Rep. Jenkins introduced a bill, H.R. 5120, to amend title 35, United States Code, to change the provisions for patent term extensions for drup patents. Specifically, the bill would amend 35 USC 156, which extends the term for a patent where the product has been subject to a regulatory review period before its commercial marketing or use (i.e., pharmaceuticals), to allow for an unintentional delay in filing for the extension.

The Drug Price Competition and Patent Term Restoration Act of 1984 amended 35 USC § 156 to provide for the extension of the normal 20 years from filing patent term of a product, use or process patent if the product which is the subject of the patent is required by Federal law to be approved before it is commercially marketed [PL No 98-417, (1984)]. The Act was passed in recognition of the fact that both the U.S. Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) conduct extensive reviews of human and animal drug applications to determine the safety and efficacy of the drugs or products, including the submission of several years of test data prior to approving a drug for sale and use in the US.

Prior to the enactment of the Drug Price-Patent Term Act, surveys demonstrated that from 1966 to 1979, the effective life of a patent which required regulatory review fell from 13.6 years to 9.5 years. Later studies indicate that the mean effective life fell further until less than one-half of the original patent term remained after regulatory approval. The Act amended 35 USC § 156 with the underlying purpose to recover the time lost to the regulatory approval process.

HR 5120 would now provide for acceptance of an extension request that is filed late were the delay is unintentional. Under this provision:

…the Director may accept an application under this section that is filed not later than 5 days after the expiration of the 60-day period provided in subsection (d)(1) if the applicant files a petition showing, to the satisfaction of the Director, that the delay in filing the application was unintentional. Such petition must be filed with the application in the case of an application filed on or after the date of the enactment of this subsection and must be filed not later than 5 days after such date of enactment in the case of an application which, on such date of enactment, is pending, is the subject of a request for reconsideration of a denial of a patent term extension under this section, or has been denied a patent term extension under this section in a case in which the period for seeking reconsideration of such denial has not yet expired. The Director shall make a determination on a petition under this subsection not later than 30 days after the date on which the petition is received. If no determination has been made on the petition within that 30-day period, the petition shall be deemed to be denied.

The amendments made by this section shall take effect on the date of the enactment of this Act, and shall apply to any application for patent term extension under section 156 of title 35, United States Code, which (1) is filed on or after the date of the enactment of this Act; or (2) on such date of enactment (A) is pending; (B) is the subject of a request for reconsideration of a denial of a patent term extension under section 156; or (C) has been denied a patent term extension under such section 156 in a case in which the period for seeking reconsideration of such denial has not yet expired.

In case you haven’t guessed, patent term extensions or restorations are critical to the research-based pharmaceutical industry. With drugs, a missed filing for an extension of time can mean the loss of hundreds of millions of dollars in revenue.

Promote the Progress asks: Makes you wonder who missed a filing….

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