DCT

1:14-cv-00389

Eli Lilly Co v. Accord Healthcare Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:14-cv-00389, S.D. Ind., 11/20/2015
  • Venue Allegations: Venue is alleged to be proper in the Southern District of Indiana because the Defendants market, sell, and distribute generic drugs in the state, enjoy substantial income from those sales, and have maintained systematic and continuous business contacts within the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market generic versions of the anti-platelet drug Effient® constitutes an act of infringement of two patents covering medicinal compositions and methods of using prasugrel in combination with aspirin.
  • Technical Context: The technology relates to anti-thrombotic therapies, specifically the combination of the anti-platelet agents prasugrel and aspirin to prevent and treat cardiovascular events such as those associated with acute coronary syndrome.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of an ANDA to the FDA. The complaint states that on April 6, 2015, and again on September 30, 2015, Defendants sent Paragraph IV certification letters notifying Plaintiffs that they seek to market a generic product before the expiration of the patents-in-suit, alleging the patents are invalid, unenforceable, and/or will not be infringed.

Case Timeline

Date Event
2000-12-25 Priority Date for ’703 and ’325 Patents
2013-03-26 U.S. Patent No. 8,404,703 Issues
2013-10-29 U.S. Patent No. 8,569,325 Issues
2015-04-06 Lupin sends first Paragraph IV Notification Letter to Plaintiffs
2015-09-30 Lupin sends second Paragraph IV Notification Letter to Plaintiffs
2015-11-20 First Amended Complaint for Patent Infringement Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,404,703 - Medicinal Compositions Containing Aspirin, issued March 26, 2013

The Invention Explained

  • Problem Addressed: The patent background describes the need for therapeutic agents that can prevent or treat diseases caused by thrombus or embolus, such as stable or unstable angina pectoris and other cardiovascular or cerebrovascular disorders (’703 Patent, col. 3:6-18). It identifies both prasugrel and aspirin as known compounds with inhibitory activity against platelet aggregation (’703 Patent, col. 1:30-43).
  • The Patented Solution: The invention is a pharmaceutical composition that combines two active ingredients: prasugrel (specifically, 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine) or its salt, and aspirin (’703 Patent, Abstract). This combination is asserted to possess excellent inhibitory activity against both platelet aggregation and thrombogenesis, providing an improved treatment for diseases caused by thrombus or embolus (’703 Patent, col. 3:1-5).
  • Technical Importance: The combination of two antiplatelet agents with different mechanisms of action is a recognized strategy for achieving more potent and comprehensive inhibition of thrombogenesis in high-risk patients (’703 Patent, col. 3:1-5).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims (Compl. ¶45). Independent claim 1 is representative:
    • A medicinal composition comprising 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine or a pharmaceutically acceptable salt thereof,
    • and aspirin,
    • as active ingredients.

U.S. Patent No. 8,569,325 - Method of Treatment with Coadministration of Aspirin and Prasugrel, issued October 29, 2013

The Invention Explained

  • Problem Addressed: Similar to the ’703 Patent, the background of the ’325 Patent identifies a need for improved methods to treat diseases caused by thrombus or embolus by inhibiting platelet aggregation (’325 Patent, col. 1:30-43; col. 3:6-18).
  • The Patented Solution: The invention is a method of treatment that involves co-administering prasugrel and aspirin to a human patient in need of such treatment (’325 Patent, Abstract). The patent suggests this co-administration can occur simultaneously or sequentially, and the specification notes that the two components can be prepared as separate formulations (’325 Patent, col. 3:64-67; col. 4:63-65).
  • Technical Importance: The claimed method provides a therapeutic regimen for leveraging the combined anti-platelet effects of prasugrel and aspirin, which is particularly relevant for patients with conditions like acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI) (Compl. ¶20, ¶24).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims (Compl. ¶54). Independent claim 1 is representative:
    • A method for treatment of a disease caused by thrombus or embolus,
    • which comprises co-administering to a human in need of said treatment
    • (i) 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine or a pharmaceutically acceptable salt thereof, and
    • (ii) aspirin.

III. The Accused Instrumentality

  • Product Identification: Defendants' generic prasugrel hydrochloride tablets for oral administration, in 5 mg and 10 mg strengths, as described in ANDA No. 205930 (the "Lupin Products") (Compl. ¶29-30).
  • Functionality and Market Context: The Lupin Products contain the same active ingredient (prasugrel hydrochloride) as Plaintiffs' Effient® products and are alleged to be bioequivalent (Compl. ¶33-34). The complaint alleges that upon FDA approval, Defendants intend to market these products for the reduction of thrombotic cardiovascular events (Compl. ¶10). Crucially, the complaint alleges that the instructions for use accompanying the Lupin Products will "substantially copy the instructions for Effient® products, including instructions for administering the Lupin Products with aspirin" (Compl. ¶35). The filing of the ANDA itself is the statutory act of infringement alleged for purposes of establishing jurisdiction under 35 U.S.C. § 271(e)(2) (Compl. ¶45, ¶54).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’703 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A medicinal composition comprising 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine or a pharmaceutically acceptable salt thereof, The Lupin Products contain prasugrel hydrochloride, the salt form of the claimed compound. ¶30, ¶33 col. 2:23-31
and aspirin, The complaint alleges that the Lupin Products will be administered with aspirin, pursuant to instructions that will accompany the product. The use as instructed is alleged to result in the claimed composition. ¶35 col. 4:48-67
as active ingredients. The complaint alleges that both prasugrel hydrochloride and aspirin will be used as active ingredients for the reduction of thrombotic cardiovascular events, mirroring the approved use of Plaintiffs' Effient® product. ¶24, ¶35 col. 3:1-5
  • Identified Points of Contention:
    • Scope Questions: The primary question for the ’703 Patent may be definitional. Does the term "medicinal composition comprising" the two agents require that they be formulated in a single dosage form? The complaint's theory appears to rely on the co-administration of two separate products (the Lupin Product and an aspirin product) to meet this limitation, which raises the question of whether this constitutes direct infringement of the composition claim or if infringement can only be established under a theory of inducement.

