Hunton & Williams LLP keeps pace with the scientific discoveries of our clients, and we work swiftly to protect and leverage their intellectual property. Members of our Life Sciences team combine their expansive legal and technical experience to provide clients with knowledgeable and effective representation in all aspects of intellectual property law.
A number of the firm’s intellectual property practice group members devote their practice almost exclusively to chemical, pharmaceutical and biotech matters. These attorneys, many with advanced degrees, handle a wide range of issues covering the biotechnology and pharmaceutical spectrum.
We have handled every aspect of practice before the US Patent and Trademark Office, including preparation and prosecution, filing of appeals, reissues and reexaminations. Additionally, we have significant experience in clearance review, Hatch-Waxman litigation, due diligence and enforcement of life science patents at the district court and federal circuit levels and before the US International Trade Commission.
Our team represents clients of diverse sizes and interests, from established multinational corporations to emerging biotechnology, biologic, pharmaceutical and medical device companies. We represent private entrepreneurs, including specialty industries such as plant biotech, enzyme engineering, pharmaceutical, research tools, vaccines, diagnostics, medical devices, medical IT, genomics and theranostics. We are keenly aware of the obstacles facing the industry today and develop a life-of-product intellectual property strategy tailored specifically to each client's needs.
Adversarial Proceedings at the USPTO
Of particular note is the team’s experience with adversarial proceedings at the USPTO. We have represented pharmaceutical, biotechnology, and other companies, as well as universities, in the panoply of adversarial proceedings available to parties at the USPTO. These include inter partes review, covered business method review, inter partes and ex partes reexaminations, and interferences. Our team includes a number of former USPTO patent examiners and other professionals whose educational backgrounds and private-sector experience run the gamut of technical disciplines. We are deeply familiar with the operations and activities of the USPTO, and are adept at handling complex issues arising from USPTO post-grant proceedings and concurrent federal district and appellate court litigation. We also played an active role in the implementation of the AIA, and draw on this firsthand knowledge when advising clients on how to optimize their positions through the use of these new procedures.
Patent Preparation and Prosecution
The issues facing our clients put us in the thick of the most challenging areas of law, and we guide our innovative clients through the processes and procedures involved in obtaining comprehensive protection for their inventions. We understand patent law and technology, and adapt quickly to developments in the law and the life sciences industry.
Patent Opinion Work
More than almost any other technology, the preparation of thorough and well-reasoned opinions is critical for our clients operating in the life sciences. Frequently, our advice sets the client's strategic agenda for years to come. In the life sciences, "bet the company" decisions turn on the strength of intellectual property claims — hence, our opinions on patentability, validity and infringement. Many of our clients have relied on our experience in deciding whether to pursue research programs and/or financing in particular areas of technology.
Beginning with the assessment of patent portfolios and analysis of ANDA applications, and continuing through strategy and litigation, our work with pharmaceutical industry clients addresses every phase of Hatch-Waxman representation. In addition to skilled patent litigators, our team includes PhDs with specific technical experience who understand the science behind pharmaceutical and biotech products. These attorneys collaborate closely with members of the firm’s Food and Drug Regulatory and Antitrust practices to respond to all phases of Hatch-Waxman litigation.
Our technical experience provides a powerful tool in analyzing the validity and infringement issues associated with Hatch-Waxman litigation. Team members capably assess the science behind drug applications and develop strategies tailored to each matter. We have litigated Hatch-Waxman matters in United States district courts and before the FDA, obtaining successful results for numerous clients.
Team members are also experienced in all aspects ancillary to Hatch-Waxman litigation, including counseling and pre-litigation strategy advice, patent settlements, patent listing issues, 180-day exclusivity and follow-on biologic and complex molecules. We have counseled companies concerning Hatch-Waxman legislation, the Medicare Modernization Act, the Food and Drug Administration Modernization Act and legislation relating to pediatric exclusivity, follow-on proteins, authorized generics and citizen petitions.
Our attorneys have experience in the following areas, among others:
- Small molecule pharmaceuticals
- Pharmaceutical carriers
- Absorbent products and hygienics
- Diagnostic compositions and kits
- Medical devices
- Polymerase chain reaction (PCR) processes
- Automated diagnostics
- Noninvasive sampling
- Combinatorial chemistry
- Proteomic analysis
- Antiviral and antibacterial therapeutics
- Polymer formations
- Gene identification technology
- HIV detection and characterization
- Gene arrays/pharmaceutical receptors
- Gene shuffling technology
- Single nucleotide polymorphisms (SNPs)
- Vector systems for gene expression