The Everlasting Patent Or Just a 15-Year Protection?



    Drug patents typically last for 20 years from the date of filing to the patent office. After expiration, other companies can submit abbreviated new drug applications (ANDAs) to the FDA for generic drugs - drugs with therapeutically equivalent safety and effectiveness as the original brand-name drug but which are cheaper.  The Hatch-Waxman Amendments to the FD&C Act were introduced in 1984 to ensure that brand-name drug manufacturers could have a fruitful patent protection period and to ensure that consumers would eventually benefit from lower-priced generic versions of the innovative drugs.  However, companies often see the 20-year patent cliff as an obstacle since they have to make as much money as possible from their brand-name drug to cover the costs of development.

    In December 2014 Senator Orrin Hatch (R-UT) introduced the Dormant Therapies Act.  This act was intended to "remove the 'ticking patent clock' that forces companies to prioritize research based on which drugs can be marketed more quickly.  Earlier this year the 21st Century Cures Act was released which contained a new provision in its Subtitle M, Title I.  Subtitle M creates a guaranteed 15-year "protection period" for new drugs and biologicals approved for "dormant therapies" (as opposed to the current 5 years for new drugs).  Dormant therapies is defined as any medical research being done to treat "unmet medical needs".  Any drug that falls under this protection would have an extended period of exclusivity, rendering the sponsor immune from competition of any ANDAs or new NDAs and BLAs for drugs which contain "forms of the active moiety of the dormant therapy and highly similar active moieties".

    One reading of the new provisions of Subtitle M statutory text could be that any old patent which is reasonably related to a drug or biologic classified under dormant therapies could be "protected" for 15 years from any new competition. The sponsor could simply apply for multiple designations of dormant therapies for the same patent and thus create an "everlasting patent".

    However, another reading of the provisions is that a dormant therapy can benefit from only one protection period, "measured from the first day of the first approved indication for a therapy" which cannot be further extended. In such a case the patent cannot be further extended. The applicant sponsor would therefore not gain exclusivity for the patent beyond the initial 15 year protection period. Furthermore according to another provision of Subtitle M, even if the same patent were ever to be extended a second time because a different active moiety was added, the "Hatch-Waxman limitations" would be enforced, limiting the extension terms.

    Thus, while the dream for sponsor companies to retain unlimited exclusivity over all their most valuable patents remains just that, the 21st Century Cures Act has opened up a new debate over whether patent exclusivity should be extended for longer periods of time for urgent medical treatments and for how long such extensions should be allowed.


    Hatch-Waxman Amendments 1984:

    FDA Law Blog, ever lasting patent renewal:

    RAPs Regulatory Explainer: The (Updated) 21st Century Cures Act: