FDA Sees Patents Boosting Drug Competition

FDA says there are things the U.S. Patent and Trademark Office (USPTO) could do to increase drug competition and help address the high cost of medicines. In a 9/10 letter, FDA acting commissioner Janet Woodcock says that while FDA recognizes that patents are critical to fostering innovation, the impact of certain drug company patent practices on the marketplace has attracted attention within the debate over drug pricing.

“FDA is actively evaluating the impact of pharmaceutical patents in certain areas relevant to FDA regulations of drug products,” she writes, “with a focus on facilitating timely access to drug products approved under our abbreviated pathways. These abbreviated pathways, which enable the approval of generic drugs and biosimilars, play a foundational role in ensuring access to affordable medications for American patients. We invite USPTO to collaboratively engage with us in these efforts and in any complementary activities under your purview that can advance competition and access in the marketplace.”

Woodcock says FDA is concerned that certain uses of the patent system have been criticized for allowing companies to inappropriately impede competition from generic, biosimilar, and interchangeable biological products. She raises several agency concerns and then suggests ways in which FDA and USPTO could engage in further dialog on ways the two can better work together to address possible misuse of the patent system, adequate time and resources for PTO examiners, and the workings of the Patent Trial and Appeal Board.

She also solicits USPTO ideas for other areas in which the two agencies can exchange information and experience to enhance efforts by both to “address the need for an appropriate balance between innovation and patient access to needed medicines.”