Case 2:15-cv-03324-SRC-CLW Document 162 Filed 11/19/18 Page 1 of 17 PageID: 4306
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`NOT FOR PUBLICATION
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`_______________________________________
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`HORIZON PHARMA, INC., HORIZON
`PHARMA USA, INC., and POZEN INC.,
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`Plaintiffs,
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`v.
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`DR. REDDY’S LABORATORIES, INC.
`and DR. REDDY’S LABORATORIES,
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`HORIZON PHARMA, INC., HORIZON
`PHARMA USA, INC., and POZEN INC.,
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`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS INC.,
`MYLAN LABORATORIES LIMITED, and
`MYLAN, INC.,
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`Defendants.
`_______________________________________:
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` Civil Action No. 15-3324 (SRC)
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` OPINION
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`(consolidated for discovery
`purposes with Civil Action
`Nos. 16-4918, 16-9035,
`15-3327, 16-4921, 15-3326,
`and 16-4920)
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`Defendants.
`_______________________________________:
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`HORIZON PHARMA, INC., HORIZON
`PHARMA USA, INC., and POZEN INC.,
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`Plaintiffs,
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`v.
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`LUPIN LTD. and LUPIN
`PHARMACEUTICALS INC.,
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`Defendants.
`_______________________________________:
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`Page 1 of 17
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`Patent Owner Ex. 2007
`DRL v. Horizon
`IPR2018-01341
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`Case 2:15-cv-03324-SRC-CLW Document 162 Filed 11/19/18 Page 2 of 17 PageID: 4307
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`CHESLER, U.S.D.J.
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`This matter comes before this Court on the motion for summary judgment of invalidity
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`by Defendants Dr. Reddy’s Laboratories Inc., Dr. Reddy’s Laboratories Ltd., Mylan Inc., Mylan
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`Laboratories Limited, and Mylan Pharmaceuticals Inc. (collectively, “Defendants.”) Defendants
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`move for summary judgment of invalidity of U.S. Patent Nos. 9,220,698 (the “‘698 patent”) and
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`9,393,208 (the “‘208 patent”) on the ground of indefiniteness. Plaintiffs Horizon Pharma, Inc.,
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`Horizon Pharma USA, Inc., and Pozen Inc. (collectively, “Plaintiffs”) have opposed the motion.
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`For the reasons that follow, the motion will be granted.
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`These cases arise from Hatch-Waxman litigation regarding patents related to the drug
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`Vimovo®. Plaintiffs hold the patents and the various Defendants are pharmaceutical companies
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`which have filed ANDA applications to produce generic versions. Both patents at issue disclose
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`methods of treatment using pharmaceuticals containing naproxen and esomeprazole. Both
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`patents have only one independent claim, which is claim 1 in each patent.
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`Defendants move for summary judgment of invalidity on the ground of indefiniteness.
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`Claim 1 of the ‘698 patent is representative:1
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`A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing
`spondylitis comprising orally administering to a patient in need thereof an AM
`unit dose form and, 10 hours (.+-.20%) later, a PM unit dose form, wherein:
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`the AM and PM unit dose forms each comprises: naproxen, or a pharmaceutically
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`1 Claim 1 of the ‘208 patent is quite similar. During the Markman briefing, at the
`Markman hearing, and in the present briefing, the parties have uniformly treated claim 1 of the
`‘698 patent as representative of the independent claims in both patents. No one has contended
`that claim 1 of the ‘698 patent differs materially from claim 1 of the ‘208 patent with regard to
`the “target” claim language at issue on this motion. This Court will therefore focus in this
`opinion, as it did in the Markman opinion, on claim 1 of the ‘698 patent, but will draw
`conclusions about the first claims of both patents.
