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