DCT

1:10-cv-00106

Alcon Research Ltd v. Sandoz Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:10-cv-00106, S.D. Ind., 01/27/2010
  • Venue Allegations: Venue is based on allegations that Sandoz is subject to personal jurisdiction in Indiana, where it markets and distributes pharmaceutical products.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the Pataday™ ophthalmic solution constitutes an act of infringement of three patents covering the drug's formulation and method of use.
  • Technical Context: The technology concerns topical ophthalmic formulations containing olopatadine hydrochloride, an antihistamine and mast cell stabilizer, for treating allergic eye diseases.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following a notice letter from Sandoz, dated December 14, 2009, informing Plaintiffs of its ANDA filing and its certification that the asserted patents are invalid, unenforceable, or will not be infringed. U.S. Patent No. 5,641,805 underwent an ex parte reexamination, which concluded on February 13, 2014, confirming the patentability of claims 4 and 8.

Case Timeline

Date Event
1995-06-06 Priority Date for U.S. Patent No. 5,641,805
1997-06-24 U.S. Patent No. 5,641,805 Issued
2001-06-27 Priority Date for U.S. Patent Nos. 6,995,186 & 7,402,609
2006-02-07 U.S. Patent No. 6,995,186 Issued
2008-07-22 U.S. Patent No. 7,402,609 Issued
2009-12-14 Sandoz sends Notice Letter regarding ANDA filing
2010-01-27 Complaint Filed
2014-02-13 Reexamination Certificate for U.S. Patent No. 5,641,805 Issued

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

U.S. Patent No. 5,641,805 - "Topical Ophthalmic Formulations for Treating Allergic Eye Diseases"

  • Patent Identification: U.S. Patent No. 5,641,805, "Topical Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June 24, 1997. (Compl. ¶10).

The Invention Explained

  • Problem Addressed: The patent’s background section highlights that anti-allergy drug effects observed in rodent mast cells are not predictive of effects in human mast cells, particularly the conjunctival mast cells of the eye, which are the target for treating eye allergies. (’805 Patent, col. 2:42-56).
  • The Patented Solution: The invention provides a method of treating allergic eye diseases by topically applying a formulation containing olopatadine. The patent claims this method works by specifically "stabilizing" human conjunctival mast cells, thereby preventing the release of histamine and other inflammation-causing agents directly at the site of the allergic reaction. (’805 Patent, col. 3:17-19, col. 8:27-34). The specification provides data from experiments on human conjunctival tissue to demonstrate this stabilizing effect. (’805 Patent, col. 3:41-46, Table 1).
  • Technical Importance: The invention established a method of use for olopatadine based on its demonstrated efficacy on the specific human cells relevant to allergic eye disease, providing a more targeted therapeutic approach than previously available. (’805 Patent, col. 2:20-31).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims, alleging infringement of "one or more claims." (Compl. ¶20). Independent claim 1 is representative:
  • Claim 1:
    • A method for treating allergic eye diseases in humans
    • comprising stabilizing conjuctival [sic] mast cells
    • by topically administering to the eye a composition comprising a therapeutically effective amount of 11-(3-dimethylaminopropylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid or a pharmaceutically acceptable salt thereof.

U.S. Patent No. 6,995,186 - "Olopatadine Formulations for Topical Administration"

  • Patent Identification: U.S. Patent No. 6,995,186, "Olopatadine Formulations for Topical Administration," issued February 7, 2006. (Compl. ¶32).

The Invention Explained

  • Problem Addressed: The patent identifies a need for topical olopatadine formulations with prolonged therapeutic activity, enabling a convenient once-a-day dosing schedule for allergic conditions of the eye and nose. (’186 Patent, col. 2:5-12).
  • The Patented Solution: The invention discloses an aqueous formulation with a higher concentration of olopatadine (0.17-0.62%) than existing products. To maintain physical stability at this higher concentration, the formulation includes a specific polymeric ingredient—either polyvinylpyrrolidone (PVP) or polystyrene sulfonic acid—and has a low viscosity of 1-2 centipoise (cps). (’186 Patent, Abstract; col. 2:16-24).
  • Technical Importance: This formulation technology facilitates the development of an effective once-a-day treatment for ocular allergies, which can improve patient compliance and therapeutic outcomes. (’186 Patent, col. 2:8-12).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims." (Compl. ¶42). Independent claim 1 is representative:
  • Claim 1:
    • A topically administrable solution comprising olopatadine and a polymeric ingredient, with the improvement being a solution where:
    • The olopatadine amount is 0.17-0.62% (w/v);
    • The polymeric ingredient is a "physical stability-enhancing ingredient consisting essentially of polyvinylpyrrolidone or polystyrene sulfonic acid";
    • The composition has a viscosity of 1-2 cps; and
    • The composition "does not contain" a specific list of other polymers, including polyvinyl alcohol and xanthan gum.