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`acceptable salt thereof, in an amount to provide 500 mg of naproxen, and
`esomeprazole, or a pharmaceutically acceptable salt thereof, in an amount to
`provide 20 mg of esomeprazole; said esomeprazole, or pharmaceutically
`acceptable salt thereof, is released from said AM and PM unit dose forms at a pH
`of 0 or greater,
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`the AM and PM unit dose forms target:
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`i) a pharmacokinetic (pk) profile for naproxen where: a) for the AM dose of
`naproxen, the mean C.sub.max is 86.2 .mu.g/mL (.+-.20%) and the median
`T.sub.max is 3.0 hours (.+-.20%); and b) for the PM dose of naproxen, the mean
`C.sub.max is 76.8 .mu.g/mL (.+-.20%) and the median T.sub.max is 10 hours
`(.+-.20%); and ii) a pharmacokinetic (pk) profile for esomeprazole where: a) for
`the AM dose of esomeprazole, the mean area under the plasma concentration-time
`curve from when the AM dose is administered to 10 hours (.+-.20%) after the AM
`dose is administered (AUC.sub.0-10,am) is 1216 hr*.mu.g/mL (.+-.20%), b) for
`the PM dose of esomeprazole, the mean area under the plasma concentration-time
`curve from when the PM dose is administered to 14 hours (.+-.20%) after the PM
`dose is administered (AUC.sub.0-14,pm) is 919 hr*.mu.g/mL (.+-.20%), and c)
`the total mean area under the plasma concentration-time curve for esomeprazole
`from when the AM dose is administered to 24 hours (.+-.20%) after the AM dose
`is administered (AUC.sub.0-24) is 2000 hr*.mu.g/mL (.+-.20%);
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`and the AM and PM unit dose forms further target a mean % time at which
`intragastric pH remains at about 4.0 or greater for about a 24 hour period after
`reaching steady state that is at least about 60%.
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`Defendants contend that the claim language involving “target” is indefinite. Claim 1 contains
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`two “target” clauses, the first of which begins with, “the AM and PM unit dose forms target,”
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`and the second of which begins with, “and the AM and PM unit dose forms further target.”
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`These shall both be referred to as “the target clauses.”
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`In the Markman Opinion, this Court construed “target” to mean “set as a goal,” but
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`reserved decision on the issue of whether the target clauses operate as claim limitations.
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`Defendants had contended that the target clauses do not limit the claims, while Plaintiffs posited
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`the contrary. Although Defendants still contend that the target clauses are not limiting, they
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`make this motion based on the contingency that this Court might rule in Plaintiffs’ favor in
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`finding that the target clauses limit the claims. The parties agree that this issue is the threshold
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`issue for the present motion: if this Court decides that the target clauses are not claim limitations,
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`the motion is moot. Thus, this Court begins with the question of whether the target clauses are
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`claim limitations. The parties did not rebrief this issue, and so the Court considers the arguments
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`presented during the Markman proceeding.
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`During the Markman proceeding, Defendants argued that the target clauses do not limit
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`the claims because they merely recite intended results of the claimed method, citing the Federal
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`Circuit’s decision in Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376
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`(Fed. Cir. 2001). In BMS, the Federal Circuit held that the preamble of a method claim did not
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`operate as a claim limitation on these grounds: “[W]e agree with the defendants that this
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`language is only a statement of purpose and intended result. The expression does not result in a
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`manipulative difference in the steps of the claim.” Id. Defendants also cite Syntex (U.S.A.)
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`LLC v. Apotex, Inc., 407 F.3d 1371, 1378 (Fed. Cir. 2005), in which the Federal Circuit
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`affirmed the district court’s decision that a term within the body of the claim, “in a stabilizing
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`amount,” was not limiting because it only described the intended result of a method step.
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`Plaintiffs argue that the target clauses limit the claims for several reasons, one of which is
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`quite strong: the applicants clearly treated them as such during prosecution. Plaintiffs point to
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`the response to final office action, dated September 25, 2015, filed by the applicants.
