DCT
1:19-cv-01246
Eli Lilly Co v. DR Reddys Laboratories
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Eli Lilly and Company (Indiana)
- Defendant: Dr. Reddy's Laboratories, Ltd. (India) and Dr. Reddy's Laboratories, Inc. (New Jersey)
- Plaintiff’s Counsel: Barnes & Thornburg LLP; Williams & Connolly LLP
- Case Identification: 1:19-cv-01246, S.D. Ind., 03/27/2019
- Venue Allegations: Plaintiff alleges venue is proper in the Southern District of Indiana because Defendants conduct substantial business in Indiana, previously availed themselves of the jurisdiction by filing counterclaims in a prior related case, and the alleged injury is suffered by Plaintiff at its Indiana headquarters.
- Core Dispute: Plaintiff alleges that Defendant's filing of an amendment to a New Drug Application (NDA) for a generic version of the cancer drug ALIMTA® constitutes an act of infringement of a patent covering a method of administering the drug in combination with vitamin supplements to reduce patient toxicity.
- Technical Context: The technology concerns combination therapies designed to mitigate severe side effects of antifolate chemotherapy agents, a critical consideration for improving patient safety and treatment tolerance in oncology.
- Key Procedural History: This action follows a prior lawsuit between the same parties involving the same patent and the same NDA, in which the court found that Defendants' proposed 100 mg/vial and 500 mg/vial products would infringe under the doctrine of equivalents. Plaintiff asserts that the current lawsuit, concerning a 1g/vial product, involves identical legal and factual questions and that Defendants should be barred from re-litigating these issues under the doctrines of res judicata and collateral estoppel. The patent's validity was previously upheld by the Federal Circuit in separate litigation.
Case Timeline
| Date | Event |
|---|---|
| 2000-06-30 | '209 Patent Priority Date |
| 2010-08-10 | '209 Patent Issue Date |
| 2015-12-22 | DRL Notifies Lilly of Initial NDA Filing |
| 2016-02-05 | Lilly Files First Infringement Suit Against DRL |
| 2018-07-27 | Court Enters Final Judgment in Lilly's Favor in First Suit |
| 2019-02-11 | DRL Notifies Lilly of Amendment to its NDA |
| 2019-03-27 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,772,209 - "Antifolate Combination Therapies"
The Invention Explained
- Problem Addressed: The patent's background explains that while antifolate drugs are effective for cancer treatment, their use is limited by "potentially, life-threatening toxicity" (’209 Patent, col. 2:9-11). The inability to control these toxicities had previously led to the abandonment of some promising antifolate drugs during clinical development (’209 Patent, col. 2:1-7).
- The Patented Solution: The invention is a method for improving the safety of antifolate drugs by co-administering them with a "methylmalonic acid lowering agent," such as vitamin B12, and optionally with folic acid (’209 Patent, Abstract; col. 2:31-41). The patent describes the surprising discovery that this combination significantly reduces toxic side effects like skin rashes and fatigue "without adversely affecting therapeutic efficacy" (’209 Patent, col. 2:37-39).
- Technical Importance: This method provides a way to improve the "therapeutic utility of antifolate drugs" by reducing their associated toxicity, thereby allowing for safer and more effective cancer treatment regimens (’209 Patent, col. 2:39-41).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-22 of the '209 patent (Compl. ¶33). Independent claims 1 and 12 are foundational.
- Independent Claim 1 recites:
- A method for administering pemetrexed disodium to a patient.
- Comprising administering an effective amount of folic acid.
- And administering an effective amount of a "methylmalonic acid lowering agent" (e.g., vitamin B12).
- Followed by administering an effective amount of pemetrexed disodium.
- Independent Claim 12 recites:
- An improved method for administering pemetrexed disodium to a patient for chemotherapy.
- Comprising administering specific doses of folic acid (350-1000 µg) and vitamin B12 (500-1500 µg) prior to the pemetrexed disodium.
- And administering pemetrexed disodium.
III. The Accused Instrumentality
Product Identification
- Defendant's "Pemetrexed for Injection 1g/vial product" ("DRL's NDA Product"), which is the subject of an amendment to NDA No. 208297 (Compl. ¶1). The complaint states the product contains pemetrexed ditromethamine as its active ingredient (Compl. ¶30).
Functionality and Market Context
- DRL's NDA Product is a proposed generic competitor to Plaintiff's branded chemotherapy drug, ALIMTA® (Compl. ¶1).
- The infringement allegation centers on the method of using the product as directed by its proposed labeling (Compl. ¶32). The complaint alleges that the only difference between the currently accused product and the products found to infringe in prior litigation is the dosage quantity per vial (Compl. ¶3).
