DCT
1:10-cv-00024
Allergan Inc. v. Sandoz Inc.
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Allergan, Inc. (Delaware)
- Defendant: Sandoz, Inc. (Colorado)
- Plaintiff’s Counsel: Fish & Richardson P.C.; Gibson Dunn & Crutcher LLP
- Case Identification: 1:10-cv-00024, D. Del., 01/08/2010
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Sandoz conducts substantial business in the state, is registered with the Delaware Board of Pharmacy, derived over $30.6 million in revenue from Delaware sales in 2008, and has previously availed itself of the forum to litigate other patent disputes.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's LUMIGAN® ophthalmic solution constitutes infringement of two patents covering the drug's active ingredient and its method of use for treating glaucoma.
- Technical Context: The technology involves non-acidic prostaglandin analogues formulated as ophthalmic solutions to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
- Key Procedural History: This is a Hatch-Waxman action filed under 35 U.S.C. § 271(e)(2). Allergan holds an approved New Drug Application (NDA 02-1275) for its 0.03% bimatoprost ophthalmic solution (LUMIGAN®) and has listed the patents-in-suit in the FDA's "Orange Book." The lawsuit was triggered by Allergan's receipt of a letter notifying it that Sandoz had filed an ANDA (No. 200487) with a "Paragraph IV certification," asserting that the patents-in-suit are invalid and/or would not be infringed by Sandoz's proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 1992-09-21 | Priority Date for ’819 and ’649 Patents |
| 1997-11-18 | ’819 Patent Issue Date |
| 2002-06-11 | ’649 Patent Issue Date |
| 2009-12-14 | Date of Sandoz letter regarding ANDA filing |
| 2010-01-08 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,688,819 - "Non-Acidic Cyclopentane Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents," issued November 18, 1997
The Invention Explained
- Problem Addressed: The patent describes that while prostaglandins are known to be highly effective agents for lowering intraocular pressure in glaucoma patients, their clinical potential is limited by side effects, particularly "ocular surface (conjunctival) hyperemia" (redness of the eye) ('819 Patent, col. 2:41-49).
- The Patented Solution: The invention claims to solve this problem by creating derivatives of cyclopentane heptanoic acid where the carboxylic acid group is replaced by a "non-acidic substituent" ('819 Patent, col. 3:11-12). These modified compounds are described as potent ocular hypotensive agents that, in certain instances, cause "no or significantly lower ocular surface hyperemia than the parent compounds" ('819 Patent, col. 3:17-19).
- Technical Importance: The technology provided a potential pathway to decouple the therapeutic pressure-lowering effect of prostaglandin analogues from their dose-limiting side effects, a significant goal in ophthalmic drug development.
Key Claims at a Glance
- The complaint does not specify which claims it asserts, but a representative independent claim is Claim 5, which covers a method of use.
- The essential elements of independent claim 5 are:
- A method of treating ocular hypertension or glaucoma
- which comprises applying to the eye an amount sufficient to treat ocular hypertension or glaucoma
- of a compound represented by a specified chemical formula, which includes key limitations such as:
- "X" is a radical selected from the group consisting of —OR⁴ and —N(R⁴)₂
- "Z" is =O or represents 2 hydrogen radicals
- "R₁" and "R₂" are specified functional groups (e.g., -OH) on the cyclopentane ring
- "R₃" defines the side chain attached to the cyclopentane ring
U.S. Patent No. 6,403,649 - "Non-Acidic Cyclopentane Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents," issued June 11, 2002
The Invention Explained
- Problem Addressed: The '649 Patent, which shares a specification with the ’819 Patent, addresses the same technical problem: the need for potent ocular hypotensive agents that avoid the side effects, such as hyperemia, associated with conventional prostaglandins ('649 Patent, col. 2:45-53).
- The Patented Solution: The invention is directed to a specific non-acidic prostaglandin analogue and its use in treating ocular hypertension and glaucoma ('649 Patent, col. 3:11-20). By claiming a specific chemical entity rather than a broad genus, the patent provides focused protection on what appears to be a lead compound.
- Technical Importance: This patent narrows the broad genus disclosed in the earlier patent family to a single chemical compound, reflecting the identification of a specific molecule (bimatoprost) with a desirable therapeutic profile for commercial development.
Key Claims at a Glance
- The complaint does not specify which claims it asserts. The patent contains one independent compound claim (Claim 1) and two independent method claims (Claims 2 and 3) that depend on it. A representative independent claim is Claim 2.
- The essential elements of independent claim 2 are:
- A method of treating ocular hypertension
- which comprises applying to the eye an amount sufficient to treat ocular hypertension
- of the compound of claim 1, which is "cyclopentane N-ethyl heptenamide-5-cis-2-(3a-hydroxy-5-phenyl-1-trans-pentenyl)-3,5-dihydroxy, [1α, 2β, 3α, 5α])"
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is Sandoz's proposed generic 0.03% bimatoprost ophthalmic solution, for which Sandoz filed ANDA No. 200487 with the FDA (Compl. ¶¶24, 27).
- Functionality and Market Context: The product is a drug intended for topical ophthalmic administration to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension (Compl. ¶27). The complaint alleges that Sandoz seeks to market its product as a generic version of Allergan's LUMIGAN® product before the expiration of the patents-in-suit, positioning it as a lower-cost alternative to the brand-name drug (Compl. ¶24).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that the filing of the ANDA is an act of infringement under 35 U.S.C. § 271(e)(2) and that commercialization of the proposed product would constitute direct, induced, and contributory infringement (Compl. ¶¶27-28, 30-31). The theory is that Sandoz's product contains an active ingredient covered by the patent claims and that its proposed label will instruct users to perform the patented methods of treatment.
