DCT

2:15-cv-03327

Horizon Pharma Inc v. Mylan Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:15-cv-03327, D.N.J., 05/13/2015
  • Venue Allegations: Venue is alleged based on Defendants' sales of pharmaceutical products and business operations within New Jersey, establishing systematic contacts and general jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' VIMOVO® product infringes two patents covering pharmaceutical compositions for the coordinated delivery of naproxen and esomeprazole.
  • Technical Context: The technology concerns combination drug formulations designed to mitigate the known gastrointestinal side effects of non-steroidal anti-inflammatory drugs (NSAIDs) by co-administering a stomach acid inhibitor.
  • Key Procedural History: Plaintiffs note several other pending lawsuits they have filed against different generic drug manufacturers (Dr. Reddy's, Lupin, Actavis, and Mylan itself) concerning the same drug formulations and related patents, suggesting a history of enforcement of this patent portfolio. These cases have been consolidated for discovery before the same judicial officers.

Case Timeline

Date Event
2001-06-01 Earliest Priority Date for '636 and '996 Patents
2005-08-09 Issue Date of related U.S. Patent No. 6,926,907
2013-05-16 ANDA Notice Letter sent regarding '907 and '285 patents
2013-10-15 Issue Date of related U.S. Patent No. 8,557,285
2014-10-07 U.S. Patent No. 8,852,636 Issues
2014-10-14 U.S. Patent No. 8,858,996 Issues
2015-01-23 Plaintiffs request Defendants provide Paragraph IV certifications
2015-02-09 ANDA Notice Letters sent regarding '285, '636, and '996 patents
2015-05-13 Complaint Filed

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

U.S. Patent No. 8,852,636 - "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs"

  • Patent Identification: U.S. Patent No. 8,852,636, "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs", issued October 7, 2014.

The Invention Explained

  • Problem Addressed: The patent addresses the well-known problem that non-steroidal anti-inflammatory drugs (NSAIDs), while effective for pain, can cause significant gastrointestinal damage, such as ulcers and erosions, particularly due to the presence of stomach acid (’636 Patent, col. 1:36-44). The patent notes that while existing acid inhibitors can help, they are often too slow to act or their effect diminishes between doses, leaving the gut lining vulnerable when the NSAID is active (’636 Patent, col. 2:1-12).
  • The Patented Solution: The invention is a unit dosage tablet that coordinates the release of two drugs. It features an outer layer containing an acid inhibitor (esomeprazole) that dissolves immediately upon ingestion to quickly raise the stomach's pH. This outer layer surrounds an inner core containing an NSAID (naproxen). The inner core is protected by a special enteric coating that prevents the NSAID from being released until the stomach's pH has been raised to a safer, less acidic level (e.g., pH 3.5 or higher) by the acid inhibitor (’636 Patent, Abstract; col. 4:46-65).
  • Technical Importance: This coordinated-release formulation represents a method to provide the pain relief of an NSAID while proactively protecting the stomach lining from the drug's damaging effects by ensuring the gastric environment is rendered less acidic before the NSAID is released (’636 Patent, col. 1:21-27).

Key Claims at a Glance

  • The complaint asserts claims 1–4, 7–10, and 13–18 (composition claims) and claims 5–6 and 11–12 (method of use claims) (Compl. ¶11).
  • Independent Claim 1 requires:
    • A pharmaceutical composition in a unit dose tablet form.
    • An effective amount of esomeprazole to raise gastric pH to at least 3.5.
    • An effective amount of naproxen.
    • The naproxen is located in a core.
    • The core is surrounded by a coating that prevents naproxen release until the surrounding pH is 3.5 or higher.
    • The esomeprazole is in one or more layers outside the core, is not itself enterically coated, and is released upon ingestion into the stomach.

U.S. Patent No. 8,858,996 - "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs"

  • Patent Identification: U.S. Patent No. 8,858,996, "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs", issued October 14, 2014.

The Invention Explained

  • Problem Addressed: The ’996 Patent addresses the identical technical problem as the ’636 Patent: the risk of gastroduodenal lesions from NSAID therapy due to stomach acid exposure (’996 Patent, col. 1:35-44).
  • The Patented Solution: The solution described is functionally identical to that of the ’636 Patent: a multilayer tablet providing for the immediate release of an acid inhibitor (esomeprazole) from an outer layer to raise gastric pH, followed by the delayed, pH-triggered release of an NSAID (naproxen) from an enterically coated inner core (’996 Patent, Abstract; col. 4:45-64).
  • Technical Importance: As with the ’636 patent, this approach aims to uncouple the timing of NSAID release from the period of highest gastric acidity, thereby reducing the risk of mucosal injury (’996 Patent, col. 1:21-27).

