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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`BTG INTERNATIONAL LIMITED,
`et al.,
`
`Civ. No. 15-cv-5909 (KM)(JBC)
`
`Plaintiffs,
`
`v.
`
`ACTAVIS LABORATORIES FL, INC.,
`et al.,
`
`Defendants.
`
`OPINION
`(Markman Patent Claim Construction)
`
`MCNULTY, U.S.D.J.:
`
`This Hatch-Waxman litigation arises out of the defendants’ submissions
`of Abbreviated New Drug Applications (“ANDAs”) with Paragraph IV
`certifications to the United States Food and Drug Administration (the “FDA”).’
`The plaintiffs, BTG International Limited (“BTG”), Janssen Biotech, Inc.,
`Janssen Oncology, Inc. (“Janssen Oncology”), and Janssen Research &
`Development, LLC (collectively, “Plaintiffs”), are the owners or exclusive
`licensees of two patents on a branded drug, ZYTIGA® (abiraterone acetate)
`Tablets (“ZYTIGA®”): United States Patent Nos. 8,822,438 (the “438 patent”)
`and 5,604,213 (“the ‘213 patent”). The defendants are generic drug companies
`who seek to engage in the commercial manufacture, use, offer for sale, or sale
`of a generic version of the plaintiffs’ drug.
`The plaintiffs claim that the defendants have infringed by submission of
`their ANDAs, and that the defendants’ manufacture or sale of a generic version
`
`1
`
`A Paragraph IV certification submits that the patent covering the branded drug
`currently being marketed is invalid, unenforceable, or will not be infringed by the
`manufacture, use, or sale of the proposed generic drug product for which the ANDA is
`submitted. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV); see also Defendant Actavis Laboratories
`Fl, Inc.’s Answer and Counterclaims to Plaintiffs’ First Amended Complaint for Patent
`Infringement (ECF No. 85).
`
`JANSSEN EXHIBIT 2004
`Mylan v. Janssen IPR2016-01332
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`

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`of the drug will infringe the ‘438 and ‘213 patents.2 Defendants have denied
`
`infringement and counterclaimed for declaratory judgment that Plaintiffs’
`
`patents are not infringed or are invalid.
`
`This Opinion pertains only to construction of the ‘438 patent, entitled
`
`“Methods and Compositions for Treating Cancer,” which the USPTO issued on
`September 2, 2014. That patent covers all FDA-approved indications of
`
`ZYTIGA®, a therapy that has demonstrated efficacy in extending the lives of
`
`advanced prostate cancer patients.3 In connection with preparations for a
`
`•
`
`BTG owns the ‘213 patent and Janssen Oncology owns the ‘438 patent. The
`2
`Janssen plaintiffs are the exclusive licensees of the ‘213 patent. (See Amended
`Complaint (ECF No. 47) ¶J 57—60.) Currently pending before this court is a separate
`motion to amend the complaint seeking to add patent infringement claims against
`certain of the Defendants as to U.S. Patent No. 8,236,946 and U.S. Patent No.
`8,389,714, both also owned and/or licensed by the plaintiffs, but neither of which is
`at issue in this Opinion. (See ECF No. 204.)
`Also pending is a motion to Set a Hearing and Correct Inventorship of the ‘438
`patent by Plaintiffs, with which Plaintiffs filed a proposed Second Amended Complaint
`(No. 176) that seeks to add an additional inventor to the ‘438 patent and to add BTG
`as a plaintiff with respect to counts asserted and recovery sought under the ‘438
`patent. Thus, BTG is not a plaintiff with respect to the counts asserted under the ‘438
`patent at this time.
`For purposes of this opinion, citations to the record will be abbreviated as
`3
`follows:
`‘438 patent = Copy of U.S. Patent No. 8,822,438, Exhibit 1 to the Declaration of
`Brendan F. Barker in Support of Defendants’ Claim Construction Brief (ECF No.
