Case 2:18-cv-02065-SRC-CLW Document 131 Filed 10/05/18 Page 1 of 35 PageID: 2743
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`____________________________________
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`SUMITOMO DAINIPPON
`PHARMA CO., LTD. et al.,
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`Plaintiffs,
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`v.
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`EMCURE PHARMACEUTICALS
`LIMITED et al.,
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`Civil Action No. 18-2065 (SRC)
`(Consolidated)
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` OPINION & ORDER
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`Defendants.
`____________________________________:
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`SUMITOMO DAINIPPON
`PHARMA CO., LTD. et al.,
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`Plaintiffs,
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`v.
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`AUROBINDO PHARMA LTD. et al.,
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`Civil Action No. 18-2620 (SRC)
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`Defendants.
`____________________________________:
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`CHESLER, U.S.D.J.
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`This matter comes before the Court on the application for claim construction by
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`Plaintiffs Sunovion Pharmaceuticals Inc. and Sumitomo Dainippon Pharma Co., Ltd. and
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`Defendants Emcure Pharmaceuticals Ltd., Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories,
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`Ltd., Dr. Reddy’s Laboratories, Inc., Lupin Ltd., Sun Pharma Global FZE, Accord Healthcare
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`Inc., Amneal Pharmaceuticals, LLC, InvaGen Pharmaceuticals, Inc., Torrent Pharmaceuticals
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`Ltd., Watson Laboratories Inc., and Zydus Pharmaceuticals (USA) Inc. (collectively,
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`“Defendants”). In these consolidated patent infringement actions, the parties seek construction of
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`claim terms in U.S. Patent No. 9,815,827 (“the ’827 patent”), and a subset of the parties seek
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`construction of claim terms in U.S. Patent No. 9,907,794 (“the ’794 patent”).1
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`These consolidated cases are patent infringement actions under the Hatch-Waxman Act.
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`Plaintiffs are pharmaceutical manufacturers which own the ‘827 and ‘794 patents. The ‘827
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`patent is directed to methods of using lurasidone, the active ingredient in Plaintiffs’ Latuda ®
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`product. The’794 patent is directed to particular lurasidone formulations. Defendants are
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`pharmaceutical manufacturers who seek to manufacture and distribute generic versions of
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`Latuda®.
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`After opening and responsive briefs were filed, the Court allowed submission of a reply
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`brief. The Court heard oral argument on September 26, 2018, and allowed the parties to submit
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`post-hearing supplemental briefs.
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`I.
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`The law of claim construction
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`ANALYSIS
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`A court’s determination “of patent infringement requires a two-step process: first, the
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`court determines the meaning of the disputed claim terms, then the accused device is compared
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`to the claims as construed to determine infringement.” Acumed LLC v. Stryker Corp., 483 F.3d
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`800, 804 (Fed. Cir. 2007). “[W]hen the district court reviews only evidence intrinsic to the
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`patent (the patent claims and specifications, along with the patent’s prosecution history), the
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`judge’s determination will amount solely to a determination of law.” Teva Pharms. USA, Inc. v.
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`1 Plaintiffs do not assert the ‘794 patent against Defendants Torrent, Amneal, or Lupin.
`Those Defendants, along with Dr. Reddy’s and Sun Pharma, take no position on the construction
`of the ‘794 patent.
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`2
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`Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
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`The focus of claim construction is the claim language itself:
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`
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`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.’
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`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir.
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`2004) (citations omitted).
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`The Federal Circuit has established this framework for the construction of claim
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`language:
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`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. . .
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`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.
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).
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`II.
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`Claim construction of the disputed terms
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`The parties dispute a set of related claim terms in the ‘827 patent and a single term in the
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`‘794 patent. At issue in the ‘827 patent is the meaning of a set of claim terms which, generally,
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`describe the patented method as “without a clinically significant weight gain” or as “without a
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`weight gain.”
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`Plaintiffs, in their opening and responsive briefs, had proposed that the weight gain terms
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`did not limit the claims; in the alternative, Plaintiffs proposed that the weight gain phrases should
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`be understood to have the phrase “on average” inserted into them. Prior to oral argument,
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`Plaintiffs abandoned their primary argument and conceded that the weight gain terms in the ‘827
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`patent are claim limitations. Then, in the post-hearing supplemental briefing, Plaintiffs
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`abandoned their proposed alternative construction that sought to interpret the weight gain terms
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`as applying to population averages. Instead, Plaintiffs now ask the Court to construe “a patient”
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`in the ‘827 patent to mean “a patient population.” Plaintiffs argue that, when the Court reaches
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`the infringement analysis, the Court will need to figure out whether to use averages or frequency
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`counts to assess weight gain on a population-wide basis, but that it need not deal with that issue
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`during claim construction.
