The ongoing biotechnology revolution affects all aspects of our lives: the way we live, the foods we eat, and the way we care for our health and our environment. Despite the benefits they deliver, life sciences and pharmaceuticals companies, researchers, and educational institutions operate in one of the most highly regulated and contentious areas of commerce.
The experienced pharmaceuticals and life sciences team at Crowell & Moring helps businesses and individuals explore and exploit new opportunities and markets for their products and ideas, ensure compliance with international and national regulatory requirements, and resolve disputes through litigation, mediation, and settlement. Our clients include individual inventors, research labs, privately owned start-ups, small to large biotech product and platform companies, and multinational pharmaceutical, bioagricultural, and chemical companies.
We provide full-spectrum legal counsel in the following areas:
Business Formation, Corporate Transactions and Finance
Crowell & Moring represents clients in a variety of corporate securities and business transactions, including business formation, debt and equity financing, cross-border transactions, initial public offerings, mergers and acquisitions, joint ventures, tax, divestitures, domestic and global distribution agreements, scientific research funding arrangements, and wholesaler joint ventures and marketing arrangements.
Patents and Intellectual Property
Our lawyers provide a full range of patent law services to pharmaceutical and life sciences industry clients, including patent prosecution and litigation involving patent validity and enforceability. We are also home to a growing team of patent litigators representing and advising clients in Hatch-Waxman cases. Through ongoing intellectual property audits, we help businesses identify and exploit their IP assets, negotiate licensing and data transfer agreements, and protect their IP rights through effective litigation.
Regulatory and Fraud and Abuse Compliance
We advise clients on a variety of regulatory and fraud and abuse issues, including Medicaid "best price" and other statutory pricing requirements, federal and state anti-kickback and consumer protection laws, development and implementation of formularies, legal risks associated with potential conflicts of interest in business relationships, and DEA investigations of pharmacy drug handling and recordkeeping. Our lawyers also develop compliance programs and policies, and regularly conduct internal investigations and compliance reviews.
Crowell & Moring's renowned antitrust team handles a broad range of antitrust and trade regulation litigation and counseling matters. We regularly advise clients on mergers and acquisitions, joint ventures, licensing arrangements, brand-generic competition restraints, price discrimination issues, distribution-related challenges, unfair competition claims, and exclusion of pharmacy chains from managed care networks.
Crowell & Moring has counseled pharmaceutical manufacturers, medical technology and equipment manufacturers, and prescription benefit managers on Veterans Administration and General Services Administration procurements, Federal Supply Service defective pricing issues, Federal Employees Health Benefit Program requirements, issues related to Medicaid rebates, and matters related to the Multiple Award Schedule.
Litigation and Government Investigations
Crowell & Moring lawyers have represented clients in a broad range of commercial and criminal litigation, including federal antitrust litigation and unfair trade practice investigations, as well as enforcement actions by state and federal regulators. We have successfully represented businesses in antitrust litigation challenging allegedly discriminatory pharmaceutical pricing, fraud and abuse investigations involving rebate arrangements, SEC investigations, and Superfund and environmental crimes litigation and investigations.
Torts/Product Liability Prevention and Counseling
Crowell & Moring's torts practice spans the full gamut of capabilities, including class actions, multidistrict proceedings, and national and regional coordination of litigation. Our lawyers have litigated large-scale product/torts lawsuits involving pharmaceuticals, toxic substances, trade association liability matters, and other significant fraud/product claims, including the high-profile Ritalin pharmaceutical consumer fraud/personal injury cases. Our substantial product litigation experience positions us well to help our clients avoid litigation. We utilize Six Sigma methodology to advise clients on matters involving product safety, including reporting of product issues, interactions with the government on products matters, recall and related remedy options, and retention of experts and associated testing issues for agency proceedings.
International Law and Regulation
Crowell & Moring's U.S., London and Brussels office lawyers advise pharmaceutical and life sciences industry clients on the application and interpretation of EU directives and regulatory matters concerning marketed products, including labeling and advertising, import and export controls, preparation and negotiation of research, development, licensing, and manufacturing agreements for corporate and commercial transactions, licensing of medical products, and antitrust and competition matters. Through our affiliate C&M International, we also works with clients to develop positive life sciences initiatives and manage risk in a variety of international fora, including the World Trade Organization, the Organization for Economic Cooperation and Development, the Asia-Pacific Economic Cooperation forum, and the U.N. negotiations on the Biosafety Protocol.