Case 1:10-cv-01376-TWP-DKL Document 115 Filed 06/20/12 Page 1 of 22 PageID #: 2140
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
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`ELI LILLY AND COMPANY,
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`Plaintiff,
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`TEVA PARENTERAL MEDICINES, INC.,
`APP PHARMACEUTICALS, LLC,
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`PLIVA HRVATSKA D.O.O., TEVA
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`PHARMACEUTICALS USA, INC. and
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`BARR LABORATORIES, INC.,
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`Defendants.
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`) Case No. 1:10-cv-1376-TWP-DKL
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`ENTRY ON CLAIM CONSTRUCTION
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`This patent infringement case is before the Court for construction of patent terms relevant
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`to methods of administering the compound pemetrexed disodium (“pemetrexed”), the active
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`pharmaceutical ingredient in the drug ALIMTA®
`. The Plaintiff in this matter is Eli Lilly and
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`Company
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`(“Lilly”) and
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`the Defendants are Teva Parenteral Medicines,
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`Inc., App
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`Pharmaceuticals, LLC, Pliva Hrvatska, D.O.O., Teva Pharmaceuticals USA, Inc., and Barr
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`Laboratories, Inc. (collectively, “Defendants”). On April 24, 2012, the Court conducted a
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`Markman hearing at which time the parties presented oral arguments as to the proper
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`construction of two disputed terms of the patent at issue, U.S. Patent No. 7,772,209 (the “‘209
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`patent”). The parties submitted thorough and well-crafted briefs and helpful presentations at the
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`Markman hearing. Jurisdiction is proper under 28 U.S.C. §§ 1331, 1338, 2201 and 2202.
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`I. FACTUAL BACKGROUND
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`Lilly and Defendants are companies involved in the formulation and manufacture of
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`pharmaceuticals. The patent at issue in this infringement suit, the ‘209 patent, relates to Lilly’s
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`Wockhardt Exhibit 1025 - 1
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`Case 1:10-cv-01376-TWP-DKL Document 115 Filed 06/20/12 Page 2 of 22 PageID #: 2141
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`anti-cancer agent ALIMTA®, which is used to treat mesothelioma – the cancer caused by
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`asbestos exposure – and other forms of lung cancer. Lilly contends that the Abbreviated New
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`Drug Applications (“ANDAs”) filed by the Defendants with the Food and Drug Administration
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`(“FDA”) for the manufacture and sale of generic versions of ALIMTA® before the ‘209 patent
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`expires, infringes upon the ‘209 patent. As a result, Lilly filed this action against Defendants on
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`October 29, 2010.
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`ALIMTA’s® active ingredient, pemetrexed, is an antifolate that is known to disrupt the
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`folic acid pathway which can contribute to the reduction of cancer cells. The ‘209 patent relates
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`to a method of administering pemetrexed, along with folic acid and vitamin B12, a
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`methylmalonic acid lowering agent, in order to reduce the toxicities associated with the
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`administration of pemetrexed. This discovery made by Lilly results in a significant reduction of
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`certain toxic effects caused by the administration of antifolates, such as pemetrexed, through the
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`presence of a methylmalonic acid lowering agent without adversely affecting therapeutic
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`efficacy. Dkt. 1-1, col. 2, ll. 32-37. As a result of ALIMTA® therapy, mesothelioma patients
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`often live longer and the severity of the disease has been lessened so that patients are able to
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`have a more normal life.
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`Originally, Defendants had five claims that they proposed were in dispute, however, the
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`parties now agree upon the construction of three of those terms. Only two terms remain in
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`dispute as they relate to the ‘209 patent: 1) the first concerns the proper construction of the term
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`“patient” and 2) the second concerns the proper construction of the term “vitamin B12.”
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`Additional facts are added below as needed.
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`2
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`Wockhardt Exhibit 1025 - 2
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`II. LEGAL STANDARD
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`Prevailing in a patent infringement suit requires “a finding that the patent claim ‘covers
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`the alleged infringer’s product or process,’ which in turn necessitates a determination of ‘what
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`the words in the claim mean.’” Markman v. Westview Instruments, Inc., 517 U.S. 370, 374
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`(1996) (citation omitted); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1581-82 (Fed.