U.S. Patent No. 7,402,609 - "Olopatadine Formulations for Topical Administration"

  • Patent Identification: U.S. Patent No. 7,402,609, "Olopatadine Formulations for Topical Administration," issued July 22, 2008. (Compl. ¶54).

The Invention Explained

  • Technology Synopsis: Continuing the work of the ’186 patent, this patent claims a specific topical solution for treating eye and nose allergies. The formulation "consists essentially of" olopatadine at a concentration of 0.18-0.22%, polyvinylpyrrolidone (PVP) at 1.5-2%, a preservative, edetate disodium, a tonicity-adjusting agent, a buffering agent, and water, with a defined pH (6.5-7.5) and viscosity (1-2 cps). (’609 Patent, Abstract, Claim 1).
  • Asserted Claims: The complaint asserts the patent's single claim, Claim 1. (Compl. ¶59).
  • Accused Features: The accused instrumentality is Sandoz's proposed generic 0.2% olopatadine solution, which the complaint alleges is covered by this claim. (Compl. ¶¶60, 64).

III. The Accused Instrumentality

Product Identification

  • Sandoz's ANDA Product, identified as "Olopatadine Hydrochloride ophthalmic solution/drops 0.2% Eq. Base" submitted to the FDA under ANDA No. 200410. (Compl. ¶16).

Functionality and Market Context

  • The product is a generic version of Plaintiffs' Pataday™ ophthalmic solution, intended for topical administration to the eye for treating allergic eye conditions. (Compl. ¶¶8, 16). The complaint alleges that Sandoz’s product contains the "same ingredients, or equivalents thereof, in the same amounts, or equivalent amounts, as Pataday™" and that Sandoz seeks approval to market it prior to the expiration of the patents-in-suit. (Compl. ¶16).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’805 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating allergic eye diseases in humans comprising stabilizing conjuctival mast cells by topically administering to the eye a composition... Sandoz’s filing of its ANDA to obtain approval for its product before patent expiration is a statutory act of infringement. (Compl. ¶22). The complaint further alleges the use of the product as directed by its proposed labeling for treating eye allergies will infringe. (Compl. ¶24). ¶¶22, 24 col. 3:17-19
...comprising a therapeutically effective amount of 11-(3-dimethylaminopropylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid [olopatadine] or a pharmaceutically acceptable salt thereof. Sandoz’s ANDA Product is an ophthalmic solution containing olopatadine hydrochloride. (Compl. ¶16). The intended use to treat allergic eye disease implies the amount is therapeutically effective. ¶16 col. 2:45-48

’186 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
the amount of olopatadine in the solution is 0.17-0.62% (w/v) Sandoz’s ANDA Product is identified as an "ophthalmic solution/drops 0.2% Eq. Base," which falls within the claimed concentration range. (Compl. ¶16). ¶16 col. 3:39-40
the polymeric ingredient is a polymeric physical stability-enhancing ingredient consisting essentially of polyvinylpyrrolidone or polystyrene sulfonic acid... The complaint alleges Sandoz’s product contains the "same ingredients, or equivalents thereof" as Pataday™. (Compl. ¶38). Infringement of this element depends on the specific, unstated excipients in Sandoz's ANDA formulation. ¶38 col. 2:18-24
wherein the composition ... does not contain polyvinyl alcohol, polyvinyl acrylic acid, hydroxypropylmethyl cellulose, sodium carboxymethyl cellulose or xanthan gum. The complaint does not detail the excipients in Sandoz’s ANDA Product. Infringement of this negative limitation hinges on the absence of these specific polymers in Sandoz's formulation. ¶¶38, 42 col. 2:58-61
  • Identified Points of Contention:
    • Functional Questions: A central question for the ’805 patent is whether the use of Sandoz's 0.2% product for treating eye allergies will inherently perform the claimed function of "stabilizing conjuctival mast cells." Proving this may require clinical or experimental evidence beyond the product's basic chemical composition.
    • Scope Questions: For the ’186 and ’609 patents, the dispute may center on the term "consisting essentially of." The infringement analysis will depend on the exact formulation in Sandoz's ANDA. The court will need to determine whether any unlisted ingredients in Sandoz's product materially alter the basic and novel properties of the claimed formulation, namely, its physical stability at a high olopatadine concentration. The complaint does not provide sufficient detail for analysis of Sandoz's specific formulation.

