Life Cycle

Arnold & Porter maintains a substantial presence in the life sciences industry, with a practice that encompasses all legal areas needed to support a product's life cycle. The firm ranks highest in pricing and reimbursement and antitrust litigation, but is also a significant player in patent litigation, patent strategy, M&A and FDA counseling. The firm offers roughly 200 attorneys dedicated to the industry area, nearly half of whom hold scientific degrees.

Life sciences practice co-chair Dan Kracov is routinely recognized as a top regulatory attorney, and is this year’s FDA Pharmaceutical Attorney of the Year for consistently strong work in the area. Fellow co-chair Allison Shuren is highly regarded for representing an array of life sciences firms against government investigations alleging violations of the False Claims Act, Anti-Kickback Statute, Stark Law, and other fraud-related actions. Pricing and reimbursement expert Jeff Handwerker was recently active for clients in price reporting matters, anti-kickback compliance and congressional inquiries. Partner Mahnu Davar joins the firm’s roster of regulatory stars this year for his active practice focused on FDA and compliance matters.

In IP, the firm drew significant awards attention for a string of noteworthy patent litigations in the life sciences arena, resulting in its recognition as the 2020 General Patent Litigation Firm of the Year. The group’s reputation is in part supported by IP group co-chair Matthew Wolf, who is one of the firm’s experienced first chair trial lawyers. Recent representations include Sanofi and Regeneron in a complete victory against Amgen related to antibodies. David Barr was also a lead partner on the matter. For patent strategy, David Marsh is recommended for his expertise managing life sciences patent portfolios.

The firm's high-caliber antitrust group includes partners Laura Shores and Saul Morgenstern, who were both active in a generic pharmaceutical antitrust litigation for Novartis subsidiaries Sandoz and Fougera. DC-based Kirk Ogrosky adds to Arnold & Porter’s government investigations offering. He is currently defending UCB in a qui tam matter involving the Anti-Kickback Statute and False Claims Act. For product liability matters, William Hoffman is labeled "one of the best practitioners in this field of law" by a peer. Hoffman was recently active for Pfizer in multiple cases, including litigation involving asbestos claims. Pamela Yates is "fantastic" and "very talented" to peers for her practice focused on class actions and product liability suits.

In the financial area, life sciences transactions co-head Derek Stoldt is active for AstraZeneca in securing global funding, development, and distribution of the potential Covid-19 vaccine by the University of Oxford. Fellow co-chair Lowell Dashefsky represents several high-profile life sciences clients in negotiating and structuring a wide range of transactions.  He and Aaron Gardner led the team advising Pfizer on its licensing agreement with Akcea Therapeutics as well as the company’s acquisition of Therachon Holding AG.

Covington & Burling offers a broad-based practice in the life sciences space, with a deep bench of attorneys who contribute to the firm's longstanding reputation in regulatory counseling, transactions, patent litigation and white-collar matters. LMG Life Sciences currently recognizes 16 individuals from the firm as stars across the four main practice areas.

For regulatory work, one peer notes Covington is the "firm to beat" in the pharmaceutical space. Active in this group is Michael Labson, who was shortlisted by LMG Life Sciences for the top attorney award in the FDA Pharmaceutical area. Pamela Forrest has over 20 years of experience handling FDA matters for medical device clients. She advises clients throughout the entire life cycle including pre-market notification and approval, product recalls, and device labeling and promotion. In the pricing space, Geoffrey Hobart is active in FDA investigations involving issues related to the False Claims Act, Anti-Kickback Act and Medicaid Rebate statute violations.

In IP, Covington offers deep expertise in general patent litigation and Hatch-Waxman disputes. George Pappas is a leading litigator in the life sciences sector, with deep experience in ANDA litigations. Notable representations include AstraZeneca, Bristol-Myers Squibb and Merck. Christopher Sipes also stands out as one of the firm’s go-to practitioners for high-stakes life sciences disputes, offering experience in patent-related trials and appeals.

For financial and corporate matters, a peer says the firm "has a strong subject matter expertise and is pragmatic in their approach." Catharine Dargan is a highly regarded life sciences practitioner and focuses her practice on advising both public and private companies in a variety of strategic transactions. Dargan was named this year’s LMG Life Sciences M&A Attorney of the Year. Life sciences group vice chair Emily Leonard is based in Redwood Shores and has particular expertise in the licensing and collaboration space. John Hurvitz is co-chair of the firm's life sciences industry group, as well as head of the technology transactions group.

