT and start-ups, academic medical centers and private equity firms on commercial transactional and investments into the research and development of life science products and therapies. The practice is co-chaired by IP litigator Jane Love in New York and Ryan Murr in San Francisco.

Practice head(s):

Jane Love; Ryan Murr

Jones Day

Jones Day acts for a varied portfolio of clients ranging from multinational and start-up pharmaceuticals, biotech, medical device companies, hospitals and research institutions to venture and private equity funds. San Francisco-based James Dutro is recognized for his work in structuring and implementing complex hospital and health system affiliations, joint ventures, and joint operating arrangements. Kenneth Field in Washington DC advises on all aspects of antitrust law in the sector, and regularly appears before regulatory and enforcement bodies including the DOJ, FTC, and various state antitrust enforcement authorities. In Cleveland, Stephen Sozio represents clients in litigation and government investigations.

Practice head(s):

James Dutro

Other key lawyers:

Kenneth Field; Stephen Sozio

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. has steadily grown the breadth of transactional and life science capabilities with the addition of several specialists in IP prosecution, private equity transactions and regulatory work. Jonathan Kravetz and William Whelan in Boston represent biotechnology, medical technologies and healthcare IT companies in M&A, venture capital and capital market transactions. In the same office, Lewis Geffen advises on capital raising, technology licensing and strategic alliances. Others to note are Christopher Jeffers and Joanne Hawana in Washington DC, who specialize in life sciences transactions and complex IP matters, and FDA regulations.

Practice head(s):

Jonathan Kravetz; William Whelan; Lewis Geffen

Other key lawyers:

Joanne Hawana

Key clients

QIAGEN N.V.

10X Genomics

Roche

Pieris Pharmaceuticals

Albireo Pharmaceuticals

Johnson & Johnson

Nucana plc

Genentech

BeiGene Ltd.

Molecular Templates

University of California (8 campuses)

Evofem Biosciences, Inc.

DermTech, Inc.

Dare Biosciences

Quanterix Corporation

Fulgent Genetics, Inc.

Exagen, Inc.

Biogen Inc.

Inhibrx, Inc.

Work highlights

  • Represented Inhibrx, Inc. in its $136.9m initial public offering underwritten by Jefferies LLC, Credit Suisse Securities and Evercore Group.
  • Represented QIAGEN N.V., a Germany-based provider of life science and molecular diagnostic solutions, in its $248m cross-border acquisition of NeuMoDx Molecular, Inc., a US-based company that designs and develops molecular diagnostic solutions for hospital and clinical reference laboratories.
  • Represented Spero Therapeutics in its collaboration with the Bill & Melinda Gates Medical Research Institute to develop Spero’s orally administered SPR720 for the treatment of tuberculosis.

Orrick, Herrington & Sutcliffe LLP

Focusing on the areas of biopharmaceuticals, healthcare technology and medical devices, Orrick, Herrington & Sutcliffe LLP is well known for its track-record as appellate counsel in mass tort and product liability litigation. The practice continues to expand its Boston-based healthcare venture capital and life sciences start-ups practice, bolstered by the recent addition of Albert Vanderlaan and New York-based Stephen Thau, who joined from Gunderson Dettmer LLP and Morrison & Foerster LLP, respectively. In Silicon Valley, Scott Iyama advises on the full life cycle of high-growth life sciences companies, assisted by Peter Lamb and senior associate Vinella Sido.

Practice head(s):

Scott Iyama

Other key lawyers:

Stephen Thau; Albert Vanderlaan; Peter Lamb; Vinella Sido

Key clients

Johnson & Johnson

Gilead Sciences, Inc.

Zimmer Biomet Holdings, Inc.

Alcon Laboratories, Inc.

Twist Biosciences Corporation

Virta Health

DURECT Corporation

Vanda Pharmaceuticals Inc.

Clover Health

Ossium Health

Varian Medical Systems, Inc.

Bayer AG

10x Genomics, Inc.

Genentech, Inc.

Catalyst Biosciences

Cambridge Antibody

Neuspera Medical

Akina Pharmaceuticals

Partner Therapeutics, Inc.

BioGen

SOC Telemed

Work highlights

  • Representing Johnson & Johnson as national trial, appellate and coordinating counsel in its massive docket of talc litigation nationwide.
  • Advised Sight Sciences, Inc., a California-based company that developed ophthalmic medical devices designed for treatment of eye disease, on its $30.8m Series D financing.
  • Advising Vanda Pharmaceuticals Inc, a biopharmaceutical company engaged in the development and commercialization of therapies, in general corporate, corporate governance, financing, technology transactions and M&A matters.

