Case 1:15-cv-00902-RGA Document 175 Filed 03/03/17 Page 1 of 7 PageID #: 2331
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BA YER INTELLECTUAL PROPERTY
`GMBH, BA YER PHARMA AG, and
`JANSSEN PHARMACEUTICALS, INC.,
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`Plaintiffs,
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`v.
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`AUROBINDO PHARMA LIMITED,
`AUROBINDO PHARMA USA, INC.,
`BRECKENRIDGE PHARMACEUTICAL,
`INC., INVAGEN PHARMACEUTICALS,
`INC., MICRO LABS LTD., MICRO LABS
`USA INC., MYLAN
`PHARMACEUTICALS INC., PRINSTON
`PHARMACEUTICAL INC.,
`SIGMAPHARM LABO RA TORIES, LLC,
`TORRENT PHARMACEUTICALS,
`LIMITED, and TORRENT PHARMA INC.,
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`Defendants.
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`Civil Action No. 1:15-cv-902-RGA
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`MEMORANDUM OPINION
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`Jack B. Blumenfeld, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE;
`Rodger D. Smith II, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE;
`Derek J. Fahnestock, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE.
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`Attorneys for Plaintiffs
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`Bruce R. Genderson, Esq., WILLIAMS & CONNOLLY LLP, Washington, DC; Adam L.
`Perlman, Esq., WILLIAMS & CONNOLLY LLP, Washington, DC; Dov P. Grossman, Esq.
`(argued), WILLIAMS & CONNOLLY LLP, Washington, DC; Alexander S. Zolan, Esq.,
`WILLIAMS & CONNOLLY LLP, Washington, DC; Martha C. Kidd, Esq., WILLIAMS &
`CONNOLLY LLP, Washington, DC, Kathryn S. Kayali, Esq., WILLIAMS & CONNOLLY
`LLP, Washington, DC.
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`Attorneys for Plaintiffs Bayer Intellectual Property GmbH and Bayer Pharma AG
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`

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`Case 1:15-cv-00902-RGA Document 175 Filed 03/03/17 Page 2 of 7 PageID #: 2332
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`David T. Pritikin, Esq., SIDLEY AUSTIN LLP, Chicago, IL; Lisa A. Schneider, Esq., SIDLEY
`AUSTIN LLP, Chicago, IL; Bindu Donovan, Esq., SIDLEY AUSTIN LLP, New York, NY; S.
`Isaac Olson, Esq., SIDLEY AUSTIN LLP, New York, NY.
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`Attorneys for Plaintiff Janssen Pharmaceuticals, Inc.
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`David E. Moore, Esq., POTTER ANDERSON & CORROON LLP, Wilmington, DE; Bindu A.
`Palapura, Esq., POTTER ANDERSON & CORROON LLP, Wilmington, DE; Stephanie E.
`O'Byrne, Esq., POTTER ANDERSON & CORROON LLP, Wilmington, DE; Douglas H.
`Carsten, Esq., WILSON SONSINI GOODRICH & ROSATI P.C., San Diego, CA; Wendy L.
`Devine, Esq., WILSON SONSINI GOODRICH & ROSATI P.C., San Diego, CA; Christina
`Dashe, Esq., WILSON SONSINI GOODRICH & ROSATI P.C., San Diego, CA; David M.
`Hanna, Esq., WILSON SONSINI GOODRICH & ROSATI P.C., San Francisco, CA.
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`Attorneys for Defendant Mylan Pharmaceuticals Inc.
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`Kenneth L. Dorsney, Esq., MORRIS JAMES LLP, Wilmington, DE; Stephen R. Auten, Esq.,
`TAFT STETTINIUS & HOLLISTER LLP, Chicago, IL; Andrew M. Alul, Esq., TAFT
`STETTINIUS & HOLLISTER LLP, Chicago, IL; Roshan P. Shrestha, Ph.D., Esq., TAFT
`STETTINIUS & HOLLISTER LLP, Chicago, IL.
