Pharmaceuticals & Healthcare

Hughes Hubbard’s Pharmaceuticals and Healthcare Practice Group advises U.S. and international pharmaceutical, biotechnology and healthcare clients on the extensive range of legal issues that impact their business.  Formed precisely to bring lawyers together
who are familiar with the culture, problems and solutions that affect international pharmaceutical and healthcare companies, our Pharmaceuticals and Healthcare Group offers sophisticated and precise guidance across a complete spectrum of legal services. Among the services we regularly provide to industry clients are the following:

Mergers & Acquisitions, Joint Ventures, Corporate Transactions and Licensing. 
Our corporate and transactional practice has assisted major international pharmaceutical companies and smaller entities entering or expanding their presence in the U.S., Europe, Latin America, and the Pacific Basin.  Our attorneys are experienced in handling:

• the unique problems associated with licensed pharmaceutical products, biologics and intellectual property
• joint ventures and strategic alliances, specifically including licensing, product development, research and marketing collaborations
• transactions involving international performance and regulatory clearances
• the creation of novel product sourcing and distribution agreements
• negotiating and implementing agreements with contracts research organizations (CROs)

Antitrust.  Our litigators advise industry members on private antitrust litigation, criminal grand jury inquiries and civil governmental inquiries.  Active antitrust review is typically required in connection with mergers, acquisitions and dispositions, and collaborative ventures.  We have represented companies in all phases of Hart-Scott Rodino and post-closing antitrust reviews of collaborations between competitors.  In addition, we regularly advise clients with respect to antitrust issues attendant to product development, marketing, and compliance.  This includes the development and implementation of corporate compliance programs addressing issues ranging from substantive limitations to document creation.  Internationally, we provide advice regarding E.U. competition rules in both our domestic and Paris offices, and have substantive expertise in the increasingly important field of competition law and enforcement in the Pacific Basin, South America, and Africa.

Litigation, Arbitration and Dispute Resolution.  Our general litigation experience includes the representation of pharmaceutical and medical device companies and other healthcare entities in billion-dollar product liability litigation, insurance coverage disputes, general civil litigation and corporate reorganization and bankruptcy cases.  Our expertise extends specifically to forms of alternative dispute resolution, which many pharmaceutical industry agreements require.  We also maintain an active practice in dispute resolution relating to pharmaceutical licensing agreements, involving both private parties and the U.S. Government.  Our Paris office performs these services throughout Europe and has brought actions before the European Commission challenging obstructionist pricing and tax policies imposed by governmental entities in the pharmaceutical industry.

Food and Drug Law.  The Firm represents multinational research-based pharmaceutical companies, as well as foreign and domestic medical device and cosmetics manufacturers of varying sizes in connection with U.S. Food and Drug Administration regulatory matters.  We have established a reputation for applying to difficult food and drug disputes, both administrative and judicial, an imaginative and intellectually rigorous approach combined with the high quality of advocacy that our clients demand.

Employment Law.  Our practice also includes representation in and counseling on U.S. employment law issues, including the development and review of compliance programs; defense in discrimination, wrongful termination and breach of contract cases; the drafting of employment agreements with key individuals; and, if applicable, the negotiation of collective bargaining agreements with local unions.

Government Contracts Law.  The Firm advises companies in connection with obtaining contracts with the U.S. Government and dealing with the Government when disputes arise.  Our services extend from bid protests to post-award audits and enforcement actions, with practice before the Executive Agencies, the General Services Administration (GSA), the boards of contract appeals and federal courts.  We also regularly advise pharmaceutical companies in connection with Federal Supply Schedule contracting under the Veterans Healthcare Act of 1992.