PTAB Declines Request to Review Method of Treating Lymphoma Claim
By: Matthew George Hartman, Akin Gump
A Patent Trial and Appeal Board (PTAB) panel declined to institute an inter partes review (IPR) of a claim directed to a method for treating low grade B-cell non-Hodgkin’s lymphoma. The challenged method required patients to be treated with cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy, followed by four once-weekly doses of 375 mg/m2rituximab, an anti-CD20 antibody, every six months for two years.
In rejecting petitioner’s anticipation and obviousness challenges, the panel found that several asserted references were not publicly accessible and, therefore, did not qualify as “printed publications.” First, although a clinical study consent form was distributed to approximately 40 prospective patients, there was no evidence that it was distributed to ordinarily skilled artisans, rather than patients. There was also no evidence to show that an interested party would have known to visit a particular oncology website to look for the consent form. Second, although petitioner’s expert testified that a clinical study protocol was “freely disseminated to any referring doctor or patient,” the panel found this testimony insufficient to establish public accessibility because the expert “[did] not identify any particular instances or the timeframe of its dissemination.” Finally, the panel held that petitioner failed to show that the rituximab label was publicly accessible. In rejecting petitioner’s assertion that the rituximab label was made publicly accessible “when Rituxan was approved,” the panel explained that petitioner failed to provide any documentary or testimonial evidence showing that the label was included in the packaging of a disseminated drug product.
The panel also rejected petitioner’s obviousness challenge because it found that the asserted references failed to disclose the particular treatment regimen and dosing amount limitations recited in the challenged claim. In reaching its decision, the panel rejected the assertion that a skilled artisan would have sought to treat low grade non-Hodgkin’s lymphoma patients with the same dosing regimen employed in a study of a wholly different patient population – namely, elderly patients having aggressive non-Hodgkin’s lymphoma. Nor did petitioner sufficiently explain why an ordinarily skilled artisan would have used arituximab dose of 375 mg/m2, given the reference’s teachings that “doses up to 500 mg/m2” had been used and that “the best dose and schedule of rituximab remain to be established.”
Celltrion, Inc. v. Biogen, Inc., IPR2017-01093 (PTAB October 6, 2017)
[Franklin, Snedden, Harlow (opinion)]
PTAB Institutes IPR Despite Potential Time Bar to Petition
By: Jenna Marie Pellecchia, Akin Gump
On October 6, 2017, the Patent Trial and Appeal Board (the “Board”) granted institution of inter partes review under 35 U.S.C. § 103(a) of claims directed to an online game. Notably, institution was granted despite the Board reserving determination on the patent owner’s argument that the petition should be denied under 35 U.S.C. § 315(b) as time-barred.
In its preliminary response, patent owner Game and Technology Co., LTD. argued that a real party-in-interest to the petitioner was served with a complaint alleging infringement of the challenged patent over a year before the filing of the petition for inter partes review, thereby time-barring Wargaming Group Limited’s petition. In support of this assertion, the patent owner submitted a declaration detailing the manner in which Wargaming’s real party-in-interest was served.
On August 11, 2017, the parties and the Board held a conference call to discuss the issue of whether the petition was time barred. During the call, counsel for petitioner denied service was made when the patent owner alleged. In fact, petitioner submitted a declaration from the individual upon whom Game and Technology alleged service was made. Ex. 1017. Petitioner’s declarant testified that he could not “recollect…receiving any documents” and that he “most likely  wasn’t in the office” when the documents were allegedly delivered. Decision, Paper 14 at p. 7; Ex. 1017 ¶¶3-5. Petitioner, however, “did not dispute that, if service of the complaint occurred pursuant to the Hague Convention more than one year before the filing of the Petition, as asserted by Patent Owner, the Petition would be time barred.” Decision, Paper 14 at p. 6.
With petitioner and patent owner urging the Board to accept the testimony of their respective declarants as fact, the Board determined that the record needed to be developed further before a decision on the potential time-bar could be made. While this record is being developed, the Board instituted review of claims 1-7 of the challenged patent as unpatentable under 35 U.S.C. § 103(a) over the combined teachings of a U.S. Patent publication and a Dungeons and Dragons Player’s handbook. The parties must now proceed with trial to determine whether claims 1-7 are obvious over the cited references without knowing whether the petition was statutorily barred.
Wargaming Group Limited v. Game and Technology Co., LTD., IPR2017-01082, Paper No. 14 (PTAB Oct. 6, 2017).
PTAB Invalidation of Patents Following Jury Verdict of Infringement Does Not Necessarily Impact Willfulness Finding
By: Daniel T. Taskalos & Rubén H. Muñoz, Akin Gump
In a recent decision, Judge Schroeder of the Eastern District of Texas rejected the argument that decisions of the United State Patent and Trade Office (USPTO) invalidating patents held infringed by a jury means that a defendant cannot be held liable for willful infringement where appellate review of the invalidity decisions is still ongoing.
Judge Schroeder’s order addressed several post-trial motions following a jury trial in September 2016. Specifically, Judge Schroeder denied defendant Apple’s motion for judgment as a matter of law and request for a new trial, and granted plaintiff VirnetX’s motions for a finding of willful infringement and enhanced damages.
The focus of VirnetX’s willfulness argument was on Apple’s conduct following the jury’s verdict on November 6, 2012. While appealing that verdict, Apple continued to sell products, including the infringing features, until September 2013, when Apple updated the operating system on the devices. The Federal Circuit remanded the case for retrial with respect to infringement by one of the accused features—holding that a claim term was improperly construed—and damages for infringement by both features. The issue of validity was not remanded for reconsideration. On remand, a new jury found the feature infringed under the new construction and awarded damages under a different damages model.
