The PTAB recently issued a final written decision in an inter partes review (IPR), refusing to cancel claims in Verinata Health, Inc.’s U.S. Patent No. 8,318,430. Ariosa Diagnostics v. Verinata Health, Inc., Cases IPR2013-00276 and -00277 (P.T.A.B. Aug. 15, 2016). The claims are directed to methods for determining the presence or absence of fetal aneuploidy in a fetus. This is the second such decision from the PTAB. The first decision was the subject of an appeal to the Federal Circuit. Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015). In that appeal, which we previously discussed, the court vacated the PTAB’s prior conclusion of nonobviousness because the court could not discern from the appeal record that the PTAB properly considered the prior art. In its recent decision, the PTAB has considered that prior art, but nevertheless reaches the same conclusion of nonobviousness.
Continue Reading PTAB Accords Little Weight to Evidence without Analysis or Explanation
Federal Circuit Refuses to Reweigh Factual Findings, But PTAB’s Conclusory Statements Are Insufficient
The Federal Circuit’s precedential decision in In re: Warsaw Orthopedic, Inc., No. 2015-1050, 2015-1058 (Fed. Cir. Aug. 9, 2016), highlights recurring themes in appeals of PTAB IPR decisions. On one hand, the Federal Circuit is reluctant to overturn a PTAB decision canceling claims for obviousness based on Patent Owner’s assertions that the PTAB failed to properly weigh certain facts found in reaching its decision. On the other hand, the Federal Circuit will not hesitate to vacate and remand PTAB decisions where the PTAB does not adequately describe its reasons for concluding a claimed invention is obvious.
Continue Reading Federal Circuit Refuses to Reweigh Factual Findings, But PTAB’s Conclusory Statements Are Insufficient
Government Weighs in on Constitutionality of Inter Partes Review
Two petitions for certiorari are pending before the Supreme Court in which the aggrieved patent owners in MCM Portfolio LLC. v. Hewlett-Packard Co. and Cooper v. Lee are challenging the constitutionality of AIA trials. The Federal Circuit in MCM Portfolio upheld the PTAB’s authority to adjudicate the validity of issued patents, determining that IPR proceedings are not unconstitutional under Article III or the Seventh Amendment right to a jury trial. MCM Portfolio LLC. v. Hewlett-Packard Co., 812 F.3d 1284 (Fed. Cir. 2015). In Cooper, the district court granted summary judgment against Cooper on administrative exhaustion grounds and the Federal Circuit summarily affirmed. Cooper v. Lee, 86 F.Supp.3d 480 (2015); Cooper v. Lee, Nos. 2015-1483, 2016-1071 (Fed. Cir. 2016). The Government filed briefs in opposition to both petitions – the Cooper opposition brief was filed in April, and the MCM opposition brief was filed in June. A decision on the petitions is expected at the beginning of the Supreme Court’s October 2016 term.
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Advise Petitioner to File Supplemental Evidence Instead Of Information
In a bit of “inside baseball,” the PTAB recently clarified the difference between supplemental evidence and supplemental information. Practitioners would do well to give careful attention to this distinction. The difference can have profound consequences to an IPR Petitioner.
In Generico LLC v. Dr. Falk Pharma GmbH, IPR2016-00297, Paper No. 15 (July 15, 2016), the PTAB entered an order regarding the conduct of proceedings. The order addressed the Petitioner’s request to file a motion to supplement information pursuant to 37 C.F.R. §42.123. The Petitioner sought to file information in response to objections the Patent Owner made to evidence submitted by Petitioner. Specifically, the Patent Owner had objected that Petitioner’s prior art references would not have been relied upon by a person of ordinary skill in the art, and that the Petitioner’s declarant was not qualified to speak to the views of a person of ordinary skill in the art. To address these objections, the Petitioner sought the PTAB’s authorization to file a supplemental declaration and documents from a parallel district court litigation.
Continue Reading Advise Petitioner to File Supplemental Evidence Instead Of Information
The Three-Front Assault: PeroxyChem Uses IPR, PGR and District Court to Challenge Opponent
In what could become a common patent challenge strategy, PeroxyChem, a chemical company that sells products useful in water and soil remediation, has employed a three-front assault—combining the relatively young post-grant review procedure, with an IPR and litigation–to take on one of its competitors, Innovative Environmental Technologies (IET). Litigation together with an IPR has become a rather common means to challenge a competitor’s patent. However, post grant review is gaining in popularity among litigants, adding to the available strategies of overcoming potential barriers to market entry for companies. For example, while 12 Petitions for PGR were filed in all of 2015, 15 have been filed so far in the first half of 2016.