The firm receives top ranking in government investigations and white-collar matters, and is also notable for its antitrust and product liability groups. Ethan Posner stands out as one of the firm's leading litigators in the white-collar space. Michael Imbroscio co-chairs the product liability practice. In the past, he has litigated on behalf of major pharmaceutical clients in products suits, including Bayer, Boehringer Ingelheim and Eli Lilly.

General practice firm Goodwin Procter offers a strong roster of attorneys servicing life sciences clients in all practice areas, but is most notable for being a powerhouse in IP and transactions. The firm receives top ranking in patent litigation, patent strategy, licensing, M&A, venture capital and general corporate work.

The firm was awarded Firm of the Year for Intellectual Property in 2020, due to its strong practices focused on patent litigation, prosecution and strategy. IP litigation chair Daryl Wiesen is a standout for disputes related to pharmaceuticals and biotechnology, and was recently active for Fresenius Kabi in a patent dispute opposite Sanofi related to the branded product Jevtana. Elaine Herrmann Blais took part in a significant Federal Circuit appeal for Dr Reddy’s involving the branded sublingual product Suboxone. She was awarded Patent Litigator of the Year in New England. For prosecution, Duncan Greenhalgh, Theresa Kavanuagh and Michael Shuster provide strategic portfolio advice to companies in novel technology areas.

In the financial area, Goodwin Procter was named 2020 Corporate Firm of the Year. The firm assisted several clients with their public offerings, including Argenx in a global offering valued at $862.5 million, and BridgeBio in the second largest biotech IPO of last year. Kingsley Taft co-chairs the firm's life sciences group, and regularly advises life sciences clients in a variety of business and financial affairs. Stuart Cable focuses on transactions and corporate financing, representing several high-profile clients. Maggie Wong advises a variety of innovative public and private life sciences clients in raising capital. She was involved in the noteworthy biotech IPO for BridgeBio.

Notable individuals in the litigation and enforcement area are Joanne Gray and William Harrington, both based in the firm's New York branch. Gray serves as chair of the firm's products liability and mass torts practice group. Harrington, whose practice focuses on government investigations and white-collar matters, has expertise in health care fraud, the Anti-Kickback Statute, False Claims Act and the Stark Act.

A leading practitioner in the regulatory group is Julie Tibbets, who specializes in product development, marketing and FDA issues that arise from transactions. In addition to pharmaceuticals, her technology expertise extends to biologics, medical devices, diagnostics, food, and other areas. Tibbets recently advised Protalix Biotherapeutics in FDA-related matters, and Henry Schein with respect to FDA and FTC matters.

Hogan Lovells is an international firm with a full-service practice in the life sciences area. The firm is notable for its all-encompassing regulatory practice, for which it receives top rankings across the board. The life sciences group also receives national ratings for its practices in general corporate, M&A, licensing and collaboration, venture capital, product liability and white-collar matters.

The firm's top-ranked regulatory practice includes "terrific" partner David Fox, who is highly regarded as an advisor to pharmaceutical companies in FDA clearance. For his stellar career and continued high-profile work in the area, Fox was inducted into the LMG Life Sciences Hall of Fame as part of the 2020 class. Medical device advisor Jonathan Kahan boasts more than 40 years of experience practicing law and is similarly recognized as one of a small group of practitioners in the Hall of Fame. He was recently active for Vayu Global Health Innovations in relation to an Emergency Use Authorization for its bubble CPAP device. In the pricing and reimbursement arena, Alice Valder Curran is widely considered one of the standouts in her field, often advising on matters related to the Medicaid Drug Rebate Program, the Medicare average sales price (ASP) reporting requirement, and the Health Resources and Services Administration (HRSA) drug pricing program. Another standout is Beth Roberts, who earned the 2020 Pricing & Reimbursement Attorney of the Year award for her involvement in a noteworthy National Coverage Determination involving CAR-T therapies.

