DCT

2:17-cv-00071

Aralez Pharma Inc v. Teva Pharma USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-00071, E.D. Tex., 01/23/2017
  • Venue Allegations: Plaintiff alleges venue is proper based on Defendant Teva USA’s business of distributing generic pharmaceutical products in Texas and the allegation that the infringing activities will be purposefully directed at the Eastern District of Texas.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug Yosprala® constitutes an act of infringement of four U.S. patents related to pharmaceutical compositions that coordinate the delivery of an acid inhibitor and an NSAID.
  • Technical Context: The technology involves combination drug formulations designed to provide the therapeutic benefits of non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin while mitigating the risk of gastrointestinal side effects by co-administering an acid-reducing agent in a coordinated-release dosage form.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following a notice letter from Teva, dated December 9, 2016, which advised Plaintiff of Teva's ANDA filing and asserted that the '907, '741, and '439 patents were invalid, unenforceable, and/or not infringed. Three of the four patents-in-suit are listed in the FDA's "Orange Book" as covering the branded drug Yosprala®.

Case Timeline

Date Event
2001-06-01 '907, '741, and '439 Patents Priority Date
2005-08-09 '907 Patent Issue Date
2011-12-28 '214 Patent Priority Date
2012-06-26 '741 Patent Issue Date
2016-06-14 '439 Patent Issue Date
2016-09-14 FDA Approval of Yosprala® NDA No. 205103
2016-12-09 Teva Notice Letter Sent to Plaintiff
2017-01-10 '214 Patent Issue Date
2017-01-23 Complaint Filing Date

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

U.S. Patent No. 6,926,907 - Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs

  • Patent Identification: U.S. Patent No. 6,926,907, “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs,” issued August 9, 2005.

The Invention Explained

  • Problem Addressed: The patent’s background section describes the problem of gastroduodenal lesions, such as ulcers and erosions, that can result from the administration of non-steroidal anti-inflammatory drugs (NSAIDs), a side effect attributed in large part to the presence of stomach acid ('907 Patent, col. 1:20-31). It notes that prior attempts to combine NSAIDs with acid inhibitors failed to provide for a coordinated release that would ensure the gastric environment is made less acidic before the NSAID is released ('907 Patent, col. 2:20-33).
  • The Patented Solution: The invention is a unit dosage form that coordinates the release of an acid inhibitor and an NSAID. The dosage form is structured so that the acid inhibitor is released immediately upon ingestion to begin raising the stomach's pH, while the NSAID is contained within a core that is surrounded by a pH-sensitive coating, which delays the NSAID's release until the gastric pH has reached a safer, less acidic level of at least 3.5 ('907 Patent, Abstract; col. 4:1-17).
  • Technical Importance: The technology sought to provide a safer method for long-term NSAID therapy by creating a single-pill formulation that actively protects the gastrointestinal tract from the NSAID's damaging effects, thereby improving patient safety and compliance ('907 Patent, col. 1:11-18).

Key Claims at a Glance

  • The complaint asserts at least independent Claim 1 (Compl. ¶58).
  • The essential elements of Claim 1 are:
    • A pharmaceutical composition in unit dosage form suitable for oral administration to a patient, comprising:
    • (a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5;
    • (b) a non-steroidal anti-inflammatory drug (NSAID) in an effective amount;
    • wherein the unit dosage form provides for coordinated release such that:
    • (i) said NSAID is surrounded by a coating that... prevents the release of essentially any NSAID... unless the pH of the surrounding medium is 3.5 or higher;
    • (ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and... is released regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 8,206,741 - Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs

  • Patent Identification: U.S. Patent No. 8,206,741, “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs,” issued June 26, 2012.

The Invention Explained

  • Problem Addressed: The ’741 Patent addresses the same technical problem as its parent '907 Patent: NSAID-induced gastrointestinal damage caused by exposure of the gastric mucosa to the drug in a highly acidic environment ('741 Patent, col. 1:25-34).
  • The Patented Solution: The patent describes a pharmaceutical composition that specifically combines a proton pump inhibitor (PPI), a potent class of acid inhibitor, with aspirin. The composition provides for coordinated release where at least a portion of the PPI is formulated for immediate release (not enterically coated) to begin raising gastric pH, while the aspirin is covered by a pH-sensitive coating that prevents its release until the surrounding pH level reaches 3.5 or higher ('741 Patent, Abstract; col. 4:15-30).
  • Technical Importance: The invention focuses the coordinated release concept on the specific combination of a PPI with aspirin, a widely used NSAID for secondary prevention of cardiovascular events, thereby addressing a significant patient population at risk for both cardiovascular events and gastric ulcers ('741 Patent, col. 10:59-64).

