Mylan Pharmaceuticals Inc v. Cosmo Technologies Ltd

1. Case Identification

• Case #: IPR2017-01034
• Patent #: 8,784,888
• Filed: March 9, 2017
• Petitioner(s): Mylan Pharmaceuticals Inc.
• Patent Owner(s): Cosmo Technologies Limited
• Challenged Claims: 1-9

2. Patent Overview

• Title: Controlled Release and Taste Masking Oral Pharmaceutical Compositions
• Brief Description: The ’888 patent describes a controlled-release oral pharmaceutical composition for treating intestinal inflammatory disease. The composition comprises a tablet core containing the active ingredient budesonide dispersed within a matrix of specific excipients, all enclosed in a gastro-resistant coating.

3. Grounds for Unpatentability

Ground 1: Obviousness over the ’120 and ’584 Patents - Claims 1-9 are obvious over Patent 6,239,120 in view of Patent 5,681,584.

• Prior Art Relied Upon: The ’120 patent (Patent 6,239,120) and the ’584 patent (Patent 5,681,584).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the ’120 patent taught the foundational elements of the invention, including a controlled-release oral composition with a budesonide core and a gastro-resistant (enteric) coating for treating intestinal inflammatory disease. While the ’120 patent disclosed general classes of excipients, such as lubricants (magnesium stearate) and cellulose derivatives, Petitioner contended that a person of ordinary skill in the art (POSA) would have looked to the ’584 patent to provide specific, well-known options for the remaining excipients. The ’584 patent, which also relates to controlled-release budesonide formulations, explicitly taught the use of amphiphilic wetting agents (lecithin) and hydrogel-forming hydrophilic binders like hydroxypropyl methylcellulose (HPMC), which satisfies the "other than a gum" limitation.
  • Motivation to Combine: Petitioner asserted that a POSA would combine these references because both were directed to the same field of controlled-release budesonide formulations for delivery to the lower intestine. A POSA would have been motivated to implement the general teachings of the ’120 patent using the specific, suitable, and well-known excipients disclosed in the ’584 patent to optimize the formulation’s dissolution and release profile.
  • Expectation of Success: The expectation of success was argued to be high because the combination involved using conventional excipients for their known and predictable properties in pharmaceutical formulations. The combination was a simple substitution of known elements to achieve a predictable result.

Ground 2: Obviousness over the ’584 Patent - Claims 1-9 are obvious over Patent 5,681,584.

• Prior Art Relied Upon: The ’584 patent (Patent 5,681,584).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the ’584 patent alone disclosed all elements of the challenged claims. It taught a controlled-release device for delivering budesonide to the colon to treat inflammatory bowel disease. The core composition included budesonide and explicitly disclosed lipophilic lubricants (stearic acid, magnesium stearate), amphiphilic wetting agents (lecithin), and hydrogel-forming hydrophilic binders (hydroxyethyl cellulose, HPMC) that are not gums. Petitioner contended that the ’584 patent’s disclosed “delay jacket,” made from polymethylmethacrylates, inherently possessed gastric-resistant properties and thus met the limitation for a "gastro-resistant film."
  • Key Aspects: A central contention was that the ’584 patent's additional "semi-permeable membrane" layer did not prevent a finding of obviousness. Petitioner argued this layer was described as providing structural support without materially affecting the drug release characteristics, and therefore its presence would not negate the "consisting essentially of" language of claim 1.

Ground 3: Anticipation by the ’208 Publication - Claims 1-9 are anticipated by Application Publication No. 2006/0134208.

• Prior Art Relied Upon: The ’208 publication (Application # 2006/0134208).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner first argued that the ’888 patent was not entitled to its claimed priority date earlier than September 14, 2012. This was because the negative limitation "other than a gum" was added during prosecution and lacked written description support in the parent applications. This late effective filing date rendered the ’208 publication, published in 2006, valid prior art under 35 U.S.C. §102(b). Petitioner then asserted that Example 2 of the ’208 publication explicitly and unambiguously disclosed every limitation of claims 1-9. Example 2 detailed a tablet formulation containing:
    • A core with budesonide.
    • Stearic acid and magnesium stearate (lipophilic excipients).
    • Lecithin (amphiphilic excipient).
    • Hydroxypropylcellulose (a hydrogel-forming hydrophilic excipient that is not a gum).
    • A coating containing Eudragit L100 and S100 (methacrylic acid polymers), satisfying the gastro-resistant film limitation.
  • Key Aspects: The viability of this entire ground hinged on Petitioner's argument successfully invalidating the ’888 patent’s claim to priority.

4. Key Claim Construction Positions

• "Macroscopically homogeneous composition": Petitioner asserted that the Broadest Reasonable Interpretation (BRI) should encompass the construction from a related district court litigation: "a composition of uniform structure throughout, as observed by the naked eye." This construction supported Petitioner's argument that simple, conventional mixing and compression, as taught in the prior art, would result in the claimed structure.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate, even though the ’120 and ’584 patents were cited during prosecution. Petitioner contended that it presented new arguments and evidence, most notably the detailed declaration of its technical expert, that "shed a different light" on the prior art references and their combination in a way not previously considered by the Examiner.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-9 of the ’888 patent as unpatentable.