For AIA trial petitions filed after November 12, 2018, the Patent Trial and Appeal Board will construe claims challenged and proposed to be amended (narrowed) in these proceedings using the same claim construction standard that is used to construe the claim in a civil action in federal district court. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). In these trials, the Board will also consider claim construction determinations made in proceedings in district courts or the International Trade Commission. A recent Federal Register notice includes the text of rules the Patent Office revised to implement these changes.
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Post Grant Review / PGR
Trial Practice Guide Updates and Future Fee Increases
Today’s Federal Register includes a notice that the Patent Office updated its August 2012 Trial Practice Guide. The Federal Circuit recently noted that the Practice Guide “is a thoughtful and useful resource to which individual Board members and the public might turn for guidance,” but “is not binding on Board panel members.” Application in Internet Time v. RPX Corp., Nos. 2017-1698, -1699, -1701, Slip Op. at 14 n.2 (Fed. Cir. July 9, 2018). The update revises six sections of the guide, including sections focused on the presentation of expert testimony, the Board’s considerations in instituting review, and briefing concerning evidentiary issues and claim amendments.
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PTAB Issues First Biotech/Pharma PGR Final Written Decision Based On Written Description Challenge
The Patent Trial and Appeal Board has received 37 petitions for post grant review of patents issuing from examination conducted by the Patent Office’s Group Art Unit 1600. The Board has issued four final written decisions thus far. We discussed the first final written decision here, where all claims were upheld in the face of a challenge based on obviousness grounds only. Three of the four final written decisions issued so far on biotech/pharma subject matter dealt only with art-based challenges. Grünenthal GmbH v. Antecip Bioventures II LLC, Case PGR2017-00008 (June 22, 2018) marks the first PGR final written decision addressing written description of a patent arising from Art Unit 1600; all claims were held to be unpatentable under Section 112.
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Proposed Hatch-Waxman Amendment Would Effectively Eliminate IPR Challenges by Generics
On June 13, 2018, Senator Orrin Hatch (R-UT) introduced to the Senate Judiciary Committee an amendment to restore the careful balance sought in the Hatch-Waxman Act, which provided incentives for both pharmaceutical innovation and drug affordability. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would modify the IPR process for pharmaceuticals—under Hatch-Waxman and the BPCIA—and would amend sections of the Federal Food, Drug and Cosmetic Act that provide abbreviated pathways for generic drug and biosimilar product approval.
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When is There Standing to Appeal a PGR Final Written Decision?
In Altaire Pharm., Inc. v. Paragon Biotek, Inc., Case No. 2017-1487 (Fed. Cir. May 2, 2018), the Federal Circuit reversed in part a PGR final written decision that upheld the patentability of challenged claims, and determined that a risk of a future lawsuit for patent infringement may be sufficient to establish Article III standing for the appeal.
Under Supreme Court precedent, Article III standing requires: (1) a concrete and particularized injury, (2) caused by the challenged conduct, (3) which can be redressed by a judicial decision. Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016). Ironically, a party that has not been charged with infringement may have sufficient standing to file a petition with the PTAB, but lack standing to appeal the PTAB’s final decision to an Article III court.
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Supreme Court Decides that IPR Final Decisions Must Address All Challenged Claims
On April 24, 2018, the Supreme Court issued its decision in SAS Institute, Inc. v. Iancu, holding that if the Patent Office institutes an inter partes review (IPR) proceeding, it must issue a final written decision with respect to the patentability of every patent claim challenged by the petitioner. The Court reversed the Federal Circuit’s judgment, which upheld the Patent Trial and Appeal Board’s (PTAB) common practice of instituting review on some, but not all challenged claims, and then issuing a final written decision addressing only the claims for which review was instituted.
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Avoid Creating Bad Blood with the Board
The Board recently denied a post grant review petition because the challenge was deemed redundant of the Patent Office’s earlier examination of similar claims in a related application. Live Nation Entertainment, Inc. v. Complete Entertainment Resources B.V., Case No. PGR2017-00038 (PTAB January 16, 2018). The decision offers a cautionary tale for patent practitioners. The Board learned of the earlier examination from the patent owner, not the petitioner who was obliged to advise the Board of “related matters.”
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Petitioners Will Pay More for Immensely Popular AIA Trials
In the November 14, 2017, Federal Register, the Patent Office issued its final rule setting and adjusting the fees the Office charges for its products and services, including relatively substantial increases for standard AIA trial fees (as shown below). As a simple example, a petitioner challenging all claims of a patent containing 30 claims will pay 37% more in fees for inter partes review ($42,500 v. $31,000), and 33% more in fees for post grant or covered business method review ($54,125 v. $40,750). These AIA trial fees become effective on January 16, 2018.
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Enactment of the STRONGER Patents Act Would Severely Limit PTAB Proceedings
The STRONGER (Support Technology & Research for Our Nation’s Growth and Economic Resilience) Patents Act of 2017 was recently introduced in the Senate. The Act is an updated version of the STRONG Patents Act of 2015 that stalled in Congress. Like its predecessor, the STRONGER Patents Act is designed to significantly modify the AIA trial proceedings at the PTAB. Enactment of this Act would severely diminish the usefulness of AIA proceedings.
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To Establish Entitlement to an Earlier Effective Filing Date, Every Claim Limitation Must be Addressed
The PTAB’s final written decision in Inguran, LLC d/b/a Sexing Techs. v. Premium Genetics (UK) LTD., Case PGR2015-00017, Paper 22 (PTAB 2016), illustrates what a Patent Owner must do to demonstrate that a challenged claim is entitled to an earlier effective filing date in an AIA trial.
The PGR involved U.S. Patent 8,933,395, which issued from an application filed on January 31, 2014, that was a continuation of pre-AIA patent applications filed before March 15, 2013, with the same text as those prior applications. As we explained in our prior post, the PTAB instituted PGR of claims 1-14, despite the patent’s claimed pre-AIA effective filing date. The PTAB found, at that institution phase, that claim 2 of the patent was only entitled to a post-AIA effective filing date and, thus, the entire patent and all of its challenged claims were eligible for PGR. The PTAB instituted review on multiple grounds, including anticipation by each of Mueth, Frontin-Rollet, and Durack.
Continue Reading To Establish Entitlement to an Earlier Effective Filing Date, Every Claim Limitation Must be Addressed