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`(Krumplitsch Dec. Ex. K.) Here, the applicants responded to the examiner’s rejection of various
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`claims, including claim 19, which matured into claim 1 of the ‘698 patent, for obviousness over
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`Hassan-Alin in view of Plachetka. (Id. at PZC_00031651.) The applicants argued:
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`To establish prima facie obviousness of a claimed invention, all the claim features
`must be taught or suggested by the prior art. . . Once again, the examiner has not
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`addressed at least the following highlighted claim features:
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`(Id.) The applicants then quoted claim 19 in its entirety, highlighting all the claim text that
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`followed the first instance of “target.” (Id. at PZC_00031651-52.) The applicants then wrote:
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`“There simply is no question, on the record, that the cited art lacks any teaching or suggestion of
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`these features.” (Id. at PZC_00031652.)
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`The Federal Circuit has held: “clear reliance on the preamble during prosecution to
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`distinguish the claimed invention from the prior art transforms the preamble into a claim
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`limitation because such reliance indicates use of the preamble to define, in part, the claimed
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`invention.” Catalina Mktg. Int'l v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
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`Although the target clauses are not preambles, this principle applies. The prosecution history
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`shows that the applicants relied on the target clauses to distinguish the claimed invention from
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`the prior art. To overcome an obviousness rejection, the applicants argued that the prior art did
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`not teach or suggest the “features”2 contained in the target clauses. This demonstrates that the
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`applicants used the target phrases to define, in part, the claimed invention. The target phrases
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`limit the claims.
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`The specification supports this conclusion. It states, in relevant part:
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`Over 15 million Americans take nonsteroidal anti-inflammatory drugs (NSAIDs)
`each day as a treatment for pain or inflammation. Unfortunately, many of these
`NSAIDs are associated with a high incidence of gastrointestinal complications . . .
`A major factor contributing to the development of gastrointestinal lesions appears
`to be the presence of acid in the stomach and upper small intestines.
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`During recent years, attempts have been made to reduce the gastrointestinal risk
`associated with taking NSAIDs by administering agents that inhibit stomach acid
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`2 The use of the word “features,” itself, indicates that the applicants understood the stated
`characteristics to be distinctive and important.
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`secretion, such as, for example, proton pump inhibitors with the NSAID. For
`example, U.S. Pat. No. 6,926,907 is directed to at least one drug dosage form
`comprising a proton pump inhibitor that raises the pH of a patient's
`gastrointestinal tract, followed by an NSAID. This, and similar, formulations can
`be effective in improving NSAID tolerability through dosages of esomeprazole
`and naproxen that produce the desired pharmacodynamic response and
`pharmacokinetic values. Parameters that may influence the desired
`pharmacodynamic response and pharmacokinetic values include, but are not
`limited to, for example, the dosage of each; extent of drug absorption; extent of
`drug distribution, and the duration of drug administration.
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`There is a need for a clinically effective therapy that delivers to a patient in need
`thereof a pharmaceutical composition in a unit dose form comprising naproxen, or
`pharmaceutically acceptable salt thereof, and esomeprazole, or pharmaceutically
`acceptable salt thereof, for a duration sufficient to achieve an instragastric pH of
`about 4 or greater and a plasma level of naproxen that is efficacious.
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`In one aspect, the disclosure is directed to a method for delivering a
`pharmaceutical composition to a patient in need thereof, comprising:
`administering to said patient a pharmaceutical composition in unit dose form
`comprising naproxen, or pharmaceutically acceptable salt thereof, and
`esomeprazole, or pharmaceutically acceptable salt thereof, wherein said
`esomeprazole, or pharmaceutically acceptable salt thereof, is released from said
`unit dose form at a pH of from about 0 or greater to target: a mean % time at
`which intragastric pH remains at about 4.0 or greater for about a 24 hour period
`after reaching steady state of at least about 41%.
