By Donald Zuhn –-
After reflecting upon the events of the past twelve months, Patent Docs presents its 16th annual list of top patent stories. For 2022, 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 2022. As with our other lists (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 2022" on January 24, 2023 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. PTAB Issues Decisions in CRISPR Interferences and University of California/Berkeley Appeals to Federal Circuit
Seven years ago, the journal Science picked the CRISPR (clustered regularly interspaced short palindromic repeats) technology as its "Breakthrough of the Year," declaring that the technology had "matured into a molecular marvel." Not surprisingly, CRISPR's status as breakthrough molecular marvel has resulted in a battle over who has the best patent position with respect to this technology. Interferences between the Broad Institute, Harvard University, and the Massachusetts Institute of Technology (as Senior Party) and the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (as Junior Party) (No. 106,115), between Toolgen as Senior Party and the parties in Interference No. 106,115 as Junior Parties, and between Sigma-Aldrich as Senior Party and the parties in Interference No. 106,115 as Junior Parties continued to move forward in 2022.
In February, in Interference No. 106,115, the Patent Trial and Appeal Board granted priority for eukaryotic CRISPR to the Broad Institute, Harvard University, and MIT ("Broad") as Senior Party and against Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier ("CVC"). Accordingly, all of Broad's patents and applications in interference remain and CVC's applications having claims directed to eukaryotic CRISPR were finally rejected for lack of priority. In November, CVC filed its brief on appeal to the Federal Circuit seeking to convince the Court that correction of the PTAB's decision is in order.
CRISPR interferences have now made five of our last six top stories lists, and the dispute over the protection of this technology could very well be on next year's list as well.
For information regarding this and other related topics, please see:
• "PTAB Redeclares Interference No. 106,132 and Suspends Priority Phase Proceedings," December 26, 2022
• "PTAB Decides Parties' Motions in CRISPR Interference," December 22, 2022
• "A Better, CRISPR World Assayed in The New York Times," December 13, 2022
• "Regeneron Files Amicus Brief in Support of CVC and Reversal in Interference No. 106,115*," November 16, 2022
• "Oral Arguments Scheduled in CRISPR Interferences," November 13, 2022
• "Scientists File Amicus Brief in Interference No. 106,115," November 8, 2022
• "CVC Files Appeal Brief in Interference No. 106,115," November 2, 2022
• "PTAB Renders Decisions in Interference No. 106,127," October 23, 2022
• "PTAB Renders Decisions in Interference No. 106,126," October 18, 2022
• "PTAB Suspends ToolGen Interferences," October 17, 2022
• "Oral Hearing in Interference No. 106,127," September 21, 2022
• "Oral Hearing in Interference No. 106,126," September 20, 2022
• "Oral Arguments Rescheduled in CRISPR Interferences," August 28, 2022
• "Oral Arguments Scheduled in CRISPR Interferences," August 4, 2022
• "Tell Us What You Really Think: CVC Asserts Board Decision in '115 Interference Negates Jurisdiction in Interference Nos. 106,127 and 106,132," June 9, 2022
• "Junior Party Broad Files Reply to Sigma-Aldrich Opposition to Broad Preliminary Motion No. 3 in Interference No. 106,133," June 1, 2022
• "Junior Party Broad Files Reply to Sigma-Aldrich Opposition to Broad Contingent Motion No. 2," May 30, 2022
• "Junior Party Broad Files Reply to Sigma-Aldrich Opposition to Substantive Preliminary Motion No. 1 in Interference No. 106,133," May 22, 2022
• "Sigma-Aldrich Files Reply to Broad’s Opposition to Sigma's Substantive Preliminary Motion No. 1 to Deny Priority Benefit in Interference No. 106,133," May 19, 2022
• "CVC Files Reply to Sigma-Aldrich Opposition to CVC's Responsive Motion No. 1," May 16, 2022
• "Junior Party CVC Files Reply to Sigma-Aldrich's Opposition to Its Preliminary Motion No. 4," May 15, 2022
• "CVC Files Reply to Senior Party Sigma-Aldrich's Opposition to CVC's Substantive Preliminary Motion No. 3 in Interference No. 106,132," May 11, 2022
• "CVC Files Reply to Sigma-Aldrich Opposition to CVC Substantive Preliminary Motion No. 1 to be Accorded Priority Benefit," May 9, 2022
• "Senior Party Sigma-Aldrich Files Reply to Junior Party CVC'S Opposition to Its Substantive Preliminary Motion No. 1 to Change Count in Interference No. 106,132," May 8, 2022
• "Senior Party Sigma-Aldrich Files Opposition to Junior Party's Preliminary Motion No. 3 in Interference No. 106,133," May 4, 2022
• "Senior Party Sigma-Aldrich Files Opposition to Broad Contingent Motion No. 2," April 21, 2022
• "Senior Party Sigma-Aldrich Files Opposition to Junior Party Substantive Preliminary Motion No. 1 in Interference No. 106,133," April 18, 2022
• "Junior Party Broad Files Opposition to Senior Party Sigma-Aldrich's Substantive Preliminary Motion No. 1 in Interference No. 106,133," April 11, 2022