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`Cir. 1996) (“A literal patent infringement analysis involves two steps: the proper construction of
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`the asserted claim, and a determination as to whether the accused method or product infringes the
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`asserted claim as properly construed.”). The construction of patent claims, which requires
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`determining the meaning and scope of the claims, is a matter of law for the court. Markman v.
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`Westview Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir. 1995), aff’d 517 U.S. 370, 116 S.Ct.
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`1384, 134 L.Ed. 2d 577 (1996). The Federal Circuit has emphasized that “[i]t is a bedrock
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`principle of patent law that the claims of a patent define the invention to which the patentee is
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`entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en
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`banc) (citations and quotations omitted); see also Vitronics, 90 F.3d at 1582 (“we look to the
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`words of the claims themselves…to define the scope of the patented invention”).
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`The words in patent claims are “given their ordinary and customary meaning”, which is
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`“the meaning that the term would have to a person of ordinary skill in the art in question at the
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`time of the invention.” Phillips, 415 F.3d at 1313; see Home Diagnostics, Inc. v. LifeScan, Inc.,
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`381 F.3d 1352, 1358 (Fed. Cir. 2004) (“customary meaning” refers to the “customary meaning in
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`[the] art field”). “In some cases, the ordinary meaning of claim language as understood by a
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`person of skill in the art may be readily apparent even to lay judges,” in which case claim
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`construction “involves little more than the application of the widely accepted meaning of the
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`commonly understood words.” Phillips, 415 F.3d at 1314; see also Renishaw PLC v. Marposs
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`3
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`Wockhardt Exhibit 1025 - 3
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`Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) (articulating that when there are
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`several common meanings for a certain term, “the patent disclosure serves to point away from
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`the improper meanings and toward the proper meaning”). However, there are two exceptions to
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`the general rule of applying the ordinary meaning to claim terms: 1) when a patentee sets out a
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`definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a
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`claim term either in the specification or during prosecution. Thorner v. Sony Computer Entm’t
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`Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).
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`To become one’s own lexicographer, a patentee must set forth a definition of the disputed
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`claim term other than the term’s ordinary and plain meaning. Id. Moreover, “it is not enough for
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`a patentee to simply disclose a single embodiment or use a word in the same manner in all
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`embodiments, the patentee must ‘clearly express an intent’ to redefine the term.” See id.; C.R.
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`Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (“[T]he inventor’s written
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`description of the invention, for example is relevant and controlling insofar as it provides clear
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`lexicography....”) (emphasis added). Additionally, “[t]he patentee may demonstrate an intent to
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`deviate from the ordinary and accustomed meaning of a claim term by including in the
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`specification expression of manifest exclusion or restriction, representing a clear disavowal of
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`claim scope.” Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002).
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`In the absence of an express intent to impart a new meaning to a claim term, the court,
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`when interpreting claim terms, first reviews the intrinsic evidence, which includes the claims
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`themselves, the specification, and the prosecution history. See Interactive Gift Express, Inc. v.
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`Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (“The words used in the claims are
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`interpreted in light of the intrinsic evidence of record, including the written description, the
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`drawings, and the prosecution history, if in evidence.”). With respect to the specification, it
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`4
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`Wockhardt Exhibit 1025 - 4
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`serves an important purpose by providing for a written description of the invention that would
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`allow a person of ordinary skill in the art to make and use the patented invention.1 See Phillips,
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`415 F.3d at 1317. Moreover, in reviewing the specification or prosecution history, if these
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`intrinsic sources define a claim term, that definition shall apply even if it differs from the term’s
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`ordinary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366-67 (Fed. Cir.
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`2002). However, although claims must be read in light of the specification, the court should not
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`limit a claim by restricting its scope based on a preferred embodiment within the specification.
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`Phillips, 415 F.3d at 1323.
