DCT
1:09-cv-01282
Eli Lilly Co v. Sandoz Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Eli Lilly and Company (Indiana)
- Defendant: Sandoz, Inc. (Colorado)
- Plaintiff’s Counsel: Barnes & Thornburg LLP
- Case Identification: 1:09-cv-01282, S.D. Ind., 10/14/2009
- Venue Allegations: Venue is asserted based on Defendant’s distribution of generic pharmaceutical products in the district and its alleged continuous and systematic contacts with the State of Indiana.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the cancer drug GEMZAR® constitutes an act of infringement of a patent covering a method of using the drug to treat tumors.
- Technical Context: The case involves method-of-use claims for gemcitabine, a nucleoside analog used in chemotherapy, in the context of the Hatch-Waxman Act, which governs the approval process for generic drugs.
- Key Procedural History: The complaint discloses that the patent-in-suit, U.S. Patent No. 5,464,826, was recently found invalid for obviousness-type double patenting in a separate case in the Eastern District of Michigan, though the order was not yet final and an appeal was planned. A trial on similar invalidity grounds in another case in the Southern District of Indiana had concluded, with a ruling pending. This history suggests that patent validity, specifically with respect to double patenting, will be a central issue.
Case Timeline
| Date | Event |
|---|---|
| 1984-12-04 | ’826 Patent Priority Date |
| 1995-11-07 | ’826 Patent Issue Date |
| 2009-08-17 | E.D. Mich. court grants summary judgment of invalidity against ’826 patent in Sun v. Lilly case |
| 2009-09-08 | Trial begins in S.D. Ind. case (Lilly v. SICOR) involving the ’826 patent |
| 2009-09-22 | Trial concludes in Lilly v. SICOR case |
| 2009-09-23 | Sandoz sends Paragraph IV Notice Letter to Lilly |
| 2009-09-28 | Lilly receives Sandoz's Notice Letter |
| 2009-10-14 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,464,826 - "Method of Treating Tumors in Mammals with 2',2'-Difluoronucleosides"
- Patent Identification: U.S. Patent No. 5464826 ("Method of Treating Tumors in Mammals with 2',2'-Difluoronucleosides"), issued November 7, 1995.
The Invention Explained
- Problem Addressed: The patent’s background section notes that despite advances in cancer therapy, "research continues to develop more effective compounds with greater safety for subjects under treatment," framing the invention as "an additional method of treating tumors" (ʼ826 Patent, col. 2:27-31).
- The Patented Solution: The patent claims a method of treating cancer ("susceptible neoplasms") by administering a "pharmaceutically effective amount" of a specific class of chemical compounds known as 2',2'-difluoronucleosides, which have a defined chemical structure (ʼ826 Patent, Abstract; col. 2:35-49). The invention is not for the compound itself, but for the method of its use in cancer treatment. Example 1 describes the synthesis of 1-(4-amino-2-oxo-1H-pyrimidin-1-yl)-2-desoxy-2,2-difluororibose, the compound known as gemcitabine (ʼ826 Patent, col. 10:35-68).
- Technical Importance: This method provided a new therapeutic approach for various cancers, and the patent includes data demonstrating the claimed compounds' cytotoxic activity against human leukemic cells and efficacy in treating various tumor models in mice (ʼ826 Patent, Tables 1-3, col. 19:1-23:55).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims, and its reference to the Defendant's notice letter indicates that claims 1-7 are at issue (Compl. ¶¶ 10, 12).
- Independent Claim 1, the broadest asserted claim, covers:
- A method of treating susceptible neoplasms in mammals
- comprising administering to a mammal in need of such treatment
- a pharmaceutically effective amount
- of a compound of a specified chemical formula (Formula I) or its pharmaceutically-acceptable salts.
- The complaint does not explicitly reserve the right to assert other claims, but the allegation of infringement of "one or more claims" preserves this option (Compl. ¶11).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant Sandoz’s "Gemcitabine for Injection, 200 mg base/vial and 1 g base/vial," for which Sandoz filed Abbreviated New Drug Application (ANDA) No. 90-993 with the U.S. Food and Drug Administration (FDA) (Compl. ¶9).
Functionality and Market Context
- The product is a generic version of Plaintiff Lilly’s branded pharmaceutical product, GEMZAR®, which is approved for treating non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer (Compl. ¶¶ 8, 9). The complaint alleges that Sandoz seeks FDA approval to market its generic product for at least one of these indications before the expiration of the ’826 patent (Compl. ¶¶ 9, 17).
- The statutory act of infringement under the Hatch-Waxman Act is the filing of the ANDA itself, which seeks approval for a use claimed in the patent (Compl. ¶11). The commercial importance lies in Sandoz's plan to market and sell its generic product upon receiving FDA approval (Compl. ¶18).
