DCT
1:18-cv-00303
Baxter Healthcare Corp v. Hospira Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Baxter Healthcare Corporation (Delaware)
- Defendant: Hospira, Inc. (Delaware) and Orion Corp. (Finland)
- Plaintiff’s Counsel: Potter Anderson & Corroon LLP; Wiley Rein, LLP
- Case Identification: 1:18-cv-00303, D. Del., 10/15/2018
- Venue Allegations: Venue is alleged to be proper in the District of Delaware as Defendant Hospira is a Delaware corporation that resides in the district, and Defendant Orion is subject to personal jurisdiction in the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its generic dexmedetomidine hydrochloride injection does not infringe, and that Defendants’ patent is invalid and unenforceable, while also alleging Defendants engaged in anticompetitive conduct and patent misuse.
- Technical Context: The dispute is in the pharmaceutical sector and concerns a method of sedating patients in an intensive care unit using the drug dexmedetomidine, marketed by Defendants as Precedex.
- Key Procedural History: The complaint alleges a complex history, asserting that the patent-in-suit, U.S. Patent No. 6,716,867, was previously found invalid as obvious by the U.S. District Court for the District of New Jersey after a full bench trial. That judgment was subsequently vacated as part of a settlement agreement between Defendants and a third-party generic manufacturer. The complaint further alleges that Defendants improperly broadened the FDA "use code" associated with the patent to delay generic competition for unpatented uses, and that Defendants have filed a counterclaim for infringement in the present action.
Case Timeline
| Date | Event |
|---|---|
| 1998-04-01 | ’867 Patent Priority Date |
| 2004-04-06 | ’867 Patent Issue Date |
| 2009-04-07 | Sandoz files first ANDA for generic Precedex concentrate |
| 2012-04-30 | D.N.J. holds ’867 Patent invalid as obvious in Sandoz litigation |
| 2013-12-01 | Invalidity judgment in Sandoz case vacated pursuant to settlement |
| 2014-01-06 | Hospira allegedly amends ’867 Patent use code with FDA |
| 2014-08-18 | FDA determines generic applicants can "carve out" patented use |
| 2016-06-06 | Baxter serves Hospira with Notice Letter for its ANDA Product |
| 2018-01-01 | Baxter receives tentative FDA approval for its ANDA Product |
| 2018-02-22 | Baxter files initial complaint for declaratory judgment |
| 2018-08-21 | Baxter receives final FDA approval for its ANDA Product |
| 2018-10-15 | First Amended Complaint Filing Date |
| 2019-03-31 | ’867 Patent Expiration Date |
| 2019-10-01 | Pediatric Exclusivity Period Expiration Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,716,867 - "Use of Dexmedetomidine for ICU Sedation"
(Compl. ¶17; ’867 Patent, p. 47)
The Invention Explained
- Problem Addressed: The patent’s background section describes the challenges of sedating critically ill patients in an Intensive Care Unit (ICU). It notes that the concurrent use of multiple drugs ("polypharmacy") can lead to adverse effects, including prolonged sedation, respiratory depression, and unpredictable hemodynamic effects. The patent identifies a need for an "ideal sedative agent" that provides sedation while allowing the patient to be easily aroused and remain hemodynamically stable. (’867 Patent, col. 2:5-65).
- The Patented Solution: The invention is a method of using dexmedetomidine to sedate a patient in an ICU. The key feature of the patented method is that the patient "remains arousable and orientated." (’867 Patent, Abstract). This is described as a "unique" quality of sedation that makes treatment easier, as patients can be awakened to respond to questions yet remain calm and tolerate procedures like intubation. The patent suggests this can be achieved using dexmedetomidine as essentially the sole active agent. (’867 Patent, col. 4:30-67).
- Technical Importance: This approach sought to provide clinicians with a method for more controlled and potentially safer sedation, aiming to avoid the complications associated with both deep, non-arousable sedation and the unpredictable effects of administering multiple sedative agents. (’867 Patent, col. 2:57-65).
Key Claims at a Glance
- The complaint asserts that the two independent claims of the ’867 Patent, claims 1 and 3, are not infringed and are invalid (Compl. ¶¶21, 129, 133).
- Independent Claim 1:
- A method of sedating a patient in an intensive care unit,
- which comprises administering to the patient an effective amount of dexmedetomidine or a pharmaceutically acceptable salt thereof,
- wherein the patient remains arousable and orientated.
- Independent Claim 3:
- A method of sedating a patient in an intensive care unit,
- comprising administering a pharmaceutical composition to the patient,
- wherein the pharmaceutical composition comprises an active agent and an inactive agent,
- wherein the active agent consists of dexmedetomidine or a pharmaceutically acceptable salt thereof, and wherein the patient remains arousable and orientated.
III. The Accused Instrumentality
Product Identification
The "Baxter ANDA Product," a generic dexmedetomidine hydrochloride injection in 200 mcg base/50 mL and 400 mcg base/100 mL dosage forms (Compl. ¶72).
