Collins, Kaine Seek to Untangle Patent Thickets With Bill Requiring Transparency

Two senators from either side of the aisle introduced a bill this week that is aimed squarely at the patent strategies that are used to block biosimilars from coming to market.

Senator Susan Collins, R-Maine, and Senator Tim Kaine, D-Virginia, introduced the Biologic Patent Transparency Act, which would require companies to publicly disclose the patents that protect their originator biologics, thus making it easier for competitors to evaluate and plan for the development of biosimilars.

It is co-sponsored by Senators Rob Portman, R-Ohio; Jeanne Shaheen, D-New Hampshire; Mike Braun, R-Indiana; and Debbie Stabenow, D-Michigan.

If the transparency bill becomes law, it would codify the publication of FDA’s Purple Book as a single, searchable list, as well as require additional information:

• Patents that claim and relate to FDA-approved biological products, including composition patents, patents claiming methods of use, and patents claiming methods of manufacture
• Information related to whether determinations of biosimilarity and interchangeability have been made for a product
• Information related to exclusivities
• Approved indications

In addition, it would limit the enforceability of late-filed patents by the biologic manufacturer when a biosimilar application has already been filed with the FDA, such as those used by AbbVie to protect its brand name adalimumab (Humira) from competition.

“The past century could be termed the Age of Miracle Drugs. Today, however, we might define a ‘miracle drug’ as one that has not doubled in price since the last refill,” Collins said in a statement. “We must provide drug makers with the ability to recoup their investments, but at the same time, we cannot be blind to the costs of these drugs, nor to cases where patent laws are manipulated to preserve monopolies. This legislation is an important step to stop the patent gaming that blocks consumers from accessing lower-cost biologics.”

“Biologic medicines can be life-changing for many patients, but we must do more to promote competition in the market to ensure patients can access and afford them. Our bill sheds light on the ways patents can be used to deter competition and encourages manufacturers to obtain key patents earlier, which will help bring new treatments to patients faster,” said Kaine.

Biologic manufacturers often seek to protect their products by using dozens or hundreds of patent thickets; even if some of the patents are later found to be invalid or unenforceable by the court or the Patent Trial and Appeal Board, expensive patent litigation can deter competitors from moving forward with developing biosimilars.

In an email to The Center for Biosimilars^® , Michael A. Carrier, JD, distinguished professor at Rutgers Law School, noted that the issue of patent thickets, which keep generic and biologic competition out of the marketplace, has been receiving a lot of scrutiny in Congress, “so it’s possible this becomes law.”

For instance, in January, during a House Committee on Oversight and Reform hearing into drug prices, Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, testified that patent exclusivities constitute government-granted monopolies on drugs and pointed to the example of Humira’s “patent thicket” that has forestalled US competition until 2023.

“The restriction of enforcement of patents issued after a biosimilar has been submitted to FDA could encourage the earlier filing of patents and significantly open the thicket, facilitating biosimilars’ entry into the market,” wrote Carrier.