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Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. New Jersey

December 21, 2018


          OPINION & ORDER

          STANLEY R. CHESLER, U.S.D.J.

         This matter comes before the Court on the application for claim construction by Plaintiff Helsinn Healthcare S.A. (“Helsinn”) and Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (collectively, “Teva”). In this consolidated patent infringement action, the parties seek construction of claim terms in U.S. Patent No. 8, 729, 094 (“the '094 patent”). For the reasons that follow, this Court adopts Teva's proposed construction.


         This case arises from a patent infringement dispute involving a pharmaceutical treatment method patent. Helsinn owns U.S. Patent No. 8, 729, 094 (the “'094 patent”) directed to, among other things, a method for reducing chemotherapy-induced nausea and vomiting using palonosetron, a compound which Helsinn markets under the brand name Aloxi®. Teva has submitted ANDA No. 090713, which seeks FDA approval to engage in the commercial manufacture and sale of generic palonosetron hydrochloride intravenous solutions prior to the expiration of the '094 patent.

         The present dispute over the '094 patent is one piece of a larger group of cases involving various palonosetron patents and various pharmaceutical companies. In brief, Judge Cooper of this Court, after conducting a trial in a subset of related cases, had issued a judgment that found a number of other palonosetron patents (but not the '094 patent) valid and infringed. Teva appealed this judgment and, on May 1, 2017, the Court of Appeals for the Federal Circuit reversed the judgment of infringement, finding the patent claims at issue to be invalid under the on-sale bar of 35 U.S.C. § 102. Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 855 F.3d 1356 (Fed. Cir. 2017). The Supreme Court granted Helsinn's petition for cert. Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 138 S.Ct. 2678 (June 25, 2018). The Supreme Court heard oral argument on December 4, 2018, and a decision is pending.


         I. The law of claim construction

         A court's determination “of patent infringement requires a two-step process: first, the court determines the meaning of the disputed claim terms, then the accused device is compared to the claims as construed to determine infringement.” Acumed LLC v. Stryker Corp., 483 F.3d 800, 804 (Fed. Cir. 2007). “[W]hen the district court reviews only evidence intrinsic to the patent (the patent claims and specifications, along with the patent's prosecution history), the judge's determination will amount solely to a determination of law.” Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015).

         The focus of claim construction is the claim language itself:

It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude. Attending this principle, a claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to ‘particularly point[] out and distinctly claim[] the subject matter which the patentee regards as his invention.'

Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir. 2004) (citations omitted).

         The Federal Circuit has established this framework for the construction of claim language:

We have frequently stated that the words of a claim ‘are generally given their ordinary and customary meaning.' We have made clear, moreover, that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application. The inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation. . .
In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words. In such circumstances, general purpose dictionaries may be helpful. In many cases that give rise to litigation, however, determining the ordinary and customary meaning of the claim requires examination of terms that have a particular meaning in a field of art. Because the meaning of a claim term as understood by persons of skill in the art is often not immediately apparent, and because patentees frequently use terms idiosyncratically, the court looks to those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean. Those sources include the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.

Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).

         II. Claim construction of the disputed terms

         The parties dispute the interpretation of two related claim terms, one in claim 4 of the '094 patent, and one in independent claim 1, on which claim 4 depends. Those two claims state:

1. A method for reducing the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising intravenously administering to a human in need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 mL sterile aqueous isotonic solution buffered at a pH of about 5.0.+.0.5, said solution comprising: about 0.05 mg/mL palonosetron hydrochloride based on the weight of its free base; about 41.5 mg/mL mannitol; about 0.5 mg/mL EDTA; and a citrate buffer, wherein said formulation is stable at 24 months when stored at room temperature, and wherein said intravenous administration to said human occurs before the start of the cancer chemotherapy.
4. The method of claim 1, wherein said intravenous administration reduces the likelihood of delayed nausea and vomiting in said human.

         The parties dispute the meaning of “reducing the likelihood” in claim 1, and “reduces the likelihood” in claim 4.[1] Both parties contend that the phrases have their ordinary meaning, but the parties disagree about what that ordinary meaning is. As to the phrase in claim 4, Helsinn proposes that it means, “prevents both delayed nausea and vomiting in a statistically significant number of patients;” Teva proposes that it means, “decreases the probability or makes it less probable that delayed CINV will occur.”[2] The proposed constructions of “reducing the likelihood” in claim 1 are parallel.

         Initially, Helsinn argues that Judge Cooper's claim construction in Helsinn v Hospira, Inc., Civil Action No. 15-2077, in which Judge Cooper adopted the same construction of “reduces the likelihood” as it proposes in this case, is correct and “should have ended the parties' current dispute.” (Pl.'s Br. 2.) What Helsinn overlooks is that a major development has occurred since the district court decisions in the prior litigations: the Federal Circuit decided the appeal of the judgment of Civil Action No. 11-3962, and related cases, in Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 855 F.3d 1356, 1375 (Fed. Cir. 2017) (“Helsinn.”) Judge Cooper's Markman construction was conducted without the benefit of the Federal Circuit's guidance in Helsinn. Helsinn is quite relevant to the claim construction dispute now submitted by the parties. This Court must therefore proceed to construe the claims in light of the Federal Circuit's binding decision.

         As the present parties are well aware, in Helsinn, the Federal Circuit reviewed, inter alia, the standard applied by the district court in deciding whether four palonosetron formulation patents, including the '724 patent, were reduced to practice before the critical date. Id. At 1371. The Federal Circuit found that the district court had applied “too demanding a standard, ” and stated:

         The evidence is overwhelming that before the critical date of January 30, 2002, it was established that the patented invention would work for its intended purpose of reducing the likelihood of emesis.

• The 1995 report from Study 2330 demonstrated that three different doses, including the 0.25 mg dose, produced statistically significant results at the 5% level for the median time it took patients to experience an emetic episode after administration of palonosetron. While this study did not show statistical significance for complete control of emesis or CINV for 24 hours, complete control is not a claim requirement. The invention is for reducing the likelihood of emesis, not necessarily completely preventing it, and the statistical significance for mean time to failure demonstrates that the product reduced the likelihood of emesis. Indeed, the Study 2330 final report concluded that the relevant dose of palonosetron “was effective ...

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