In response to VirnetX’s motion asserting willful infringement, Apple argued that it had a reasonable, long-held and continuing belief in the invalidity of the asserted patents, regardless of the 2012 verdict finding the patents not invalid. Apple asserted that its belief was based on interim rejections from an inter partes reexamination of the asserted patents, issued more than a year prior to the 2012 verdict. Apple argued that the reasonableness of this belief was confirmed by final written decisions from the USPTO finding the asserted patents invalid. Accordingly, Apple argued that it could not be found to have willfully infringed during the period after the 2012 verdict.
Judge Schroeder disagreed, finding that Apple’s continued sales following the 2012 verdict were “unreasonably risky.” Judge Schroeder’s decision specifically found unpersuasive Apple’s argument that, because the subsequent decisions found the asserted patents invalid, it could not be held liable for willful infringement. Distinguishing Fresenius USA Incorporated v. Baxter International, 721 F.3d 1330 (Fed. Cir. 2013), Judge Schroeder noted the ongoing appeal of those subsequent decisions of the USPTO, as opposed to the situation in Fresenius where the appeals process was exhausted. Moreover, Judge Schroeder found that such subsequent decisions “[did] not bear on Apple’s subjective willfulness or recklessness at the time of its infringement.” The decisions Apple relied on issued in 2015 and 2016, roughly two years after the alleged willful conduct.
The specific facts surrounding Apple’s conduct during the relevant period may have influenced Judge Schroeder’s holding that the later decisions of the USPTO invalidity of the patents could not bear on Apple’s subjective belief. According to VirnetX, Apple’s continued sale of products implementing the infringing features was not based on Apple’s appellate positions. The Federal Circuit had affirmed the jury’s 2012 verdict that the patents were not invalid. Moreover, VirnetX noted that Apple had redesigned the features, but had reverted to the jury-determined infringing designs because of implementation cost and consumer backlash, not because of any belief in Apple’s noninfringement or invalidity positions.
In view of this decision, blind reliance on the fact that the USPTO has issued decisions finding asserted claims invalid subsequent to a jury verdict of infringement as meaning one could not have willfully infringed may be a risky position. If appeals of those USPTO decisions are still ongoing, defendants should, at a minimum, focus on distinguishing the factual context and ensure that there is some connection between appellate positions and the allegedly willful conduct.
VirnetX Inc. et al. v. Apple Inc., Case No. 10-cv-00417 (E.D. Tex. Sep. 29, 2017).
PTAB Allows Petitioner to Supplement Record Regarding Publication Date of Prior Art Reference
By: Thomas W. Landers IV & Rubén H. Muñoz, Akin Gump
On October 23, 2017, a Patent Trial and Appeal Board (PTAB) panel granted Petitioner’s Motion to Submit Supplemental Information (“the Motion”) on the publication date of an asserted reference. At the time the Petition was filed, the effective filing date of the challenged claims was November 6, 1997. After the Institution Decision, however, the Patent Office issued a Certificate of Correction for a related patent that “may result in according the challenged claims an effective filing date of January 29, 1997.” Accordingly, Petitioner filed the Motion to submit information that would “further confirm the prior art status” of the reference. Critical to the PTAB’s decision was that (1) the original Petition—despite focusing on the November 6 date—contended that the reference was “published by at least January 17, 1997,” and (2) the Patent Office’s Certificate of Correction was a “post-filing change of circumstances.”
Patent Owner first argued that the information “should have and could have” been included in the Petition. The PTAB held that 37 C.F.R. § 42.123 imposes no such requirement when, as here, the party seeking to submit the information requests to file the motion within one month of the date the trial is instituted. Compare 37 C.F.R. § 42.123(b) (addressing requests more than one month after institution and requiring a showing of “why the supplemental information reasonably could not have been obtained earlier”) to 37 C.F.R. § 42.123(a) (addressing requests within one month of institution and requiring only that the information “be relevant to a claim for which the trial has been instituted”). Because the request was timely and the asserted reference’s publication date was “important” in view of the challenged claims’ potentially earlier effective filing date, the Motion met the requirements of 37 C.F.R. Section 42.123(a).
In similar arguments, Patent Owner further contended that Petitioner sought to “change the evidence originally relied upon in the Petition,” “remedy the insufficiencies in its Petition that the Board raised in the Rehearing and Institution Decision,” and “present the publication date of [the reference] as a moving target.” The PTAB rejected each of these arguments because Petitioner included the contention that the reference was published on January 17, 1997 in its original Petition and was now seeking to supplement that “original theory” in “respon[se] to circumstances that changed after institution of the proceeding.” Notably, the Institution Decision expressed concern over Petitioner’s ability to address potential changes to the challenged claims’ effective filing date. The PTAB “discern[ed] nothing improper or prejudicial to Patent Owner in responding to these efforts to sensitize the parties to post-institution developments that might bear on issues in the proceeding.”
Patent Owner also contended that “Petitioner’s supplemental information attempt[ed] to address arguments that have not been raised in these proceedings” and was “not relevant” because “the prior art status of [the reference] ha[d] not been contested.” The PTAB rejected this argument based on its “independent duty to ascertain whether a petitioner ‘prove[s] a proposition of unpatentability by a preponderance of the evidence.’” See 35 U.S.C. § 316(e).
Blue Coat Systems, Inc. v. Finjan, Inc., IPR2016-01444 (PTAB October 23, 2017)
[Arpin, Yang, Boucher (opinion)]