Valneva Austria GmbH v. Takeda Vaccines Inc

1. Case Identification

• Case #: IPR2025-00776
• Patent #: 11,730,802
• Filed: March 31, 2025
• Petitioner(s): Valneva Austria GMBH
• Patent Owner(s): Takeda Vaccines, Inc.
• Challenged Claims: 1-67

2. Patent Overview

• Title: Zika Vaccines and Immunogenic Compositions, and Methods of Using the Same
• Brief Description: The ’802 patent is directed to methods of vaccinating human subjects against the Zika virus using immunogenic compositions containing an inactivated whole Zika virus antigen. The disclosure is based in part on the finding that clonal isolated Zika viruses with an adaptation mutation in the NS1 protein grew well in Vero cells.

3. Grounds for Unpatentability

Ground I: Anticipation or Obviousness over Thomas - Claims 1-4, 6, 7, 10, 13, 19, 21, 23, 27-31, and 59 are anticipated by, or in the alternative, obvious over Thomas.

• Prior Art Relied Upon: Thomas (WO 2017/210215).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Thomas, in its "Example 5" describing human trials, disclosed every limitation of independent claim 1. Specifically, Petitioner asserted Thomas taught a method of vaccinating human subjects against Zika virus infection using a prime and boost administration of an inactivated whole Zika virus antigen. The administered 5 µg dose was within the claimed range of 1-40 µg. Crucially, Petitioner contended that Thomas’s reported 92% seroconversion rate in a population of 55 human subjects 28 days after the boost administration explicitly met the claimed limitation of inducing "a seroconversion rate of at least 80% in a population of at least 20 Zika virus seronegative subjects." Petitioner also mapped Thomas's disclosures to numerous dependent claims, including those related to dosage timing, purified antigen, and subject demographics.
  • Motivation to Combine (for §103 alternative): For the alternative obviousness argument, Petitioner asserted that a Person of Ordinary Skill in the Art (POSA) would have been motivated to use the specific vaccine parameters disclosed in Thomas's Example 5, as it presented a complete and successful clinical trial protocol.
  • Expectation of Success (for §103 alternative): A POSA would have had a high expectation of success because Thomas already demonstrated a 92% seroconversion rate, which is significantly higher than the claimed 80% threshold, indicating the method was not just feasible but proven effective.

Ground II: Obviousness over Thomas - Claims 11, 60, 61, and 62 are obvious over Thomas.

• Prior Art Relied Upon: Thomas (WO 2017/210215).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground targets independent claim 11, which differs from claim 1 by requiring a seroconversion rate of at least 60% after a single dose or prime administration. Petitioner argued that while Thomas does not expressly teach achieving this specific rate after a single dose, it provides strong reasons to pursue it. Thomas taught that a single dose could provide 100% protection in animal models and stated that "[i]deally, only one dose is needed."
  • Motivation to Combine: A POSITA would have been motivated to confirm the efficacy of a single-dose regimen to provide earlier protection against Zika infection and to reduce the need for a booster administration, a goal explicitly stated in Thomas.
  • Expectation of Success: Petitioner contended a POSITA would have reasonably expected to achieve at least a 60% seroconversion rate through routine optimization. Thomas taught that vaccine dose and adjuvants are result-effective variables affecting seroconversion, and achieving a 60% rate would be a predictable outcome of adjusting these known variables for a single-dose protocol shown to be safe and effective in animal models.

Ground III: Obviousness over Thomas and Barbero - Claims 8, 12, 14, 22, and 24 are obvious over Thomas and Barbero.

• Prior Art Relied Upon: Thomas (WO 2017/210215) and Barbero (WO 2017/109223).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Thomas's vaccine protocol, when combined with the known techniques in Barbero, rendered several dependent claims obvious. For claim 8, which required generation of neutralizing antibody titers greater than 1000 as determined by a plaque reduction neutralization test (PRNT), Petitioner asserted that Thomas taught achieving such titers but measured them using a microneutralization (MN) assay. Barbero was cited to supply the teaching of using the PRNT assay for the same purpose. For claim 14, requiring antigen purity of more than 85% by size exclusion chromatography, Petitioner argued Barbero taught a purity level of greater than 90% using this exact method, supplying the limitation not specified in Thomas.
  • Motivation to Combine: A POSITA would combine Thomas's vaccine with Barbero's teachings because they are in the same field and Barbero described well-known, alternative techniques for testing and purifying Zika vaccines. A POSITA would have looked to the art for standard methods like PRNT testing and purity analysis and found Barbero.
  • Expectation of Success: Petitioner asserted success was expected because the substitution of one known analytical method (MN) for another (PRNT) was a routine choice, with Barbero and other art (Liu) confirming the methods were interchangeable and produced correlated results.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Thomas with Murata (for plaque purification), NCT02952833 (for specific dosage amounts), and Faucette (for vaccination of pregnant women to protect a fetus).

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §314(a) is not warranted as there are no parallel district court litigations or other proceedings that would trigger a Fintiv analysis.
• Petitioner argued that denial under 35 U.S.C. §325(d) would be improper because the Examiner committed a material error during prosecution. Specifically, Petitioner asserted that Thomas was cited in an Information Disclosure Statement (IDS) but was never applied by the Examiner. Petitioner contended that had the Examiner considered Thomas, the claims would not have been allowed, as Thomas directly teaches the 80% seroconversion rate limitation that was added to overcome a rejection based on a different reference (Barbero).

5. Relief Requested

• Petitioner requests the institution of an inter partes review (IPR) and the cancellation of claims 1-67 of Patent 11,730,802 as unpatentable.