by Amanda Conschafter, blog editor
The innovative therapies that some patients need already exist – but have been shelved by companies because they take too long and cost too much to develop. Now, federal legislation proposes a solution to get so-called “dormant” medications to patients: restructure patent incentives to encourage companies to bring these therapies to market.
Known as the “Dormant Therapies Act,” the bill provides 15 years of patent exclusivity for a dormant therapy that treats a high-need disease. The 15-year period would begin at the time of Food and Drug Administration approval. To qualify, a medication must treat an unmet condition, lack adequate patent protection and not contain active ingredients already approved by the FDA.
Though current patent protection typically lasts 20 years from the time a company files an FDA application, it can take the FDA 12 to 15 years to approve a new drug. Thus, some companies are left with a much shorter timeframe in which to recoup their investment. Today it takes approximately $2 billion to develop a new drug. So when remaining patent exclusivity runs short, a company may set aside the medication under development to avoid financial repercussions.
For patients, this decision can be devastating. In a press release, Dormant Therapies Act sponsor Senator Orrin Hatch points to Alpha-1, ALS, Alzheimer’s, epilepsy, lupus, mesothelioma, and multiple sclerosis as diseases that could benefit from the bill’s incentive structure. The senator argues that his bill will reduce the influence of the “ticking patent clock” and encourage companies to develop “new treatments that could serve people with the most complex medical needs.” Opponents of the billargue that it will slow the introduction of lower-cost generic versions of these medications.
Patient advocates have rallied in support of the bill, arguing that it can “greatly improve existing care for millions of Americans living with chronic conditions.” The Dormant Therapies Act is now part of Congress’ 21st Century Cures initiative, which seeks to accelerate the pace of cures in American medicine.