Townsend has significant experience in pharmaceutical litigation arising out of the Drug Price Competition and Patent Term Restoration Act (the "Hatch-Waxman Act"), which sets forth the process by which generic drug manufacturers can file Abbreviated New Drug Applications (“ANDAs”). Our patent prosecutors and litigators combine their litigation and counseling expertise to advise a number of our clients in the pharmaceutical industry, developing a wide range of products including those directed to oral contraception, treatment of depression and sleep disorders, and antiepileptics.
Specifically with regard to ANDAs, Townsend has represented both pharmaceutical innovators and generic drug companies. Many of Townsend attorneys who practice in the pharmaceutical arts have advanced technical degrees and academic or industry experience in addition to their legal education. Our attorneys have a thorough understanding of the drug development process and the underlying science. We know what it takes to succeed in litigating patents, whether it be at the early pre-litigation stage of due diligence counseling, preparing opinions on patent validity and infringement related to the ANDA filing, pre-launch clearance search and risk assessment analyses, or actual litigation of pharmaceutical patents in the U.S. District Courts.
Areas of specialized expertise include:
- ANDA litigation
- Clearance of orange book listing
- Paragraph IV certification
- Patent non-infringement opinions