Paul, Weiss, Rifkind, Wharton & Garrison LLP

Paul, Weiss, Rifkind, Wharton & Garrison LLP is recognized for its involvement in landmark patent litigation in the biopharmaceuticals industry, highlighted by Washington DC litigators Nicholas Groombridge and Catherine Nyarady representing Amgen and others in multiple precedent-setting litigations concerning biosimilar products. In another standout case, Kenneth Gallo, a leading patent litigator with particular experience in oncology therapy, has recently defended Genentech in a infringement lawsuit in the District of Delaware brought by Baxalta concerning its potentially life-changing hemophilia treatment HEMLIBRA® (emicizumab). Also recommended is counsel Eric Alan Stone, who is sought out by innovators in the biotechnology, pharmaceutical and medical device areas.

Practice head(s):

Kenneth Gallo; Nicholas Groombridge

Other key lawyers:

Catherine Nyarady; Eric Alan Stone

Key clients

10x Genomics

Amgen Inc.

Becton, Dickinson & Co.

Genentech

Cabaret Biotech, Ltd.

Channel Medsystems

Johnson & Johnson

Chugai Pharmaceutical

Work highlights

  • Represented Becton, Dickinson and Company (BD), sucessfully dismissing an antitrust class action  alleging that BD conspired with distributors and group purchasing organizations (GPOs) in violation of Section 1 of the Sherman Act to force healthcare providers into long‐term exclusionary contracts in order to restrain trade, inflate the prices, and maintain market power in the markets for syringes and I.V. catheters.
  • Representing Cabaret in an action centered around the validity of its patent on a path-breaking cancer therapy called CAR-T.
  • Lead M&A and antitrust counsel to Elanco Animal Health Incorporated, an Indiana-based animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets, in its $7.6bn acquisition of the animal health business of Bayer AG.

Reed Smith LLP

Reed Smith LLP's life sciences practice acts for a range of investment firms, healthcare innovators and the largest international pharmaceutical and medical device companies in global commercial agreements and corporate transactions, FDA regulations and IP litigation. Leveraging a sizeable team of attorneys with specialized chemical and engineering backgrounds, it is noted for its depth of experience assisting early biosimilars entrants with their development. Diane Frenier and Betty Yan, both in Princeton, and Michael Sanders in Century City are the key figures in the transactional team.

Practice head(s):

Diane Frenier

Other key lawyers:

Betty Yan; Michael Sanders

Testimonials

‘Michael Sanders and Deborah Gunny, are very experienced and offer wonderful service. They are unique in bringing senior talent to an engagement without loading a matter with young associates who lack their experience base. Although the senior rates are higher than for associates, the time spent on a matter usually is significantly less. I have found this to be very cost effective.’

‘Michael Sanders understands that the attorney’s job is to get the deal done, rather than to find reasons to not get the deal done. Deep understanding of the key legal issues my start-ups face, but also more than willing to bring in experts from Reed Smith (and other firms) in specific fields as the situation may dictate.’

Winston & Strawn LLP

Winston & Strawn LLP's life science practice is co-chaired from Chicago by David Dahlquist and Ari Markenson, supported by a strong and growing team of litigators and pharmaceutical industry specialists based in Washington DC. The team has bolstered its offering with the recruitment in March 2020 of Winston Kirton, who has previous experience working in-house at Bristol-Myers Squibb. Further additions to the team include, litigator Amandeep Sidhu and Reed Stephens, an authority in the pharmaceutical fraud and abuse and corporate compliance space. Sidhu and Stephens joined McDermott Will & Emery LLP in March 2020. Patent litigation, product liability and mass tort cases are core areas of activity, led by Charles Klein in Washington DC, as well as by Chicago-based Matthew Campbell, Christopher Essig and Scott Ahmad.

Practice head(s):

David Dahlquist; Ari Markenson

Other key lawyers:

Winston Kirton; Amandeep Sidhu; Reed Stephens; Charles Klein; Matthew Campbell; Christopher Essig; Scott Ahmad

Testimonials

‘They understand client’s needs and work very closely to address those. Team has subject knowledge and applies it effectively in strategizing pre-litigation and litigation matters.’

‘They suggest different strategies and ideas for defenses. Also, innovative ways for settlement terms. Billing is also great and adjusts according to client’s needs.’

Key clients

Hikma Pharmaceuticals

Monsanto (now Bayer)

Otsuka America Pharmaceuticals

Fresenius Kabi

Abbott Laboratories

Associated British Foods

Sun Pharmaceuticals

Work highlights

  • Obtained a significant appellate victory for Hikma Pharmaceuticals when the Federal Circuit affirmed a lower court’s ruling invalidating six patents for Amarin’s $1bn-per year drug Vascepa.
  • Represented Monsanto Company in the first Roundup® product liability jury trial in the country defending against allegations that the herbicide causes non-Hodgkins lymphoma.
  • Lead national counsel to Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Co. Ltd in a multi-district litigation in the Northern District of Florida and various state court actions, involving allegations by more than 4,000 plaintiffs that Abilify®, an atypical antipsychotic medication, causes impulse-control disorders.