DCT
1:14-cv-00878
GlaxoSmithKline LLC v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: GlaxoSmithKline LLC (Delaware) and SmithKline Beecham (Cork) Limited (Ireland)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 1:14-cv-00878, D. Del., 08/26/2015
- Venue Allegations: Venue is alleged to be proper as Defendant is a Delaware corporation and has committed alleged acts of infringement in the district by placing carvedilol tablets into the stream of commerce.
- Core Dispute: Plaintiffs allege that Defendant’s generic carvedilol product infringes a patent claiming a method of using carvedilol for long-term treatment to decrease mortality caused by congestive heart failure (CHF).
- Technical Context: The case involves carvedilol, a beta-blocker drug, and its patented method-of-use for treating CHF, a chronic condition where the heart cannot pump blood effectively, which is a major cause of mortality.
- Key Procedural History: The patent-in-suit, RE40,000, is a reissue of U.S. Patent No. 5,760,069. The complaint alleges Defendant initially filed an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Plaintiffs' drug (COREG®) with a "skinny label" that carved out the patented CHF indication. Plaintiffs allege Defendant later amended its label to include the CHF indication and that Defendant's marketing activities induced infringement of the patent both before and after the label change.
Case Timeline
| Date | Event |
|---|---|
| 1995-02-08 | '000 Patent Priority Date |
| 1995-06-07 | Original U.S. Patent Application No. 08/483,635 ('069 patent) filed |
| 1998-06-02 | U.S. Patent No. 5,760,069 ('069 patent) issued |
| 2002-03-06 | Teva submits ANDA No. 76-373 for generic carvedilol |
| 2003-11-25 | Reissue proceeding for '069 patent instituted |
| 2007-09-05 | Teva launches generic carvedilol with "Section viii carve-out" label |
| 2008-01-08 | U.S. Patent No. RE40,000 ('000 patent) issues from reissue |
| 2011-05-01 | Teva allegedly revises its generic label to include CHF indication |
| 2015-08-26 | Second Amended Complaint for Patent Infringement filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Reissue Patent No. RE40,000 - Method of Treatment for Decreasing Mortality Resulting from Congestive Heart Failure
The Invention Explained
- Problem Addressed: The patent addresses the high mortality rate associated with congestive heart failure (CHF), a condition where the heart's pumping ability is impaired. It notes the need for therapeutic agents that can counter the harmful effects of the sympathetic nervous system, which is over-activated in CHF patients (RE40,000 Patent, col. 1:30-33, 49-54).
- The Patented Solution: The invention is a method of treatment that uses carvedilol, a compound with both beta-blocking and vasodilating properties, to decrease mortality in CHF patients. The patent highlights the surprising discovery that carvedilol, unlike other beta-blockers which were considered contraindicated, significantly reduced the risk of death when administered long-term as part of a treatment regimen (RE40,000 Patent, Abstract; col. 3:56-64). The specification describes clinical trial results showing a 67% reduction in mortality risk (RE40,000 Patent, col. 6:22-24).
- Technical Importance: The invention represented a significant departure from the conventional wisdom at the time, which held that beta-blockers were harmful to patients with heart failure (RE40,000 Patent, col. 3:56-60).
Key Claims at a Glance
- The complaint alleges infringement of "at least one claim" (Compl. ¶70). The infringement theory centers on long-term treatment. Independent claim 1 appears most relevant.
- Independent Claim 1:
- A method of decreasing mortality caused by congestive heart failure in a patient in need thereof
- which comprises administering a therapeutically acceptable amount of carvedilol in conjunction with one or more other therapeutic agents (ACE inhibitor, diuretic, and digoxin)
- wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period
- and said maintenance period is greater than six months.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
Defendant’s generic carvedilol tablets in 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg dosages (Compl. ¶69).
Functionality and Market Context
The accused products are generic versions of Plaintiffs’ COREG® drug. The complaint alleges that since at least May 2011, the product label for Teva's generic carvedilol has been "identical to GSK's COREG® labeling" and indicates its use for "mild-to-severe chronic heart failure" to increase survival and reduce hospitalization (Compl. ¶54). The complaint further alleges that even before this label change, Teva promoted its product as an "AB-rated" therapeutic equivalent to COREG®, intending for it to be substituted for all of COREG®'s indications, including the patented CHF use (Compl. ¶¶ 62, 67).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
- Claim Chart Summary: The complaint alleges inducement and contributory infringement. The following table summarizes the allegations for direct infringement by end-users, as induced or contributed to by Teva, mapped to the elements of independent claim 1 of the '000 Patent.
