DCT
1:12-cv-09295
Apotex Inc v. Daiichi Sankyo Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Apotex Inc. (Canada)
- Defendant: Daiichi Sankyo, Inc. (Delaware) and Daiichi Sankyo Co., Ltd. (Japan)
- Plaintiff’s Counsel: Husch Blackwell LLP
- Case Identification: 1:12-cv-09295, N.D. Ill., 11/20/2012
- Venue Allegations: Venue is alleged to be proper in the Northern District of Illinois based on Defendant Daiichi Sankyo Inc. having a designated agent for service of process in Illinois and both defendants having continuous and systematic business contacts with the state.
- Core Dispute: Plaintiff seeks a declaratory judgment that its proposed generic olmesartan medoxomil tablets do not infringe Defendant's U.S. Patent No. 6,878,703, which claims a combination therapy of olmesartan and a diuretic.
- Technical Context: The technology relates to pharmaceutical compositions for treating hypertension, specifically using an angiotensin II receptor antagonist, olmesartan medoxomil, which is the active ingredient in the widely prescribed drug Benicar®.
- Key Procedural History: This case arises from a unique Hatch-Waxman Act scenario. The patent-in-suit, U.S. Patent No. 6,878,703, was disclaimed in its entirety in 2006 and expired for failure to pay maintenance fees in 2009. However, it remains listed in the FDA's Orange Book. Plaintiff Apotex alleges this continued listing prevents it from obtaining final FDA approval for its generic product because a rival generic manufacturer, Mylan (as successor to Matrix Laboratories), holds a 180-day market exclusivity period that can only be triggered by a court judgment that the '703 patent is not infringed or is invalid. The lawsuit is a procedural necessity for Apotex to obtain such a judgment to start the 180-day clock and clear a path for its own market entry.
Case Timeline
| Date | Event |
|---|---|
| 2000-11-21 | '703 Patent Priority Date |
| 2005-04-12 | '703 Patent Issued |
| 2006-07-11 | Term of every claim of the '703 patent disclaimed |
| 2009-04-12 | '703 Patent expired for failure to pay maintenance fees |
| 2010-01-01 | Federal Circuit affirms validity of related '599 patent (approx.) |
| 2012-06-12 | Apotex serves Paragraph IV Notice Letter to Daiichi |
| 2012-11-20 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,878,703 - “Pharmaceutical Composition”
- Patent Identification: U.S. Patent No. 6,878,703, “Pharmaceutical Composition,” issued April 12, 2005.
The Invention Explained
- Problem Addressed: The patent acknowledges that combining an angiotensin II receptor antagonist with a diuretic is a known effective therapy for hypertension. However, the patent asserts that the specific effects of a composition containing the particular antagonist CS-866 (olmesartan medoxomil) and a diuretic "remain unknown" ('703 Patent, col. 3:32-41).
- The Patented Solution: The invention is a pharmaceutical composition that combines a specific angiotensin II receptor antagonist, olmesartan (or its salts and esters), with one or more diuretics ('703 Patent, Abstract). The patent teaches that this specific combination provides "excellent anti-hypertensive effects" and can be administered orally to treat hypertension ('703 Patent, col. 3:42-53; col. 11:7-11). The patent's own clinical data purports to show that the combination is more effective than either drug administered alone ('703 Patent, col. 13:15-46, Table 2).
- Technical Importance: The invention provides a combination therapy in a single formulation or regimen, which can improve patient compliance and provide a synergistic therapeutic effect for managing high blood pressure.
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement for all claims of the '703 patent (Compl. ¶34; Prayer for Relief ¶B). The sole independent claim is Claim 1.
- Independent Claim 1 requires:
- A method for treating hypertension
- comprising administering to a warm-blooded animal in need thereof a pharmaceutically effective amount of each of:
- (i) an angiotensin II receptor antagonist (olmesartan, or its salt or ester)
- and (ii) a diuretic which is hydrochlorothiazide.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Apotex's ANDA Product," identified as Abbreviated New Drug Application ("ANDA") 204089 for a proposed drug product containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil (Compl. ¶23).
