Amgen Pushes to Unseal Regeneron-Viatris Eylea Case Filings

Amgen Inc. urged a federal judge to unseal scores of documents in Regeneron Pharmaceuticals Inc.’s patent-infringement suit over Viatris Inc.’s proposed biosimilar version of Eylea, saying the public has a right to access filings including “potentially dispositive allegations” that the patents are unenforceable.

Amgen asked Judge Thomas S. Kleeh to let it intervene in the case “for the limited purpose of unsealing certain judicial records (or portions thereof) currently unavailable to the public, in accordance with the public’s First Amendment and common law rights,” according to Amgen’s memorandum supporting its motion filed Tuesday in the US District Court for the Northern District of West Virginia.

Regeneron sued Viatris’ Mylan Pharmaceuticals Inc. unit last Aug. 3 alleging its proposed biosimilar of Eylea, called M710, infringes 24 patents for the retinal-disease treatment. Those claims since have been slashed to just three patents.

A 10-day bench trial is set to begin June 12 in Clarksburg, W.Va.

Eylea’s US sales of $6.26 billion in 2022 accounted for more than half of Regeneron’s revenue, according to data compiled by Bloomberg LP. The drug had US sales of $5.79 billion in 2021.

Mylan is seeking the US Food and Drug Administration’s approval to sell M710. Amgen expects the final analysis of a study on the efficacy and safety of its own proposed biosimilar—called ABP 938—compared with Eylea to be completed next month, Tuesday’s filing says.

No Public Access

For the most part, Amgen said, “the docket sheet does not list motions to seal with titles explaining what documents the party seeks to seal and the public cannot access the actual motions or pleadings: the motion and number where those pleadings or motions should be listed are absent from the docket sheet.”

“The only place some of these submissions can be found is in the descriptions of orders granting various motions to seal,” Amgen said. “Other orders state ‘SEALED,’ but do not identify in the description what is being sealed or what motion is being granted. Moreover, each order granting the numerous motions to seal is itself sealed. Consequently, in general, no determination can be made as to what was sealed or the justification for sealing it.”

Mylan’s answer, defenses, and counterclaims include “allegations that certain Regeneron patents are unenforceable due to Regeneron’s inequitable conduct during prosecution before the U.S. Patent Office,” Amgen wrote. Regeneron, it said, also filed a sealed motion on Dec. 16 seeking judgments about the inequitable conduct defenses and counterclaims.

“While the patent prosecution records are publicly available, Mylan’s responsive brief and supporting exhibits were sealed in their entireties,” Amgen said. “These materials should be unsealed, or at least a redacted version should be filed, to afford the public access to these potentially dispositive allegations.”

Regeneron last month narrowed its allegations to three patents: US Patent Nos. 10,888,601, which covers dosing; 11,084,865, related to the drug’s formulation; and 11,253,572, another dosing patent. Bloomberg Law estimates they will expire in January 2032, June 2027, and January 2032, respectively.

Last November, the Patent Trial and Appeal Board voided two other dosing patents for Eylea based on reviews requested by Mylan. The week before those decisions, Regeneron narrowed its case, selecting six patents from three families for the first stage of litigation. The company also said it wouldn’t seek injunctions for alleged infringement by Mylan’s “current aBLA product” of the case’s 18 patents that weren’t among the six cited.

Johnson & Johnson’s Momenta Pharmaceuticals Inc. “is or was Mylan’s development partner for its proposed aflibercept biosimilar product,” the suit says. Aflibercept is the active ingredient in Eylea injections.

Hendrickson & Long PLLC represents Amgen. Williams & Connolly LLP; Kellogg, Hansen, Todd, Figel & Frederick PLLC; and Carey Douglas Kessler & Ruby PLLC represent Regeneron. Rakoczy Molino Mazzochi Siwik LLP and Steptoe & Johnson PLLC represent Mylan.

The case is Regeneron Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., N.D. W.Va., No. 22-cv-61, memo supporting motion to intervene filed 5/23/23.