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Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Ltd.

United States District Court, D. New Jersey

October 5, 2018

SUMITOMO DAINIPPON PHARMA CO., LTD. et al., Plaintiffs,
v.
EMCURE PHARMACEUTICALS LIMITED et al., Defendants. SUMITOMO DAINIPPON PHARMA CO., LTD. et al., Plaintiffs,
v.
AUROBINDO PHARMA LTD. et al., Defendants.

          OPINION & ORDER

          Stanley R. Chesler, U.S.D.J.

         This matter comes before the Court on the application for claim construction by Plaintiffs Sunovion Pharmaceuticals Inc. and Sumitomo Dainippon Pharma Co., Ltd. and Defendants Emcure Pharmaceuticals Ltd., Aurobindo Pharma Ltd., Dr. Reddy's Laboratories, Ltd., Dr. Reddy's Laboratories, Inc., Lupin Ltd., Sun Pharma Global FZE, Accord Healthcare Inc., Amneal Pharmaceuticals, LLC, InvaGen Pharmaceuticals, Inc., Torrent Pharmaceuticals Ltd., Watson Laboratories Inc., and Zydus Pharmaceuticals (USA) Inc. (collectively, “Defendants”). In these consolidated patent infringement actions, the parties seek construction of claim terms in U.S. Patent No. 9, 815, 827 (“the '827 patent”), and a subset of the parties seek construction of claim terms in U.S. Patent No. 9, 907, 794 (“the '794 patent”).[1]

         These consolidated cases are patent infringement actions under the Hatch-Waxman Act. Plaintiffs are pharmaceutical manufacturers which own the ‘827 and ‘794 patents. The ‘827 patent is directed to methods of using lurasidone, the active ingredient in Plaintiffs' Latuda ® product. The'794 patent is directed to particular lurasidone formulations. Defendants are pharmaceutical manufacturers who seek to manufacture and distribute generic versions of Latuda®.

         After opening and responsive briefs were filed, the Court allowed submission of a reply brief. The Court heard oral argument on September 26, 2018, and allowed the parties to submit post-hearing supplemental briefs.

         ANALYSIS

         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 a set of related claim terms in the ‘827 patent and a single term in the ‘794 patent. At issue in the ‘827 patent is the meaning of a set of claim terms which, generally, describe the patented method as “without a clinically significant weight gain” or as “without a weight gain.”

         Plaintiffs, in their opening and responsive briefs, had proposed that the weight gain terms did not limit the claims; in the alternative, Plaintiffs proposed that the weight gain phrases should be understood to have the phrase “on average” inserted into them. Prior to oral argument, Plaintiffs abandoned their primary argument and conceded that the weight gain terms in the ‘827 patent are claim limitations. Then, in the post-hearing supplemental briefing, Plaintiffs abandoned their proposed alternative construction that sought to interpret the weight gain terms as applying to population averages. Instead, Plaintiffs now ask the Court to construe “a patient” in the ‘827 patent to mean “a patient population.” Plaintiffs argue that, when the Court reaches the infringement analysis, the Court will need to figure out whether to use averages or frequency counts to assess weight gain on a population-wide basis, but that it need not deal with that issue during claim construction.

         Although Plaintiffs no longer propose that “on average” be inserted into the claims, their new proposed construction rests on arguments and evidence that were raised in the context of the “on average” construction. Examination of the evidence and arguments concerning weight gain, averages and frequencies in the ‘827 patent remains relevant. The fact that Plaintiffs now propose a different construction does not erase their previous arguments. Consideration of the arguments that supported “on average” reveals some conflicts between their prior proposed construction and their latest one.

         A. Do the ‘827 weight gain terms refer to populations and averages?

         Plaintiffs had contended that the weight gain terms[2] do not limit the claims, but have conceded that they do so. Plaintiffs had argued, in the alternative, that the weight gain terms, if found limiting, “refer to the average measure of baseline body weight gain.” (Pls.' Br. 15.) As of the supplementary briefing, Plaintiffs propose that, instead, the Court should construe “a patient” to mean “a patient population.”[3] Defendants contend that the terms have their ordinary meaning, and that “a patient” means “one or more patients.”

