The 1984 Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, paved the way for the modern generic-drug market by creating a mechanism for brand-name drug manufacturers and their generic competitors to resolve patent disputes before the generic versions reach the market.

On Thursday, April 16, 2015, Iowa College of Law alumni Erica Andersen and Andy Miller spoke to members of the Intellectual Property Law Society about their careers as Hatch-Waxman litigators. Both are senior associates: Andersen in the Washington, DC, office of Covington and Burling and Miller at the Chicago, IL, office of Locke Lord. Andersen typically represents brand-name manufacturers while Miller usually represents generic manufacturers.

Professor Jason Rantanen moderated a discussion in which Andersen and Miller talked about how Hatch-Waxman suits differs from conventional patent litigation. One important difference is discovery. The Hatch-Waxman process begins when a generic manufacturer files an Abbreviated New Drug Application. Since the Application defines the product at issue in the litigation, Andersen explained “You can know some of what you’re looking for” in discovery.

Miller added: “In the letter that accompanies the Application, the generic [manufacturer] essentially gives the brand[-name manufacturer] all their theories up front for why the generic doesn’t infringe on their patent or why the patent is invalid. That doesn’t happen in other types of litigation.”

Andersen and Miller also discussed how their roles in the litigation process have changed as they have become more experienced lawyers. Andersen stated that in her current role she reviews research and writing from more junior associates on the litigation team while interfacing with the partners on strategy, assignments, and deadlines. “From 9-to-5 a lot of what I do is try to make everyone else’s job easier—which in turn makes my job easier—and then I do the work I have on my own plate,” she said.

Miller urged the students to use the document review process as an opportunity to stand apart from their peers. “If you become the one who knows the documents the best, the senior associates and partners will come to you when they need help,” he advised. 

--Jay Stirling | May 6, 2015