DCT
1:23-cv-22112
Novo Nordisk INC. v. DR. Reddy's LABORATORIES, LTD.
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
- Defendant: Dr. Reddy's Laboratories, Ltd. (India) and Dr. Reddy's Laboratories, Inc. (New Jersey)
- Plaintiff’s Counsel: Saul Ewing LLP; Fenwick & West LLP
- Case Identification: 1:23-cv-22112, D.N.J., 11/08/2023
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the U.S. defendant (Dr. Reddy's Laboratories, Inc.) has a physical presence and conducts business in the state. The complaint further alleges that the foreign parent has previously availed itself of the jurisdiction by litigating other patent cases in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Victoza® (liraglutide) product constitutes an act of infringement of patents covering the drug's formulation and its associated injection device.
- Technical Context: The dispute involves pharmaceutical chemistry, specifically stable injectable peptide formulations, and mechanical engineering related to the design of drug delivery pens.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 214411 with a Paragraph IV certification, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed. The complaint was filed within the 45-day statutory window following receipt of Defendant's notice letter, triggering a potential 30-month stay on FDA approval of the ANDA. The complaint also notes other related litigations against different generic drug manufacturers concerning some of the same patents.
Case Timeline
| Date | Event |
|---|---|
| 2003-11-24 | U.S. Patent No. 8,114,833 Priority Date |
| 2007-02-05 | U.S. Patent No. 9,265,893 Priority Date |
| 2012-02-14 | U.S. Patent No. 8,114,833 Issued |
| 2016-02-23 | U.S. Patent No. 9,265,893 Issued |
| 2023-09-25 | Defendant's Paragraph IV Notice Letter Sent to Plaintiff |
| 2023-11-08 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,114,833 - “Propylene Glycol-Containing Peptide Formulations Which Are Optimal for Production and For Use in Injection Devices”
The Invention Explained
- Problem Addressed: The patent's background section describes problems with using mannitol, a common isotonicity agent in injectable peptide formulations. Mannitol is said to crystallize, which results in deposits on production equipment (reducing yield and increasing cleaning requirements) and can cause clogging of the fine-gauge needles used in injection devices. (’833 Patent, col. 1:30-46).
- The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent in a pharmaceutical formulation containing a peptide, such as a GLP-1 agonist. (’833 Patent, Abstract). The specification asserts that this substitution leads to a physically and chemically stable formulation that exhibits reduced deposits on manufacturing equipment and reduced clogging of injection devices, as demonstrated in comparative examples and figures. (’833 Patent, col. 2:38-51, Examples 2-3).
- Technical Importance: The claimed solution addresses key manufacturing and usability challenges for injectable biologic drugs, aiming to increase production efficiency and improve the reliability of the final drug-device combination for the patient. (’833 Patent, col. 1:36-50).
U.S. Patent No. 9,265,893 - “Injection Button”
The Invention Explained
- Problem Addressed: In many injection pens, the dose-setting mechanism requires the push button and an internal driving part to rotate relative to each other during the injection process. The patent states that the friction generated by this relative rotation contributes to the total force a user must apply to deliver a dose. (’893 Patent, col. 1:47-52).
- The Patented Solution: The invention is a specific mechanical connection between the push button and the driving part that incorporates a "pivot bearing." This bearing is formed between the bottom surface of a bore in the push button and the top surface of a protrusion on the driving part. (’893 Patent, Abstract; col. 2:27-31). This design is intended to minimize the surface area of contact and the radius of the resulting friction force, thereby lowering the force required from the user to actuate the device. (’893 Patent, col. 1:52-56).
- Technical Importance: The invention aims to improve the ergonomics and ease of use of injection pens, which is a critical factor for patient adherence, particularly for those with impaired dexterity or hand strength. (’893 Patent, col. 1:43-46).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is "Dr. Reddy's Product," a generic version of liraglutide injection, 18 mg/3 ml (6 mg/ml), identified in connection with ANDA No. 214411 submitted to the FDA (Compl. ¶¶ 7, 21).
