DCT

1:17-cv-01576

ViiV Healthcare Co v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01576, D. Del., 11/02/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Lupin Pharmaceuticals, Inc. is a Delaware corporation and both Defendants are subject to personal jurisdiction in the district through their business activities.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the HIV treatment TRIUMEQ® constitutes an act of infringement of a patent covering a specific crystalline form of dolutegravir, one of the drug's active ingredients.
  • Technical Context: The technology is in the field of pharmaceutical chemistry and relates to specific crystalline forms (polymorphs) of dolutegravir sodium, an HIV integrase inhibitor used in antiretroviral therapy.
  • Key Procedural History: The lawsuit was filed under the Hatch-Waxman Act, triggered by Defendants' submission of ANDA No. 210846 with a Paragraph IV certification. According to the complaint, Defendants' notification letter of September 19, 2017, asserted that the patent-in-suit is invalid, unenforceable, and/or not infringed. The complaint also alleges that this notification letter did not dispute that the proposed generic product would infringe claims 1-6 of the patent if those claims were found to be valid.

Case Timeline

Date Event
2008-12-11 '986 Patent Priority Date
2016-01-26 '986 Patent Issue Date
2017-09-19 Date of Defendants' Notice Letter to Plaintiffs
2017-11-02 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 9,242,986, "Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates," issued January 26, 2016. (Compl. ¶21; ’986 Patent, cover page).

The Invention Explained

  • Problem Addressed: The patent's background section describes known processes for synthesizing HIV integrase inhibitors where key chemical sidechains are attached late in the manufacturing sequence, after the formation of a core tricyclic structure. (’986 Patent, col. 1:13-33).
  • The Patented Solution: The patent describes alternative synthesis methods and also claims specific crystalline forms of the final compound. For example, the abstract describes a process where a key sidechain is attached before the creation of a final ring structure, modifying the sequence of steps from prior art methods. (’986 Patent, Abstract, col. 2:42-49). The patent goes on to claim distinct, solid-state crystalline forms of the resulting dolutegravir sodium compound, which are characterized by specific analytical data. (’986 Patent, col. 39:1-24).
  • Technical Importance: The development of specific, stable crystalline forms (polymorphs) of an active pharmaceutical ingredient is critical for ensuring consistent purity, solubility, and bioavailability in a final drug product. (’986 Patent, col. 11:51-58).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims and specifically references claims 1-12. (Compl. ¶32, ¶37, ¶40). Independent claim 1 is representative of the polymorph claims.
  • Independent Claim 1:
    • A crystal form
    • of a sodium salt of a compound of formula AA
    • having characteristic diffraction peaks at 6.4°±0.2°, 9.2°±0.2°, 13.8°±0.2°, 19.2°±0.2° and 21.8°±0.2° degrees two-theta in an X-ray powder diffraction pattern.
  • The complaint does not foreclose the assertion of other claims, including dependent claims. (Compl. ¶32).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' "Proposed ANDA Product," identified as "Abacavir, Dolutegravir and Lamivudine Tablets, 600 mg/50 mg/300 mg," which is a proposed generic version of ViiV's TRIUMEQ® tablets. (Compl. ¶11).

Functionality and Market Context

  • The Proposed ANDA Product is an oral tablet for the treatment of HIV-1 infection. (Compl. ¶11, ¶22).
  • The product contains "dolutegravir sodium equivalent to 50 mg of dolutegravir," which is the component alleged to be covered by the ’986 Patent. (Compl. ¶23, ¶28).
  • Defendants have filed ANDA No. 210846 with the FDA, which relies on data intended to demonstrate the bioequivalence of the Proposed ANDA Product to the brand-name TRIUMEQ® product. (Compl. ¶26, ¶29).

IV. Analysis of Infringement Allegations

The complaint alleges that Defendants' submission of ANDA No. 210846 for approval to market the Proposed ANDA Product is an act of infringement under 35 U.S.C. § 271(e)(2). (Compl. ¶33). The central factual allegation is that the "dolutegravir sodium as covered in one or more of the Claims of the '986 Patent is, and/or will be, present in the Proposed ANDA Product" (Compl. ¶28). The complaint does not contain a claim chart or provide specific evidence, such as analytical test results, to map elements of the accused product to the patent claims.

A significant point raised in the complaint is the allegation that in their pre-suit notification, "Defendants do not dispute that the Proposed ANDA Product will infringe Claims 1-6 of the '986 Patent unless Claims 1-6 of the '986 Patent are found invalid" (Compl. ¶37). This suggests the primary dispute regarding claims 1-6 may center on validity rather than infringement. For claims 7-12, the complaint alleges Defendants lacked a good faith basis for their non-infringement assertions. (Compl. ¶40). No probative visual evidence provided in complaint.

Identified Points of Contention

  • Technical Question (Polymorphism): The asserted claims are directed to specific crystalline forms of dolutegravir sodium, defined by precise X-ray powder diffraction (XRPD) peak locations. A central technical question will be whether the dolutegravir sodium in Defendants' product actually has the crystalline structure defined by the XRPD peaks recited in the asserted claims.
  • Scope Questions (Validity vs. Infringement): Based on the complaint's characterization of the Defendants' notice letter, a threshold question for the court regarding claims 1-6 will be whether the dispute is limited to the claims' validity, with infringement being conceded if the claims are found valid. (Compl. ¶37).

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail to identify specific claim terms that are likely to be in dispute. The asserted independent claims define the invention using quantitative, numerical values (e.g., specific angles in an X-ray diffraction pattern) rather than qualitative terms, which may reduce the scope for traditional claim construction disputes.

VI. Other Allegations

Indirect Infringement

The complaint alleges Defendants will induce infringement under 35 U.S.C. § 271(b) and contribute to infringement under § 271(c) upon FDA approval. (Compl. ¶36). This is based on allegations that Defendants will direct physicians and patients via product labeling that will "substantially copy the instructions for TRIUMEQ®". (Compl. ¶30, ¶34).

Willful Infringement

The complaint does not use the term "willful," but it lays the foundation for enhanced damages and a finding of an exceptional case under 35 U.S.C. § 285. It alleges Defendants had pre-suit knowledge of the '986 Patent when filing their ANDA and "lacked a good faith basis" for their certification of non-infringement and invalidity regarding certain claims. (Compl. ¶38, ¶40).

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

  • A central evidentiary question will be one of polymorphic identity: does the dolutegravir sodium active ingredient in Lupin's proposed generic product possess the specific crystalline structure, as defined by the X-ray diffraction data in the asserted claims of the '986 Patent? The outcome will likely depend on expert testimony and competing analytical test results of the accused product.
  • A primary legal issue, particularly for claims 1-6, will be validity. As the complaint frames the dispute, Lupin has conceded infringement of these claims if they are valid, focusing the legal battle on whether the claimed crystal forms are novel and non-obvious over the prior art.
  • A key procedural question will be one of good faith: did Lupin have a good faith basis for its Paragraph IV certification that its product would not infringe and/or that the patent claims were invalid? The resolution of this question will determine whether Plaintiffs can recover attorneys' fees under 35 U.S.C. § 285.