As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia.  The patents-at-issue are directed to formulations and dosing regimens for aflibercept, an anti-VEGF treatment for retinal disorders including age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.  At trial, Regeneron asserted infringement of claims 6 and 25 of U.S. Patent No. 11,084,865 (the “’865 patent”), which are directed to aflibercept formulations, and claims 11 and 19 of U.S. Patent No. 10,888,601 (the “’601 patent”) and claims 4, 7, 9, 11 and 14-17 of U.S. Patent No. 11,253,572 (the “’572 patent”), which are directed to dosing regimens.

Yesterday, the Court entered a public short form judgment in the litigation.  The detailed opinion is currently under seal.  The Court held that:

1. Regarding infringement:
   1. Regeneron demonstrated that Defendants infringed claims 4, 7, 9, 11, 14, 15, 16, and 17 of the ’865 Patent
   2. Regeneron demonstrated that Defendants will induce infringement of claims 6 and 25 of the ’572 Patent and claims 11 and 19 of the ’601 Patent.
2. Regarding invalidity:
   1. Mylan failed to prove that claims 4, 7, 9, 11, 14, 15, 16, and 17 of the ’865 Patent were invalid.
   2. Mylan had proven that claims 6 and 25 of the ’572 Patent are invalid as obvious, and that claim 11 and 19 of the ‘601 Patent are invalid as obvious.

The ’865 patent, which the court found to be valid and infringed, is expected to expire in June 2027.  The ’601 and ’572 patents, which were found invalid, were expected to expire Jan. 11, 2032.

As we have reported, Regeneron sought, and was granted, an expedited trial—just 10 months after filing its complaint—in order to get an opportunity to gain the benefit of a statutory permanent injunction available under 35 U.S.C. 271(e)(4)(D).  The statute states that “the court shall order a permanent injunction prohibiting any infringement of the patent by the biological product involved in the infringement until a date which is not earlier than the date of the expiration of the patent that has been infringed under paragraph (2)(C), provided the patent is the subject of a final court decision, . . . and the biological product has not yet been approved because of section 351(k)(7) of such Act.”  According to Regeneron’s argument in favor of the expedited trial, the statutory injunction would only be available if any appeal of a finding of infringement is completed before May 2024, when FDA can first approve an aflibercept biosimilar.

There has been a flurry of other litigation activity recently related to Regeneron’s patents related to its EYLEA product.  Regeneron recently filed BPCIA litigations against Celltrion, Samsung Bioepis, and Formycon for each of their proposed biosimilars of EYLEA (aflibercept), and the PTAB recently instituted IPR’s on several of Regeneron’s patents related to its EYLEA product.

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