Intervet International, B.V. v. Boehringer Ingelheim Vetmedica, Inc.

1. Case Identification

• Case #: Unassigned
• 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 ORF2 protein from Porcine Circovirus Type 2 (PCV2). The patent claims these compositions are sufficient to provide a protective effect against the clinical symptoms of PCV2 infection after a single dose.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-5, 11-13, 15-16, and 18-24 under §102(b) over Meng

• Prior Art Relied Upon: Meng (International Publication No. WO 2003/049703).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Meng teaches every element of the challenged claims. Meng disclosed immunogenic compositions containing recombinant PCV2 ORF2 protein (as both subunit and chimeric PCV1-2 virus vaccines), an inactivated viral vector, and a pharmaceutically acceptable carrier. Petitioner contended that Meng explicitly taught that its vaccine could be administered in a "single dose" to protect pigs against PCV2 infection.
  • Key Aspects: The core of the anticipation argument rested on inherency. Petitioner asserted that even if Meng did not explicitly detail the degree of protective effect from a single dose, this effect is an inherent property of the disclosed prior art composition. The discovery of an inherent property (single-dose efficacy) of a known composition does not render that composition patentable.

Ground 2: Obviousness of Claims 1-5, 11-16, and 18-24 over Meng in view of Fenaux

• Prior Art Relied Upon: Meng (WO 2003/049703) and Fenaux (a 2004 journal article on chimeric porcine circovirus).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground asserted that to the extent Meng alone was found not to enable or describe the single-dose efficacy limitation, Fenaux provided the missing disclosure. Fenaux, a follow-up study to Meng's work, presented data demonstrating that a single dose of a live chimeric PCV1-2 virus (containing recombinant ORF2 protein) developed protective immunity against wild-type pathogenic PCV2 challenge in pigs.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Meng and Fenaux because they were published by the same research group and address the same body of work. Meng taught both live and inactivated versions of a PCV1-2 vaccine, and Fenaux provided efficacy data for the live version.
  • Expectation of Success: A POSA would have a reasonable expectation of success in achieving single-dose protection with an inactivated version of the Meng/Fenaux vaccine. Fenaux's positive results with the live virus, combined with Meng's explicit teaching of inactivating the virus, would lead a POSA to expect that a safer, inactivated version would also be effective, a common and predictable modification in vaccine development.

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

• Prior Art Relied Upon: Meng (WO 2003/049703), Fenaux (a 2004 journal article), Blanchard (a 2003 journal article on PCV-2 protein protection), and/or Jestin (Patent 6,703,023).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground argued that it would have been obvious to apply the single-dose administration taught by Meng and Fenaux to the subunit vaccines taught by Blanchard and Jestin. Blanchard evaluated a subunit vaccine with recombinant PCV2 ORF2 protein and its data showed seroconversion after a single dose. Jestin taught a similar subunit vaccine and disclosed that it could be administered "one time."
  • Motivation to Combine: A POSA would be motivated to create a single-dose subunit vaccine for PCV2. Meng itself explained that subunit vaccines are advantageous because they are less toxic than whole virus vaccines. Combining the single-dose regimen of Meng/Fenaux with the safer, non-replicating ORF2 protein subunit vaccines of Blanchard and Jestin was a logical step to create a more commercially viable and safer product.
  • Expectation of Success: The expectation of success was high. Blanchard's data showed that a single dose of its subunit vaccine was sufficient to induce neutralizing antibodies. This, combined with Fenaux's proof of single-dose efficacy for a related vaccine and the known advantages of subunit vaccines, would provide a POSA with a strong expectation that a single-dose ORF2 subunit vaccine would be effective.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including Ground 4, which argued claims 6-10 are obvious over Meng/Fenaux in further view of Bublot (Patent 6,497,883) for its teachings of specific adjuvants (e.g., carbomers). Petitioner also asserted Ground 5, which argued claim 17 is obvious over Meng/Fenaux in further view of Halbur (a 2000 conference proceeding) for its teaching of vaccinating piglets at three weeks of age.

4. Key Claim Construction Positions

• “Comprising . . . protein” and “Comprising the step of”: Petitioner argued these terms must be given their open-ended meaning under the broadest reasonable interpretation (BRI), meaning they do not exclude the presence of other unrecited components (e.g., cellular lysate, other proteins) or method steps. This construction allows prior art disclosing such additional elements to meet the claim limitations.
• “Effective Amount of Recombinant PCV2 ORF2 protein”: Petitioner proposed this term encompasses a broad dosage range from 0.2 to 400 µg/dose, as supported by the patent’s specification. This wide range makes it more likely that dosages disclosed in the prior art fall within the claimed scope.
• “Provides a Protective Effect...”: Petitioner contended this phrase should be construed to mean a protective effect of any magnitude, duration, or type, as the claims and specification do not specify a minimum level of protection. This construction is central to the inherency argument, as any measurable protective effect in the prior art would satisfy the limitation.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate because the grounds presented in the petition are not the same or substantially the same as those considered during prosecution. Petitioner asserted that the Examiner never relied on the primary references of Meng or Fenaux as the basis for any rejection. Furthermore, the petition presented new evidence not before the Examiner, including expert testimony and additional secondary references, as well as new legal arguments regarding inherency that the Examiner did not consider. Petitioner also noted it was concurrently filing a second IPR petition with different grounds and argued that neither is a "follow-on" petition, making denial under §314(a) improper.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-24 of Patent 9,011,872 as unpatentable.