DR Reddy's Laboratories Inc v. Novo Nordisk AS

1. Case Identification

• Case #: IPR2024-00009
• Patent #: 10,335,462
• Filed: October 20, 2023
• Petitioner(s): Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd.
• Patent Owner(s): Novo Nordisk A/S
• Challenged Claims: 1-10

2. Patent Overview

• Title: Use Of Long-Acting Glp-1 Peptides
• Brief Description: The 10,335,462 patent discloses a method for treating type 2 diabetes by administering the glucagon-like peptide 1 (GLP-1) analogue semaglutide in a specific amount of 1.0 mg on a once-weekly basis.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-3 over WO421

• Prior Art Relied Upon: WO421 (International Publication No. WO 2011/138421).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that WO421 expressly disclosed every element of claims 1-3. WO421 taught a method for treating type 2 diabetes by administering semaglutide, specifically disclosing that it "is administered once weekly by subcutaneous injection (0.1- 1.6 mg)." Petitioner contended that this disclosure of a narrow, finite dose range (encompassing at most 16 discrete 0.1 mg increments) explicitly taught the claimed 1.0 mg dose. The express teaching of subcutaneous administration was alleged to anticipate the limitations of dependent claims 2 (parenteral administration) and 3 (subcutaneous injection).
  • Key Aspects: Petitioner asserted that where a prior art reference discloses a limited and discrete range, it anticipates every species within that genus, and that the 1.0 mg dose was not shown to be critical or different from other doses in the disclosed range.

Ground 2: Obviousness of Claims 1-10 over WO537 and Lovshin

• Prior Art Relied Upon: WO537 (International Publication No. WO 2006/097537) and Lovshin (a 2009 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner alleged that WO537 taught the use of semaglutide to treat type 2 diabetes and provided instruction on formulating it into an injectable solution for subcutaneous administration, thus disclosing the basic invention. Lovshin, a review article, was said to supply the missing dosage information by identifying semaglutide (as NN9535) as a long-acting GLP-1 agonist being investigated in Phase I-II clinical studies at "0.1-1.6 mg once weekly" doses. Petitioner argued that combining these references rendered claims 1-3 obvious. The formulation details in WO537, such as using phosphate buffers, isotonicity agents, and stabilizers like propylene glycol and phenol, were argued to make the limitations of dependent claims 4-10 obvious modifications.
  • Motivation to Combine: A person of ordinary skill in the art (POSA), knowing from WO537 that semaglutide was a treatment for diabetes, would have been motivated to consult the state of the art, such as the Lovshin review, to determine an appropriate clinical dosage. Lovshin provided a clear and narrow target range for routine dose optimization.
  • Expectation of Success: A POSA would have had a high expectation of success. The art provided a finite and narrow range of doses already under clinical investigation, and a POSA would expect similar compounds like liraglutide to have a smooth dose-response curve, making doses at the higher end of the tested range likely to be effective.

Ground 3: Obviousness of Claims 1-10 over NCT657, NCT773, and the ’424 publication

• Prior Art Relied Upon: NCT657 (a Phase II clinical trial), NCT773 (a Phase I clinical trial), and the ’424 publication (Application # US2007/0010424).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner contended that clinical trials NCT657 and NCT773 provided clear guidance for selecting the claimed 1.0 mg dose. NCT657 (a Phase II trial) studied once-weekly semaglutide doses spanning 0.1-1.6 mg. The subsequent NCT773 (Phase I) trial narrowed this range, studying doses up to a maximum of 1.2 mg. The claimed 1.0 mg dose fell directly between the two highest dose arms tested in the later NCT773 trial (0.8 mg and 1.2 mg). The ’424 publication was alleged to render the formulation limitations of claims 4-10 obvious, as it disclosed suitable formulations for GLP-1 peptides, including the use of phosphate buffers, pH ranges including 7.4, and excipients like propylene glycol and phenol.
  • Motivation to Combine: A POSA would be motivated to optimize a dosing regimen based on the most current public knowledge, which was the clinical trial data from NCT657 and NCT773. The narrowing of the dose range in the later trial would have directed a POSA to focus on doses between 0.8 mg and 1.2 mg. A POSA would then turn to a reference like the ’424 publication for standard formulation techniques.
  • Expectation of Success: The progression of clinical trials from a broader range (up to 1.6 mg) to a narrower, lower range (up to 1.2 mg) would signal to a POSA that an optimal dose balancing efficacy and side effects was being refined within that new, narrower range. This would provide a strong expectation that a 1.0 mg dose would be a successful treatment for type 2 diabetes.

• Additional Grounds: Petitioner asserted additional challenges, including that claims 1-3 are anticipated by Lovshin and that claims 1-10 are obvious over WO421 in view of the ’424 publication, relying on similar anticipation and routine optimization arguments.

4. Key Claim Construction Positions

• Petitioner argued that no claim terms required explicit construction but asserted that the preamble phrase "[a] method for treating type 2 diabetes" should be given its broad, plain and ordinary meaning.
• This construction would broadly encompass any administration of semaglutide that alleviates, reduces, or manages symptoms of type 2 diabetes, without requiring any specific degree of efficacy (e.g., a specific level of HbA1c reduction). This interpretation is critical to Petitioner’s anticipation arguments, as the prior art discloses the dose but may not contain definitive proof of efficacy for that specific dose.

5. Arguments Regarding Discretionary Denial

• §325(d) Denial: Petitioner argued denial under 35 U.S.C. §325(d) is inappropriate because the petition presents new art and arguments. Key references like WO421, Lovshin, WO537, NCT773, and the ’424 publication were never substantively considered, let alone applied, by the Examiner during prosecution. Petitioner further argued that the Examiner materially erred by misapprehending the one primary reference that was considered (NCT657), failing to recognize its disclosure of a 1.6 mg dose, which is higher than the dose ultimately claimed.
• Fintiv Denial: Petitioner contended that discretionary denial under 35 U.S.C. §314(a) based on Fintiv factors is unwarranted. It was argued that the challenge is compelling and that a Final Written Decision from the PTAB would likely issue before a decision in the parallel district court litigation, where a trial is not set until late September 2024.

6. Relief Requested

• Petitioner requests the institution of an inter partes review and the cancellation of claims 1-10 of the ’462 patent as unpatentable.