Drug Price Competition and Patent Term Restoration Act - Main Provisions of The Bill

Main Provisions of The Bill

The first provision discussed in the Act handles the issue of drug competition. Title I of the Act discusses the authorization of ANDAs and the provision that prohibits the FDA from asking for more than bioavailability studies. This part of the Act is particularly interesting because it is one of few pieces of legislation that restricts the powers and reach of a federal agency.

The Act provides for a period of exclusivity such that once a New Molecular Entity (NME) is approved, a generic version cannot be approved for five years. The Act also calls for a three-year data exclusivity period for supplements requiring clinical trials. It also sets out the condition that must be met when someone files an ANDA. The first is that the drug associated with the ANDA has not been patented. The second is that the patent for the pioneer version has expired. The third is that the generic will not go on the market until the patent for the pioneer has expired. Lastly, it is required that the patent for the pioneer drug has not been infringed or is proven invalid. These requirements are often referred to as the paragraphs I, II, III, and IV certifications.

The paragraph IV certification proved to be fairly controversial in the efforts to get the bill passed. The controversy erupted because of confusion as to how long the FDA would be required to wait before approving generics for marketing if they claimed that the patent for the pioneer was in fact invalid. Initially the wait period was decided to be eighteen months, however, this was later changed to thirty months.

In terms of patent term restoration, the bill provides that a pioneer drug can receive an extension term equal to one-half of the time of the investigational new drug (IND) period, which runs from the time human clinical trials begin to the time the NDA is submitted. In addition to getting credit for the IND period the complete period of NDA review is added as the second part of the extension. This is so long as half of the IND period plus the NDA review period is less than or equal to 5 years. Furthermore the time after the drug has been approved and is on the market cannot exceed fourteen years. This numbers are strictly arbitrary numbers that were deemed to be sufficiently long to provide incentive for research based pharmaceuticals companies to develop new drugs. The regulations also speak as to how extensions for pipeline drugs, drugs currently under FDA review should be handled. The Act provides that pipeline drugs would receive two years or less of extended term. This was based on the assumption that if they were under review already that they would be approved in a year or two, making there no need to provide a larger extension. However, some pipeline drugs have taken eight years for approval, which exposes the flaws in this logic. (This patent term restoration part of the Act appears in title 35 of the United States Code.)

Lastly, the Act provides that if the pioneer company fails to exercise due diligence when seeking patent term restoration a period amounting to the time delay will be subtracted from the patent extension period.