On April 1, 2013, the USPTO published an “interim final rule” relating to Patent Term Adjustment (PTA), to implement changes to the PTA statute embodied in the AIA Technical Corrections Act. Although the rule changes have an immediate effective date, the USPTO will consider written comments submitted within 60 days, e.g., by May 31, 2013.Continue reading this entry
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.)
The Senate has passed a modified version of HR 6621, which focuses on changes “[t]o correct and improve certain provisions of the Leahy-Smith America Invents Act” and also includes other provisions unrelated to the AIA, such as those impacting Patent Term Adjustment (PTA). The President is expected to sign the bill soon, and it will take effect on the date of enactment, unless otherwise provided.
The AIA Changes
HR 6621 makes several “technical amendments” to the AIA, some simply correcting “scrivener’s errors” and others making more substantive changes.
Inter Partes Review
One of the most significant changes in HR 6621 closes the Inter Partes Review (IPR) “dead zone.” The original IPR statute provides that IPR cannot be requested within the first 9 months of a patent’s grant date. This time period will complement the time period for Post Grant Review (PGR), once PGR is available because PGR only can be requested within 9 months of a patent’s grant date. But, PGR only is available against certain business method patents and patents examined under the first-to-file version of 35 USC § 102, which does not take effect until March 16, 2013. Thus, under the original IPR statute, patents granted now cannot be challenged in an inter partes USPTO proceeding until they have been in force for 9 months.
HR 6621 eliminates this “dead zone” by providing that the 9-months-from-grant requirement does not apply to patents that are not examined under the first-to-file version of 35 USC § 102. (Congress does not shy away from double negatives!)
HR 6621 also eliminates a similar “dead zone” for reissue patents, by providing that the 9-months-from-grant requirement does not apply to reissue patents.
HR 6621 changes the time period for filing an executed inventor’s oath/declaration (or substitute statement) from “by allowance” to “no later than the date on which the issue fee .. . paid.” This will greatly simply allowance procedures, and will permit the USPTO to issue a Notice of Allowance even when an executed inventor’s oath/declaration has not yet been filed.
Advice Of Counsel
HR 6621 provides that the section of the AIA deeming that evidence of any failure to obtain “advice of counsel” cannot be used to establish willfulness or intent to induce infringement apply to “any civil action commenced on or after the date of enactment” of HR 6621.
HR 6621 clarifies the deadline for bringing a derivation proceeding, and provides that such a proceeding must be brought within one year of the publication or grant of a relevant claim in the earlier-filed application. This is consistent with how the USPTO had interpreted the original language of the derivation statute.
HR 6621 also defines “earlier application” and re-writes much of the derivation statute in terms of the “earlier application.”
HR 6621 clarifies that the USPTO Patent Trial and Appeal Board (PTAB) and Federal Circuit can hear appeals of interferences commenced after the effective date of the AIA’s amendments to § 135(a).
Patent Term Adjustment Provisions
HR 6621 includes the changes to the Patent Term Adjustment statute that I discussed in this article, including changes that I think may be problematic.
In his speech providing a “section-by-section summary” of HR 6621, Rep. Lamar Smith expressed his views that the district court decision in Exelixis v. Kappos (which I wrote about here) will cause “absurd and undesirable results” that will undermine Congressional goals in adopting a 20-year patent term. (The USPTO has appealed the Exelixis decision.)
Pending, Unpublished Pre-GATT Patent Applications
As I wrote previously, HR 6621 was amended to eliminate the controversial provisions that effectively would have eliminated the term of pending, unpublished pre-GATT patent applications, and instead would have required the USPTO to issue a report on such applications. The Senate took that revision one step further and removed all provisions relating to pre-GATT patent applications.
Effective Date of HR 6621
The default effective date of HR 6621 is its date of enactment, and it will apply “to proceedings commenced on or after” that date, except where it states otherwise.
More Changes Ahead?
In his speech providing a “section-by-section summary” of HR 6621, Rep. Lamar Smith indicated that further changes to the AIA may be under consideration. In particular, he indicated that Congress is considering changing the “raised or could have been raised” PGR estoppel provisions. Additionally, Congress clearly wants to address the problem of pending pre-GATT applications, which is discussed in more detail in this article.
As expected, the USPTO has filed a Notice of Appeal in the Exelixis patent term adjustment (PTA) case. As I summarized in this article, in a decision issued November 1, 2012 in Exelixis, Inc. v. Kappos, the U.S. District Court for the Eastern District of Virginia 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. 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 will be interesting to see if Exelixis or amici urge a fall-back interpretation of the RCE carve-out, such as the interpretation discussed in this article.
