Intervet Intl BV v. Boehringer Ingelheim Vetmedica Inc

1. Case Identification

• Case #: IPR2018-01788
• Patent #: 9,011,872
• Filed: September 24, 2018
• Petitioner(s): Intervet Inc. a/k/a Merck Animal Health
• Patent Owner(s): Boehringer Ingelheim Vetmedica, Inc.
• Challenged Claims: 1-24

2. Patent Overview

• Title: Immunogenic Compositions for Porcine Circovirus (PCV2)
• Brief Description: The ’872 patent relates to immunogenic compositions comprising the Porcine Circovirus Type 2 (PCV2) ORF2 protein. The patent claims that these compositions are effective for inducing a protective immune response against clinical symptoms associated with PCV2 infection after the administration of a single dose.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-5, 11-16, and 18-24 under 35 U.S.C. §102 by Blanchard

• Prior Art Relied Upon: Blanchard et al., “Protection of swine against post-weaning multisystemic wasting syndrome (PMWS) by porcine circovirus type 2 (PCV-2) proteins,” VACCINE 21:4565-4575 (2003) (“Blanchard”).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Blanchard disclosed every element of the challenged claims. Blanchard described a subunit vaccine comprising recombinant PCV2 ORF2 protein produced in a baculovirus expression system. Petitioner asserted that the dose administered in Blanchard’s trials (calculated to be between 106 and 169 µg) constituted an "effective amount." The composition also included an inactivated viral vector (the baculovirus) and an adjuvant. Critically, Petitioner contended that Blanchard’s data inherently or expressly disclosed that a single dose provided a protective effect, as shown by seroconversion and the production of neutralizing antibodies within two weeks of the first injection, prior to any subsequent booster.

Ground 2: Anticipation of Claims 1-5, 11-13, 15-16, and 18-24 under 35 U.S.C. §102 by Jestin

• Prior Art Relied Upon: Jestin et al. (Patent 6,703,023).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Jestin described immunogenic compositions containing an effective amount of recombinant PCV2 ORF2 protein. Petitioner highlighted that Jestin expressly taught its vaccine "will be administered one time or several times" and is administered in an amount "protective against piglet weight loss disease." The vaccine composition, prepared using a baculovirus system, necessarily contained an inactivated viral vector as a result of the protein recovery process. Petitioner further asserted that the dosage taught by Jestin (calculated to be between 63.3 µg and 271.4 µg) fell within the claimed ranges and was shown to be effective.

Ground 3: Obviousness of Claims 1-5, 11-16, and 18-24 over Blanchard and/or Jestin in view of Meng and Fenaux

• Prior Art Relied Upon: Blanchard (2003 journal article), Jestin (Patent 6,703,023), Meng (International Publication No. WO 2003/049703), and Fenaux (2004 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that to the extent the Board finds Blanchard and Jestin do not explicitly teach a single-dose protective effect, this feature would have been obvious. Meng and Fenaux taught that single-dose vaccines containing the PCV2 ORF2 protein (as part of a chimeric PCV1-2 virus) provided a protective effect against clinical symptoms.
  • Motivation to Combine: A POSITA would combine these teachings because all references are directed to the same technical problem: creating an effective PCV2 vaccine using the ORF2 protein. The demonstrated success of a single-dose regimen in Meng and Fenaux would motivate a POSITA to apply this preferred, more efficient, and economically advantageous dosing schedule to the safer subunit vaccines disclosed by Blanchard and Jestin.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because Blanchard’s own data showed a strong immune response (seroconversion) after just one dose. This, combined with the proven single-dose efficacy of a structurally similar antigen in Meng and Fenaux, would strongly suggest that a single dose of the Blanchard or Jestin subunit vaccine would be effective.
• Additional Grounds: Petitioner asserted obviousness challenges for claims 6-10 over Blanchard and/or Jestin in view of Bublot (Patent 6,497,883) for specific adjuvant formulations (e.g., carbomers). Petitioner also challenged claim 17 as obvious over Blanchard and/or Jestin in view of Halbur for its limitation of administering the vaccine at about 3 weeks of age.

4. Key Claim Construction Positions

• "Effective Amount of Recombinant PCV2 ORF2 protein": Petitioner argued this term should be construed broadly to encompass the full range disclosed in the specification, from 0.2 to about 400 µg/dose. This broad construction would cover the amounts disclosed in the prior art references.
• "Provides a Protective Effect...": Petitioner contended this phrase should encompass a protective effect of any magnitude, duration, or type against any clinical symptom associated with PCV2 infection. The argument was that the patent did not specify a minimum level of protection, so any demonstrable effect would meet the limitation.
• "Comprising": Petitioner argued that the open-ended term "comprising" means the claimed compositions could contain other unrecited components, and the claimed methods could include unrecited steps, which is relevant for mapping prior art that discloses complex vaccine formulations.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under 35 U.S.C. §325(d), asserting that the grounds presented in the petition were neither the same nor substantially the same as those considered by the Examiner during prosecution.
• Petitioner stated that although Blanchard was cited during prosecution, the Examiner never substantively analyzed its teachings or explained its relevance before dropping it from the rejection. Key prior art like Jestin was not the basis for any rejection. Furthermore, the petition presented new evidence not before the Examiner (e.g., admissions from a related IPR) and new legal arguments concerning inherency that were never addressed during prosecution.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-24 of Patent 9,011,872 as unpatentable under 35 U.S.C. §§ 102 and 103.