Life Sciences

Overview

Arent Fox understands the competitive environments and the underlying technologies and confidentiality issues associated with life sciences products and research. We help our clients manage the entire product life cycle, from scientific breakthrough, through product development and production, to global marketing and distribution.

Clients benefit from Arent Fox’s expertise in intellectual property, corporate transactions and litigation, regulatory compliance and international trade. We concentrate on strategic goals and business issues, helping clients adapt to rapid changes in the marketplace and focus on long-term objectives.

Arent Fox clients range from entrepreneurs and startups to Fortune 100 companies, including food, drug, medical device and cosmetic companies, health care providers, biotechnology firms, pesticide and industrial chemical producers, as well as innovators in nutraceuticals, biologics, microbials, enzymes, telemedicine, nano-scale materials and other emerging technologies.

Arent Fox offers life sciences clients expertise in these areas:

Intellectual Property

We clear, obtain, exploit, police and enforce intellectual property rights worldwide. We help clients:

• Identify intellectual property in early stages of product development.
• Prepare patent and trademark applications.
• Develop long-term patent- and trademark-protection strategies as they move toward product commercialization and distribution.
• Protect their intellectual property rights by identifying unauthorized uses and strategically assessing patent, trademark and copyright infringement.

Government Contracts

Arent Fox represents clients who contract with or receive grants from federal or state governments. Services include:

• Assessing government markets and obtaining government contracts and grants.
• Representing companies in their dealings with federal agencies and Congress.
• Counseling clients in bid protests, claims and other litigation related to government contracts.
• Licensing and protecting intellectual property (patents, technical data and software) under government contracts and subcontracts.
• Helping companies develop research and development strategies that maximize the benefits of government funding while using private funds to protect the company’s intellectual property rights.

Antitrust and Competition Law

Arent Fox counsels life sciences clients on joint ventures and strategic alliances and represents them before antitrust enforcement agencies. Services include:

• Preparing pre-merger antitrust notifications.
• Monitoring competitors’ joint venture operations.
• Monitoring activities as clients’ market share grows.

Health Care

Arent Fox represents a wide range of health care clients, touching on all aspects of the life sciences, including manufacturers of pharmaceuticals and medical devices, hospitals, physicians, long-term care facilities, home health agencies and hospices.

While our clients are working to obtain regulatory approval and bring their products to market, services include:

• Developing strategies for obtaining Medicare coverage, reimbursement and coding of their products.
• Advocating for changes in the existing reimbursement structure.
• Representing health care providers in corporate transactions.
• Advising them on corporate structure and organization, managed care contracting and federal and state licensing and certification.

Food and Drug

Arent Fox works with clients from the beginning of product development to evaluate the regulatory landscape and develop strategies for testing and approval of innovative consumer, medical, industrial and agricultural products, including products improved through biotechnology. Genetically engineered seeds and plants often require clearance from several federal agencies.

Services include:

• Negotiating with regulatory agencies such as Federal Drug Administration, Drug Enforcement Administration, Environmental Protection Administration and US Department of Agriculture.
• Securing product approvals.
• Coordinating clinical studies, field tests and environmental assessments.
• Reviewing product labeling and advertising and managing recalls and enforcement actions.
• Developing risk management strategies.
• Counseling clients on regulatory compliance issues, including export/import clearances, adverse incident and other reporting requirements, government inspections and audits and protection of trade secrets and other proprietary information.

Litigation

Arent Fox’s team of trial lawyers works with life sciences clients to identify and analyze potential risks associated with the distribution of their products.

White-Collar Defense

Arent Fox specialists in white-collar defense defend clients against administrative, civil and criminal enforcement actions and False Claims Act / qui tam actions. Litigation experts also defend food, drug and device developers, manufacturers and distributors faced with product liability lawsuits.

Customs and International Trade

Arent Fox assists clients with aspects of the import and export process. We also respond to challenges from the US Customs Service, defend against and pursue fair trade challenges and monitor and assist in negotiating international agreements affecting trade.

Government Relations

Arent Fox develops legislative strategies on regulatory issues important to life sciences clients. Our government relations team includes former government officials who work with clients to build strategic coalitions and relationships on Capitol Hill, within federal agencies and at the state and local levels.

Notable Clients

• Novavax
• Wal-Mart
• Genzyme
• Elan
• US Oncology

Discover the broad scope of capabilities of the Arent Fox Life Sciences group.