`2 10-3)
`P1. Br. = Plaintiffs’ Opening Claim Construction Brief (ECF No. 209)
`•
`• Def. Br. = Defendants’ Opening Claim Construction Brief (ECF No. 210)
`•
`P1. Resp.= Plaintiffs’ Responsive Claim Construction Brief (ECF No. 220)
`• Def. Resp. = Defendants’ Responsive Claim Construction Brief (ECF No. 221)
`• Barker Decl. = Declaration of Brendan F. Barker in Support of Defendants’
`Claim Construction Brief (ECF No. 2 10-2)
`• Barker Resp. Deci. = Declaration of Brendan F. Barker in Support of
`Defendants’ Responsive Claim Construction Brief (ECF No. 221-1)
`• Fruehauf Dccl. = Declaration of John P. Fruehauf, M.D., Ph.D. on Claim
`Construction (ECF No. 2 10-1)
`• Miller Deci. = Declaration of Keith J. Miller, Esq. in Support of Plaintiffs’
`Opening Claim Construction Brief (ECF No. 209-1)
`2
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`Markman hearing, it emerged that the key disputed terms are “treatment” and
`
`“treating”. For the reasons discussed below, the court adopts the plaintiffs’
`
`proposed construction of the terms “treatment” and “treating”.
`
`I.
`
`FACTUAL BACKGROUND AND PROCEDURAL HISTORY
`The parties’ dispute as to construction of the ‘438 patent is a narrow one:
`
`what is the meaning of the terms “treatment” and “treating” in the claimed
`
`methods? Claim 1, the only independent claim of the ‘438 patent, states:
`1. A method for the treatment of a prostate cancer in a
`human comprising administering to said human a
`therapeutically effective amount of abiraterone acetate or
`a pharmaceutically acceptable salt thereof and a
`therapeutically effective amount of prednisone.
`
`(‘438 patent, 16:16—20 (emphasis on disputed term).) “Treatment” is the only
`disputed term that appears in claim 1. The parties also include the term
`
`“treating,” however, because “treating” appears in their proposed joint
`
`construction of the term ‘therapeutically effective amount.” The parties agree
`
`that a “therapeutically effective amount” means “an amount effective for
`
`treating cancer.” (See Def. Br. 5 n.4 (emphasis on disputed term).)4
`
`Plaintiffs submit that “treatment” and “treating” must be given a
`
`restrictive construction that encompasses only “reducing the growth and
`
`spread of cancer cells.” (P1. Br. 2) Defendants, on the other hand, argue for a
`
`more inclusive construction that covers “all of the uses and therapeutic
`
`benefits known” when this method for treating prostate cancer in patients was
`
`invented. Defendants’ more inclusive construction would encompass
`
`• MJCC = So-Ordered Letter Modifying Joint Claim Construction and Prehearing
`Statement (ECF No. 208)
`Additionally, the parties agree that the preamble of claim 1, on which claims 2-
`20 of the ‘438 patent depend and reads “A method for the treatment of a prostate
`cancer in a human,” is “limiting, and limits the claims to the treatment of a prostate
`cancer in a human.” They agree that “refractory prostate cancer” means “Prostate
`cancer that is not responding to an anti-cancer treatment or prostate cancer that is
`not responding sufficiently to an anticancer treatment. Refractory prostate cancer can
`also include recurring or relapsing prostate cancer.” And, they agree that
`“therapeutically effective amount” means “an amount effective for treating cancer.”
`(MJCC 2.)
`
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`treatments targeted at reducing the actual prostate cancer, but also “reducing
`
`the pain associated with prostate cancer and replacing the normal production
`
`of glucocorticoids that is blocked when patients are given CYP1 7 inhibitors.”
`
`(Def. Br. 1.) To simplify, Plaintiffs say that the ‘438 patent covers only a
`
`treatment for shrinking and/or killing actual cancerous tumor cells;
`
`Defendants agree that it covers this, but say the patent also covers pain relief
`
`and glucocorticoid replacement.
`
`To reflect their positions, the parties propose the following constructions
`of “treatment” / “treating”:
`• Plaintiffs propose: “the eradication, removal,
`modification, management or control of a tumor or
`primary, regional, or metastatic cancer cells or tissue
`and the minimization or delay of the spread of cancer.”
`
`• Defendants propose: “including the eradication,
`removal, modification, management or control of a
`tumor or primary, regional, or metastatic cancer cells
`or tissue and the minimization or delay of the spread
`of cancer.”
`
`(See MJCC; ECF Nos. 231, 232 (October 21, 2016 letters from parties reflecting
`
`further revision to joint construction) (emphasis added).) The proposed
`
`definitions are identical, except for the word “including” which appears at the
`
`beginning of Defendants’ proposal.