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`‘698 patent, col.1 ll.19-59. In this passage, the specification places the invention in the context
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`of the prior art and the problem to be solved. The second-to-last paragraph describes the
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`problem to be solved, in short, as a need for a pharmaceutical composition comprising naproxen
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`and esomeprazole that delivers these components “for a duration sufficient to achieve an
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`instragastric pH of about 4 or greater and a plasma level of naproxen that is efficacious.” ‘698
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`patent, col.1 ll.46-48. The next paragraph describes one aspect of the invention as having release
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`characteristics that target a solution to the part of the problem just pointed out. Now compare the
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`second target clause in claim 1:
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`and the AM and PM unit dose forms further target a mean % time at which
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`intragastric pH remains at about 4.0 or greater for about a 24 hour period after
`reaching steady state that is at least about 60%.
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`This claim language clearly relates to the statement of the problem to be solved, and also to the
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`statement of that aspect of the invention which attempts to implement a solution to that problem.
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`It refers to a significant aspect of what the inventor actually invented. See Phillips v. AWH
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`Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (“The construction that stays true to the claim
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`language and most naturally aligns with the patent’s description of the invention will be, in the
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`end, the correct construction.”) In the context of the inquiry into whether a preamble phrase
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`limits the claim, the Federal Circuit has held: “The effect preamble language should be given can
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`be resolved only on review of the entirety of the patent to gain an understanding of what the
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`inventors actually invented and intended to encompass by the claim.” Corning Glass Works v.
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`Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). It is unmistakable that the
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`second target clause derives from what the inventors state they actually invented and attempts to
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`“define, in part, the claimed invention.” Catalina, 289 F.3d at 808.
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`The intrinsic evidence contained in the prosecution history and the specification
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`demonstrates that the target clauses are claim limitations. Having resolved that issue, the Court
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`finds that the motion for summary judgment is not moot, but is now ripe for consideration.
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`Defendants move for summary judgment of invalidity of the ‘698 and ‘208 patents on the
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`ground that the claims are indefinite due to the target clauses. In short, Defendants argue that,
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`given this Court’s construction of “target” as “set as a goal,” the “patents provide no guidance
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`regarding how often, if ever, the recited ranges must be met or how close one must come to those
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`ranges to infringe the asserted claims.” (Defs.’ Br. 2.)
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`The parties do not dispute the applicable legal standard: “a patent is invalid for
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`indefiniteness if its claims, read in light of the specification delineating the patent, and the
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`prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the
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`scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014).
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`Indefiniteness is a question of law, which may rely on subsidiary determinations of underlying
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`facts. Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334, 1343 (Fed. Cir. 2016).
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`Patents are presumed to be valid; the challenger bears the burden of establishing invalidity by
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`clear and convincing evidence. 35 U.S.C. § 282(a); Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S.
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`91, 95 (2011).
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`Because this Court construed “target” to mean, “set as a goal,” this requires that the PK
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`and PD profiles stated in the target clauses define the goals to be set. Plaintiffs argue, in essence,
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`that those profile definitions are quite clearly delineated, but that misses the problem. The fact
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`that a goal is clearly defined does not mean that the act of targeting that goal is clearly defined,
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`and this is the crux of the definiteness problem here. The fundamental difficulty is that both key
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`phrases here are incomprehensible: “the AM and PM unit dose forms target:” and “the AM and
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`PM unit dose forms further target.” It is not possible to comprehend what these phrases mean,
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`because pills cannot be said to set goals. In ordinary usage, we understand a goal to be
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`something that people, or perhaps living creatures, set; inanimate objects set no goals.
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`Moreover, it would be of no help to Plaintiffs to say, well, we know what the applicants
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`were trying to say, and it is the physician treating the patient who sets these goals. There are two
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`problems with this. First, that is not what the patentees wrote, and this Court will not redraft the
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`claims to preserve their validity. See Becton Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792,
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`799 n.6 (Fed. Cir. 1990) (“Nothing in any precedent permits judicial redrafting of claims.”)
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`Second, even if the claims were so rewritten, this change alone would not suffice to make them
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`comprehensible. Even if – for the sake of discussion only – there was some valid way to
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`construe the claims to mean that the treating physician sets these goals, it still fails to inform
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`with reasonable certainty about the scope of the invention.
