Noven Pharmaceuticals, Inc., v. Actavis Laboratories UT, Inc.

A judge for the US District Court for the District of Delaware ruled in favor of Analysis Group client Noven Pharmaceuticals, Inc. on two key aspects of its patent infringement action against Actavis Laboratories UT, Inc. The defendant had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking to market a generic version of Minivelle®, Noven's transdermal drug delivery system for the hormone estradiol (i.e., an estrogen therapy skin patch approved by the FDA for treatment of vasomotor symptoms due to menopause and for the prevention of post-menopausal osteoporosis).

On behalf of the plaintiff, the law firm Foley & Lardner LLP retained a team from Analysis Group, led by Managing Principal John Jarosz, to evaluate the commercial success of the patent, including whether there is a causal relationship (or “nexus”) between the invention claimed in the patent and the commercial success of Minivelle. Mr. Jarosz testified at deposition and during a three-day bench trial. Mr. Jarosz opined, in part, that Minivelle had distinguished itself in the market relative to competitors by delivering a therapeutically effective amount of estradiol in a very small patch, and had generated demand (via prescription refill rate) that outpaced that of Noven's prior transdermal patch, Vivelle-Dot®. Mr. Jarosz also opined that, because the size of the patch (a feature claimed by the patent) was repeatedly cited by physicians as a leading reason for prescribing Minivelle, this demonstrated a causal nexus. 

The Court concluded that Noven had demonstrated both commercial success and a causal nexus, citing Mr. Jarosz's testimony on several occasions. The Court also found that Actavis had failed to prove, by clear and convincing evidence, that the asserted claims of Noven's patent were invalid as obvious. However, the Court was unable to reach a conclusion as to whether Noven had proven literal infringement, and as part of its order will solicit the parties' views as to whether the case should be administratively closed and/or whether the Court should enter partial final judgment on one or both of the issues it has been able to resolve.

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