Teva Pharmaceuticals USA, Inc. v. ViiV Healthcare Co.

1. Case Identification

• Case #: Unassigned (Petition seeks joinder with IPR2014-00876)
• Patent #: 6,417,191
• Filed: January 8, 2015
• Petitioner(s): TEVA PHARMACEUTICALS USA, INC.
• Patent Owner(s): VIIV HEALTHCARE CO., VIIV HEALTHCARE UK LTD.
• Challenged Claims: 1-51

2. Patent Overview

• Title: Synergistic Combinations of Zidovudine, 1592U89 and 3TC
• Brief Description: The ’191 patent discloses pharmaceutical compositions, methods for treating HIV infection, and patient packs comprising combinations of three known anti-HIV drugs: abacavir (also known as 1592U89), zidovudine (AZT), and lamivudine (3TC). All three are nucleoside analog reverse transcriptase inhibitors (NRTIs).

3. Grounds for Unpatentability

Ground 1: Claims 1-51 are obvious over Cameron in view of Daluge.

• Prior Art Relied Upon: Cameron (European Patent Application EP 0 513 917 A1) and Daluge (Abstracts of the 34th ICAAC, 1994).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that the combination of Cameron and Daluge renders all challenged claims obvious. Cameron taught a synergistic combination of AZT and 3TC for treating HIV and expressly suggested that its combination could be used with "other therapeutic and/or prophylactic ingredients." Daluge, published two years later, introduced abacavir as a "promising new treatment" and an "attractive candidate for clinical evaluation." Daluge disclosed that abacavir was a potent and selective anti-HIV agent, was "equivalent in potency to AZT," and acted synergistically in in vitro assays with other NRTIs, including AZT. Petitioner argued that combining these teachings directly leads to the claimed three-drug combination of abacavir, AZT, and 3TC for treating HIV. The petition provided extensive mapping for all independent and dependent claims, arguing that features like dosage ranges, ratios, and administration forms (tablets, capsules) were either directly taught by the prior art or would have been the result of routine optimization by a person of ordinary skill in the art (POSA).
  • Motivation to Combine: A POSA would combine Cameron’s highly effective AZT/3TC base therapy with Daluge’s "promising" new drug, abacavir. The motivation was clear: to create a more potent three-drug regimen to improve therapeutic efficacy and combat the known problem of HIV drug resistance. Cameron explicitly provided the motivation by teaching the addition of other agents to its combination, and Daluge presented abacavir as an ideal candidate for such an addition due to its potency, selectivity, and known synergistic activity with AZT.
  • Expectation of Success: A POSA would have had a high expectation of success. All three drugs were known to be effective and relatively safe anti-HIV agents. Crucially, synergistic effects were already known for the AZT/3TC pair (from Cameron) and the AZT/abacavir pair (from Daluge). Therefore, it would have been reasonable to expect that combining all three would result in a successful and likely synergistic therapeutic for treating HIV.
  • Key Aspects: A central component of the petition was a preemptive rebuttal of the Patent Owner's likely arguments regarding secondary indicia of non-obviousness. Petitioner argued that any claims of "unexpectedly superior results" were unsupported. It contended that the in vitro synergy of the triple combination was predictable from the known synergy of its component pairs. Furthermore, it asserted that clinical data for the commercial products (Trizivir) showed efficacy that was merely "comparable," "modest," or "non-inferior" to the prior art standard of care, not unexpectedly superior.

4. Key Claim Construction Positions

• Common Names: Petitioner argued that the full chemical names used in the claims for the three active ingredients should be construed to encompass their well-known common names: abacavir, zidovudine (AZT), and lamivudine (3TC), as these were used interchangeably in the art and the patent itself.
• "Physiologically Functional Derivative": This term should be given its explicit definition from the ’191 patent specification, which includes salts, esters, and other compounds capable of providing the active drug upon administration.
• "Patient Pack": For claim 31, Petitioner argued the phrase "at least one" active ingredient means that, under the broadest reasonable interpretation, the pack need only contain one of the three drugs plus an information insert describing the use of all three in combination.
• "Therapeutically Effective Amount": Petitioner contended this term should be given its ordinary meaning and does not require any particular magnitude of therapeutic effect or level of efficacy, as none is specified in the claims.

5. Key Technical Contentions (Beyond Claim Construction)

• Predictability of Synergy: Petitioner's core technical contention was that the synergistic effect of the three-drug combination was not unexpected. It argued that because the prior art already demonstrated synergy for the AZT/3TC pair and the AZT/abacavir pair, a POSA would have reasonably expected that combining all three NRTIs—which target the same enzyme but compete with different native nucleosides—would also result in a synergistic effect.
• Clinical Efficacy Not "Unexpectedly Superior": Petitioner heavily contested the non-obviousness of the claimed invention by analyzing the Patent Owner's own clinical trial data. It argued this data showed the claimed combinations were, at best, "non-inferior" or "comparable" to the existing standard of care (the AZT/3TC combination). The results were described in studies as "modest," which Petitioner argued fails to meet the legal standard for unexpectedly superior results needed to overcome a strong case of obviousness.

6. Arguments Regarding Discretionary Denial

• Petitioner preemptively addressed the one-year time bar under §312(a)(1), acknowledging it was served with a complaint more than one year prior to filing the petition. However, Petitioner argued for an exception under 37 C.F.R. § 42.122(b), as it was concurrently filing a motion for joinder with an already-instituted IPR on the same patent (IPR2014-00876, Apotex v. ViiV). The petition was filed within one month of the Board's decision to institute the Apotex IPR, which Petitioner contended makes the filing timely under the rules governing joinder.

7. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-51 of Patent 6,417,191 as unpatentable under 35 U.S.C. §103.