Morgan Lewis & Bockius

Morgan Lewis & Bockius is a full-service global law firm specializing in representing emerging businesses and investment management firms, mainly from the Princeton office, but also from the West Coast. One peer remarks the firm as having a deep bench of licensing and collaboration specialists. Morgan is active in IPOs; having recently done a $46 million initial public offerings for Antares Pharma, Inc. and a $26 million one for Cerecor Inc. Notable clients include Shire, Takeda, Boston-based Radius Health, and Lundbeck, a Danish pharmaceutical company.

Randall Sunberg chairs the firm's Life Sciences Transactions Practice, from Princeton, alongside David Glazer, Emilio Ragosa, and Alan Leeds, who are active in life sciences M&A, collaboration and licensing split between pharma and biotech and medical devices. Currently, he represents Teva in their acquisition of Allergan's generic business. He has represented GlaxoSmithKline in divesting its remaining rights to Vectibix, XGEVA, and Prolia and restructuring its collaboration agreement with Amgen. He also recently represented pharmaceutical client Incyte in connection with the negotiation of a global license and $770 million collaboration agreement with Jiangsu Hengrui Medicine, a China-based pharmaceutical company, for the development and commercialization of a monoclonal antibody for treating cancer. This deal is winner of a 2016 LMG Life Sciences award for Collaboration Impact Deal of the Year.

Morgan Lewis & Bockius is active in the Hatch Waxman branded space and works in close collaboration with the transactional subgroup. The firm is skilled in pre-litigation planning and patent prosecution as well. Recently, Morgan Lewis won an inter partes matter for Israeli pharma company Kamada against Spanish company Grifols, in relation to Grifol's patent for PROLASTIN-C, which has US sales of more than $500 million. Litigator Richard De Bodo, who joined from Bingham McCutchen is a lead trial counsel in patent and trade secrets cases and tries Hatch-Waxman cases and cases. Jeffry Mann is primarily a prosecutor in a diverse grouping of areas through the life sciences, including pharma, as well as probes, reagents, diagnostics, genomics, and digital PCR. Additionally, he is active in transactional and premarketing diligence.

Morgan Lewis & Bockius is a global full-service law firm with the size and scope to service every need of life sciences companies. Next to financial services, life sciences is the firm's largest practice area. The firm has offices across the world and is particularly well known for its regulatory capabilities based out of Washington DC. Stephen Paul Mahinka leads the firm's life sciences practice; he also founded the FDA regulatory practice and has led the antitrust practice. Through his interest in product lifecycle development, he was integral to changing the firm's management structure to an industry-based approach around the year 2000. This has shaped the firm's hiring moves and geographic expansions within the last 15 years. The firm is now active in about 40 percent more areas, having expanded its West Coast capabilities through its acquisition of the Brobeck, Phleger & Harrison firm in 2003 and boosted East Coast capabilities with the acquisition of Bingham McCutcheon. Morgan has extended its IP capabilities, and Chicago and California are home to many of the firm's patents litigators, who deal regularly with Hatch Waxman and biosimilars issues. Integral to this turn of events was this year's addition of four K&L Gates partners including 2016 LMG Life Sciences Star Michael Abernathy who have expertise in drug patent litigation in federal district courts and before the U.S. International Trade Commission Today, Morgan services both startups and established companies in corporate structuring, formation, and funding, while also protecting technology on the patent, trademark, and FDA exclusivity ends. Additionally, Morgan Lewis has the R&D capabilities to assist with agreements, clinical trials, regulatory approvals, and clinical trials. Morgan Lewis prides itself on its team-oriented work culture.

The regulatory practice comprises FDA, healthcare, and regulatory capabilities. Kathleen Sanzo, a 2016 addition to the LMG Life Sciences Hall of Fame is an FDA practice leader active in foods, drugs, combination products, and diagnostics. She is one of a handful of leading drug lawyers in the nation and, with Mahinka, she has co-written the chapter on pharmaceutical marketing and promotion for a Food and Drug Law Institute treatise.

Donna Yesner is a valuable asset to the firm's general health-care reimbursement capabilities, specializing in government purchasing and contracting. The rising importance of e-health, telemedicine, and medical devices has raised FDA regulatory and corporate issues, as well as FCC and FTC regulation questions in the last couple of years. The Bingham merger allowed Morgan to expand into telecommunication, since Bingham has one of the leading telecommunications practice in the US. Michele Buenafe is a leading attorney in digital health issues who focuses her practice on counseling, pre-market issues, and postmarket compliance.

