In a recent appeal from a PTAB final written decision, the Federal Circuit determined that a patentee was not denied notice or an opportunity to respond to references cited in the final written decision as representing the state of the art, but that were not the basis for a grounds for institution. (Genzyme Therapeutic Prods. Ltd. v BioMarin Pharm. Inc., Appeal Nos. 2015-1720, -1721 (Fed. Circ., June 14, 2016)). The court concluded that there is no requirement, either in the PTAB’s regulations, in the Administrative Procedure Act (APA), or as a matter of due process, for the institution decision to anticipate and set forth every legal or factual issue that might arise during the trial, and that the PTAB acted properly in citing the additional references.
Continue Reading Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution
Federal Circuit to PTAB – Explain yourself!!
The Federal Circuit recently vacated or reversed-in-part two PTAB final written decisions on the basis that the PTAB did not adequately describe its reasons for concluding the claimed invention is obvious. In both instances, the court criticized the Board’s “broad, conclusory statements” regarding one of ordinary skill’s motivation to adjust prior art teachings. These decisions highlight an attractive grounds for appealing a PTAB’s final written decision.
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Board Need Not Consider Arguments Beyond Those Actually Raised By Patentee In Motion To Amend
An updated discussion of this issue is available here: Who Must Bear the Burden of Proof Regarding Patentability of Amended Claims?
The Federal Circuit confirmed in a precedential opinion that the burden to prove patentability of an amended claim in an IPR proceeding rests squarely with the patentee, and in deciding a motion to amend claims, the Board only need consider the arguments presented by the patentee, not perform a full reexamination of the proposed claims. In In re Aqua Products, Inc., Appeal No. 2015-1177 (Fed. Cir. May 25, 2016), the Federal Circuit affirmed the PTAB’s denial of patentee Aqua’s motion to substitute claims because Aqua failed to prove patentability of the substitute claims. Aqua then appealed challenging the Board’s amendment process.
Continue Reading Board Need Not Consider Arguments Beyond Those Actually Raised By Patentee In Motion To Amend
The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition
On May 20, 2016, the PTAB granted Kyle Bass and Erich Spangenberg’s petition for IPR (IPR2016-00245) against a patent owned by Alpex Pharma SA (Alpex). The petition sought cancellation of claims 1-9 of U.S. Patent No. 8,440,170, asserting that the claims were obvious in view of numerous references. The claims of the ‘170 patent are generally directed to orally disintegrating tablets with a speckled appearance. According to the ‘170 patent, the speckled appearance can be achieved by using colored granules of a water-soluble sugar, and provides easy identification by doctors and patients. Bass and Spangenberg argue in the petition that the patent is invalid as obvious because speckles comprising colored granules of a water-soluble sugar were well-known in the art at the time of the invention.
Continue Reading The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition
Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs
The Federal Circuit recently affirmed the Board’s IPR decision that IBS failed to satisfy its burden of demonstrating obviousness of the challenged claims of Illumina’s U.S. Patent No. 7,566,537 (“the ‘537 patent), and determined that the Board did not abuse its discretion in refusing to consider IBS’s reply brief. Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., Case No. 2015-1693 (Fed. Cir. May 9, 2016). Illumina contended that its challenged claims, directed to a method of labeling nucleotides to determine their identity in a sequencing by synthesis (SBS) method, were nonobvious based on its use of a particular azidomethyl group as a 3′ OH blocking (or protecting) group.
Continue Reading Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs
Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR
In IPR2015-01537, Momenta petitioned for IPR of claims 1-15 of U.S. Patent No. 8,476,239 owned by Bristol-Myers Squibb (BMS) on grounds of obviousness over three references: Cohen, Shire, and Carpenter. Petitioner also relied on expert testimony. The claims recite formulations containing CTLA4Ig, which is a stabilized form of a negative regulator (checkpoint inhibitor) of the immune system useful in treating autoimmune disease and rheumatoid arthritis, for example. The Patent Owner opposed institution by attacking the Petitioner’s position as failing to provide a reason to combine the cited references and as relying on impermissible hindsight in arriving at a formulation that satisfied all features recited in the claims (i.e., tonicity, pH, excipient concentration, excipient:therapeutic mass ratio, volume, and stability).
Continue Reading Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR
PTAB Grants Motion to Amend Claims
In IPR2015-00208, Shinn Fu petitioned for IPR of USPN 6,681,897 owned by Tire Hanger. All five claims of the patent were drawn to methods of supporting vehicle wheels removed from a vehicle while on a service lift, wherein the supports would allow technicians to remove and replace the wheels without risking back injury by bending. By all accounts, Shinn Fu mounted a strong attack against all claims in the ‘897 patent, and the PTAB instituted review. Foregoing a dogged defense of the granted claims, Tire Hanger maintained a clear head and responded to the petition by filing a contingent motion to amend the claims rather than a Patent Owner Response.
Continue Reading PTAB Grants Motion to Amend Claims
It’s Complicated: PTAB Reinforces Notion That Petitioners Should Consider Expert Testimony in Complex Technology Areas
This Blog previously highlighted the risks involved when a petitioner does not submit an expert declaration with their petition. This risk may be lessened where the “the invention and prior art references are directed to relatively straightforward and easily understandable technology.” [Paper No. 41 at 17 n.6 of IPR2014-00169] (ruling in favor of petitioner despite its failure to present expert declaration until its Reply brief). However, a petitioner should strongly consider submitting an expert declaration to support their arguments in technology areas that are considered complex.
Continue Reading It’s Complicated: PTAB Reinforces Notion That Petitioners Should Consider Expert Testimony in Complex Technology Areas
Failure to Establish Published U.S. Application is Prior Art Dooms IPR under Dynamic Drinkware
The PTAB’s final written decision in Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, should serve as a reminder to Petitioners challenging claims under 35 U.S.C. § 102(e) – take care to establish that your reference is prior art.
Continue Reading Failure to Establish Published U.S. Application is Prior Art Dooms IPR under Dynamic Drinkware
Failure To Identify The Difference Makes A Difference
There have been a few short articles floating around over the past few years that list the top (usually four or five) mistakes that petitioners have made to doom their IPR/CBM petitions. These articles sometimes refer to the need for the petitioner to pay attention to detail, but then often fail to go into detail about what those details might be.
Continue Reading Failure To Identify The Difference Makes A Difference