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`The Supreme Court has stated that a patent rewards innovation with a temporary
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`monopoly: “The monopoly is a property right; and like any property right, its boundaries should
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`be clear.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 730 (2002).
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`Thus, a patent must inform the public of those boundaries: “A patent holder should know what
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`he owns, and the public should know what he does not.” Id. at 731. The problem here is that the
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`target clauses fail to draw clear boundaries. Suppose you are a physician who has obtained pills
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`that provide 500 mg of naproxen and 20 mg of esomeprazole, and you want to treat a patient
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`suffering from osteoarthritis, but you want to avoid infringing the ‘698 patent. How do you
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`determine the boundary for what you may legally do and what you may not? If we understand
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`these target clauses to mean that the pills cannot set particular goals, you can relax about
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`infringing, because your pills will never set any goals. If we understand these target clauses to
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`mean that you, the treating physician, cannot yourself set treatment goals for PK and PD
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`outcomes that fall within the claimed values, do you now know, with reasonable certainty, what
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`you may permissibly do and what you may not? This Court sees no way that defining the goals
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`for a method can, without more, inform the public of how to act to avoid infringement.3 This is
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`3 This is not a mere bicker over the meaning of one word, “target;” this Court truly cannot
`discern what the claimed method is. The method begins with orally administering to a patient in
`need a pharmaceutical that provides 500 mg of naproxen and 20 mg of esomeprazole – that
`method step is clear. The remainder of claim 1, the two target clauses, do not appear to be
`cognizable as method steps. Instead, the most reasonable inference is that they reflect attributes
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`Defendants’ point, and this Court agrees.
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`To make this analysis less abstract, consider Defendants’ argument that “claims that
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`target PK and PD values as a goal for the dosage forms lack the ‘objective boundaries’ required
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`under § 112, ¶ 2 because they provide no discernable standard for how far a particular
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`formulation administered to any given patient or group of patients can stray from the stated goals
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`and still infringe the claims.” (Defs.’ Br. 10.) Had this Court agreed with Plaintiffs during claim
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`construction that “target” meant “produce,” it would be clear enough that you, the physician
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`wanting to avoid infringing the ‘698 patent, must somehow take care to ensure that your
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`naproxen/esomeprazole pills do not achieve blood levels and intragastric pH levels in the treated
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`patient that fall within the scope of the PK and PD characteristics defined in the claim. It would
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`be clear that, to avoid infringing claim 1 of the ‘698 patent, you must avoid effecting these
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`particular, defined outcomes. Because, however, this Court concluded that “target” means “set
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`as a goal,” it is not possible to discern what the target clauses are telling you to do or not do.
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`Defendants are correct that the patent provides no discernable standard for drawing the line that
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`distinguishes infringing acts from noninfringing ones – because the target clauses are
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`incomprehensible. As the claim is written, you must take care that your pills do not set certain
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`goals, which is nonsensical. Even if, somehow, we construe the claim to mean that the physician
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`sets the goals, it appears that you, the treating physician, must avoid having a subjective intent to
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`achieve the defined outcomes. This is neither comprehensible nor cognizable as a claim
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`of the effect of the pharmaceutical on a population of patients. As already explained, this
`Court’s construction of “target” precludes construing it as “produce.” Because “target” does not
`mean “produce,” the clauses which might define attributes of the pharmaceutical’s effect are,
`effectively, left marooned, with no comprehensible connection to the administration step.
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`limitation: it simply cannot be that the question of infringement of a method patent turns on the
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`mental state of the accused infringer, or of a pill that does not have one.