’325 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treatment of a disease caused by thrombus or embolus, The Lupin Products are generic versions of Effient®, which is approved for the reduction of thrombotic cardiovascular events. The complaint alleges Lupin intends to market its product for the same use. ¶10, ¶20, ¶24 col. 3:6-18
which comprises co-administering to a human in need of said treatment The complaint alleges that the instructions accompanying the Lupin Products will direct physicians and patients to "co-administer" the product with aspirin. This act of instructing the claimed method is the basis for the allegation of induced infringement. ¶35, ¶36, ¶38 col. 4:50-54
(i) 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine or a pharmaceutically acceptable salt thereof, and The Lupin Products contain prasugrel hydrochloride as their active ingredient. ¶30, ¶33 col. 1:12-20
(ii) aspirin. The instructions for the Lupin Products will allegedly direct co-administration with aspirin. ¶35 col. 1:12-20
  • Identified Points of Contention:
    • Technical Questions: For the method claims of the ’325 patent, the infringement theory of inducement based on the proposed product label is direct. The central dispute will likely focus not on the technical operation of the product, but on the validity and enforceability of the patent claims themselves, as challenged by Lupin in its Paragraph IV certifications (Compl. ¶31, ¶32). The specific grounds for Lupin's invalidity challenge are not detailed in the complaint.

V. Key Claim Terms for Construction

  • The Term: "medicinal composition comprising" (’703 Patent, Claim 1)

  • Context and Importance: The construction of this term is critical to determining the scope of the composition patent. Practitioners may focus on this term because if it is construed to require a single formulation containing both active ingredients, Defendants may argue that their product (containing only prasugrel) cannot directly infringe, and that instructing its use with a separate aspirin product does not create the claimed "composition."

    • Intrinsic Evidence for a Broader Interpretation: The patent repeatedly uses the open-ended term "comprising." The specification discusses the two agents as active ingredients for pharmaceutical compositions without explicitly limiting them to a single dosage form, stating they "can be prepared respectively as separate formulations" (’703 Patent, col. 4:63-64).
    • Intrinsic Evidence for a Narrower Interpretation: Defendants may argue that the ordinary meaning of "composition" implies a physical mixture or combination of ingredients. The patent’s formulation examples might describe only single-unit dosage forms, which could be cited to support a narrower construction limited to such embodiments.

  • The Term: "co-administering" (’325 Patent, Claim 1)

  • Context and Importance: This term defines the central action of the asserted method claim. Its temporal scope—whether it requires simultaneous, sequential, or merely overlapping administration within a therapeutic window—will be important for defining infringement.

    • Intrinsic Evidence for a Broader Interpretation: The patent specification explicitly contemplates flexible dosing regimens, stating the active ingredients may be administered "simultaneously or sequentially" (’325 Patent, col. 4:65-67).
    • Intrinsic Evidence for a Narrower Interpretation: While the specification provides for flexibility, Defendants might argue that specific examples or the context of treating acute conditions imply a need for administration within a narrow timeframe that their product label might not explicitly require, potentially creating a non-infringement argument.

VI. Other Allegations

  • Indirect Infringement: The complaint's primary theory for infringement of the ’325 Patent is indirect. It alleges that Lupin will actively induce infringement by physicians, healthcare providers, and patients because the Lupin Products will be accompanied by instructions that "substantially copy the instructions for Effient® products, including instructions for administering the Lupin Products with aspirin" (Compl. ¶35, ¶38). It is further alleged that the Lupin Products are not a staple article suitable for substantial non-infringing use (Compl. ¶41).
  • Willful Infringement: The complaint alleges that Lupin had pre-suit knowledge of the patents-in-suit (Compl. ¶29). It further alleges that Lupin’s Paragraph IV certifications, which asserted that the patents are invalid, unenforceable, and/or not infringed, "lacked a good faith basis" and were "wholly unjustified" (Compl. ¶48, ¶57). These allegations form the basis for a potential willfulness claim and a request that the case be deemed exceptional under 35 U.S.C. § 285 (Compl., Prayer for Relief ¶F).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of claim scope for the composition patent: Can the term "medicinal composition comprising" in the ’703 patent be construed to cover a therapeutic regimen where two separate products—a prasugrel tablet and an aspirin tablet—are administered to a patient per instructions, or is the claim limited to a single, combined-ingredient formulation?
  • A second core issue will relate to patent validity: Because the infringement allegation for the ’325 method patent is based on inducing acts directed by the proposed product label, the case will likely pivot from infringement to the substantive invalidity and unenforceability arguments raised by Lupin in its Paragraph IV certification letters. The viability of Plaintiffs' case will depend on the strength of the asserted claims against challenges of anticipation and obviousness.