`
`The ‘438 patent itself defines the disputed terms in the specification as
`
`follows:
`
`As used herein, and unless otherwise defined, the terms
`“treat,” “treating” and “treatment” include the
`eradication, removal, modification, management or
`control of a tumor or primary, regional, or metastatic
`cancer cells or tissue and the minimization or delay of
`the spread of cancer.
`(‘438 patent 3:46—50 (“Definitions” section).)S
`
`Plaintiffs have informed this court they “have no objection to the Court’s
`adopting this express definition from the patent with the word ‘include,’ so long as the
`Court clarifies that the word ‘include’ is used in this definition in its restrictive sense.”
`(October 21, 2016 Letter from Justin T. Quinn (ECF No. 232).)
`4
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`A bit of scientific background may assist in clarifying the issues. The
`
`parties generally agree as to the following description of the treatment of
`
`prostate cancer generally and specifically with ZYTIGA®. Prostate cancer is the
`
`uncontrollable proliferation of prostate cells. Male sex hormones called
`
`androgens promote the growth of prostate cancer cells, so a common treatment
`
`for prostate cancer is androgen deprivation therapy (“ADT”). ADT aims to lower
`
`the body’s production and circulation of testosterone, a naturally occurring
`
`androgen, in the body. The drug abiraterone acetate belongs to a class of drugs
`
`known as CYP1 7 inhibitors, which block production of testosterone in a
`
`patient’s adrenal glands. CYP17 inhibitors, however, also block production of
`
`other steroids and hormones, which can lead to serious side effects. To reduce
`
`such side effects, patients receiving this class of drugs often receive steroid
`
`replacement therapy. Steroid replacement therapy often involves
`
`administration of prednisone, a synthetic type of a subclass of steroid called a
`
`glucocorticoid. Steroids like prednisone inhibit the growth of cancer cells; they
`
`also provide pain relief, or palliative treatment, to prostate cancer patients. (See
`
`P1. Br. 2—3; Def. Br. 3—4.)
`
`ADT is not considered a cure for prostate cancer because in most
`
`patients, it eventually loses effectiveness in inhibiting tumor growth. Prior to
`
`the invention described in the ‘438 patent, prostate cancer not responsive to
`
`ADT (known as or metastatic castration-resistant prostate cancer (“mCRPC”),
`
`had few treatment options. The ‘438 patent invention—specifically the
`
`combination of therapeutically effective amounts of abiraterone acetate and
`
`prednisone, marketed as ZYTIGA®—has proven effective in extending the lives
`
`of patients with mCRPC. (See P1. Br. 3—4; Def. Br. 3—4.)
`
`Plaintiffs submit that the efficacy of the ‘438 patent invention was novel
`
`and surprising. At the time of the invention, they say, researchers doubted that
`
`an androgen-suppression drug like abiraterone acetate would be effective in
`
`castration-resistant prostate cancer patients; the prior art, moreover, did not
`
`suggest that prednisone could have any anti-cancer effect, alone or in
`
`combination with abiraterone acetate. (P1. Br. 3.) Plaintiffs acknowledge that
`
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`glucocorticoids like prednisone had been used for palliation of chemotherapy-
`related side effects. But treatment with abiraterone acetate alone, say plaintiffs,
`did not cause such side effects, and therefore a person skilled in the art would
`not have seen a need to combine abiraterone acetate with a glucocorticoid. (Id.
`4.)
`
`The ‘438 patent is generally directed to methods for treating prostate
`cancer in humans. It discloses such methods as administration of a CYP17
`inhibitor like abiraterone acetate in combination with another therapeutic
`agent such as an anti-cancer agent or steroid. The ‘438 patent identifies
`prednisone as one such therapeutic agent that can be combined with
`abiraterone acetate. (Id.)
`Patent construction must of course precede any analysis of patent
`infringement. Therefore, on October 25, 2016, I convened a Markman hearing
`to determine the meaning of the disputed terms. See Markman v. Westview
`Instruments, Inc., 52 F.3d 967, 976—79 (Fed. Cir. 1995) (en banc), affd, 517
`U.s. 370, 116 S. Ct. 1384, 134 L. Ed. 2d 577 (1996). I have carefully
`considered the parties’ written submissions and arguments. In this Opinion I
`set forth my construction of the disputed patent terms.
`II.