Functionality and Market Context
The product is a generic version of Defendants' branded drug, Precedex. The central feature relevant to the infringement dispute is its FDA-approved labeling. The complaint alleges that Baxter purposefully excluded the indication for "sedating a patient in an intensive care unit" from its product label. This practice is known as a "section viii carve-out." (Compl. ¶¶74-75, 129). The product is approved for the "Procedural Indication," which involves the sedation of non-intubated patients prior to and/or during surgical and other procedures (Compl. ¶¶34, 74). The product is intended to be a lower-priced competitor to Precedex (Compl. ¶119).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of non-infringement. The following table summarizes Baxter's primary non-infringement argument, which is based on the theory that its product label omits, or "carves out," the patented method of use.
’867 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of sedating a patient in an intensive care unit, | The approved label for the Baxter ANDA Product does not include an indication for sedating patients in an intensive care unit. The product is indicated for procedural sedation, which Plaintiff alleges is distinct from the claimed ICU use. | ¶129, ¶74 | col. 14:15-16 |
| which comprises administering to the patient an effective amount of dexmedetomidine... | The Baxter ANDA Product is a dexmedetomidine hydrochloride injection intended for administration to patients. | ¶72 | col. 14:17-19 |
| wherein the patient remains arousable and orientated. | The complaint does not provide sufficient detail for analysis of this element, as its non-infringement argument rests primarily on the "intensive care unit" limitation. | N/A | col. 14:20-21 |
- Identified Points of Contention:
- Scope Questions: The central dispute appears to be whether the administration of Baxter's product for the labeled "Procedural Indication" (e.g., sedation during a surgical procedure) constitutes practicing the claimed method of "sedating a patient in an intensive care unit." This raises the question of whether the claim term is limited to a specific physical location in a hospital, or if it can be read more broadly to cover a type of care that might occur in other settings. The complaint alleges that Defendants have taken contradictory positions on this issue, previously arguing in separate litigation that the patent was limited to ICU sedation but now asserting it against Baxter's product (Compl. ¶¶55, 88).
- Technical Questions: The complaint's non-infringement theory is based on a label carve-out and does not raise specific factual disputes about the technical operation of the drug itself compared to the claim limitations regarding its effect (i.e., that the patient remains arousable and orientated). The primary question is one of induced infringement based on the product's label.
V. Key Claim Terms for Construction
- The Term: "in an intensive care unit"
- Context and Importance: The construction of this term is dispositive of Baxter's non-infringement argument. A narrow construction limiting the claim to methods performed exclusively within a designated ICU department would support Baxter's position that its product label, which carves out this use, does not induce infringement. A broader, functional definition could create a triable issue of fact regarding whether the approved "Procedural Indication" overlaps with the claimed method (Compl. ¶¶22-23, 129).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that "the word intensive care unit includes any setting that provides intensive care" (’867 Patent, col. 1:17-19, col. 4:45-46). Defendants may cite this language to argue for a functional definition that is not limited by the physical walls of a hospital's ICU ward.
- Evidence for a Narrower Interpretation: The patent's title, abstract, and claims consistently use the specific phrase "intensive care unit." The background focuses on problems arising during a patient's "ICU stay" (’867 Patent, col. 1:33). Plaintiff may argue this context limits the term to its plain and ordinary meaning. The complaint further alleges that Defendants previously argued in court that "the '867 patent is the patent for ICU sedation," distinguishing it from other uses (Compl. ¶55).
VI. Other Allegations
- Indirect Infringement: Baxter's argument for non-infringement is founded on the principle of avoiding liability for indirect infringement. The complaint alleges that by purposefully excluding the patented ICU indication from its product's FDA-approved label via a "section viii carve-out," it does not provide instructions that would encourage or induce physicians to perform the claimed method (Compl. ¶¶74, 129). The complaint does not detail Defendants' specific allegations of inducement from their counterclaim.
- Willful Infringement: The complaint does not provide details regarding Defendants' allegations of willful infringement. However, the complaint makes extensive allegations that Defendants' own assertion of the ’867 patent is objectively baseless and brought in bad faith, given the prior (though vacated) judicial finding of invalidity and Defendants' alleged knowledge of the patent's unenforceability (Compl. ¶¶88-89, 161).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "in an intensive care unit," which is central to every claim, be construed to cover the sedation of non-intubated patients during surgical or other procedures, or is it limited to sedation occurring within the specific hospital department designated as the ICU?
- A second critical issue will be the patent’s viability: can the ’867 patent survive challenges of obviousness and unenforceability due to inequitable conduct? The complaint heavily relies on a prior district court ruling that found the patent invalid and alleges that a co-inventor failed to disclose material prior art to the PTO.
- A final key question will be one of anticompetitive conduct: separate from the patent infringement analysis, the court will need to determine whether Defendants' alleged scheme—which includes settling litigation to vacate an invalidity judgment, manipulating FDA use codes, and asserting a patent known to be invalid—constitutes patent misuse and violates federal antitrust laws.