DCT
1:23-cv-01277
Eli Lilly Co v. MSN Laboratories Pvt Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Eli Lilly & Co. (Indiana), Incyte Corp. (Delaware), and Incyte Holdings Corp. (Delaware)
- Defendant: MSN Laboratories Private Limited (India) and MSN Pharmaceuticals Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:23-cv-01277, D. Del., 11/08/2023
- Venue Allegations: Venue is alleged to be proper as to MSN Laboratories Private Limited because it is a foreign corporation that may be sued in any judicial district, and as to MSN Pharmaceuticals Inc. because it is a Delaware corporation that resides in the district.
- Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) for a generic version of the drug Olumiant® constitutes an act of infringement of a patent covering the drug's active pharmaceutical ingredient.
- Technical Context: The technology relates to Janus kinase (JAK) inhibitors, a class of small molecule drugs used to treat inflammatory and autoimmune diseases by modulating the JAK-STAT signaling pathway.
- Key Procedural History: The patent-in-suit is listed in the FDA's "Orange Book" for Plaintiffs' branded drug, Olumiant® (baricitinib). This action follows Defendants' amendment of a previously filed ANDA, which originally sought approval for 1 mg and 2 mg generic tablets, to now include a 4 mg strength. The initial ANDA submission prompted a prior lawsuit between the parties in August 2022.
Case Timeline
| Date | Event |
|---|---|
| 2008-03-11 | ’616 Patent Priority Date |
| 2012-04-17 | ’616 Patent Issue Date |
| 2018-05-31 | FDA grants approval for Olumiant® (1 mg and 2 mg) for rheumatoid arthritis |
| 2022-05-10 | FDA grants supplemental approval for Olumiant® (4 mg) for COVID-19 |
| 2022-06-13 | FDA grants supplemental approval for Olumiant® (4 mg) for alopecia areata |
| 2022-07-25 | MSN notifies Plaintiffs of its initial ANDA submission for 1 mg and 2 mg strengths |
| 2022-08-24 | Plaintiffs file prior infringement suit against MSN based on initial ANDA |
| 2023-09-29 | MSN notifies Plaintiffs of amended ANDA to include 4 mg strength |
| 2023-10-03 | MSN sends subsequent notice letter regarding amended ANDA |
| 2023-11-08 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,158,616 - "Azetidine and Cyclobutane Derivatives as JAK Inhibitors"
- Patent Identification: U.S. Patent No. 8,158,616, "Azetidine and Cyclobutane Derivatives as JAK Inhibitors", issued April 17, 2012.
The Invention Explained
- Problem Addressed: The patent addresses the need for new therapeutic agents that can inhibit the activity of the Janus Kinase (JAK) family of enzymes. The patent background explains that dysregulated JAK signaling plays a key role in immune-related conditions, including inflammatory diseases, autoimmune diseases, and certain cancers, creating a need for effective inhibitors. (’616 Patent, col. 1:36-67).
- The Patented Solution: The invention provides a class of chemical compounds—specifically azetidine and cyclobutane derivatives—that function as JAK inhibitors. The detailed description and summary of the invention disclose specific molecular structures, represented by Formulas I-IV, designed to block signal transduction at the JAK kinase level. (’616 Patent, Abstract; col. 2:5-47).
- Technical Importance: This technical approach provides a means to treat JAK-associated diseases by directly modulating the cytokine-dependent signaling pathways involved in the immune response. (’616 Patent, col. 27:36-42).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 (Compl. ¶44).
- The essential elements of Claim 1 are:
- A compound identified by the chemical name {1-(Ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]azetidin-3-yl}acetonitrile
- or a pharmaceutically acceptable salt thereof.
- The complaint alleges infringement of "one or more claims" of the ’616 Patent, thereby reserving the right to assert other claims (Compl. ¶46).
III. The Accused Instrumentality
Product Identification
- Defendants’ "Proposed ANDA Product," which is a generic version of Olumiant® (baricitinib) tablets in a 4 mg dosage strength (Compl. ¶1).
