DCT

2:25-cv-13936

Gilead Sciences Inc v. Aspiro Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-13936, D.N.J., 07/30/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Hetero USA resides and has a principal place of business in the state, while foreign defendants Aspiro Pharma and Hetero Labs are subject to personal jurisdiction in the district and have previously not contested venue in this court.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's antiviral drug VEKLURY® (remdesivir) constitutes an act of infringement of six U.S. patents covering compositions and methods of use for remdesivir.
  • Technical Context: The technology relates to pharmaceutical formulations of the antiviral nucleotide analog remdesivir, an RNA polymerase inhibitor significant for its use as a treatment for COVID-19.
  • Key Procedural History: This action was triggered by Defendants' filing of ANDA No. 220566, which seeks FDA approval to market a generic version of VEKLURY® before the expiration of the asserted patents. The ANDA included a Paragraph IV Certification, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the generic product. Plaintiff commenced this action within the 45-day statutory period following receipt of Defendants' notice letter, which triggers a 30-month stay of FDA approval for the ANDA.

Case Timeline

Date Event
2017-07-11 Priority Date for ’296, ’681, and ’017 Patents
2020-05-29 Priority Date for ’169, ’953, and ’012 Patents
2020-06-09 U.S. Patent No. 10,675,296 Issues
2022-03-08 U.S. Patent No. 11,266,681 Issues
2022-11-08 U.S. Patent No. 11,491,169 Issues
2024-02-20 U.S. Patent No. 11,903,953 Issues
2024-05-07 U.S. Patent No. 11,975,017 Issues
2024-05-07 U.S. Patent No. 11,975,012 Issues
2025-06-18 Plaintiff receives Defendants' Notice Letter
2025-07-30 Complaint Filing Date

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

U.S. Patent No. 10,675,296 - "Compositions Comprising an RNA Polymerase Inhibitor and Cyclodextrin for Treating Viral Infections"

  • Patent Identification: U.S. Patent No. 10,675,296, "Compositions Comprising an RNA Polymerase Inhibitor and Cyclodextrin for Treating Viral Infections," issued June 9, 2020.

The Invention Explained

  • Problem Addressed: The patent background identifies the active antiviral ingredient, remdesivir (referred to as "Compound 1"), as being "relatively insoluble and chemically unstable in aqueous media" (’296 Patent, col. 1:38-42). These properties create significant challenges for developing a formulation suitable for parenteral (e.g., intravenous) administration, which is necessary for treating certain patients (’296 Patent, col. 1:42-49).
  • The Patented Solution: The invention is a pharmaceutical formulation that solves the stability and solubility problems by combining remdesivir with cyclodextrin, a type of cyclic oligosaccharide used as a solubilizing agent (’296 Patent, col. 2:1-5). The patent describes a process where these components are combined and then lyophilized (freeze-dried) to create a stable powder that can be reconstituted with water for injection, yielding a solution suitable for intravenous use (’296 Patent, col. 2:32-44).
  • Technical Importance: This formulation technology enables the intravenous delivery of a potent antiviral agent that would otherwise be difficult to administer effectively to hospitalized patients with severe viral infections.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶63).
  • Essential elements of claim 1 include:
    • A composition comprising (i) Compound 1 (remdesivir) or a salt thereof, in an amount of from 1% to 10% w/w;
    • and (ii) cyclodextrin in an amount of from 90% to 99% w/w;
    • wherein the composition is a lyophilized composition.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 11,266,681 - "Compositions Comprising an RNA Polymerase Inhibitor and Cyclodextrin for Treating Viral Infections"

  • Patent Identification: U.S. Patent No. 11,266,681, "Compositions Comprising an RNA Polymerase Inhibitor and Cyclodextrin for Treating Viral Infections," issued March 8, 2022.

