Dr. Reddy's Labs. v. Genentech, Inc.

• Decision Date: 19 April 2023
• Docket Number: IPR2023-00052,Patent 11,110,087 B2
• Parties: DR. REDDY's LABORATORIES, INC., Petitioner, v. GENENTECH, INC., HOFFMAN-LA ROCHE AG, and ABB VIE INC., Patent Owner.
• Court: Patent Trial and Appeal Board

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DR. REDDY's LABORATORIES, INC., Petitioner, v. GENENTECH, INC., HOFFMAN-LA ROCHE AG, and ABB VIE INC., Patent Owner.

IPR2023-00052

Patent 11,110,087 B2

United States Patent and Trademark Office, Patent Trial and Appeal Board

April 19, 2023

PETITIONER:

Brandon White

Christopher Jones

Jonathan Tietz

PERKINS COIE LLP

PATENT OWNER:

Anthony Insogna

Matthew Johnson

JONES DAY

Before JEFFREY N. FREDMAN, ZHENYU YANG, and ROBERT A. POLLOCK, Administrative Patent Judges.

DECISION

INSTITUTION OF INTER PARTES REVIEW

35 U.S.C. § 314

FREDMAN, Administrative Patent Judge.

I. INTRODUCTION

Dr. Reddy's Laboratories, Inc. ("Petitioner") filed a Petition (Paper 1, "Pet.") requesting inter partes review of claims 1-4, 8-14, and 18-26 (the "challenged claims") of U.S. Patent No. 11,110,087 B2 (Ex. 1001, "the '087 patent"). Genentech, Inc., Hoffman-La Roche AG, and Abbvie Inc. ("Patent Owner") filed a Preliminary Response. Paper 6 ("Prelim. Resp.").

We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition "shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition."

A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S.Ct. 1348, 1359-60 (2018). In addition, if the Board institutes trial, it will "institute on all grounds in the petition." PTAB Consolidated Trial Practice Guide, 5-6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require "a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition").

Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.

II. REAL PARTIES-IN-INTEREST

Petitioner identifies Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc. as the real parties-in-interest. Pet. 3. Patent Owner states "the real parties-in-interest are Genentech, Inc., Hoffmann-La Roche Inc., and Abb Vie Inc., the assignees of record for U.S. Patent No. 11,110,087." Paper 4, 1.

III. RELATED MATTERS

Petitioner identifies the '087 patent as a continuation of U.S. 10,993,942 ('"942 patent") and related to three pending applications, U.S. 17/395,366, 17/709,324, and 17/834,709. Pet. 4. Petitioner identifies two district court cases directly related to the '087 and '942 patents: AbbVie Inc. v. Alembic Pharms., Ltd., No. 20-cv-01009 (D. Del.) and AbbVie Inc. v. Dr. Reddy's Labs., Ltd., No. 20-cv-00968 (D. Del). Petitioner also identifies a related instituted post grant review ("PGR") challenge: Dr. Reddy 's Labs., Inc. v. Genentech, Inc., PGR2022-00023, Paper 8 (PTAB July 25, 2022).

IV. THE '087 PATENT and RELEVANT BACKGROUND

The '087 patent states the "invention is directed to a combination therapy involving a type II anti-CD20 antibody and a selective Bcl-2 inhibitor for the treatment of a patient suffering from cancer, particularly a CD20-expressing cancer." Ex. 1001, 1:22-25. The '087 patent teaches, in one embodiment, that "the selective Bcl-2 inhibitor is GDC-0199." Id. at 4:6-7. The '087 patent teaches the treatment may comprise "administering to said human a GA101 antibody and/or GDC-0199 in multiple dosing cycles. In an embodiment, each dosing cycle of the multiple dosing cycle is for at least 1 week." Id. at 4:12-15. According to Patent Owner GDC-0199 is "now known as venetoclax" and marketed "as the FDA-approved drug Venclexta®." POPR 1. See also Ex. 1020 ¶ 2 (Dr. Oleksowicz's testimony that GDC-0199 is synonymous with Venclexta).

V. ILLUSTRATIVE CLAIMS

Petitioner challenges claims 1-4, 8-14, and 18-26, of which only claims 1 and 19 are independent:

1. A method for treating lymphoma or leukemia in a human patient, the method comprising orally administering once daily GDC-0199 to the patient in dosing cycles comprising escalating doses, wherein the escalating doses comprise a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.

19. A method for treating lymphoma or leukemia in a human patient, the method comprising orally administrating once daily GDC-0199 in escalating doses to the patient, wherein the escalating doses comprise a daily dose of 100 mg of GDC-0199.

Ex. 1001, 35:26-34; 36:45-49.

VI. ASSERTED GROUND

Petitioner contends that the challenged claims are unpatentable based on the following ground. Pet. 6.

Reference

Basis

Claims Challenged

Venclexta Label (November 2018) (Ex. 1053).

§ 102

1-4, 8-14, 18-26

Petitioner relies also on the Declaration of Leslie Oleksowicz, M.D. See Ex. 1020.

VII. CLAIM INTERPRETATION

Petitioner contends that the preamble recitation to treat particular cancers is a limitation "because it both frames and governs the ultimate timing and dosing choices of the claimed method of treatment." Pet. 26.

Patent Owner contends that "[although Patent Owners agree that the preamble is limiting, construing the preamble is unnecessary to resolve any controversy." Prelim. Resp. 15.

The parties do not identify any issue relating to the preamble that would impact our analysis. We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) ("[C]laim terms need only be construed 'to the extent necessary to resolve the controversy.'") (quoting Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).

VIII. LEVEL OF ORDINARY SKILL IN THE ART

Petitioner asserts

A person of ordinary skill in the art ("POSA") in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a Pharm D with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29.

Pet. 15-16. Patent Owner asserts "that a POSA for purposes of the '087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers)." Prelim. Resp. 13. Patent Owner asserts "Petitioner's definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners' definition of a POSA, on the other hand, accounts for the claims' focus on lymphoma and leukemia." Id. at 14.

At this stage in the proceeding, we find that Patent Owner's analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).

IX. PRINCIPLES OF LAW

"In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable." Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify "with particularity ... the evidence that supports the grounds for the challenge to each claim")). This burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).

"[T]o gain the benefit of the filing date of an earlier application under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112." Zenon Envtl, Inc. v. U.S. Filter Corp., 506 F.3d 1370, 1378 (Fed. Cir. 2007); see also In re Hogan, 559 F.2d 595, 609 (CCPA 1977) ("[T]here has to be a continuous chain of copending applications each of which satisfies the requirements of § 112 with respect to the subject matter presently claimed.")

"[T]he test for [compliance with the written description requirement of § 112, ¶ 1] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). "[W]hile the description requirement does not demand any particular form of disclosure, or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement." Id. at 1352 (citations omitted). "[T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art." Id. at 1351.

"Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo" In re Aoyama, 656 F.3d 1293 1296 (Fed. Cir. 2011). "The second step [of an anticipation analysis] involves comparing the claims to the...