IP Pharmaceutical & Biotechnology

Real-World Experience

Many of our lawyers and scientific advisers have Ph.D.s in the chemical and biological arts. They have developed and executed successful intellectual property strategies for a range of technologies, such as immunology, vaccines, neurobiology, growth factors, protein expression, PCR, pharmaceuticals (protein-based and small molecule), lipid-based drug delivery systems, gene therapy, phage display and microarrays.

Our real-world experience enables us to counsel clients on virtually any legal issue surrounding a lawsuit or transaction without losing sight of the science or technology involved. Pharmaceutical and biotechnology companies also turn to us for assistance in structuring transactions, building strategically solid portfolios and identifying and protecting IP rights. We represent clients’ interests in all facets of U.S. Patent and Trademark Office practice, including inter partes reviews and reexamination proceedings and appeals with the Patent Trial and Appeal Board.

Fighting for Your Interests in Courts

Our lawyers have significant courtroom experience with bench and jury trials, emergency hearings and Markman hearings in federal district courts across the United States. We regularly represent clients in appeals before the U.S. Court of Appeals for the Federal Circuit. Many of our cases have resulted in landmark decisions in pharmaceutical and biotechnology patent law. Some of these decisions set the standards for inherent anticipation of polymorph patents, confirming that the submission of an ANDA is not alone an act of willful infringement, and prohibiting the assertion under the Hatch-Waxman Act of patents claiming “off label” uses of a drug. We have also represented pharmaceutical clients in high-stakes antitrust litigation as well as proceedings before the Federal Trade Commission.

Hatch-Waxman Experience

Locke Lord is among the most accomplished firms in Hatch-Waxman litigation, with vast experience at both the trial and appellate levels litigating patent infringement actions involving blockbuster prescription drugs. We routinely assist on ANDAs and §505(b)(2) applications, paragraph IV certifications and notice letters, exclusivity and forfeiture issues, at-risk launches and patent settlements. We advocate your interests before the FDA and, if necessary, litigate approval and exclusivity issues against the agency.

FDA Regulatory Knowledge

We have deep experience in FDA regulatory matters in all facets of pharmaceuticals, biologics, medical devices, REMS, food, cosmetics and dietary supplements. We represent clients in all phases of the product life cycle, in approvals, post-market compliance, strategic counsel on exclusivities as well as managing enforcement actions, recalls and other regulatory priorities. Clients can also benefit from our experience managing international inspections undertaken by the FDA. Locke Lord has represented pharmaceutical industry clients in high-stakes antitrust litigation as well as proceedings before the Federal Trade Commission.