DR Reddy's Laboratories Inc v. Novo Nordisk As

Prosecution History analysis

Examiner Search analysis

Invalidity Framework analysis

Petition

Petition Analysis

## 1. Case Identification
- Case #: [IPR2024-00009](https://ai-lab.exparte.com/case/ptab/IPR2024-00009)
- Patent #: [10,335,462](https://ai-lab.exparte.com/patent/10335462)
- Filed: October 20, 2023
- Petitioner(s): [Dr. Reddy's Laboratories, Inc.](https://ai-lab.exparte.com/party/dr-reddys-laboratories-ltd) and [Dr. Reddy's Laboratories, Ltd.](https://ai-lab.exparte.com/party/dr-reddys-laboratories-ltd)
- Patent Owner(s): [Novo Nordisk A/S](https://ai-lab.exparte.com/party/novo--nordisk-inc)
- Challenged Claims: 1-10

## 2. Patent Overview
- Title: Use Of Long-Acting Glp-1 Peptides
- Brief Description: The ’462 patent is directed to a method for treating type 2 diabetes. The claimed method comprises administering the long-acting Glucagon-like peptide 1 (GLP-1) agonist semaglutide in a specific amount of 1.0 mg, once weekly.

## 3. Grounds for Unpatentability

#### Ground 1: Anticipation over WO421 - Claims 1-3 are anticipated by WO421.
- **Prior Art Relied Upon:** [WO421](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1011) ([WO 2011/138421](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1011)).
- **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued that WO421, a published patent application, explicitly disclosed every element of claims 1-3. WO421 taught a method for treating type 2 diabetes using semaglutide and specified that semaglutide "is administered once weekly by subcutaneous injection (0.1 to 1.6 mg)." Petitioner contended that this disclosure of a narrow, finite dose range (encompassing at most 16 discrete 0.1 mg increments) anticipated the specific 1.0 mg dose of claim 1, as nothing in the prior art or the [’462](https://ai-lab.exparte.com/patent/10335462) patent suggested the 1.0 mg point was critical or functioned differently from other doses in the range. The explicit teaching of subcutaneous injection was argued to anticipate dependent claims 2 (parenteral administration) and 3 (subcutaneous injection).

#### Ground 2: Obviousness over WO421 and the ’424 publication - Claims 1-10 are obvious over WO421 in view of the ’424 publication.
- **Prior Art Relied Upon:** WO421 ([WO 2011/138421](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1011)) and the [’424 publication](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1016) (Application # [US2007/0010424](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1016)).
- **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner asserted that WO421 disclosed a method of treating type 2 diabetes with once-weekly semaglutide in a dose range of 0.1-1.6 mg, which encompassed the claimed 1.0 mg dose. For the formulation limitations in dependent claims 4-10, Petitioner pointed to the ’424 publication, which disclosed formulating peptides like GLP-1 agonists with standard components such as a phosphate buffer, a pH range of 7.0-9.0, propylene glycol, and phenol, all of which were recited in the dependent claims.
    - **Motivation to Combine:** A Person of Ordinary Skill in the Art (POSA), starting with the treatment method in WO421, would be motivated to select a specific dose from the narrow 0.1-1.6 mg range as a matter of routine optimization. To create a suitable drug product, the POSA would then naturally look to well-known formulation art, such as the ’424 publication, which provided established methods for creating stable and safe injectable peptide formulations.
    - **Expectation of Success:** A POSA would have a reasonable expectation of success because selecting a dose from a small, disclosed range for a known drug class is a predictable endeavor. Combining this with the standard, proven formulation techniques for peptides described in the ’424 publication would present no significant technical hurdles.

#### Ground 3: Obviousness over Clinical Trials and the ’424 publication - Claims 1-10 are obvious over NCT657 and NCT773 in view of the ’424 publication.
- **Prior Art Relied Upon:** [NCT657](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1013) (Clinical Trial No. [NCT00696657](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1013)), [NCT773](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1014) (Clinical Trial No. [NCT00851773](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1014)), and the ’424 publication (Application # [US2007/0010424](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1016)).
- **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued that publicly available clinical trial data rendered the claims obvious. The NCT657 (Phase II) trial disclosed once-weekly semaglutide doses up to 1.6 mg. The subsequent NCT773 (Phase I) trial studied a narrower dose range up to 1.2 mg. The claimed 1.0 mg dose fell directly between the highest dose arms tested in the later NCT773 trial (0.8 mg and 1.2 mg). The ’424 publication again provided the necessary formulation elements for dependent claims 4-10.
    - **Motivation to Combine:** A POSA would be motivated by the public clinical trial data to pursue a once-weekly 1.0 mg dose. The narrowing of the dose range from the NCT657 trial to the NCT773 trial would signal to a POSA that the optimal dose was being refined and likely lay within the 0.8 mg to 1.2 mg range. Selecting 1.0 mg would be a logical step in this predictable, data-driven optimization process.
    - **Expectation of Success:** The expectation of success was high because the use of these doses in human clinical trials implied that extensive preclinical data had already established their safety and likely efficacy. A POSA would understand that dose-ranging studies are designed to find an optimal dose and that doses at the higher end of the tested range, such as 1.0 mg, would be expected to be effective.

- **Additional Grounds:** Petitioner asserted additional anticipation challenges (e.g., over [Lovshin](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1012)) and obviousness challenges (e.g., over [WO537](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1015) and Lovshin) based on similar arguments that the prior art disclosed a narrow, finite dosing range for semaglutide that encompassed the claimed 1.0 mg dose.

## 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 understood broadly. Based on the specification, this phrase does not require a particular degree of efficacy or treatment effect. This construction is important for the invalidity arguments, as it allows prior art to be anticipatory or rendering a claim obvious even if it does not contain definitive clinical results, so long as it discloses the method of treatment.

## 5. Key Technical Contentions (Beyond Claim Construction)
- A central technical contention was that a POSA would view dose selection within a narrow, disclosed range (e.g., 0.1-1.6 mg) as routine optimization, not an inventive step, particularly for a known class of drugs (GLP-1 agonists).
- Petitioner further contended that a POSA’s understanding of the clinical trial process is key. The public disclosure of dose-ranging studies (like NCT657 and NCT773) and the subsequent narrowing of dose ranges would provide a strong signal and reasonable expectation of success for selecting a dose (like 1.0 mg) located within the refined, higher end of the tested doses.

## 6. Arguments Regarding Discretionary Denial
- **§325(d) (Same Art/Arguments):** Petitioner argued against discretionary denial under §325(d) because the key prior art references (WO421, [Lovshin](https://ai-lab.exparte.com/case/ptab/IPR2024-00009/doc/1012), NCT773, ’424 publication) and the core arguments based on them were never considered by the Examiner during prosecution. Petitioner further argued the Examiner materially erred by misapprehending the one primary reference that was considered (NCT657), failing to recognize that it disclosed a 1.6 mg dose, which is higher than the claimed 1.0 mg dose.
- **§314(a) (Fintiv Factors):** Petitioner argued against discretionary denial under *Fintiv*, noting that the parallel district court trial is not scheduled until late 2024, meaning a Final Written Decision in the IPR would likely issue first. Petitioner also stipulated that it will not pursue in district court any grounds on which the Board institutes review, weighing in favor of institution.

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

Dr. Reddy's targets Novo Nordisk's semaglutide patent: prior art & trials cited for anticipation & obviousness of 10 claims over the 1.0mg weekly dose.