Life Cycle

Arnold & Porter maintains a substantial presence in the life sciences space, 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.

A peer says about the firm's regulatory practice: "They do a lot of work in the drug space [with] Dan Kracov there, a leading practitioner for a number of years." Kracov strategizes with leading companies on their pathways to FDA approval. He handles FDA submissions, subpoena responses and post-market issues, among other areas. Jeffrey Handwerker expertly advises companies and associations in price reporting and transparency, Anti-Kickback matters, and issues regarding Medicaid and Medicare, including the 340b program. His clients includes Pharmaceutical Manufacturers Association (PhRMA) as well as multiple major drug companies.

In IP, the firm is equally strong in contentious patent matters and strategic counseling, evidenced by a significant body of work over the past year from the firm's patent-focused attorneys. David Barr is considered "excellent in the field" by a peer, whose practice is focused on Hatch-Waxman litigation and other patent disputes. He and leading IP trial lawyer Matthew Wolf were involved in the newsworthy case Amgen v Sanofi, which recently saw a permanent injunction against clients Sanofi and Regeneron vacated and a jury verdict reversed by the Federal Circuit. Other notable patent litigators include Daniel DiNapoli and Aaron Stiefel, who both represent Pfizer in multiple patent suits, and Deborah Fishman who won at the Federal Circuit for Elan Pharmaceuticals. David Marsh is one of the firm's leading patent strategists, who currently handles IP portfolios for notable clients including Monsanto and Bruin Biometrics.

In litigation and enforcement, Arnold & Porter receives a top rating for its capabilities in competition and antitrust matters. One of the standouts in the area is Saul Morgenstern from the New York office, who recently defended King Pharmaceuticals in several federal and state class actions valued at $300 million, related to the company's product Skelaxin. DC-based Laura Shores is described by a peer as a "hard-nosed antitrust trial lawyer," and has recently been active for Pfizer and its subsidiary Warner-Lambert in a defense against antitrust claims. In product liability, Anand Agneshwar, Andrew Solow and Pamela Yates are leading individuals in the practice. Solow and Yates have been representing Endo as national counsel in litigations related to its testosterone products since 2013.

Derek Stoldt serves as co-head of the firm's M&A and life sciences transactions practice groups from the New York office. He was recently part of a team that advised Novartis in a licensing agreement with Spark Therapeutics related to gene therapy technology. Julia Vax is a standout in the firm's corporate practice, whose representations include medical device, diagnostics and biopharmaceutical companies. Aaron Gardner recently acted for Novartis in the acquisition of a priority review voucher from BioMarin.

Covington & Burling offers a broad-based practice in the life sciences, with a deep bench of attorneys who contribute to the firm's longstanding reputation as a high-quality practice. The firm receives top ranking in FDA pharmaceutical counseling, licensing and collaboration, Hatch-Waxman disputes and white-collar matters.

In the regulatory space, the firm has particular expertise handling FDA issues on behalf of pharmaceutical clients. The group provides extensive experience in compliance matters and enforcement for clients in both pre-market and post-market stages. A peer regards the firm as a "powerhouse," and another considers it one of the "go-to-firm[s] for the branded industry." Michael Labson regularly advises and strategizes with pharmaceutical companies on FDA matters. His practice has involved FDA disputes, market exclusivities, clinical trial misconducts, and REMS. Geoffrey Hobart also focuses on handling FDA investigations, representing pharmaceutical companies dealing with the FDA and its investigations into the clients' practices.

A peer says the firm "provides excellent service in the Hatch-Waxman area," a practice many of the firm's notable patent litigators are experienced in. George Pappas is among one of the most noteworthy senior patent trial lawyers in the field, who has represented the likes of AstraZeneca, Bristol-Myers Squibb and Merck. Christopher Sipes and Jeffrey Elikan also stand out in the life sciences practice as some of the firm's most skilled patent litigators. Sipes is described by a peer as a "good courtroom lawyer," and a "real intellect in the field." Andrea Reister serves as head of the Patent Office trials practice group, who, in addition to her post-grant work, also specializes in district court litigations and patent strategy.

Emily Leonard serves as vice-chair of the firm's life sciences industry and is one of the firm's go-to practitioners for licensing agreements and collaborations. Edward Britton and Van Ellis also contribute to the firm's licensing capabilities. John Hurvitz is vice-chair of the corporate group and life sciences industry co-chair. He handles transactions for clients in the pharmaceutical, biotech, med tech and diagnostics industries, among other areas. Catherine Dargan brings deep expertise in M&A and other financial matters.

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.

General practice firm Goodwin Procter is well-equipped to represent 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. Goodwin Procter was recognized by LMG Life Sciences as the 2018 Life Cycle Firm of the Year for its outstanding work in each of these disciplines.

The firm is known as one of the premier Hatch-Waxman practices representing generic clients, supported by a deep bench of experienced patent litigators. "Goodwin Procter consistently has top talent, from the first-chair trial partners to junior associates," says a competitor. Elizabeth Holland is one of the leading names in this area, who is deemed "stellar" by a peer. Daryl Wiesen is a "very practical, but creative thinker," says a client, and further bolsters the firm's Hatch-Waxman capabilities. He was involved in GlaxoSmithKline v Teva, which resulted in the reversal of a $235 million verdict against client Teva. Douglas Kline serves as the firm's IP litigation chair from the Boston office.

Frederick Rein is one of the founders of the New York IP litigation practice. Elaine Blais was recently successful for Celltrion in an IPR, which cancelled Genentech's patent claims related to its product Herceptin. In patent strategy, Duncan Greenhalgh is renowned for his ability to navigate clients' IP portfolios. He is labelled "excellent" by a peer. Marta Delsignore focuses her practice on portfolio management, opinions and other patent-related client counseling. Patent attorney Theresa Kavanaugh is noted by a client for her "outstanding technical advice."

In the financial and corporate space, Kingsley Taft and Mitchell Bloom are two of the firm's leaders and co-chairs of the national life sciences group. Bloom recently represented biotech client Ablynx NV in its $200 million IPO, and again months later in its acquisition by Sanofi. Sarah Solomonrepresented Wave Life Sciences in a global strategic collaboration with Takeda to discover, develop and commercialize nucleic acid therapies for CNS disorders. Stuart Cable serves as chair of the M&A and corporate finance practices in the firm's life sciences group. He recently acted for life sciences consulting company Parexel in its acquisition by Pamplona Capital Management, valued at $5 billion.

Scott Lassman is a regulatory attorney equipped to handle FDA matters at all stages of a product's development. He currently advises client Teva on issues related to product approval, exclusivity and administrative litigation. Julie Tibbets oversees marketing and labeling of both generic drugs and specialty brands in West-Ward Pharmaceutical's product portfolio. In addition to pharmaceuticals, her technology expertise extends to biologics, medical devices, diagnostics, food, and other areas.

Notable individuals in the litigation and enforcement area are Joanne Gray and William Harrington, both 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.

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 high ratings for its practices in M&A, licensing and collaboration and white-collar matters.

For regulatory matters, Hogan Lovells is a go-to practice for life sciences companies, for its size, talent and breadth of expertise. One peer calls the group a "first-class FDA practice." Among the firm's standout FDA counselors are David Fox and Lynn Mehler, who expertly navigate pathways to complex approvals for the firm's extensive book of clients. In the medical device space, Jonathan Kahan recently led a team that obtained a complicated FDA market clearance for Hitachi's proton beam therapy systems. Standouts in the firm's pricing and reimbursement group are Beth Roberts, Joy Sturm, and Alice Valder Curran. Sturm assists clients on compliance issues related to federal contracts and programs. Valder Curran specializes in pricing and compliance related to Medicare and Medicaid programs. Roberts is described as "the crème of the crop" by a client.