A peer praises the firm for its "strong regulatory group supporting the transactional practices," and "excellent, deep knowledge of the life sciences industry" as it relates to corporate matters. Baltimore-based Asher Rubin is global head of the firm's life sciences group, who recently led the Hogan team representing NextCure, a biotechnology company focused on cancer and immune-related diseases, with its $86 million IPO as well as a development collaboration with Eli Lilly. Adam Golden is head of the corporate group in New York, and represents clients in several high-profile transactions as well as collaboration agreements. Philadelphia-based Steve Abrams represented Optinose, a pharmaceutical company focused on patients treated by ear, nose, and throat (ENT) specialists, with its public offering worth $39 million.

Jonathan Diesenhaus has extensive experience advising a number of life science clients involving criminal investigations and enforcement matters. Nationally renowned attorney Neal Katyal contributes to the firm’s deep appellate capabilities, often in the product liability space. Lauren Colton serves as head of the firm's products law practice group, offering expertise in mass torts and class actions facing life sciences companies.

Latham & Watkins is an international firm with a strong roster of litigators and counselors focused on the life sciences industry. The firm is deeply qualified in the financial space, evidenced by its top ranking in every practice area involving transactional and corporate work. Its litigation department also stands out for its offering in IP, antitrust and white-collar matters. For its wide-ranging activity in the industry, Latham & Watkins was awarded 2020 Life Cycle Firm of the Year by LMG Life Sciences, a recognition earned for the second year in a row.

Judith Hasko is vice chair of Latham's life sciences and healthcare group, and is widely recognized for her work in the licensing and collaboration space. She is a member of the LMG Life Sciences Hall of Fame for her status in the industry. Hasko’s recent representations include Oasmia Pharmaceuticals in its strategic partnership with Elevar Therapeutics, and Ridgeback Biotherapeutics in its collaboration with Merck. Co-chair of the firm’s life sciences and healthcare group is Brian Cuneo was named Venture Capital Attorney of the Year in 2020 for his notable activity in financings. He was recently active for Omniome in its $60 million Series C financing, and Insitro in its $143 million Series B. About Boston-based partner Peter Handrinos, a client says: “He's very good at clearly explaining complex things and reassuring non-lawyers that everything is okay. I like his team and trust the lawyers he chooses. He has a good feel for people.”

IP litigation co-chair Michael Morin receives acclaim from numerous peers in the space, supported by his continued work in high-profile matters related to biologics. He and partner David Frazier recently acted for client AbbVie and Pharmacyclics in two patent infringement suits against AstraZeneca related to its Imbruvica drug. Morin was the 2020 winner of the Patent Litigator of the Year award in DC. Maximilian Grant is a respected litigator who had a major part in the firm’s IP growth. He recently represented InfoBionic in two cases brought by competitor CardioNet. Kenneth Schuler and Daniel Brown acted for Par Pharmaceutical in a Hatch-Waxman dispute in the District of Delaware.

For non-IP litigation, the firm garnered significant awards attention in 2020 for its involvement in a noteworthy litigation involving an HHS rule. The matter, Merck & Co v United States Department of Health and Human Services, was one of the Non-IP Impact Cases of the Year, and involved one of the year’s litigation awardees Daniel Meron. Meron is healthcare and life sciences group co-chair, and a specialist in regulatory enforcement, investigations and other areas of litigation. Global antitrust chair Amanda Reeves and partner Daniel Wall were active for Genentech in an antitrust suit filed in the Southern District of New York by a Russian biotech company, alleging the client engaged in anticompetitive activity.

Latham's regulatory team includes standout attorneys Benneville Haas, Stuart Kurlander and John Manthei. Manthei serves as global co-chair of the firm's healthcare and life sciences practice group, and is focused on representing clients in all areas of a product's regulatory life cycle. Manthei led the Latham team representing Chinese conglomerate Tencent, advising on FDA requirements and other tariff questions in relation to the company’s donation of personal protective equipment (PPE) to US hospitals as a result of the Covid-19 outbreak. Kurlander heads a Latham team that serves as regulatory and reimbursement counsel to Abbott Diabetes Care.

Morgan Lewis & Bockius has an all-encompassing practice in the life sciences space. The firm receives national ranking for its involvement in white-collar matters, licensing and collaboration, patent litigation, regulatory counseling and general corporate work. Recently, the firm made news for its significant streak of lateral hires, particularly in the IP group.

