January 20, 2011 – Blog Post

Genetics & IVF Institute, an exclusive licensee of a patent owned by the U.S. Department of Agriculture (USDA), recently served a complaint on the USPTO for suit in the U.S. District Court for the Eastern District of Virginia. The suit related to a petition that Genetics & IVF filed with the USPTO for an extension of time to file an application for a second patent term extension.

35 U.S.C. § 156 gives a patent holder an opportunity to apply for a one-year extension of its patent term if FDA approval is pending near the end of the original patent term. It also allows for as many as four subsequent one-year extensions if FDA approval is still pending near the end of the previously-extended term. Regarding these subsequent extensions, the statute states in § 156(d)(5)(C) that “Each such subsequent application shall be made during the period beginning 60 days before, and ending 30 days before, the expiration of the preceding interim extension.”

The exclusive license from the USDA obligated Genetics & IVF to file for FDA approval to use the licensed patent, which was originally set to expire on August 4, 2009. Genetics & IVF applied with the FDA accordingly. Because the FDA was still reviewing Genetics & IVF’s product near the end of the original patent term, Genetics & IVF filed a June 8, 2009 request with the USPTO pursuant to § 156. The USPTO granted the extension, changing the expiration date of the patent term to August 4, 2010. Thus, according to § 156(d)(5)(C), Genetics & IVF could apply for a subsequent one-year extension beginning on June 5, 2010 and ending on July 6, 2010 (July 5 was a federal holiday). However, though FDA approval was still pending at that time, Genetics & IVF did not request an extension during that period. Instead, on July 27, 2010, Genetics & IVF filed a petition for an extension of time to file for a second extension. The complaint does not explain this delay. The USPTO issued a final decision denying this petition on August 2, 2010. Genetics & IVF challenged this final decision in federal court under the Administrative Procedure Act, which states at 5 U.S.C. § 702 that “A person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof.”

Genetics & IVF argued in its complaint that § 156 authorizes the USPTO to grant a second one-year extension outside of the statutory window specified in § 156(d)(5)(C). In the context of the statute and analogous USPTO regulations, Genetics & IVF argued that the relevant statutory language is permissive and discretionary, giving the USPTO wide latitude in its ability to grant patent term extensions. The complaint calls the § 156(d)(5)(C) time period “simply a matter of procedure, not substance,” making it “merely ‘directory,’ not ‘mandatory.’” Furthermore, § 156 is part of the Hatch-Waxman Act, an act that Genetics & IVF argued is a remedial act compensating for the delays caused by FDA approval of patented drugs. Because of this aspect of the Hatch-Waxman Act, Genetics & IVF suggested that courts should construe § 156 liberally in favor of patent holders. Genetics & IVF alleged that, but for its tardiness, it met the requirements for obtaining a second patent term extension, and that therefore the USPTO’s decision to deny a second patent term extension was arbitrary, capricious, or an abuse of discretion.

A ruling in favor of Genetics & IVF in this case would give drug patent holders with pending FDA approval more flexibility in their ability to file for patent term extensions. If courts rule that the USPTO can and should grant patent term extensions outside of the time periods set forth in § 156(d)(5)(A) and (C), such drug patent holders could file for extensions later, or potentially even earlier, than the statutory window. Thus, a ruling in favor of Genetics & IVF would give drug patent holders the opportunity to decide whether to file for term extensions over a wider time range. A ruling against Genetics & IVF, on the other hand, would require patentees seeking term extensions to firmly adhere to the filing windows in § 156.