`DISCUSSION
`A. Standard of Review
`
`“Whoever invents or discovers any new and useful process, machine,
`manufacture, or composition of matter, or any new and useful improvement
`thereof, may obtain a patent therefor, subject to the conditions and
`requirements of this title.” 35 U.S.C. § 101. In order to obtain a patent, the
`inventor must submit a written application providing (1) “a specification as
`prescribed by 35 U.S.C. § 112”; (2) “a drawing as prescribed by § 113”; and (3)
`“an oath or declaration as prescribed by § 115.” See 35 U.S.C. § 111.
`The patent’s specification must contain:
`a written description of the invention, and of the manner
`and process of making and using it, in such full, clear,
`concise, and exact terms as to enable any person skilled
`in the art to which it pertains, or with which it is most
`
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`nearly connected, to make and use the same, and shall set
`forth the best mode contemplated by the inventor or joint
`inventor of carrying out the invention.
`
`Id. § 112.
`The patent’s “claims” round out the specification by “particularly
`pointing out and distinctly claiming the subject matter which the inventor or a
`joint inventor regards as the invention.” Id. § 112.
`The function of claims is (a) to point out what the invention
`is in such a way as to distinguish it from what was
`previously known, i.e., from the prior art; and (b) to define
`the scope of protection afforded by the patent. In both of
`those aspects, claims are not technical descriptions of the
`disclosed inventions but are legal documents like the
`descriptions of lands by metes and bounds in a deed.
`In re Vamco Mach. & Tool, Inc., 752 F.2d 1564, 1577 n. 5 (Fed. Cir. 1985).
`Patent infringement analysis requires two steps: (1) determining the meaning
`and scope of the patent claims asserted to be infringed (i.e. “claim
`construction”); and (2) comparing the properly construed claims to the device
`or method accused of infringing. See Markman, 52 F.3d at 976; RF Delaware,
`Inc. v. Pac. Keystone Techs., Inc., 326 F.3d 1255, 1266 (Fed. Cir. 2003) (“An
`infringement analysis involves two steps in which the court first determines the
`correct claim scope, and then compares the properly construed claim to the
`accused method or device to determine whether all of the claim limitations are
`present either literally or by a substantial equivalent.”). Here, we are concerned
`only with step one, which involves “a matter of law exclusively for the court.”
`Markman, 52 F.3d at 977.
`
`A fundamental principle of claim construction is that
`patent claims must have the same meaning to all persons
`times, and that the meanings of the claims are
`at all
`determined and fixed at the time the [PTO]
`issued the
`patent. The purpose of a Markman hearing is for the court
`and the parties to settle conclusively on the interpretation
`of disputed claims. Indeed,
`the need for uniformity of
`claim construction and concerns about
`fairness
`to
`competitors inform the policy of reserving the claim
`construction function to the trial judge.
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`Novartis Corp. v. Teva Pharms. USA, Inc., 565 F.Supp.2d 595, 603 (D.N.J. 2008)
`
`(internal citations omitted). “When a court construes the claims of the patent, it
`
`is as if the construction fixed by the court had been incorporated in the
`
`specification, and in this way the court is defining the federal legal rights
`
`created by the patent document.” Markrnan, 52 F.3d at 978 (internal
`
`quotations and citation omitted).
`
`When construing claims, a district court should give the claim terms
`
`their “ordinary and customary meaning.” Phillips v. AWH Corp., 415 F.3d 1303,
`
`1312 (Fed. Cir. 2005) (quoting Vitronics Corp. V. Conceptronic, Inc., 90 F.3d
`
`1576, 1582 (Fed. Cir. 1996)). “Ordinary and customary meaning” however, is
`
`not limited to the understanding of the average person. Rather, it must be
`
`assessed from the standpoint of a hypothetical “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.”5 Id. at 1313. That hypothetical person is sometimes
`
`abbreviated as a “PHOSITA” or “POSA”6
`
`.
`
`...
`
`[The] objective baseline from which to begin claim
`interpretation
`is
`the well-settled
`based
`on
`understanding that inventors are typically persons skilled
`in the field of the invention and that patents are addressed
`to and intended to be read by others of skill
`in the
`pertinent art. .
