On January 28, 2013, Judge Brinkema of the U.S. District Court for the Eastern District of Virginia issued a decision in a different Exelixis v. Kappos Patent Term Adjustment (PTA) case (1:12cv574) (Exelixis II) that affirms the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(i). Judge Brinkema’s decision in Exelixis II is in direct conflict with the decision issued by her colleague, Judge Ellis, III, in Exelixis v. Kappos (1:12cv96) (Exelixis I) on November 1. 2012. As I wrote previously, the USPTO already has appealed Exelixis I. I expect Exelixis to appeal Exelixis II.Continue reading this entry
In another significant Patent Term Adjustment (PTA) case decided last week (Novartis AG v. Kappos, Civ. Action No. 10-cv-1138 (Nov. 15, 2012)), the U.S. District Court for the District of Columbia found that Novartis could benefit from “ordinary tolling” but not “equitable tolling” in its efforts to obtain additional PTA for 23 patents. This decision by Judge Huvelle addresses several interesting issues that may arise in other PTA cases.Continue reading this entry
MicuRx Pharmaceuticals, Inc. appears to be one of the first patent holders to sue the USPTO for additional Patent Term Adjustment (PTA) based on the recent district court decision in Exelixis, Inc. v. Kappos, No. 1:12cv96 (E. D. Va. Nov. 1, 2012). The patent at issue (U.S. Patent 8,178,683, directed to oxazolidinone antibiotic agents) was filed August 6, 2008, and granted May 15, 2012. The USPTO awarded some PTA for its failure to grant the patent within three years of the filing date, but did not award any PTA for the days after March 5, 2012—the date on which a Request for Continued Examination (RCE) was filed. Thus, MicuRx seeks an additional 71 days of PTA—the number of days from March 5 to May 15. The complaint was filed within the 180 day window for bringing a civil action under 35 USC § 154(b)(4)(A).
In a decision issued November 1, 2012 in Exelixis, Inc. v. Kappos, the U.S. District Court for the Eastern District of Virginia has found that the USPTO’s interpretation and application of the “RCE carve-out” provision of the Patent Term Adjustment (PTA) statute is contrary to law. Although I wrote about some “RCE carve-out” challenges just last week, the decision here reaches an even broader interpretation of the statute.
Under the district court’s interpretation, 35 USC § 154(b)(1)(B)(i) only comes into play if a Request for Continued Examination (RCE) is filed within the three-year period from the application’s filing date. Under this interpretation, a significantly greater number of patents may be entitled to significantly greater PTA awards. It is too early to know whether the USPTO will appeal this decision. In the meantime, patent holders with affected patents may wish to consider pursuing additional PTA in a Request for Reconsideration filed with the USPTO or in a district court proceeding, if the deadline for pursuing such an action has not passed.Continue reading this entry
In a complaint filed October 19, 2012, Biogen Idec MA Inc. joined patent holders such as Exelixis, Inc. and Human Genome Sciences, Inc., who are challenging the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(i)). As I wrote previously, I think these challenges may have merit, and patent holders facing similar PTA calculations may want to consider pursuing similar civil actions against the USPTO.Continue reading this entry
In an August 16, 2012 Federal Register Notice, the USPTO announced final rules that change the way that Patent Term Adjustment (PTA) will be calculated after a Notice of Appeal has been filed. The final rules generally follow the rules that were proposed in December of 2011 and treat “appellate review” for PTA purposes as commencing when jurisdiction over a patent application passes to the Board. According to the Federal Register Notice, new PTA deductions will apply to patent applications in which a Notice of Appeal is filed on or after September 17, 2012, and the new PTA calculations will be applied to patent applications in which a Notice of Allowance is issued on or after September 17, 2012. Other patentees may be able to benefit from the rule changes if they can file timely requests for reconsideration of the PTA awarded to their patents under the current rules. Continue reading this entry
Deca-Medics, Inc. has filed a complaint in the U.S. District Court for the Eastern District of Virginia challenging a Patent Term Adjustment (PTA) award based on how its patent application was processed after a Notice of Appeal was filed. While I have written about the problem with the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(ii) and the USPTO is considering changing the rule that interprets that portion of the PTA statute, Deca-Medics takes a different approach in its complaint.Continue reading this entry
Recently several cases have been filed that challenge the USPTO’s Patent Term Adjustment (PTA) calculations in patents where an RCE has been filed. For example, both Exelixis, Inc. v. Kappos (Civ. Action No. 1:12-cv-00574-LMB-TCB) (E.D. Va. May 25, 2012) and Human Genome Sciences, Inc. v. Kappos (Civil Action No. 1:12-cv-00607-GBL-TCB) (E.D. Va. June 1, 2012) raise the same issue regarding the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(i)). I think these challenges may have merit, and patent holders facing similar PTA calculations may want to consider pursuing similar civil actions against the USPTO.Continue reading this entry