DCT

1:22-cv-01395

Novartis Pharma Corporation v. MSN Pharma Inc.

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I. Executive Summary and Procedural Information

Case Timeline

Date Event
2005-11-09 '918 Patent Priority Date
2021-08-24 U.S. Patent No. 11,096,918 Issues
2022-10-24 Complaint Filed
2026-11-08 '918 Patent Expiration Date (as stated in Complaint)

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”

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

The Invention Explained

  • Problem Addressed: The patent background describes hypertension and heart failure as complex diseases that are often not adequately controlled by a single drug (monotherapy) ('918 Patent, col. 2:20-24). This creates a need for effective combination therapies that do not introduce deleterious side effects ('918 Patent, col. 2:38-44).
  • The Patented Solution: The invention is a "dual-acting compound" that combines two active agents—an angiotensin receptor blocker (ARB) and a neutral endopeptidase inhibitor (NEPi)—into a single "supramolecular complex" with a cation ('918 Patent, col. 2:30-37; Abstract). This complex is not a simple physical mixture but a distinct molecular entity held together by non-covalent intermolecular bonds, such as ionic and hydrogen bonds, which gives it unique physical and chemical properties ('918 Patent, col. 7:18-34). The patent specifically claims an amorphous, non-crystalline solid form of this compound.
  • Technical Importance: By creating a single supramolecular complex from two different active pharmaceutical ingredients, the invention provides a novel chemical entity potentially offering improved stability, manufacturability, or therapeutic performance compared to simply co-administering the two separate drugs ('918 Patent, col. 17:46-51).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the '918 patent without specifying particular claims (Compl. ¶117). The patent contains two independent claims.
  • 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 (valsartan)
      • anionic (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester (sacubitril)
      • and sodium cations
    • in a 1:1:3 molar ratio.
  • Independent Claim 2: A pharmaceutical composition comprising the amorphous solid form of Claim 1 and at least one pharmaceutically acceptable excipient.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the generic sacubitril/valsartan tablets for which Defendants have filed ANDAs Nos. 213682, 213605, 213748, 213646, and 213671 (Compl. ¶¶ 9, 19, 31, 64, 73).

Functionality and Market Context

  • The complaint alleges that each Defendant's ANDA product is a pharmaceutical composition formulated as a tablet intended to serve as a generic equivalent to Novartis's ENTRESTO® (Compl. ¶1). The core of the infringement allegation is that these tablets comprise the specific chemical form protected by the ’918 Patent: "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. ¶¶ 118, 126, 134, 142, 150). For defendants Crystal and Mylan, the complaint further specifies that this amorphous form is present "in an amount less than 10% by weight of the total amount of active ingredient in the tablet" (Compl. ¶¶ 126, 142).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,096,918 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 a compound. ¶118 col. 17:42-44
of a compound comprising (i) anionic (S)-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine, The compound in the accused products is alleged to comprise "anionic valsartan." ¶118 col. 11:60-65
(ii) anionic (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester, The compound in the accused products is alleged to comprise "anionic sacubitril." ¶118 col. 13:36-40
and (iii) sodium cations The compound in the accused products is alleged to comprise "sodium cations." ¶118 col. 15:6-8
in a 1:1:3 molar ratio. The valsartan, sacubitril, and sodium cations in the accused products' compound are alleged to be present "in a 1:1:3 molar ratio." ¶118 col. 16:3-5
  • Identified Points of Contention:
    • Technical Question: The central factual dispute will be whether the defendants' proposed generic products, as described in their confidential ANDA filings, actually contain the specific chemical entity claimed. The case will depend on evidence establishing the solid-state form (amorphous vs. crystalline), the nature of the association between the components (a single compound vs. a physical mixture), and the precise 1:1:3 molar ratio.
    • Scope Questions: A primary legal dispute may arise over the meaning of "amorphous solid form." While the claim is to an amorphous form, the patent specification contains extensive data characterizing a crystalline embodiment ('918 Patent, col. 18-20). This could create ambiguity that defendants may use to argue for a narrow construction or to distinguish their product. The allegation that some accused products contain "less than 10%" of the claimed form (Compl. ¶¶ 126, 142) raises the question of whether the presence of a minority fraction of the claimed material is sufficient to infringe a claim directed to the bulk composition.

V. Key Claim Terms for Construction

  • The Term: "amorphous solid form"

    • Context and Importance: This term is the cornerstone of Claim 1, distinguishing the invention from crystalline forms. Whether the defendants' products meet this limitation will be a dispositive issue. Practitioners may focus on this term because the patent discloses and extensively characterizes a crystalline form, yet the independent claims are directed to an amorphous one.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party could argue for the plain and ordinary meaning: any solid material lacking the long-range periodic order of a crystal lattice. Example 4 of the patent describes a method for preparing an amorphous sample, which provides explicit support for such a form ('918 Patent, col. 31:45-col. 32:13).
      • Evidence for a Narrower Interpretation: A party could argue that the term is defined by the properties of the material produced by the method in Example 4. Given the detailed characterization of a crystalline form, a defendant might argue that the patent implicitly defines "amorphous" in contrast to the specific crystalline structure disclosed, potentially limiting its scope.

  • The Term: "compound"

    • Context and Importance: This term distinguishes the claimed invention from a simple physical mixture of its constituent parts (valsartan, sacubitril, and sodium). Infringement hinges on whether the accused products contain a single, integrated chemical entity.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines the invention as a "supramolecular complex" where the components are associated via non-covalent intermolecular bonding, including ionic and hydrogen bonds ('918 Patent, col. 7:18-34). Plaintiff will likely argue that any formulation exhibiting this network of interactions constitutes the claimed "compound."
      • Evidence for a Narrower Interpretation: A defendant may argue that "compound" requires a more definite and ordered association, such as that found in the patent's crystalline example, and that a disordered amorphous material does not meet this threshold. They may contend their product is a salt mixture that lacks the specific supramolecular structure described in the patent.

VI. Other Allegations

  • Willful Infringement: The complaint does not make a formal allegation of willful infringement or seek enhanced damages under 35 U.S.C. § 284. It does, however, request a declaration that the case is "exceptional" and seeks an award of attorney's fees under 35 U.S.C. § 285 (Compl. ¶¶ 160, 168, 176, 184, 192).

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

  • A core issue will be one of evidentiary proof: Can Novartis, through discovery of the confidential ANDA submissions, demonstrate that Defendants' proposed generic products will, in fact, contain the specific "amorphous solid form of a compound" with a 1:1:3 molar ratio as recited in Claim 1?
  • The case will also turn on a question of definitional scope: Does the term "compound," as used in the patent, read on the defendants' formulations, or can the defendants successfully characterize their products as a physical mixture of separate components that falls outside the claim?
  • A key infringement question will be one of quantitative threshold: For the defendants accused of having "less than 10%" of the claimed form, does the presence of a minority species of the patented amorphous compound within a larger tablet render the entire product infringing?