ViiV Healthcare Co v. DR Reddys Laboratories Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: ViiV Healthcare Company (Delaware), Shionogi & Co., Ltd. (Japan), and ViiV Healthcare UK (No. 3) Limited (United Kingdom)
  • Defendant: Dr. Reddy's Laboratories, Inc. (New Jersey) and Dr. Reddy's Laboratories, Ltd. (India)
  • Plaintiff’s Counsel: McCarter & English LLP
• Case Identification: 3:17-cv-11873, D.N.J., 11/20/2017
• Venue Allegations: Venue is alleged based on Defendant Dr. Reddy’s Laboratories, Inc. being incorporated in New Jersey and both defendants conducting substantial and continuous business within the district.
• Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the HIV drug TRIUMEQ® constitutes an act of infringement of a patent covering specific crystalline forms of the active ingredient dolutegravir sodium.
• Technical Context: The technology concerns specific, stable crystalline structures, or polymorphs, of dolutegravir sodium, an HIV integrase inhibitor critical for certain antiviral therapies.
• Key Procedural History: This Hatch-Waxman action was triggered by Defendant’s submission of ANDA No. 210899 with a Paragraph IV certification, asserting non-infringement or invalidity of the patent-in-suit. The complaint notes that it was filed as a "protective suit" in parallel with an action in the District of Delaware to preserve the filing date in the event of a successful venue challenge in the Delaware case.

Case Timeline

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

U.S. Patent No. 9,242,986 - Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates

• Issued: January 26, 2016

The Invention Explained

• Problem Addressed: While the patent's background discusses various chemical synthesis pathways for HIV integrase inhibitors, the claimed invention addresses a different, fundamental challenge in pharmaceutical development: ensuring a drug compound has consistent and stable physical properties (col. 1:12-33). An active pharmaceutical ingredient can exist in multiple crystalline forms (polymorphs), each with different characteristics affecting manufacturing, stability, and bioavailability.
• The Patented Solution: The patent claims specific, isolated crystalline forms of dolutegravir sodium, including an anhydrous sodium salt and a hydrated sodium salt (col. 10:36-44). These forms are precisely defined by their physical characteristics, such as specific peaks in an X-ray powder diffraction (XRPD) pattern (Fig. 1, 4) and specific absorption bands in an infrared (IR) spectrum (Fig. 2, 5). By defining these specific polymorphs, the invention provides a composition of matter with predictable and reproducible properties.
• Technical Importance: The identification and characterization of a stable, pure crystalline form of a drug is critical for ensuring lot-to-lot consistency in large-scale manufacturing and for developing a safe and effective final drug product with predictable absorption by the body (col. 11:51-58).

Key Claims at a Glance

• The complaint asserts infringement of one or more claims from 1-12 (Compl. ¶49). The independent claims are 1, 4, 6, 7, 10, and 12.
• Independent Claim 1: Claims a crystal form of a sodium salt of the compound of formula AA (dolutegravir) that is characterized by having five specific diffraction peaks in its X-ray powder diffraction (XRPD) pattern.
• Independent Claim 4: Claims a crystal form of a sodium salt of the compound of formula AA that is characterized by having four specific absorption spectra in its infrared (IR) spectrum.
• Independent Claim 6: Claims a crystal form of a sodium salt of the compound of formula AA, without reference to specific physical characterization data in the claim body.
• Independent Claim 7: Claims a crystal form of a hydrate of a sodium salt of the compound of formula AA, characterized by five specific XRPD peaks.
• Independent Claim 10: Claims a crystal form of a hydrate of a sodium salt of the compound of formula AA, characterized by four specific IR spectra.
• Independent Claim 12: Claims a crystal form of a hydrate of a sodium salt of the compound of formula AA, characterized by an XRPD pattern "substantially as shown in FIG. 4" and/or an IR spectrum "substantially as shown in FIG. 5."
• The complaint generally alleges infringement of "one or more Claims of the '986 Patent," implicitly reserving the right to assert any of the patent's claims (Compl. ¶44).

III. The Accused Instrumentality

Product Identification

• The "Proposed Combination Product" is the generic drug product that is the subject of Defendants' ANDA No. 210899 (Compl. ¶10). This product is a generic version of TRIUMEQ® and is formulated as tablets containing abacavir, dolutegravir, and lamivudine (Compl. ¶10).

