Opinions and Editorials

Jan. 6, 2022

RealClearPolicy: Can We Please Get Serious About Patents and Drug Pricing? By Bernard Cassidy

In a recent letter to the U.S. Patent and Trademark Office (USPTO), eleven Members of Congress sounded an electrifying alarm, stating that the USPTO has been “frequently” denying petitions for inter partes review (IPR), which “has made it more difficult to curtail anti-competitive practices by prescription drug companies.”

It’s a false alarm and an unfortunate distraction from the robust debate the nation desperately needs to address deep-seated and longstanding issues we face about access to health care and drug pricing anomalies.

An IPR is a process by which the USPTO’s Patent and Appeal Board (PTAB) can review and, when appropriate, invalidate an existing patent. The IPR process was established by 2011 patent reform legislation known as the America Invents Act, which required that IPRs be conducted at the discretion of the USPTO Director pursuant to a speedier, less expensive alternative to traditional patent litigation conducted in federal courts.

The creation of a separate and parallel review of a patent’s validity complicated matters for both patentees and patent challengers, not to mention the two sets of judges (in the PTAB and in federal district courts) responsible for interpreting the law. After roughly a decade of sorting through those complications the USPTO issued the Fintiv decision, which identified neutral factors to be applied when determining whether instituting an IPR would be inappropriate when the same patent was being simultaneously challenged in a federal district court. Appropriately, higher courts have consistently upheld the Fintiv decision, which essentially identifies a standard for traffic control between two court systems Congress intended to be non-duplicative.