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`Plaintiffs’ opposition to the motion for summary judgment fails principally because of
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`two defects. First, Plaintiffs give only lip service to this Court’s claim construction decision that
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`“target” means “set as a goal.” Plaintiffs’ arguments reflect a total denial of this Court’s
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`rejection of their proposed construction, and are presented as if this Court had accepted, rather
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`than rejected, their proposed construction. For example – and this goes to the heart of Plaintiffs’
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`argument that the claims are definite –, Plaintiffs state: “If such a ‘goal’ or ‘target’ is not met,
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`then an accused product does not infringe the asserted claims.” (Pls.’ Opp. Br. 6.) Plaintiffs thus
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`continue to insist that “target” means “produce,” and that everything is clear because the claim
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`requires the accused infringer to meet the goal; there is no meaningful difference between this
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`reading of the claim and the one this Court rejected during claim construction.
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`Second – and this flows from the first defect –, Plaintiffs repeatedly focus on the larger
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`part of the target clauses which they contend is definite and not on the smaller portion which this
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`Court finds indefinite. Consider, for example, the second target clause in claim 1 of the ‘698
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`patent:
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`and the AM and PM unit dose forms further target a mean % time at which
`intragastric pH remains at about 4.0 or greater for about a 24 hour period after
`reaching steady state that is at least about 60%.
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`This can be broken into two basic parts:
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`“and the AM and PM unit dose forms further target”
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`“a mean % time at which intragastric pH remains at about 4.0 or greater for about
`a 24 hour period after reaching steady state that is at least about 60%.”
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`The fact that the second part of the clause may be definite is a different issue from whether the
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`first part is indefinite. Plaintiffs focus on the second part and, generally, overlook the major
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`problems with the first part.
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`In opposition, Plaintiffs make four different arguments. Plaintiffs first argue:
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`“Defendants’ arguments that the asserted claims are indefinite are premised on a mistaken
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`reading of the Court’s Markman Order: they focus on individual patients while ignoring the
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`claims read in light of the patent specification.” (Pls.’ Opp. Br. 4.) This Court disagrees and
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`finds that it is Plaintiffs who have made a mistaken reading of the claim construction decision.
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`This Court made no decision about whether the target clauses describe PK and PD values for
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`individual patients or for groups of patients. That issue was tangential to the claim construction
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`disputes. In the decision, the Court referenced the parties’ positions on this issue as it considered
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`the meaning of “target,” and nothing more.
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`Furthermore, because the section of Plaintiffs’ opposition brief which makes this first
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`argument is quite confused and contradictory, it is difficult to find the sense in this first
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`argument. Plaintiffs begin by quoting the claim construction decision out of context:
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`If Plaintiffs are correct in their contention that the PK and PD values in claim 1
`are averages for a group, the claim, using this construction, makes sense: one
`administers the method to an individual patient with the goal of obtaining these
`values, on average, for a group of patients.
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`(Opinion & Order of November 14, 2017 at 11.) In the next line, Plaintiffs write: “The Court’s
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`explanation of the claimed PK and PD parameters above, is consistent with Plaintiffs’
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`understanding, and renders the asserted claims definite.” (Pls.’ Opp. Br. 5.) It is difficult to
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`interpret what Plaintiffs have really said here, since they have misread the decision and quoted it
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`out of context. Consider the original quote in context. The Court was discussing Defendants’
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`proposed construction of target, “to establish as a goal.” (Opinion & Order of November 14,
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`2017 at 11.) The Court then wrote:
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`If Plaintiffs are correct in their contention that the PK and PD values in claim 1
`are averages for a group, the claim, using this construction, makes sense: one
`administers the method to an individual patient with the goal of obtaining these
`values, on average, for a group of patients. From this perspective, the PK and PD
`profiles in claim 1 do not serve as limitations for the method, but as statements of
`a goal aspired to, but not met, for every patient.
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`(Id.) Among a number of problems, Plaintiffs have overlooked the word “if” that begins the first
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`quoted sentence above. The word “if” signals the reader that what follows is contingent on the
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`correctness of the predicate proposition, which has not been determined. This Court did not
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`make any determination as to the correctness of that predicate.