- A central technical allegation is that while DRL's product contains pemetrexed ditromethamine, it is "equivalent to" and "insubstantially different from" the claimed pemetrexed disodium because both forms dissociate in aqueous solution to yield the "exact same active pemetrexed moiety" (Compl. ¶¶ 30, 31).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’209 Patent Infringement Allegations
| Claim Element (from Independent Claim 12) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment... | The proposed labeling for DRL's NDA Product directs its use for treating various types of cancer, which would be administered by physicians to patients. | ¶1, ¶19, ¶32 | col. 11:26-28 |
| a) administration of between about 350 µg and about 1000 µg of folic acid prior to the first administration of pemetrexed disodium; | The complaint alleges that the proposed labeling for DRL's NDA Product "involves administration of folic acid." | ¶32 | col. 11:34-37 |
| b) administration of about 500 µg to about 1500 µg of vitamin B12, prior to the first administration of pemetrexed disodium; | The complaint alleges that the proposed labeling for DRL's NDA Product "involves administration of... vitamins B12." | ¶32 | col. 11:38-41 |
| c) administration of pemetrexed disodium. | The complaint alleges that administration of DRL's NDA Product, which contains pemetrexed ditromethamine, is equivalent to administering pemetrexed disodium because both dissociate to the same active moiety in solution. | ¶30, ¶31 | col. 11:42-43 |
Identified Points of Contention
- Scope Questions: The primary legal and technical question is whether the administration of "pemetrexed ditromethamine" can infringe a claim limited to "pemetrexed disodium." The complaint's theory relies on the doctrine of equivalents, arguing the different salt forms are insubstantially different in the context of the claimed method (Compl. ¶¶ 30-31, 33). This raises the question of whether the court will be bound by its finding on this same issue in the prior litigation.
- Technical Questions: A key evidentiary question is what DRL's proposed product label specifically instructs regarding vitamin supplementation. The complaint alleges the label "involves" administration of folic acid and B12 (Compl. ¶32), but the sufficiency of these instructions to meet the specific dosage and timing limitations of the claims will be a point of analysis for determining inducement.
V. Key Claim Terms for Construction
- The Term: "pemetrexed disodium"
- Context and Importance: This term is central to the infringement dispute because the accused product contains a different salt, pemetrexed ditromethamine (Compl. ¶30). The case may turn on whether this term is construed narrowly to its literal meaning or if the accused product is found to be equivalent. Practitioners may focus on this term because the prior litigation between the parties already adjudicated the equivalence of this different salt form.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that the point of novelty is the vitamin co-administration method, not the specific salt of the antifolate. The specification frequently refers to the drug more generally as "pemetrexed disodium (ALIMTA)," suggesting the brand name and the chemical are used interchangeably (’209 Patent, col. 4:42-43). This could suggest the exact salt form is not the critical feature of the invention.
- Evidence for a Narrower Interpretation: The claims explicitly and repeatedly recite "pemetrexed disodium" (’209 Patent, col. 11:26, 29, 42). A defendant would argue that the patentee deliberately chose this specific chemical entity and should be held to that limitation, distinguishing it from other possible salt forms.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement, stating DRL plans to market its product with labeling that will direct physicians and patients to perform the patented method (Compl. ¶¶ 32, 40). Knowledge and intent are alleged based on DRL's awareness of the patent from the prior litigation (Compl. ¶39). The complaint also alleges contributory infringement, asserting DRL's product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶41).
- Willful Infringement: The complaint does not use the word "willful," but alleges facts to support it by claiming DRL has knowledge of the patent and the court's prior infringement finding, yet continues to seek approval for its product (Compl. ¶¶ 2, 39). The prayer for relief seeks a finding that the case is "exceptional" and an award of attorneys' fees pursuant to 35 U.S.C. § 285, which is the statutory remedy for such conduct (Compl. p. 12, ¶(e)).
VII. Analyst’s Conclusion: Key Questions for the Case
- A threshold question will be one of issue preclusion: to what extent does the court's prior judgment prevent DRL from re-litigating whether the administration of its pemetrexed ditromethamine product is equivalent to the claimed administration of "pemetrexed disodium," given the complaint's assertion that the only new fact is the product's vial size?
- A central substantive issue will be one of chemical equivalence: assuming the dispute is not entirely precluded, does the administration of pemetrexed ditromethamine perform substantially the same function (delivering the active pemetrexed moiety) in substantially the same way (via dissociation in solution) to achieve the same result (safer chemotherapy) as the claimed "pemetrexed disodium"?
- An evidentiary question for inducement will be one of label-based intent: do the specific instructions in DRL's proposed product labeling direct or encourage medical professionals to administer the drug and vitamin supplements in a manner that satisfies all limitations of the asserted claims, including dosage and timing requirements?