We help clients keep up and thrive in a constantly shifting landscape. Our attorneys are at the forefront of industry trends, advising clients on everything from adopting new business models and navigating the regulatory landscape, to devising innovative IP protection and monetization strategies.
The global life sciences industry is advancing rapidly. Increased generic competition, the changing patent landscape, evolving regulations, and pricing pressures present new challenges and opportunities for companies across the sector.
Our cross-disciplinary team can steer you through every phase of your life cycle, helping you carefully consider all of your options, and execute effective growth strategies—whether through licensing, M&A deals, or other types of transactions.
And while we have a lot of experience with transactions and litigation for large public companies, we have a passion for helping mid-market and start-up companies grow.
The rapidly changing life sciences ecosystem presents a lot of exciting opportunities. We’re focused on helping clients leverage those opportunities and make strategic decisions that maximize their business potential.
Who we work with
- Biotech companies
- Medical device companies
- Pharmaceutical companies
- Academic medical centers
- Leading universities
Representative Corporate, Regulatory, and Transactional Matters:
- Representing a Canadian company in coordinating the research, development and licensing of medical isotope technology with a U.S. Government laboratory and state university.
- Representing a start-up company developing a care model for diabetes in the licensing of intellectual property from a university and the formation of a joint venture with a bioinformatics company to develop and commercialize the technology.
- Represented the world's largest biological resource center and the most comprehensive source of reference cultures and reagents used by researchers, in negotiating and drafting numerous distribution and development agreements with companies throughout the world.
- Counseling a large biologics company, providing an opinion on the eligibility of its new drug product for marketing exclusivity and patent term extension.
- Representing a medical device company in responding to an FDA import detention and refusal involving products made by its contract manufacturer in China, and responding to a Form FDA-483, Inspectional Observations, regarding compliance with Current Good Manufacturing Practice (“CGMP”) requirements.
- Assisting a large biologics manufacturer on the preparation of a challenge to an FDA decision awarding orphan drug exclusivity to a competitor.
- Represented a biologics company in preparing and obtaining a successful response to a citizen’s petition from the FDA. The problem involved limits on orphan drug designation.
- Advised a biopharmaceutical company focused on new drugs candidates targeting GPCR, in a multi-million dollar financing.
- Advised a company specializing in proton therapy treatment, in its $10 million financing from existing shareholders.
- Advised a French biopharmaceutical company in its fund raising from seed to Series A, B and C rounds, and on a broad range of matters such as build-up operations, mergers, spin-off, asset deals, employment and executive management remuneration and incentive packages, joint venture agreements, and partnerships.
- Represented a biotechnology company focused on novel pharmaceutical therapies that seek to exploit RNA editing and DNA editing enzymes, in negotiating a license into the company relating to its core technology, and represent the company with regard to the creation and maintenance of its stock option plan and other general legal matters.
- Represented a growth-stage medical device company focused on the development of biodegradable silk-based scaffolds for use in tissue regeneration in numerous therapeutic areas in its sale to a multi-specialty health care company that develops pharmaceuticals, biologics, medical devices and over-the-counter consumer products.
- Represented a Swedish medicinal and analytical chemistry company in the acquisition of two product lines and associated business from a leading provider of cutting-edge technologies in the life science industry.
- Represent a well-known biopharmaceutical company in a variety of real estate transactions including leasing, permitting, construction contracting, and financing, related to multiple client facilities and offices.
- Handle leasing work on behalf of a large manufacturer of analytical and medical instruments.
Representative Litigation Matters:
- Represented the plaintiff, a well-known medical device company, in a patent infringement case in the U.S. District Court for the District of Massachusetts. Our client was awarded a multi- million dollar verdict for lost profits and a 16% royalty (on sales not included in lost profits).
- Represented one of the largest healthcare companies in the world in connection with the company’s global settlement of three separate government investigations for $3 billion—the largest health care fraud settlement in U.S. history. Of the three investigations, Nixon Peabody attorneys were the primary counsel for the company in the defense of an investigation by the Department of Justice relating to the company’s Medicaid “best price” reporting. Our attorneys were also significantly involved in the defense of the investigation by the U.S. Attorney’s Office for the District of Massachusetts relating to the government’s allegations of off-label promotion and anti-kickback violations. The case settled favorably for our client.
- Represented the plaintiff, a leading medical device company, in a patent infringement case in the U.S. District Court for the Northern District of Illinois. The case was settled on terms favorable to our client.
- Served as Counsel for over 66 pharmaceutical companies in role as liaison counsel for Average Wholesale Pricing matters venued in commercial court in New York. The case was favorably resolved for our clients.
- Currently defending Shire Human Genetic Therapies in a Lanham Act false advertising case brought by Genzyme.
- Represented a pharmacy chain and a national grocery store and in a putative class action in the Northern District of California involving alleged inflation of average wholesale pricing (AWP) for prescription drugs by national pharmacy chains Supervalu Inc., New Albertson’s Inc., Walgreens Co., Longs Drugs Stores Corp., The Kroger Co., Safeway Inc., Wal-Mart Stores Inc., CVS Caremark Corp., and Rite Aid Corp. In January 2010, the case was dismissed with prejudice by the trial court for failure to state a claim. On February 9, 2012, the Ninth Circuit Court of Appeals unanimously affirmed the trial court’s dismissal.
Awards & Rankings
- The Legal 500 United States
- Recommended as a leader in the Healthcare: Life Sciences industry
- Managing IP magazine’s World IP Survey
- Recognized as a national leader in the patent category for bio life sciences
- Dealmakers Q&A
Law360 | August 13, 2014
Health Care and Life Sciences leader Michele Masucci is profiled in this Law360 Q&A series with dealmaking movers and shakers.
- FDA's Biggest New Policies of 2014: Midyear Report
Law360 | July 28, 2014
Washington, DC, Health Care and Life Sciences partner Areta Kupchyk is quoted in this forward-looking feature story on new rules and guidance from the U.S. Food and Drug Administration making waves for drug and device makers.
- What's Trending with Mobile Medical Apps and Health IT?
Bloomberg BNA Health IT Law & Industry Report | July 21, 2014
Washington, DC, Health Care and Life Sciences partner Areta Kupchyk authored this article discussing a potential new Food and Drug Administration framework for mobile medical apps and health IT. Click here to read the full article.