PTO’s ANGIOMAX PTE Denial is Vacated and the Case Goes Back to PTO – What Happens in the Interim?

March 17, 2010

By Kurt R. Karst –      

In a March 16, 2010 opinion and order, Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) vacated the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin), and remanded the case to the PTO “for reconsideration as to the date of approval under [35 U.S.C. § 156] and to take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings.”  The question of the availability of a PTE for the ‘404 patent has been going on for many years, and has involved all three branches of government.  The ‘404 patent is scheduled to expire on March 23, 2010, and is subject to a 6-month period of pediatric exclusivity.

FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under New Drug Application (“NDA”) No. 20-873, and MDCO submitted its PTE application to the PTO on February 14, 2001 – 62 days after NDA approval (including the December 15, 2000 date of approval).  Under 35 U.S.C. § 156(d)(1), the submission of a PTE application must occur “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” (i.e., within 60-days of the date of NDA approval).  Under 35 U.S.C. § 156(g)(1)(B)(ii), for purposes of calculating the PTE “regulatory review period,” the approval phase begins on the date the NDA application was initially submitted under FDC Act § 505 for the approved product and ends “on the date such application was approved under such section.”

Judge Hilton’s decision stems from a January 2010 Complaint and Motion for Summary Judgment following the PTO’s January 8, 2010 denial of MDCO’s December 2009 Request for Reconsideration asking the PTO to employ a “rule of construction” under which the Office would consider the 60-day PTE application submission period at 35 U.S.C. § 156(d)(1) to commence on the first business day after the day the FDA transmits notice of NDA approval of the drug product if that transmittal occurs after normal business hours.  In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on December 18, 2000 and the PTE application would have been timely filed within 35 U.S.C. § 156(d)(1). 

MDCO’s Complaint alleges that the PTO’s denial of the company’s PTE application for the ‘404 patent and FDA’s decision regarding PTE application timeliness violated the Administrative Procedure Act (5 U.S.C. § 706(2)(A)).  Among other things, MDCO argues that there is a discrepancy in how FDA (and the PTO) treats the dates of NDA receipt and approval:

[U]nder the government’s approach to [the PTE] statute, an application for approval of a new drug received by the FDA after business hours is deemed to be filed on the following business day.  By contrast, when a [NDA] is approved after business hours, the government deems the approval to have occurred on the same business day and takes the position that this day starts the 60-day period for filing a patent term extension application.  Despite this inconsistency, the PTO somehow concluded that its interpretation was mandated by statute and regulation.

As a result, MDCO alleges that “[t]he PTO’s decision is not merely arbitrary and capricious; it is profoundly unfair and undermines the remedial design of the patent term restoration system.” 

In his 18-page decision, Judge Hilton included a litany of reasons that the PTO’s PTE denial was supposedly deficient:

  • There is a strong presumption that when Congress repeats the same word in the same statute, it intends for that word to be given the same meaning. In this case, the PTO and the FDA interpreted the word date to have two different meanings in the very same provision, and the PTO offered no explanation for that inconsistency.  The PTO also misperceived the scope of its authority.  The PTO believed that it was precluded from adopting a business hours interpretation of the word date in § 156(d)(1).  But, neither the statutory text nor any other authority forecloses that reading. While the PTO believed that the term date can only be construed to mean calendar day, the statute cannot be so inflexible because the FDA interprets the same word in the same section to mean business day.

  • The PTO incorrectly thought a business hours interpretation was foreclosed and did not consider central arguments MDCO advanced, and gave no reason for rejecting them.

  • The PTO erroneously believed that it was compelled to follow the FDA's interpretation of the provision of § 156(g)(1)(B)(ii) marking the end of the regulatory review period.  The agency also incorrectly believed that a business hours interpretation of § 156(d)(1) was foreclosed by the plain text of the statute, Federal Circuit precedent, and its own regulations.  Because it believed its hands were tied, the PTO never even considered whether it should exercise its discretion to adopt a "business hours" rule.  Indeed, the PTO must have believed it had no option but to construe the statute as it did: Had the PTO recognized any statutory ambiguity, it should have addressed in its decision the issues raised by MDCO.

  • The PTO also incorrectly concluded that Unimed. Inc. v. Quigg, 888 F.2d 826 (Fed. Cir. 1989), controlled this case. Unimed never addressed the question presented here. . . . A few sentences in Unimed could be read to suggest that the date that starts the 60-day period in § 156(d)(1) is the date stamped on the FDA approval letter. But the question at issue here – the proper treatment of an after hours letter – was not presented in Unimed because the extension application at issue there was filed "more than a year after the FDA's final approval letter."

  • The PTO's decision was also flawed because the Office erroneously concluded that a next business day rule would be contrary to regulations.

  • Finally, the PTO incorrectly believed that in interpreting § 156(d)(1), it was bound to follow the FDA's interpretation of § 156(g)(1)(B)(ii).  Although the PTO asserted that it was independently interpreting § 156{d)(1) and relying on the FDA only to provide it with facts regarding the drug approval process, the PTO effectively determined that the 60-day period under § 156(d)(1) must necessarily start to run whenever the FDA determined that the regulatory review period under § 156(g)(1)(B)(ii) ends.  Consistent with the FDA's interpretation, the PTO concluded that the date stamped in a NDA approval letter is the appropriate trigger for section 156(d)(1).  The PTO's position, however, ignores material differences between § 156(d)(1) and § 156(g)(1)(B)(ii).  The relevant statutory language is different. Section 156(d)(1) calls for the PTO to determine when the product received permission, while § 156(g)(1)(B)(ii) calls for the FDA to determine when the new drug application was approved.  Congress's use of different words suggests that the two terms do not necessarily have the same meaning. . . .   Moreover, the two provisions serve distinct purposes.

Judge Hilton remanded the case to the PTO for reconsideration and directed the PTO to take steps to ensure that the ‘404 patent does not expire pending further resolution of the PTE litigation.  Unless the case is resolved before expiration of the ‘404 patent next week (which seems unlikely), the PTO will probably issue an interim PTE.  35 U.S.C. §  156(e)(1) provides for a PTE to compensate for delays in FDA regulatory review of an NDA, and 35 U.S.C. § 156(e)(2) provides for an interim PTE if the patent “would expire before a certificate of extension is issued or denied under paragraph (1).”  Although the Federal Circuit ruled in 2007 in Somerset Pharmaceuticals v. Dudas that an interim PTE is not available when the PTO has already denied a PTE application, Judge Hilton’s decision vacating the PTO’s denial of a PTE for the ‘404 patent should clear the way for an interim PTE. 

Categories: Hatch-Waxman