On Friday, December 16, 2022, Regeneron moved to dismiss Mylan’s inequitable conduct defense and counterclaim against two of the six patents asserted in the parties’ BPCIA suit concerning Mylan’s proposed biosimilar to EYLEA.  As previously reported, Regeneron narrowed the twenty-four patents originally asserted against Mylan to six following the Northern District of West Virginia’s October 25, 2022 decision to expedite the trial.  The two patents at issue in the present motion, U.S. Patent Nos. 10,888,601 (“’601 patent”) and 11,253,572 (“’572 patent”), cover administration of aflibercept to patients with angiogenic eye disorders at specified dosages and intervals.  According to Regeneron, “Mylan argues without sufficient factual basis that three instances of alleged inequitable conduct during proceedings concerning two earlier patents in the same family (the ’338 and ’069 patents) tainted the ’601 and ’572 patents, rendering them unenforceable.”  Specifically, Regeneron argues, inter alia, that (1) Mylan has failed to satisfy the Federal Circuit’s standard for pleading inequitable conduct with particularity, (2) even if Mylan has sufficiently pled inequitable conduct as to the ’338 and ’069 patents, the later ’601 and ’572 patents are not “infected” because the allegedly withheld references were disclosed during prosecution of those patents, and (3) “mere attorney argument,” cannot form the basis of an inequitable conduct claim.

Mylan’s response to Regeneron’s motion is due on December 30th.

Stay tuned to Big Molecule Watch for further developments on this BPCIA case.

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