Healthcare: life sciences in United States
Co-chaired by Daniel Kracov and Allison Shuren, Arnold & Porter's practice assists life sciences clients with regulatory, antitrust, white collar, IP, product liability and transactional matters. Highlights include acting for Monsanto in the client’s $66bn acquisition by Bayer and assisting Danish multinational company Novo Nordisk with regulatory matters, including a developing stem cell initiative. Pfizer and Novartis are long-standing clients. The team also includes Jeffrey Handwerker, who is well versed in pharmaceutical pricing and investigations, government contracts and commercial litigation; litigator Steven Benz; Mahnu Davar, who assists FDA-regulated entities with regulatory and compliance matters; Ariane Horn, who specializes in fraud and abuse compliance and FDA regulation of pharmaceuticals and biological products; and associate Abeba Habtemariam, who provides compliance counseling to pharmaceutical and medical device manufacturers. In March 2018, Senator Christopher Dodd joined the practice as senior counsel. All named individuals are based in Washington DC.
Hogan Lovells US LLP covers the full gamut of life sciences-related work, including regulatory, commercial, IP and patent litigation, product liability, corporate and M&A, and compliance and investigations. The practice also has ‘unprecedented experience’ in a number of crucial issues for the industry, such as cell and gene therapies, pricing and reimbursement, digital health, AI, cybersecurity and biosimilars. Global chair Asher Rubin, who splits his time between Baltimore and Boston, assisted molecular diagnostic company Exact Sciences with its collaboration agreement with Pfizer to co-promote Cologaurd, a DNA screening test for early detection of colorectal cancer. Corporate expert Adam Golden from the New York office led a global team of life sciences transactions lawyers to advise London-listed rare diseases specialist Shire on closing all ex-US aspects of its global stock and asset sale of their oncology business to France-based Servier. Other key contacts are David Fox in Washington DC, who specializes in regulatory matters before the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA); medical technology expert Janice Hogan from the Philadelphia office; Baltimore-based counsel Adriana Tibbitts ; pharma and biotech practice head Philip Katz, Susan Lee and counsel Anishiya Abrol, who are all based in Washington DC. Stephen Loney Jr and Allison Pugsley were promoted to partner in Philadelphia and Washington DC respectively.
The ‘highly pragmatic and commercial’ firm King & Spalding LLP is particularly praised by clients for its ‘strong IP expertise’ and its ‘keen understanding of how FDA works’. The life sciences practice is co-headed by Nikki Reeves, Mark Brown and Seth Lundy. Reeves and Atlanta’s Andy Bayman successfully defended Vertical Pharmaceuticals and BioDelivery Sciences International (BDSI) in a lawsuit filed by the State of Arkansas and various Arkansas counties and cities, which aimed at recouping the public health costs associated with the abuse of opioid analgesics allegedly marketed and distributed by the clients in the State. Other clients include Medtronic and Boehringer. With her ‘unending enthusiasm to take on clients’ causes as her own’, former FDA’s Lisa Dwyer ‘stands above the crowd’. David Farber, who ‘comes to the table with years of developed wisdom in the pharma space’, Preeya Noronha Pinto and Jessica Ringel are also recommended. The ‘unique team’ of patent litigators Gerald Flattmann, Evan Diamond and Vanessa Yen joined the New York office from Paul Hastings LLP in July 2018. Stephen Abreu left to Sidley Austin LLP. Names of individuals are based in Washington DC unless otherwise indicated.
Considered by clients as ‘superior’, Latham & Watkins LLP's life sciences practice stands out for its ‘expertise, breadth of capabilities, diligence and customer focus’. Washington DC’s regulatory expert John Manthei acted for pharmaceutical manufacturer Alvogen, obtaining a temporary restraining order preventing the State of Nevada from using medication distributed by the client in an execution. Manthei and Ben Haas (who is also based in Washington DC) assisted Endo and its subsidiary Par Sterile Products with a challenge to FDA’s implementation of the 2013 Drug Quality and Security Act (DQSA) in relation to the regulation of pharmaceutical compounding by outsourcing facilities. Silicon Valley’s Alan Mendelson represents emerging and public growth life sciences companies in a number of business transactions, including M&A, private placements and public offerings. The ‘fully engaged and very accessible’ Nathan Ajiashvili, who is based in New York and specializes in capital markets, and Washington DC’s associate Eitan Bernstein are also recommended.
