As a result of the Drug Price Competition and Patent Term Restoration Act of 1984, the patent regulations provide owners of patents on certain drugs, food or color additives, medical devices, and biological products an opportunity to restore to the terms of those patents some of the time lost while awaiting premarket regulatory approval.  Patents available for such extensions, however, are limited to those that cover an approved product.  The formal requirements for applying for patent term extension are generally set forth in Rule 1.740, and Rules 1.775 to 1.779 set forth methods of calculating the extension periods.  This brief article reviews Rule 1.777, which sets forth the method of calculating the extension period for a medical device patent.  Though the method is somewhat complicated, extending the term of a patent on a medical device can protect market share for many years in very lucrative markets.

Paragraph (c) of Rule 1.777 establishes that the Secretary of Health and Human Services (“Secretary”) first calculates the length of the review period for a medical device as the sum of (1) the days from the start of a clinical investigation on humans to submission of an application for the device under the Federal Food, Drug, and Cosmetic Act (“Act”); and (2) the days from the submission of the application to its approval, or the period from submission of a notice of completion of a product development protocol under the Act to the date the protocol was completed.

Paragraph (d)(1) of the Rule then requires certain subtractions from the calculated length of the review period.  The amounts subtracted are:  (i) the days in the review period on and before issuance of the patent; (ii) the days in the review period during which the Secretary determines that the applicant did not act with diligence; and (iii) one-half of the days remaining in the period defined by paragraph (c)(1) [i.e., the start of clinicals to submission of the application] after that period is reduced according to (i) and (ii).

Next, paragraph (d)(2) instructs to add the number of days determined by paragraph (d)(1) to the original patent term.  Paragraph (d)(3) further instructs to add fourteen years to the date of approval of the application or the date a product development protocol was completed.  Paragraph (d)(4) then requires comparing the end dates obtained by paragraphs (d)(2) and (d)(3), and selecting the earlier date.

If the patent issued after September 24, 1984, paragraph (d)(5) instructs to (i) add five years to the original expiration date of the patent and (ii) select the earlier of the dates obtained according to paragraphs (d)(4) and (d)(5)(i).  This paragraph therefore restricts a patent term extension to at most five years for patents issued after September 24, 1984.

If, however, the patent issued before September 24, 1984, the extension is restricted to at most five or two years.  For such patents, if no human clinicals were started or no product development protocol was submitted before September 24, 1984, paragraph (d)(6)(i) instructs to (A) add five years to the original patent expiration date and (B) select the earlier of the dates obtained according to paragraphs (d)(4) and (d)(6)(i)(A).  However, if human clinicals were started or a product development protocol was submitted before September 24, 1984, and the commercial marketing or use of the product was not approved by that date, paragraph (d)(6)(ii) instructs to add (A) two years to the original expiration date of the patent and (B) select the earlier of the dates obtained according to paragraphs (d)(4) and (d)(6)(ii)(A).