Key Claims at a Glance

  • The complaint asserts at least independent Claim 1 (Compl. ¶69).
  • The essential elements of Claim 1 are:
    • A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
    • (a) a proton pump inhibitor selected from a group including omeprazole, wherein at least a portion of said proton pump inhibitor is not surrounded by an enteric coating; and
    • (b) aspirin, wherein said aspirin is surrounded by a coating that inhibits its release... unless said dosage form is in a medium with a pH of 3.5 or higher;
    • wherein the unit dosage form provides for release of said proton pump inhibitor and said aspirin such that:
    • (i) upon introduction... at least a portion of said proton pump inhibitor is released regardless of the pH of the medium; and
    • (ii) said aspirin is released when the pH of said medium is 3.5 or higher.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent but does allege infringement of one or more claims generally (Compl. ¶66).

U.S. Patent No. 9,364,439 - Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs

  • Patent Identification: U.S. Patent No. 9,364,439, “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs,” issued June 14, 2016 (Compl. ¶21).
  • Technology Synopsis: This patent claims a pharmaceutical composition combining omeprazole and aspirin in a single unit dosage form to reduce the risk of NSAID-induced gastric ulcers (’439 Patent, Abstract). The invention ensures that at least a portion of the omeprazole is available for immediate release to raise gastric pH, while the aspirin component is enterically coated to delay its release until the gastric pH is 3.5 or higher, thereby preventing the aspirin from contacting the stomach lining in a highly acidic state (’439 Patent, col. 11:43-64).
  • Asserted Claims: At least independent Claim 1 (Compl. ¶88).
  • Accused Features: The accused features are the omeprazole and coated aspirin components of Teva's generic product, which are alleged to be formulated for the coordinated release claimed by the patent (Compl. ¶89).

U.S. Patent No. 9,539,214 - Compositions and Methods for Delivery of Omeprazole Plus Acetylsalicylic Acid

  • Patent Identification: U.S. Patent No. 9,539,214, “Compositions and Methods for Delivery of Omeprazole Plus Acetylsalicylic Acid,” issued January 10, 2017 (Compl. ¶22).
  • Technology Synopsis: This patent is directed to methods of delivering a pharmaceutical composition of omeprazole and acetylsalicylic acid (aspirin) to a patient to achieve specific pharmacokinetic (PK) profiles (’214 Patent, Abstract). The claimed method involves administering a unit dose form where omeprazole is released immediately (at a pH of 0 or greater) and aspirin release is delayed until the pH is approximately 3.5 or higher, targeting specific plasma concentration levels and absorption times for both drugs (’214 Patent, col. 67:1-68:45).
  • Asserted Claims: The complaint alleges infringement of one or more method claims but does not identify specific claim numbers in the body of Count IV (Compl. ¶¶106, 107).
  • Accused Features: The accused feature is the act of administering Teva's generic product to patients in accordance with Teva's proposed product label, which Plaintiff alleges will result in direct infringement of the claimed methods by physicians and patients (Compl. ¶107).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Teva's Generic Product," identified as Aspirin Delayed-release and Omeprazole Tablets in dosages of 81 mg aspirin/40 mg omeprazole and 325 mg aspirin/40 mg omeprazole (Compl. ¶26).

Functionality and Market Context

  • The product is a generic version of the branded drug Yosprala® and, by virtue of its ANDA filing, is represented to have the same active ingredients, dosage form, strength, and bioequivalence as Yosprala® (Compl. ¶¶26, 30).
  • It is intended for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are also at risk of developing aspirin-associated gastric ulcers (Compl. ¶¶18, 31).
  • The product combines an immediate-release acid inhibitor (omeprazole) with a delayed-release NSAID (aspirin) in a single tablet (Compl. ¶26).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’907 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5... Teva's Generic Product contains omeprazole, an acid inhibitor. ¶59 col. 3:23-28
(b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effective to reduce or eliminate pain or inflammation... Teva's Generic Product contains aspirin, an NSAID. ¶59 col. 3:40-42
(i) said NSAID is surrounded by a coating that... prevents the release of essentially any NSAID... unless the pH of the surrounding medium is 3.5 or higher The aspirin component of Teva's Generic Product is described as "Delayed-release," and the complaint alleges it will meet this limitation. ¶¶26, 59 col. 4:6-9
(ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and... is released regardless of whether the pH... is below 3.5 or above 3.5 The omeprazole component of Teva's Generic Product is alleged to be formulated for immediate release to meet this limitation. ¶59 col. 4:12-17