Functionality and Market Context

• The product is intended for the treatment of HIV-1 infection (Compl. ¶24). The infringement allegation centers on the "dolutegravir sodium" component of the combination tablet (Compl. ¶30). Defendants' ANDA filing necessarily contains data intended to demonstrate that their proposed product is bioequivalent to the branded TRIUMEQ® drug (Compl. ¶31).

IV. Analysis of Infringement Allegations

The complaint, filed to meet the statutory deadline under the Hatch-Waxman Act, does not contain a detailed infringement analysis or claim chart. It makes general allegations on "information and belief" and states that discovery is required to confirm the specifics of the infringement (Compl. ¶43). The following chart summarizes the allegations against a representative independent claim.

No probative visual evidence provided in complaint.

'986 Patent Infringement Allegations

• Identified Points of Contention:
  • Technical Question: The central factual dispute will be whether the specific crystalline form of dolutegravir sodium manufactured by Defendants and described in their ANDA possesses the physical properties (e.g., the specific XRPD peaks or IR spectra) recited in the asserted claims. The complaint provides no direct evidence on this point, framing it as a question to be resolved through discovery (Compl. ¶43).
  • Scope Questions: The interpretation of terms defining the claimed physical properties, such as "characteristic diffraction peaks" and the "±0.2°" tolerance, will be critical. The case may raise the question of whether the listed peaks are a complete and mandatory set or merely an illustrative fingerprint of the claimed polymorph.

V. Key Claim Terms for Construction

• The Term: "characteristic diffraction peaks" (Claim 1)

• Context and Importance: This term is central to defining the scope of the claimed polymorph. Infringement will depend on whether Defendants' product exhibits an XRPD pattern with peaks matching those recited in the claim. Practitioners may focus on this term because its construction will determine whether the list of peaks is an exhaustive, mandatory requirement or a representative, non-exclusive list.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent does not use limiting language such as "consisting of" or "consisting only of" the listed peaks, which may suggest the list is a representative fingerprint of the crystal form, allowing for the presence of other, unlisted peaks.
  • Evidence for a Narrower Interpretation: The claims recite highly specific peak positions with a narrow tolerance (e.g., "6.4°±0.2°"), suggesting that these specific peaks are the essential, defining features of the invention. The specification repeatedly refers to these as "characteristic" peaks, implying they are necessary identifiers ('986 Patent, col. 10:5-9).

• The Term: "substantially as shown in" (Claim 12)

• Context and Importance: This term directly ties the claim scope to the graphical data presented in patent figures (e.g., FIG. 4). The interpretation of "substantially" will dictate how closely the accused product's XRPD pattern must match the figure to infringe.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The word "substantially" inherently provides for some degree of variation from the exact depiction in the figure, which could mean that minor differences in peak intensity or position do not avoid infringement.
  • Evidence for a Narrower Interpretation: A party could argue that "substantially as shown in" requires a very close, almost identical match, and that any meaningful deviation removes a product from the claim's scope. The specification presents the figures as the definitive patterns for the claimed crystal forms (e.g., "FIG. 4 shows an X-ray power diffraction pattern of a crystal of compound 13b") ('986 Patent, col. 1:59-61).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendants will induce infringement by providing product labeling that substantially copies the instructions for the branded TRIUMEQ® product. These instructions allegedly will direct physicians and patients to administer the infringing product (Compl. ¶32, ¶48).
• Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the '986 Patent at the time they filed the ANDA, as evidenced by their Paragraph IV certification (Compl. ¶50). Plaintiffs further allege that Defendants' certification of non-infringement lacked a good faith basis, making the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶52).

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

• A central issue will be one of polymorphic identity: Will discovery and expert analysis reveal that the crystalline form of dolutegravir sodium in Dr. Reddy's proposed generic product exhibits the specific X-ray diffraction patterns and infrared spectra required by the asserted claims of the '986 patent?
• The case will also turn on a question of definitional precision: How will the court construe claim terms such as "characteristic...peaks" and "substantially as shown in"? The interpretation of these terms will define the precise boundaries of the patented crystalline forms and determine how much deviation, if any, is permitted for a competing product to be deemed non-infringing.