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`Although Plaintiffs no longer propose that “on average” be inserted into the claims, their
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`new proposed construction rests on arguments and evidence that were raised in the context of the
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`“on average” construction. Examination of the evidence and arguments concerning weight gain,
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`averages and frequencies in the ‘827 patent remains relevant. The fact that Plaintiffs now
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`propose a different construction does not erase their previous arguments. Consideration of the
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`arguments that supported “on average” reveals some conflicts between their prior proposed
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`construction and their latest one.
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`A.
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`Do the ‘827 weight gain terms refer to populations and averages?
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`Plaintiffs had contended that the weight gain terms2 do not limit the claims, but have
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`conceded that they do so. Plaintiffs had argued, in the alternative, that the weight gain terms, if
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`found limiting, “refer to the average measure of baseline body weight gain.” (Pls.’ Br. 15.) As
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`of the supplementary briefing, Plaintiffs propose that, instead, the Court should construe “a
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`patient” to mean “a patient population.”3 Defendants contend that the terms have their ordinary
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`meaning, and that “a patient” means “one or more patients.”
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`For example, consider claim 1:
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`1.
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`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.
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`Plaintiffs had proposed this construction of the body of the claim: “administering orally to the
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`patient [the chemical] or a pharmaceutically acceptable salt thereof at a dose of from 20 to 120
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`mg/day such that, on average, the baseline body weight of patients undergoing treatment does not
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`2 “Weight gain language,” or “weight gain terms,” as used herein, refers to phrases like,
`“such that the patient does not experience a clinically significant weight gain.”
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`3 In the claims, the weight gain phrases sometimes refer to “a patient” and sometimes to
`“the patient.” Neither the parties nor this Court have treated the difference in article used as
`meaningful in the context of this analysis.
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`increase by 7%.”4 Now, however, Plaintiffs’ proposed construction for claim 1 would construe
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`“the patient” to mean “the patient population.”
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`Plaintiffs have proposed that the phrase “weight gain,” in the context of the ‘827 patent,
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`“would be well understood by those skilled in the art to refer to the average weight gain across a
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`population of patients.” (Pls.’ Br. 16.) In support, Plaintiffs offered the declaration of their
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`expert, Dr. Newcomer. Dr. Newcomer states:
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`29.
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`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.
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`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.
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`31.
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`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
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`4 This proposed construction will be considered in two stages. First, the Court will
`consider the subject of populations and averages. Then, the Court will consider the “ 7%” term.
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`events seen in the study sample as a whole. (’827 patent at 7:42-44.)
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`32.
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`33.
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`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.
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`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.
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`Dr. Newcomer thus concluded that the skilled artisan would understand the term “weight gain” to
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`refer to average weight gain in a population.
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`As to the proposition that the phrase, “weight gain,” itself, in the context of the patent,
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`refers to average weight gain in a population, Dr. Newcomer’s first paragraph undermines this
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`position and his own conclusion. Dr. Newcomer states that the skilled artisan may use either an
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`average or a frequency count in evaluating a treatment method; without using these words, it is
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`apparent that Dr. Newcomer means that skilled artisans use both averages and frequency counts
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`as summary statistics of research data. Dr. Newcomer states that the skilled artisan may use one,
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`or the other. This is at odds with Plaintiffs’ prior position. Plaintiffs had argued that the skilled
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`artisan would consider just one, the average.5
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`The specification of the ‘827 patent contains no clear statements about how to assess
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`weight gain. In fact, the specification says very little about weight gain at all. The phrase
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`5 At oral argument, the Court queried Plaintiffs about this issue, and Plaintiffs stated that
`they could accept the use of either averages or frequencies. Plaintiffs’ post-hearing brief puts
`that position in writing. That modified position, however, contradicts the conclusion of their
`expert and their previous argument.
