DCT

1:21-cv-01330

Novartis Pharma Corp v. Torrent Pharma Inc

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I. Executive Summary and Procedural Information

Case Timeline

Date Event
2005-11-09 '918 Patent Priority Date
2019-09-01 Torrent Pharma Notice Letter Date
2019-09-06 Aurobindo Pharma Notice Letter Date
2019-09-06 Laurus Labs Notice Letter Date
2019-09-09 Alkem Laboratories Notice Letter Date
2019-09-11 Macleods Pharmaceuticals Notice Letter Date
2019-09-18 Dr. Reddy's Laboratories Notice Letter Date
2019-09-18 Hetero Labs Notice Letter Date
2021-08-24 U.S. Patent No. 11,096,918 Issued
2021-09-20 Complaint Filed

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

U.S. Patent No. 11,096,918 - "Amorphous solid form of compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and sodium cations"

  • Issued: August 24, 2021
  • Patent Identification: U.S. Patent No. 11,096,918

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of treating complex diseases like hypertension, which are often not adequately controlled by a single drug (monotherapy) (’918 Patent, col. 2:19-22). While combining drugs with different mechanisms of action can be effective, simply mixing them does not guarantee an optimal therapeutic product and can introduce deleterious side effects (’918 Patent, col. 2:36-44).
  • The Patented Solution: The invention is a specific "dual-acting compound" that combines two active pharmaceutical ingredients—the angiotensin receptor blocker (ARB) valsartan and the neutral endopeptidase inhibitor (NEPi) sacubitril—into a single "supramolecular complex" with sodium cations (’918 Patent, Abstract; col. 2:45-53). This complex is not merely a physical mixture but a distinct chemical entity formed through non-covalent interactions, such as ionic and hydrogen bonds, creating a stable, unified structure (’918 Patent, col. 5:61-6:1; col. 7:20-30).
  • Technical Importance: Creating a single supramolecular entity from two distinct drugs allows for the creation of a new solid-state form with unique physicochemical properties (e.g., stability, solubility, manufacturability) that may differ from the individual components or a simple physical mixture (’918 Patent, col. 17:46-54).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the ’918 patent (Compl. ¶132). The analysis below focuses on the sole independent claim, Claim 1.
  • Independent Claim 1:
    • An amorphous solid form
    • of a compound comprising
    • anionic (S)-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine [anionic valsartan],
    • anionic (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester [anionic sacubitril], and
    • sodium cations
    • in a 1:1:3 molar ratio.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the generic sacubitril/valsartan tablet products for which each defendant has filed an Abbreviated New Drug Application (ANDA) with the FDA (Compl. ¶¶ 5, 15, 25, 39, 52, 63, 73).

Functionality and Market Context

  • The complaint alleges that each defendant’s ANDA product is a pharmaceutical composition formulated as a tablet that comprises the specific substance claimed in the ’918 Patent (Compl. ¶¶ 133, 141, 149, 157, 165, 173, 181). Specifically, the complaint alleges the products contain "an amorphous solid form of a compound comprising (i) anionic valsartan, (ii) anionic sacubitril, and (iii) sodium cations in a 1:1:3 molar ratio" (Compl. ¶133).
  • The accused products are generic versions of Novartis’s branded drug Entresto®, which is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure (Compl. ¶128). The filing of the ANDAs is an attempt to enter the market with a lower-cost generic equivalent upon receiving FDA approval (Compl. ¶1).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The infringement allegation is statutory, arising from the filing of an ANDA under 35 U.S.C. § 271(e)(2), which seeks FDA approval to market a generic drug prior to the expiration of the patent-in-suit (Compl. ¶131). The complaint alleges that the product described in the ANDA filings, if commercially manufactured and sold, would directly infringe the ’918 Patent.

'918 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An amorphous solid form The accused ANDA Products are alleged to be a pharmaceutical composition comprising an "amorphous solid form" of the specified compound. ¶133 col. 23:41
of a compound comprising The accused products are alleged to contain a compound with the three subsequent components. ¶133 col. 2:45-53
anionic (S)-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine [anionic valsartan], The accused products are alleged to contain anionic valsartan. ¶133 col. 12:5-9
anionic (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester [anionic sacubitril], The accused products are alleged to contain anionic sacubitril. ¶133 col. 14:1-10
and sodium cations The accused products are alleged to contain sodium cations. ¶133 col. 15:59-62
in a 1:1:3 molar ratio. The valsartan, sacubitril, and sodium cations are alleged to be present in a 1:1:3 molar ratio. ¶133 col. 16:1-4