Key Claims at a Glance

  • The complaint asserts claims 1–9 and 12–15 (composition claims) and claims 10–11 and 16–19 (method of use claims) (Compl. ¶14).
  • Independent Claim 1 of the ’996 Patent is substantively identical to Claim 1 of the ’636 Patent, requiring:
    • A unit dose tablet composition.
    • An effective amount of esomeprazole to raise gastric pH to at least 3.5.
    • An effective amount of naproxen.
    • A structure where naproxen is in an enterically coated core (release triggered at pH ≥ 3.5) and esomeprazole is in an immediate-release outer layer.

III. The Accused Instrumentality

  • Product Identification: The complaint identifies "Mylan's ANDA Product" as the primary accused instrumentality, described as generic versions of VIMOVO® Delayed-Release Tablets (Compl. ¶23). It refers to ANDA No. 204920 for this product (Compl. ¶23). However, the infringement counts for the '996 Patent are directed at "Actavis' ANDA Product" under ANDA No. 204470, creating a significant inconsistency within the pleading (Compl. ¶¶ 66, 68). The prayer for relief refers only to Mylan's ANDA No. 204920 (Compl. ¶17.B).
  • Functionality and Market Context:
    • The accused product is a delayed-release tablet containing either 375 mg or 500 mg of naproxen combined with 20 mg of esomeprazole magnesium (Compl. ¶23).
    • The complaint alleges that Mylan seeks FDA approval to manufacture, use, and sell this product in the United States as a generic equivalent to Plaintiffs' branded VIMOVO® tablets (Compl. ¶23). VIMOVO® is approved to relieve symptoms of arthritis and to decrease the risk of stomach ulcers from NSAID treatment (Compl. ¶10). The filing of the ANDA itself constitutes the act of infringement under the Hatch-Waxman Act (Compl. ¶45).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that Defendants' ANDA product contains the same pharmaceutical composition patented in the '636 and '996 patents and that its making, use, or sale will infringe the patents (Compl. ¶¶ 44, 46, 68, 70). The infringement theory relies on the ANDA product being a generic copy of VIMOVO®, thereby necessarily practicing the patented coordinated-release formulation.

'636 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition in unit dose form... comprising... esomeprazole present in an amount effective to raise the gastric pH of said patient to at least 3.5... The accused ANDA product is a tablet containing 20 mg of esomeprazole magnesium, alleged to be an effective amount. ¶23 col. 4:43-45
[and] naproxen present in an amount effective to reduce or eliminate pain or inflammation... The accused ANDA product contains 375 mg or 500 mg of naproxen, alleged to be an effective amount. ¶23 col. 4:2-4
wherein... said unit dosage form is a tablet in which said naproxen is present in a core; The accused ANDA product is alleged to be a generic copy of VIMOVO® and to contain the patented composition, which has a naproxen core. ¶46 col. 4:30-32
said tablet comprises a coating, wherein said coating surrounds said core and does not release said naproxen until the pH of the surrounding medium is 3.5 or higher; The accused product is described as "Delayed-Release Tablets," which implies a pH-sensitive enteric coating that delays release of the naproxen core. ¶23 col. 4:55-59
and iii) said esomeprazole is in one or more layers outside said core... not surrounded by an enteric coating; and... release said esomeprazole into said patient's stomach. The accused ANDA product is alleged to have the same structure as the patented composition, which features an immediate-release outer layer of esomeprazole. ¶46 col. 4:46-54

