Mylan Technologies Inc v. Noven Pharmaceuticals Inc

1. Case Identification

• Case #: IPR2018-01119
• Patent #: 9,833,419
• Filed: May 18, 2018
• Petitioner(s): Mylan Technologies, Inc.
• Patent Owner(s): Noven Pharmaceuticals, Inc.
• Challenged Claims: 1-15

2. Patent Overview

• Title: Monolithic Transdermal Estradiol Delivery System
• Brief Description: The ’419 patent is directed to a monolithic (single drug-containing layer) transdermal patch for administering estradiol. The patch comprises a backing layer and a single adhesive polymer matrix with specific parameters for coat weight, drug loading, and estradiol flux.

3. Grounds for Unpatentability

Ground 1: Anticipation over Mueller - Claims 1, 2, 8, and 10-15 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 Mueller’s Example 3 discloses a single embodiment that meets every limitation of the challenged claims. Specifically, Mueller described a monolithic transdermal system for estradiol with a backing layer and a single polymer matrix containing estradiol as the only drug. Petitioner contended that Mueller’s patch has a coat weight of 11.5 mg/cm² (meeting the “greater than 10 mg/cm²” limitation), an estradiol dose per unit area of 0.1725 mg/cm² (meeting the “greater than 0.156 mg/cm²” limitation), and achieves an estradiol flux between 0.014 and 0.015 mg/cm²/day, which falls within the claimed range of "0.0125 to about 0.05 mg/cm²/day." Petitioner further asserted that dependent claims are met, as Mueller’s matrix includes acrylic and silicone adhesives and polyvinylpyrrolidone (PVP) (claim 2) and delivers a therapeutically effective amount for at least 72 hours (claim 8).

Ground 2: Obviousness over Mueller, Vivelle-Dot, and Kanios - Claims 3-7 are obvious under 35 U.S.C. §103 over Mueller in view of Vivelle-Dot® Label and Kanios.

• Prior Art Relied Upon: Mueller (Application # US2003/0099695), Vivelle-Dot® Label, and Kanios (Application # US2006/0078602).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that claim 3 recites specific weight percentage ranges for acrylic adhesive (2-25%), silicone adhesive (45-70%), and soluble PVP (2-25%). While Mueller’s Example 3 formulation falls outside some of these ranges (e.g., 79.52% silicone adhesive), Kanios teaches formulations with higher hydrophile polymer content (acrylic, PVP) and correspondingly lower silicone content.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would be motivated to increase the flux of the Mueller patch to create smaller, more efficient patches, a known objective in the art. Mueller itself taught that increasing hydrophile content increases flux. Kanios provided specific examples and taught that adjusting the proportions of hydrophile polymers relative to the silicone adhesive base was an effective method to achieve higher flux. A POSITA would therefore combine these teachings to modify Mueller's formulation to have the component ratios recited in claim 3.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because both references operate in the same technical field, describe similar patch compositions, and teach a predictable relationship between component concentrations and drug flux.

Ground 3: Obviousness over Mueller, Kanios, and Chien - Claims 1-15 are obvious under 35 U.S.C. §103 over Mueller in view of 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: The primary argument for this ground centered on Chien, which was not considered during prosecution. Petitioner argued that the Patent Owner obtained allowance by asserting it was "surprising and unexpected" that increasing the patch's coat weight would increase its flux. Chien’s Figure 5 graphically demonstrates that increasing the coating thickness (i.e., coat weight) of a monolithic estradiol patch directly and substantially increases its flux.
  • Motivation to Combine: A POSITA starting with the base formulation from Mueller and Kanios and seeking to further increase flux would have been motivated by Chien’s clear teaching to simply increase the coat weight of the adhesive matrix. This was presented as a known, straightforward, and routine method for achieving the desired result of higher flux and smaller patch size.
  • Expectation of Success: Chien’s data showed a clear, positive, and predictable correlation between coat weight and flux, which would have provided a POSITA with a high degree of confidence that applying a thicker layer of the formulation would predictably result in increased flux.

• Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 2) for claims 1, 2, and 8-15 over Mueller and Vivelle-Dot® Label, arguing Vivelle-Dot® provided the motivation for delivering standard, known therapeutic doses and for sizing the patches accordingly.

4. Key Claim Construction Positions

• "About": Petitioner argued that, based on the ’419 patent's own specification, this term should be construed as "up to plus or minus 10% of the particular term." This construction was critical to Petitioner's arguments that numerical values disclosed in the prior art (e.g., Mueller's 1.50% estradiol content) meet claimed limitations such as "about 1.6% by weight estradiol."
• "Flux": Petitioner asserted that flux can be calculated as the change in permeation over time, based on data presented in tables or graphs in prior art, a method allegedly consistent with that used by the Applicant during prosecution. This construction was essential for Petitioner's quantitative analysis showing the flux rates disclosed in Mueller fall within the claimed ranges.

5. Key Technical Contentions (Beyond Claim Construction)

• Predictability of Coat Weight vs. Flux: The petition's central technical contention was that the positive relationship between the coat weight of a monolithic patch and its resulting drug flux was a well-known and predictable principle in the art. Petitioner argued that the Patent Owner secured the patent by incorrectly characterizing this relationship as "surprising and unexpected." The petition cited Chien, Kim, and Ghosh as evidence that this was a routine optimization technique, not an inventive discovery.

6. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate because the petition relies on prior art and arguments not previously considered by the USPTO. Specifically, references like Chien, which directly teach that increasing coat weight increases flux, were not before the Examiner. Petitioner contended that because the Examiner allowed the patent based on the allegedly "unexpected" nature of this very relationship, the presentation of this new, contradictory evidence warrants institution.

7. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1-15 of Patent 9,833,419 as unpatentable.