Regeneron Pharmaceuticals Inc v. Novartis Vaccines Diagnostics Inc

1. Case Identification

• Case #: IPR2019-01086
• Patent #: 5,688,688
• Filed: May 14, 2019
• Petitioner(s): Regeneron Pharmaceuticals, Inc.
• Patent Owner(s): Novartis Vaccines and Diagnostics, Inc., Grifols Worldwide Operations Limited
• Challenged Claims: 1-2, 4-6, 8-9, 13-14, and 17

2. Patent Overview

• Title: Vector for Expression of a Polypeptide in a Mammalian Cell
• Brief Description: The ’688 patent describes genetic vectors for expressing polypeptides in mammalian cells. The invention centers on using a transcription regulatory region from the human cytomegalovirus immediate early region (HCMV IE1) to drive high-level expression of a desired polypeptide. While the claims are broad, the patent's specification is narrowly focused on expressing Human Immunodeficiency Virus (HIV) polypeptides.

3. Grounds for Unpatentability

Ground 1: Anticipation over ’949 Patent due to Lack of Priority - Claims 1-2, 4-6, 8-9, 13-14, and 17 are anticipated under 35 U.S.C. §102(b) by the ’949 patent.

• Prior Art Relied Upon: Patent 5,156,949 (“the ’949 patent”).

• Core Argument for this Ground: Petitioner argued that the challenged claims of the ’688 patent are not entitled to the 1987 priority date of their parent application (the ’894 application). The core contention was that the ’894 application’s specification provides no written description support for the broad, generic claims of the ’688 patent, which cover expression of any heterologous or mammalian polypeptide. Instead, the priority application disclosed only a single species: the pCMV6a vector used to express one specific HIV polypeptide (gp120) in one type of cell (COS monkey cells). Petitioner asserted that the specification lacks any "broadening language" to suggest the inventors possessed a generic invention beyond this single example.

  Consequently, Petitioner argued the challenged claims’ effective filing date is no earlier than August 10, 1994, the filing date of the application that directly led to the ’688 patent. This date is critical because the ’949 patent, which issued on October 20, 1992, from the same parent application, qualifies as prior art under §102(b).

  • Prior Art Mapping: The ’949 patent shares an identical specification with the ’688 patent. Therefore, it explicitly disclosed the same single species: a non-human mammalian host cell expression system (COS cells) using the pCMV6a vector to express the gp120 polypeptide. Petitioner mapped this specific disclosure to every limitation of the challenged claims. For example, claim 1 requires a vector with an upstream SV40 origin of replication, a downstream SV40 polyadenylation region, and an HCMV IE1 transcription regulatory region. The ’949 patent’s disclosure of the pCMV6a plasmid met each of these limitations, thereby anticipating the broader generic claim. Similar analyses were applied to the remaining independent and dependent claims.

Ground 2: Anticipation of Claim 17 over Boshart 1985 - Claim 17 is anticipated under 35 U.S.C. §102(b) by Boshart 1985.

• Prior Art Relied Upon: Boshart et al., "A Very Strong Enhancer Is Located Upstream of an Immediate Early Gene of Human Cytomegalovirus," Cell 41: 521-530 (1985) (“Boshart 1985”).
• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Boshart 1985, a seminal scientific article published in June 1985, disclosed every element of independent claim 17. Claim 17 recites an "isolated nucleic acid molecule" comprising an "enhanced promoter" from HCMV IE1 (including the promoter and first intron), where the promoter is "operably linked" to a sequence encoding a mammalian polypeptide.

    Boshart 1985 described constructing a plasmid (pβX-1429), which Petitioner contended is an "isolated nucleic acid molecule." This plasmid contained the HCMV IE1 transcription regulatory region (including the promoter, enhancer, and first intron), which meets the "enhanced promoter" limitation. This promoter was shown to be operably linked to, and directed the transcription of, a nucleic acid sequence encoding rabbit β-globin, which is a mammalian polypeptide. Petitioner asserted that Boshart 1985’s disclosure of the pβX-1429 plasmid therefore anticipated every limitation of claim 17.

4. Key Claim Construction Positions

• Petitioner submitted that no claim terms required construction to resolve the anticipation grounds. However, if the Board found construction necessary for "mammalian polypeptide" (claim 17), Petitioner argued for its plain and ordinary meaning: "a polypeptide that is found naturally in a mammal."
• This construction was proposed based on dictionary definitions and the patent owner’s reliance on the plain meaning of the term during reexamination. Petitioner argued this construction was relevant because the ’688 patent’s specification provided no examples of expressing a mammalian polypeptide using an HCMV IE1 vector, whereas the Boshart 1985 reference explicitly did.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should institute the IPR because the petition presented arguments and evidence not previously considered by the PTO. Specifically, the PTO never addressed the threshold priority issue—that the generic claims lack written description support in the parent applications.
• As a result of not addressing the priority date, the PTO never considered the ’949 patent as anticipatory §102(b) prior art. Furthermore, while Boshart 1985 was cited during prosecution, it was not used to reject the issued claims, and the specific anticipation argument against claim 17 was never considered by the examiner.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-2, 4-6, 8-9, 13-14, and 17 of Patent 5,688,688 as unpatentable.