PTAB

IPR2013-00264

EID Parry India Ltd v. Lycored Ltd

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Synergistic Compositions of Lycopene and Vitamin E
  • Brief Description: The ’018 patent discloses synergistic pharmaceutical or dietary compositions containing lycopene and vitamin E. The patent also claims methods of using these compositions to block the oxidation of low-density lipoproteins (LDL) and arrest the progression of atherosclerosis.

3. Grounds for Unpatentability

Ground 1: Claims 1-22 are obvious over Aviram in view of the ’110 application.

  • Prior Art Relied Upon: Aviram (a 1996 journal article by one of the named inventors) and the ’110 application (UK Application # GB 2 280 110).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Aviram, an article authored by one of the inventors of the ’018 patent, establishes the background knowledge for the invention. Aviram taught that both lycopene and vitamin E are antioxidants that can inhibit LDL oxidation, a key factor in atherosclerosis. Crucially, Aviram suggested a potential synergistic relationship, noting that lycopene’s protective effect was observed "only in LDL samples with high vitamin E content." The ’110 application disclosed dietary compositions containing both lycopene and vitamin E for reducing the risk of coronary heart disease by preventing LDL oxidation. Petitioner contended that the ’110 application disclosed all elements of the claimed composition except for an explicit teaching of synergy. For dependent claims, the ’110 application taught the use of conventional excipients (claims 6, 13, 20) and formulation into tablets or capsules (claims 7, 14, 21).
    • Motivation to Combine: A POSITA, aware from Aviram that combining lycopene and vitamin E could produce a synergistic antioxidant effect, would be motivated to test the known composition from the ’110 application to confirm this synergy. The motivation was to improve a known composition for its intended purpose—preventing LDL oxidation—based on a specific suggestion in the art.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because both references operated in the same field (antioxidants for cardiovascular health) and addressed the same problem (LDL oxidation). Aviram’s suggestion of synergy provided a clear path for a POSITA to modify or verify the properties of the composition in the ’110 application.

Ground 2: Claims 1-22 are obvious over Aviram in view of the ’217 publication.

  • Prior Art Relied Upon: Aviram (a 1996 journal article) and the ’217 publication (WO 96/19217).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground relied on the same foundational teachings from Aviram regarding the potential synergy between lycopene and vitamin E. The ’217 publication was presented as an alternative reference disclosing compositions with both active ingredients. The ’217 publication disclosed methods of using lycopene to treat high cholesterol and noted that antioxidants like vitamin E are beneficial. It provided explicit examples of compositions combining lycopene with vitamin E (alpha-tocopherol) or with peanut oil, a natural source of vitamin E. The publication further stated that vitamin E can "broaden and enhance" the therapeutic spectrum of lycopene, which a POSITA would recognize as indicating potential synergy.
    • Motivation to Combine: The motivation was similar to Ground 1. A POSITA would be motivated by Aviram’s suggestion of synergy and the ’217 publication’s "enhancement" language to test the disclosed compositions for synergistic effects in inhibiting LDL oxidation. The ’217 publication’s focus on treating cardiovascular disease provided a direct reason to optimize the disclosed antioxidant combinations.

Ground 3: Claims 1-3 and 6-7 are anticipated by Nir.

  • Prior Art Relied Upon: Nir (a 1993 article titled "Lycopene From Tomatoes: A New Commercial Natural Carotenoid").

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that this anticipation ground was based on an admission in the challenged ’018 patent itself. The ’018 patent explicitly stated that "tomato's oleoresin...contains a combination of antioxidants" and that its inhibitory effect on LDL oxidation provides evidence of synergy. Therefore, Petitioner asserted that the ’018 patent taught that synergy is an inherent property of tomato oleoresin. The Nir reference, which predates the patent, disclosed a commercially available 5% tomato oleoresin for use in nutraceutical formulations like multivitamin tablets. Petitioner contended that since Nir disclosed tomato oleoresin, and the ’018 patent admitted that tomato oleoresin is inherently synergistic and contains both lycopene and vitamin E, Nir's disclosure inherently anticipated claim 1.
    • Key Aspects: This argument uniquely leveraged the patent's own text against its claims. Petitioner argued Nir also anticipated dependent claims 2 (lycopene from tomato oleoresin), 3 (vitamin E concentration, which would be inherent), 6 (excipients, as Nir taught use in tablets), and 7 (dosage forms like tablets).

  • Additional Grounds: Petitioner asserted an additional, more complex obviousness challenge against claims 1-22 based on Aviram and Patent 5,871,766 in view of Patent 5,976,568 and the ’624 application, which together taught various multivitamin formulations and the potential for synergy between antioxidants.

4. Key Claim Construction Positions

  • "synergistic effective amounts of administering/contacting": Petitioner argued that for the purposes of the IPR, this phrase should not be interpreted as requiring anything more than administering a composition that is itself synergistic. It should not be construed as a separate limitation on the method of administration.
  • "contacting the serum": Petitioner argued that this limitation in claim 15 should be given a broad construction covering not only direct in vitro contact but also indirect in vivo contact that occurs after oral administration and absorption of the composition.
  • Concentration and Ratio Limitations: For claims reciting specific concentrations or molar ratios (e.g., claims 3-5), Petitioner argued the broadest reasonable interpretation would cover either the concentration in the composition itself or the resulting concentration in the blood serum after administration. This was crucial for their argument that these limitations merely recited inherent properties of an obvious formulation.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 1-22 of Patent 6,515,018 as unpatentable.