`. Importantly, the person of ordinary skill
`in the art is deemed to read the claim term not only in the
`context of the particular claim in which the disputed term
`appears, but in the context of the entire patent, including
`the specification. Id. (internal citations omitted); see also
`Novartis Corp., 565 F. Supp. 2d at 604 (“Although an
`invention is defined by a patent’s claims, they do not stand
`alone. Instead, claims are part of a fully integrated written
`instrument consisting principally of a written description
`of the invention, often referred to as the specification, and
`concluding with the claims. For that reason, claims must
`be read in view of the specification, of which they are a
`part.”) (internal quotations and citations omitted).
`
`For consistency with the parties’ briefing, I will use the acronym “POSA” in this
`6
`Opinion.
`
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`In some cases, the meaning of claim terms as understood by a POSA 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.” Phillips, 415 F.3d at 1314. In other cases,
`however, the meaning is not so easily ascertained, and the court must look to
`the “sources available to the public that show what a person of skill in the art
`would have understood disputed claim language to mean.” MBO Labs 474 F.3d
`at 1329 (quoting Phillips, 415 F.3d at 1314). “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, 415 F.3d at 1314
`(quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d
`1111, 1116 (Fed. Cir. 2004)).
`Those sources are not necessarily weighted equally; there is a hierarchy
`of relevance. Generally, the patent’s “intrinsic evidence”—”the patent itself
`including the claims, the specification and, if in evidence, the prosecution
`history”—”is the most significant source of the legally operative meaning of
`disputed claim language.” Novartis, 565 F. Supp. 2d at 603-04 (quoting
`Vitronics Corp., 90 F.3d at 1582).
`The patent’s specification, “the single best guide to the meaning of a
`disputed term,” should be consulted first. Phillips, 415 F.3d at 1317 (citing
`Vitronics, 90 F.3d at 1582). The specification may reveal “whether the inventor
`has used any terms in a manner inconsistent with their ordinary meaning. The
`specification acts as a dictionary when it expressly defines terms used in the
`claims or when it defines terms by implication.” Novartis, 565 F. Supp. 2d at
`604 (quoting Vitronics, 90 F.3d at 1582). After consulting the specification, the
`court should review the patent’s prosecution history, which also is “part of the
`‘intrinsic evidence’ that directly reflects how the patentee has characterized the
`invention.” MBO Labs., Inc., 474 F.3d at 1329 (quoting Vitronics, 90 F.3d at
`1317). The prosecution history includes statements made by the patentee
`during reexamination. See Krippelz v. Ford Motor Co., 667 F.3d 1261, 1266
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`(Fed. Cir. 2012) (“A patentee’s statements during reexamination can be
`considered during claim construction, in keeping with the doctrine of
`prosecution disclaimer”) (citation omitted). Finally, if the specification and the
`patent’s intrinsic evidence do not clarify the claim terms, the court may consult
`“extrinsic evidence”—testimony, dictionaries, learned treatises or other
`materials not part of the public record. See Phillips, 415 F.3c1 at 1317.
`B. Analysis
`1.
`The Specification
`Plaintiffs argue that the dispute is resolved by the patent specification,
`which expressly defines “treatment” and “treating” with reference only to
`reducing the growth or spread of cancer, and not to additional therapeutic
`benefits. (P1. Br. 8—9.) Plaintiffs correctly state that a patentee is entitled to act
`“as his own lexicographer” by clearly defining a claim term in the patent. This
`is so even where the claim term defined in the specification departs from its
`ordinary meaning. See Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir.
`2005) (“[O]ur cases recognize that the specification may reveal a special
`definition given to a claim term by the patentee that differs from the meaning it
`would otherwise possess. In such cases, the inventor’s lexicography governs.”);
`CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)
`(“[T]he claim term will not receive its ordinary meaning if the patentee acted as
`his own lexicographer and clearly set forth a definition of the disputed claim
`term in either the specification or prosecution history.”).
`Defendants affirm these legal principles, but seize on the word “include”
`in the definition of “treatment” and “treating”:
`As used herein, and unless otherwise defined, the terms
`“treat,” “treating” and “treatment” include the eradication,
`removal, modification, management or control of a tumor
`or primary, regional, or metastatic cancer cells or tissue
`and the minimization or delay of the spread of cancer.
