Morgan Lewis & Bockius

International firm Morgan Lewis & Bockius is equipped to handle legal needs across the life sciences spectrum, showing particular strength in the financial & transactional space, and capable groups dealing in IP, regulatory and compliance matters. “Morgan Lewis offers expertise in a wide range of specialties that are of use to mid-sized biotechnology companies, and has a long track record of providing excellent advice in the life sciences fields,” a biopharmaceutical client says about the firm’s varied practice. The firm expanded its reach with the absorption of Bingham McCutchen, giving Morgan Lewis a window into the Boston life sciences market.

Morgan Lewis 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.

In the non-IP litigation department, Kathleen “Katie” McDermott shines with a particularly active practice as of late. She recently persuaded the US Attorney’s Office in Jacksonville, Florida to decline a False Claims Act qui tam action against the Mayo Clinic and two of its physicians who performed electrophysiology procedures at Mayo. Gordon Cooney is a commercial practitioner with specific skill in class actions and is widely praised among peers in his Pennsylvania base and beyond. He achieved a favorable settlement for Merck as resolution counsel in connection to longstanding antitrust claims made by a class of direct purchasers citing they were overcharged by hundreds of millions by a Merck predecessor. John Dodds operates in the white-collar, antitrust and commercial litigation space, recently notching a win for medical device client CR Bard and subsidiary Bard Access Systems in a False Claims Act (FCA) case. Antitrust lawyer Willard Thom is singled out by a peer who says he is “a real breakout star, a great thinker and a good guy.” The regulatory practice comprises FDA, healthcare, and regulatory capabilities. Kathleen Sanzo 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.

The firm’s global head of intellectual property Eric Kraeutler is described by a peer as a “very good lawyer,” and “an exceptional IP litigator across a variety of technologies, including biotech.” Life sciences IP practice leader Richard de Bodo shines as another one of the firm’s star trial lawyers, fronting much of the practice’s Hatch-Waxman and general patent litigations. He also offers expertise counseling clients seeking to launch biosimilars under the Biologics Price Competition and Innovation Act (BPCIA). Recently, de Bodo successfully represented Allergan, Aptalis and Forest Laboratories in three separate high-stakes Hatch-Waxman suits in the District of New Jersey related to Aptalis’ top-selling Canasa product. He is shortlisted for the 2017 LMG Life Sciences General Patent Litigator of the Year Award for California. Michael Abernathy is an expert in Section 337 ITC proceedings, currently serving as lead counsel in an ITC litigation for client Baxalta related to patents which cover its product Advate.

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.

Kathleen "Katie" McDermott, who operates from the DC and Boston offices and mines a specialty in the life sciences sphere, has seen a particularly vibrant spike in activity of late. She persuaded the US Attorney's Office in Jacksonville, Florida to decline a False Claims Act qui tam action against the Mayo Clinic and two of its physicians who performed electrophysiology procedures at Mayo. The action was brought by a former employee who alleged a multitude of regulatory and billing violations. After Mayo received a civil investigative demand from the DOJ, McDermott worked with Mayo's legal and clinical teams to quickly assess the allegations and present to the DOJ an argument that the regulatory and billing practices for the procedures did not violate Medicare or other regulations. The DOJ declined to intervene in the action, and subsequently, the former employee dismissed the action before litigation ensued. McDermott is also national counsel for Genesis Healthcare in several False Claims Act investigations asserted against legacy providers acquired by Genesis in recent transactions. The investigations and litigation are now part of a global settlement that has been reached with DOJ and several whistleblowers for an amount significantly less than demanded.

Philadelphia's Gordon Cooney, a commercial practitioner with a sub-specialty in class actions who is widely praised among peers in Pennsylvania and beyond, was retained by Merck as resolution counsel in connection with long-standing antitrust claims of a certified class of direct purchasers who claimed they were overcharged by hundreds of millions of dollars on their purchases of the potassium supplement, K-Dur 20, sold by Merck's predecessor, Schering Plough. Plaintiffs alleged that Schering entered into an unlawful settlement agreement with a prospective generic competitor in the context of Hatch-Waxman patent litigation, which allegedly delayed or blocked the market entry of less expensive, generic versions of K-Dur 20. At the time Morgan Lewis was retained, the case had been pending for approximately 15 years and had been returned to the district court after its summary judgment decision was appealed to the Third Circuit and then to the US Supreme Court. Cooney and his team worked with Merck and trial counsel to develop a resolution strategy and then led the mediation, which resulted in a favorable settlement of the claims of the class. The settlement was preliminarily approved by the district court in May 2017. 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."

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