Morgan, Lewis & Bockius LLP has a ‘smart, focused, and dedicated’ team, which offers ‘invaluable’ help to life sciences clients in regulatory, corporate and M&A, IP, antitrust, tax and labour matters, and in litigation. Randall Sunberg (Princeton), Kathleen Sanzo (Washington DC), Jeffry Mann (San Francisco and Singapore) and Michael Abernathy (Chicago) jointly head the practice. Highlights include advising AstraZeneca in the co-development agreement between its subsidiary Pearl Therapeutics and Avillion, which envisages the advancement of Pearl Therapeutics' product PT027 through a global clinical development program for the treatment of asthma. Merck and 23andMe are other key clients. FDA specialist Michele Buenafe, from the Washington DC office, is ‘a true partner in every sense of the word’. Alan Leeds and Oren Livne in Princeton and the ‘very knowledgeable’ Benjamin Pensak in San Francisco are also recommended. Corporate expert Eric Hwang joined the Silicon Valley and San Francisco offices from WilmerHale, while a team of nine patent prosecution and litigation partners joined the Orange County office from McDermott Will & Emery LLP.
Ropes & Gray LLP handles transactional, regulatory and IP work, assisting biotechnology, pharmaceutical and medical device clients, as well as financial institutions investing in the industry. The practice is co-chaired by Boston’s Michael Beauvais and Washington DC’s Gregory Levine, who specialize in transactional and regulatory matters respectively. Levine has been acting for generic pharmaceuticals manufacturer Akorn in relation to alleged breaches of FDA data integrity requirements that led to the purported termination by German health care company Fresenius Kabi of a $4.3bn merger with the client in April 2018. Boston-based Marc Rubenstein advised Chinese biopharmaceutical company Zai Lab on several US business development transactions. The team was reinforced by the arrivals of FDA’s Beth Weinman, who is now counsel in Washington DC, and IP litigators Charlotte Jacobsen and Filko Prugo, who joined the New York office from Fitzpatrick, Cella, Harper & Scinto and O'Melveny & Myers LLP respectively.
The ‘great team’ at Cooley LLP is well known for IP and patent work, while also specializing in partnering and licensing transactions, venture financings, capital markets, M&A and regulatory support. Barbara Kosacz, who heads the practice from the Palo Alto office, assisted personal genomics and biotechnology company 23andMe with its long-standing collaboration with GlaxoSmithKline (GSK), particularly in relation to the development of innovative new medicines and potential cures based on human genetics and the $300m equity investment by GSK. The ‘top patent practitioner’ Ivor Elfiri, who is based in New York, advised Avexis on the in-license and filing of critical patents related to the client’s platform technology for gene therapy for the treatment of spinal muscular atrophy (SMA) in infants. The client base also includes the University of Colorado and Exosome Diagnostics. Palo Alto’s Mark Weeks, who has expertise representing emerging and public growth companies, is another name to note.
The ‘highly creative’ practice at Dechert LLP is co-headed by Andrea L C Reid in Boston and David S Rosenthal in New York, who focus on IP and corporate work respectively. Reid advised clinical-stage biopharmaceutical company PureTech Health on IP-related aspects of its deal with Hoffman-La Roche to advance its milk-derived exosome platform technology for the oral administration of Roche’s antisense oligonucleotide platform. Rosenthal has assisted Egalet with an asset purchase agreement to acquire four FDA-approved, non-narcotic pain products from Iroko. Product liability litigators Sheila Birnbaum and Mark Cheffo, who joined the New York office from Quinn Emanuel Urquhart & Sullivan, LLP in July 2018, have been acting for Purdue in over 1,400 cases related to its prescription opioid pain medications. Patent specialist Chad Davis from Goodwin is another recent arrival in Boston. The ‘incredible’ Carl Morales in New York, who is experienced in developing and prosecuting patent portfolios for FDA-approved or soon-to-be approved drug products, is also recommended.
Co-heads of DLA Piper LLP (US)'s practice, San Diego-based Lisa Haile and Matthew Holian in Boston, specialize in patentability and licensing strategies, and product liability and mass tort, respectively. Recent highlights include obtaining issuance of multiple patents for Aegis Therapeutics’ key product areas and assisting Pfizer and Bristol-Myers Squibb (BMS) with multidistrict and state court litigation concerning alleged defects of the clients’ blockbuster anticoagulant medication Eliquis. New York-based litigator Loren Brown has been acting for Medtronic and Covidien in product liability litigation related to complications allegedly caused by some of Covidien’s implantable hernia mesh products. San Diego’s Larry Nishnick and Austin’s Aaron Fountain are names to note for corporate investment and patent litigation respectively.