Functionality and Market Context
The complaint alleges that Dr. Reddy's Product is a generic version of Novo Nordisk's Victoza®, a pharmaceutical product for the treatment of diabetes (Compl. ¶¶ 1, 21). The ANDA filing itself is the statutory act of infringement, based on the allegation that the product, if approved and marketed, would infringe the patents-in-suit (Compl. ¶25, 31). The complaint alleges the product is bioequivalent to Victoza® and that its use involves an injection device (Compl. ¶¶ 22, 32). The product aims to compete directly with the branded Victoza® product upon receiving FDA approval.
IV. Analysis of Infringement Allegations
The complaint alleges that the submission of the ANDA itself constitutes infringement of all claims of the '833 Patent and claims 1-6 of the '893 Patent, as the product described therein, if marketed, would infringe (Compl. ¶¶ 26, 32). The analysis below is based on the asserted independent claims and the implied characteristics of the accused product as a generic version of Victoza® and its delivery system.
- '833 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation comprising at least one GLP-1 agonist, | The complaint alleges Dr. Reddy's Product is a "liraglutide injection solution," where liraglutide is a GLP-1 agonist. | ¶21 | col. 33:50-51 |
| a disodium phosphate dihydrate buffer | The complaint alleges infringement of claims covering the Victoza® formulation, which, by implication from the ANDA filing, will contain the claimed buffer. | ¶¶ 1, 19, 26 | col. 33:51-52 |
| and propylene glycol, | The complaint alleges infringement of the patent covering the Victoza® formulation, which, by implication from the ANDA filing, will contain propylene glycol as the isotonicity agent instead of an agent like mannitol. | ¶¶ 1, 19, 26 | col. 33:52-53 |
| wherein said propylene glycol is present in said formulation in a final concentration of from about 1 mg/ml to about 100 mg/ml | The complaint alleges the accused product is a generic version of Victoza® and will have the claimed concentration of propylene glycol. | ¶¶ 21, 22, 26 | col. 33:53-55 |
| and wherein said formulation has a pH of from about 7.0 to about 10.0. | The complaint alleges the accused product is a generic version of Victoza® and will have a pH within the claimed range. | ¶¶ 21, 22, 26 | col. 33:55-57 |
A visual from the patent exhibit, Figure 7, contrasts a needle dosed with a mannitol formulation (top panel) showing significant white crystalline deposits, against a needle dosed with a propylene glycol formulation (bottom panel) showing no deposits, illustrating the technical problem the patent purports to solve ('833 Patent, Fig. 7).
- '893 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A push button connection for an injection device comprising: a push button mountable on a driving part being rotatable relatively to the push button | The complaint alleges infringement by the injection device intended for use with Dr. Reddy's Product, which is a generic of Victoza® and delivered via a pen-style injection device. | ¶¶ 1, 32 | col. 42:39-43 |
| and which push button further comprises a bore with a bottom surface and which bore surrounds a protrusion on the driving part | The complaint's allegation of infringement implies the injection device for Dr. Reddy's Product will contain this specific geometry. | ¶¶ 32 | col. 42:43-46 |
| which protrusion has a top surface and wherein a pivot bearing is formed between the bottom surface and the top surface, | The complaint's allegation of infringement implies the accused device's mechanism will form the claimed pivot bearing to reduce rotational friction. | ¶¶ 32 | col. 42:46-49 |
| wherein when a user presses on the push button the force is directed toward the driving part and wherein the driving part rotates relative to the push button. | This functionality is inherent to the operation of the type of injection pen device that the complaint alleges will be used with the accused product. | ¶¶ 32 | col. 42:49-51 |
A visual from the patent exhibit, Figure 1, provides a detailed cross-section of the claimed connection, showing the push button (10) with its bore (12) mounted on the protrusion (21) of the driving part (20), illustrating the location of the pivot bearing (18, 22) and radial bearings (13, 14) ('893 Patent, Fig. 1).
