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Janssen Pharmaceutica, N.V. v. Kappos

Citations: 844 F. Supp. 2d 707; 101 U.S.P.Q. 2d (BNA) 1924; 2012 U.S. Dist. LEXIS 17065; 2012 WL 441429Docket: No. 1:11cv969 (LMB/IDD)

Court: District Court, E.D. Virginia; February 9, 2012; Federal District Court

Narrative Opinion Summary

In this case, a Belgian corporation, Janssen Pharmaceutica, filed a lawsuit against the United States Patent and Trademark Office (USPTO) and its director, seeking an additional 98-day extension of the patent term for U.S. Patent No. 7,741,356 based on Patent Term Adjustment (PTA). The dispute centered around the interpretation of 35 U.S.C. § 154 and the proper calculation of PTA, as well as the jurisdictional and procedural requirements for challenging the USPTO's determination. The defendants, USPTO and its director, moved to dismiss the case, arguing that the proper venue for such actions is the United States District Court for the District of Columbia as mandated by 35 U.S.C. § 154(b)(4)(A), and that the statute of limitations had expired. The court agreed with the defendants, ruling that the case was improperly filed outside of the specified jurisdiction and was beyond the allowable timeframe unless tolling applied. Consequently, the court granted the motion to dismiss for improper venue but denied the dismissal on statute of limitations grounds without prejudice, transferring the case to the District of Columbia. The court emphasized that specific statutory provisions take precedence over general administrative law, reinforcing the exclusive forum and time restrictions set by Congress for patent term disputes.

Legal Issues Addressed

Administrative Procedure Act (APA) Applicability

Application: The plaintiff cannot invoke the APA to circumvent the specific venue and timing requirements of 35 U.S.C. § 154(b)(4)(A).

Reasoning: The patent statute's stringent limitations replace the more lenient provisions of the APA for these cases.

Jurisdiction under 35 U.S.C. § 154(b)(4)(A)

Application: The court lacks jurisdiction to hear the case, as challenges to patent term adjustments must be filed in the United States District Court for the District of Columbia within 180 days.

Reasoning: The Court concludes that the challenged decision by the USPTO is governed by 35 U.S.C. § 154(b)(4)(A), necessitating that the action be filed in the United States District Court for the District of Columbia.

Patent Term Adjustment Calculation

Application: The USPTO correctly calculated the patent term adjustment using the April 9, 2007, office action date as the basis for determining delays.

Reasoning: For calculating patent term adjustment, the Office action from April 9, 2007, was appropriately utilized to assess whether the USPTO delayed the patent’s issuance by failing to notify under 35 U.S.C. 132 within 14 months of the application filing.

Statute of Limitations for Patent Term Adjustment Appeals

Application: The complaint is time-barred by the 180-day limitation period set forth in 35 U.S.C. § 154(b)(4)(A) unless tolling applies.

Reasoning: The lawsuit, initiated on September 9, 2011, is time-barred because it exceeds the 180-day limit from the patent issued on June 22, 2010, unless the statute of limitations is tolled.