After a Massachusetts drug company missed–by a single day–a non-extendable deadline for filing for a patent term extension, H.R. 5120 was recently proposed in the U.S. House of Representatives to amend 35 U.S.C. 156, the statute governing patent term extensions based on regulatory review delay. Some people are calling H.R. 5120 the "Dog Ate My Homework Act."
Under the current version of 35 U.S.C. 156, a patent applicant has 60 days after approval under the relevant regulatory review (generally FDA review and approval of new drugs) in which to submit an application to the U.S. Patent Office for patent term extension; no allowance is made for a late filing. H.R. 5120 would amend 35 U.S.C. 156 to provide the U.S. Patent Office with discretion in accepting late applications, so long as (a) the application was filed within 5 days after expiration of the 60-day period, and (b) the delay was unintentional.
As drafted, the amendment would go into effect on the day of its enactment, and would apply not only to applications for patent term extension pending on or filed after the date of enactment, but also to those applications which are "the subject of a request for reconsideration of a denial of a patent term extension," such as the Medicine Company's, or which have "been denied a patent term extension . . . in which the period for seeking reconsideration of such denial has not yet expired."
The 2005 Medicines Company annual report indicates that the company continues to explore alternatives to extend the term of the patent. If enacted as proposed, H.R. 5120 might be such an alternative.
The Medicines Company, based in Massachusetts, licensed a patent owned by Biogen covering the drug Angiomax and its use in preventing blood clots from forming during angioplasty. The Medicines Company application for a patent term extension was filed on the 61st day following FDA approval of Angiomax; as a result, the U.S. PTO denied the request for patent term extension. The Medicines Company has filed a request for reconsideration of the application for patent term extension. A copy of the file history of the relevant patent, including the application for patent term extension, decision on the petition, and request for reconsideration, can be found here.
The House bill was sponsored by Representative Jenkins (TN), and co-sponsored by Representatives Andrews (NJ), Delahunt (MA), Frank (MA), Hyde (IL), Meehan (MA), Sessions (TX), Boucher (VA), Duncan (TN), Gallegly (CA), Jones (OH), and Rothman (NJ). The bill has been referred to the House Committee on the Judiciary.
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