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.

The firm's regulatory practice is one of the premier groups focused on pharmaceutical and medical device clients. One client highlights the firm "does excellent work, is client-focused, and realistic." A peer adds, "They have some of the best pricing litigators in the country." Life sciences practice co-chair Dan Kracov supports the firm's reputation for regulatory work, with one client labeling him "the highest caliber." Jeff Handwerker is well-regarded for his work advising a number of life sciences companies in all aspects of their product development, with a particular expertise assisting pharmaceutical and medical device clients. LMG Life Sciences newcomer Mahnu Davar regularly works with Kracov assisting clients on a host of FDA-related regulatory and compliance matters.

In IP, group co-chair Matthew Wolf was awarded General Patent Litigator of the Year in Washington, DC for an active year in high-profile disputes. Among his notable representations was a case for Boston Scientific against Edwards Lifesciences, which recently settled, ending the global dispute between the two companies. David Barr and Deborah Fishman also acted alongside Wolf in the closely watched antibody dispute Amgen v Sanofi, which involves how broadly antibodies can be covered by patents. Daniel DiNapoli and Aaron Stiefel are currently acting for Pfizer in Hatch-Waxman litigations challenging two of the client's products, Xeljanz and Bosulif.

The firm's high-caliber antitrust group includes senior partner Laura Shores, who brings more than 25 years of experience in litigation. She recently acted for Novartis in multiple matters, one involving "pay for delay" allegations brought by pharmaceutical company Miami-Luken. The 2019 Government Investigations Attorney of the Year award went to DC-based Kirk Ogrosky, who 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.

Derek Stoldt serves as co-head of the firm's M&A and life sciences transactions practice groups from the New York office. He and Aaron Gardner recently advised Novartis in its sale of cystic fibrosis products to Mylan, valued at $463 million. Julia Vax is a standout in the firm's corporate practice, who regularly represents medical device, diagnostics and biopharmaceutical companies. Past representations include Bayer in the sale of commercial rights to a compound.

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 is experienced advising major pharmaceutical and biotechnology companies with FDA-related issues. Pamela Forrest, a new addition to the stars list, 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.

The firm's IP team was recently involved in a matter deemed a Patent Impact Case of the Year, led by DC-based litigator Christopher Sipes. The case, Momenta Pharmaceuticals v Bristol-Myers Squibb, resulted in a precedential decision from the Federal Circuit regarding standing in an IPR appeal. Also in DC is George Pappas, who is a leading litigator in the life sciences sector, particularly for ANDA litigations. Notable representations include AstraZeneca, Bristol-Myers Squibb and Merck. Jeffrey Elikan is another standout practitioner serving pharmaceutical clients in patent disputes against generic challengers.

For financial and corporate matters, a peer says the firm "has a strong subject matter expertise and is pragmatic in their approach." Emily Leonard serves as vice chair of the firm's life sciences industry group, 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. Notable representations include Gilead Sciences, Pfizer and Johnson & Johnson subsidiary Acclarent in government investigations. 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. Among the firm's noteworthy matters from the past year was the Supreme Court case Helsinn v Teva, which was decided in favor of client Teva and clarified legal questions in relation to the "on-sale bar."

IP litigation co-chair Daryl Wiesen is well versed in disputes related to pharmaceuticals and biotechnology. "He is just a superb lawyer," a peer says. "It's a pleasure to be litigating against someone who is really talented. He brings the fight to you." Elizabeth Holland is well known for her experience in Hatch-Waxman litigation, often for generic pharmaceutical clients. She recently acted for Teva entity Actavis in a patent suit. Theresa Kavanaugh focuses her practice on patent prosecution and portfolio development for early stage companies. Duncan Greenhalgh has a strong reputation as a patent advisor to life sciences companies and a "great depth of biotech knowledge," according to a peer.

In financial matters, a peer says of the firm: "They have one of the largest and most successful corporate IP life sciences practices in Boston and the US." Kingsley Taft co-chairs the firm's life sciences group and is highly regarded in the field. One peer notes Taft is "definitely one of the leading lawyers in the life sciences sector," and that he is "not just a star, but a superstar" in the space. Serving alongside Taft as co-chair of the life sciences group is Mitchell Bloom, who "has a great knowledge base and is great to work with," a peer says. Stuart Cable focuses on transactions and corporate financing, representing several clients in the past year. He recently assisted Rubius Therapeutics in its initial public offering, and advised Spark Therapeutics in its $4.8 billion merger agreement with Roche. Maggie Wong assists a variety of life sciences companies with raising capital.

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. He is currently representing a client in a civil and criminal investigation brought by the Department of Justice.

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.

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.

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. He is currently representing AllerQuest in its FDA approval process for developing an innovative penicillin allergy test. Medical device advisor Jonathan Kahan boasts more than 40 years of experience practicing law. He is currently assisting Hitachi with FDA market clearance for its proton beam therapy (PBT) systems. In the pricing and reimbursement arena, Alice Valder Curran is widely considered one of the standouts in her field. She currently serves as chair of the firm's global regulatory practice. Another standout is Beth Roberts, who has a "stellar reputation" in reimbursement matters for life sciences companies.