The firm offers deep expertise in the financial and corporate space, most notably in M&A and licensing and collaboration. Asher Rubin serves as head of the firm's global life sciences group from the Baltimore office. He recently represented Tmunity Therapeutics, a University of Pennsylvania entity, in a Series A financing round. Corporate practice group head Adam Golden specializes in M&A, IP transactions and general corporate matters for life sciences companies. He recently represented biopharmaceutical client Celgene in two multibillion-dollar acquisitions. Steve Abrams, a member of the firm's global life sciences leadership group, led a Hogan Lovells team advising specialty pharmaceutical company Optinose in its $138 million IPO.

The group's litigation capabilities are bolstered by a deep bench of attorneys versed in product liability, antitrust, government investigations and white-collar matters. Neal Katyal is a significant appellate specialist who has argued more than three dozen cases before the Supreme Court. One of his latest wins at the highest court was a case for client Bristol-Myers Squibb, which ruled on states' ability to hear mass tort, product liability cases brought by plaintiffs that did not purchase or use the product in the state. Lauren Colton represents Amgen as lead counsel in a number of product liability suits related to the client's product Enbrel. Two of the group's prominent litigators handling investigations are Jonathan Diesenhaus and Ginny Gibson.

Arlene Chow is one of the firm's leading life sciences patent practitioners, with a deep focus on the biotechnology and pharmaceutical areas. She specializes in contentious proceedings before the Patent Office, an area she was heavily active in over the past year. "She does a great job in the courtroom," a peer says. "She's a good lawyer that can interface with opposing counsel on a civil level." A client calls her a "smart, proactive lawyer." Chow is currently handling seven IPR proceedings for Merck related to patents covering pneumococcal vaccine Prevnar 13.

Latham & Watkins is an international firm with an impressive 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. "Latham is one of the few firms that we see across the entire life cycle of the life sciences practice," a corporate attorney at a competing firm says. The firm is also a major IP player in biosimilars disputes and litigations under the Hatch-Waxman Act.

The firm is a powerhouse in financial matters, bolstered by its extensive bench of attorneys versed in licensing, M&A, venture capital and general corporate matters. Licensing group chair Judith Hasko is labeled "one of the top people in the collaborations space" by a peer. For her outstanding career in the industry, this year Hasko was one of the few attorneys inducted into the LMG Life Sciences Hall of Fame. Alan Mendelson serves as co-chair of the life sciences industry group, and focuses his individual practice on representing emerging companies in various financial matters. He recently represented Sienna Biopharmaceuticals and Unity Biotechnology in multimillion-dollar IPOs. Charles Ruck has a broad-based practice in the financial sector. This year he was shortlisted for two awards by LMG Life Sciences – corporate attorney and M&A attorney of the year.

Michael Morin and David Callahan lead the firm's global IP litigation practice group, and are involved in some of the firm's most notable patent disputes. Morin is active as lead counsel for AbbVie in multiple matters, including a five-patent suit against Gilead involving the blockbuster drug Harvoni. Callahan defended Zimmer Biomet in a multibillion-dollar dispute against Howmedica which lasted 13 years. Kenneth Schuler and Daniel Brown are both significantly involved in Hatch-Waxman disputes for generic client. They have represented Mallinckrodt in a series of pharmaceutical patent disputes. David Frazier is defending AbbVie alongside Michael Morin in the noteworthy biologic dispute Amgen v AbbVie. Other notable patent practitioners at the firm include Richard Bress, Roger Chin and Maximilian Grant.

In litigation and enforcement, Latham is top-ranked for competition and antitrust matters, and is also notable for its capabilities in the white-collar space. Daniel Meron is global co-chair of the healthcare and life sciences practice group, and one of the firm's stellar practitioners handling government investigations work. Katherine Lauer, also co-chair of the healthcare and life sciences group, focuses on healthcare fraud and qui tam matters. David Schindler co-heads the firm's white-collar defense and investigations practice.

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. Kurlander is one of the firm's experts in pricing and reimbursement matters. Haas represents companies in various regulatory matters, with a particular focus advising clients in clinical trials.

Morgan Lewis & Bockius has an all-encompassing practice in the life sciences. The firm receives top marks for its involvement in white-collar matters, licensing and collaboration, and general corporate work. The group is also notable for a significant regulatory team equipped to handle the full gamut of FDA issues, and a patent group active in litigation and counseling.