         For example, consider claim 1:

1. A method for treating schizophrenia in a patient without a clinically significant weight gain, comprising: administering orally to the patient (1R, 2S, 3R, 4S)-N-[(1R, 2R)-2-[4-(1, 2-benzoisothiazol-3-yl)-1-piperazinyl met- hyl]-1-cyclohexylmethyl]-2, 3-bicyclo[2.2.1]heptanedicarboximide or a pharmaceutically acceptable salt thereof at a dose of from 20 to 120 mg/day such that the patient does not experience a clinically significant weight gain.

         Plaintiffs had proposed this construction of the body of the claim: “administering orally to the patient [the chemical] or a pharmaceutically acceptable salt thereof at a dose of from 20 to 120 mg/day such that, on average, the baseline body weight of patients undergoing treatment does not increase by 7%.”[4] Now, however, Plaintiffs' proposed construction for claim 1 would construe “the patient” to mean “the patient population.”

         Plaintiffs have proposed that the phrase “weight gain, ” in the context of the ‘827 patent, “would be well understood by those skilled in the art to refer to the average weight gain across a population of patients.” (Pls.' Br. 16.) In support, Plaintiffs offered the declaration of their expert, Dr. Newcomer. Dr. Newcomer states:

29. In evaluating treatment methods using various drugs, the data that those skilled in the art most generally use is data representing the average or mean measured across a sample of observed patients. Other relevant data used in evaluating treatment methods include the frequency of occurrence of certain favorable or unfavorable events of interest. When prescribing a drug to a patient, a physician does not know in advance how the drug will perform in that specific patient, but understands what the expectations are based on the known averages or frequency of events in a previously treated population.
30. With this background knowledge, and when reading the claims of the '827 patent together with the patent's specification, a person skilled in the art understands that the “weight gain” concepts recited in the claims are referring to the average effects experienced within the population of patients undergoing treatment.
31. The '827 patent specification describes a clinical trial on lurasidone that supports my opinion that a person skilled in the art would read the weight gain terms in the claims as referring to the average medication-related body weight gain compared to baseline among the patients undergoing treatment. In the discussion of that clinical study, the data for both efficacy and safety of lurasidone is described in terms of the sample of patients evaluated, as is the general practice for reporting the results of clinical studies. The average efficacy data is presented in Tables 2 and 3. And the safety data, which reports adverse events that were “observed in 10% or more of patients” in the population, is presented in Table 5 and the surrounding text. The specification reports that “114 subjects among 149 subjects (77%) showed adverse events, ” referring to the rate of adverse events seen in the study sample as a whole. ('827 patent at 7:42-44.)
32. As for weight gain specifically, the specification reports that weight gain “was not observed” in the study population tested. (Id. at 7:66-67.) There is no specific average or mean weight gain reported for the population undergoing treatment.
33. A person skilled in the art would understand that the invention claimed in the '827 patent is based, at least in part, on the clinical trial described in the specification. As such, a person skilled in the art, when reading the claims that are based in part on that clinical trial, would understand that terms such as “weight gain” refer to average or mean weight effects experienced within the population of patients undergoing treatment.

Dr. Newcomer thus concluded that the skilled artisan would understand the term “weight gain” to refer to average weight gain in a population.

         As to the proposition that the phrase, “weight gain, ” itself, in the context of the patent, refers to average weight gain in a population, Dr. Newcomer's first paragraph undermines this position and his own conclusion. Dr. Newcomer states that the skilled artisan may use either an average or a frequency count in evaluating a treatment method; without using these words, it is apparent that Dr. Newcomer means that skilled artisans use both averages and frequency counts as summary statistics of research data. Dr. Newcomer states that the skilled artisan may use one, or the other. This is at odds with Plaintiffs' prior position. Plaintiffs had argued that the skilled artisan would consider just one, the average.[5]

         The specification of the ‘827 patent contains no clear statements about how to assess weight gain. In fact, the specification says very little about weight gain at all. The phrase “weight gain” appears only once in the specification of the ‘827 patent, in this statement about the frequency of side effects in a clinical study: “Either body weight gain, bulimia, impotence, erectile dysfunction or convulsion was not observed.” ‘827 patent, col.7 ll.66-67. Table 5, which lists adverse events observed in the study, contains data in the form of frequencies and percentages. There are no averages in Table 5, nor are averages mentioned in the specification's discussion of Table 5. Plaintiffs, nonetheless, argue that the applicants here are discussing the population tested rather than individual data. This may be true, but, again, the fact that the patentees summarized the side effects experiences obtained in a clinical study does not mean that they conceived of the invention as a method to treat populations, not individuals.

