Arnold & Porter

Arnold & Porter maintains a strong financial and corporate life sciences practice, with a team of reputable attorneys assisting a variety of clients in corporate counseling, licensing and collaborations, mergers, and other transactions.

Derek Stoldt is co-chair of the firm’s transactions practice, advising both life sciences companies as well as financial institutions in securities offerings, joint ventures, mergers, and other complex transactional matters. Stoldt currently leads an Arnold & Porter team representing 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. Among his recent matters, Dashefsky led the team advising Pfizer on its licensing agreement with Akcea Therapeutics as well as the company’s acquisition of Therachon Holding AG, a clinical-stage biotechnology company focusing on rare diseases.

Aaron Gardner is a perennial LMG Life Sciences star, who last year worked alongside Dashefsky on the Pfizer-Akcea licensing agreement. Gardner has significant experience assisting life sciences companies, as well as private equity funds, in transactional matters. Gardner was also part of the team led by Stoldt that represented Novartis in the sale of its Signifor drug.

Arnold & Porter offers an IP group with strong practices in general patent litigation, Hatch-Waxman disputes and patent strategy for clients across technology areas. Major IP clients of the firm include Boston Scientific, Hologic, Sanofi and Bayer. For the group’s activity in high-profile, novel cases, Arnold & Porter was named 2020 General Patent Litigation Firm of the Year by LMG Life Sciences.

IP group co-chair Matthew Wolf is a trial-tested first chair attorney, whose past year included a complete victory for Sanofi and Regeneron in the closely watched antibody dispute against Amgen. Wolf was also active for Hologic in a Federal Circuit appeal against Enzo Life Sciences resulting in a decision that addressed enablement. Wolf was shortlisted for the General Patent Litigator of the Year award in Washington, DC by LMG Life Sciences. New York partner David Barr was also a lead partner on the Sanofi/Regeneron matter, and is one of the firm’s experienced litigators for Hatch-Waxman and competitor suits.

Daniel DiNapoli and Aaron Stiefel are currently acting for Pfizer in Hatch-Waxman litigations defending against generic challenges to the client's Xeljanz products. Silicon Valley partner Deborah Fishman represents Regeneron in ex parte patent challenges related to its Eylea drug. She is well-versed in Patent Office proceedings and other IP disputes.

For patent strategy, David Marsh is recommended for his expertise managing life sciences patent portfolios. He is currently active for Bayer and Bruin Biometrics in prosecution and strategy.

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.

Arnold & Porter is a full-service life sciences firm with top-tier status in antitrust and product liability matters, with an additional national ranking in white-collar defense. A peer notes the firm has "solid credentials" in life sciences-related litigation. For the firm's involvement in high-profile competition suits, Arnold & Porter was awarded 2020 Antitrust Firm of the Year by LMG Life Sciences, the second year in a row the firm earned the honor.

Partners Saul Morgenstern and Laura Shores support the firm’s high caliber antitrust group, recently drawing attention for their involvement in a generic pharmaceutical antitrust litigation for Novartis subsidiaries Sandoz and Fougera. Morgenstern was shortlisted for the 2020 Antitrust Litigator of the Year award, a category he won last year from LMG Life Sciences.

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, as well as Bristol-Myers Squibb and Sanofi in investigations related to promotion of the drug Plavix.

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. Los Angeles partner Pamela Yates is "fantastic" and "very talented" to peers for her practice focused on class actions and product liability suits. She is noteworthy for her high-profile representations in the life sciences area, exemplified by her recent activity for Endo defending the client from claims related opioid products. New York partner Anand Agneshwar is representing Bristol-Myers Squibb in ongoing product liability matters, one of which was recently dismissed by federal MDL court. Lori Leskin and Andrew Solow both bring significant experience in product liability matters, supporting the firm’s top-tier ranking in the area.

Headquartered in DC, Arnold & Porter is a full-service firm with an established reputation for assisting a wide range of life science clients with regulatory issues. In addition to handling all matters for pharmaceutical and medical device companies in front of the FDA, the firm also has experienced professionals in the pricing and reimbursement space.

Life sciences practice co-chair Dan Kracov is routinely recognized as a top regulatory attorney, with one peer exclaiming he is “very sharp” and “if I had any enforcement issues I would send it to Dan.” Kracov, who is this year’s FDA Pharmaceutical Attorney of the year, also represents companies in biotechnology, medical device and diagnostics space throughout the entire life cycle including development, approval, and marketing issues.

Fellow co-chair Allison Shuren focuses her practice on regulatory compliance matters, specifically healthcare abuse and fraud. She 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.

Jeff Handwerker dedicates his practice advising a number of life sciences companies in all aspects of their product development, with a particular expertise assisting in the pharmaceutical space. He was recently active for clients in price reporting matters, anti-kickback compliance and congressional inquiries.

Another star practitioner at the firm is Mahnu Davar, who regularly works with Kracov assisting clients on a host of FDA-related regulatory and compliance matters. Davar, alongside Kracov, Shuren, and Handwerker, have been leading the firm’s efforts in assisting life sciences clients in the development of COVID-19 vaccines, drugs, medical devices and diagnostics.