Mylan Technologies Inc v. Noven Pharmaceuticals Inc

1. Case Identification

• Case #: IPR2018-00174
• Patent #: 9,730,900
• Filed: December 4, 2017
• Petitioner(s): Mylan Technologies, Inc.
• Patent Owner(s): Noven Pharmaceuticals, Inc.
• Challenged Claims: 1-23

2. Patent Overview

• Title: Monolithic Transdermal Estradiol Delivery System
• Brief Description: The ’900 patent is directed to a monolithic (single-layer) transdermal drug delivery system for administering estradiol. The claims recite a patch comprising a backing layer and a single drug-containing adhesive polymer matrix with specific parameters for coat weight, estradiol dose per-unit-area, and estradiol flux.

3. Grounds for Unpatentability

Ground 1: Anticipation over Mueller - Claims 1-2, 8, 10-16, and 18-23 are anticipated under 35 U.S.C. §102 by Mueller.

• Prior Art Relied Upon: Mueller (Application # US2003/0099695).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that a single embodiment in Mueller (Example 3) discloses every element of the challenged claims. Mueller’s Example 3 describes a monolithic transdermal system for estradiol with a coat weight of 11.5 mg/cm² (meeting the claimed "greater than about 10 mg/cm²"), an estradiol dose of 0.1725 mg/cm² (meeting the claimed "greater than 0.156 mg/cm²"), and an estradiol flux of 0.015 mg/cm²/day (falling within the claimed range of "about 0.0125 to about 0.05 mg/cm²/day"). Furthermore, Mueller explicitly taught a polymer matrix containing an acrylic adhesive, a silicone adhesive, and soluble polyvinylpyrrolidone (PVP), anticipating claim 2.

Ground 2: Obviousness over Mueller and Vivelle-Dot® - Claims 1-2 and 8-23 are obvious over Mueller in view of Vivelle-Dot® Label.

• Prior Art Relied Upon: Mueller (Application # US2003/0099695) and Vivelle-Dot® Label.
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Mueller taught the core transdermal patch system with the claimed structural and performance characteristics, including high flux. The Vivelle-Dot® Label, an FDA-approved product label, taught the standard, therapeutically effective daily doses of estradiol (e.g., 0.025, 0.0375, 0.05 mg/day) recited in dependent claim 9.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine Mueller's high-flux patch formulation with the well-known, standard therapeutic doses described in the Vivelle-Dot® Label. The motivation was to achieve a known therapeutic goal using a more advanced patch design that allowed for a smaller surface area, which was a recognized advantage in the field.
  • Expectation of Success: A POSITA would have had a high expectation of success in using Mueller’s patch system to deliver the standard doses described by Vivelle-Dot®, as the components and principles were well-understood in the art of transdermal delivery.

Ground 3: Obviousness over Multiple References - Claims 1-23 are obvious over Mueller, Vivelle-Dot® Label, Kanios, and Chien.

• Prior Art Relied Upon: Mueller (Application # US2003/0099695), Vivelle-Dot® Label, Kanios (Application # US2006/0078602), and Chien (Patent 5,145,682).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the prior combinations, asserting that Mueller and Vivelle-Dot taught the basic patch structure and standard dosages. Kanios was introduced to teach the specific component percentage ranges recited in claims 3-7, showing that a POSITA would have found it obvious to modify Mueller’s polymer ratios (e.g., increasing hydrophile content) to further increase flux. Critically, Chien explicitly taught that increasing the coat weight (thickness) of a monolithic estradiol patch directly increases its flux.
  • Motivation to Combine: A POSITA would combine these references to optimize a known drug delivery system. The motivation was to achieve higher flux and reduce patch size—a well-established goal. Kanios provided specific formulation guidance for optimizing polymer blends, while Chien provided a straightforward, alternative method of increasing flux by increasing coat weight.
  • Expectation of Success: The principles taught by the references were predictable. A POSITA would have reasonably expected that increasing the hydrophile content as taught by Kanios or increasing the coat weight as taught by Chien would successfully increase the flux of a patch like Mueller's.
  • Key Aspects: This combination of references, particularly Chien (which was not before the Examiner during prosecution), was argued to directly refute the Patent Owner’s successful argument of "surprising and unexpected results." The Petitioner contended that the relationship between increased coat weight and increased flux was, in fact, well-known and expected.

4. Key Claim Construction Positions

• "About": Petitioner argued this term should be construed based on its explicit definition in the ’900 patent specification: "up to plus or minus 10% of the particular term." This construction was central to demonstrating that flux values disclosed in the prior art, such as Mueller's 0.012 mg/cm²/day, fell within the scope of claims reciting "about 0.0125 mg/cm²/day."
• "Flux": Petitioner proposed that, consistent with the approach taken by the Patent Owner during prosecution, "flux" can be calculated from prior art data as the change in permeation (e.g., µg/cm²) over the change in time (e.g., hours). This allowed for direct comparison between claimed flux values and data presented in prior art graphs and tables.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) would be inappropriate because the petition raised new evidence and arguments not considered by the Examiner. Specifically, Petitioner highlighted that Chien, which explicitly teaches that increasing coat weight increases estradiol flux, was not of record during prosecution. This reference directly contradicts the "unexpected results" argument that formed the basis for allowance, suggesting the Examiner erred in allowing the claims without the benefit of this key prior art.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-23 of Patent 9,730,900 as unpatentable.