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
A number of Patent Term Adjustment (PTA) cases have been filed in the U.S. District Court for the Eastern District of Virginia since the November 1, 2012 decision in Exelixis, Inc. v. Kappos. While most have presented straight-forward fact patterns, one complaint caught my attention because it brings to mind how applicants could manipulate the patent prosecution process to ensure that they fall under Exelixis. The USPTO is likely to use examples like these in support of its Federal Circuit appeal.
The Exelixis Decision
As I explained in this article, the Exelixis decision relates to the interpretation of 35 USC § 154(b)(1)(B)(i) and the calculation of PTA when the USPTO took more than three years to grant the patent, and a Request for Continued Examination was filed during prosecution (i.e., the “RCE carve-out” of the “B delay” award). Under the district court’s interpretation of the statute, the carve-out only comes into play if a Request for Continued Examination (RCE) is filed within the three-year period from the application’s filing date. Otherwise, as stated by the court, “RCE’s have no impact on PTA if filed after the three year deadline has passed.”
The Hypermed Imaging Complaint
Hypermed Imaging, Inc. filed the Exelixis-based PTA case that caught my eye. According to the complaint, the patent application at issue was filed in March of 2007, the first RCE was filed in June 2010 (more than three years after the filing date), and the patent was issued in July of 2012 (more than five years after the filing date).
What makes this case interesting is that the application was “unintentionally abandoned” between April 2009 and July 2010. Indeed, the first RCE was filed with the Petition to Revive. If the application had not been unintentionally abandoned, it is likely that the first RCE would have been filed before the application had been pending for three years. Under those circumstances, the RCE would have impacted the B delay PTA calculation, even under Exelixis.
While the unintentional abandonment might permit Hypermed Imaging to accrue B delay under Exelixis, it also negatively impacts the total PTA award for the patent. This is because periods of unintentional abandonment constitute “Applicant delay” that is subtracted from USPTO delay when calculating the final PTA award. According to Hypermed Imaging’s complaint, the total days of USPTO delay exceeded the total days of Applicant delay, even with 452 days of Applicant delay during the period of abandonment.
Manipulating Patent Prosecution To Maximize PTA
Prosecution of the applications at issue in the cases being filed now were not manipulated to benefit from Exelixis, because they were prosecuted under the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(i), under which the USPTO did not award any PTA for B delay once an RCE was filed. But the fact pattern in this case and others filed in the wake of the Exelixis decision bring to mind how patent prosecution could be manipulated to increase the likelihood that a first RCE will not be filed until after the application has been pending for at least three years, to ensure that the patent can accrue B delay under Exelixis.
Of course, an applicant could not purposefully “unintentionally abandon” an application in order to extend the time to a first RCE, but applicants can extend response periods to prolong prosecution. Any such strategies could backfire, however, if the total number of days of B delay is not greater than the total number of days of Applicant delay required to prolong the filing of the first RCE. Still, for an application that is not close to allowance and/or where the RCE is likely to languish on the USPTO examiner’s docket, the delay tally may be more likely to end up in the applicant’s favor. (Please see this article for a discussion of the USPTO’s latest efforts to address RCE backlog problem.)
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
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