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`Along with the specification, the Court may also review the prosecution history, as part
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`of the intrinsic record, in determining whether a patentee intended to define a particular term
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`differently from its ordinary and customary meaning. Teleflex, 299 F.3d at 1326. Further, the
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`prosecution history can act to “limit[] the interpretation of claims so as to exclude any
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`interpretation that may have been disclaimed or disavowed during prosecution in order to obtain
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`claim allowance.” Id. (citing Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed.
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`Cir. 1985)).
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`In addition to relying on intrinsic evidence in ascertaining the scope of an invention’s
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`claim, the Court also can rely upon extrinsic evidence, which includes evidence outside of the
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`patent and prosecution history, such as expert testimony, dictionaries, and learned treatises.
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`Phillips, 415 F.3d at 1317. However, “[C]ourts may rely on dictionary definitions when
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`construing claim terms, ‘so long as the dictionary definition does not contradict any definition
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`found in or ascertained by a reading of the patent documents.” (internal citation omitted); see
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`also Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999).
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`1 Pursuant to 35 U.S.C. § 112, “the specification shall 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…to make and use the same….” 35 U.S.C. § 112 ¶ 1.
`5
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`Wockhardt Exhibit 1025 - 5
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`Lastly, indefiniteness, like claim construction, “is a legal question.” Young v. Lumenis,
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`Inc., 492 F.3d 1336, 1344 (Fed. Cir. 2007). To satisfy the definiteness requirement of 35 U.S.C.
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`§ 1122, “the boundaries of the claim, as construed by the court, must be discernible to a skilled
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`artisan based on the language of the claim, the specification, and the prosecution history, as well
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`as her knowledge of the relevant field of art.” Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d
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`1343, 1350 (Fed. Cir. 2010) (citation omitted). A claim is indefinite if it is “not amenable to
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`construction or [is] insolubly ambiguous.” Datamize LLC v. Plumtree Software, Inc., 417 F.3d
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`1342, 1347 (Fed. Cir. 2005).
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`III. DISCUSSION
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`For the purposes of this discussion, the Court will briefly trace the background of the
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`‘209 patent, resolve the disagreement regarding the person of ordinary skill in the art and then
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`construe the disputed claim terms at issue.
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`A.
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`The ‘209 Patent
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`The ‘209 patent is directed at administering pemetrexed in combination with folic acid
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`and a methylmalonic acid lowering agent to reduce the toxicity levels associated with
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`administration of pemetrexed.
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` Specifically, the antifolate, pemetrexed, prevents other
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`compounds, known as reduced folates, from binding to particular enzymes that are essential in
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`the growth of potentially cancerous tumors. However, certain toxicities are associated with the
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`administration of pemetrexed disodium. The ‘209 patent discloses a method of administering
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`pemetrexed in conjunction with certain amounts of folic acid and a methylmalonic acid lowering
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`agent, such as vitamin B12, to reduce the toxicity levels without affecting the efficacy of the
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`antifolate.
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`2 35 U.S.C. § 112 ¶ 2 sets forth the definite requirement, which provides that specification of a patent must
`“conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the
`applicant regards as his invention.” 35 U.S.C. § 112 ¶ 2.
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`6
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`Wockhardt Exhibit 1025 - 6
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`B.
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`Person of Ordinary Skill in the Art
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`Claim terms are construed from the perspective of the person of ordinary skill in the art to
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`whom the patent is addressed. Phillips, 415 F.3d at 1313 (“The descriptions in patents are not
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`addressed to the public generally, to lawyers or to judges, but, as section 112 [of title 35] says, to
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`those skilled in the art to which the invention pertains or with which it is most nearly
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`connected.”). Although the determination of whom the person in the ordinary skill in the art is
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`not dispositive of the claims construction in this case, the resolution of this issue is helpful to the
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`Court.