The firm receives top rankings in licensing and collaboration and general corporate work. One of the leaders in the licensing area is Randall Sunberg, who co-heads the life sciences transactions group. His specialties include complex collaborations, M&A, joint ventures and licensing agreements. Sunberg recently led a Morgan Lewis team acting for Shire in an agreement with biopharma company Novimmune, which granted the client rights to develop an antibody platform. Alan Leeds co-heads the transactions group with Sunberg. He recently assisted Regeneron in a collaboration with ISA Pharmaceuticals to fund and conduct clinical trials for cancer treatments. Mark Stein and Steven Navarro offer expertise in corporate transactions and mergers and acquisitions. Stein recently represented an investor in a Series C financing, and Navarro assisted in a private placement sale of common stock for a pharmaceutical company focused on cancer therapies.

Morgan Lewis is equipped to represent companies at all stages of a product's life cycle as it relates to regulatory matters. The firm receives national rankings in all three main regulatory practice areas, including FDA counseling in the pharmaceutical and medical device spaces, and pricing and reimbursement. The team includes Kathleen Sanzo, whose practice focuses on FDA compliance for companies both in the pre-market and post-market stage. One client says, "Kathy is an FDA and regulatory expert, and is my first point of call for the great variety of legal questions that confront us during clinical trials of new biotherapeutics." Michele Buenafe has recently handled and submitted 510(k) submissions for several medical device companies, and has further assisted the clients in responding to questions raised by the FDA. Andrew Ruskin concentrates on handling clients' healthcare pricing and reimbursement matters, providing advice and strategy to clients facing issues with Medicare and Medicaid especially.

In the litigation and enforcement area, Morgan Lewis receives top marks for its strength in investigations and white-collar matters, and is also notable for its antitrust practice. Stephen Paul Mahinka has a diverse practice focused on both antitrust and regulatory matters. He is the founder of the firm's FDA practice, and is versed in compliance issues. Kathleen McDermott is a top practitioner in the government investigations space, notably in matters related to the False Claims Act. She has recently been active for multiple life sciences clients in matters related to the statute. Eric Sitarchuk is another standout in the investigations and white-collar area, who recently represented Rite Aid in a False Claims Act suit filed in state court in California.

The firm's patent litigation group is supported by Michael Abernathy, Richard de Bodo and Eric Kraeutler, three seasoned trial lawyers with deep experience helming life sciences cases. Abernathy recently secured a favorable outcome for Mallinckrodt in an 11-patent suit against Praxair. Kraeutler is currently part of a team defending Acerta Pharma against patent infringement claims in the District of Delaware. Jeffrey Mann is a standout member of the firm's patent prosecution and counseling practice, with a specialty in IP transactions and portfolio management. He recently acted for cell therapy client Medisix Therapeutics in a $20 million Series A funding. Patent attorney Steven Frank offers expertise in the medical device area.

Sidley Austin's top 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, antitrust, patent litigation, pricing, M&A, and others. "Sidley is the one to beat in life sciences litigation," a peer says. "They seem to attract much of this type of work, and they have people that they can pull from anywhere to deal with it. They have a lot of arrows in the quiver, and some of the sharpest ones too."

The firm's premier litigation group sweeps all practice areas with top rankings in antitrust, product liability, government investigations and white-collar matters. Notable litigators include product liability group head Sara Gourley, who is representing Smith & Nephew in suits related to the company's hip-resurfacing prosthesis. Maja Eaton leads the global product liability and mass torts group. She currently represents Ferring Pharmaceuticals in class action litigations arisen out of the recall of the company's product fertility drug Bravelle. Debra Pole, a "product liability rock star" to a peer, recently won for Janssen in a suit related to the antipsychotic drug Risperdal. White-collar practice group leader Kimberly Dunne defended Celgene in a False Claims Act suit, which settled in August 2017.

