By Donald Zuhn --
Last month, in a letter to Congressional leadership, 79 Members of Congress expressed their support for the Innovation Act (H.R. 9) but sought inclusion of language in the bill "to preserve the integrity of the Drug Price Competition and Patent Term Restoration Act (commonly known as Hatch-Waxman), and the Biologics Price Competition and Innovation Act (BPCIA)." Stating that "any patent litigation legislation must represent the views of the full spectrum of different industries and sectors reliant on a well-functioning U.S. patent system," the letter asserted that at least one additional change to the legislation was needed to address concerns of the life sciences community.
According to the letter's signatories, "the patent challenge system created under the America Invents Act, specifically the IPR system, threatens to undermine the specialized patent resolution frameworks [i.e., Hatch-Waxman and the BPCIA] in a way that was not intended when Congress created it." Explaining that "[p]atents are critically important for developing FDA-approved biopharmaceutical products," the Representatives note that "[u]nlike companies in other sectors, biopharmaceutical companies are not able to immediately capitalize on the value of their patents," and instead "must spend almost a decade and, on average, $2.6 billion, before they can receive approval from the FDA to bring new medicines to market." In support for the Hatch-Waxman regime, the letter points out that generics currently make up 88% of all prescriptions in the U.S., up from 19% prior to enactment of Hatch-Waxman, and that generics saved the U.S. health care system almost $1.5 trillion between 2004 and 2013. The letter also notes that meanwhile "investment in research and development (R&D) is at an all-time high and there were a record number of new medicines approved by the FDA in 2014, allowing patients to live longer healthier lives."
The Representatives state that "[t]he IPR process, as implemented by the Patent and Trademark Office (PTO), must not be allowed to upset this delicate balance," and contend that Congress can address concerns of the life sciences sector "by including language in H.R. 9 to make clear that the IPR process does not apply to biopharmaceutical patents that are subject to challenge under Hatch-Waxman and BPCIA." According to the signatories, such an approach "would protect the delicate balance Congress struck in Hatch-Waxman and BPCIA while in no way harming the intent behind the IPR process."