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`Lilly suggests that “the person of ordinary skill in the art for the’209 patent would have
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`the skills of a medical oncologist, with the knowledge and experience regarding the use of
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`antifolates in the treatment of cancer, as well as knowledge and experience regarding the use of
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`antifolates in the treatment of cancer, as well as knowledge and experience regarding the
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`management of toxicities….” Pl. Claim Const. Br., Dkt. 94 at 9. Defendants argue that a person
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`of ordinary skill in the art “would have a medical degree and additional qualifications or
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`experience in the field of nutritional sciences and/or oncology, as well as practical experience in
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`a clinical setting and/or academia.” Def. Resp. Br., Dkt. 97 at 6. In addition, Defendants
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`contend that the person of ordinary skill in the art would collaborate with other medical
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`professionals in certain fields, including oncology. Id. The parties agreed at the Markman
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`hearing that the person of ordinary skill in the art would be a medical doctor, Dkt. 114, Tr. at p.
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`25, ll. 16-19, but disagreed on whether the person of ordinary skill in the art can be only a
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`medical oncologist or whether he or she could be a medical doctor with expertise in nutritional
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`sciences.3
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`3 Both parties reiterated during oral arguments that the issue of determining who is the person of ordinary skill in the
`art as it applies to the ‘209 patent is not dispositive with respect to the Court’s resolution of the parties’ proposed
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`Wockhardt Exhibit 1025 - 7
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`In the Court’s view, neither party’s proposal is incorrect. Based on the ‘209 patent and
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`the representations of the parties and their experts, the Court finds that the person of ordinary
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`skill in the art, for purposes of this claim construction order, can be a medical doctor who
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`specializes in oncology or a medical doctor with extensive experience in the areas of nutritional
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`sciences involving vitamin deficiencies. However, as to the latter person, this individual would
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`need to have collaborated with medical oncologists who have knowledge and experience in the
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`treatment of cancer through the use of antifolates.
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`C.
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`The Disputed Terms
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`The parties dispute two terms in the ‘209 patent for the purposes of claim construction.
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`Each disputed term is addressed in turn.
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`Claim 1:
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`A method of administering pemetrexed disodium to a patient in need thereof
`comprising administering an effective amount of folic acid and an effective
`amount of folic acid and an effective amount of a methylmalonic acid
`lowering agent followed by administering an effective amount of pemetrexed
`disodium, wherein
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`the methylmalonic acid lowering agent is selected from the group
`consisting
`of
`vitamin B12,
`hydroxocobalamin,
`cyano-10-
`chlorocobalamin,
`aquocobalamin
`perchlorate,
`aquo-10-
`chlorocobalamin
`perchlorate,
`azidocobalamin,
`cobalamin,
`cyanocobalamin, or chlorocobalamin.4
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`constructions of the disputed claim terms. See Tr. at p.25, ll. 10-15. However, for purposes of this claim
`construction order the Court finds it necessary to resolve the dispute. See Candela Corp. v. Palomar Medical Techs.
`Inc., 2008 WL 3285255, at *2-*3 (E.D. Tex. Aug. 6, 2008) (resolving the parties’ dispute concerning who is the
`person of ordinary skill in the art before construing the disputed claim terms); Black & Decker Inc. v. Robert Bosch
`Tool Corp., 389 F. Supp.2d 1010, 1017 (N.D. Ill.) aff’d in part, vacated in part for other reasons, 260 Fed. Appx.
`284 (Fed. Cir. 2008) (citing Phillips, 415 F.3d at 1313) (“The Court must construe the claims from the vantage point
`of a person of ordinary skill in art…therefore, [the Court] must determine the level of ordinary skill in the art for
`purposes of this [claim construction] motion.”).
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` 4
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` The term “hydroxycobalamin” in claim 1 has been corrected to read “hydroxocobalamin.” Additionally, there is a
`typographical error in claim 1: “aquo-10-cobalamin perchlorate” should read “aquo-10-chlorocobalamin
`perchlorate.” Dkt. 95-2 at 21, ¶7 n.4; Dkt. 99-1at 21, ¶54 n.6.
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`Wockhardt Exhibit 1025 - 8
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`Claim 12:
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`An improved method for administering pemetrexed disodium to a patient in
`need of chemotherapeutic treatment, wherein the improvement comprises:
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`a) administration of between about 350 µg and about 1000 µg of folic
`acid prior to the first administration of pemetrexed disodium;
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`b) administration of about 500 µg to about 1500 µg of vitamin B12,
`prior to the first administration of pemetrexed disodium; and
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`c) administration of pemetrexed disodium.
