DCT

1:19-cv-00626

Bausch Health Ireland Ltd v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00626, D. Del., 04/03/2019
  • Venue Allegations: Plaintiffs allege venue is proper in the District of Delaware because two Defendant entities are incorporated in Delaware and the foreign Defendant entities have purposefully availed themselves of the jurisdiction by, among other things, filing the Abbreviated New Drug Application (ANDA) that is the subject of this suit and previously litigating in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an ANDA to market a generic version of the prescription colon-cleansing solution Plenvu® constitutes an act of infringement of five U.S. patents listed in the FDA’s Orange Book.
  • Technical Context: The technology relates to high-performance, low-volume oral solutions for cleansing the colon prior to medical procedures, where patient compliance and palatability are significant market drivers.
  • Key Procedural History: The litigation was triggered by Defendants’ submission of ANDA No. 212934 to the U.S. Food and Drug Administration (FDA) and Plaintiffs' subsequent receipt of a "Notice of Certification" letter dated February 18, 2019, which constitutes a statutory act of infringement under the Hatch-Waxman Act.

Case Timeline

Date Event
2012-09-11 Patent Priority Date ('313, '969, '252, '297, '504 Patents)
2015-04-07 U.S. Patent No. 8,999,313 Issued
2016-05-03 U.S. Patent No. 9,326,969 Issued
2017-03-14 U.S. Patent No. 9,592,252 Issued
2017-07-18 U.S. Patent No. 9,707,297 Issued
2018-05-04 FDA Approval for Plenvu® (NDA No. 209381)
2018-07-10 U.S. Patent No. 10,016,504 Issued
2019-02-18 Plaintiffs Received Defendants’ ANDA Notice Letter
2019-04-03 Complaint Filing Date

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

U.S. Patent No. 8,999,313 - Compositions

  • Patent Identification: U.S. Patent No. 8,999,313, Compositions, issued April 7, 2015.
  • The Invention Explained:
    • Problem Addressed: The patent describes a need for colon cleansing solutions that are effective in smaller volumes and are more palatable to patients than prior art formulations, which often require ingesting two to four liters of an unpleasant-tasting liquid, leading to poor patient compliance ('313 Patent, col. 1:40-54).
    • The Patented Solution: The invention is a colon cleansing solution comprising polyethylene glycol (PEG) and a specific mixture of ascorbic acid and one or more salts of ascorbic acid. The key to the solution is a specific molar ratio of the acid to the salt, which the patent asserts balances the salty taste of the ascorbate salt with the sourness from the acid, resulting in a "surprisingly palatable taste" while maintaining osmotic effectiveness ('313 Patent, col. 2:51-64).
    • Technical Importance: This approach aims to improve patient compliance, a critical factor for successful pre-procedural bowel preparation, by reducing the required volume and improving the taste of the solution ('313 Patent, col. 1:51-54).
  • Key Claims at a Glance:
    • The complaint asserts claims 1-4, 7-9, 11-14, 16-20, 22-23, and 29 (Compl. ¶41).
    • Independent Claim 1:
      • A colon cleansing solution comprising:
      • a) 300 to 800 mmol per liter ascorbate anion provided by a mixture of: (i) ascorbic acid and (ii) one or more salts of ascorbic acid,
      • the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and
      • b) 10 to 200 g per liter polyethylene glycol.

U.S. Patent No. 9,326,969 - Compositions

  • Patent Identification: U.S. Patent No. 9,326,969, Compositions, issued May 3, 2016.
  • The Invention Explained:
    • Problem Addressed: The '969 Patent addresses the same technical problem as the '313 Patent: the need for more tolerable and effective low-volume colon cleansing regimens to improve patient compliance before medical procedures ('969 Patent, col. 1:47-54).
    • The Patented Solution: This patent claims the method of cleansing a colon by administering the palatable solution described in the '313 Patent, which contains PEG and the specific molar ratio of ascorbic acid to an ascorbate salt ('969 Patent, col. 2:51-64). The focus is on the act of using the composition for its intended therapeutic purpose.
    • Technical Importance: By claiming the method of use, the patent seeks to protect the specific application of the formulation, complementing the composition claims of related patents ('969 Patent, col. 12:1-13).
  • Key Claims at a Glance:
    • The complaint alleges infringement of at least one claim without specifying which ones (Compl. ¶57).
    • Independent Claim 1:
      • A method of cleansing the colon of a mammal, the method comprising administering to the mammal a colon cleansing solution comprising:
      • a) an ascorbate component comprising 300 to 800 mmol per liter ascorbate anion provided by a mixture of: (i) ascorbic acid and (ii) one or more salts of ascorbic acid,
      • the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and
      • b) polyethylene glycol.