         The specification thus mentions weight gain only in the context of describing the results of a clinical study of side effects of lurasidone treatment. Plaintiffs contend that the way in which the patentees presented clinical study results supports their proposed “population” construction. Table 5 contains only frequency counts, as raw frequencies or percentages; it contains no averages. Moreover, nearly the entire discussion of the side effects data in the specification refers only to frequencies, not to averages.[6] ‘827 patent, col.7 l.42-col.10 l.5. The intrinsic evidence does not support the Plaintiffs' contention that the skilled artisan, reading the patent, would choose the average weight gain in the population, rather than the frequency of weight gain in the population, to summarize side effects data and performance.

         Having abandoned their “on average” construction, the evidence in the specification that Plaintiffs point to in support of their “population” construction concerns: 1) clinical study results; and 2) plurals. As to clinical study results, Plaintiffs point out that, in the specification, the results are summarized for groups of patients. What is the logical connection between this point and the proposed construction? Yes, as a general rule, people often find summary statements about groups of people to be useful. Plaintiffs have not persuaded this Court that the fact that the patentees used summary statistics to summarize the results of clinical studies - the kind of summary study statistics that this Court sees routinely in treatment method patents - says anything about the meaning of particular claim terms.

         Plaintiffs also point to the use of plural forms, “patients, ” in the specification. It is true that, in some places, the specification uses the plural form, “patients, ” while in others, it uses the singular form, “patient.” Plaintiffs have not shown that the use of the plural form in some places reveals that the inventors understood the invention as a method for treating populations rather than individuals.

         Next, Plaintiffs cite the file history but, again, they point to an example of the applicants using summary statistics to describe clinical study results.[7] Again, this does not illuminate the meaning of any claim term. This Court finds no intrinsic evidence that supports any of Plaintiffs' proposed constructions.

         Lastly, in Plaintiffs' opening and post-hearing briefs, Plaintiffs point to parts of the Latuda® label and labels of other pharmaceuticals. The Court does not find this extrinsic evidence helpful to understanding any terms in the claims in the ‘827 patent. Thus, this Court finds no intrinsic or extrinsic evidence which supports the “population” construction.

         To support the “population” construction, Plaintiffs rely principally on the Federal Circuit's decision in Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1357 (Fed. Cir. 2014), in which the Court dealt with a composition patent and construed “a patient” to mean “a patient population.” It is well understood that Federal Circuit decisions cannot be read as codebooks, and that the construction in a patent in one case cannot be used as a translation for language in an unrelated patent. This Court concludes that Braintree is distinguishable.

         At the outset, this Court notes that, in Braintree, the Federal Circuit construed “a patient” to mean “a patient population.” In the instant case, Plaintiffs did not initially ask this Court to construe “a patient” to mean “a patient population.” It was only after oral argument that they proposed this construction.

         Nor does the legal reasoning the Braintree Court applied fit what Plaintiffs have proposed in the instance case.[8] The Federal Circuit's reasoning had its foundation in another preamble construction case, Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (citations omitted), in which the Federal Circuit held:

The determination of whether preamble recitations are structural limitations or mere statements of purpose or use can be resolved only on review of the entirety of the patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim. The inquiry involves examination of the entire patent record to determine what invention the patentee intended to define and protect.

         The Braintree Court applied this principle and concluded that the patentees intended to protect an invention that was better understood in terms of “a patient population, ” rather than “a patient.” Braintree, 749 F.3d at 1357. The Federal Circuit found support for this construction in the specification in several places. Id.

         The ‘827 patent, on the other hand, does not suggest the same. Rather, again consider claim 1:

1. A method for treating schizophrenia in a patient without a clinically significant weight gain, comprising: administering orally to the patient (1R, 2S, 3R, 4S)-N-[(1R, 2R)-2-[4-(1, 2-benzoisothiazol-3-yl)-1-piperazinyl met- hyl]-1-cyclohexylmethyl]-2, 3-bicyclo[2.2.1]heptanedicarboximide or a pharmaceutically acceptable salt thereof at a dose of from 20 to 120 mg/day such that the patient does not experience a clinically significant weight gain.

         Note the terminal phrase, “such that the patient does not experience a clinically significant weight gain.” This can only be understood in terms of an individual.[9] A group of patients cannot meaningfully be said to experience a clinically significant weight gain, on a group-wide or average basis. Individuals experience weight gain; while summary statistics may summarize the weight gain of all of the members of the group, the group does not “experience” collective weight gain. Plaintiffs ...


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