Nixon Peabody offers a highly integrated, cross-practice approach to serving the complete legal needs of life sciences companies. Consistent with the firm’s emphasis on collaboration and team work, more than 50 attorneys across the firm work seamlessly on the full range of transactional, regulatory, and litigation challenges faced by pharmaceutical, biotechnology, and medical device companies.
Our approach to serving the life sciences industry is to consider legal services in the context of the company life cycle. Whether developing devices or drug formulations, life sciences companies face unique challenges:
- Start-up: Concerns about time-to-market limiting pool of potential investors
- Financing: Keep promising, but unproven, technologies funded
- Research & Development: Increasing regulatory scrutiny by the FDA
- IP Protection: Patentability questions associated with emerging technologies
- Sales & Marketing: Investigations focused on sales force management, labeling, and marketing practices
Recognizing that the legal issues faced at each stage of the company life cycle can be complex, Nixon Peabody’s corporate, regulatory, and litigation attorneys work together to bring diversity of perspectives and experience to solutions:
- University research centers are connected to capital that bridges the funding gap between seed money and private equity through a team experienced in intellectual property, tax exempt financing, and charitable trusts.
- Emerging companies secure financial backing in tandem with needed patent protection from our team of corporate and intellectual property attorneys.
- Venture capital firms work with corporate, FDA, and intellectual property lawyers who perform necessary regulatory and intellectual property due diligence as part of the investment and financing transaction.
- Established companies work with an interdisciplinary sales and marketing team that addresses pricing, advertising, privacy, and regulatory enforcement concerns to assure compliance with marketing products.
At Nixon Peabody, we understand that to be effective, we need to consider your company’s place in its life cycle, the issues you face in advancing to the next stage, and which of our attorneys and professional specialists bring the most relevant resources to your team. This highly industry-focused, client-centric approach is unusual among law firms, and differentiates our life sciences services.
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.
- FDA Cracking Down on Compounders at Historic Pace
Law360 | April 22, 2013
Washington, DC, health services and life sciences partner Areta Kupchyk provides commentary in this feature article discussing the U.S. Food and Drug Administration’s efforts to police the compounding pharmacy sector.
- Medical App Makers Await Regulator Checkups
The Recorder | March 15, 2013
Silicon Valley Global Business & Transactions partner Mavis Yee and Washington, DC, Health Services and Life Sciences partner Areta Kupchyk are featured throughout this article noting that the mobile medical app industry is awaiting formal regulatory guidelines from lawmakers.
- Social Media and the De-Identification of Protected Health Information
Bloomberg BNA Social Media Law & Policy Report | March 12, 2013
This article, co-authored by partner & leader of the health services practice Michele Masucci and Long Island health services associate Carly Eisenberg, addresses the rising popularity of social media bring new challenges for health care providers. Click here to read the article.