Functionality and Market Context
- The active pharmaceutical ingredient (API) in the accused product is baricitinib, which the complaint identifies as a Janus kinase (JAK) inhibitor (Compl. ¶¶25, 38).
- The complaint alleges that Defendants' ANDA relies on the FDA's prior approval of Olumiant® and contains data intended to demonstrate the bioequivalence of the accused product to Olumiant® (Compl. ¶39). The accused product is intended to compete with Olumiant®, which is approved for treating conditions including rheumatoid arthritis, COVID-19 in certain hospitalized adults, and severe alopecia areata (Compl. ¶¶1, 24).
Visual Evidence
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’616 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| {1-(Ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]azetidin-3-yl}acetonitrile, or a pharmaceutically acceptable salt thereof. | The complaint alleges that the active ingredient in the Proposed ANDA Product is baricitinib, and that baricitinib is a compound with the chemical name {1-(Ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]azetidin-3-yl}acetonitrile. | ¶25, ¶45 | col. 27:9-16 |
- Identified Points of Contention:
- Factual Question: The central question for literal infringement appears to be factual: is the API in Defendants' Proposed ANDA Product the specific chemical compound recited in Claim 1? The complaint alleges a direct structural identity between baricitinib and the claimed compound (Compl. ¶¶25, 45).
- Scope Questions: The complaint does not detail Defendants’ basis for their Paragraph IV certification of non-infringement. A potential dispute could relate to the scope of the term "pharmaceutically acceptable salt thereof." The analysis may raise the question of whether the specific salt form used in the accused generic product falls within the patent's definition of that term.
V. Key Claim Terms for Construction
- The Term: "pharmaceutically acceptable salt thereof"
- Context and Importance: As Claim 1 is a compound claim, construction of its terms may be less central than in other types of patents. However, the scope of "pharmaceutically acceptable salt" could become a key issue if Defendants' product utilizes a particular salt form that they argue falls outside the claim's scope. Practitioners may focus on this term because the specific formulation of an API can be a basis for a non-infringement defense in ANDA litigation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification provides a broad definition, stating that "‘pharmaceutically acceptable salts’ refers to derivatives of the disclosed compounds wherein the parent compound is modified by converting an existing acid or base moiety to its salt form," and includes examples such as "mineral or organic acid salts of basic residues such as amines." (’616 Patent, col. 8:21-28).
- Evidence for a Narrower Interpretation: A party seeking a narrower construction may point to the specific salts synthesized or disclosed in the patent, such as the trifluoroacetic acid salt prepared in Example 1 or the phosphoric acid salt mentioned in the specification, to argue that the scope should be limited to forms contemplated by the patentee. (’616 Patent, col. 27:17-21; col. 52:5-14).
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b) (Compl. ¶56). The factual basis for this allegation is that Defendants' proposed product label will instruct and encourage the administration of 4 mg baricitinib tablets for therapeutic use (Compl. ¶¶40, 54). The complaint alleges Defendants have the requisite intent and knowledge, citing the listing of the ’616 Patent in the FDA's Orange Book (Compl. ¶¶53, 55).
- Willful Infringement: The complaint does not contain a separate count for willful infringement. However, it alleges facts that may support such a claim, including that Defendants were aware of the ’616 Patent when they amended their ANDA and have "no reasonable basis to believe" their product would not infringe (Compl. ¶¶37, 49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of factual identity: does the baricitinib API in Defendants’ Proposed ANDA Product meet every structural limitation of the compound recited in Claim 1 of the ’616 Patent? Given the complaint's direct allegation of identity, the basis for Defendants’ certified non-infringement position will be a central point of discovery and argument.
- A primary focus of the litigation may be on validity: because the infringement theory appears straightforward on the face of the complaint, Defendants will likely rely heavily on their Paragraph IV assertion that the claims of the ’616 Patent are invalid, the grounds for which are not specified in the complaint.
- A secondary question may concern the definitional scope of the claim term "pharmaceutically acceptable salt thereof," and whether the specific salt form utilized in the accused generic product is encompassed by the claim as construed in light of the patent's specification.