Janssen Biotech Inc v. United States

1. Case Identification

• Case #: IPR2021-01484
• Patent #: 9,765,342
• Filed: September 9, 2021
• Petitioner(s): Janssen Biotech, Inc.
• Patent Owner(s): U.S. Department of Health and Human Services
• Challenged Claims: 1-9, 13, 17, and 19

2. Patent Overview

• Title: Chimeric Antigen Receptors Targeting B-cell Maturation Antigen
• Brief Description: The ’342 patent discloses chimeric antigen receptors (CARs) specifically engineered to target B-cell Maturation Antigen (BCMA). The technology involves modifying T-cells to express these CARs, enabling the resulting CAR-T cells to recognize and eliminate cancer cells expressing BCMA, particularly those associated with hematologic malignancies like multiple myeloma.

3. Grounds for Unpatentability

Ground 1: Claims 1-9, 13, 17, and 19 are obvious over Milone in view of Kalled.

• Prior Art Relied Upon: Milone (a 2009 journal article on CAR-T efficacy) and Kalled (WO 2010/104949).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the combination of Milone and Kalled rendered all challenged claims obvious under 35 U.S.C. §103. Milone taught a proven, second-generation CAR framework (the "BB-ζ" construct) for treating hematologic malignancies, which contained all elements of the claimed "T-cell activation moiety," including a CD8α transmembrane domain, a 4-1BB costimulatory domain, and a CD3ζ signaling domain. Kalled identified BCMA as a validated target for multiple myeloma (a hematologic malignancy) and disclosed specific anti-BCMA antibodies and single-chain variable fragments (scFvs) that function as the claimed "antigen recognition moiety." Petitioner asserted that simply substituting Kalled’s known targeting moiety into Milone’s established and modular CAR framework disclosed every limitation of the challenged claims.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Milone and Kalled because adapting modular CAR frameworks to new, validated targets was a well-established and predictable strategy in the field. Milone provided a successful framework optimized for blood cancers and expressly taught its suitability for redirection to new targets. Kalled provided a promising target (BCMA) and the corresponding targeting molecule (anti-BCMA scFv) for a similar type of blood cancer (multiple myeloma). The combination represented a straightforward application of known techniques to address the known need for new multiple myeloma therapies.
  • Expectation of Success: A POSA would have a reasonable expectation of success in making a functional anti-BCMA CAR. The modularity of CARs was a fundamental principle of the technology, Milone’s CAR framework was proven to be effective and stable, and Kalled’s antibodies were already shown to successfully recognize and bind BCMA on target cancer cells. Combining these known components for their intended and known functions was expected to yield a predictable result.

4. Key Claim Construction Positions

• "antigen recognition moiety": Petitioner asserted this term should be construed to include a monoclonal antibody or an antigen-binding portion thereof, such as a single-chain variable fragment (scFv), as supported by the patent’s specification. This construction is critical because it allows the anti-BCMA antibodies and scFvs disclosed in Kalled to satisfy this claim element.
• "T-cell activation moiety": Petitioner contended this term, which the claim states "comprises a transmembrane domain," should be understood to also include one or more intracellular T-cell signaling domains, consistent with the specification and the state of the art. This construction is necessary to map the complete, functional CAR framework taught by Milone to the claims and to properly distinguish the claimed invention from a simple antibody.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate because the Examiner committed material error during the original prosecution. The Examiner never considered an obviousness rejection combining a CAR framework reference (like Milone) with a targeting moiety reference (like Kalled). Instead, the prosecution history shows the Examiner rejected the claims as anticipated by Kalled alone, fundamentally mischaracterizing a complete CAR as being equivalent to a simple antibody. The claims were only allowed after the applicant added a "transmembrane domain" limitation, which the Examiner apparently believed distinguished the claims from an antibody, thereby overlooking that complete CAR frameworks containing this exact element were already well-known.

6. Relief Requested

• Petitioner requests the institution of an inter partes review (IPR) and the cancellation of claims 1-9, 13, 17, and 19 of the ’342 patent as unpatentable.