DR Reddy's Laboratories Inc v. Genentech Inc

1. Case Identification

• Case #: PGR2022-00023
• Patent #: 10,993,942
• Filed: February 3, 2022
• Petitioner(s): Dr. Reddy's Laboratories, Inc.
• Patent Owner(s): Genentech, Inc., Hoffmann-La Roche AG, and Abbvie Inc.
• Challenged Claims: 1-3, 5-6, 14, 25-27, and 30

2. Patent Overview

• Title: Combination Therapy of a Type II Anti-CD20 Antibody with a Selective Bcl-2 Inhibitor
• Brief Description: The ’942 patent claims are directed to methods of treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering the compound GDC-0199 as a monotherapy in specific, escalating doses.

3. Grounds for Unpatentability

Ground 1: Lack of Written Description - Claims 1-3, 5-6, 14, 25-27, and 30 are invalid under 35 U.S.C. § 112

• Prior Art Relied Upon: Not applicable (challenge based on the patent’s own specification).
• Core Argument for this Ground: Petitioner argued that the ’942 patent’s specification fails to provide adequate written description for the challenged claims, which are directed to an escalating-dose GDC-0199 monotherapy. The core argument rests on three main points: the specification’s exclusive focus on combination therapy, the absence of the specific claimed dosing regimen, and the lack of guidance to combine the disparate claim elements.
  • Monotherapy vs. Combination Therapy: Petitioner contended that the specification exclusively describes the invention as a combination therapy requiring both GDC-0199 and an anti-CD20 antibody. This is evidenced by the patent’s title, abstract, summary, figures, and all experimental examples, which consistently frame the invention as a treatment involving two compounds. Petitioner argued that the claimed GDC-0199 monotherapy is therefore not described, and in fact, the specification’s examples discourage the use of GDC-0199 alone by showing it to be inferior to the combination treatment in mouse models. The specification’s entire focus on CD20-expressing cancers and anti-CD20 antibodies was presented as further evidence that the antibody is an essential element of the disclosed invention, not an optional component.
  • Lack of Dose Regimen Disclosure: Petitioner asserted that the specification fails to describe the specific escalating-dose regimens recited in the claims. While the specification mentions some of the claimed dose amounts (e.g., 20, 50, 100, 200, 400 mg) and durations (e.g., "one week"), it does so within the context of broad "laundry lists" of possibilities without providing guidance or "blaze marks" to select the specific combinations claimed. Petitioner noted that the only examples of dose escalation appear in figures depicting a combination therapy, and even those do not disclose the full sequence of doses recited in the claims. The absence of guidance was argued to be particularly significant given the patent owner’s prosecution arguments that dosing for GDC-0199 is unpredictable and critical for avoiding toxicity.
  • Lack of Combination of Elements: Petitioner argued that even if the individual elements of the claims could be found separately within the specification, there is no disclosure of their combination. A person of ordinary skill in the art (POSA) would have to first discard the specification’s central teaching of a combination therapy, then ignore the fixed-dose data from the examples, and finally assemble the specific escalating doses and timings from scattered, non-guiding lists. Petitioner contended that the specification provides no motivation or roadmap for a POSA to perform this synthesis, rendering the claimed invention undescribed as an integrated whole.

4. Key Claim Construction Positions

• Preamble term “treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)”: Petitioner argued this preamble term is a limitation and not merely a statement of intended use. It was asserted that the preamble gives life and meaning to the claims by framing the method of treatment. Petitioner noted that the patent owner relied on this cancer-treating context during prosecution to argue for non-obviousness based on unexpected results and the complexities of clinical trials. Furthermore, the preamble provides the necessary context for dependent claim limitations such as "reduced tumor burden" and provides the antecedent basis for the term "a patient."

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial would be inappropriate under both § 325(d) and § 324(a) (via the Fintiv factors).
• Under § 325(d), Petitioner contended that the written description arguments presented in the petition are new, as the examiner did not raise any § 112 rejections during prosecution.
• Regarding the parallel district court proceeding and the Fintiv factors, Petitioner asserted that the litigation was in its infancy. The ’942 patent was asserted against Petitioner approximately six months after issuance, and the litigation involves minimal investment to date. With no trial date set, a final written decision in the post-grant review (PGR) would likely issue first, simplifying or resolving issues for the district court and thus favoring institution.

6. Relief Requested

• Petitioner requested institution of a PGR and cancellation of claims 1-3, 5-6, 14, 25-27, and 30 of the ’942 patent as unpatentable for lacking adequate written description under § 112.