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`Attorneys for Defendants Micro Labs, Ltd. and Micro Labs USA, Inc.
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`John C. Phillips, Jr., Esq., PHILLIPS, GOLDMAN MCLAUGHLIN & HALL, P.A.,
`Wilmington, DE; Megan C. Haney, Esq., PHILLIPS, GOLDMAN MCLAUGHLIN & HALL,
`P.A., Wilmington, DE; B. Jefferson Boggs, Esq., MERCHANT & GOULD PC, Alexandria, VA;
`Matthew L. Fedowitz, Esq., MERCHANT & GOULD PC, Alexandria, VA; Christopher J.
`Sorenson, Esq., MERCHANT & GOULD PC, Minneapolis, MN.
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`Attorneys for Defendant Breckenridge Pharmaceutical Inc.
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`Richard L. Renck, Esq., DUANE MORRIS, LLP, Wilmington, DE; Anthony J. Fitzpatrick, Esq.
`(argued), DUANE MORRIS, LLP, Boston, MA; Vincent L. Capuano, Ph.D., Esq., DUANE
`MORRIS, LLP, Boston, MA; Emily N. Winfield, Esq., DUANE MORRIS, LLP, Chicago, IL.
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`Attorneys for Defendant Prinston Pharmaceutical Inc.
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`John W. Shaw, Esq., SHAW KELLER LLP, Wilmington, DE; Jeffrey T. Castellano, Esq.,
`SHAW KELLER LLP, Wilmington, DE; Nathan R. Hoeschen, Esq., SHAW KELLER LLP,
`Wilmington, DE.
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`Attorneys for Defendants Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc.
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`March :J, 2017
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`

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`Case 1:15-cv-00902-RGA Document 175 Filed 03/03/17 Page 3 of 7 PageID #: 2333
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`ANDRE~~
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`Presently before the Court is the issue of claim construction of a single term in U.S.
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`Patent No. 7,157,456 ("the '456 patent"). The Court has considered the Parties' Claim
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`Construction Briefs. (D.I. 144, 156, 162, 168). The Court heard oral argument on March 3,
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`2017.
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`I.
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`BACKGROUND
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`This suit arises from Defendants' filing Abbreviated New Drug Applications ("ANDA")
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`for generic versions of Plaintiffs' anticoagulant, sold under the brand name XARELTO. (D.I.
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`144 at 6). Plaintiffs filed suit, alleging that the generic products that are the subjects of the
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`ANDA filings would infringe a number of Plaintiffs' patents. (D.I. 1). The patents-in-suit claim
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`compounds for use in treating thromboembolic disorders and methods of treatment using these
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`compounds.
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`II.
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`LEGALSTANDARD
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`"It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude." Phillips v. A WH Corp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). "'[T]here is no magic formula or
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`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
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`weight to appropriate sources 'in light of the statutes and policies that inform patent law.'"
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`SoflView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
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`415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the
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`literal language of the claim, the patent specification, and the prosecution history. Markman v.
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`Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370
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`(1996). Of these sources, "the specification is always highly relevant to the claim construction
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`Case 1:15-cv-00902-RGA Document 175 Filed 03/03/17 Page 4 of 7 PageID #: 2334
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`analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term."
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`Phillips, 415 F.3d at 1315 (internal quotation marks omitted).
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`"[T]he words of a claim are generally given their ordinary and customary meaning ....
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`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention, i.e., as of the effective filing date of the patent application."
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`Id. at 1312-13 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a
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`claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
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`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
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`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
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`construction in such cases involves little more than the application of the widely accepted
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`meaning of commonly understood words." Id. at 1314.
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`When a court relies solely upon the intrinsic evidence-the patent claims, the
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`specification, and the prosecution history-the court's construction is a determination oflaw.
