Judge Stark of the District of Delaware invalidated three Noven patents directed to its Minivelle estrogen therapy patch under § 112, finding that each claim failed to enable and provide written description support for the full scope of the claim.  Noven Pharms., Inc. v. Amneal Pharms. LLC, No. 18-699 (D. Del. 2020).  Noven’s Minivelle product, and defendant Amneal’s generic equivalent, are transdermal patches for delivery of the hormone estradiol.

Noven’s patents each claimed “transdermal drug delivery systems.”  Fatally, however, the shared specifications of Noven’s patents’ broadly defined “transdermal” as “delivery, administration or application of drug by means of direct contact with skin or mucosa” (emphasis added).  The specification further went on to state that “such delivery, administration or application is also known as dermal, percutaneous, transmucosal and buccal.  As used herein, ‘dermal’ includes skin and mucosa, which includes oral, buccal, nasal, rectal and vaginal mucosa.”  Thus, all of Noven’s patent claims were broad enough to cover not just transdermal systems, but also transmucosal systems for various mucosae.

Amneal argued that Noven had not enabled the full scope of the claim because there was no enabling disclosure for transmucosal delivery, only transdermal delivery.  The Court agreed, finding that the specification failed to disclose any working examples of a transmucosal patch system.  In fact, the only references in the specification to mucosa were in the definitions of “transdermal” and “flux.” Moreover, there was no mention in the specification of whether or how the “central discovery” of the patents—increasing coat weight to increase flux—would apply in the various mucosae.  The specification was silent as to how a POSA could have obtained the claimed flux values while keeping the estradiol concentrations in the claimed range in the context of a transmucosal adhesive patch.  Although Noven pointed to information in the prior art relating to transmucosal patches to support its enablement position, the Court found that these disclosures did not provide a POSA with the information needed to fill the holes in Noven’s patent specifications, and, regardless, “disclosures in the  prior art cannot, as a matter of law, make up for deficiencies in a non-enabling specification.”  (citing ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941 (Fed. Cir. 2010)).

The Court found that Noven’s patent claims also failed the written description requirement of § 112.  The patents’ shared specification lacks any description or example of a transmucosal estradiol system, including any description or example of any oral, buccal, nasal, rectal, or vaginal patch system, even though such systems are within the scope of the claims.  The Court was persuaded that “transmucosal delivery and formulation is a separate and distinct scientific field from transdermal formulation,” and, as such, a POSA would not understand the disclosures in the specification about embodiments for the skin to also relate to the claimed transmucosal systems.

Noven argued that the specification’s references to “bioadhesive polymer” and “adhesive polymer” conveyed to a POSA that the inventor possessed the claimed transmucosal invention. And Noven’s expert explained that, in his opinion, the inventor had possession of the claimed mucosal invention because he “had the tools required to make that happen.”  The Court disagreed that this satisfied written description, and further noted that Noven’s arguments “appeared to be largely directed to the proposition that a POSA would have found the Asserted Claims obvious” based on the specification.  This does not, the Court noted, meet the written description standard.

This case is instructive for ANDA filers who may be faced with patent claims where the branded patent holder obtains patent claims beyond the scope of their actual product development.  Although there is little doubt in this case that the patent disclosures satisfied enablement and written description requirements for the portion of the claims actually directed to transdermal systems, the patent’s breadth in its definitions led to a lack of enablement and written description for the remaining scope of the claims.