Pharmaceutical and Life Sciences

Experience

• Selected for monitorship of one of the world's largest manufacturers of generic medicines as part of FCPA settlement. Includes creation and implementation of multi-jurisdictional DOJ compliance program.
• Represent several pharmaceutical company officers in a large, multi-jurisdictional DOJ investigation involving FDA issues and anti-kickback statutes related to nationwide sales practices of opioid painkiller products.
• Represent pharmaceutical company and its affiliate in five new Hatch-Waxman patent litigations seeking to introduce generic pharmaceuticals into the market.
• Represent pharmaceutical client in defense of trademark infringement complaint filed in US District Court for District of Massachusetts, obtaining full dismissal of claims.
• Represent Sagent Pharmaceuticals, a leading provider of affordable pharmaceuticals to hospital market, in its $40 million acquisition of a portfolio of five ANDAs in the United States from Teva Pharmaceutical Industries and Actavis (Allergan Generics) as a result of the largest merger of generic pharmaceutical companies in history.
• Represent biopharmaceutical company with a focus on the treatment of patients with rare and debilitating dermatologic and head and neck conditions in its receipt of a $48 million investment from affiliates of Fidelity Investments.
• Defended nutritional ingredients and medical foods developer and manufacturer, and its directors and officers, in securities class action over alleged failure to disclose that sales of a product would be greatly affected by changes in the Chinese regulations of infant formula manufacturers in its IPO and secondary offering documents.
• Represented biopharmaceutical company Amarin in a securities class action over an alleged misrepresentation to investors regarding the likelihood of FDA approval for a broader indication.
• Represented pharmaceutical company in antitrust and breach of contract suit against a multinational consumer goods company over the right to sell a generic decongestant. The consumer goods company agreed to sell the plaintiffs a generic form of the anti-congestion drug if they failed to obtain FDA approval for their own generic before a third party launched a similar version.
• Represented Apotex in antitrust and patent claims—including Walker Process fraud, the Therasense standard for inequitable conduct and reverse-payment liability theories—in relation to being illegally excluded from the billion-dollar-a-year market for a narcolepsy drug.
• Represented privately held China-based company provider of pharmaceutical products in its sale to a US-based, China-focused specialty pharmaceutical company valued at more than $100 million.
• Represent Hospira, a leading company in generic injectable pharmaceuticals, in a joint venture with a private equity fund for development, regulatory approval, commercialization and distribution of three biosimilar products.
• Outside compliance counsel to an innovator of medical devices and solutions in orthopedics, spinal care and neuroscience. We provide regulatory compliance advice related to sales practices and physician relationships, conduct multiple internal investigations, and interface with the DHHS Office of Inspector General.
• Represent former member of the board of directors of a pharmaceutical corporation in an SEC and DOJ investigation of the company involving possible violations of the FCPA concerning drug approval and price reimbursement in China as well as various restatements of the company's financials unrelated to any alleged FCPA violations.
• Represented investment firm and its related funds in purchasing up to $36 million of convertible notes issued by a publicly held pharmaceuticals developer. Involved restructuring our client's prior loan to the developer.
• Defended biotechnology company in putative class action brought in the US District Court for the District of New Jersey under Section 10(b) of the Securities Exchange Act of 1934. Plaintiffs also alleged violations of Section 11 of the Securities Act of 1933 based on purportedly misleading statements made during a secondary stock offering. We obtained dismissal based on failure by plaintiffs to state legally sufficient claims under the Exchange Act and Securities Act and scienter.
• Represented president of a pharmaceutical company in a seven-week federal criminal jury trial in the US District Court for the Eastern District of New York. The case concerned the alleged importation of pharmaceuticals that were not approved by the FDA. We obtained acquittals on the most serious counts in the indictment, The US Court of Appeals for the Second Circuit erased all convictions and ordered a new trial.
• Represented global pharmaceutical company in patent dispute in a Hatch-Waxman litigation over an antibiotic drug. We sought and received an expedited proceeding that led to an optimal settlement structure after our summary judgment briefing was filed.
• Represent one of the largest Japanese generic pharmaceutical companies based in two Hatch-Waxman patent litigations seeking to introduce generic pharmaceuticals into the market.