35 U.S.C. § 156(d)(1) requires the submission of a patent term extension (PTE) application within 60 days from the date the patentee obtains permission from the FDA to commercially market or use a drug product that is the subject of a new drug application (NDA). This provision was enacted because FDA review of NDAs may take years after a patent covering the drug that is the subject of the NDA has issued by the PTO. On June 23, 2008, the U.S. House of Representatives passed by voice vote H.R. 6344 , which had been introduced the same day by Rep. Delahunt (D-MA), and is similar to a provision included in the House version of the Patent Reform Act of 2007. The current bill is entitled "To provide emergency authority to delay or toll judicial proceedings in United States district and circuit courts, and for other purposes." Sec. 4 states: "The Director may accept an application under this section that is filed not later than 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." The bill would retroactively cover Massachusetts-based The Medicines Company, which filed a PTE application for U.S. Patent No. 5,196,404 on the 62d day after FDA approved its NDA for ANGIOMAX, an ...
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