The House patent reform bill (HR 1249) that was passed last week includes a provision that impacts the deadline for filing an application for patent term extension under 35 USC § 156 after receiving FDA approval for a patented product. Although the House provision addresses the issue before the district court in The Medicines Co. v. Kappos, it does not provide the fix we need.
The Congressional Fix
Section 37 of HR 1249 is entitled “CALCULATION OF 60-DAY PERIOD FOR APPLICATION OF PATENT TERM EXTENSION.” It provides as follows:
(a) IN GENERAL.—Section 156(d)(1) of title 35, United States Code, is amended by adding at the end the following flush sentence:
“For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive such permission on the next business day. For purposes of the preceding sentence, the term ‘business day’ means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5.”.
(b) APPLICABILITY.—The amendment made by subsection (a) shall apply to any application for extension of a patent term under section 156 of title 35, United States Code, that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of the enactment of this Act.
Thus, this revision to §156 would legislatively affirm the district court’s narrow decision in The Medicines Co. v. Kappos, which I wrote about here.
The Real Problem
The relevant portion of 35 USC § 156 states:
(d)(1) To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use.
The real problem with this provision stems from the USPTO’s interpretation of the time period it establishes. While the statute refers to a “sixty-day period,” the USPTO has adopted an interpretation that in effect creates a 59-day application period. That is because the USPTO counts the date of the FDA approval letter as “day one” of the 60-day period. This is contrary to most deadline statutes, where “day one” usually is the first day after the triggering event.
The USPTO cites the “within the sixty-day period” language of §156(d)(1) as requiring this interpretation, and also has cited language in the Federal Circuit decision in Unimed, Inc. v. Quigg, although the district court held that that case does not address this issue.
A Real Solution
If Congress is going to address the timing requirement of §156(d)(1), it should not side step this trap for the unwary, but should clarify its intent to provide a full 60 days for a patent holder to prepare and file an application for patent term extension.
The Senate patent reform bill (S 23) does not include a counterpart to section 37 of HR 1249. Thus, this provision may fall out of any final patent reform that is enacted. Still, it would be nice if Congress—or the judiciary—would eliminate this pitfall in the already complex patent term extension process.