Goodwin 's Boston-based practice co-head Mitchell Bloom, who specializes in venture capital firms and investment banks focused on life sciences, recently assisted Ablynx with its €3.9bn agreement to be acquired by Sanofi, and advised California-based biopharmaceutical company Eidos on its $106m initial public offering. Co-head Kingsley Taft (also based in Boston) advised long-standing client Moderna on a $500m equity financing round. Surface Oncology and Zagfen are other notable clients. New-York-based Elizabeth Holland is well versed in Hatch-Waxman litigation, while Washington DC’s Julie Tibbets, who joined from Alston & Bird LLP in February 2018, focuses on FDA regulatory work. Other key arrivals in 2018 include New York-based Jonathan Schur and Kristopher Brown from Dechert LLP, San Francisco’s IP litigator Darryl Woo from Vinson & Elkins LLP and Silicon Valley’s Shane Albright from DLA Piper LLP (US). Boston’s Chad Davis moved to Dechert LLP.
Jones Day assists pharmaceutical, medical device and biotechnology clients with regulatory, transactional and contentious matters. The team's expertise spans from antitrust, business and tort litigation to labor and employment, IP and healthcare matters, and M&A and tax issues. Maureen Bennett, who splits her time between Boston and San Francisco, co-heads the practice with Stephen Sozio in Cleveland. Highlights included assisting Celgene with IP and technology transaction aspects of its cash-and-stock merger with Bristol-Myers Squibb, and advising Incyte Pharmaceuticals on its strategic collaboration and license agreement with Innovent Biologics for the regulatory development and commercialization of three clinical stage pharmaceutical products for treatment of hematological and oncological diseases in China. Other names to note are global IP practice chair Anthony Insogna in San Diego, Jonn Beeson in Irvine for M&A deals, and commercial litigator Tina Tabacchi from the Chicago office.
Mayer Brown’s ‘service level and attention is extremely high’. The practice is jointly led by New York-based corporate lawyer Reb Wheeler, whose team has ‘the full range of skills for the sector’, and IP specialists James Ferguson and Joseph Mahoney in the Chicago office. Highlights include assisting the manufacturer of opioid overdose treatment Narcan Adapt Pharma with its sale to Emergent BioSolutions. Gilead and Medtronic are also clients. Patent litigator Lisa Ferri in New York is another key contact.
McDermott Will & Emery LLP's patent litigators William (Bill) Gaede in Silicon Valley and Sarah Columbia in Boston have been acting for Amgen in a patent lawsuit brought by the client against Sanofi and Regeneron and alleging the defendants’ patent infringement of Amgen’s patents to antibody therapies designed to lower cholesterol. The client base also includes 23andMe and Allergan. Other key members of the team are Chicago-based Kristian Werling, who co-heads the practice with Boston’s Stephen Bernstein; Washington DC-based Paul Radensky, who specializes in regulatory and reimbursement matters; IP and commercial transactions expert Sarah Hogan in Boston; FDA regulatory practitioner Vernessa Pollard in Washington DC; and Roger Kuan from the San Francisco office, which was opened in March 2018.
Norton Rose Fulbright’s areas of strength in the life sciences industry include antitrust, IP, data privacy and cybersecurity matters as well as litigation. Global head of the life sciences and healthcare practice is Stacey A Martinez, who splits her time between Austin and Houston, while Debbi M Johnstone leads the US team from the Houston office. New York's antitrust specialist Robin Adelstein is well versed in class action litigation. Gina Shishima in Austin is recommended for her patent law expertise. Former practice co-head Frederik Robinson and Cori Annapolen Goldberg moved to Reed Smith LLP, while health technology transaction expert Andres Liivak left to White & Case LLP.
O'Melveny & Myers LLP’s practice co-head Lisa Pensabene in New York specializes in IP litigation and has been assisting Amgen’s company Onyx with filing lawsuits against 11 generic pharmaceutical companies which sought FDA approval to market generic versions of Onyx’s cancer drug Kyprolis prior to the expiration of the client’s nine patents. Other practice co-heads are corporate and transactional expert Scott Elliott in San Francisco, Ross Galin in New York, who focuses on white collar defense and government investigations, and product liability and mass torts litigator Richard Goetz from the Los Angeles office. Patent litigator Hassen Sayeed joined the New York team from Paul Hastings LLP, while IP and technology transactions specialist Geoff Kuziemko is a new arrival in the San Francisco office from Latham & Watkins LLP. Filko Prugo left to Ropes & Gray LLP.
