After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine 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. Today, we count down stories #9 to #7, and later this week we will count down the top six stories of 2021. As with our other lists (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.
9. FDA Approves First Interchangeable Biosimilars
In August, the U.S. Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval that was notable because it was the first approved interchangeable biosimilar product under the Biological Price Competition and Innovation Act of 2009 (BPCIA), enacted with the Affordable Care Act (commonly known as "Obamacare"). The approved interchangeable product is Semglee (insulin glargine-yfgn), produced by Mylan Pharmaceuticals, Inc., and under this approval, it is interchangeable with Lantus (insulin glargine) made by Sanofi. While there has been some concern with the perceived slow pace of biosimilar uptake by physicians and patients, one of the benefits of interchangeability is that physicians' input (and approval) is not needed and can be implemented at the pharmacy level. The approval of Semglee was followed by the approval a few weeks later of the interchangeable biosimilar drug Cyltezo (adalimumab-adbm), which is produced by Boehringer Ingelheim. Whether a dam-burst of interchangeable biosimilar drug products will now arise remains to be seen.
For information regarding this and other related topics, please see:
• "FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA," November 7, 2021
• "FDA Approves Another Interchangeable Biosimilar Drug," October 21, 2021
• "FDA Approves Biosimilar Drug for Treating Macular Degeneration," September 20, 2021
• "FDA Approves First Interchangeable Biological Product," August 5, 2021
8. CRISPR Interference(s) Move Forward
Six 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. And despite the continuing pandemic, Interference No. 106,115 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) continued to move forward in 2021 with the two Parties presenting various motions and oppositions to those motions.
Meanwhile, in February the U.S. Patent and Trademark Office Patent Trial and Appeal Board declared two additional interferences between Toolgen as Senior Party and the parties in Interference No. 106,115 as Junior Parties. And then in June the Board declared two more interferences naming Sigma-Aldrich as Senior Party and the parties in Interference No. 106,115 as Junior Parties. CRISPR interferences have now made four of our last five top stories lists, and with five pending interferences, 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 Sets Motions and Times in CVC vs. Sigma Interference No. 106,132," December 28, 2021
• "PTAB Sets Motions and Times in Broad vs. Sigma Interference No. 106,133," December 26, 2021
• "Sigma-Aldrich and CVC Propose Preliminary Motions in CRISPR Interference No. 106,132," December 19, 2021
• "Sigma-Aldrich and Broad Propose Preliminary Motions in Recent CRISPR Interference No. 106,133," December 15, 2021
• "Sigma-Aldrich Joins the CRISPR Interference Fray," December 13, 2021
• "Inequitable Conduct by Senior Party Broad Alleged in Interference No. 106,115 (and PTAB May Finally Hear Evidence About It)," December 6, 2021
• "SNIPR Technologies Ltd. v. The Rockefeller University (PTAB 2021)," December 6, 2021
• "ToolGen Files Motion to Exclude Evidence, Broad Opposes, and ToolGen Replies in Interference No. 106,126," November 23, 2021
• "ToolGen Files Motion to Exclude Evidence, CVC Opposes, and ToolGen Replies in Interference No. 106,127," November 21, 2021
• "CVC Files Motion to Exclude Evidence, ToolGen Opposes, and CVC Replies in Interference No. 106,126," November 18, 2021
• "Broad Files Reply to ToolGen Opposition to Broad Preliminary Motion No. 1," November 1, 2021