'996 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition in unit dosage form... comprising... esomeprazole in an amount of from 5 to 100 mg... and naproxen in an amount of 200-600 mg... The complaint alleges "Actavis' ANDA Product" contains the patented composition, which would include effective amounts of esomeprazole and naproxen. ¶70 col. 21:26-31
wherein upon introduction of said unit dosage form into a medium... release of at least a portion of said naproxen is inhibited unless the pH of said medium is 3.5 or higher. The complaint alleges "Actavis' ANDA Product," as a generic of VIMOVO®, would have a delayed-release mechanism for naproxen that is pH-dependent. ¶70 col. 21:35-39
[and] at least a portion of said esomeprazole is released regardless of the pH of the medium... The complaint alleges "Actavis' ANDA Product" would have an immediate-release component for esomeprazole. ¶70 col. 21:32-35
  • Identified Points of Contention:
    • Factual Question (Product Identity): A threshold issue is the complaint's inconsistent identification of the accused product for the '996 Patent. The court will need to resolve whether the allegations for the '996 Patent pertain to Mylan's ANDA No. 204920 or, as pleaded, to Actavis's ANDA No. 204470 (Compl. ¶¶ 23, 68).
    • Technical Question (pH Trigger): A potential dispute may arise over whether the specific formulation in Defendants' ANDA product contains a coating that dissolves at the precise pH threshold claimed in the patents ("3.5 or higher"). The exact dissolution profile defined in the ANDA will be critical evidence.
    • Scope Question (Effectiveness): The claims require an amount of esomeprazole "effective to raise the gastric pH... to at least 3.5." The infringement analysis will depend on whether the 20 mg of esomeprazole in the accused product can be proven to achieve this functional outcome in a patient.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a full claim construction analysis. However, based on the technology, certain terms are likely to be central.

  • The Term: "a coating... [that] does not release said naproxen until the pH of the surrounding medium is 3.5 or higher" (’636 Patent, Claim 1)

  • Context and Importance: This term defines the functional behavior of the enteric coating that is critical to the invention's coordinated-release mechanism. The entire infringement case rests on whether the accused product's coating performs this specific, pH-defined function. Practitioners may focus on this term because the difference between infringement and non-infringement could be a small variation in the dissolution pH profile of the accused product's coating.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides some flexibility, stating the pH should be "at least 3.5, preferably to at least 4, and more preferably to at least 5" (’636 Patent, col. 4:1-3). A party could argue "3.5 or higher" sets a floor, not a precise target.
    • Evidence for a Narrower Interpretation: A party might argue that the term implies a sharp dissolution trigger around pH 3.5, pointing to specific examples in the patent, such as Example 1 which describes a coating designed to dissolve above pH 5.5, to argue for a more specific range of performance (’636 Patent, col. 9:33-36).

  • The Term: "effective to raise the gastric pH of said patient to at least 3.5" (’636 Patent, Claim 1)

  • Context and Importance: This is a functional limitation that defines the required performance of the esomeprazole component. The dispute will be over what evidence is required to prove "effectiveness."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification broadly describes the goal of raising pH to a "non-toxic level" before the NSAID is released, suggesting any formulation achieving this goal would be covered (’636 Patent, col. 2:31-33).
    • Evidence for a Narrower Interpretation: The patent includes clinical study data (Example 9) that correlates specific gastric pH levels (e.g., pH > 4) with reduced gastric damage, which could be used to argue that "effective" requires meeting a specific clinical endpoint demonstrated in the patent (’636 Patent, col. 20:43-56).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges facts supporting both contributory and induced infringement. It states that Mylan's ANDA product is "especially made or especially adapted for use in an infringement" and is not a "staple article or commodity of commerce suitable for substantial noninfringing use" (contributory infringement) (Compl. ¶46). It further alleges that Defendants are aware that their product, if approved, "will be used in contravention of Plaintiffs' rights" (induced infringement) (Compl. ¶46).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it does allege that Defendants were aware of the patent family through a May 2013 notice letter and were specifically aware of the patents-in-suit through a February 2015 notice letter, establishing pre-suit knowledge (Compl. ¶¶ 24, 26, 42, 65). The prayer for relief seeks attorneys' fees under 35 U.S.C. § 285, which are awardable in exceptional cases (Compl. ¶18.H).

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

  1. A critical pleading question: Does the complaint state a valid claim for infringement of the '996 Patent against Mylan when the infringement counts for that patent are explicitly directed at "Actavis' ANDA Product," an entity not party to the suit, and reference a different ANDA number from the one central to the rest of the case?
  2. A key technical question of infringement: Does the specific formulation detailed in Mylan's ANDA No. 204920 possess a delayed-release coating that meets the functional and pH-specific limitations of the asserted claims (i.e., release of naproxen is inhibited until the pH is 3.5 or higher)?
  3. An evidentiary question of claim scope: What is the scope of the functional limitation requiring an amount of esomeprazole "effective to raise the gastric pH... to at least 3.5"? The case may turn on whether this is interpreted as a structural requirement inherent in a bioequivalent formulation or a functional outcome that Plaintiffs must independently prove the accused product achieves.