The Invention Explained

  • Problem Addressed: This patent, from the same family as the ’296 Patent, addresses the identical technical problem: the poor aqueous solubility and chemical instability of remdesivir ("Compound 1"), which complicates the development of a parenteral formulation (’681 Patent, col. 1:44-48).
  • The Patented Solution: The invention claims methods of treating viral infections by using the formulation technology described in the ’296 Patent. The claims cover the steps of reconstituting a lyophilized powder containing remdesivir and cyclodextrin with water and then administering the resulting solution to a human patient suffering from a viral infection caused by specific families of viruses (’681 Patent, col. 26:11-27).
  • Technical Importance: This patent protects the specific method of using the formulated remdesivir product to treat viral infections such as those caused by Coronaviridae.

Key Claims at a Glance

  • The complaint asserts at least independent claims 1 and 28 (Compl. ¶75).
  • Essential elements of claim 1 include:
    • A method of treating a viral infection in a human;
    • comprising (a) reconstituting with safe water for injection a lyophilized pharmaceutical composition;
    • wherein the composition comprises (i) Compound 1 (remdesivir) at 1% to 10% w/w and (ii) cyclodextrin at 90% to 99% w/w;
    • thereby forming a reconstituted pharmaceutical composition;
    • and (b) administering a therapeutically effective amount of the reconstituted composition to the human;
    • wherein the viral infection is caused by an Arenaviridae virus, a Coronaviridae virus, a Filoviridae virus, or a Paramyxoviridae virus.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 11,975,017 - "Compositions Comprising an RNA Polymerase Inhibitor and Cyclodextrin for Treating Viral Infections"

  • Patent Identification: U.S. Patent No. 11,975,017, "Compositions Comprising an RNA Polymerase Inhibitor and Cyclodextrin for Treating Viral Infections," issued May 7, 2024.
  • Technology Synopsis: This patent is also in the same family as the ’296 and ’681 patents. It addresses the poor solubility and stability of remdesivir by claiming compositions that combine the active ingredient with cyclodextrin to enable parenteral administration (’017 Patent, col. 1:40-49).
  • Asserted Claims: Claims 1, 17, and 33 (Compl. ¶87).
  • Accused Features: The accused features are the formulation components of the Defendants' ANDA Product, which is alleged to contain remdesivir and a cyclodextrin excipient (Compl. ¶87).

U.S. Patent No. 11,491,169 - "Remdesivir Treatment Methods"

  • Patent Identification: U.S. Patent No. 11,491,169, "Remdesivir Treatment Methods," issued November 8, 2022.
  • Technology Synopsis: This patent addresses a method for treating viral infections with remdesivir. It claims a method of administration that specifically excludes concomitant treatment with chloroquine or an analog thereof, purportedly to avoid interference that could reduce the antiviral efficacy of remdesivir (’169 Patent, col. 1:40-47, col. 2:25-33).
  • Asserted Claims: Claim 1 (Compl. ¶99).
  • Accused Features: The complaint alleges that the instructions for use in the proposed label for Defendants' ANDA Product will induce healthcare providers to administer the generic remdesivir product in a manner that infringes the claimed method (Compl. ¶101).

U.S. Patent No. 11,903,953 - "Remdesivir Treatment Methods"

  • Patent Identification: U.S. Patent No. 11,903,953, "Remdesivir Treatment Methods," issued February 20, 2024.
  • Technology Synopsis: Belonging to the same family as the ’169 Patent, this patent also claims methods of treating viral infections with remdesivir. The claims include a negative limitation requiring that the patient is not being treated with chloroquine or its analogs, which could otherwise diminish the therapeutic effect of remdesivir (’953 Patent, col. 1:41-48, col. 2:26-34).
  • Asserted Claims: Claim 1 (Compl. ¶111).
  • Accused Features: The allegation is that the proposed product label for Defendants' generic will induce infringement of the claimed method by healthcare providers (Compl. ¶113).

