On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled glass syringe for injecting a VEGF-antagonist into the eye.  This is the second time the PTAB reviewed Regeneron’s petition to institute an IPR over the ’631 patent.  Last time, the PTAB denied Regeneron’s petition based on an ongoing proceeding at the International Trade Commission (ITC), without addressing the merits.

Regeneron makes Eylea (Aflibercept), a recombinant VEGF-binding fusion protein, and Novartis makes Lucentis (Ranibizumab), a humanized monoclonal antibody fragment binding to VEGF.  Both products have been approved for treating age-related macular degeneration and other retina diseases, and are being sold in pre-filled syringes.

On June 19, 2020, Novartis filed a complaint at the ITC alleging that Regeneron infringed the ’631 patent.  Soon after, Regeneron filed a petition at the PTAB on July 16, 2020 to challenge the validity of the ’631 patent.  The PTAB denied Regeneron’s petition on prudential grounds due to the ITC’s scheduled trial in 2021.  On April 8, 2021, shortly before the ITC trial was set to begin, Novartis unilaterally withdrew its complaint at the ITC but maintained a co-pending infringement action against Regeneron in the U.S. District Court for the Northern District of New York (NDNY).  In NDNY, Judges McAvoy and Suddaby recused themselves and the case was reassigned to Judge Hurd.  A hearing regarding the briefing schedule on Regeneron’s Motion to Stay is scheduled for November 5, 2021.  Regeneron filed this IPR petition on April 16, 2021, renewing the invalidity arguments from its prior petition.  In addition to the IPR and the NDNY action, the parties are in litigation in the U.S. District Court for the Southern District of New York (SDNY), where Regeneron has accused Novartis of violating antitrust laws by using its licensing scheme and patent suits related to the eye disease treatment.

In its opinion, the Board first addressed whether discretion should be exercised to deny the institution of the IPR.  The Board started with analyzing the Fintiv factors[1] and declined to deny the institution under 35 U.S.C. § 314(a).  In particular, the Board found that there are circumstances weighing strongly against denying the institution.  The Board pointed out that its discretionary denial of Regeneron’s prior IPR petition was relied on Novartis’ representation that the ITC would issue a final determination addressing the validity of the ’631 patent.  However, Novartis unilaterally terminated the ITC investigation after the Board denied the petition.

The Board further considered whether discretion under § 314(a) should be exercised in a “serial petition” situation.  Applying the factors provided in General Plastic[2], the Board concluded that discretionary denial is not warranted because Regeneron’s filing of multiple IPR petitions is a unique situation created solely by Novartis’s unilateral termination of the ITC investigation on the eve of trial.

The Board also considered whether it should deny institution under 35 U.S.C. § 325(d), because the same or substantially the same prior art or argument were previously presented.  Applying the two-part framework test provided in Advanced Bionics[3], the Board found that the prior art presented by Regeneron in the IPR petition is not the same or substantially the same as the references considered by USPTO during prosecution of the ’631 patent.  In view of these analysis, the Board refused to exercise its discretion to deny the institution of the IPR.

Next, the Board analyzed the prior art and arguments presented by Regeneron and found that Regeneron has persuasively shown how each element of claim 1 is taught by the combination of the references and provided sound reasoning for combining the references.  However, the Board found no nexus between the objective evidence related to secondary considerations and the claims.  Weighing all information presented, the Board held that there is a reasonable likelihood that Regeneron would prevail in showing at least one claim of the ’631 patent is unpatentable, and instituted the IPR to all claims of the ’631 patent.

According to the scheduling order entered with the institution decision, Novartis will have until January 18, 2022 to file a response to the Petition.  Subsequently, Regeneron will have until April 12, 2022 to file a reply to Novartis’ response.  We will keep monitoring this case and report on future developments.

[1] See Apple Inc. v. Fintiv, Inc., IPR2020–00019, Paper 11 (Mar. 20, 2020) (“Fintiv”).

[2] Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 15–16 (PTAB Sept. 6, 2017).

[3] Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020).