`(‘438 patent 3:46—50 (“Definitions” section) (emphasis added).) They argue that
`“include,” by its plain meaning, indicates an open-ended list and thus is not
`
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`limiting. Further, they contend, a non-limiting construction is consistent with
`the intrinsic record.7
`
`a)
`Neighboring Language and Cited Text
`Defendants contrast the verb “include” with the verb “means.” “Means,”
`they say, is the verb of choice for defining other terms in the specification. They
`argue that the patentees used “means” as a word of limitation, but used
`“include” to indicate open-endedness. (Def. Resp. 4—5.) In Defendants’ view,
`“include” is equivalent to “including but not limited to,” a phrase which also
`appears throughout the ‘438 patent specification. Plaintiffs, of course, take the
`opposite view. (See P1. Resp. 7—8; Def. Resp. 4—5.)
`Both parties rely on the hornbook canon of statutory construction
`directing me to interpret words so as to avoid rendering other words
`redundant.8 Upon examination of the ‘438 patent, I am unconvinced that this
`canon of construction is of assistance in resolving this dispute. To begin with,
`the canon itself is far from definitive: “that the use of both terms in close
`proximity in the same claim gives rise to an inference that a different meaning
`should be assigned to each .
`. is not conclusive; it is not unknown for different
`words to be used to express similar concepts, even though it may be poor
`drafting practice.” Bancorp Serus., L.L.C. v. Hartford Life Ins. Co., 359 F.3d
`
`.
`
`For claim construction purposes, it does not matter, but I will say a word about
`a counterintuitive configuration in which the patent holder attempts to minimize the
`scope of its patent, while the would-be infringer attempts to expand it.
`At the Markman hearing, Defendants acknowledged that their proposed broad
`construction is intended to advance a future challenge to the ‘438 patent’s validity.
`Here, the issue, essentially, is whether unspecified benefits—palliative care and
`glucocorticoid replacement— are “included,” so that, for example, the claim might be
`rendered invalid for obviousness in light of prior art describing the use of abiraterone
`acetate and/or prednisone for palliative care and/or glucocorticoid replacement.
`“When interpreting statutes, a court looks to the language of the statute and
`construes it according to the traditional tools of statutory construction, including
`certain well known canons of construction.” Markman v. Westview Instruments, Inc.,
`52 F.3d 967, 987 (Fed. Cir. 1995), aff’d, 517 U.S. 370, 116 5. Ct. 1384, 134 L. Ed. 2d
`577 (1996); see Ethicon Endo—Surgery, Inc. v. U.S. Surgical Corp., 93 F.3d 1572, 1578
`(Fed. Cir. 1996) (avoiding construction that renders claim language mere surplusage);
`Texas Instruments, Inc. v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1171 (Fed. Cir.
`1993) (same).
`
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`.
`
`1367, 1373 (Fed. Cir. 2004). And those “other words” do not fall into a pattern
`that would permit the court to conclude that one construction or the other
`would render them redundant. The definitions section of the ‘438 patent
`specification uses three definitional formulations: “include, but are not limited
`to”; “means”; and “refers.” (See ‘438 patent, cols. 4—5) It cycles through those
`words or phrases, however, with no discernible rhyme or reason. As for the
`concept of “including,” the definitional section uses each of the following words
`or phrases one time each: “include” (the disputed word at issue, id. 3:47); “can
`include” (id. 4:5); “can also include” (id. 4:26—27). Once, in a more express
`disclaimer, the patent uses the phrase “should not be interpreted as being
`limited to” (id. 4:15—16). It does not really matter whether the ambiguity arising
`from these varying terms “is the result of sloppy drafting .
`. [or drafting with a
`degree of indefiniteness so as to leave room to later argue for a broad
`interpretation designed to capture later-developed competition.” Either way, it
`is clear that scrutinizing this language “becomes a game of crystal ball gazing.”
`3M Innovative Props. Co. V. Tredegar Corp., 725 F.3d 1315, 1335 (Fed. Cir.
`2013) (Plager, J., concurring). I, at least, cannot discern that the drafters had
`any overarching rationale for choosing one term rather than the other in a
`particular case. Nor can I extract from the context a definition of the terms that
`would dictate either party’s interpretation, or force a conclusion that one
`party’s interpretation would render another term superfluous. In short, neither
`interpretation emerges from this process as a winner.
`Defendants also contend that the specification explicitly “discloses the
`known use of prednisone to provide glucocorticoid replacement therapy when
`treating prostate cancer in patients who are administered CYPI7 inhibitors.”
