Senate Bill Offers 15 Years of Data Exclusivity for Drugs for Unmet Needs

A bill was introduced in the U.S. Senate late last week that would provide a drug maker with an unprecedented 15 years of data exclusivity for a medicine that meets an unmet medical need. Specifically, this refers to the amount of time during which a generic drug maker would be prevented from using the data generated by a brand-name drug maker to then obtain regulatory approval and sell its own similar medicine.

The legislation – which is essentially a companion piece to a bill that was introduced last year in the U.S House of Representatives – is called the Dormant Therapies Act. The idea is to offer an incentive to drug makers, which would have to request that a new drug – and only a new drug – is designated as a dormant therapy by the FDA.

Currently, drug makers can receive five years of data exclusivity for a new prescription medicine and 12 years for a biologic. However, the pharmaceutical industry has regularly complained that time-consuming R&D needed to obtain regulatory approval eats away at exclusivity periods, effectively preventing drug makers from gaining the full benefit.

“We hope to create a time-certain protection to encourage innovators to capture lost opportunities and bring new and essential products to market for the patients who need them,” said U.S. Senator Orrin Hatch, (R-Utah), who co-sponsored the bill, in a statement. He argues that the bill will remove the “ticking patent clock” conundrum that forces drug makers to direct R&D to the most lucrative opportunities.

The bill closely resembles the Modernizing our Drug & Diagnostics Evaluation and Regulatory Network Cures Act. Also known as the Moddern Cures Act, this legislation also offers 15 years of data exclusivity for new medicines that are designated as dormant therapies that would address unmet medical needs. Although it has not made any progress, there are now 94 co-sponsors.

Eli Lilly, for instance, has been an enthusiastic backer. “This will help provide companies with the incentive to pursue the best medicines, not just the medicines with the best patents,” the drug maker writes on its website. “This change will help innovative scientists create the best possible treatments without being unnecessarily hampered by pressures from diminishing intellectual property protection.”

We asked Lilly if the company also supports the latest bill and will update you with any reply. A spokesman for the Pharmaceutical Research and Manufacturers of America, says the industry trade group is still reviewing the bill and at this time has not established a position.

The underlying notion in both bills, however, has also been criticized over concerns that, by extending data exclusivity beyond the existing timeframes, the law could slow the introduction of lower-cost generic versions of many drugs. Consequently, prices would remain higher, an issue that Express Scripts chief medical officer Steve Miller raised at a congressional hearing last year.

At the same hearing, which was held to review the 21^st Century Cures Initiative designed to spur medical innovation, Columbia University Law School professor C. Scott Hemphill cautioned that many products would qualify as an unmet medical need under the existing FDA definition. The suggestion was that dormant therapy designation could slow generic competition.

“This is yet another way of extending monopolies on drugs. The companies like the data exclusivity model, because it eliminates even the need to show invention,” says Jamie Love of Knowledge Ecology International, a non-profit group that tracks patents and access to medicines issues. “The standard for qualifying is addressing ‘one or more unmet medical needs,’ and this is both vague and easy to satisfy.”

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