35 U.S.C. § 315(a)(1) bars institution of an IPR if, before the date on which a petition for the review is filed, a petitioner or real party in interest filed a civil action challenging the validity of a claim of the patent. But what happens when a petitioner has previously filed a declaratory judgment action of non -infringement that resulted in an affirmative defense of invalidity? The Board addressed this issue in Ariosa Diagnostics v. Isis Innovation Ltd., IPR2012-00022 (February 12, 2013) (Paper No. 20).

In Ariosa Diagnostics, the Board rejected the Patent Owner’s request to deny inter partes review of U.S. Patent No. 6,258,540 (“the ’540 patent”), on the basis that the Petitioner, Arisoa, lacks standing to file the petition. Prior to filing its IPR petition, Ariosa soughtdeclaratory judgment ofnoninfringement against Sequenom, the exclusive licensee of the ’540 patent. Sequenom counterclaimed for infringement, and Ariosa answered by raising an affirmative defense of invalidity of the ’540 patent.

Isis argued that the Ariosa was barred under Section 315(a) from filing a petition for inter partes review, and that the exception of Section 315(a)(3) does not apply to Ariosa’s petition. The Board disagreed with Isis, and concluded that a civil action for a declaratory judgment of non-infringement is not a civil action challenging the validity of a patent for the purposes of Section 315(a)(1). The Board explained that the statute’s reference to “filing a civil action” refers to filing a complaint with the court to commence the civil action.

The Board also found that Ariosa’s affirmative defense of invalidity did not preclude it from filing its IPR petition. The Board confirmed thatits statutory interpretation ofSection 315(a)(1) does not conflict with the explicit exclusion in Section 315(a)(3) of filing a counterclaim for invalidity. The Board clarified that Section 315(a)(3) is intended to allow a party faced with a claim of infringement to bring the independent claim of invalidity as a counterclaim and an IPR. The Board noted that, because asserting an affirmative defense of invalidity is treated differently than a counterclaim for invalidity, raising an affirmative defense cannot be considered a filing of a civil action under Section 315(a)(1).

Finally, the Board disagreed with Isis’s position that allowing Ariosa to file a declaratory judgment action and a petition for inter partes review would be contrary to the intent of Congress. The Board noted that Congress intended to allow an accused infringer to file a declaratory judgment action on the same day or after a petition for IPR to allow him to presumptively choose his venue. Moreover, the Board asserted that the filing of both a declaratory judgment action and an IPR petition does not constitute harassment, because a party must meet Article III’s case-or-controversy requirements to file the declaratory judgment action.

Accordingly, the Board concluded that Section 315(a) does not deprive Ariosa of standing to petition for inter partes review.

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