The ‘experienced and very effective’ team at Paul Hastings LLP is headed by Bruce Wexler, who acted successfully for Boehringer Ingelheim in a multi-defendant litigation against six generic challengers to the client’s patents protecting blood-thinner Pradaxa. The practice is also assisting Johnson & Johnson’s company Actelion with a patent infringement suit against Sun Pharmaceuticals related to the client’s drug Veletri. Investigation and white collar crime expert Gary Giampetruzzi and the ‘excellent’ litigator Preston Ratliff are other names to note. Hassen Sayeed left to O'Melveny & Myers LLP. Named individuals are based in New York.
Proskauer Rose LLP specializes in patent litigation and corporate transactions, with a focus on the growing biosimilar industry. The practice is led by corporate lawyer Daryn Grossman in the New York office, who has advised Celgene on its acquisition of Juno Therapeutics. Los Angeles-based litigator Sige Gutman acted for Amgen in a patent matter under the Biologics Price Competition and Innovation Act (BPCIA) and concerning the client’s development and commercialization of a biosimilar to Genentech’s monoclonal antibody cancer therapy Avastin. Patent and IP transactional specialist Fangli Chen in Boston is another key contact.
Reed Smith LLP
Reed Smith LLP's Princeton-based co-head Diane Frenier and Betty Yan focus on corporate transactions, such as advising a client on its acquisition of a basket of generic pharmaceutical assets from a company, and assisting a company with a partnership aimed at the commercialization of a biosimilar. IP, FDA regulatory work and litigation are other areas of strength. Melissa Geist in Princeton and Scot Hasselman in Washington DC are the other co-heads of the practice. Washington DC-based Frederik Robinson and Cori Annapolen Goldberg in New York joined the practice with 13 other practitioners from Norton Rose Fulbright US LLP.
Skadden, Arps, Slate, Meagher & Flom LLP
Skadden, Arps, Slate, Meagher & Flom LLP focuses on a wide range of life sciences-related matters, including M&A, corporate restructurings, financings, private equity, licensing transactions, product liability cases, IP, regulatory advice, investigations and enforcement, antitrust and securities litigation. The names to note are Washington-based enforcement expert John Bentivoglio and FDA regulatory specialist Jennifer Brag as well as litigators Maya Florence in Boston and Douglas Nemec, who is based in New York and is well versed in patent litigation under the Hatch-Waxman Act. The client base includes Allergan, Merck and Pfizer.
Weil, Gotshal & Manges LLP focuses on corporate matters and litigation with a ‘deep understanding of both the technology and the law’ and the ability to ‘plan appropriately and communicate effectively’. Practice co-head Elizabeth Weiswasser advised Sanofi on a bench trial in the client’s patent litigation infringement case against Merck, involving Sanofi’s insulin biologic blockbuster Lantus Solostar. Jeffrey Osterman, Michael Aiello and Jackie Cohen have been assisting Avista with its acquisition of regenerative medicine developer Organogenesis. Silicon Valley-based co-head Edward Reines and Derek Walter, who was made partner in 2018, are ‘the ultimate professionals’, and Michael Epstein is renowned for his technology and IP transaction expertise. Named individuals are based in New York unless otherwise indicated.
WilmerHale's life sciences practice is co-headed from Boston by Stuart Falber, who represents a variety of clients including start-up private companies, mature public companies, investment banks and venture capital fund, and Belinda Juran, who focuses on technology transactions. Corporate specialists Steven Barrett and Steven Singer (based in Boston and New York respectively) advised biotechnology company Vividion on its strategic research collaboration with Celgene, while Washington DC-based litigator Amy Wigmore has been acting for AbbVie in a number of disputes under the Biologics Price Competition and Innovation Act (BPCIA) related to the proposed sale of a biosimilar version of the client’s product Humira. Boston’s Lisa Pirozzolo and New York-based counsel Lily Wound are other names to note.