For non-IP litigation, group chair Eric Sitarchuk is one of the firm's senior practitioners focused on white-collar and corporate investigations. He and partner Steven Reed are currently active for Teva and affiliated companies in its defense of numerous claims concerning opioid sales and distribution John Dodds has experience representing pharmaceutical and medical device companies in government investigations, bolstered by his credentials as a former prosecutor in the public sector. Among his current representations, Dodds is active for a drug maker client in an ongoing investigation. Antitrust stars Gordon Cooney and Steven Reed are representing Teva and Glenmark in a multidistrict litigation (MDL) that arose from a Department of Justice investigation involving alleged price fixing practices among generic drug makers.

In the financial and corporate group, global life sciences co-chair Alan Leeds was awarded Licensing & Collaborations Attorney of the Year. One peer notes Leeds is “very good, thoughtful, reasonable, and helps clients in a practical way.” In the past year, Leeds was part of a team representing Regeneron in a collaboration with Vyriad, which develops targeted cancer therapies. Leeds also led a team that advised Celgene in its collaboration agreement with Editas Medicine. Benjamin Pensak is a go-to for life sciences-related licensing agreements and collaborations. He recently advised Eli Lilly in its collaboration with Evox Therapeutics to develop treatments for neurological disorders. David Glazer is “fantastic” notes one peer and worked with Leeds on the Regeneron-Vyriad partnership.

The firm offers a full suite of regulatory services to clients in the industry, with the ability to advise clients at all stages of product development. Kathleen Sanzo has extensive experience assisting a number of high-profile pharmaceutical and biotechnology companies with regulatory and compliance issues. In 2020, she was shortlisted for the FDA Pharmaceutical Attorney of the Year award for her work in the area. Michele Buenafe advises both pharmaceutical and medical device clients in a host of matters, including development, manufacturing, marketing, labeling and advertising issues. Buenafe is the leader of the firm's digital health initiative and co-leader of the firm's cross-practice healthcare initiative.

In IP, the firm drew awards attention for its involvement in of the Patent Impact Cases of the Year: iNo Therapeutics v Praxair Distribution. Life sciences IP group co-head Michael Abernathy was a lead on the matter, which resulted in a Federal Circuit decision involving method of treatment claims that were found invalid under Section 101. In prosecution and strategy, Jeffry Mann is one of the firm's leading practitioners for life sciences patent advice. He specializes in patent preparation and prosecution, IP portfolio monetization, due diligence and licensing. Boston-based Steven Frank focuses his practice on IP transactions, patent prosecution and strategic counseling. LMG Life Sciences newcomers Louis Beardell, Christopher Betti and Gargi Talukder also contribute to the firm’s strong patent offering.

Sidley Austin's national rankings in nearly all areas of life sciences law positions the firm as one of the premier practices to call on for life cycle management of a product. Areas the firm is highly ranked include product liability, government investigations, patent litigation, pricing, M&A, and licensing, among others.

Litigation partner and "product liability rock star" Debra Pole was one of a few practitioners inducted into the LMG Life Sciences Hall of Fame, highlighting her leading status in the industry. She has been consistently ranked for her practice focused on trials and multidistrict litigation. Co-head of the firm's product liability and mass torts practice Heidi Levine is lauded by peers for her representation of pharmaceutical and medical device clients in large-scale actions. Maja Eaton is another leader in the product liability group, offering deep expertise in mass torts and class actions. Paul Kalb plays multiple leading roles at the firm, including his positions as global head of the healthcare and FDA practice, and life sciences industry group co-chair. Kristin Koehler is an active practitioner in the firm’s government investigations group, who recently acted for a major pharmaceutical client in a qui tam matter related to government contracts.

In IP, the firm received significant awards attention in 2020, winning multiple practitioner categories and a Patent Impact Case of the Year award for its involvement in the high-profile appeal Immunex v Sandoz. One of the firm’s IP litigation heads is Jim Badke, who is currently active for Bayer Healthcare in a biologics litigation against Baxalta and Nektar involving the client’s Jivi product. Ching-Lee Fukuda is the 2020 Post-Grant Proceedings Attorney of the Year for her significant activity in PTAB matters, including the recent appeal of an IPR for client Nevro invalidating a key Boston Scientific patent. She was also active in a Patent Impact Case of the Year CardioNet v InfoBionic, which reversed a ruling citing Section 101. The firm was also recognized for its appellate win in Immunex v Sandoz appeal, which dealt with obviousness-type double patenting.

