PTAB

IPR2018-01789

Intervet Intl BV v. Boehringer Ingelheim Vetmedica Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Immunogenic Composition for PCV2
  • Brief Description: The ’872 patent relates to immunogenic compositions comprising a recombinant Porcine Circovirus Type 2 (PCV2) Open Reading Frame 2 (ORF2) protein. The patent claims that these compositions are effective in providing a protective effect against clinical symptoms of PCV2 infection in a pig after administration of a single dose.

3. Grounds for Unpatentability

Ground 1: Anticipation over Meng - Claims 1-5, 11-13, 15-16, and 18-24 are anticipated by Meng under 35 U.S.C. §102(b).

  • Prior Art Relied Upon: Meng (International Publication No. WO 2003/049703).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Meng disclosed every element of the challenged claims. Meng allegedly taught immunogenic compositions, including inactivated chimeric virus vaccines and subunit vaccines, containing an effective amount of recombinant PCV2 ORF2 protein. Petitioner asserted that Meng explicitly disclosed that its vaccine could be administered in a single dose for the purpose of protecting pigs against viral infection or Post-Weaning Multisystemic Wasting Syndrome (PMWS) caused by PCV2. Petitioner contended that the claimed protective effect from a single dose was, at a minimum, an inherent property of the compositions and methods disclosed by Meng.
    • Key Aspects: The core of this ground rested on the argument of inherency—that even if Meng did not explicitly provide data showing single-dose efficacy, the disclosed composition would necessarily provide that effect, and the later recognition of this inherent property does not make the composition patentable.

Ground 2: Obviousness over Meng and Fenaux - Claims 1-5, 11-16, and 18-24 are obvious over Meng in view of Fenaux and the knowledge of a POSA under 35 U.S.C. §103.

  • Prior Art Relied Upon: Meng (WO 2003/049703) and Fenaux (a 2004 article in the Journal of Virology).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Meng disclosed the foundational elements, including various PCV2 vaccines containing recombinant ORF2 protein and the option for single-dose administration. Fenaux, a follow-up study to Meng's work, provided explicit data demonstrating that a single dose of a live chimeric PCV1-2 virus (containing the recombinant ORF2 protein from Meng) provided a protective effect against clinical symptoms of PCV2 infection in piglets. Fenaux's data allegedly confirmed the single-dose efficacy that was inherent in or suggested by Meng.
    • Motivation to Combine: A POSITA would combine Meng and Fenaux because they were published by the same research group and related to the same body of work. Fenaux directly studied and provided efficacy data for the vaccine constructs described in Meng.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because Meng taught that a single dose induced an antibody response, and Fenaux provided data confirming this single dose was effective against a pathogenic PCV2 challenge. Although Fenaux used a live virus, Meng expressly taught inactivating its chimeric virus, and viral inactivation was a routine and predictable technique.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including:

    • Combining Meng and/or Fenaux with Blanchard (a 2003 journal article) and/or Jestin (Patent 6,703,023) to further support the efficacy of a single-dose ORF2 subunit vaccine.
    • Combining Meng and/or Fenaux with Bublot (Patent 6,497,883) to render obvious claims related to specific vaccine adjuvants like carbomers (claims 6-10).
    • Combining Meng and/or Fenaux with Halbur (a veterinary publication) to render obvious the method of vaccinating a pig at about 3 weeks of age (claim 17).

4. Key Claim Construction Positions

  • "Comprising ... Recombinant PCV2 ORF2 protein" / "Comprising the step of": Petitioner argued these open-ended terms should be given their broadest reasonable interpretation. This means the composition claims do not exclude other components (e.g., DNA, cellular lysate), and the method claims do not exclude additional steps.
  • "Effective Amount of Recombinant PCV2 ORF2 protein": Petitioner contended this term encompassed a broad range from 0.2 to 400 µg/dose, as described in the ’872 patent specification for inducing a desired immune response.
  • "Provides a Protective Effect...": Petitioner argued this phrase should be construed to mean a protective effect of any magnitude, duration, or type against any clinical symptom. The patent did not specify a minimum level of protection, so any degree of effect against any symptom would meet the limitation.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under §325(d) would be inappropriate. It asserted that the grounds presented were not the same or substantially similar to those considered during prosecution. Specifically, the primary references of Meng and Fenaux were not relied upon by the Examiner for any rejection. Furthermore, the petition relied on new evidence, including Patent Owner's own admissions from a different proceeding and expert testimony, and presented legal arguments regarding inherency that the Examiner did not consider.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-24 of the ’872 patent as unpatentable.