Intellectual Property Litigation

Hatch-Waxman governs patent fights triggered when a generic drug maker seeks FDA approval. When a brand company receives a Paragraph IV certification, it has 45 days to file suit, and doing so triggers a 30-month stay that holds up FDA approval of the generic. These cases sit at the intersection of patent law and FDA regulation, so they call for fluency in both.

Under the Defend Trade Secrets Act and state law, you have to show three things: the information actually qualifies as a trade secret, you took reasonable steps to keep it secret, and the defendant misappropriated it. If you prove your case, remedies can include an injunction and damages, plus exemplary damages in cases of willful and malicious misappropriation. The 'reasonable measures' piece is where many claims succeed or fail, so how you handled the information internally matters.

The International Trade Commission investigates unfair import practices, including patent and trademark infringement on goods coming into the country. ITC cases move faster than district court and can produce an exclusion order that blocks infringing imports at the border. If your problem is infringing products being imported, the ITC can be a strong enforcement option, often used alongside a parallel district court suit.

The Patent Trial and Appeal Board hears challenges to patent validity through inter partes review, post-grant review, and covered business method review. These proceedings are usually faster and cheaper than litigating validity in district court, which is why they've become a central part of patent strategy. An accused infringer will often file a PTAB petition to challenge the patent while the district court case is pending.