ICYMI: USPTO, FDA ANNOUNCE PLAN TO CRACK DOWN ON BIG PHARMA’S PATENT ABUSE

Joint Effort Aims to Curb Anti-Competitive Tactics Used by Brand Name Drug Companies to Block More Affordable Alternatives

In case you missed it, the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) recently announced a joint effort to crack down on Big Pharma’s anti-competitive gamesmanship of the patent system. The effort was outlined by Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, and Robert Califf,  FDA Commissioner in a joint blog published earlier this month.

“These initiatives will strengthen our relationship and expand the resources available for assessing patentability and addressing instances of patents being used improperly to delay competition,” Vidal and Califf said.

USPTO pledged to “protect against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents. This effort can lead to lower drug prices because drug companies will not be able to unjustifiably delay generic competition based on trivial changes to a drug product.”

CSRxP has long encouraged the FDA and USPTO to take additional steps to crack down on Big Pharma’s patent abuse. In June testimony for the record for the U.S. Senate Committee on the Judiciary Subcommittee on Intellectual Property, CSRxP provided recommendations for USPTO strategies to promote greater access to affordable alternatives, writing, “in support of improvements to the U.S. Patent and Trademark Office Patent Trial and Appeals Board (USPTO PTAB), which will thwart abuses of the patent system by brand drug makers that limit competition and inappropriately extend product monopolies.”

Read the full USPTO blog HERE.

Read CSRxP’s testimony outlining strategies for USPTO to crack down on Big Pharma’s patent abuse and encourage prescription drug competition HERE.

Read what U.S. Federal Trade Commission officials and academic experts had to say about Big Pharma’s patent abuse during a recent workshop HERE.

Read more about how Big Pharma’s patent abuse blocks competition, harms consumers and contributes to ballooning taxpayer spending HERE.

Read more on market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.