Identified Points of Contention
- Scope Questions: A central question for the '833 patent will be the validity of claims directed to substituting one known excipient (mannitol) for another (propylene glycol). For the '893 patent, a question of claim scope will be whether the specific interface in the accused device constitutes a "pivot bearing" as that term is understood in light of the patent's specification and prosecution history.
- Technical Questions: For the '833 patent, the key technical question, likely to be argued in the context of obviousness, is whether the benefits of using propylene glycol (reduced clogging and deposits) were unexpected or would have been predictable to a person of ordinary skill in the art of pharmaceutical formulation.
V. Key Claim Terms for Construction
'833 Patent
- The Term: "about" (as in "from about 1 mg/ml to about 100 mg/ml" and "about 7.0 to about 10.0")
- Context and Importance: The scope of the claimed concentration and pH ranges depends on the interpretation of "about." This term's construction will be critical for the infringement analysis, as it determines how close the accused product's formulation must be to the recited numerical endpoints to fall within the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent uses the term to suggest the ranges are not intended to be strictly exact. Practitioners often use "about" to encompass equivalents and normal manufacturing variances. (’833 Patent, col. 33:54, 56).
- Evidence for a Narrower Interpretation: The specification provides specific examples with precise concentrations (e.g., "13.7 mg/ml" and "14.0 mg/ml") and pH values (e.g., "pH: 8.15"). A defendant may argue that these specific embodiments limit the reasonable scope of "about." (’833 Patent, col. 16:8; col. 19:14, 60).
'893 Patent
- The Term: "pivot bearing"
- Context and Importance: This term is the central feature of the claimed mechanical improvement. The infringement and validity analyses will depend entirely on what specific structures meet this definition. Practitioners may focus on this term because it is not a standard component with a universal definition and must be defined by the patent itself.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the function of the pivot bearing as minimizing "the surface area of interaction" and keeping the "radius of the resulting friction force... at a minimum." This functional description could support a broader construction that covers any point-contact interface that achieves this result. (’893 Patent, col. 1:52-56).
- Evidence for a Narrower Interpretation: The detailed description of the embodiment discloses a very specific structure: "the most proximal bottom surface 17 of the bore 12 is formed with a raised pointer forming a pivot 18." This explicit definition of the pivot as a "raised pointer" could be used to argue for a narrower construction limited to that specific geometry. (’893 Patent, col. 42:15-18).
VI. Other Allegations
- Indirect Infringement: The complaint focuses on the statutory act of direct infringement created by the ANDA submission under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶ 25, 31). It does not contain separate counts for induced or contributory infringement.
- Willful Infringement: The complaint alleges that Defendant "was aware" of the patents-in-suit when it submitted its ANDA, as evidenced by its service of a Paragraph IV certification (Compl. ¶¶ 29, 35). This allegation of pre-suit knowledge forms the basis for seeking a finding that the case is "exceptional" and an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶¶ 29, 35).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue for the '833 patent will be one of obviousness: Can Novo Nordisk defend the patentability of replacing one known pharmaceutical excipient (mannitol) with another (propylene glycol)? The case may turn on whether Dr. Reddy's can demonstrate with clear and convincing evidence that the specific benefits of reduced needle clogging and production deposits were predictable and rendered the invention obvious to a skilled formulator at the time.
- A central question for the '893 patent will be one of claim construction and infringement: Does the mechanical interface in the injection device intended for use with Dr. Reddy's generic product create a "pivot bearing" as that term is defined by the patent? The outcome will likely depend on whether the court adopts a broader functional definition or a narrower structural one based on the patent's specific embodiments.
- The overarching question is whether Defendant's Paragraph IV challenge will succeed. Given the context of ANDA litigation, the case will primarily be a defensive battle for Dr. Reddy's, focusing on proving by clear and convincing evidence that the asserted claims are invalid, most likely for obviousness over the prior art.