U.S. Patent No. 11,975,012 - "Remdesivir Treatment Methods"

  • Patent Identification: U.S. Patent No. 11,975,012, "Remdesivir Treatment Methods," issued May 7, 2024.
  • Technology Synopsis: This patent is also from the same family as the ’169 and ’953 patents. It protects methods of administering remdesivir for viral infections while excluding concurrent treatment with chloroquine or its analogs, based on the potential for those drugs to antagonize the antiviral activity of remdesivir (’012 Patent, col. 1:43-49, col. 2:28-36).
  • Asserted Claims: Claims 1 and 27 (Compl. ¶123).
  • Accused Features: Infringement is alleged based on the instructions for use that will be included with Defendants' ANDA product, which is alleged to induce performance of the claimed method (Compl. ¶125).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' proposed generic version of Gilead's VEKLURY®, identified as "remdesivir powder, intravenous, 100mg/vial" and referred to as "Defendant's ANDA Product" (Compl. ¶33). The product is the subject of ANDA No. 220566 filed with the FDA (Compl. ¶1).

Functionality and Market Context

The complaint alleges that the ANDA Product contains the active ingredient remdesivir, the chemical structure of which is shown in the complaint (Compl. ¶27, 63). The complaint alleges that the ANDA product is a generic version of Veklury®, which is a sterile, preservative-free lyophilized powder requiring reconstitution for intravenous infusion (Compl. ¶28, 33). The complaint further alleges that the ANDA contains data demonstrating the bioequivalence of the ANDA Product and VEKLURY® (Compl. ¶36). The product is intended to compete directly with Gilead's VEKLURY®, which is the first FDA-approved therapy for the treatment of COVID-19 (Compl. ¶2). The complaint includes a figure depicting the chemical structure of remdesivir, identifying the active ingredient in the accused product (Compl. ¶27).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,675,296 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising (i) a Compound 1...or a pharmaceutically acceptable salt thereof... Defendants' ANDA Product contains remdesivir, which is identified as Compound 1 in the patent. ¶63 col. 1:30-37
...and (ii) cyclodextrin... Gilead's VEKLURY® product, which Defendants' product is alleged to copy, contains betadex sulfobutyl ether sodium, which is a type of cyclodextrin. ¶28 col. 3:19-25
...Compound 1 in an amount of from 1% to 10% w/w...and cyclodextrin in an amount of from 90% to 99% w/w The complaint alleges the ANDA Product falls within the scope of the claim but does not specify the weight-by-weight percentages of the components. ¶63 col. 25:48-51
...wherein the composition is a lyophilized composition. The ANDA Product is described as a "remdesivir powder" for injection, which corresponds to the lyophilized (freeze-dried) form of the patented composition. ¶33 col. 2:32-34

U.S. Patent No. 11,266,681 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a viral infection in a human... The proposed label for Defendants' ANDA Product will instruct its use for treating viral infections, such as COVID-19. ¶25, 33 col. 1:15-20
comprising (a) reconstituting with safe water for injection a lyophilized pharmaceutical composition... The proposed product label will instruct healthcare providers to reconstitute the lyophilized powder prior to administration. ¶28, 77 col. 26:12-14
wherein the composition comprises (i) Compound 1...and (ii) cyclodextrin... Defendants' ANDA Product is alleged to be a lyophilized powder containing remdesivir (Compound 1) and a cyclodextrin. ¶33, 75 col. 26:15-20
and (b) administering a therapeutically effective amount of the reconstituted pharmaceutical composition to the human... The proposed product label will provide dosage and administration instructions for treating patients. ¶29, 77 col. 26:21-23
wherein the viral infection is caused by an Arenaviridae virus, a Coronaviridae virus, a Filoviridae virus, or a Paramyxoviridae virus. The product will be indicated for treating COVID-19, which is caused by a Coronaviridae virus (SARS-CoV-2). ¶2, 25 col. 26:24-27
  • Identified Points of Contention:
    • Evidentiary Questions: For the composition patents (’296, ’681, ’017), a primary question will be evidentiary: what are the exact weight-by-weight percentages of remdesivir and the specific cyclodextrin used in Defendants' ANDA product? The complaint alleges these fall within the claimed ranges but provides no specific data, making this a central point for discovery and factual dispute.
    • Scope Questions: For the method patents (’169, ’953, ’012), the analysis may focus on the scope of the negative limitation "wherein the human is not being treated with chloroquine." A potential issue is whether the proposed product label will be sufficient to induce infringement of this negative step, or whether there is a substantial non-infringing use for the generic product that would defeat the inducement claim.