Morgan has extended its IP capabilities, and Chicago and California are home to many of the firm's patents litigators, who deal regularly with Hatch Waxman and biosimilars issues. This practice feeds into the firm's regulatory practice bringing up issues around market exclusivity, counterclaims for improper orange book listing, and patent extension issues. Based on the West Coast, Richard De Bodo is a lead trial counsel in patent and trade secrets cases and tries Hatch-Waxman cases and cases. Jeffry Mann is primarily a prosecutor in a diverse grouping of areas through the life sciences and is active in transactional and premarketing diligence.

Morgan is very active with emerging businesses in the big centers of finance and developments for life sciences companies including Boston and Silicon Valley. From the Princeton office, Randall Sunberg, Emilio Ragosa, Alan Leeds, and David Glazer are active in M&A, collaboration and licensing which is split between pharma, biotech, and medical devices. Morgan represents banks in transactions, but more often than not, life sciences companies. The firm's FDA group is tightly knit to the corporate business and finance group, being active in pharmaceutical due diligence. Morgan Lewis has a handful attorneys in the US that focus on life sciences licensing transactions dealing with product approval processes and split territories.

Having seen considerable expansion since its beginnings as a Philadelphia-based full-service firm, Morgan Lewis & Bockius continues to enjoy a reputation as one of the most prominent players in all aspects of the life sciences sphere. Leading litigators have been identified nationally, in offices from Philadelphia, Washington, DC, San Francisco, Dallas and New York. The firm's footprint was widened further by its 2014 absorption of Bingham McCutchen, which brought the firm to the forefront of the Boston market as well, and added a particular enhancement to Morgan Lewis's antitrust capacity as well as its portfolio of pro bono matters.

Philadelphia's Gordon Cooney, a commercial practitioner with a sub-specialty in class actions who is widely praised among peers in Pennsylvania and beyond, recently logged a significant victory for pharmaceutical manufacturer Cephalon when the US Court of Appeals for the Third Circuit in August 2015 upheld a district court's dismissal of an action brought by various Travelers Insurance entities against the client. Travelers sought $22 million in workers' compensation claims related to prescriptions of Actiq and Fentora, two medicines indicated for the treatment of cancer-related pain, which Travelers alleged were the result of off-label promotion. In affirming the district court's dismissal, the Third Circuit found that Travelers failed to plead its fraud claims with sufficient specificity.This thereby caused health care providers to submit false claims for Medicare and Medicaid reimbursement.

White-collar, antitrust and commercial partner John Dodds achieved a significant victory for medical device manufacturer C.R. Bard and subsidiary Bard Access Systems in a long-standing False Claims Act (FCA) case. The plaintiff originally filed the case in 2011 in the US District Court for the Eastern District of Louisiana, alleging that Bard violated the FCA by fraudulently marketing reverse taper peripherally inserted central catheters and thereby caused health care providers to submit false claims for Medicare and Medicaid reimbursement. In September 2015, Dodds secured dismissal of all claims against Bard with prejudice, less than a month before the close of discovery. In the firm's DC office, antitrust nominee Willard Thom is respected by peers as "a real breakout star, a great thinker and a good guy."

Morgan Lewis & Bockius operates a FDA practice largely from the Washington DC office but works closely with the corporate, finance, and investment group, particularly in the due diligence behind collaborations agreements. The firm has boosted the number of technology clients it represents, particularly in telemedicine (i.e. remote diagnosis and treatment), through a recent merger with Bingham McCutchen, which had one of the nation's leading telecommunications practices. Stephen Paul Mahinka is the head of the firm's regulatory practice and life sciences groups. In 2000, he was integral in reorganizing the firm into industry groups. He is also a key founder of the "lifecycle" law firm concept, an idea he gleaned from the product life cycle analysis concept developed at Harvard Business School. Kathleen Sanzo operates a full-service FDA practice, working mostly in drugs and foods but increasingly in combination products and companion diagnostics and in-vitro diagnostics used to diagnose certain disease conditions that then can be treated with drugs and therapies.

Michele Buenafe is a partner in the FDA practice group, who also has experience as a GMP consultant for pharmaceutical manufacturers; she focuses her practice on counseling, pre-market issues, and postmarket compliance. Buenafe is particularly active in digital health, an extension of her medical device practice – having worked with a wide range of medical and fitness technologies, including health information systems, clinical decision support software, fitness applications, and wearables. She has represented the Consumer Technology Association to shape FDA policies by determining what issues are impacting electronic companies; she has also represented the University of Pittsburgh Medical Center (UPMC) in the development of telehealth software.