Our Greatest Hope for Lowering Drug Prices?

Andrei Iancu, JD, was sworn in as director of the U.S. Patent and Trademark Office (PTO) in February, amid efforts by lawmakers and demands from President Trump to curb skyrocketing drug prices.

While the U.S. Food and Drug Administration (FDA) has contributed to the efforts to lower drug prices by increasing competition and bringing more generic drugs to market, the role the PTO will play is still unclear. Because Mr. Iancu holds substantial sway over the intellectual property system as PTO director, he has the ability to directly rein in drug makers who have blocked generic drug development by extending their monopolies through questionable tactics, such as making slight modifications to products and then filing for new patents.

Mr. Iancu also can encourage thorough review of original patent applications and make decisions about the ease with which originator or generic drug makers receive patents. In an interview with STAT News, though, he remained vague about his priorities. “For now, I’m meeting everybody in the office, learning the system, and formulating our agenda,” he said.

The litmus test for how he intends to lead the office will likely follow the Supreme Court’s ruling in the Oil States Energy Services v. Greene’s Energy Group case, in which the court will decide the constitutionality of the inter partes review (IPR) process. The IPR process, which reduces the burden of proof for anyone challenging a patent’s legitimacy, is designed to simplify legal battles over a patent’s validity. Branded drug makers worry that it makes it too easy to throw out valid patents, while generic drug manufacturers see it as essential for weeding out follow-on patents that stymie innovation. Any changes to the IPR process that result from the Supreme Court’s ruling will be overseen by Mr. Iancu.

When STAT News asked about his plans to address IPR, he said simply, “It is one of the issues we’re looking at.”

Source: STAT News, March 1, 2018.