On June 28th, Magistrate Judge Stark issued an order granting Mylan Pharmaceuticals, Inc.’s motion to amend its infringement response to include an allegation of unenforceability due to inequitable conduct, based on plaintiff Galderma Laboratories’ failure to disclose an allegedly material FDA action during prosecution.
The Court held that the proposed amendment pled inequitable conduct with the required particularity, and it allowed the amendment because Mylan had not acted in bad faith or with a dilatory motive in omitting the allegation from its original answer, and because there was no undue prejudice to plaintiffs. Plaintiffs had failed to disclose the relevant FDA Memo despite the fact that it was responsive to a timely document request, and the Court accepted Mylan’s explanation that it had not discovered the FDA litigation previously because it had “limited its search to patent infringement actions” (even though “it is clear that a search of all federal court decisions (on Westlaw or Lexis, for example) for [the drug name] would have retrieved the FDA action.”). Id. at 6.
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