For patent work, David Pritikin is a top litigator at the firm, and one of the country's most renowned. He lends decades of experience as first chair in numerous competitor patent suits, and lately has been involved in noteworthy biosimilar disputes. Together, Pritikin and New York partner Bindu Donovancurrently represent Johnson & Johnson in consolidated Hatch-Waxman disputes involving 14 generic defendants. Jim Badke is another standout in the IP litigation group, who has recently been involved in a high-profile patent suit for Nevro against infringement claims made by Boston Scientific. Ching-Lee Fukuda and Jeffrey Kushan are two of the firm's key specialists in PTAB litigation and other contentious proceedings.

Sidley receives top marks for its work in the M&A and general corporate space, credited to the firm's impressive roster of finance attorneys. The group took part in notable deals over the past year, including its recent representation of Nektar Therapeutics in a multibillion-dollar transaction with Bristol-Myers Squibb. Joshua Hofheimer was responsible for negotiating and drafting the collaboration agreement, and Sam Zucker led the corporate team in the transaction. Jennifer Fitchen and Sharon Flanagan recently represented Roche in its $1.7 billion merger with Ignyta. Michael Gordon advised Forward Pharma in an exclusive licensing agreement with Biogen, effectively resolving a longtime patent dispute between the two parties. Pran Jha stands out for his deep expertise in corporate matters, including mergers and acquisitions, joint ventures and corporate governance, among other areas.

The regulatory group receives top rankings across the board for its capabilities in FDA pharmaceutical and medical device counseling, as well as pricing and reimbursement. Coleen Klasmeier leads the firm's food, drug and medical device regulatory practice. She is highly experienced in FDA litigation and regulatory strategy, offering substantive knowledge of issues related to consumer fraud, the Hatch-Waxman statue, and other areas. Raj Pai recently represented a major drug manufacturer in assessing the company's FDA compliance of manufacturing sites, and responding to inspection observations made by the FDA. Allison Fulton recently represented a major international pharmaceutical and biotechnology company, counseling the client with respect to its Good Manufacturing Practice, conducting investigations, responding to regulatory inspections, and providing strategy for compliance. William Sarraille recently represented a leading pharmaceutical company in an investigation regarding price reporting, discount and bona fide service fee issues.

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.

The firm remains at the leading edge of the patent litigation space, exemplified by its work last year in the award-winning case Millennium Pharmaceuticals v Sandoz, which resulted in a precedential opinion from the Federal Circuit. A key component of the IP group is William Lee, who is undoubtedly one of the most celebrated patent practitioners in the field. He is lately involved in biosimilars disputes for clients, and has deep experience trying cases in the small molecule and medical device sectors. Practice group leader Lisa Pirozzolo was named New England General Patent Litigator of the Year by LMG Life Sciences for substantial case work on behalf of the firm's high-profile life sciences clients. Emily Whelan is singled out by peers as a noteworthy post-grant specialist. Litigation group co-chair Amy Wigmore is currently acting for Bristol-Myers Squibb and Pfizer in one of the largest Hatch-Waxman disputes ever filed. Robert Gunther is another patent litigator from the firm's New York office. He was shortlisted for the New York General Patent Litigator of the Year Award in 2018.

WilmerHale is highly ranked in licensing and collaboration and general corporate work. Notable practitioners in the corporate area include group co-chairs Stuart Falber and Lia Der Marderosian, who both practice in the firm's Boston office. Falber, who acts as life sciences group co-chair, recently assisted a client in a Series C financing, followed by an IPO a few months later. Der Marderosian, who is corporate group co-chair, led a team representing a client in an IPO valued at more than $100 million. Belinda Juran is life sciences group co-chair along with Falber, and herself is deeply experienced in licensing and technology transactions. She recently represented biotech company Visterra in a research collaboration and exclusive licensing agreement with Vir Biotechnology. Steve Barrett co-chairs the licensing group with Juran, offering expertise in strategic collaborations and tech transfers.

In litigation and enforcement, Wilmer is highly ranked for its white-collar and government investigations practice. Howard Shapiro serves as chair of the litigation group, and is currently representing a major pharmaceutical maker in an investigation by the Department of Justice. Michael Bongiorno is defending Solid Biosciences in securities class action suits. Emily Schulman is a trial lawyer with experience in internal and government investigations and white-collar defense.