Fintiv Denials in Drug Cases

Robins Kaplan LLP has run a study to determine the extent to which the Patent Trial and Appeal Board (“PTAB”) has invoked the Fintiv doctrine to deny institution of post-grant challenges in pharmaceutical cases. As detailed in this accompanying spreadsheet, the PTAB has issued approximately 604 opinions at the institution phase that cite to the Fintiv doctrine, determining whether or not to institute either IPR, PGR, or CBM proceedings, as of October 29, 2021. Of these 604 institution rulings, eight of the challenges were directed to pharmaceutical patents.  Of those eight challenges, the PTAB exercised its discretion to deny institution of the challenges under the Fintiv doctrine in four cases. Two of those cases were IPR challenges, and two were PGR challenges.  Those four Fintiv denials in pharmaceutical cases are the following matters:

• IPR2020-00440, Mylan Laboratories Ltd. V. Janssen Pharmaceutica NV
• IPR2020-01317, Regeneron Pharmaceutical, Inc. v. Novartis Pharmaceuticals Corp.
• PGR2021-00030, Daiichi Sankyo, Inc. v. Seagen Inc. f/k/a Seattle Genetics, Inc.
• PGR2021-00042, Daiichi Sankyo, Inc. v. Seagen Inc. f/k/a Seattle Genetics, Inc.

Methodology

A search was run in Docket Navigator in the PTAB Institution of Review directory, in the date range from January 1, 2020 through October 29, 2021, with the search term “Fintiv.” The search returned a total of 665 results. After sorting by case number to identify instances of multiple rulings in the same case, and thereby disregarding unsuccessful rehearing petitions, disregarding the original institution rulings that were overruled by a successful rehearing petition, and disregarding requests for additional briefing, a total of 604 rulings were identified. In those cases litigated by life sciences companies, the opinions were reviewed to determine if the patent being challenged was directed to drugs. In column H of the spreadsheet, a “YES” means the ruling is directed to a drug patent, and a “NO” means that the rulings is not (with a descriptor of the technology in those life sciences cases that are not counted as drug cases).