Life Sciences

Overview

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 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.

Intellectual Property

Our lawyers have excellent technical and legal credentials and, in many cases, invaluable industry experience in the life sciences, chemistry, and biotechnology spaces. Crowell & Moring meets the diverse needs of clients in the life sciences industry by drawing from a wealth of intellectual property and information technology experience. Our lawyers have excellent technical and legal credentials and, in many cases, have worked directly in the life sciences, chemistry, and biotechnology spaces. Our services encompass everything from providing guidance in the development, protection, and monetization of assets to enforcing and defending clients’ IP rights.

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.

Antitrust

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.

Government Contracts

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 mass tort, product, and consumer litigation practice spans the full gamut of capabilities, including class actions, multidistrict proceedings, and national and regional coordination of litigation. Our lawyers have litigated high profile and complex cases involving pharmaceuticals, medical devices, and toxic substances. Our substantial product litigation experience positions us well to help our clients avoid litigation. We advise clients on matters involving product safety, including risk management advice and counseling; product labeling issues including indications for use and warnings; and products investigations, addressing defects, and handling recalls.

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.

Insights

Firm News | 2 min read | 03.14.24

Chambers Ranks Crowell Lawyers and Practices in 2024 Europe Guide

Chambers and Partners has ranked five Crowell & Moring practice groups and seven individual lawyers in the Chambers Europe 2024 guide.

Representative Matters

  • Patent license litigation. Represented a plaintiff licensor of drug development technology in a breach of patent license action in the Southern District of New York. Prevented assertion of patent invalidity and patent misuse defenses on grounds of licensee estoppel. Icahn School of Medicine at Mount Sinai v. Neurocrine Biosciences, Inc.
  • Patent infringement litigation.Represented the University of California in three related patent infringement actions asserting UCSF patents covering methods of treating atrial fibrillation in the Northern District of California. Regents of the University of California v. St. Jude Medical, Boston Scientific Corp. and Atricure, Inc.
  • $34 million jury award for soft-tissue graft technology.Represented plaintiff LifeNet in patent-infringement action involving soft-tissue grafts in the Eastern District of Virginia. Jury awarded LifeNet over $34 million; decision affirmed on appeal. LifeNet Health v. Life Cell Corp.
  • Trade secrets litigation win. Successfully represented a generic pharmaceutical company in a breach of contract and misappropriation of trade secrets claim in the District of Delaware. Lonza Sales AG v. Progenics Pharmaceuticals, Inc.
  • Patent Trial and Appeal Board victory for anti-cancer drugs. Represented petitioner Apotex in inter partes review before the PTAB related to anti-cancer drugs, securing victory for Apotex.
  • Appellate victory for multiple sclerosis drug.Represented petitioner Apotex in inter partes review before the PTAB related to a multiple sclerosis drug, securing victory for Apotex at the PTAB and in the resulting appeal at the Federal Circuit. Apotex, Inc., et al. v. Novartis AG, et al.
  • Coumadin® antitrust and consumer fraud cases. Represented a pharmaceutical manufacturer in Federal Trade Commission (FTC) proceedings and as national coordinating trial and appellate counsel in a series of antitrust and consumer fraud class actions directed at alleged misrepresentations regarding a pharmaceutical product and its generic competition.
  • Brand name prescription drug antitrust litigation. Defended a major pharmaceutical company against a nationwide class of retail pharmacies and thousands of individual opt-out pharmacies alleging antitrust claims in federal court. We also represented the company in numerous parallel state court class actions brought by retail pharmacies and consumers alleging state law antitrust and consumer fraud violations.
  • Acquittal of criminal charges. Obtained acquittal of the vice president for quality assurance of a major pharmaceutical company, accused of conspiracy, obstruction and other charges, in federal court in Maryland after the company itself had pleaded guilty and paid a $10 million fine for the same.
  • Grand jury investigations. Represented of the leading blood bank in the New York metropolitan area, and one of the largest in the country, in two grand jury investigations of alleged falsification of viral testing. Despite the conviction of two lab supervisors, no criminal changes were brought against our client.
  • New Drug Application (NDA) approval process assistance. Blocked the Food and Drug Administration (FDA) from giving a competitor's product an unfair advantage in the NDA approval process. On behalf of a drug manufacturer, we petitioned the agency to treat similar products similarly, and successfully sued in federal court when FDA failed to do so.
  • Product seizures. Represented an over-the-counter (OTC) drug manufacturer in federal court and in negotiations with FDA to resolve the agency's seizure of a large quantity of product at a distributor's warehouse. The settlement permitted the company to continue distributing the product.
  • Investigator disqualification hearings. Defended a clinical investigator in the first disqualification hearing held in years, the result of FDA's increasingly aggressive enforcement activities aimed at clinical investigators and their institutions.
  • Trade matters. Defended the boycott and restraint of trade charges against a health plan for maintenance of a limited pharmacy network.
  • Antitrust litigation. Served successfully as defense counsel in antitrust litigation in Alabama arising out of the pricing system that pharmaceutical manufacturers have implemented that differentiates between "retail" pharmacies and managed care payers/providers of prescription drug products.
  • Junk science cases. Prepared successful Amici briefs in Daubert v. Merrell Dow Pharmaceuticals, Inc., and Carmichael v. Kumho Tire Co., two Supreme Court junk science cases.

Insights

Firm News | 2 min read | 03.14.24

Chambers Ranks Crowell Lawyers and Practices in 2024 Europe Guide

Chambers and Partners has ranked five Crowell & Moring practice groups and seven individual lawyers in the Chambers Europe 2024 guide.

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Professionals

Insights

Firm News | 2 min read | 03.14.24

Chambers Ranks Crowell Lawyers and Practices in 2024 Europe Guide

Chambers and Partners has ranked five Crowell & Moring practice groups and seven individual lawyers in the Chambers Europe 2024 guide.