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. Asher Rubin is global head of the firm's life sciences group, who recently advised Tesaro in its $5.1 billion acquisition by GlaxoSmithKline. Rubin was shortlisted by LMG Life Sciences for the Corporate Attorney of the Year award in 2019. Adam Golden is head of the life sciences corporate group and is well known for his representation of clients in high-profile transactions and collaboration agreements. He recently represented Celgene in its strategic collaboration with Obsidian Therapeutics. Steve Abrams assists a variety of life sciences companies with corporate financing, transactions, licensing agreements and collaborations. He recently assisted in initial public offerings for Arbutus Biopharma and EyePoint Pharmaceuticals.

Jonathan Diesenhaus has extensive experience advising a number of life science clients involving criminal investigations and enforcement matters. Among his current clients, Diesenhaus represents William Beaumont Hospital in a multi-year investigation and associated qui tam litigation brought by the Department of Justice. Leading appellate practitioner Neal Katyal recently acted for Bristol-Myers Squibb and Pfizer in a multidistrict litigation that challenged the labeling of the clients' anticoagulant drug Eliquis, resulting in a successful dismissal with the verdict upheld on appeal. Lauren Colton recently represented Amgen as lead counsel in a number of product liability suits related to the client's biologic product Enbrel. Colton serves as head of the firm's products law practice group.

For IP matters, Arlene Chow is one of the firm's leading life sciences practitioners, with a deep focus on the biotechnology and pharmaceutical areas. She specializes in contentious proceedings before the Patent Office, an area of continued focus in her practice. According to a client, Chow has "a very deep knowledge of the law and the science and the industry. [Her] skills in depositions and at oral hearings are superb." Chow is currently handling IPR proceedings for Merck related to patents covering pneumococcal vaccine Prevnar 13.

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. "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. For its wide-ranging activity in the industry, the firm was awarded 2019 Life Cycle Firm of the Year by LMG Life Sciences.

The firm's financial and corporate group is well known for having an "excellent market share" of life sciences work, says a peer. Industry group vice chair Judith Hasko is a luminary in the licensing and collaboration space, who was recently recognized through her induction into the LMG Life Sciences Hall of Fame. She recently represented Daiichi Sankyo in a $6.9 billion collaboration agreement with AstraZeneca. Alan Mendelson is experienced in a variety of corporate matters, including public offerings, transactions, collaborations and venture capital financing. Transactions star Charles Ruck acted as financial advisor to K2M in its acquisition by Stryker in a deal worth $1.4 billion.

In the patent group, IP litigation co-chair Michael Morin and partner David Frazier acted for client AbbVie in lawsuits related to various products in its portfolio, including the company's top-selling drug Humira. Morin was shortlisted in 2019 for the DC General Patent Litigator of the Year award by LMG Life Sciences. Respected litigator Maximilian Grant continues to represent InfoBionic in two cases brought by competitor CardioNet. David Callahan was recently involved in a 13-year dispute representing for Zimmer Biomet, which eliminated a multibillion-dollar damages claim and awarded the client $14 million in attorneys' fees. Callahan was shortlisted for the Midwest General Patent Litigator of the Year award.

For non-IP litigation, the firm had some newsworthy activity in a securities-life sciences crossover matter that garnered considerable attention. LMG Life Sciences newcomers Andrew Clubok and Michele Johnson were involved in a noteworthy matter that was recognized as an Impact Case of the Year in 2019. The case, Hsu v Puma Biotechnology, is a securities class action that alleged client Puma released misleading statements to investors related to its breast cancer drug Nerlynx. In a rare jury trial, the verdict found three of the four contested statements were not misleading, and the liability amounted to less than 5% of the damages sought. Daniel Wall is a leader in the antitrust group and a "stellar presence" according to a peer. He is currently active for Genentech in a district court matter involving anticompetitive claims. Healthcare and life sciences group co-chair Daniel Meron is a specialist in regulatory enforcement and investigations.

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. He recently represented Alvogen in a matter against the State of Nevada preventing use of the client's drug for lethal injection. Kurlander is one of the firm's experts in pricing and reimbursement matters. Haas represents companies in various regulatory matters, with a particular focus on clinical trial advice.

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 was recently active for Rite Aid in a qui tam matter involving allegations made by California's medical assistance program Medi-Cal. 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 a case involving the False Claims Act. Antitrust stars Gordon Cooney and Steven Reed are representing Teva and Glenmark in a multidistrict litigation that was consolidated in the Eastern District of Pennsylvania. Co-head of the healthcare industry initiative Howard Young recently advised medical technology client Philips in regulatory compliance issues related to its acquisition of healthcare IT company Carestream.

