Chemical, Biotechnology & Pharmaceutical
Foley’s Chemical, Biotechnology & Pharmaceutical attorneys serve the diverse needs of life sciences companies looking to meet the challenges of a competitive, dynamic marketplace. Our attorneys work with you to secure, manage, and enforce strong patents throughout the world.
All life sciences companies — whether start-ups or commercial-stage enterprises — grapple with challenges ranging from securing global IP protection to obtaining regulatory approvals. Our Chemical, Biotechnology & Pharmaceutical attorneys provide legal services to help protect your innovations while helping you identify opportunities to remain competitive in the industry.
The legal solutions we have provided to our clients include:
- U.S. and foreign patent procurement, including accelerated examination and patent prosecution highway
- Patent portfolio management
- Patent enforcement
- Freedom to operate analysis and product clearance
- Licensing and technology transfer
- Due diligence in mergers and acquisitions and financing transactions
- Defense of infringement claims
Our Chemical, Biotechnology & Pharmaceutical Practice comprises more than 60 core members, including attorneys, patent agents, technical specialists, and specialized professionals, and more than two-thirds of our team has earned advanced degrees in chemical and biological sciences. By combining our educational and technical backgrounds with our legal services experience, we have the ability to understand your innovations and issues inside and out. Some of the areas in which we counsel clients like you include:
- Biotechnology: Pharmacology; vaccine development; gene therapy technologies; diagnostic medicine; stem cell technologies; personalized medicine technologies; drug delivery and design; immunology and virology; antibodies; and biomedical research and development
- Chemical: Chemical engineering; organic and inorganic chemistry; small molecule chemistry; chiral chemistry; metallurgy; semiconductor and superconductor materials; polymers; enzymes; and pharmaceutical formulations and delivery systems
- Agricultural Biotechnology: Plant sciences; fertilizers; and green energy technologies
- Nutraceuticals
- Synthetic Biology
Our practice also offers a deep bench of patent agents, former USPTO examiners, former clerks to judges of the U.S. Court of Appeals for the Federal Circuit, and prolific writers and speakers on issues pertinent to the life sciences industry. This experience enables us to provide you with a full-range of IP services with a detailed understanding of your technical needs.
We understand that patent procurement and IP management occurs within the context of your company’s business objectives and goals. We approach your IP management strategy with your unique business objectives and goals in mind, providing careful drafting of patent applications and skillful procurement of worldwide patent rights. We also provide due diligence and counseling while negotiating competitive licensing and distribution agreements and technology transfers on your behalf. As necessary, we will advise you on litigation, interferences, International Trade Commission actions, and other inter partes matters to ensure optimal protection and exploitation of your valuable technologies.
In addition, with offices strategically located throughout the United States and in Brussels, Tokyo, and Shanghai, we are able to draw on the firm’s worldwide resources and global presence to help you achieve your IP and business objectives in the most direct and cost-effective manner anywhere in the world. We can help you obtain trademark and patent protection in the United States, the European Union, and throughout Asia, assisting in the negotiating the unique requirements of each region. This work often involves the investigation of infringement, research of specific protections, and the analysis of current patents.
In addition to serving as your IP counsel, we can advise you on state and federal regulatory compliance, assist in inquiries and investigations, and guide you through the regulatory permitting and approval process, including hearings and documentation requirements. We can provide comprehensive counsel to you on all aspects of regulatory compliance and enforcement involving small molecule, biologic, and biotechnical drugs — both prescription and OTC — before the FDA and its counterpart authorities abroad. This counseling includes strategic business planning, product development and testing, submissions, product marketing, regulatory compliance and enforcement, advertisement and promotion, and legislative branch lobbying at both the federal and state levels.
Foley clients ultimately benefit from our full-service approach to handling each unique product life cycle. As a single-source legal services provider, we offer you the ability to quickly and efficiently draw on our full-service team to anticipate challenges, seize opportunity, and ultimately protect valuable assets. We regularly counsel clients like you on corporate issues from organizational strategy and planning for marketing and promotion to comply with federal regulatory and Uniform Commercial Code guidelines. We provide strategic planning for Medicare, Medicaid, and private payer coverage and reimbursement, and advise you on compliance with health-care-specific laws relating to kickbacks, self-referrals, and patient inducements.
We also provide counsel on employment agreements, such as confidentiality agreements, agreements on the ownership of processes and research, noncompete agreements, and agreements with distributors and dealerships.