Hatch-Waxman Litigation

The complex statutory and regulatory schemes governing generic pharmaceuticals and U.S. patent law complicate generic pharmaceutical litigation. At Robins Kaplan LLP, our Hatch-Waxman attorneys work across the full spectrum of Hatch-Waxman/ ANDA matters.  Our experience includes representation of small and large start-ups, generic pharmaceutical and innovator pharmaceutical companies, and companies that do both. We also draw on the knowledge and experience of the attorneys and scientists throughout the firm who have relevant technological backgrounds, including advanced degrees in biology, chemistry, biochemistry, biomedical engineering, pharmacology, and physics. Together, our trial litigation and technical breadth offers clients a big-picture perspective on what’s needed when pursuing matters under the Hatch-Waxman Act and informs our strategic ANDA counseling and advice to industry members.

In addition, we publish GENERICally Speaking: A Hatch-Waxman Litigation Bulletin to help clients and subscribers stay on top of industry news and outcomes, follow trends in the judiciary and the steps others are taking, and keep informed of recently enacted rules and legislation. Each quarter, we summarize and provide insight into relevant case decisions, and list newly filed cases, settlements, ANDA approvals, and generic drug launches.