For regulatory matters, the firm draws on a deep bench of experienced attorneys to assist clients in all areas of product development and pricing matters. Coleen Klasmeier is former head of the firm's food, drug and medical device regulatory practice and a member of the firm's executive committee. She focuses her practice on representation of life sciences companies in contentious proceedings involving the FDA. Another standout in the regulatory group is Raj Pai, who focuses his practice on clients in the pharmaceutical and biotechnology sectors. He has previously represented companies in government investigations, enforcement proceedings, and litigation.

The financial and corporate group leverages its global team to assist clients with public offerings, transactions, licensing, collaborations, and venture capital financing. West Coast-based Joshua Hofheimer represented Yuhan Corporation in its licensing and collaboration agreements with Gilead and Janssen, a division of Johnson & Johnson. Pran Jha is experienced in public offerings, transactions, and collaborations. He recently represented clients CSL Behring and Vifor Pharma in notable deals. Bay Area-based partners Jennifer Fitchen and Sharon Flanagan add to the firm’s West Coast credentials. Fitchen is global co-leader of the firm's mergers and acquisitions practice.

WilmerHale is recognized as a leading firm in the life sciences sector for its multifaceted practice assisting companies in pre- to post-market matters. The firm is graded highly in a number of legal disciplines, including patent litigation, white-collar matters, licensing and collaboration, and general corporate work.

New York partner Robert Gunther is a key member of the firm’s life sciences patent litigation bench, and was honored in 2020 as the General Patent Litigator of the Year in New York for his significant activity in the area. Among his notable representations was a consolidated case for Roche and Becton Dickinson against Enzo Life Sciences, which resulted in a noteworthy Federal Circuit ruling involving enablement issues. The matter was named one of 2020’s Patent Impact Cases of the Year. IP litigation group co-chair Lisa Pirozzolo is an experienced first-chair trial lawyer who is representing several notable life sciences clients, including CSL Behring in a dispute against Biogen related to hemophilia treatment. William Lee is one of the most celebrated patent litigators in the country, offering more than four decades of experience in law. DC-based partner Amy Wigmore is currently active for Bristol-Myers Squibb and Pfizer in a Hatch-Waxman litigation opposite several generic manufacturers that at one point totaled 25 challengers.

The firm's corporate capabilities are supported by several experienced attorneys, including Steven Barrett, who co-chairs the technology transactions and licensing practice group. He recently represented Ribometrix in a collaboration with Vertex Pharmaceuticals, and Medtronic in funding agreements with Blackstone Life Sciences. Transactional department chair Lia Der Marderosian represented Pandion Theraupetics, a biotechnology company focused on autoimmune diseases, in its $80 million Series B financing. Life sciences group co-chair Stuart Falber advises a variety of life sciences clients ranging from startups to established companies in the space. He specializes in corporate and venture capital transactions, as well as licensing and collaboration agreements. Among his notable matters, Fabler advised Epizyme in its $270 million collaboration agreement with Royalty Pharma. Steven Singer has over 30 years of experience assisting both public and private life sciences companies in various transactions. A new addition to this year’s list is Cynthia Mazareas, who represents both a number of high-profile private and public life sciences companies with a variety of issued related to corporate governance and transactions.

In the enforcement area, the firm is noteworthy for its practice focused on government investigations and white-collar matters. Securities litigation practice co-chair Michael Bongiorno recently took part in an appellate matter for Ocular Therapeutix and its former officers, resulting in a First Circuit ruling that the clients did not mislead investors regarding manufacturing and regulatory aspects of drug candidate Dextenza. Howard Shapiro is chair of the firm's litigation and controversy department, with more than three decades of experience handling disputes, particularly in the area of white-collar defense. Reginald Brown is new to the LMG Life Sciences stars list this year for his strong practice focused on investigations and compliance-related matters. Brown currently serves as head of the congressional investigations practice, and was recently active in matters for multiple pharmaceutical companies.