After vigorous debate, H.R. 6344 passed 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.

This has been bounced around for several years now, and is intended (very specifically) to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. Pat. No. 5,196,404 for ANGIOMAX (bivalirudin) 61 days after FDA approved its New Drug Application (NDA) .  In case you haven’t already guessed, the patent term extension law requires the submission within 60-days of the date of NDA approval.

Known as the “Dog Ate My Homework Act”, Section 4 of the bill involves a grant of authority to the Director or the United States Patent and Trademark Office (USPTO) to excuse specific late filings—this time, in connection with unintentional human error.  Section 4 would provide the USPTO with the authority to accept an application for patent term restoration under the Hatch-Waxman Act if that application is filed within three business days after the expiration of the 60-day period provided in subsection (d)(1) if the applicant files a petition, not later than five business days after the expiration of that 60-day period, showing, to the satisfaction of the Director, that the delay in filing the application was unintentional.

What’s most amazing is that the Act requires a payoff in order to effect a patent term extension — the patent holder must pay a fee to the United States Treasury equal to:

(i) $65,000,000 with respect to any original application for a patent term extension, filed with the United States Patent and Trademark Office before the date of the enactment of this Act, for a drug intended for use in humans that is in the anticoagulant class of drugs; or

(ii) the amount estimated under subparagraph (B) with respect to any other original application for a patent term extension.

Subparagraph (B) says the Director will estimate the amount required as the amount equal to the sum of:

(i) any net increase in direct spending arising from the extension of the patent term (including direct spending of the United States Patent and Trademark Office and any other department or agency of the Federal Government); (ii) any net decrease in revenues arising from such patent term extension; and (iii) any indirect reduction in revenues associated with payment of the fee under this subsection.

I supposed that $65M is not a bad deal for getting a patent extension depending on the patent.  The Medicines Co. wants its patent to be extended 1,773 days, giving it exclusive rights to the drug until Dec. 15, 2014.  Medicines expects Angiomax to generate more than $500 million in sales in the United States by 2010.

What a Diff’rence a Day Makes!

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    […] a decade to check on how things are going.  Unless you can get Congressional relief.  But, if it cost the Medicines Company $65,000,000 for one day, imagine what it would cost for a decade. Posted June 30th, 2008 by Stephen Albainy-Jenei in USPTO […]

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    […] a decade to check on how things are going.  Unless you can get Congressional relief.  But, if it cost the Medicines Company $65,000,000 for one day, imagine what it would cost for a decade. Posted June 30th, 2008 by Stephen Albainy-Jenei in USPTO […]