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`1.
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`Term 1: “patient”
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`Claim Term/Phrase
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`“patient”
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`Plaintiff’s Proposed
`Construction
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`“human undergoing medical
`treatment”
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`Defendants’ Proposed
`Construction
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`“mammal”
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`The parties dispute the meaning of the term “patient” as it is referred to in the claims of
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`the ‘209 patent. Lilly argues that “patient” should have its ordinary and customary meaning,
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`which is: a human undergoing medical treatment. Pl. Claim Const. Br., Dkt. 94 at 27.
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`Defendants counter that the intrinsic record establishes that the term “patient” means mammal
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`for two reasons: 1) Lilly implicitly redefined the term “patient” in the specification when it used
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`it interchangeably with mammal, and 2) the proposed construction of “patient” is supported by
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`the ‘209 patent’s prosecution history. After reviewing the ‘209 patent, the Court agrees with
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`Lilly’s construction that the ordinary and customary meaning of “patient” should apply over the
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`construction proposed by Defendants.
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`There is a presumption that the claim terms chosen by the patentee “mean what they say
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`and have the ordinary meaning that would be attributed to those words by persons skilled in the
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`relevant art.” ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003). However,
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`determining the ordinary and customary meaning of a claim term, in certain fields of art, requires
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`9
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`Wockhardt Exhibit 1025 - 9
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`a further examination of “those sources available to the public that show what a person of skill in
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`the art would have understood the disputed claim language to mean.” Phillips, 415 F.3d at 1314
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`(quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed.
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`Cir. 2004)). These sources include the claims themselves, the specification, the prosecution
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`history and extrinsic evidence. Id.
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`a.
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`The ‘209 Patent Claims
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`The Federal Circuit has articulated that the courts should also consider the context of the
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`surrounding words of the claims in an effort to determine the ordinary and customary meaning of
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`a disputed term. ACTV, 346 F.3d at 1088. In addition, claim terms are usually understood to
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`carry their ordinary and customary meaning. Phillips, 415 F.3d at 1312 (citing Vitronics, 90
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`F.3d at 1582). In this case, the claims of the ‘209 patent describe that a “patient” is to be
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`administered effective amounts of methylmalonic acid lowering agent, folic acid, and
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`pemetrexed disodium. Lilly contends that “patient” should be construed to have its ordinary and
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`customary meaning – a human being undergoing medical treatment – however, the Court must
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`review the specification to determine if Lilly has used the term “patient” in a manner that is
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`inconsistent with its ordinary meaning. Vitronics, 90 F.3d at 1582.
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`b.
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`The ‘209 Patent Specification
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`In their briefing and oral argument, the parties agreed that the words “patient” and
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`mammal are used in the specification. Defendants argue that the plain and ordinary meaning of
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`the term “patient” cannot be adopted when it was implicitly redefined in the specification
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`because the patentee used the word mammal and “patient” interchangeably in the ‘209 patents
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`specification, therefore they must have the same meaning. And, Defendants argue that this
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`interchange shows that “patient” was redefined to mean mammal. Pursuant to Phillips, the Court
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`10
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`Wockhardt Exhibit 1025 - 10
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`will give “patient” it’s ordinary and customary meaning unless Lilly has redefined the term by
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`acting as its own lexicographer or disavowed the full scope of the claim term. See Thorner, 669
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`F.3d at 1365 (setting forth the exceptions to the general rule of applying the plain and ordinary
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`meaning of a claim term). Defendants argue that Lilly redefined the term “patient” by using that
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`term in conjunction with the word mammal in the following section of the specification:
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`As used herein, the term “in combination with” refers to the administration of the
`methylmalonic acid lowering agent, the antifolate drug, and optionally the folic
`acid; in any order such that sufficient levels of methylmalonic acid lowering agent
`and optionally folic acid are present to reduce the toxicity of an antifolate in a
`mammal. The administration of the compounds maybe simultaneous as a single
`composition or as two separate compositions or can be administered sequentially
`as separate compositions such that an effective amount of the agent first
`administered is in the patient’s body when the second and/or third agent is
`administered. The antifolate drug may be administered to the mammal first,
`followed by treatment with the methylmalonic acid lowering agent. Alternatively,
`the mammal may be administered the antifolate drug simultaneously with the
`methylmalonic acid lowering agent. Preferably, the mammal is pretreated with
`the methylmalonic acid lowering agent and then treated with the antifolate. If
`folic acid is to be administered in addition to the methylmalonic acid lowering
`agent, the folic acid may be administered at any time prior, post, or
`simultaneously to the administration of either the methylmalonic acid lowering
`agent or the antifolate. Preferably, the mammal is pretreated with the
`methylmalonic acid, and then treated with folic acid, followed by treatment with
`the antifolate compound.