Multi-Patent Capsule: U.S. Patent No. 9,592,252 - Colonoscopy-Preparation

  • Patent Identification: U.S. Patent No. 9,592,252, Colonoscopy-Preparation, issued March 14, 2017 (Compl. ¶31).
  • Technology Synopsis: This patent addresses poor patient compliance with colonoscopy preparations by claiming solutions with high concentrations of ascorbate anion to reduce the required volume ('252 Patent, col. 2:3-10). It also claims kits containing the compositions for preparing such solutions ('252 Patent, col. 41:4-42).
  • Asserted Claims: Claims 1-9 are asserted (Compl. ¶41).
  • Accused Features: The accused features are the formulation and components of Lupin's ANDA Product, alleged to be a generic version of Plenvu® (Compl. ¶¶8, 37).

Multi-Patent Capsule: U.S. Patent No. 9,707,297 - Compositions

  • Patent Identification: U.S. Patent No. 9,707,297, Compositions, issued July 18, 2017 (Compl. ¶32).
  • Technology Synopsis: This patent claims kits for preparing the palatable, low-volume colon cleansing solution containing a specific molar ratio of ascorbic acid to ascorbate salt, along with PEG ('297 Patent, col. 41:9-24). The claims focus on the combination of components provided to a user for preparing the final solution.
  • Asserted Claims: Claims 1-6, 8-18, and 20-24 are asserted (Compl. ¶41).
  • Accused Features: The accused features are the formulation and components of Lupin's ANDA Product, alleged to be a generic version of Plenvu® (Compl. ¶¶8, 37).

Multi-Patent Capsule: U.S. Patent No. 10,016,504 - Compositions

  • Patent Identification: U.S. Patent No. 10,016,504, Compositions, issued July 10, 2018 (Compl. ¶33).
  • Technology Synopsis: This patent claims colon cleansing solutions comprising the specific palatable mixture of ascorbic acid and ascorbate salt, along with PEG, and further claims methods of preparing these solutions ('504 Patent, col. 61:14-19).
  • Asserted Claims: Claims 1-11, 13-14, and 20 are asserted (Compl. ¶41).
  • Accused Features: The accused features are the formulation and components of Lupin's ANDA Product, alleged to be a generic version of Plenvu® (Compl. ¶¶8, 37).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is "Lupin's ANDA Product," a generic drug for which Defendants seek FDA approval under ANDA No. 212934 (Compl. ¶¶8, 36).
  • Functionality and Market Context: The product is an oral solution intended to be a generic version of Plaintiffs’ Plenvu® product, used for colon cleansing (Compl. ¶37). The complaint identifies the active ingredients as polyethylene glycol 3350 (140 g), sodium ascorbate (48.11 g), sodium sulfate (9 g), ascorbic acid (7.54 g), sodium chloride (5.2 g), and potassium chloride (2.2 g) (Compl. ¶8). Plaintiffs allege that Lupin’s ANDA Product is the same or substantially the same as Plenvu®, which is listed in the FDA’s Orange Book as being covered by the patents-in-suit (Compl. ¶¶42-43).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed, element-by-element infringement analysis. The central allegation is that the filing of ANDA No. 212934 for a product with the specified formulation constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2) because the product, if marketed, would infringe the patents-in-suit (Compl. ¶¶46-47).