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed, element-by-element infringement analysis. The infringement theory is based on 35 U.S.C. § 271(e)(2), where the filing of an ANDA for a drug claimed in a patent, or for a use claimed in a patent, is a statutory act of infringement. The underlying premise is that the future use of Sandoz's product, as directed by its proposed label, will infringe the ’826 patent.
’826 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating susceptible neoplasms in mammals | Sandoz has filed an ANDA seeking authorization to market its Gemcitabine for Injection drug product, and its proposed label will instruct for its use in treating one or more cancers for which Lilly's GEMZAR® is approved (Compl. ¶¶ 8, 9, 16, 17). | ¶¶8, 9, 16, 17 | col. 16:11-19 |
| comprising administering to a mammal in need of such treatment a pharmaceutically effective amount | Sandoz’s ANDA seeks approval for specific dosages (200 mg and 1 g vials) of its gemcitabine product, and the proposed label will instruct doctors to administer these dosages to patients (Compl. ¶¶ 9, 12). | ¶¶9, 12 | col. 15:56-64 |
| of a compound of the formula... and the pharmaceutically-acceptable salts thereof. | Sandoz's ANDA product is identified as "Gemcitabine for Injection," a compound which falls within the chemical structure defined in Claim 1 and is specifically described in the patent (Compl. ¶9). | ¶9 | col. 10:35-39 |
No probative visual evidence provided in complaint.
Identified Points of Contention
- Validity: The primary point of contention identified in the complaint is not infringement, but validity. Sandoz's notice letter alleges that claims 1, 2, 6, and 7 are invalid under the judicial doctrine of obviousness-type double patenting (Compl. ¶10). The prior adverse ruling against the patent on these same grounds in another district court makes this a central issue (Compl. ¶6).
- Scope Questions: Sandoz's notice letter alleges non-infringement of claims 3, 4, and 5 (Compl. ¶10). These dependent claims recite specific chemical modifications to the base compound. The dispute will likely turn on a direct comparison of the chemical structure of Sandoz's generic gemcitabine with the specific structures recited in those claims. For instance, claim 5 recites a compound with a methyl group, which is not present in gemcitabine.
V. Key Claim Terms for Construction
- The Term: "susceptible neoplasm"
- Context and Importance: This term defines the scope of the patented method. Practitioners may focus on this term because its breadth determines which types of cancer treatments are covered by the patent. The patent itself uses the term broadly and provides examples including leukemias, sarcomas, carcinomas, and myelomas (ʼ826 Patent, col. 24:60-62). Infringement requires that the indication for which Sandoz seeks approval falls within the definition of a "susceptible neoplasm."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states the compounds are useful against a "variety of tumors" and have a "broad spectrum of activity" (ʼ826 Patent, col. 16:15-19). The patent also provides a list of neoplasms that are considered susceptible, which could be interpreted as exemplary rather than exhaustive (ʼ826 Patent, col. 24:60-62).
- Evidence for a Narrower Interpretation: A defendant could argue that the term should be limited to the specific types of tumors for which efficacy data is presented in the patent's examples (e.g., L1210V lymphocytic leukemia) (ʼ826 Patent, Table 2, col. 20).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Sandoz's conduct will constitute inducement of infringement under 35 U.S.C. § 271(b) and contributory infringement under § 271(c) (Compl. ¶19). The factual basis for this allegation is that Sandoz, upon approval, will market and sell its gemcitabine product with a label that instructs physicians and patients to use it in a manner that directly infringes the method claims of the ʼ826 patent (Compl. ¶¶12, 16).
- Willful Infringement: The complaint alleges that Sandoz "did not exercise due care in analyzing the '826 patent" before filing its ANDA and Paragraph IV certification (Compl. ¶13). It further seeks a declaration that the case is "exceptional" and an award of attorney's fees (Compl. p. 5, ¶(e)). The basis for willfulness appears to be Sandoz's pre-suit knowledge of the patent, as evidenced by its filing of a certification specifically challenging the patent.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of patent validity: Can the ’826 patent survive a defense of invalidity based on obviousness-type double patenting, particularly in light of the adverse summary judgment ruling in the Eastern District of Michigan referenced in the complaint? The outcome of the related litigation may be highly influential.
- A secondary issue will be one of infringement scope: For the dependent claims Sandoz alleges it does not infringe (claims 3-5), the key question will be a straightforward factual determination of whether the chemical structure of Sandoz's generic product meets the specific limitations of those narrower claims.
- Finally, a key legal question for damages and remedies will be one of willfulness: Did Sandoz's pre-suit analysis of the ’826 patent, undertaken as part of its ANDA filing, constitute a lack of due care sufficient to support a finding of willful infringement and an exceptional case, should the patent be found valid and infringed?