Debevoise & Plimpton LLP's practice is co-headed by corporate lawyer Andrew Bab and Kevin Rinker, litigators Maura Monaghan and Marc Goodman and FDA regulator Paul Rubin, who is based in Washington DC. The practice prepared a report on medical device cybersecurity in collaboration with the Medical Device Innovation Consortium (MDIC) Steering Committee, which included FDA officials and representatives from large medical device manufacturers. The client portfolio also includes GlaxoSmithKline and Merck. Antitrust litigator Ted Hassi joined from O'Melveny & Myers LLP in July 2018. Named individuals are based in New York unless otherwise indicated.
At Dentons, practice co-head Jeffrey Baumel, who splits his time between New York and Short Hills, is deeply experienced in securities law. Co-head Stephanie Seidman in San Diego specializes in the development and commercialization of patent portfolios for the biopharma industry, while co-head Gadi Weinreich is based in Washington DC and focuses on healthcare fraud and abuse as well as regulatory compliance. The client portfolio includes Adma Biologics, PharmAthene and HealthCare Ventures.
Foley & Lardner LLP
Foley & Lardner LLP's life sciences practice is jointly led by Monica Chmielewski in Chicago, Gabor Garai, who focuses on private equity and venture capital and splits his time between Boston and New York, San Diego’s corporate expert Richard Kaufman, IP specialist Antoinette Konski in Palo Alto and Washington DC-based David Rosen, who is well versed in health law and FDA regulatory issues. The client portfolio includes Indiana university Health, Arkansas Surgical Hospital and hospital equipment company BidMed.
Gibson, Dunn & Crutcher LLP
Gibson, Dunn & Crutcher LLP specializes in patent and product liability litigation, FDA regulatory compliance and enforcement, white collar defense and investigations, antitrust and trade regulation, M&A, capital markets and debt financing transactions as well as licensing, collaborations, joint ventures, and strategic alliances. Practice co-heads are Dallas’ Tracey Davies, who focuses on IP-related technology-based disputes, San Francisco’s corporate specialist Ryan Murr and New-York-based litigator Daniel Thomasch. Depomed, Sanofi and Allergan are key clients.
Kirkland & Ellis LLP's biotechnology, pharmaceutical and life sciences practice is co-led by Chicago-based James Hurst, who acted for AbbVie in a product liability case concerning the client’s alleged fraudulent misrepresentation of the risks of its blockbuster testosterone replacement drug AndroGel. Co-head Jay Lefkowitz in the New York office assisted Akorn in litigation brought by Fera alleging a number of breaches of the parties’ contract between the client and the plaintiff. Co-heads Patricia Carson and Leora Ben-Ami, who are based in New York and specialize in IP disputes, defended Merus in patent infringement litigation filed by Regeneron and concerning genetically engineered animals used in the production of human biopharmaceutical therapeutics. Chicago-based litigator Diana Watral is ‘brilliant, creative and tenacious’.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Jonathan Kravetz and William Whelan co-chair Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 's practice from the Boston office and focus on securities and capital markets, and M&A and venture capital financing respectively. Susan Berson, who is based in Washington DC and chairs the health law practice, has been assisting private equity firm TPG with healthcare regulatory due diligence and industry insight in relation to the client’s potential investments in the healthcare industry. CVS Health and US Family Health Plan are other key clients. Terri Shieh-Newton from the San Francisco office is another name to note for her expertise in patent strategy and comprehensive portfolio management in the life sciences and clean technology sectors.
Morrison & Foerster LLP’s team is made up of corporate, transactional, IP and litigation professionals. The names to note are San Diego-based senior counsel David Doyle, who focuses on patent litigation disputes for pharmaceutical, biotechnology, medical device and other technology companies; corporate and M&A specialist Spencer Klein in New York; and Palo Alto’s Janet Xiao, who advises clients on patent procurement, patent portfolio management and strategic planning. Abraxis BioScience, DaVita and Sandoz are recent clients. Bethany Hill joined the New York office from Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., in a move that strengthens the team's FDA regulatory capabilities.
Wilson Sonsini Goodrich & Rosati
Wilson Sonsini Goodrich & Rosati is well known for its expertise in assisting clients from the biotechnology sector and focuses on IP and patents, venture finance, collaborations, partnering agreements and joint ventures, regulatory and compliance advice, initial public offerings, M&A and litigation. The key contacts are corporate specialists Lowell Segal and Kenneth Clark in Palo Alto, patent expert Vern Norviel in the San Francisco office and San Diego-based Douglas Carsten, who is well versed in litigation.