• "CVC Files Opposition to Senior Party Sigma-Aldrich's Substantive Preliminary Motion No. 1 to Change Count in Interference No. 106,132," March 27, 2022
• "Senior Party Sigma-Aldrich's Opposition to CVC's Substantive Preliminary Motion No. 4 in Interference No. 106,132," March 22, 2022
• "Senior Party Sigma-Aldrich's Opposition to CVC's Substantive Preliminary Motion No. 3 in Interference No. 106,132," March 20, 2022
• "Sigma-Aldrich Files Opposition to CVC Substantive Preliminary Motion No. 1 to be Accorded Priority Benefit," March 15, 2022
• "PTAB Holds for Broad in CRISPR Interference: The Reasoning," March 7, 2022
• "PTAB Grants Priority for Eukaryotic CRISPR to Broad in Interference No. 106,115," February 28, 2022
• "Sigma-Aldrich Files Substantive Preliminary Motion No. 2 to Remove Broad Application from Interference," February 20, 2022
• "Sigma-Aldrich Files Substantive Preliminary Motion No. 1 to Deny Broad Priority Benefit to Its Earliest-filed Provisional Application," February 16, 2022
• "Broad Files Substantive Preliminary Motion No. 3 to Designate Claims as not Corresponding to Count in Interference No. 106,133," February 13, 2022
• "Broad Files Contingent Preliminary Motion No. 2 to Designate Claims Corresponding to Substitute Count 3," February 10, 2022
• "PTAB Hears Oral Argument in Interference No. 106,115," February 7, 2022
• "Broad Files Substantive Preliminary Motion No. 1 to Substitute the Count," February 2, 2022
• "CVC Files Responsive Preliminary Motion No. 1 for Priority Benefit," January 31, 2022
• "Patent Trial and Appeal Board Set Date for Oral Hearing in Interference No. 106,115," January 30, 2022
• "Sigma-Aldrich Files Substantive Preliminary Motion 1 to Change the Count in Interference No. 106,133," January 19, 2022
• "CVC Files Substantive Miscellaneous Motion No. 4 to Add Senior Party Patents and Designate Claims Corresponding to the Count," January 13, 2022
• "CVC Files Substantive Preliminary Motion No. 3 to Substiture the Count," January 12, 2022
• "CVC Substantive Preliminary Motion No. 1 for Priority Benefit," January 10, 2022
6. Federal Circuit Continues to Focus on Written Description
In 2017, the Federal Circuit's decision in Amgen Inc. v. Sanofi brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies, and that decision came in at #11 on our top stories list. Last year, the Federal Circuit issued several decisions implicating the written description and enablement requirements, and the Federal Circuit's continuing development (and limitation of) § 112 made it to #5 on our top stories list.
Last year, the Federal Circuit continued to focus on the written description requirement. For example, in June, in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the Federal Circuit granted a panel rehearing and vacated a panel decision between these parties that had been decided in January. In the panel rehearing, Chief Judge Moore (who dissented in January) was joined by Judge Hughes (who replaced Judge O'Malley, who left the Court in May) in vacating the January decision (over a dissent by Judge Linn, who had joined Judge O'Malley in the majority in January). The panel majority opinion tracks the Chief Judge's dissent in the Court's earlier decision, that negative limitations do bear a burden of disclosure different from affirmative ones. According to the Chief Judge, this burden can be satisfied, for example, by including "a reason to exclude the relevant [element]," or by including "'statements in the specification expressly listing the disadvantages of using' that element," or by distinguishing among the excluded element and advantageous alternatives. The opinion calls "the common denominator" of all these rubrics disclosure of the element to be excluded, repeating the Chief's aphorism from her earlier dissent that "silence is not disclosure." While not disputing the principle that "a negative limitation need not be recited in the specification in haec verba," the majority opinion asserts the need for "something" to be disclosed in the specification "that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives."
For information regarding this and other related topics, please see:
• "Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)," June 21, 2022
• "Federal Circuit Denies Petition for Rehearing en Banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.," March 17, 2022
• "Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)," January 4, 2022
5. UPC Postpones Start of Sunrise Period
Last month, the Unified Patent Court (UPC) announced that the start of Sunrise Period –- when patent owners can begin to remove European patents and European patent applications from the jurisdiction of the UPC, i.e., opt-out -- was being postponed by two months from January 1, 2023 to March 1, 2023. The UPC indicated that the initial plan called for the Sunrise Period to begin on January 1, 2023, with the Agreement on a Unified Patent Court (UPCA) coming into force on April 1, 2023. However, following the UPC's adjustment, the Sunrise Period will begin on March 1, 2023, and the UPCA will come into force on June 1, 2023. The UPC also noted that it "expect[s] no further delay of the start of the UPC beyond 1 June 2023."