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`“weight gain” appears only once in the specification of the ‘827 patent, in this statement about
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`the frequency of side effects in a clinical study: “Either body weight gain, bulimia, impotence,
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`erectile dysfunction or convulsion was not observed.” ‘827 patent, col.7 ll.66-67. Table 5,
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`which lists adverse events observed in the study, contains data in the form of frequencies and
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`percentages. There are no averages in Table 5, nor are averages mentioned in the specification’s
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`discussion of Table 5. Plaintiffs, nonetheless, argue that the applicants here are discussing the
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`population tested rather than individual data. This may be true, but, again, the fact that the
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`patentees summarized the side effects experiences obtained in a clinical study does not mean that
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`they conceived of the invention as a method to treat populations, not individuals.
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`The specification thus mentions weight gain only in the context of describing the results
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`of a clinical study of side effects of lurasidone treatment. Plaintiffs contend that the way in
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`which the patentees presented clinical study results supports their proposed “population”
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`construction. Table 5 contains only frequency counts, as raw frequencies or percentages; it
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`contains no averages. Moreover, nearly the entire discussion of the side effects data in the
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`specification refers only to frequencies, not to averages.6 ‘827 patent, col.7 l.42-col.10 l.5. The
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`intrinsic evidence does not support the Plaintiffs’ contention that the skilled artisan, reading the
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`patent, would choose the average weight gain in the population, rather than the frequency of
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`weight gain in the population, to summarize side effects data and performance.
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`Having abandoned their “on average” construction, the evidence in the specification that
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`Plaintiffs point to in support of their “population” construction concerns: 1) clinical study results;
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`6 Only Table 8 contains averages, concerning three side-effects rating scales. ‘827 patent,
`col.10 ll.5-19. The claim terms at issue do not concern rating scales.
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`and 2) plurals. As to clinical study results, Plaintiffs point out that, in the specification, the
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`results are summarized for groups of patients. What is the logical connection between this point
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`and the proposed construction? Yes, as a general rule, people often find summary statements
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`about groups of people to be useful. Plaintiffs have not persuaded this Court that the fact that the
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`patentees used summary statistics to summarize the results of clinical studies – the kind of
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`summary study statistics that this Court sees routinely in treatment method patents – says
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`anything about the meaning of particular claim terms.
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`Plaintiffs also point to the use of plural forms, “patients,” in the specification. It is true
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`that, in some places, the specification uses the plural form, “patients,” while in others, it uses the
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`singular form, “patient.” Plaintiffs have not shown that the use of the plural form in some places
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`reveals that the inventors understood the invention as a method for treating populations rather
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`than individuals.
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`Next, Plaintiffs cite the file history but, again, they point to an example of the applicants
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`using summary statistics to describe clinical study results.7 Again, this does not illuminate the
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`meaning of any claim term. This Court finds no intrinsic evidence that supports any of Plaintiffs’
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`proposed constructions.
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`Lastly, in Plaintiffs’ opening and post-hearing briefs, Plaintiffs point to parts of the
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`Latuda® label and labels of other pharmaceuticals. The Court does not find this extrinsic
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`evidence helpful to understanding any terms in the claims in the ‘827 patent. Thus, this Court
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`7 For example, in the applicants’ remarks in response to the Office Action of October 19,
`2016, the applicants discussed a research study and cited weight gain summary statistics from it.
`(‘827 File History Ex. at LATUDA00000211.) The discussion contains some summary statistics
`that are averages, and some that are percentage incidence rates. (Id.)
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`finds no intrinsic or extrinsic evidence which supports the “population” construction.
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`To support the “population” construction, Plaintiffs rely principally on the Federal
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`Circuit’s decision in Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1357 (Fed. Cir.
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`2014), in which the Court dealt with a composition patent and construed “a patient” to mean “a
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`patient population.” It is well understood that Federal Circuit decisions cannot be read as
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`codebooks, and that the construction in a patent in one case cannot be used as a translation for
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`language in an unrelated patent. This Court concludes that Braintree is distinguishable.
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`At the outset, this Court notes that, in Braintree, the Federal Circuit construed “a patient”
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`to mean “a patient population.” In the instant case, Plaintiffs did not initially ask this Court to
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`construe “a patient” to mean “a patient population.” It was only after oral argument that they
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`proposed this construction.
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`Nor does the legal reasoning the Braintree Court applied fit what Plaintiffs have proposed
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`in the instance case.8 The Federal Circuit’s reasoning had its foundation in another preamble
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`construction case, Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (citations omitted), in which
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`the Federal Circuit held:
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`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.
