Bipartisan Patent Transparency Bill Introduced in House of Representatives

A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.

The Biologic Patent Transparency Act aims to end patenting practices that make it difficult for biosimilars to enter the market by increasing transparency in the prescription drug market and promoting competition. The act 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.

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.

Biologic manufacturers often seek to protect their products by using dozens or hundreds of patents; 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 litigation can deter competitors from moving forward with developing biosimilars.

Representatives Abigail Spanberger, D-Virginia, and Tom Reed, R-New York, introduced the bill; they are both members of the bipartisan Problem Solvers Caucus, which includes a bicameral prescription drug task force that Spanberger chairs. In June, they both announced support for new principles to address rising prescription drug prices, including fighting for greater transparency, competition, and affordability.

“As the co-chair of the Diabetes Caucus, one of the things we noticed when conducting our recent insulin report was the myriad of patent abuses that prevented new biologics from coming to market. This bill goes a long way in addressing this critical issue,” said Reed in a statement. “As the father of a type 1 diabetic, I care about ensuring people with diabetes have access to fairly priced insulin, and I know this bill will help people across the United States to lower the cost of their prescription drugs by injecting competition into the market,” Reed added.

“Across Central Virginia, I hear story after story about how high prescription drug costs are crippling the financial security of working families, retirees, and those with chronic conditions. For many of our neighbors, expanded access to lifesaving generic alternatives like biosimilars would help lower costs and give them new peace of mind—but the current level of complexity in the patent system makes it impossible for new drugs to compete,” said Spanberger.

Senator Susan Collins, R-Maine, and Senator Tim Kaine, D-Virginia, introduced the Senate bill in March.