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`Dkt. 1-1, col. 4, 11. 4-27. Defendants also emphasized the interchangeable use of the two terms
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`in the following description of a preferred embodiment:
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`In the especially preferred embodiment of this invention, about 0.1 mg to about
`30 mg, most preferably about 0.3 mg to about 5 mg, of folic acid is administered
`orally to a mammal about 1 to 3 weeks post administration of the methylmalonic
`acid lowering agent and about 1 to 24 hours prior to the parenteral administration
`of the amount of an antifolate. However, it will be understood that the amount of
`the methylmalonic acid lowering agent actually administered will be determined
`by a physician, in light of the relevant circumstances, including the condition to
`be treated, the chosen route of administration, the actual agent administered, the
`age, weight, and response of the individual patient, and the severity of the
`patient’s symptoms, and therefore the above dosage range are not intended to
`limit the scope of the invention in any way.
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`11
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`Wockhardt Exhibit 1025 - 11
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`Id. at col. 6, ll. 35-54.
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`The Court is not persuaded by Defendants’ argument. Here, Defendants conceded in
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`their claim construction response brief that the term “patient” is not explicitly defined in the ‘209
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`patent specification. See Def. Resp. Br., Dkt. 97 at 26. Thus, their argument is narrowed to
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`whether Lilly implicitly redefined the term “patient.” In order for a term to be redefined
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`implicitly, “the redefinition must be so clear that it equates to an explicit one.” Thorner, 669
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`F.3d at 1368. Thorner further states that “a person of ordinary skill in the art would have to read
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`the specification and conclude that the applicant has clearly disavowed claim scope or has acted
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`as its own lexicographer.” Id. The Court finds that Lilly has not acted as its own lexicographer
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`or disavowed the full scope of the claim term “patient.” Even though the two terms appeared in
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`the specification, there is nothing problematic with Lilly’s use of the term “patient” in describing
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`that a human undergoing medical treatment will be administered the methylmalonic acid
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`lowering agent, folic acid, and antifolate. See id. (“Simply referring to two terms as alternatives
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`or disclosing embodiments that all use the term the same way is not sufficient to redefine a claim
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`term.”).
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`Moreover, Defendants proposed construction of the term “patient” is not consistent with
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`how the term is interpreted in light of the specification. As the Defendants conceded, the
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`specification did not explicitly define the term “patient.” In addition, the Federal Circuit has
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`emphasized that courts cannot rewrite claims, but instead should give effect to the claim terms
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`chosen by the patentee. K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1364 (Fed. Cir. 1999).
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`Additionally, the Court finds that the specification does not support the Defendants’
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`proposed construction of the term “patient” to encompass mammals. Specifically, a person of
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`ordinary skill in the art reading the specification would not associate the administration of
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`pemetrexed disodium and methylmalonic acid lowering agent to mammals. The fact that the
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`specification sets forth the administration of methylmalonic acid lowering agents and folic acid
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`to mammals in pre-clinical trials does not mean that the claim term “patient” must be construed
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`to encompass all potential functions outlined in the specification. See Phillips, 415 F.3d at 1327
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`(“We have held that ‘the fact that a patent asserts that an invention achieves several objectives
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`does not require that each of the claims be construed as limited to structures that are capable of
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`achieving all of the objectives.’”) (internal citation omitted).
