PTAB

IPR2016-00085

Complex Innovations LLC v. Amgen Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pharmaceutical Compositions
  • Brief Description: The ’595 patent discloses pharmaceutical compositions comprising the calcium receptor-active compound cinacalcet hydrochloride (HCl) combined with at least one pharmaceutically acceptable excipient. The patent also claims methods of using these compositions to treat diseases in humans, such as hyperparathyroidism.

3. Grounds for Unpatentability

Ground 1: Obviousness over Van Wagenen and HPE - Claims 1-25 are obvious over Van Wagenen in view of the Handbook of Pharmaceutical Excipients and the general knowledge of a POSITA.

  • Prior Art Relied Upon: Van Wagenen (Patent 6,211,244) and the Handbook of Pharmaceutical Excipients (3rd ed. 2000) ("HPE").
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of the prior art and the general knowledge of a Person of Ordinary Skill in the Art (POSITA) rendered all challenged claims obvious.
      • Independent Claim 1: This claim recites a pharmaceutical composition with specific weight percentage ranges for cinacalcet HCl and six common excipients (microcrystalline cellulose, povidone, starch, crospovidone, colloidal silicon dioxide, and magnesium stearate). Petitioner asserted that Van Wagenen, which is cited on the face of the ’595 patent, expressly disclosed using cinacalcet HCl as an active pharmaceutical ingredient (API) in compositions with acceptable carriers (excipients). Petitioner contended that the specific excipients and their corresponding weight percentage ranges recited in claim 1 were all standard, well-known, and predictable choices for a pharmaceutical formulator. The HPE was presented as a reference manual that teaches the use of each claimed excipient within ranges that overlap or suggest the claimed ranges, confirming this was all within the general knowledge of a POSITA.
      • Dependent Claims 2-25: Petitioner argued that the additional limitations recited in the dependent claims were merely conventional and predictable modifications. These limitations included adding lubricants and coating materials (claims 2-3), specifying the physical form of the cinacalcet HCl particles (claims 4-5), defining particle size (claim 6), formulating the composition as granules or tablets (claims 7-8), specifying granule size (claims 9-10), and claiming methods for treating known diseases like hyperparathyroidism (claims 11-14, 24-25). Petitioner asserted that each of these features represented a routine design choice or optimization step that a POSITA would have considered and implemented without inventive skill. For example, Van Wagenen was cited as explicitly teaching the use of cinacalcet HCl to treat hyperparathyroidism, directly mapping onto the method claims.
    • Motivation to Combine: Petitioner argued that a POSITA, starting with Van Wagenen's disclosure of cinacalcet HCl as a therapeutic agent, would have been motivated to develop a commercially viable oral dosage form. This market-driven need would lead a formulator directly to well-known formulation handbooks like the HPE and to apply their general knowledge to select a suitable combination of excipients. The HPE itself provided the rationale for combining these specific excipients with an API, explaining their well-known functions (e.g., povidone as a dissolution enhancer for poorly soluble drugs, microcrystalline cellulose as a binder/disintegrant, magnesium stearate as a lubricant). The motivation was not to solve a particular unexpected problem, but to apply standard formulation techniques to a known drug.
    • Expectation of Success: Petitioner contended that a POSITA would have had a high expectation of success in combining cinacalcet HCl with the claimed excipients. The petition emphasized that formulating a known API with a finite list of standard, well-characterized excipients is a routine and predictable process in pharmaceutical development. A formulator would have reasonably expected to produce a stable and effective composition, with any necessary adjustments to the weight percentages achievable through routine experimentation and optimization, not inventive insight.

4. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-25 of Patent 7,829,595 as unpatentable under 35 U.S.C. §103.