Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation

Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed

As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia.  On December 27, 2023, the court entered a public short form judgment in the litigation finding certain claims of Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”) valid and infringed and other patent claims invalid.  On January 26, 2024, both Regeneron and Biocon filed notices of appeal from the court’s judgment.  On January 31, 2024, a redacted 313-page memorandum opinion and order following bench trial was filed and made available to the public.

Biocon Defendants’ motion for expedited second trial is denied

On January 30, 2024, the Biocon Defendants filed an expedited motion for entry of a scheduling order, requesting “entry of an expedited schedule to address the remaining issues following the June 2023 trial in this matter” and proposing an October 7, 2024 trial to resolve the same.  Biocon suggested that this schedule “would align with the anticipated timing of” a decision on appeal from the court’s December 27, 2023 judgment, pursuant to the parties’ “discussions regarding an expedited Federal Circuit appeal.”   The motion further provides, “An expedited schedule will allow the Biocon Defendants to achieve a level of certainty and finality with regard to the asserted patents that remain in the case.  The Biocon Defendants were subjected to a rapid first wave litigation, where Regeneron chose a subset of its patent claims for the first wave trial.  There remain 18 patents asserted against the Biocon Defendants that were not litigated in the first wave trial in June 2023[.] ”  The Biocon Defendants asserted, “What remains may be the dregs of Regeneron’s portfolio, consisting of a hodge-podge of patents that the Biocon Defendants do not infringe or that are invalid—which explains why they did not make Regeneron’s cut for assertion in the first wave trial.  The Biocon Defendants are nevertheless entitled to finality on those Remaining Patents.”  Among other things, the Biocon Defendants noted that they “sit in a unique and advanced position compared to the other biosimilar applicants” Regeneron has sued to date—CelltrionSamsung Bioepis, Formycon, and Amgen—and that “the differences between the products and manufacturing processes of the different aflibercept biosimilar applicants further distinguishes those cases from the Biocon Defendants’.”

On February 6, 2024, Regeneron filed an opposition to the Biocon Defendants’ expedited motion for entry of a scheduling order.  The opposition states, “Biocon already has the certainty it requires for years to come—it is an adjudged infringer of a patent that does not expire until June 2027 and will not be able to commercialize its product until at least that time.  Instead, coordination of Biocon’s case with cases against other Defendants on the same patents will promote efficiency[.]”  In this regard, Regeneron further indicated that “permanent injunction proceedings against Biocon with respect to the ʼ865 patent likely are imminent.”

On February 8, 2024, the court issued an order denying the Biocon Defendants’ expedited motion for entry of a scheduling order.  The order provides, “This Court has found that Defendants will infringe the ’865 patent and that Defendants failed to prove the ’865 patent was invalid.  The ’865 patent does not expire until June 2027.  As such, there is no urgent need to schedule a trial in October 2024 on the remaining patents.”

Stay tuned to Big Molecule Watch for updates on this BPCIA litigation.