Hatch-Waxman Litigation

We are recognized nationally as outstanding trial lawyers who can win in court for our pharmaceutical clients. The statutory and regulatory schemes governing generic pharmaceuticals and U.S. patent law are highly complex, and they call for highly knowledgeable and experienced trial lawyers. 

The Hatch-Waxman attorneys at Robins Kaplan LLP work across the full spectrum of Hatch-Waxman/ANDA matters, as well as strategic litigation-focused counseling during due diligence and formulation development, and in pharmaceutical-related antitrust matters, drawing upon decades of experience in both patent litigation and the life sciences industry to provide exceptional representation to our clients. Our experience includes representation of companies seeking 505(b)(2) approvals for complex dosages, small and large start-ups, generic pharmaceutical and innovator pharmaceutical companies, and companies that do all three.

We also draw on the knowledge and experience of attorneys and in-house 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, enables a comprehensive understanding of the issues surrounding complex drugs and dosages, and informs our strategic 505(b)2 and ANDA counseling and advice to industry members.

Keeping Our Clients Informed

At Robins Kaplan, we have our finger on the pulse of Hatch-Waxman/ANDA litigation trends.  Each quarter, our attorneys 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. In each issue, we summarize and provide insight into relevant case decisions, and list newly filed cases, settlements, ANDA approvals, and generic drug launches. To receive our quarterly newsletter you can subscribe here.

GENERICally Speaking has repeatedly won recognition from legal publisher JD Supra; most recently, GENERICally Speaking’s authors and articles earned JD Supra’s "Top Author" and "Top Read Article" awards in the life sciences category.