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Idorsia Pharmaceuticals Ltd. v. Iancu

United States District Court, E.D. Virginia, Alexandria Division

July 22, 2019

IDORSIA PHARMACEUTICALS LTD., Plaintiff,
v.
ANDRE IANCU, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant.

          MEMORANDUM OPINION

          T.S. ELLIS, UNITED STATES DISTRICT JUDGE

         Plaintiff, a Swiss limited liability company, brings this action pursuant to 35 U.S.C. § 154(b)(4)(A), the Administrative Procedures Act ("APA"), [1] and the Fifth Amendment of the United States Constitution, challenging the United States Patent and Trademark Office's ("PTO") calculation of the length of a patent term adjustment ("PTA") for plaintiffs patent, U.S. Patent No. 8, 518, 912 ("the '912 Patent"). In total, plaintiff seeks an additional 102 days of A-Delay PTA to be added to the term of the '912 Patent, which would increase the total PTA from 311 to 413 days. At issue in this matter are the parties' cross-motions for summary judgment with respect to plaintiffs challenge to the PTO's PTA determination.

         I.

         The APA confines judicial review of agency decisions to the administrative record of proceedings before the agency. See 5 U.S.C. § 706; see also Camp v. Pitts, 411 U.S. 138, 142 (1973). Put another way, "when a party seeks review of agency action under the APA, the district judge sits as an appellate tribunal." Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C. Cir. 2001). Given the district court's limited role in reviewing the administrative record, the ordinary summary judgment standard does not apply. The key difference in an APA case is that "the presence or absence of a genuine dispute of material fact is not in issue, as the facts are all set forth in the administrative record." Hyatt v. U.S. Patent & Trademark Office, 146 F.Supp.3d 771, 780 (E.D. Va. 2015). Therefore, in a review of agency action under the APA, "[t]he 'entire case' on review is a question of law." Am. Bioscience, Inc., 269 F.3d at 1083.

         The administrative record pertaining to the PTO's determination of the correct amount of PTA to be awarded to the '912 Patent reflects the following relevant facts.

• Actelion Pharmaceutical, Ltd. ("Actelion"), plaintiffs predecessor in interest in the '912 Patent, filed United States Patent Application No. 12/745, 358 ("the '358 Application") as an international application pursuant to the Patent Cooperation Treaty. The '358 Application claimed priority to International Patent Application No. PCT/IB2007/054850, which was filed on November 29, 2007.
• The '358 Application disclosed an independent compound claim 1, which recited the formula P(0)R5R8.
• On March 14, 2012, the PTO examiner issued the first restriction requirement for the '358 Application. All pending claims (claims 1-14 and 16) were made subject to the restriction requirement. The examiner identified six distinct inventive groups for all the claims based upon possible composition variations for the P(O)R5R8 chemical structure disclosed by the '358 Application. The examiner explained his view that the restriction was necessary because "[t]he inventions of Groups I-VI [were] independent and distinct from each other because they [were] directed to structurally dissimilar compounds that lack[ed] a common core as noted [sic] the various P(O)R5R8." AR426.[2]
• After the PTO issued the first restriction requirement, Actelion notified the examiner via telephone call that the first restriction requirement omitted subject matter from the claims. The examiner agreed that the restriction requirement omitted subject matter from the claims and indicated that a new restriction requirement would be issued to supersede the first restriction requirement. Actelion did not elect any of the invention groups in the first restriction requirement or oppose the restriction requirement on the merits.
• The PTO issued a second restriction requirement for the '358 Application on April 18, 2012. The second restriction requirement superseded and replaced the first restriction requirement, and it divided the '358 Application's claims into eight invention groups.
• After the PTO issued the second restriction requirement, Actelion notified the examiner via telephone call that the second restriction requirement omitted subject matter from the claims. The examiner agreed that the restriction requirement omitted subject matter from the claims and indicated that a third restriction requirement would be issued to supersede the second restriction requirement. Actelion did not elect any of the invention groups in the second restriction requirement or oppose the restriction requirement on the merits.
• The PTO issued a third restriction requirement for the '358 application on June 21, 2012. The third restriction requirement superseded and replaced the first restriction requirement, and it divided the '358 Application's claims into three invention groups.
• Actelion filed a response to the third restriction requirement on July 23, 2012, in which Actelion elected one of the invention groups defined in the third restriction requirement, made an election of species, and traversed.
• The '358 Application issued as the '912 Patent on August 27, 2013. The PTO issued an initial PTA determination on August 27, 2013, totaling 314 days of PTA, including 229 days of A-Delay.
• In response, Actelion filed an application for Patent Term Adjustment followed by a Request for Reconsideration of Patent Term Adjustment in view of the AIA Technical Corrections Act. On September 29, 2014, the PTO issued a recalculation of 311 days of PTA. This recalculation reduced the amount of A-Delay from 229 days to 226 days, by redetermining the national stage commencement date to be June 1, 2010, the next PTO business day after May 29, 2010.
• Actelion filed an Application for Patent Term Adjustment in response to the PTO's PTA determination of 311 days. On November 10, 2014, the PTO determined the PTA to be 346 days on the ground that the accrual of A-Delay was stopped by the second restriction requirement issued by the PTO, but not by the first restriction requirement. On April 7, 2015, the PTO issued a final decision on PTA for the '912 Patent upholding the PTO's calculation of 346 days of PTA, including 261 days of A-Delay.
• On October 1, 2015, Actelion filed suit in the Eastern District of Virginia pursuant to 35 U.S.C. § 154(b)(4)(A) to challenge the PTO's determination of PTA for the '912 Patent. On March 26, 2016, the District Court remanded the case to the PTO to reconsider its determination of PTA for the '912 Patent in light of the ...

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