Although most of HR 6621 (introduced by Rep. Lamar Smith on Nov. 30, 2012) would make changes “[t]o correct and improve certain provisions of the Leahy-Smith America Invents Act,” the bill includes other provisions that are entirely unrelated to the AIA and that would dramatically impact patent term. The provision receiving the most public attention would eliminate the term of patent applications filed before June 7, 1995 (“pre-GATT applications”) that are still pending. But another provision would affect all pending and new applications, as well as recently granted patents, by changing the way that Patent Term Adjustment (PTA) is calculated and challenged under 35 USC § 154(b). 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 University of Massachusetts v. Kappos, the United States District Court for the District of Colombia held that an Office Action that was “fundamentally flawed” still stopped the Patent Term Adjustment (PTA) clock that was running against the USPTO under 35 USC § 154(b)(2)(A). The court distinguished this case from the Oncolytics case, where it was the USPTO itself who decided that a vacated Office Action would not be counted for PTA purposes. This case indicates that it may be difficult to challenge PTA awards for A-type delay based on alleged inadequacies in an Office Action, or on other factual grounds. Continue reading this entry
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
Although 35 USC § 21(b) provides that a response that falls due on a weekend or Federal holiday is timely when filed on the next business day, we often try to file a response before such a deadline because the USPTO has interpreted the relevant provision of the Patent Term Adjustment (PTA) statute as not being subject to that grace provision. That practice can come to an end for three month response deadlines, because the District Court for the District of Columbia has determined that the USPTO’s interpretation is not correct, and the USPTO did not appeal that decision.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
The USPTO has filed a motion requesting reconsideration in Bristol Meyers Squibb Co. v. Kappos, where the U.S. District Court for the District of Columbia found that the statutory deadline for bringing a civil action to challenge the Patent Term Adjustment (PTA) awarded by the USPTO is tolled when the patentee pursues reconsideration of the agency decision. As I wrote previously, the court’s original ruling was significant, because the 180-day statutory period often runs before the USPTO has issued its final decision. If the deadline is not tolled, a patentee must decide whether to bring a civil action to contest a PTA award even before the USPTO has made it’s final PTA calculation. Continue reading this entry
In a decision issued January 27, 2012, in Bristol Meyers Squibb Co. v. Kappos, the U.S. District Court for the District of Columbia found that the statutory deadline for bringing a civil action to challenge the Patent Term Adjustment (PTA) awarded by the USPTO is tolled when the patentee pursues reconsideration of the agency decision. This ruling is significant, because the 180-day statutory period often occurs before the USPTO issues its final decision on a request for reconsideration. Continue reading this entry
In a Federal Register Notice issued December 28, 2011, the USPTO announced that it is considering changes to the Patent Term Adjustment (PTA) rules relating to “appellate review by the Board.” I have written previously about the post-Notice of Appeal gap left by the current PTA rules, and believe that these new proposed changes would go far to close that gap, although they will not benefit all applications on appeal. The USPTO will accept written comments on these proposed rule changes through January 27, 2012. Continue reading this entry
In a Federal Register Notice issued December 1, 2011, the USPTO issued a final rule that tweaks the patent term adjustment rules to permit applicants to promptly file McKesson-type Information Disclosure Statements (IDSs) without incurring a patent term adjustment deduction. The rule change took effect on December 1, 2011.
(The Federal Register Notice indicates that previously proposed changes to the calculation of patent term adjustment when the USPTO reopens prosecution after a Notice of Appeal are being revised and will be published for comment separately.) Continue reading this entry
In an action that has advanced to the summary judgment stage, ArQule, Inc. is challenging the PTO’s practice of charging “applicant delay” when a response is filed on the next business day after a deadline that fell on a Federal holiday. While a decision in ArQule’s favor could impact numerous patents, the single day at issue is not likely to spawn an onslaught of litigation.
On April 6, 2011, the USPTO announced proposed changes to the Patent Term Adjustment (PTA) rules that would award PTA for USPTO delay when an examiner reopens prosecution after a notice of appeal has been filed. While I have written previously about the gap left by the USPTO’s current PTA rules, I am afraid that the new proposal raises more problems than it solves.
Yet another complaint has been filed against the USPTO challenging Patent Term Adjustment. The issue raised in Oncolytics Biotech Inc. v. Kappos is whether a deficient Office Action that was subsequently vacated by the USPTO nevertheless satisfied the USPTO’s obligation to take action within four months of the applicant’s previous reply.
Hoffman-La Roche Inc. and Morphosys AG are among the latest patent holders to file a Patent Term Adjustment (PTA) action against the USPTO. Their complaint is somewhat unique in that it challenges the factual basis for PTA deductions based on “Applicant Delay,” rather than challenging the USPTO’s interpretation of the PTA statute.
Although it has been over a year since the Federal Circuit decision in Wyeth v. Kappos, Wyeth-related Patent Term Adjustment (PTA) problems continue. One issue raised in several pending district court cases is whether a patentee can invoke the doctrine of equitable tolling to bring a civil action more than 180 days after the patent was granted. Schering v. Kappos raises this issue in the starkest terms, because Schering never sought reconsideration of the PTA award at issue. It will be interesting to see how the court resolves this case, and whether it opens the door for other patent holders to obtain the full patent term due under the statute.
Since the Federal Circuit decision in Wyeth v. Kappos, we have been applying greater scrutiny to the USPTO’s interpretations of the Patent Term Adjustment (PTA) statute. While we previously reviewed the USPTO’s calculations to ensure that the USPTO delays and Applicant delays were correctly counted in accordance with the rules, we find ourselves more frequently questioning whether the rules themselves are in accord with the statute. Just like the Federal Circuit determined that the USPTO’s interpretation of 35 USC § 154(b)(2)(A) was inconsistent with the statute, I think that the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(ii) improperly excludes time that has nothing to do with an actual appeal to the Board.