Functionality and Market Context
- The product is a generic version of Daiichi Sankyo's brand-name drug, Benicar® (Compl. ¶19). Its function is to treat hypertension by acting as an angiotensin II receptor antagonist (Compl. ¶1). The complaint alleges that Apotex's product contains only olmesartan medoxomil and does not contain the diuretic hydrochlorothiazide required by the asserted patent's claims (Compl. ¶1, ¶23). The lawsuit is driven by Apotex's desire to enter the market with its generic product to compete with the brand-name drug (Compl. ¶26). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of non-infringement. Apotex's theory is that its product does not meet the limitations of the asserted claims. The primary basis for non-infringement is summarized in the table below.
'703 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating hypertension comprising administering... | Apotex's product is intended for the treatment of hypertension. | ¶1, ¶19 | col. 1:12-26 |
| (i) an angiotensin II receptor antagonist selected from the group consisting of a compound having the following formula (I)... a pharmacologically acceptable salt thereof, a pharmacologically acceptable ester thereof... | Apotex's ANDA product contains olmesartan medoxomil, which is an ester of the compound of formula (I) and thus falls within this limitation. | ¶23 | col. 4:41-46 |
| and (ii) a diuretic which is hydrochlorothiazide. | Apotex's ANDA product is described as "olmesartan medoxomil tablets" and does not contain hydrochlorothiazide. Therefore, administration of the product would not satisfy this required element of the claimed method. | ¶1, ¶23 | col. 14:47-49 |
- Identified Points of Contention:
- Legal Question: A threshold question is whether an expired and disclaimed patent can be the basis for an infringement action or, as here, a declaratory judgment action necessary to resolve a regulatory blockade under the Hatch-Waxman Act (Compl. ¶¶15-16, 30, 36).
- Technical Question: The central infringement question is whether a product containing only one of two required active ingredients can infringe a claim that explicitly requires the administration of both. The complaint's description of its product as containing only olmesartan medoxomil suggests a fundamental mismatch with the claim language (Compl. ¶23).
V. Key Claim Terms for Construction
- The Term: "and (ii) a diuretic which is hydrochlorothiazide"
- Context and Importance: Apotex's entire factual non-infringement argument rests on the assertion that its product does not contain this second required active ingredient. The interpretation of this phrase is therefore dispositive. Practitioners will focus on this term because if it is a required limitation, Apotex cannot infringe.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not appear to provide any basis for interpreting the claim to not require hydrochlorothiazide. The term "and" is conjunctive, and the language is unambiguous.
- Evidence for a Narrower Interpretation: The plain language of Claim 1, which requires "each of" part (i) "and" part (ii), strongly supports that both components are necessary for infringement ('703 Patent, col. 14:40-49). The specification reinforces this by consistently framing the invention as a combination of an antagonist and a diuretic ('703 Patent, Abstract; col. 3:12-16). Furthermore, Test Example 1 is designed to show the superior hypotensive effect of the combination (CS-866 + HCTZ) compared to each agent alone, which underscores that the claimed invention is the combination itself ('703 Patent, Table 2, col. 14).
VI. Other Allegations
- Indirect Infringement: Apotex seeks a declaration that it does not induce or contribute to infringement (Compl. ¶34). The basis for this is the same as for direct non-infringement: because Apotex's product lacks a necessary element of the claimed method (hydrochlorothiazide), it cannot be used to directly infringe, and therefore its sale cannot constitute inducement or contributory infringement.
- Willful Infringement: This is a declaratory judgment action brought by the accused infringer; willfulness is not at issue.
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to be less about a substantive patent dispute and more about using the judicial process to resolve a regulatory impasse created by the Hatch-Waxman framework. The central questions for the court are:
- A Question of Jurisdiction and Remedy: Does the court have declaratory judgment jurisdiction over a disclaimed and expired patent, where the patent's continued listing in the FDA Orange Book creates a real and immediate commercial injury to the plaintiff by blocking its path to market entry?
- A Question of Claim Scope: Assuming jurisdiction, can a claim that explicitly requires the administration of two distinct pharmaceutical agents (olmesartan and hydrochlorothiazide) be infringed by a product that contains only one of those agents? The patent's text appears to make the answer to this straightforward, suggesting a swift resolution on the merits.