• "Broad Files Reply to ToolGen's Opposition to Broad's Preliminary Motion No. 3," October 24, 2021
• "CVC Files Reply to ToolGen's Opposition to CVC's Substantive Preliminary Motion No. 2," October 20, 2021
• "Broad Files Reply to ToolGen Opposition to Broad's Contingent Preliminary Motion No. 2," October 18, 2021
• "ToolGen Reply to Broad Opposition to ToolGen Preliminary Motion No. 1," October 12, 2021
• "CVC Files Reply to ToolGen's Opposition to CVC Preliminary Motion No. 3," October 3, 2021
• "CVC Files Reply to ToolGen's Opposition to CVC's Responsive Motion No. 1," September 29, 2021
• "CVC Files Reply to ToolGen Opposition to CVC Preliminary Motion No. 1," September 26, 2021
• "ToolGen Files Reply Brief to CVC's Opposition to its Substantive Preliminary Motion No. 2," September 22, 2021
• "ToolGen Files Reply to CVC Opposition to ToolGen Substantive Motion No. 1," September 21, 2021
• "CVC Files Opposition to ToolGen Substantive Motion No. 1," September 19, 2021
• "ToolGen Files Opposition to Broad Contingent Preliminary Motion No. 2 to Add Claims Corresponding to the Count," September 15, 2021
• "ToolGen Files Opposition to Broad Preliminary Motion No. 3 to De-Designate Claims as Corresponding to Either Interference Count," September 14, 2021
• "ToolGen Files Opposition to Broad Preliminary Motion No. 1 to Change Interference Count," September 9, 2021
• "Broad Files Opposition to ToolGen Substantive Preliminary Motion No. 1," September 7, 2021
• "ToolGen Files Opposition to CVC Contingent Responsive Preliminary Motion No. 1," September 1, 2021
• "ToolGen Files Opposition to CVC Substantive Preliminary Motion No. 3 to Add Claims in ToolGen Patent," August 31, 2021
• "ToolGen Files Opposition to CVC Substantive Preliminary Motion No. 2 to Deny Priority Benefit," August 24, 2021
• "ToolGen Files Opposition to CVC Substantive Preliminary Motion No. 1 for Priority Benefit," August 17, 2021
• "CVC Files Opposition to ToolGen's Substantive Preliminary Motion No. 2," August 15, 2021
• "Broad Files Substantive Preliminary Motion No. 3 in CRISPR Interference," August 11, 2021
• "Broad Files Contingent Preliminary Motion No. 2 in CRISPR Interference," August 8, 2021
• "Broad Files Substantive Preliminary Motion No. 1 in CRISPR Interference," August 2, 2021
• "PTAB Denies Two CVC Requests Regarding Motions," July 27, 2021
• "CVC Files Responsive Preliminary Motion No. 1 Contingent on Grant of ToolGen Substantive Preliminary Motion No. 2," July 11, 2021
• "CVC Substantive Preliminary Motion No. 3 To Add Claims in ToolGen Patent," July 8, 2021
• "News from Abroad: European CVC CRISPR Patent Revoked Because of Invalid Priority Claim," July 6, 2021
• "CVC Substantive Preliminary Motion No. 2 to Deny Priority Benefit," July 4, 2021
• "CVC Substantive Preliminary Motion No. 1 for Priority Benefit," June 29, 2021
• "ToolGen Files Substantive Preliminary Motion No. 2 to Deny CVC of Priority Benefit," June 27, 2021
• "Meanwhile . . . ToolGen Files Substantive Motion No. 1 in Interference with CVC," June 22, 2021
• "CVC Opposes Broad's Motion to Exclude Evidence and Broad Files Reply," June 17, 2021
• "Broad Opposes CVC's Motion to Exclude Evidence and CVC Files Reply," June 15, 2021
• "CRISPR Interference Parties File Motions to Exclude Evidence and for Oral Hearing," June 9, 2021
• "Broad Files Reply to CVC's Opposition to Broad's Priority Motion," June 6, 2021
• "Broad Files Reply to CVC's Opposition to Broad's Contingent Motion to Correct Inventorship," June 1, 2021
• "CVC Files Reply to Broad's Opposition to CVC Motion for Misjoinder of Inventorship under 35 U.S.C. § 102(f)," May 27, 2021
• "CVC Files Reply to Broad's Opposition to CVC's Priority Motion," May 25, 2021