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`8 In their post-hearing brief, Defendants distinguish Braintree on another basis: it
`concerned a composition patent, rather than a method patent, as in the instant case. One
`consequence of this difference, Defendants argue, is that a generic pharmaceutical manufacturer
`can only infringe indirectly, whereas the Braintree majority expressed concern about the impact
`of the construction on finding direct infringement. The Court finds this to be a meaningful
`distinction.
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`The Braintree Court applied this principle and concluded that the patentees intended to protect an
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`invention that was better understood in terms of “a patient population,” rather than “a patient.”
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`Braintree, 749 F.3d at 1357. The Federal Circuit found support for this construction in the
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`specification in several places. Id.
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`The ‘827 patent, on the other hand, does not suggest the same. Rather, again consider
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`claim 1:
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`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.
`
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`Note the terminal phrase, “such that the patient does not experience a clinically significant
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`weight gain.” This can only be understood in terms of an individual.9 A group of patients cannot
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`meaningfully be said to experience a clinically significant weight gain, on a group-wide or
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`average basis. Individuals experience weight gain; while summary statistics may summarize the
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`weight gain of all of the members of the group, the group does not “experience” collective
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`weight gain. Plaintiffs have not persuaded this Court that the ‘827 patentees understood “the
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`patient” to mean “the patient population.”
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`Lastly, as Defendants had argued, the effect of inserting “on average” into the claim
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`language would be “to cover the treatment of individual patients who do gain weight – exactly
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`what the plain language prohibits.” (Defs.’ Br. 3.) Although Plaintiffs have now abandoned the
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`9 If we rewrite claim 1 of the ‘827 patent to follow Braintree, claim 1 states “such that the
`patient population does not experience a clinically significant weight gain,” which makes no
`sense.
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`“on average” construction, the “population” construction has the same effect – except that now,
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`the effect is latent for the time being, to be uncovered and addressed later. Plaintiffs have clearly
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`stated that their plan is to persuade the Court to determine infringement by looking at weight gain
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`across a population, whether through the use of averages or of frequencies. But, as to
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`Defendants’ argument that this construction recaptures surrendered subject matter, this is the
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`same thing.10 If, as Plaintiffs contend, the patent covers the treatment of populations which do
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`not have clinically significant weight gain, rather than individuals, this opens the door to finding
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`that patients who do gain weight are infringers. Plaintiffs’ “population” construction could thus
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`have the effect of negating the express limits on scope stated in the claims – which limit the
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`scope of the invention to patients who do not gain weight – and extending the scope of patent
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`protection to include exactly that group of patients that the applicants expressly excluded – the
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`patients who do gain weight.
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`In Braintree, the Federal Circuit explained the reasoning for the decision that “a patient”
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`means “a patient population.” In particular, the Court wrote: “This definition of a patient is
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`consistent with the ‘invention the patentee intended to define and protect.’” Braintree, 749 F.3d
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`at 1357. This is one of the fundamental principles of claim construction, as the Federal Circuit
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`has explained at greater length elsewhere:
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`Ultimately, the interpretation to be given a term can only be determined and
`confirmed with a full understanding of what the inventors actually invented and
`intended to envelop with the claim. The construction that stays true to the claim
`language and most naturally aligns with the patent's description of the invention
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`10 Deferring until trial the inquiry into the method for assessing weight gain, as Plaintiffs
`now propose, conceals the improper broadening of claim scope that is latent in the “population”
`construction. While the “on average” construction made the attempted recapture of surrendered
`subject matter conspicuous at claim construction, the “population” construction leaves it latent.
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`will be, in the end, the correct construction. A claim construction is persuasive,
`not because it follows a certain rule, but because it defines terms in the context of
`the whole patent.
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`Renishaw PLC v. Marposs Societa' Per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) (citations
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`omitted). Thus, in Braintree, the Federal Circuit concluded that the construction, “a patient
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`population,” best aligned with the patent’s description of what the inventor actually invented.
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`The construction, “a patient population,” therefore neither broadened nor narrowed the scope of
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`the claim or of the invention.
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`In contrast, here, Plaintiffs have proposed a construction – “a patient population” – that
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`greatly broadens the scope of the claim, and broadens it well beyond what the inventors actually
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`invented. Although Plaintiffs have now argued that the Court need not, at this juncture,
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`contemplate how infringement is determined, it seems probable that the procedure would involve
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`assessing the weight gain of individuals who receive lurasidone treatment, but then combining
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`the results for patients who gained weight and patients who did not, and then computing either
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`the average weight gain or looking at summary frequency statistics for the population. If we
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`assess infringement across a population in such way, the claims could also cover patients who do
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`gain weight – as long as their population (however that is defined) does not gain weight (however
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`that is determined). As Defendants argue, this has the perverse effect of letting the claims cover
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`people who, by the clear language of the claims, are outside the metes and bounds of the
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`invention.
