DCT
1:22-cv-02342
Apotex Inc v. Eli Lilly & Co
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Apotex Inc. and Apotex Corp. (Canada, Delaware)
- Defendant: Eli Lilly & Company (Indiana)
- Plaintiff’s Counsel: Cozen O'Connor
- Case Identification: 1:22-cv-02342, S.D. Ind., 12/06/2022
- Venue Allegations: Venue is alleged to be proper in the Southern District of Indiana because Defendant Eli Lilly & Company resides there, has its headquarters and principal place of business there, and has committed acts giving rise to the declaratory judgment claim in the district.
- Core Dispute: Plaintiff Apotex, a generic drug manufacturer, seeks a declaratory judgment that its proposed teriparatide injection pen product does not infringe Defendant Eli Lilly's patent for a medication dispensing apparatus.
- Technical Context: The technology concerns disposable, multi-dose medication injector pens, specifically focusing on mechanical features for dose delivery and a non-resettable safety lock that activates after the final dose is administered.
- Key Procedural History: This declaratory judgment action arises under the Hatch-Waxman Act. Apotex, as a "subsequent filer" of an Abbreviated New Drug Application (ANDA), is blocked from receiving final FDA approval by the 180-day marketing exclusivity period held by an unidentified "first-filer." Apotex seeks a court judgment of non-infringement, which would trigger a forfeiture of the first-filer's exclusivity and clear the path for Apotex's market entry. The complaint notes that Lilly previously sued Apotex over the same patent and ANDA on April 4, 2018, but that action was jointly dismissed without prejudice on December 3, 2018.
Case Timeline
| Date | Event |
|---|---|
| 2004-03-30 | '334 Patent Priority Date |
| 2009-04-14 | '334 Patent Issue Date |
| 2015-07-27 | First substantially complete ANDA with Paragraph IV cert. received by FDA |
| 2018-02-22 | Apotex sends Paragraph IV notice letter to Lilly |
| 2018-04-04 | Lilly files prior infringement complaint against Apotex |
| 2018-12-03 | Prior Lilly v. Apotex lawsuit dismissed without prejudice |
| 2022-12-06 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,517,334 - "Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose"
- Patent Identification: U.S. Patent No. 7,517,334, "Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose," issued on April 14, 2009.
The Invention Explained
- Problem Addressed: The patent background describes shortcomings in prior art injector pens, including designs that may not offer manufacturers sufficient options for setting the mechanical advantage (e.g., to deliver a small volume dose with suitable plunger travel) and a desire for a reliable mechanism to prevent use after the final dose is administered (’334 Patent, col. 1:41-54).
- The Patented Solution: The invention is a disposable injector pen with a specific internal mechanism to deliver fixed doses and, critically, to automatically and permanently lock the device after the final dose. This is achieved through a "latching element" with a "skid" that slides along a surface of a "drive member" during normal use, keeping a spring-loaded "latching lip" disengaged. Upon administration of the final dose, the drive member advances to a point where the skid moves off this surface, allowing the spring to push the latching lip into a position where it physically engages and locks the plunger mechanism, preventing further dose preparation or injection (’334 Patent, Abstract; col. 7:34-8:15).
- Technical Importance: The invention provides an automatic, non-resettable safety lockout for a multi-dose disposable pen, which can enhance patient safety by preventing attempts to use an empty device.
Key Claims at a Glance
- The complaint asserts non-infringement of independent claim 1.
- Essential elements of independent claim 1 include:
- a housing;
- a drive member movable in a distal direction;
- a fluid container with a movable piston;
- a plunger element;
- a "gear set including first and second pinions," which is pivotal on the plunger element and engages a "first rack" (axially stationary) and a "second rack" (movable);
- a "latching element including a latching lip and a skid";
- a specific interaction where the skid slides along a "skid-engaging surface" on the drive member to keep the latching lip disengaged until the final dose, at which point the skid passes beyond the surface, allowing the latching lip to engage a latchable element and lock the plunger.
- The complaint notes that claims 2-10 are dependent on claim 1 and are therefore also not infringed (Compl. ¶¶ 51, 67).
III. The Accused Instrumentality
Product Identification
- Product Identification: Apotex's generic version of Lilly's Forteo® (teriparatide injection), a 600 mcg/2.4 mL prefilled teriparatide pen, as described in Apotex's ANDA No. 211097 (Compl. ¶47).
Functionality and Market Context
- The complaint describes the accused product as a "simple, multiple-dose, fixed-dose, pre-filled disposable pen designed for manual insertion of the needle and manual injection and delivery of liquid drug" (Compl. ¶48).
- The core of Apotex’s complaint is that its product achieves its function without using the specific mechanisms claimed in the ’334 patent (Compl. ¶¶ 57, 64). Apotex is prepared for commercial marketing immediately upon final FDA approval, which it alleges is currently blocked by a first-filer's 180-day exclusivity period (Compl. ¶37).