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`When the ‘209 patent specification discussed pre-clinical trials, it disclosed tests
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`involving mice and referred to them as animals. See Dkt. 1-1, col. 6, l. 56 – col. 8, l. 38. When
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`the specification discussed clinical trials, on the other hand, it used the term “patient” in
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`association with the treatment of cancer through the administration of an antifolate. For
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`example, following the discussion of mice involved in a pre-clinical study, the specification
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`discussed the administration of an antifolate “[i]n a typical clinical evaluation involving cancer
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`patients.” Dkt. 1-1, col. 8, ll. 39-42. A person of ordinary skill in the art would understand the
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`term patient when discussed in the context of a clinical trial to involve a human undergoing
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`medical treatment and not a mammal. Accordingly, the Court finds that the specification of the
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`‘209 patent supports Lilly’s proposed construction of the claim term “patient.”
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`c.
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`The Prosecution History of the ‘209 Patent
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`In addition to consulting the specification, courts should also consult the prosecution
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`history, which consists of the complete record of the proceedings before the United States Patent
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`and Trademark Office (“PTO”). Phillips, 415 F.3d at 1317 (“Like the specification, the
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`prosecution history provides evidence of how the PTO and the inventor understood the patent.”).
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`The ‘209 patent was issued from the U.S. Patent Application No. 11/776,329 (“the ‘329
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`application”), which was filed as a division of U.S. Patent Application No. 11/288,807 (“the ‘807
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`application). In addition, the ‘807 application was filed as a division of U.S. Patent Application
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`No. 10/297,821 (“the ‘821 application”). In support of their position, Defendants cite to two
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`draft claims originating from the ‘807 application and the ‘329 application, respectively.
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`Amended claim 3 of the ‘807 application stated the following: “A method of inhibiting tumor
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`growth in humans comprising….” Dkt. 98-10 at 3 (emphasis added). Amended claim 29 of the
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`‘329 application stated the following: “an improved method for administering pemetrexed
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`disodium to a patient in need of chemotherapeutic treatment, wherein the improvement
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`comprises….” Dkt. 98-14 at 3 (emphasis added). Based on these amendments, Defendants
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`contend that the change from the word “human” to the word “patient” had a broadening effect so
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`that the amended claim included non-humans. See Def. Resp. Br., Dkt. 97 at 29.
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`The Court disagrees. Defendants emphasis on the prosecution history related to the
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`issuance of the ‘209 patent to show that the claim term “patient” was broadened is misplaced; the
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`claim scope was actually narrowed – not broadened – by the use of the term “patient” instead of
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`human. Unlike the word human, “patient” encompasses a human undergoing medical treatment,
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`whereas the word human, by itself, does not refer to a human receiving any additional treatment.
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`After all, some humans go decades without visiting the doctor. Accordingly, the prosecution
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`history does not support the Defendants’ proposed construction.
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`d.
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`Extrinsic Evidence
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`Finally, in construing the meaning of claim terms a court can turn to the extrinsic
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`evidence, such as dictionaries, treaties, and expert testimony in determining patent claim scope.
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`See Phillips, 415 F.3d at 1317-18. On their own, the claims do not provide sufficient aid in
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`defining the term “patient” because “patient” is not explicitly defined in the specification or in
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`the prosecution history. Thus, the Court looks to the extrinsic evidence to provide context in an
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`effort to arrive at the ordinary and customary meaning of the term. See Phillips, 415 F.3d at
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`1317 (articulating that courts may refer to extrinsic evidence if they deem it useful in
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`determining a claim term’s true meaning).
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`The first source describes “patient” as “[a] person receiving or registered to receive
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`medical treatment; a sick person, esp. one staying in a hospital.” New Shorter Oxford English
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`Dictionary 2123 (1993). The second source describes “patient” as “a person who is under
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`medica