PTAB

IPR2023-00052

DR Reddy's Laboratories Inc v. Genentech Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Combination Therapy of a Type II Anti-CD20 Antibody with a Selective Bcl-2 Inhibitor
  • Brief Description: The ’087 patent claims methods for treating lymphoma or leukemia in a human patient by orally administering escalating daily doses of the compound GDC-0199 (venetoclax) in specific dosing regimens.

3. Grounds for Unpatentability

Ground 1: Anticipation over the 2018 Venclexta Label - Claims 1-4, 8-14, and 18-26 are anticipated by the November 2018 Venclexta Label.

  • Prior Art Relied Upon: November 2018 Venclexta Label ("2018 Label").
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that the 2018 Label, a publicly available product insert for the drug Venclexta (whose active ingredient is GDC-0199), expressly discloses every limitation of the challenged claims. Independent claim 1 recites a method of treating lymphoma or leukemia with escalating daily doses of 100 mg, followed by 200 mg, then 400 mg of GDC-0199. The 2018 Label disclosed specific "ramp-up" dosing schedules for treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) that included these exact escalating daily doses. For example, the schedule for AML involved administering 100 mg on day 1, 200 mg on day 2, and 400 mg on day 3. The 2018 Label also disclosed that these ramp-ups were part of larger "dosing cycles" and that treatment should continue "until disease progression is observed," mapping directly to limitations in dependent claims 2-4, 8, and others.
    • Key Aspects: The central thesis of the petition is that the ’087 patent is not entitled to its asserted September 7, 2012 priority date. Petitioner argued that the priority applications fail both the written description and enablement requirements of 35 U.S.C. §112. Without the benefit of priority, the patent’s effective filing date is its actual filing date of February 26, 2021. This renders the 2018 Label, published in November 2018, a valid printed publication under §102 that anticipates the claims.

4. Key Claim Construction Positions

  • "method for treating lymphoma or leukemia in a human patient": Petitioner argued this preamble term is limiting. It asserted that the preamble is necessary to give life and meaning to the claims, as it governs the dosing choices and provides antecedent basis for "the patient" and "disease progression" recited in the claim bodies. Petitioner noted that the Patent Owner relied on the cancer-treating context to overcome an obviousness rejection during prosecution, underscoring the preamble's essential nature.

5. Key Technical Contentions (Beyond Claim Construction)

  • Lack of Priority Under §112: Petitioner's primary technical-legal contention is that the challenged claims are not supported by the asserted priority applications.
    • No Written Description: Petitioner argued the priority documents fail to demonstrate that the inventor possessed the claimed invention in 2012. The specifications allegedly provide only disconnected "laundry lists" of potential dose amounts, frequencies, and durations without any guidance or "blaze marks" to lead a person of ordinary skill in the art (POSA) to the specific claimed escalating dose regimens. Furthermore, Petitioner contended that the priority documents consistently and exclusively describe a combination therapy involving GDC-0199 and an anti-CD20 antibody. The claims, however, are directed to a GDC-0199 monotherapy, which Petitioner argued is a fundamentally different invention that is not described.
    • No Enablement: Petitioner also argued that the priority documents do not enable the full scope of the claims without undue experimentation. Citing the breadth of the claims (covering any lymphoma/leukemia), the unpredictability of cancer treatment (an admission made by Patent Owner during prosecution), and the lack of working examples, Petitioner asserted a POSA would have to engage in a substantial research program to determine which of the countless possible dosing regimens were effective, particularly for monotherapy.

6. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under §314(a) based on the Fintiv factors would be inappropriate.
    • Trial Schedule and Investment: No trial date has been set in the parallel district court litigation, and expert discovery is not expected to close until at least April 2024, well after the statutory deadline for a Final Written Decision (FWD) in this inter partes review (IPR). Investment in the parallel case was argued to be in early stages regarding the ’087 patent.
    • Merits of the Petition: Petitioner emphasized the strength of its anticipation challenge, arguing the 2018 Label is a "carbon-copy match" for the claims. It also noted that the core priority challenge is a new issue not considered by the Examiner during prosecution, as the Examiner assumed the priority claim was valid.

7. Relief Requested

  • Petitioner requested institution of IPR and cancellation of claims 1-4, 8-14, and 18-26 of the ’087 patent as unpatentable under 35 U.S.C. §102.