'313 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A colon cleansing solution comprising: The complaint alleges Lupin's ANDA product is a colon cleansing solution that is the same or substantially the same as Plenvu®. ¶¶8, 37, 43 col. 1:29-34
a) 300 to 800 mmol per liter ascorbate anion provided by a mixture of: (i) ascorbic acid and (ii) one or more salts of ascorbic acid, Lupin's product is alleged to contain ascorbic acid (7.54 g) and sodium ascorbate (48.11 g), which together provide the claimed ascorbate anion. ¶8 col. 2:53-56
the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; The complaint alleges infringement, which suggests the specified amounts of ascorbic acid and sodium ascorbate in Lupin's product result in a molar ratio within the claimed range. ¶¶8, 47 col. 2:58-61
and b) 10 to 200 g per liter polyethylene glycol. Lupin's product is alleged to contain polyethylene glycol 3350 (140 g). ¶8 col. 2:62-63

'969 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of cleansing the colon of a mammal, the method comprising administering to the mammal a colon cleansing solution comprising: The filing of the ANDA seeks approval to market the product with proposed labeling that will instruct medical professionals and patients to administer it for the purpose of cleansing the colon. ¶¶37, 57, 59 col. 1:29-34
a) an ascorbate component comprising 300 to 800 mmol per liter ascorbate anion provided by a mixture of: (i) ascorbic acid and (ii) one or more salts of ascorbic acid, the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and b) polyethylene glycol. As described above for the '313 Patent, the solution to be administered is alleged to contain the claimed mixture of ascorbic acid, sodium ascorbate, and polyethylene glycol meeting the claimed ratio. ¶¶8, 58 col. 2:51-64
  • Identified Points of Contention:
    • Factual Question: The complaint provides the weights of the components in Lupin's ANDA product, but not the final volume of the reconstituted solution or the resulting molar concentrations and ratios (Compl. ¶8). A primary point of contention will be a factual one: does the formulation specified in ANDA No. 212934, when prepared according to its proposed instructions, result in a solution that meets the specific molar ratio and concentration limitations required by the asserted claims?
    • Scope Question: The dispute may raise the question of whether the claimed ranges, such as the "molar ratio of from 1:4.5 to 1:7.0," are entitled to a literal scope that covers Defendants' formulation, or if prosecution history or prior art could limit the interpretation of this range.

V. Key Claim Terms for Construction

  • The Term: "a mixture of... ascorbic acid and... one or more salts of ascorbic acid... in a molar ratio of from 1:4.5 to 1:7.0" ('313 Patent, Claim 1)
  • Context and Importance: This ratio is presented in the patent as the central feature for achieving improved palatability by balancing sour and salty tastes ('313 Patent, col. 2:51-64). Its construction and the methodology for its calculation will be critical to the infringement analysis, as even a small deviation in the accused product's formulation could move it outside the literal scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides several embodiments and progressively narrower preferred ranges, which may suggest that the broadest range recited in the claim should be given its full scope. For example, the patent states the ratio is "from 1:4.5 to 1:7.0," and then describes more preferable ranges, such as "from 1:5.0 to 1:6.0" ('313 Patent, col. 7:25-27), implying the claim covers the entire 1:4.5 to 1:7.0 range.
    • Evidence for a Narrower Interpretation: A party might argue that the term should be limited by the explicit purpose of achieving a palatable taste, as described in the "Summary of the Invention" ('313 Patent, col. 2:51-64). The detailed description also provides specific weight ratios corresponding to the molar ratios, which could be used to argue for a more constrained interpretation based on those specific examples ('313 Patent, col. 4:47-60).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval and marketing, Defendants will contributorily infringe and/or induce infringement of the asserted claims (Compl. ¶¶48, 59, 70, 81, 92). This allegation suggests that Defendants' product labeling and instructions for use will actively encourage or instruct medical providers and patients to use the ANDA product in a manner that directly infringes the method claims.
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, in the Prayer for Relief, Plaintiffs request the Court to "Declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4) and award Plaintiffs costs, expenses, and disbursements in this action, including reasonable attorney's fees" (Compl. Prayer for Relief ¶9).

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

  • A core issue will be one of factual proof: Can Plaintiffs demonstrate through chemical analysis or from the contents of the ANDA itself that Defendants' product, when reconstituted according to its proposed label, necessarily meets the specific quantitative limitations of the asserted claims, particularly the molar ratio of ascorbic acid to ascorbate salt?
  • A central legal question will be one of claim scope: How will the court construe the numerical ranges of the asserted claims? The case may turn on whether Defendants' formulation falls squarely within a literal reading of those ranges or if it resides in a peripheral area where arguments over claim construction and the doctrine of equivalents could become decisive.