For information regarding this and other related topics, please see:
• "UPC Postpones Start of Sunrise Period to March 1, 2023," December 12, 2022
Top Stories of 2022: #8 to #10
By Donald Zuhn –-
10. Federal Circuit Denies En Banc Review in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA
The 2020 decision by a divided Federal Circuit panel in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA regarding the extent to which an ANDA applicant who obtained regulatory approval under the carve-out provisions of 21 U.S.C. § 355(j)(2)(A)(viii) could be liable for inducement of infringement under 35 U.S.C. § 271(b) caused something of an uproar, leading to a panel rehearing on the matter but ultimately coming to the same conclusion. Both decisions were issued in the face of a strong dissent by Judge Prost, in the first decision while she was Chief Judge. In February, the Federal Circuit decided not to rehear the matter en banc, over the dissenting opinions of three of the judges (including Judge Prost). The decision by the full Court was announced in a simple Order to that effect, noting that Judges Lourie and Cunningham did not participate in the decision. The Order was accompanied by three written dissents: one by Judge Prost, joined by Judges Dyk and Reyna; another by Judge Dyk writing alone, and the third by Judge Reyna. The majority consisted of Chief Judge Moore and Judges Newman (who was the third member of the original panels), O'Malley, Taranto, Chen, and Stoll. Provided that the panel decision does not significantly inhibit "skinny-label" practice, these issues are sure to recur and be the subject of additional Federal Circuit decisions which will make the consequences of this decision, and the Federal Circuit's decision not to review the panel opinion en banc, more evident.
For information regarding this and other related topics, please see:
• "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2022)," February 15, 2022
9. New York Times Reopens Attack on U.S. Patent System
Over the years, this blog has found itself at odds with The New York Times on the issue of patenting. See, e.g., "Anti-Patent ("Sullivan?") Malice by The New York Times," January 29, 2007; "Science Fiction in The New York Times," February 13, 2007; "The Anti-Patent Beat Goes on at The New York Times," July 1, 2007; "The Continuing Assault on Innovation at The New York Times," July 15, 2007; "New York Times to Innovation: Drop Dead," April 30, 2008; "New Attack on Patenting in The New York Times," September 7, 2008; "More Patent Nonsense from The New York Times," April 17, 2011.
In April, The New York Times published an editorial opinion entitled "Save America's Patent System," in which the paper bemoaned the purported prevalence of "bad patents" -- including "uninspiring tweaks" to existing products -- that supposedly undermine innovation. The Times Editorial Board decided that it was time to announce that the "United States Patent and Trademark Office is in dire need of reform." Were that the case, the Times' rhetoric would deserve serious consideration; as it is, the paper continues a history of wrongheaded, faux populist rhetoric that comes to the entirely wrong conclusion.
For information regarding this and other related topics, please see:
• "Faux-Populist Patent Fantasies from The New York Times," April 17, 2022
• "Before You Complain About So-Called Bad Patents, Read This," April 17, 2022
8. Senator Tillis Releases Proposal to Reform 35 U.S.C. § 101
In August, Republican Senator Thom Tillis of North Carolina released a new proposal to reform the text of 35 U.S.C. § 101. The Senator's last effort in doing so died on the vine in 2019, purportedly due to stakeholders being too far apart in their visions of what patent eligibility should be all about. But there seems to be a renewed interest in addressing at least some of the ambiguities introduced by the Supreme Court in Alice Corp. v. CLS Bank Int'l and Mayo Collaborative Services v. Prometheus Laboratories, Inc. Those decisions, which came down in 2014 and 2012, respectively, led to the current state of affairs in which diagnostic methods are effectively unpatentable and software patents can be invalidated based on fuzzy, conclusory reasoning. Senator Tillis' proposed revisions to § 101 attempt to find a middle ground between varying stakeholder concerns by overruling some aspects of the Supreme Court's recent eligibility jurisprudence and codifying other aspects. It is unlikely that any one stakeholder will be entirely satisfied with this proposal, but as a starting point the patent community could do much worse.
For information regarding this and other related topics, please see:
• "The EFF is Patently Wrong," August 24, 2022 (Tillis bill)
• "More on Professor Sarnoff's Perspective on Tillis Patent Eligibility Bill," August 9, 2022
• "Professor Sarnoff Provides His Perspective on Tillis Bill," August 8, 2022
• "Senator Tillis' Patent Eligibility Reform Proposal: A Biopharma Perspective," August 3, 2022
• "Senator Tillis Proposes Patent Eligibility Reform (Again)," August 3, 2022
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