Posted 12 December 2014

Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products.

Background

The bill, known as the Dormant Therapies Actof 2014, is the second piece of legislation introduced in as many days by Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Acton 10 December 2014.

Unlike the PATH Act, which is primarily intended to incentivize the development of new antibiotics, the Dormant Therapies Act is aimed at providing an attractive incentive to invest in diseases for which there are "one or more unmet medical needs."

The bill would create a new designation—Dormant Therapy Designation—modeled off of FDA's other existing designation programs, including breakthrough therapy designation, orphan product designation and fast-track designation. Those programs are intended to offer designees special incentives, such as added periods of marketing exclusivity (orphan product designation) and additional support during the review process (fast-track and breakthrough therapy designations).

As with the other programs, the legislation requires a sponsor to specifically request the designation from FDA. As the legislation makes clear, the designation will only be given to new drugs (either a different active moiety, or a biological product that is "not highly similar to" an approved biologic).

Heavy Focus on Patents

Sponsors hoping to obtain the designation—and its 15 years of market exclusivity—will also need to waive all patent rights to the drug, including all patents "that may be reasonably construed to provide protection for the medicine,” after the 15 years of exclusivity ends. The unusual language seems intended to avoid lengthy patent battles between patent holders and prospective generic entrants. At present, patent litigation can sometimes add months or years of marketing exclusivity to a drug's lifetime.

However, it's unclear how the patent waiver would—or if it would—apply to patents applied for and granted after the approval of a medicine. Many of these patents cover the manufacture of medicines using new methods, which can be used to delay or prevent generic competition. The legislation is also unusual in that it would allow patents to be extended throughout the entire 15-year period of dormant product exclusivity "if the patent would otherwise expire before the end of the protection period."

How Much Exclusivity is too Much?

The legislation is closely modeled off of the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures (MODDERN Cures) Act of 2013, a piece of legislation heavily advocated for by the pharmaceutical manufacturer Eli Lilly.

In particular, Hatch and Bennet's legislation is essentially Title II of the MODDERN Cures Act—"Capturing Lost Opportunities for Patients," which also establishes the Dormant Therapies designation.

Sponsors, including Lilly, have said the bill would help drive development of new drugs for treatments that lack adequate treatment options. "The MODDERN Cures Act would align the patent term and data protection period at the FDA approval date for these dormant therapies," Lilly explains on its website. "This will help provide companies with the incentive to pursue the best medicines, not just the medicines with the best patents."

That legislation, however, has come under fire by some critics as being overly generous. In particular, critics have targeted the legislation's proposed 15 years of marketing exclusivity, which would be provided to any product intending to treat a disease for which there is "one or more unmet need." That, as it turns out, is quite a large number of diseases. In fact, many of the drugs FDA already approves each year as new drug products would be eligible for the "dormant" exclusivity, which is considerably longer than the current periods of exclusivity afforded to new drugs (e.g. 5 years for new drugs, 3 years for new uses for old drugs, 7 years for orphan drugs, and 12 years for biologics.)

That has some advocates worried that the added exclusivity could be used to maintain high drug prices for years, all without the threat of generic competition. Provisions of the bill also provide added protections to drugmakers' patents, potentially making them even more difficult to challenge.

Despite its critics, the MODDERN Cures bill has proven popular in Congress. The bill now has 91 co-sponsors from both sides of the political aisle, though it has thus far not been voted on.

Dormant Therapies Act (S.3004)

Hatch, Bennet Introduce Dormant Therapies Act

MODDERN Cures Act of 2013