Statistics at a Glance

Statistics
at a Glance

 

This figure shows the bases for PGR denials over time.  The PTAB has increasingly denied PGR (and IPR) institutions for procedural reasons.  In 2021, procedural denials were the most frequent reason for PGR institution denials.

The increase in the use of procedural denials under 324(a) is largely the result of changes in PTAB procedures beginning in 2019 related to its 2018 NHK v. Intri-Plex Technologies decision, designated as precedential in May 2019[1], and the Apple v. Fintiv[2] decision designated as precedential in May 2020, the latter in which the PTAB elaborated on NHK, providing a list of factors to be weighed in determining whether to institute an IPR where there is a parallel proceeding in district court or in the International Trade Commission.  In Fintiv, applying these factors, the PTAB affirmed discretionary denial where a parallel district court litigation was at an advanced stage.

The NHK-Fintiv factors have been controversial.  While cases challenging them in the Supreme Court were denied certiorari this year,[3] their fate remains unclear as the PTO has solicited public comments on the use of the NHK-Fintiv factors, and Senator Leahy has sought to eliminate their use through a bill, the “Restoring the America Invents Act,” introduced in the Senate in September 2021.  Changes to the ability of the PTAB to use procedural denials based on NHK-Fintiv factors will likely affect the rate of PGR institutions going forward.

 

[1] NHK Spring Co. v. Intri-Plex Technologies, Inc., No. IPR2018-00752, 2018 WL 4373643 (P.T.A.B. Sept. 12, 2018).

[2] Apple Inc. v. Fintiv, Inc., No. IPR2020-00019, 2020 WL 2126495 (P.T.A.B. Mar. 20, 2020).

[3] See Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., Supreme Court Case No. 21-202 (cert denied January 18, 2022);  Apple Inc. v. Optis Cellular Technology, LLC, Supreme Court Case No. 21-118 (cert denied January 18, 2022).

* 2022 estimates are based on Q1 2022 data.  It is too early in the year to draw any conclusions on trends in 2022.

 

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    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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