Two of the firm's leading regulatory practitioners are Stephen Paul Mahinka and Kathleen Sanzo, who are deeply experienced advisors to clients in the life sciences sector. Sanzo specializes in approval, marketing, labeling and compliance issues for companies across technology areas, including pharmaceutical and device manufacturers. Mahinka is well versed in compliance and antitrust issues. Michele Buenafe is the leader of the firm's digital health initiative and co-leader of the firm's cross-practice healthcare initiative. She has experience advising pharmaceutical and medical device clients. In the pricing and reimbursement space, Andrew Ruskin brings over 20 years of experience assisting a variety of healthcare, pharmaceutical, and medical device companies with Medicare and Medicaid matters.

In the financial and corporate group, Benjamin Pensak is a go-to for life sciences-related licensing agreements and collaborations. He recently advised Eli Lilly in its collaboration with Sigilon Therapeutics to develop cell therapy treatment of Type 1 diabetes. Global life sciences group co-chair Alan Leeds and partner David Glazer are highly experienced attorneys with a reputation for advising major companies in the industry. Mark Stein and Steven Navarro represent both investors and companies in a variety of corporate matters including financing, public offerings, transactions, and venture funding.

Life sciences IP group co-head Michael Abernathy recently acted for Praxair in an 11-patent infringement case against Mallinckrodt, INO Therapeutics and Ikaria in the District Court of Delaware. Another standout patent litigator is global IP head Eric Kraeutler, who has more than four decades of experience in law. 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. He recently represented cell therapy company Medisix Therapeutics in a $20 million Series A funding led by Lightstone Ventures. Boston-based Steven Frank focuses his practice on IP transactions, patent prosecution and strategic counseling.

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. "I can't think of any firm off the top of my head that even comes close," ventures a peer. "From regulatory clearance, to IP, and right down to all-out court battles, Sidley has got it all covered. They really do it all." The firm was involved in two award-winning matters last year, including a top deal for Nurix Therapuetics valued at $2.5 billion, and a notable biologics patent dispute for Bayer Healthcare.

The firm's strong reputation in product liability matters is supported by co-chair Heidi Levine, who is lauded by peers for her representation of pharmaceutical and medical device clients in large-scale actions. Debra Pole is a "product liability rock star" according to a peer. Pole recently represented Janssen Pharmaceuticals in a claim involving its antipsychotic drug Risperdal. Maja Eaton recently represented Ferring Pharmaceuticals in a class action litigation, and personal injury and economic loss lawsuits related to the client's recall of fertility drug Bravelle. 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.

IP litigation head David Pritikin is deeply experienced in life sciences cases involving pharmaceuticals, medical devices, and more recently, biologics. He and experienced litigation partner Vernon Winters are currently active for Amgen in one of the earliest BPCIA disputes against Sandoz, involving the client's biologic product Enbrel. A team of New York-based partners including Jim Badke, Sona De and Ching-Lee Fukuda were involved in a significant innovator-versus-innovator biologics dispute for client Bayer. The case, which involved Shire entity Baxalta on the other side, ended in favor of the client with a patent infringement verdict of $182 million.

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. William Sarraille is a senior member of the firm's healthcare group, and has extensive experience assisting clients with matters related to Medicare and Medicaid reimbursement, price reporting, and product marketing.

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 recently 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, which he recently showcased with his representation of pharmaceutical giant GlaxoSmithKline in the sale of an investigational therapeutic product. Jennifer Fitchen and Sharon Flanagan also stand out in the firm's corporate group.

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.

In IP, WilmerHale was awarded 2019 General Patent Litigation Firm of the Year by LMG Life Sciences for an active year in high-profile disputes. One of the firm's involved litigators is William Lee, who currently represents client Ancestry.com in a dispute against 23andMe involving genetic testing patents. IP litigation group co-chair Lisa Pirozzolo is an experienced first-chair trial lawyer who is representing a number of notable life sciences clients, including CSL Behring in a dispute against Biogen related to hemophilia treatment. "She is deeply respected by her clients," a peer says. "In terms of a strategic thinker, she's very good." New York partner Robert Gunther is involved in a variety of life sciences patent disputes, most recently in cases involving biologics and diagnostics. DC-based partner Amy Wigmore recently represented AbbVie in a newsworthy biosimilar case against Boerhinger Ingelheim, which involved entry of the opponent's version of blockbuster drug Humira.

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 Agios Pharmaceuticals in an exclusive collaboration with CStone Pharmaceuticals. Transactional department chair Lia Der Marderosian represented Kala Pharmaceuticals and Constellation Pharmaceuticals with their initial public offerings. 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. Steven Singer has over 30 years of experience assisting both public and private life sciences companies in various transactions.

In the enforcement area, the firm is described by a peer as "a go-to firm for the big-bucks litigation." Securities litigation practice co-chair Michael Bongiorno is currently active for client Solid Biosciences in a matter involving the company's IPO and post-IPO statements as it relates to a product in clinical development. Bongiorno and his team obtained a ruling preventing a Massachusetts state court from moving forward with a nationwide class action. 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. He is currently representing a pharmaceutical company in a Department of Justice investigation.