ANDA Litigation

The passage of the Hatch-Waxman Act more than 30 years ago linked the approval of generic pharmaceutical products to the U.S. patent system. Over time, it has become clear that the regulatory and certification steps under Hatch-Waxman create multiple issues that may only be resolved through litigation in the federal courts. Farney PC attorneys have the proven ability to win these cases, based on a deep and practical understanding of the law, complex litigation, the judiciary and technology. From the outset of litigation, we develop a strategy for winning a Hatch-Waxman matter that is consistent with the objectives of the client. Our attorneys have an impressive record of success in these cases through pretrial summary judgment and at trial, and we also work to find a business solution outside the courtroom when that will achieve our client’s objectives.