After the Medicines Company, based in Massachusetts, missed a non-extendable deadline for filing for a patent term extension by a single day, Rep William Jenkins [TN] introduced H.R. 5120 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.

Known as the “Dog Ate My Homework Act”, the Act would allow the Director of the United States Patent and Trademark Office (USPTO) to accept an application for an extension of the term of a patent which claims a product, a method of using a product, or a method of manufacturing a product if: (1) such application is filed no more than 5 days late; and (2) the applicant files a petition showing that the delay in filing the application was unintentional. The Act also deems such petition to be denied if no determination has been made on the petition within 30 days of filing.

The Act applies to any application for patent term extension which: (1) is pending on the date of enactment; (2) is the subject of a request for reconsideration of a denial of a patent term extension; or (3) has been denied a patent term extension in a case in which the period for seeking reconsideration of such denial has not yet expired. Currently, a patent applicant has to file no later than 60 days after the Food and Drug Administration approves the drug for commercial use and sale. There are no exceptions to that window, so patent officials rejected the application.

The Medicines Co. filed for a patent extension on its drug Angiomax (an anticoagulant that prevents clot formation during angioplasty) on Feb. 14, 2001, one day later than the application deadline. The company wants its patent to be extended 1,773 days, giving it exclusive rights to the drug until Dec. 15, 2014. This is a high-stakes game of chance as the Medicines Co. expects Angiomax to generate more than $500 million in sales in the United States by 2010. To show how much it cares, the company spent $440,000 on lobbying last year – all in the name of progress.

While some would say that “deadlines are deadlines” and it’s just tough luck for those who miss them, it doesn’t make sense to deny any kind of equity. It also doesn’t make sense to extend the deadline for 5 days. Where did that number come from? I think the standard should be the same reviving an application that becomes abandoned because of failure to timely pay the issue fee or respond to a Patent Office deadline, that is, when the abandonment was unavoidable and unintentional. Both require a fee where the fee for unintentional is a huge fee compared with unavoidable since fault is admitted on the part of the applicant.

For both unavoidable and unintentional revival there is no time limit, but the applicant must state that the entire delay between abandonment and the filing of the revival petition was unavoidable or unintentional. For equity’s sake, a terminal disclaimer would then be filed equal to the time that the application was abandoned. Why should extensions receive different treatment than other types of “oops”?

What a Diff’rence a Day Makes!

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