Identified Points of Contention

  • Factual Question: The central dispute will be factual: does the solid form of the active ingredient in the defendants' proposed generic products meet the "amorphous" limitation of Claim 1? This will require extensive discovery and expert analysis using techniques like X-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC).
  • Scope Questions: A primary legal question concerns the scope of the term "a compound comprising." Does this term require the specific "supramolecular complex" structure detailed extensively in the patent's specification (e.g., col. 7:20-30), or does it simply require the presence of the three listed components in an amorphous state? The patent's detailed characterization of a "crystalline" form of the complex (’918 Patent, col. 17-20), despite the claim's recitation of an "amorphous" form, raises the question of whether features of the described complex are implicit limitations on the claimed amorphous form.

V. Key Claim Terms for Construction

  • The Term: "amorphous solid form"

    • Context and Importance: This term is the primary structural limitation of the independent claim. The patent's validity and the infringement analysis will hinge on whether the accused products possess this form, as distinguished from crystalline or other forms. Practitioners may focus on this term because the patent specification provides extensive data for a "crystalline" form of the supramolecular complex, which could be used to argue about the proper scope and definition of the claimed amorphous version.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term itself has a well-understood plain meaning in chemistry: a solid that lacks the long-range order characteristic of a crystal. The patent explicitly contemplates that the invention can exist in an "amorphous" state (’918 Patent, col. 17:42-45).
      • Evidence for a Narrower Interpretation: Defendants may argue that the term cannot be read in isolation from the specification's repeated emphasis on the invention being a "supramolecular complex" (’918 Patent, col. 5:61-6:1). They may contend that the claimed "amorphous solid form" must be an amorphous version of that specific complex, not just any amorphous mixture of the components, pointing to the specification's statement that the invention is "preferably in the crystalline form" (’918 Patent, col. 17:44-45) as context for what the inventors truly regarded as their invention.

  • The Term: "a compound comprising"

    • Context and Importance: The construction of this phrase determines whether the claim requires a specific chemical association between the three components (valsartan, sacubitril, sodium cations) or merely their co-presence in a formulation. This is critical because proving the existence of a specific complex is more difficult than proving the presence of its constituent parts.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The word "comprising" is well-established in patent law as an open-ended transition, meaning the compound must contain the listed elements but may also contain others. A plaintiff may argue that any substance containing these three components in the specified ratio and amorphous form meets the limitation.
      • Evidence for a Narrower Interpretation: The specification consistently describes the invention not as a mixture but as a "dual-acting compound," a "new molecular or supramolecular entity," and a "complex" (’918 Patent, col. 5:65-6:1, col. 7:22-23). Defendants will likely argue that "compound" should be interpreted in light of this consistent description to mean the specific supramolecular complex, where the components are associated through non-covalent bonds, rather than simply being mixed.

VI. Other Allegations

  • Indirect Infringement: The complaint's primary allegation is statutory infringement under 35 U.S.C. § 271(e)(2) based on the ANDA submissions (Compl. ¶131). It further seeks a declaratory judgment that the future commercialization of the ANDA products will constitute direct infringement (Compl. ¶137). Specific allegations of inducement or contributory infringement are not separately pleaded.
  • Willful Infringement: The complaint does not use the term "willful infringement." However, for each defendant, it requests a declaration that the case is "exceptional" pursuant to 35 U.S.C. § 285 and seeks an award of attorney's fees (Compl. ¶¶ 191, 199, etc.). The basis for this appears to be the act of filing an ANDA with a Paragraph IV certification, which demonstrates knowledge of the patent and an intent to infringe if the patent is not found invalid or not infringed.

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

  • A central evidentiary question will be one of structural characterization: Can Novartis prove that the solid-state form of the active ingredient in the Defendants' proposed generic products is, in fact, "amorphous" as required by Claim 1? This will likely be a battle of experts and sophisticated analytical testing.
  • A core legal question will be one of claim scope: Will the court construe the term "a compound" broadly to mean any substance containing the three listed components, or will it be limited by the specification's detailed disclosure to require proof of the specific "supramolecular complex" structure? The resolution of this issue will define the evidentiary burden for proving infringement.
  • A key question for validity, which will be central to the defendants' counterclaims, will be the patentability of the amorphous form: Given the patent's extensive disclosure of a related crystalline complex and its relationship to a family of earlier patents, the court will have to determine whether the claimed amorphous form was non-obvious and adequately described at the time of the invention.