`(Def. Resp. 5.) A POSA, say the Defendants, would understand that disclosure
`to mean that prednisone is being used in the treatment of prostate cancer “to
`provide not just its known anti-cancer benefits, but also its known palliative
`and glucocorticoid replacement benefits.” (Id. 8).
`I think the point is exaggerated at best. Certainly the patent nowhere
`uses the words “palliative and glucocorticoid replacement benefits.” Here are
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`two pieces of evidence, however, that the defendants cite in support of their
`argument that a POSA would infer such a reference:
`1. The specification discloses a practice of administering a CYP17 inhibitor
`such as abiraterone acetate “in combination with at least one additional
`therapeutic agent such as an anti-cancer agent or a steroid.” (Def. Br. 11
`(citing ‘438 patent, Abstract, 1:7—12, 2:9—17, 5:9—13) (underline added)).
`Defendants contend that the “or” reflects a distinction between “anti
`cancer agents” and “steroids.” And that distinction, according to
`defendants, reveals that the patentees had in mind both cancer-targeted
`and therapeutic results as distinct purposes for their alleged invention.
`Defendants add that in the ‘438 patent’s preferred embodiments,
`prednisone is listed as both a type of “anti-cancer agent” and as a type of
`steroid. (SeeDef. Br. 11—13.)
`2. The Defendants focus on a citation in the specification to a
`pharmacological textbook by Goodman and Gilman. The citation appears
`at the end of a paragraph identifying types of steroids within the scope of
`the disclosure. Defendants characterize this “see, e.g.” citation as
`incorporating the textbook into the specification by reference, and cite
`one chapter in the textbook (not specified in the citation) about steroids.
`The absence of any reference in that chapter to the use of steroids to
`attack cancer, they claim, would cause a POSA to interpret the
`specification language to encompass palliative and glucocorticoid
`replacement purposes. (Id. 12—13.)
`Defendants urge that these two pieces of evidence, taken together,
`“confirm[J that steroids like prednisone were known to provide replacement
`therapy when a patient’s normal production of glucocorticoids is
`impaired.. .
`.“ And this conclusion, in turn, supports Defendants’ proposed
`construction that the terms “treatment” and “treating” encompass more than
`anti-cancer effects. (Id. 13)
`Plaintiffs point out that the specification never actually refers to use of a
`steroid for palliation. And it is significant, they say, that the specification
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`.
`
`states: “The amount of the steroid administered to a mammal having cancer is
`an amount that is sufficient to treat the cancer whether administered alone or
`in combination with a l7cz-hydroxylase/C17 20-lyase inhibitor.” (‘438 patent
`10:19—24 (emphasis added).) At the Markman hearing, Plaintiffs submitted that
`if Defendants’ construction had been intended, the claim would state: “A
`method for the treatment of a patient with prostate cancer,” as opposed to “A
`method for the treatment of a prostate cancer in a human. .
`I agree with the Plaintiffs that the Defendants’ parsing of the specification
`language is unconvincing. In my view, a POSA9 would not interpret a “see, e.g.”
`citation as incorporating by reference the entirety of a textbook for definitional
`purposes. Still less does the patent incorporate a particular chapter, not
`specifically cited, concerning steroids and their use for palliative care and
`glucocorticoid replacement. Nor does it justify Defendants in building a
`definition of a key patent term upon the absence from that chapter of any
`reference to use of steroids in cancer-attacking therapy. Incorporation by
`reference must be clearer than that: “To incorporate material by reference, the
`host document must identify with detailed particularity what specific material
`it incorporates and clearly indicate where the material is found in the various
`documents.” Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272,
`1282 (Fed. Cir. 2000) (citing cases); see SkinMedica, Inc. v. Histogen, 727 F.3d
`1187, (Fed. Cir. 2013) (observing that textbook which patent purported to
`incorporate by reference was not helpful to claim construction analysis because
`the inventor did not “refer with any detailed particularity to the passages in
`[the textbook]” which the plaintiff claimed supported the plaintiffs proposed
`construction of a disputed term). The Gilman and Goodman citation fails this
`test.
`
`Whether a material is incorporated by reference is a question of law to be
`determined based on whether a POSA would consider the material incorporated with
`sufficient particularity. See AstraZeneca AB v. Hanmi USA, Inc., No. CIV.A. 11-760
`JAP, 2012 WL 6203602, at *7 (D.N.J. Dec. 12, 2012), affd, 554 F. App’x 912 (Fed. Cir.
`2013).
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`Th