• "ToolGen Files Proposed Protective Orders in CRISPR Interferences," April 14, 2021
• "CVC Files Motion Opposing Broad Motion to Correct Inventorship," April 11, 2021
• "Broad Files Motion Opposing CVC Motion for Misjoinder of Inventorship under 35 U.S.C. § 102(f)," April 7, 2021
• "CVC Files Motion in Opposition to Broad Priority Motion," April 6, 2021
• "Broad Files Motion in Opposition to CVC Priority Motion," April 4, 2021
• "Time Periods in Toolgen Interferences Extended by Party Stipulation," April 1, 2021
• "CRISPR Chronicles Continue," March 16, 2021
• "PTAB Sets Preliminary Motions in Broad v. ToolGen Interference," March 10, 2021
• "PTAB Sets Preliminary Motions in CVC v. ToolGen Interference," March 4, 2021
• "The Toolgen Interference: Broad Preliminary Motions List," February 14, 2021
• "The Toolgen Interference: Preliminary Motions Lists," February 10, 2021
• "The Toolgen Interference: CVC Preliminary Motions List," February 7, 2021
• "The CRISPR Chronicles: Enter Toolgen," February 3, 2021
• "PTAB Grants CVC Motion for Marraffini Deposition," January 27, 2021
• "Separate Interferences Declared between Toolgen and Broad and CVC over CRISPR Priority Question," January 13, 2021
• "CVC Files Reply to Broad's Opposition to CVC's Miscellaneous Motion No. 6; Board Issues Orders," January 10, 2021
7. Congress Discussing Proposals to Change U.S. Patent System
In November, Representatives Thomas Massie (R-KY), Louie Gohmert (R-TX), Paul Gosar (R-AZ), and Tom McClintock (R-CA) introduced the "Restoring America's Leadership in Innovation Act of 2021" (H.R. 5874). The bill recites Congress' findings that the Leahy-Smith America Invents Act (along with "several decisions by the Supreme Court") have harmed the progress of Science and the useful Arts by eroding the strength and value of the patent system, and proposes to rectify the situation by restoring the U.S. patent system to be one that awards a patent to the "first to invent," complete with the one-year grace period and having the same definitions of the terms "in public use" and "on sale in this country" as they had before enactment of the AIA. The bill would also abolish the inter partes and post-grant review provisions of the AIA and the Patent Trial and Appeal Board and resurrect interferences. In addition, the bill would abrogate the Supreme Court's recent jurisprudence regarding subject matter eligibility and revise 35 U.S.C. § 101, restore 35 U.S.C. § 102 (for the most part) to its pre-AIA contours, and end the automatic publication of pending U.S. patent applications.
Although we referred to passage of H.R. 5874 as a "pleasant fantasy," Senators Thom Tillis (R-NC) and Tom Cotton (R-AR) in March made a more reasonable request of Drew Hirshfeld, the Commissioner for Patents at the U.S. Patent and Trademark Office, to conduct a pilot program on a sequenced approach to patent examination, in which applications are first examined for compliance with 35 U.S.C. §§ 102, 103, and 112, and then for compliance with 35 U.S.C. § 101. The Senators sugested that a sequenced approach to patent examination could "avoid unnecessary and inefficient rejections on grounds of patent eligibility." Last week, the Patent Office announced that the Deferred Subject Matter Eligibility Response (DSMER) Pilot Program would launch on February 1, 2022 (see "USPTO Announces Deferred Subject Matter Eligibility Response Pilot Program").
For information regarding this and other related topics, please see:
• "Congressional Republicans Propose to Abolish America Invents Act (and a Bit More)," November 10, 2021
• "Senate Passes the Endless Frontier Act," June 21, 2021
• "Senators Ask President to Prioritize Appointment of IP Officials," April 13, 2021
• "Senators Tillis and Cotton Propose Sequenced Examination Approach," March 24, 2021
