By Donald Zuhn –-
After reflecting upon the events of the past twelve months, Patent Docs presents its 17th annual list of top patent stories. For 2023, we identified ten stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. On Monday, we counted down stories #10 to #8, and today we count down stories #7 to #5, as we work our way towards the top four stories of 2023. As with our other lists (2022, 2021, 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2023" on January 23, 2024 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.
7. University of California/Berkeley Appeals PTAB Ruling in CRISPR Interference; FDA Approves CRISPR Gene Editing Treatment
In December 2022, the Patent Trial and Appeal Board rendered its decision on Preliminary Motions in Interference No. 106,133 between Senior Party Sigma-Aldrich and Junior Party The Broad Institute, Harvard University, and MIT (collectively, "Broad"). As with the priority phase in co-pending Interference Nos. 106,126, No. 106,127, and No. 106,132, the Board suspended the priority phase in Interference No. 106,133 until the appeal in Interference No. 106,115 has been decided by the Federal Circuit. 2022 and 2023 saw briefing in that appeal.
Meanwhile, the significance of the final outcome in the CRISPR interferences was demonstrated last fall, when the U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee announced on October 27 that exagamglogene autotemcel (exa-cel), which was the subject of biologics license application (BLA) 125787 from Vertex Pharmaceuticals, Inc. in collaboration with CRISPR Therapeutics (Zug, Switzerland) and provides for the first time gene therapy for sickle cell anemia, was shown to be effective, having 29 of 30 patients stay pain-free for 18 months. On October 31, the Advisory Committee issued its recommendation that exa-cel is safe for clinical use, and the FDA then approved the treatment on December 8. The treatment, being marketed as CASGEVY, is the first CRISPR-based gene-editing therapy to be approved in the U.S.
For information regarding this and other related topics, please see:
• "FDA Signals Willingness to Approve CRISPR-Based Treatment for Sickle Cell Anemia," November 2, 2023
• "Broad Files Reply Brief in Interference No. 106,115 Cross-Appeal," September 7, 2023
• "CVC Files Response and Reply Brief in Interference No. 106,115 Appeal," August 27, 2023
• "Amici Support Reversal of PTAB Decision in CRISPR Interference," July 25, 2023
• "Broad Files Opening Brief and Cross-Appeal in CRISPR Interference," July 23, 2023
• "CVC Appeals PTAB Decision in CRISPR Interference," July 12, 2023
• "PTAB Rules on Preliminary Motions in Interference No. 106,133," January 22, 2023
6. Judicial Council of Federal Circuit Suspends Judge Newman
Efforts to have Judge Pauline Newman, Circuit Judge on the Court of Appeals for the Federal Circuit, removed from the Federal Circuit for being unfit or guilty of misconduct were the subject of several reports in mid-2023. In September, the Judicial Council of the Federal Circuit ordered Judge Newman to be suspended from the court for one year. The Judicial Council's Order repeated allegations made previously against Judge Newman, supplemented with 16 (sometimes) heavily redacted Exhibits and notations and other supporting exhibits that were redacted in their entirety for confidentiality purposes. The arguments and supporting exhibits were apparently provided to justify the grounds for the decision, which were Judge Newman's purported refusal to cooperate with the Special Committee's investigation into her competency (despite the Judge having provided medical and psychological results from her own doctors rather than the Committee's hand-picked ones). The suspension remains subject to Judge Newman's on-going lawsuit in the D.C. District Court asserting that the Council's suspension is unconstitutional and a violation of Judge Newman's due process rights.
For information regarding this and other related topics, please see:
• "Judge Newman Suspended for One Year by Federal Circuit," September 20, 2023
• "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman," August 6, 2023
• "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing," June 21, 2023
• "Judge Newman Matter Continues," June 20, 2023
• "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit," May 21, 2023
5. Supreme Court Denies CareDx Petition; Senators Coon & Tillis Try to Fix Patent Eligibility (Again)
In May, CareDx and Stanford University filed a petition for certiorari in CareDX, Inc. v. Natera, Inc. and CareDx, Inc. v. Eurofins Viracor, Inc. At the time, we noted that the arguments in the petition threaded a very narrow needle in giving the Court a reason to grant certiorari and emphasize (as has been emphasized before) the need to do so. In particular, the petition directed the Court's attention to the "heav[y] investment CareDx made in bringing this technology to market" and infringing behavior of both Natera and Eurofin in bringing their own "copycat" products to market. Those hoping for a certiorari grant (and positive outcome), however, were frustrated (yet again) when the Court denied the patentees' petition in October.
Given the refusal of the Supreme Court to wade back into the subject matter eligibility waters, Senators Coons and Tillis, who chaired a series of Congressional hearings on patent eligibility in 2019, who have asked the U.S. Patent and Trademark Office for its statistics and other information on patent eligibility, and who have proposed several bills providing various iterations of legislative solutions, proposed their latest attempt to provide a legislative solution in June when they introduced "The Patent Eligibility Restoration Act of 2023." As we noted at the time, this proposal marks the third time that one or both of the Senators have proposed or introduced a bill to revise § 101. The first two attempts garnered discussion but little tangible progress, leaving the patent community feeling like Charlie Brown repeatedly getting the football yanked away.
In one bit of good news on the subject matter eligibility front, the storied case of American Axle v. Neapco Holdings entered a new chapter in July -- not the final chapter, but the plot thickened considerably. We provided a recap at the time, noting that Judge Stark, then of the District Court for the District of Delaware, had found all asserted claims of U.S. Patent No. 7,774,911 invalid under 35 U.S.C. § 101 as being directed to a law of nature implemented by well-understood, routine, and conventional means, a decision that was affirmed by the Federal Circuit, with the majority subsequently withdrawing its original opinion and handing down a revised opinion (finding claim 22 still ineligible but vacating and remanding the District Court's decision on claim 1) in response to a petition for en banc rehearing, and the Supreme ultimately denying American Axle's petition for certiorari. On remand, Judge Williams (who had taken on the case given Judge Stark's promotion to the Federal Circuit), denied Neapco's motion for summary judgment of invalidity pursuant to § 101 and granted American Axle's motion for summary judgment of no invalidity.
For information regarding this and other related topics, please see:
• "American Axle's Claims Found Eligible on Remand," August 1, 2023
• "Senators Tillis and Coons Once More Attempt to Fix Patent Eligibility," June 25, 2023
• "Senate Bill Proposed to Provide Subject Matter Eligibility Solution," June 22, 2023
• "Can Judge Michel and John Duffy Convince the Supreme Court to Revisit Subject Matter Eligibility?" May 31, 2023
• "Stanford Asks Supreme Court to Revisit Subject Matter Eligibility on Diagnostic Claims," May 3, 2023
• "Sequoia Technology LLC v. Dell Inc. (Fed. Cir. 2023)," April 23, 2023
• "On Alice Rejections per USPTO Technical Center," March 6, 2023
• "ITC Takes Section 101 to Its Illogical Extreme," March 1, 2023
• "Chromadex, Inc. v. Elysium Health, Inc. (Fed. Cir. 2023)," February 15, 2023
• "PTAB Remains Hostile to Section 101 Appeals," January 31, 2023
• "The Mental Process Exception to Patent Eligibility is Remarkably Brainless," January 9, 2023
Updates on Judge Newman available from David Lat.
Not sure these will change anyone's mind.
Posted by: skeptical | January 23, 2024 at 02:50 PM