’741 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) a proton pump inhibitor selected from the group consisting of omeprazole... wherein at least a portion... is not surrounded by an enteric coating Teva's Generic Product contains omeprazole, a PPI, which the complaint alleges is formulated for immediate release. ¶70 col. 22:2-6
(b) aspirin, wherein said aspirin is surrounded by a coating that inhibits its release... unless said dosage form is in a medium with a pH of 3.5 or higher Teva's Generic Product contains aspirin with a delayed-release coating. ¶¶26, 70 col. 22:6-9
(i) upon introduction... at least a portion of said proton pump inhibitor is released regardless of the pH of the medium The omeprazole component is alleged to be formulated for immediate release, independent of pH. ¶70 col. 22:13-16
(ii) said aspirin is released when the pH of said medium is 3.5 or higher The delayed-release aspirin component is alleged to release only at or above the specified pH threshold. ¶70 col. 22:17-18
  • Identified Points of Contention:
    • Scope Questions: A likely point of contention will be the scope of functional language in the claims, such as the requirement that the acid inhibitor be "effective to raise the gastric pH... to at least 3.5." The infringement analysis may depend not only on the composition of Teva's product but on clinical or bioequivalence data demonstrating this in vivo effect.
    • Technical Questions: A key technical question will be whether Teva's specific formulation for its delayed-release aspirin meets the negative limitation of "prevents the release of essentially any NSAID" below pH 3.5 as required by Claim 1 of the ’907 Patent. The complaint relies on Teva's ANDA representations (Compl. ¶30) rather than providing specific dissolution data for the accused product, raising the question of what evidence will support this element.

V. Key Claim Terms for Construction

  • The Term: "prevents the release of essentially any NSAID" (’907 Patent, Claim 1)

    • Context and Importance: This term is central to the infringement analysis because it defines the performance standard for the pH-sensitive coating on the NSAID. Practitioners may focus on this term because the extent of any "leaky" release from Teva's delayed-release aspirin component at a pH below 3.5 will determine whether the product infringes. The definition of "essentially any" is not quantified in the patent and will likely be a significant subject of claim construction.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent’s overall objective is to reduce "gastrointestinal damage" and "unwanted side effects" ('907 Patent, col. 1:11-18). A party could argue that "essentially any" should be interpreted functionally to mean preventing the release of a clinically significant or damaging amount of the NSAID, rather than a standard of absolute or near-absolute prevention.
      • Evidence for a Narrower Interpretation: The use of the strong term "prevents" combined with "essentially any" could support an interpretation requiring a very high degree of release inhibition below pH 3.5. A party might argue that if any measurable amount of NSAID is released below the threshold, the limitation is not met. The specification does not provide a specific percentage threshold, leaving the term open to interpretation based on its plain meaning.

  • The Term: "coordinated release" (’907 Patent, Claim 1 preamble)

    • Context and Importance: Although appearing in the preamble, this concept is described as the core of the invention in the patent's title and summary ('907 Patent, Title; col. 3:3-17). Practitioners may focus on this term because the dispute hinges on whether Teva's product, by being a bioequivalent generic of Yosprala®, inherently performs the claimed "coordinated release," even if the term itself is not a formal limitation in the claim body. The term frames the sequential action required: acid inhibitor release first, followed by pH-triggered NSAID release.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the concept broadly as a sequence of events: "the acid inhibitor is released first and the release of NSAID is delayed until after the pH in the GI tract has risen" ('907 Patent, col. 4:1-4). This functional description could support a construction that covers any formulation achieving this result, regardless of its specific structure.
      • Evidence for a Narrower Interpretation: The patent’s preferred embodiment is a "multilayer tablet" ('907 Patent, col. 4:2-5; FIG. 1). A party could argue that the term, when read in light of the specification, is tied to the disclosed structures that enable this coordination, potentially narrowing its scope to exclude alternative formulation strategies that might achieve a similar but not identical release profile.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced and contributory infringement for the '741, '439, and '214 patents, which contain method of treatment claims (Compl. ¶¶75-80, 93-99, 107-113). The allegations are based on the assertion that Teva's product label will instruct physicians and patients to administer the generic product for its approved indications, and that such administration will directly infringe the method claims (Compl. ¶¶35, 74, 93, 107). Teva’s alleged knowledge of the patents and intent to cause infringement are based on the Orange Book listings and its notice letter (Compl. ¶¶71, 77).
  • Willful Infringement: The complaint does not contain a formal count for willful infringement. However, it repeatedly alleges that the case is "exceptional" under 35 U.S.C. § 285 and requests an award of attorney fees (Compl. ¶¶62, 81, 100; Prayer for Relief ¶E). The basis for this allegation is Teva's pre-suit knowledge of the patents-in-suit via the Orange Book and its own notice letter, coupled with the assertion that Teva's non-infringement and invalidity arguments "are devoid of an objective good faith basis in either the facts or the law" (Compl. ¶62).

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

  • A core issue will be one of functional performance: does Teva’s ANDA product, upon administration to a patient, achieve the functional limitations recited in the claims, such as raising gastric pH to at least 3.5 before the aspirin is released? The outcome may turn on bioequivalence data and clinical evidence rather than solely on the product’s physical composition.
  • A key question of claim construction will center on the scope of the term "prevents the release of essentially any NSAID." The dispute will likely require the court to define a quantitative threshold for this limitation, which will then be compared against factual evidence of the accused product's dissolution profile at low pH levels.
  • A central evidentiary question will be whether Plaintiff can prove intent for inducement. Given that infringement of the method claims will be performed by third-party physicians and patients, the case will require an analysis of whether Teva's proposed product labeling provides sufficient instruction and encouragement to actively induce those third parties to perform the patented methods.