Continue Reading The Three-Front Assault: PeroxyChem Uses IPR, PGR and District Court to Challenge Opponent
Been There, Done That: Petitioners Should Find Art and Arguments Not Previously Considered During Prosecution
This blog has previously explained on July 23, 2015, December 10, 2015, and December 16, 2015 why it is important for parties to AIA trials to carefully consider the patent prosecution history. Under 35 U.S.C. § 325(d), the Board has discretion to deny an AIA trial if “the same or substantially the same prior art or arguments previously were presented to the Office.” The Board recently exercised that discretion in denying an inter partes review petition and, in doing so, provided yet another warning to petitioners: do not waste the Board’s time presenting in a petition prior art and arguments that were already considered during prosecution, and be sure to address deficiencies in prior art combinations the patentee overcame during prosecution. Drug Prices for Consumers, LLC v. Forest Labs. Holdings Ltd., Case IPR2016-00379, Paper 14 (PTAB July 1, 2016).
Continue Reading Been There, Done That: Petitioners Should Find Art and Arguments Not Previously Considered During Prosecution
The Possibility of Inconsistent Results Inherent to Congress’s Design of AIA Trial Reviews
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In Cuozzo Speed Technologies, LLC v. Lee, the Supreme Court recognized that a “district court may find a patent claim to be valid, and the agency may later cancel that claim in its own review.” The Court also recognized that because of the different evidentiary burdens in court versus before the agency—the Patent Office—“the possibility of inconsistent results is inherent to Congress’[s] regulatory design.” Is that inconsistency sensible? As good a case as any to consider that question involves a global pharmaceutical company, one of its top-selling drug products, and a patent it owns that covers the administration of that drug product.
Continue Reading The Possibility of Inconsistent Results Inherent to Congress’s Design of AIA Trial Reviews
An Overview of Amendments to the PTAB Rules
On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided an overview of the new PTAB rules during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference. The final rule on Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board, which we have previously discussed [April 21, 2016 and August 20, 2015] was published on April 1, 2016, and was later revised in a correction to the final rule on April 27, 2016. APJ Bonilla commented on the new rules relating to the standard for claim construction, preliminary responses by the patent owner, including testimonial evidence, word count, Rule 11-type certification, and motions for sanctions.
Continue Reading An Overview of Amendments to the PTAB Rules
En Banc Rehearing Petition Denied – PTAB Retains Authority to Institute IPR and Issue Final Decision
We previously reported on the Federal Circuit’s decision that neither the AIA nor the Constitution precludes the same PTAB panel from rendering both institution and final decisions in Ethicon Endo-Surgery, Inc. v. Coviden LP, No. 2014-1771 (Fed. Cir. 2016). Last week, in a 10-1 decision, the Federal Circuit denied Ethicon’s petition for rehearing en banc.
Continue Reading En Banc Rehearing Petition Denied – PTAB Retains Authority to Institute IPR and Issue Final Decision
Supreme Court Vacates Federal Circuit Decision that Refused to Review PTAB’s Application of the Time Bar to AIA Trials
Update: The Supreme Court issued a decision on April 20, 2020 holding that the patent statute (35 U.S.C. § 314(d)) bars judicial review of a PTAB decision of whether an inter partes review petition is time-barred pursuant to 35 USC 315(b). As stated by the Court, the PTAB’s “application of §315(b)’s time limit, we hold, is closely related to its decision whether to institute inter partes review and is therefore rendered nonappealable by§314(d).”
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An updated discussion of this issue is available here: Federal Circuit to Take AIA Time Bar Issue En Banc
Original Post: In a non-precedential decision late last year, the Federal Circuit dismissed a patent owner’s appeal of a Patent Trial and Appeal Board decision that refused to apply a statutory time-bar to deny institution of an inter partes review proceeding. Click-to-Call Technologies, LP v. Oracle Corp., 622 Fed. Appx. 907 (Fed. Cir. 2015) (per curiam). The court relied on the “No Appeal” provision in 35 USC § 314(d), which states that the “determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.”
Continue Reading Supreme Court Vacates Federal Circuit Decision that Refused to Review PTAB’s Application of the Time Bar to AIA Trials