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`Having misread the claim construction decision, it is difficult to figure out what Plaintiffs
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`are agreeing to when they say that the Court’s explanation of the PK and PD parameters is
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`consistent with their understanding. If the quote is considered in context, it appears that
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`Plaintiffs are saying that they agree that “the PK and PD profiles in claim 1 do not serve as
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`limitations for the method, but as statements of a goal aspired to, but not met, for every patient.”
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`That would be contrary to their stated position, which is that they do serve as claim limitations.
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`What is clear in this section is that Plaintiffs contend that “the claims, read in light of the
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`specification, refers [sic] to average PK and PD values derived from multiple individual
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`patients.” (Id.) This Court continues to take the position that it need not reach the question of
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`whether this tangential contention is correct. Even if Plaintiffs are correct on this point, “target”
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`is still indefinite, and quite possibly this makes the claim less comprehensible. Do Plaintiffs
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`contend that claim 1 of the ‘698 patent should be understood to disclose a method of treating “a
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`patient” that entails the pill or the physician targeting average PK and PD characteristics for
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`some group of patients? How does this help make the claim comprehensible? As Defendants
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`argue, the patent still fails to teach how to draw the line to determine what to do to avoid
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`infringing. What does their being averages have to do with ascertaining the meaning of “target”
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`with reasonable certainty?
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`The indefiniteness problem here lies in the first element of the target clause, not the
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`second: it is in the use of the word “target,” not in the following language that states some
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`definition of what the target is. The claim language delineating the target could be clear as day,
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`and “target” would still be indefinite. Deciding whether or not the target values are averages
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`from multiple patients has no impact on this problem.
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`Plaintiffs then write:
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`While individual patients may fall outside the claimed range, the averages for the
`group of patients fall clearly within the claimed ranges. As Dr. Taft explains,
`“[t]he claims are as reasonably certain as they could be, given the variability in
`PK/PD values.” (Ex. A, Taft Rebuttal Report, ¶ 78.)
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`Defendants also assert that the record provides no basis to identify “how much the
`results of such targeting can deviate from those goals and still fall under the
`claims.” (ECF No. 119 at 16.) On the contrary, the claims themselves provide a
`clear basis to identify such deviation. As Dr. Taft explains, “[a] person of
`ordinary skill in the art would know that the PK and PD values in claim 1 of both
`patents are average values. Thus, a skilled artisan would be targeting ±20% of an
`average parameter.” (Ex. A, Taft Rebuttal Report, ¶ 73.) The metes and bounds of
`the claims are clearly defined by claimed the range of ±20% of the average PK
`and PD values (i.e. Cmax, AUC, etc.).
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`(Pls.’ Opp. Br. 7.) The proffered explanations from expert Dr. Taft do not help solve the
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`problem of the meaning of “target.” Dr. Taft does no more than say that the claim language
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`clearly defines the bounds of the target. As already explained, this does not remedy the problem
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`of the indefiniteness of the word “target,” itself. Dr. Taft states: “ a skilled artisan would be
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`targeting ±20% of an average parameter.”4 (Id.) Given that this Court has construed “target” to
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`mean, “set as a goal,” the Court interprets Dr. Taft’s statement to be that “a skilled artisan would
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`set as a goal ±20% of an average parameter.” Even if Dr. Taft is correct, this still does not solve
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`the problem raised by Defendants: the claim provides “no discernable standard for how far a
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`particular formulation administered to any given patient or group of patients can stray from the
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`stated goals and still infringe the claims.” (Defs.’ Br. 10.)
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`Plaintiffs’ second argument challenges Defendants’ contention that it is problematic that
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`the claim does not specify who is doing the targeting:
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`As discussed above, the metes and bounds of the claims are definite and clear. A
`dosage form of the claimed composition that results in a group of individuals with
`average PK and PD values falling within the claimed parameters infringes the
`asserted claims . . .
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`(Pls.’ Opp. Br. 8.) This argument rests on a rejected predicate. Plaintiffs argue as if the Court
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`had adopted their proposed construction of “target,” which was “produce.” The Court rejected
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`Plaintiffs’ proposal