V. Key Claim Terms for Construction

For the ’805 Patent

  • The Term: "stabilizing conjuctival mast cells"
  • Context and Importance: This functional language is the core of the claimed method. Practitioners may focus on this term because infringement will require Plaintiffs to show that the directed use of Sandoz's product necessarily results in this biological effect, a higher burden than proving simple compositional identity.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification broadly states that the claimed compound possesses "human conjunctival mast cell stabilizing activity" and that this is the mechanism for treating allergic eye diseases. (’805 Patent, col. 3:17-19).
    • Evidence for a Narrower Interpretation: The patent details a specific in-vitro experiment measuring the "inhibition of histamine release" from human conjunctival mast cells. (’805 Patent, Table 1, col. 3:41-46). A party could argue that "stabilizing" must be defined by the specific outcomes and conditions of this disclosed experimental protocol.

For the ’186 Patent

  • The Term: "consisting essentially of"
  • Context and Importance: This is a legal term of art that defines the scope of the claimed composition. Practitioners may focus on this term because it permits the presence of unlisted ingredients only if they do not materially affect the "basic and novel properties" of the invention. The case may turn on identifying those properties (e.g., long-term physical stability) and then assessing the role of any additional excipients in Sandoz's ANDA product.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that so long as an additional ingredient does not actively destabilize the high-concentration olopatadine solution, it does not materially affect its properties and is thus permitted within the claim.
    • Evidence for a Narrower Interpretation: The patent contrasts the invention with prior art polymers and explicitly names PVP and polystyrene sulfonic acid as the "polymeric physical stability-enhancing ingredient." (’186 Patent, col. 2:18-24). This could support an argument that the "basic and novel" property is achieving stability using only these specific polymers, making the presence of other stabilizers material.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents. The inducement allegation is based on the assertion that Sandoz's proposed product labeling will instruct and encourage medical providers and patients to perform the infringing use. (Compl. ¶¶26, 48, 70). The contributory infringement allegation is based on the assertion that Sandoz's product is especially made for an infringing use and is not suitable for a substantial non-infringing use. (Compl. ¶¶27, 49, 71).
  • Willful Infringement: The complaint alleges that Sandoz acted "without a reasonable basis" for believing it would not be liable for infringement. (Compl. ¶¶29, 51, 73). This is predicated on Sandoz’s knowledge of the patents, evidenced by its filing of a Paragraph IV certification as part of its ANDA. (Compl. ¶¶17, 39, 61).

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

  • A core issue will be one of compositional scope: for the ’186 and ’609 patents, can Sandoz's proposed generic formulation, once its full ingredient list is revealed in discovery, be considered to meet the "consisting essentially of" limitation? This will require the court to define the invention's "basic and novel properties" and determine if any unlisted excipients in the Sandoz product materially affect them.
  • A key evidentiary question will be one of functional infringement: for the ’805 patent's method claim, what level of proof will be required to show that the directed use of Sandoz's 0.2% product necessarily performs the biological function of "stabilizing conjuctival mast cells," a mechanism of action rather than a simple compositional feature?
  • A third question, underlying the entire case, is the validity of the patents. While the complaint asserts infringement, Sandoz’s Paragraph IV certification alleges that the patents are invalid or unenforceable, setting the stage for a defense that will challenge the patents’ novelty, obviousness, or compliance with other statutory requirements.