Dormant Therapies Act Establishes New Class of Pharmaceuticals

December 16, 2014
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.

 

A bill was introduced in the United States Senate last week that would support extension of a drug’s exclusivity period to 15 years, reported the Regulatory Affairs Professionals Society (RAPS). The new legislation, called the Dormant Therapies Act of 2014, seeks to provide incentive to drug makers to develop medications that may not otherwise have the most profitable patents.

Supporters of the bill, which was introduced by Senators Orrin Hatch (R, Utah) and Michael Bennet (D, Colorado), argue that because patents last 20 years, and it takes an average of 14 years for a compound to become available to a patient, much of the patent life is expended by the time a drug actually gets to market. According to a press release from the Hatch camp, the provision will “remove the ‘ticking patent clock’ conundrum that forces companies to prioritize research based on which compounds can be brought quickly to market.”

Much like other FDA incentive programs, such as the Breakthrough, Fast-Track, and Orphan Drug designation initiatives, this bill would create a brand-new designation, called the Dormant Therapy Designation. This epithet would be associated with 15 years of data exclusivity and would only be awarded to new drugs with unmet medical need. Generic equivalents and follow-on therapies would be excluded from consideration.

A major section of the legislation is devoted to the subject of a patent waiver, which a drug sponsor would be required to sign should they apply for a Dormant Therapy Designation. After the 15 years of exclusivity ends, the drug manufacturer would not be able to try to extend the patent life or enter into patent litigation suits with prospective generic competitors.

According to RAPS, the legislation closely resembles the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures (MODDERN Cures) Act of 2013. This bill has not been voted on in Congress yet, but is reportedly supported by both democrats and republicans.

Critics of the bill worry the long patent period could support artificially high drug prices for longer periods of time. The 15-year period is the longest yet; the proposed timeframe is three years longer than the patent protection time for biologics. Others are concerned that many products would qualify as fulfilling an unmet medical need under the existing FDA definition and could easily get a “dormant” status, reports The Wall Street Journal