IV. Analysis of Infringement Allegations
'334 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a gear set including first and second pinions, said gear set pivotal on said plunger element and shiftable proximally and distally with the plunger element; a first rack engaged with said first pinion and axially stationary within said housing; a second rack engaged with said second pinion and movable within said housing on a piece clutchably connected to said drive member; | The complaint alleges that the Apotex ANDA Product does not include these required elements of the dosing mechanism. Figure 2 of the complaint shows a cross-section of the patented embodiment containing a "gear set" (52). | ¶57, ¶58, ¶59 | col. 9:56-10:5 |
| a latching element including a latching lip and a skid; said drive member including an axially extending, skid-engaging surface along which said skid is slidable... [maintaining] said latching lip against a spring force in a first position... prior to a final dose administration; and wherein said skid-engaging surface shifts distally of said skid such that said skid passes beyond the proximal end upon administration of a final dose allowing said latching lip to be urged by said spring force... to physically lock said plunger element to prevent further dose preparing and injecting. | The complaint alleges that the Apotex ANDA Product does not include a "latching element including a latching lip and a skid" as required by the claim. Figure 9 of the complaint shows the patented embodiment's "latch lip" (186). | ¶64, ¶65, ¶66 | col. 10:5-13 |
- Identified Points of Contention:
- Technical Questions: The central dispute is factual and technical: does the Apotex product's drive mechanism and/or its end-of-life lockout mechanism contain the structures recited in claim 1, or their equivalents? The complaint, filed by Apotex, asserts a complete absence of these features (Compl. ¶¶ 57, 64). The case will depend on a comparison between the specific design of the Apotex pen (which is not detailed in the complaint) and the claimed invention.
- Scope Questions: The litigation may raise the question of how broadly the claim terms "gear set" and "latching element including a latching lip and a skid" can be interpreted. While the complaint argues for non-infringement based on a complete absence of these features, a court will need to construe these terms to determine the precise boundaries of the claimed invention.
V. Key Claim Terms for Construction
The Term: "a gear set including first and second pinions... a first rack... a second rack"
Context and Importance: This term is critical because Apotex's primary non-infringement theory is that its product lacks this specific dosing mechanism entirely (Compl. ¶57). The construction of "gear set" will define the structural requirements of the patented dosing system. Practitioners may focus on this term because its high level of structural detail in the claim itself could limit its scope.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that "gear set" is a general term for a mechanical arrangement that converts motion, although the claim's specificity makes this a difficult position.
- Evidence for a Narrower Interpretation: The claim language itself is highly detailed, reciting two distinct pinions and two distinct racks with specific relationships to the housing and plunger element (’334 Patent, col. 9:56-10:5). The specification further describes this specific arrangement with reference to multiple figures, such as showing "first 'pinion' (160) and a second 'pinion' (166)" (Compl. ¶54, citing Fig. 6). This detailed disclosure may support a construction limited to the specific rack-and-pinion architecture described.
The Term: "a latching element including a latching lip and a skid"
Context and Importance: This term defines the patented safety lockout mechanism and is Apotex's second main basis for non-infringement (Compl. ¶64). The interpretation of the interaction between the "skid" and the "skid-engaging surface" will be pivotal.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that this term functionally covers any two-component lockout where one piece (the "skid") holds a second piece (the "lip") in a safe position until being moved out of the way at the end of travel.
- Evidence for a Narrower Interpretation: The claim requires a specific action: the "skid passes beyond the proximal end" of the "skid-engaging surface" to trigger the lock (’334 Patent, col. 10:9-11). This language, combined with the specification's description of the skid "slid[ing] off the proximal end... of smooth surface 71" (’334 Patent, col. 8:1-3), may support a narrower construction requiring this specific "sliding off the end" trigger mechanism, as opposed to other ways a lock could be activated. The complaint references Figure 9 from the patent, which depicts a "latch lip" (186) and an "upstanding lip" (117) (Compl. ¶61).
VI. Other Allegations
- Indirect Infringement: The prayer for relief seeks a judicial declaration that Apotex's product will not "infringe or induce or contribute to the infringement of the '334 patent" (Compl. p. 22, ¶b). However, the factual allegations in the complaint focus exclusively on the design of the device itself and argue for a lack of direct infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action appears designed to resolve Apotex's ability to enter the market by challenging the reach of Lilly's patent. The outcome will likely depend on the answers to two central questions:
- A key question will be one of technical and structural comparison: Does the undisclosed design of Apotex’s injector pen utilize a drive mechanism that falls within the scope of the claimed "gear set including first and second pinions," or does it employ a fundamentally different mechanical system for dose administration?
- A second core issue will be one of claim scope and equivalence: Can the patent’s "latching element," which is described as a "skid" that "passes beyond" a surface to trigger a lock, be construed to cover the specific end-of-life safety feature, if any, used in the Apotex pen, either literally or under the doctrine of equivalents?