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`To put this another way, Plaintiffs’ proposed construction could operate to make
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`infringers out of physicians who treated patients with generic lurasidone or the patients
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`themselves, if those patients gained weight – if the patients are included in a population which,
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`on some summary measure, does not show clinically significant weight gain overall. This result
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`is directly contrary to the plain meaning of the claim language: only physicians who treat patients
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`with generic lurasidone (or the patients themselves), when those patients do not gain weight,
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`should be infringers. This application of Plaintiffs’ proposed construction leads to the absurd
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`result of infringement even if the patient’s use of lurasidone causes a significant weight gain.
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`Because Plaintiffs have not explained how infringement would be determined, the Court is left to
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`wonder whether a physician who treated only patients who gained weight could become an
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`infringer by virtue of having those patients eventually included in some larger population which,
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`on average or by some summary measure of frequency, shows no clinically significant weight
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`gain. In such a scenario, the infringement determination has nothing to do with the physician’s
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`conduct, or with the patients’ conduct, but is based on arbitrary groupings of results after
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`treatments are concluded. When the infringement determination is this arbitrary, the patent fails
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`to serve its function of notifying the public of the boundaries of the invention in a way that
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`allows definiteness and certainty about what is claimed.
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`Moreover, Plaintiffs’ proposed construction broadens the scope of the claims to cover
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`subject matter that the applicants surrendered. Consider the Supreme Court’s holding in Smith v.
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`Magic City Kennel Club, Inc., 282 U.S. 784, 789-90 (1931) (citations omitted):
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`The case, in our opinion, thus calls for the application of the principle that where
`an applicant for a patent to cover a new combination is compelled by the rejection
`of his application by the Patent Office to narrow his claim by the introduction of a
`new element, he cannot after the issue of the patent broaden his claim by dropping
`the element which he was compelled to include in order to secure his patent. . . .
`The applicant having limited his claim by amendment and accepted a patent,
`brings himself within the rules that if the claim to a combination be restricted to
`specified elements, all must be regarded as material, and that limitations imposed
`by the inventor, especially such as were introduced into an application after it had
`been persistently rejected, must be strictly construed against the inventor and
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`looked upon as disclaimers. The patentee is thereafter estopped to claim the
`benefit of his rejected claim or such a construction of his amended claim as would
`be equivalent thereto.
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`Applying Smith requires considering the prosecution history of the ‘827 patent.
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`The prosecution history shows that the application which led to the ‘827 patent was filed
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`on August 28, 2014 as a continuation of pending prior application number 10/525,021. (‘827
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`File History Ex. at LATUDA00000050-52.) The proposed claims submitted in this continuation
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`application do not mention weight or weight gain. (Id. at LATUDA00000071-73.) Instead,
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`proposed claims 1 and 8 disclose that the treatment method is “without being accompanied by
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`any extrapyramidal symptoms.”11 (Id. at LATUDA00000071-72.) The proposed abstract does
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`not mention weight or weight gain but, instead, states that the treatment works “without being
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`accompanied by extrapyramidal symptoms.” (Id. at LATUDA00000074.)
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`The applicants filed a preliminary amendment with the continuation application, which
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`cancelled all pending claims and submitted new claims 20 through 27. (Id. at
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`LATUDA00000076-79.) Claim 20, the only independent claim, began as follows: “A method
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`for treating schizophrenia in a patient, without causing clinically significant body weight gain in
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`the patient, the method comprising administering to the patient a dose of 5 mg to 120 mg of the
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`active compound . . .”12 (Id. at LATUDA00000078.) The proposed claims in the preliminary
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`amendment contain no other language related to weight or weight gain. On October 19, 2016,
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`11 The proposed specification explains: “However, phenothiazine derivatives,
`phenothiazine analogues, and butyrophenone derivatives may cause serious side effects of
`extrapyramidal symptoms showing parkinsonism such as the stiff gait of skeletal muscles, tremor
`of muscles, lack of facial expression, salivation, etc.” (Id. at LATUDA00000054.)
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`12 On October 5, 2015, the applicants filed an additional preliminary amendment which
`made a minor change to claim 20. (Id. at LATUDA00000134.)
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