As I’ve explained in previous newsletters, Congress is considering several bipartisan bills, including Senator Welch’s “Bill to Address Patent Thickets” and Senator Cornyn’s “Affordable Prescriptions for Patients Act,” that take positive steps to address the pharmaceutical industry’s exploitation of our patent system. However, there is one bill that would actively take us backwards.
The Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL) — a bill that uses a pile of garbled-up, feel-good language in its title to hide its true intentions — threatens to undo any gains that have been made thus far by severely limiting a component that maintains important checks and balances on the patent system: The Patent Trial and Appeal Board (PTAB) Inter Partes Review (IPR) proceedings.
On Tuesday, we joined a coalition led by the Public Interest Patent Law Institute in sending a letter to Senator Dick Durbin, Chairman of the Committee on the Judiciary, explaining why the IPR mechanisms are crucial to safeguarding the accessibility of medicines and promoting a more robust, competitive pharmaceutical industry.
“The mechanisms that Congress created are vitally important to the pharmaceutical sector, where patents often serve as formidable barriers to research, competition, and access to medicine. By facilitating the cancellation of wrongly granted patents, IPRs facilitate the removal of these barriers when they are unjust, thus opening the door to research and competition that improve the quality and affordability of medical care.”
The PREVAIL Act is a brazen effort to hand even more power to brand-name pharmaceutical companies.
The pharmaceutical industry has been pushing to insulate pharmaceutical patents from IPR proceedings since 2015. Senators Coons and Tillis’s initial attempts to achieve this through The Stronger Patents Act hit a wall, Now, they are reviving their efforts under a rebrand that is as deceptive as the original bill they tabled. If passed, PREVAIL would take away the public’s last-remaining pathway to challenge wrongly-granted patents that fence off research or block cheaper generic and biosimilar competitors from entering the market. For the few stakeholders who would retain the right to challenge patents, it would make the process of doing so much tougher by forcing PTAB judges to meet a higher evidentiary standard favoring patent owners when assessing a patent’s validity.
Legislators who are fighting to lower drug prices shouldn’t undermine their own efforts by making compromises with PREVAIL.
Onwards,
Tahir
WHAT WE’RE DOING
In our new video, I break down how Bristol Myers Squibb uses its patent thicket on Eliquis to block Americans from accessing cheaper generic alternatives. After you watch the video, read our latest blueprint to learn how legislators and the USPTO can close the loopholes that companies like Bristol Myers Squibb exploit.
The pharmaceutical industry is constantly telling us that high drug prices are an unavoidable reality Americans must endure because they’re the only way to finance the R&D needed to develop future treatments. In my recent Biospace op-ed, I explain why this couldn’t be further from the truth.
RELEVANT NEWS RUNDOWN
On the global front, the Colombian government made a significant move by issuing its first-ever compulsory license so it can obtain lower-cost versions of the HIV medicine dolutegravir. According to the Colombian government, the estimated cost of the drug was $1,224 per patient per year in 2023 in Colombia, a considerable markup on the $22.80 or $44 per patient per year price for generic dolutegravir offered through the Global Fund and Pan-American Health Organization (PAHO), from which Colombia is not permitted to procure from. The price under the new compulsory license will be $44 per patient per year.
In other good news, the FTC is continuing to clear out junk patents that could be used to delay earlier generic entry. The agency is challenging more than 300 improperly-listed Orange Book patents across 20 different brand-name products, including the blockbuster weight-loss drug Ozempic. The next, much-needed step is for the USPTO and FDA to start taking action to prevent junk patents from being granted in the first place.