’819 Patent Infringement Allegations
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating ocular hypertension or glaucoma | Sandoz’s ANDA seeks approval to market its generic bimatoprost product for treating elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. | ¶27 | col. 13:50-54 |
| which comprises applying to the eye an amount sufficient to treat ocular hypertension or glaucoma | The proposed FDA-approved label for Sandoz's product would instruct medical professionals and patients to apply the ophthalmic solution to the eye. | ¶28 | col. 13:50-54 |
| of the formula wherein... X is a radical selected from the group consisting of —OR⁴ and —N(R⁴)₂... | The active ingredient in Sandoz's product is bimatoprost, a compound which Allergan alleges falls within the chemical structure defined by the claim's formula. | ¶27 | col. 13:55-66 |
’649 Patent Infringement Allegations
| Claim Element (from Independent Claim 2) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating ocular hypertension | Sandoz’s ANDA seeks approval for its product to be used for the treatment of ocular hypertension. | ¶30 | col. 14:8-10 |
| which comprises applying to the eye an amount sufficient to treat ocular hypertension | The proposed label for Sandoz's product would instruct users to apply the solution to the eye for this purpose. | ¶31 | col. 14:8-10 |
| of the compound of claim 1. | Sandoz's product contains bimatoprost as its active ingredient, which the complaint alleges is the specific chemical compound recited in claim 1. | ¶30 | col. 14:4-7 |
- Identified Points of Contention:
- Scope Questions: For the ’819 Patent, a central issue may be whether the specific bimatoprost molecule (an N-ethyl amide) falls within the scope of the genus defined in claim 5. The analysis will likely focus on whether the bimatoprost structure meets the definition of the Markush group elements in the claim, particularly the definition of the "X" radical.
- Technical Questions: For the ’649 Patent, infringement appears to hinge on a direct factual comparison. The key question is whether Sandoz's bimatoprost active pharmaceutical ingredient is structurally identical to the specific compound defined in claim 1. Any differences in chemical structure, stereochemistry, or purity could form the basis of a non-infringement defense.
V. Key Claim Terms for Construction
For the ’819 Patent:
- The Term: ""X is a radical selected from the group consisting of —OR⁴ and —N(R⁴)₂"" (from claim 5)
- Context and Importance: This term is critical because it defines the "non-acidic" moiety that distinguishes the claimed compounds from prior art carboxylic acids. The infringement analysis for the ’819 Patent depends on whether the N-ethyl amide group of bimatoprost is properly characterized as falling within the scope of "—N(R⁴)₂".
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines R⁴ as "hydrogen, a lower alkyl radical having from one to six carbon atoms," or certain acyl groups ('819 Patent, col. 3:50-55). Allergan may argue that the nitrogen atom of the bimatoprost amide, along with its attached hydrogen and ethyl groups, satisfies the "-N(R⁴)₂" structure. The specification also provides numerous examples of amide compounds, such as "cyclopentane heptenamide," suggesting amides were contemplated by the inventors ('819 Patent, col. 7:23).
- Evidence for a Narrower Interpretation: A defendant may argue that the claim term "—N(R⁴)₂" recites an amine functional group, which is chemically distinct from the amide functional group (
-C(=O)N-) found in bimatoprost. It could be argued that if the inventors intended to explicitly cover amides in this claim, they would have used more precise language to do so.
For the ’649 Patent:
- The asserted claims of the ’649 Patent depend on claim 1, which recites a specific chemical compound by its structural name. As such, disputes are less likely to center on claim construction and more likely to involve a factual determination of whether Sandoz’s bimatoprost is the same compound as the one claimed.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents (Compl. ¶¶28, 31). The factual basis for inducement is that Sandoz’s ANDA filing, including its proposed product labeling, demonstrates an intent to encourage doctors and patients to use the generic product in a manner that directly infringes the patented methods of treatment (Compl. ¶¶27, 30).
- Willful Infringement: The complaint does not use the word "willful" but does ask the court to declare the case "exceptional under 35 U.S.C. § 285" and award attorneys' fees (Compl. p. 7, ¶e). The basis for this allegation appears to be Sandoz's pre-suit knowledge of the patents, evidenced by their listing in the FDA's Orange Book and Sandoz's act of sending a Paragraph IV certification letter to Allergan (Compl. ¶¶23-24).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue for the ’819 Patent will be one of claim scope: can the Markush group language in claim 5, particularly the limitation "—N(R⁴)₂", be construed to read on the N-ethyl amide structure of bimatoprost, or is the claim limited to amine-containing compounds?
- For the ’649 Patent, a key evidentiary question will be one of factual identity: does the bimatoprost active ingredient in Sandoz's proposed product meet every structural and stereochemical limitation of the specific compound recited in claim 1, or is there a legally significant difference that supports a finding of non-infringement?
- A central pillar of the defense, as foreshadowed by the Paragraph IV certification, will be invalidity: Sandoz has alleged that the patents are invalid (Compl. ¶25). The case will therefore likely involve significant disputes over whether the claimed inventions were obvious over the prior art or fail to meet other statutory requirements for patentability, such as written description and enablement.