V. Key Claim Terms for Construction

  • The Term: "lyophilized composition"

  • Context and Importance: This term appears in the independent claims of the composition-focused patents (’296, ’681, ’017). The infringement allegation hinges on Defendants' ANDA Product, a powder for injection, meeting this definition. Practitioners may focus on this term because the specific manufacturing process used by Defendants could be argued to fall outside the scope of what one of ordinary skill would consider "lyophilized" in the context of the patent.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent does not provide a specific definition for "lyophilized," which may support applying its plain and ordinary meaning of a freeze-dried substance, as would be understood by a person of ordinary skill in the art (’296 Patent, col. 2:32-35).
    • Evidence for a Narrower Interpretation: The specification describes a specific process for preparing the composition that involves dissolving remdesivir in an acidic solution of cyclodextrin, adjusting the pH to create a "supersaturated solution," and then lyophilizing that specific solution (’296 Patent, col. 25:21-40). A defendant could argue that "lyophilized composition" should be construed more narrowly to be limited to a product made by this specific process.

  • The Term: "cyclodextrin"

  • Context and Importance: This term is critical because infringement of the composition patents requires the ANDA product to contain a compound that falls within its scope. The VEKLURY® label identifies "betadex sulfobutyl ether sodium" as an inactive ingredient, which the patent explicitly lists as a type of cyclodextrin (Compl. ¶28; ’296 Patent, col. 4:63-64). The dispute will turn on whether the specific excipient in Defendants' product meets the claim's definition.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification provides a broad definition, describing cyclodextrin as a "chemical family of cyclic compound typically having 6, 7, or 8 sugar units" and includes non-limiting examples of derivatives such as "sulfobutylalkylether-beta-cyclodextrin" and "betadex-sulfobutylether sodium" (’296 Patent, col. 3:19-25, col. 4:56-64).
    • Evidence for a Narrower Interpretation: While the definition is broad, a defendant might attempt to distinguish its specific excipient by arguing it possesses a structure or property that places it outside the definition understood by a person of ordinary skill in the art at the time of the invention, despite a superficial similarity.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement of the method of use patents (’681, ’169, ’953, ’012) because the product labeling for the ANDA Product will instruct healthcare professionals to administer the generic drug in a manner that practices the steps of the claimed methods (Compl. ¶77, 101, 113, 125).
  • Willful Infringement: The complaint alleges that Defendants were aware of each of the asserted patents at the time they submitted their ANDA (Compl. ¶72, 84, 96, 108, 120, 132). It further alleges that Defendants' assertions of invalidity in their Paragraph IV notice letter are "devoid of a good faith basis in either the facts or the law," which, if proven, could support a finding of willful infringement (Compl. ¶72).

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

  • A core issue will be one of evidentiary proof: can Gilead establish through discovery that the precise quantitative formulation of Defendants' ANDA Product—specifically, the weight-by-weight ratios of remdesivir to the chosen cyclodextrin excipient—falls squarely within the ranges recited in the composition claims? The complaint's lack of specificity on this point suggests it will be a central factual battleground.
  • A second issue will be one of claim validity: given that cyclodextrins are well-known solubilizing agents in the pharmaceutical arts, the case will likely involve a significant dispute over whether the claimed compositions were obvious at the time of the invention. The complaint's repeated assertion that Defendants' invalidity arguments lack a good-faith basis indicates that Gilead anticipates and is prepared to counter a robust obviousness challenge.
  • A third question will be one of induced infringement for the method claims: can Gilead prove that the proposed label for Defendants' generic product will inevitably lead healthcare providers to infringe the asserted method claims, particularly the negative limitation of not co-administering chloroquine? The analysis will likely focus on whether there are substantial non-infringing uses and whether the label's instructions are sufficiently specific to meet the standard for inducement.