Intellectual property, regulatory, scientific and courtroom experience clients trust.
Pharmaceutical and biotechnology industry clients rely on Locke Lord to bring collaborative teams from the Firm’s many practice areas to address every legal and business objective. Our seasoned lawyers protect your most valuable IP assets. They have decades of experience advising on FDA regulatory and public policy matters and also support pharmacy clients and pharmacy benefit management companies (PBMs), providing operational, regulatory and transactional advice, no matter how complex.
Take full advantage of our technical understanding in a variety of scientific fields, including:
This real-world experience enables us to advise pharma clients on virtually any legal issue without losing sight of the science involved. We represent IP interests in all facets of U.S. Patent and Trademark Office practice, including inter partes reviews and reexamination proceedings and appeals. Our FDA Regulatory lawyers have worked in government service and the private sector, and have backgrounds in science, regulation and public policy.
Focused on Your Interests
Our lawyers have significant courtroom experience with bench and jury trials, emergency hearings and Markman hearings. We have represented 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 litigation. We have also represented pharmaceutical clients in high-stakes antitrust litigation as well as proceedings before the Federal Trade Commission.
Locke Lord is among the most accomplished firms in Hatch-Waxman litigation, with vast experience at both the trial and appellate levels. We routinely assist on ANDA and §505(b)(2) drug 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 pharmaceutical, biologic, medical device, 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.
Pharmacies and PBMs
As an integral part of our practice, we also advise retail, mail service, internet, infusion, specialty and institutional pharmacies on licensure, change of control requirements, FDA and DEA regulations and compliance. We also provide operational, regulatory and transactional support to pharmacy benefit management companies and other organizations that provide various pharmacy benefit administration services or support.