RE40,000 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of decreasing mortality caused by congestive heart failure in a patient in need thereof | Teva's product label allegedly instructs administering the drug for treating "mild-to-severe chronic heart failure... to increase survival" in patients with CHF (Compl. ¶34, 54). | ¶54 | col. 8:30-32 |
| which comprises administering a therapeutically acceptable amount of carvedilol in conjunction with one or more other therapeutic agents, said agents being selected from the group consisting of an... (ACE)..., a diuretic, and digoxin | The Teva label allegedly states that carvedilol is administered "usually in addition to diuretics, ACE inhibitors, and digitalis" (Compl. ¶54). | ¶54 | col. 8:32-36 |
| wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period | Teva's label allegedly describes long-term use, cautions patients not to interrupt or discontinue the drug suddenly, and includes data from long-term clinical trials, which suggests a period of maintenance treatment (Compl. ¶¶ 56-58). | ¶¶56-58 | col. 8:37-39 |
| and said maintenance period is greater than six months. | The complaint alleges Teva's label instructs and encourages administering the tablets "long term (extending for more than six months)" and references clinical trials with durations of 7 months, 10 months, and 18-24 months to demonstrate efficacy (Compl. ¶¶ 54, 57). Safety data is also reported from trials with mean exposure of 4.8 years (Compl. ¶58). | ¶¶54, 57 | col. 8:40-41 |
- Identified Points of Contention:
- Scope Questions: A central question is whether Teva’s conduct, particularly during the period it marketed its product with a "skinny label" that carved out the CHF indication, can still constitute inducement of the patented method. The complaint alleges that other approved uses on the skinny label (e.g., for post-myocardial infarction) would inevitably lead to treating patients who also had CHF, for longer than six months (Compl. ¶52).
- Technical Questions: What evidence demonstrates that Teva's actions, through its labels and marketing, caused physicians to prescribe and patients to use carvedilol for the specific purpose of "decreasing mortality" over a "maintenance period greater than six months," as required by the claim, rather than for general symptom management?
V. Key Claim Terms for Construction
- The Term: "maintenance period ... greater than six months"
- Context and Importance: This temporal limitation appears to be the primary element distinguishing the patented method from prior art uses of beta-blockers. The infringement analysis, particularly for inducement, will turn on whether Teva's product label and marketing materials instructed or encouraged a course of treatment meeting this specific duration.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent’s "Experimental" section describes the underlying clinical program where patients were assigned to "6-12 months' treatment" and where the program was monitored for 25 months before termination, suggesting that "long-term" was a core concept (RE40,000 Patent, col. 5:9-10, 5:18-19). This may support a view that any continuous therapy extending beyond six months meets the limitation.
- Evidence for a Narrower Interpretation: Claim 1 explicitly requires a "maintenance period" that "is greater than six months" (RE40,000 Patent, col. 8:39-41). A party could argue this requires a distinct, planned period of continuous treatment intended from the outset to last more than six months, rather than a treatment of indefinite duration that happens to exceed that time.
VI. Other Allegations
- Indirect Infringement: The complaint makes detailed allegations of inducement, asserting Teva intended to cause infringement through its product labels (both the "skinny" and full labels), press releases touting the product as an "AB-rated" equivalent to COREG®, and marketing it as "fully substitutable" (Compl. ¶¶ 62-63, 67, 69). The complaint also pleads contributory infringement, alleging carvedilol has no substantial non-infringing uses and is especially made or adapted for the patented long-term CHF treatment method (Compl. ¶¶ 80, 83).
- Willful Infringement: Willfulness is alleged based on Teva’s knowledge of the original '069 patent since at least its 2002 ANDA filing and its subsequent knowledge of the reissued '000 patent (Compl. ¶71). The complaint claims Teva acted despite an objectively high likelihood of infringement or, alternatively, was willfully blind to the infringing nature of its sales (Compl. ¶¶ 72, 74).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of inducement and intent: can Plaintiffs prove that Teva, particularly during the period it used a "skinny label" that omitted the CHF indication, nonetheless possessed the specific intent to encourage physicians to perform the complete, patented method, including the "greater than six months" limitation?
- A key question for contributory infringement will be whether substantial non-infringing uses exist for Teva's carvedilol. The case may turn on evidence of how carvedilol is prescribed in practice and whether the uses for hypertension and post-myocardial infarction are commercially and medically significant enough to defeat the claim that the product is a staple article of commerce (Compl. ¶¶ 34, 80).
- The outcome may also depend on a claim construction question: does the limitation "maintenance period ... greater than six months" require a pre-planned therapeutic course of a specific duration, or is it satisfied whenever treatment happens to extend beyond six months, regardless of the initial plan?