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`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
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`make factual findings based upon consideration of extrinsic evidence, which "consists of all
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`evidence external to the patent and prosecution history, including expert and inventor testimony,
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`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks
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`omitted). Extrinsic evidence may assist the court in understanding the underlying technology,
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`the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic
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`evidence, however, is less reliable and less useful in claim construction than the patent and its
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`prosecution history. Id.
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`"A claim construction is persuasive, not because it follows a certain rule, but because it
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`defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per
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`2
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`Case 1:15-cv-00902-RGA Document 175 Filed 03/03/17 Page 5 of 7 PageID #: 2335
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`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would
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`exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int 'l Trade
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`Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation and internal quotation marks omitted).
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`III. CONSTRUCTION OF DISPUTED TERMS
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`The '456 patent is directed to compounds and methods for treatment of thromboembolic
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`disorders. The only disputed term appears in dependent claim 14, which reads as follows:
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`14.
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`The compound of claim 6 that is purified and isolated.
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`(' 456 patent, claim 14) (disputed terms italicized). Independent claim 6, from which
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`claim 14 depends, reads as follows:
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`6.
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`The compound having the following formula
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`o/\
`'-(N
`
`0
`
`0
`
`NAO
`~ Cl
`s '
`
`HN ~
`
`0
`or a pharmaceutically acceptable salt or hydrate thereof.
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`(' 456 patent, claim 6).
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`1.
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`"The compound of claim 6 that is purified and isolated."
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`a.
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`b.
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`Plaintiffs' proposed construction: "The compound of claim 6 that is sufficiently
`free of impurities and any synthesis-related compounds to permit its use in a
`pharmaceutical composition. The claim does not exclude a pharmaceutical
`composition that contains the compound of claim 14 and one or more
`pharmacologically acceptable auxiliaries or excipients."
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`Defendants' proposed construction: "The compound of claim 6 that is sufficiently
`free of impurities and any synthesis-related compounds to permit its use in a
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`3
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`Case 1:15-cv-00902-RGA Document 175 Filed 03/03/17 Page 6 of 7 PageID #: 2336
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`pharmaceutical composition, including but not limited to compounds such as
`pharmacologically acceptable auxiliaries and excipients."
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`c.
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`Court's construction: "The compound of claim 6 that is sufficiently free of
`impurities and any synthesis-related compounds to permit its use in a
`pharmaceutical composition. The claim does not exclude a pharmaceutical
`composition that contains the compound of claim 14 and one or more
`pharmacologically acceptable auxiliaries or excipients."
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`The only dispute with respect to this term is whether, as Defendants argue, it includes an
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`implied negative limitation that, in order to be "purified and isolated," the compound cannot
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`contain any pharmacologically acceptable auxiliaries or excipients. Defendants argue that this
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`limitation is required in order to give meaning to the term "isolated." (D.I. 156 at 7). Defendants
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`further argue that Plaintiffs' proposed construction is an attempt to improperly broaden the scope
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`of the claim, as well as an attempt to rescue dependent claim 18, which Defendants contend is
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`invalid for improper dependency under their proposed construction. (Id. at 7-8). Plaintiffs counter
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`that the intrinsic record, including the patent's other claims, the specification, and the prosecution
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`history all support their argument that the phrase "purified and isolated" does not exclude inactive
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`pharmaceutical ingredients. (D.I. 144 at 8).
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`I agree with Plaintiffs. Claim 18 reads, "A pharmaceutical composition comprising the
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`compound of claim 14 and one or more pharmacologically acceptable auxiliaries or excipients."
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`Any compound that meets the limitations of claim 18 must also meet the limitations of the
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`necessarily broader claim 14. It seems to me that this means that Defendants' proposed limitation
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`is inconsistent with the claims themselves. Defendants counter that it is claim 18 that is invalid
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`because it "does not incorporate 'all the limitations of the claim to which it refers' and further fails
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`to 'specify a further limitation of the subject matter claimed' in claim 14." (D.I. 156 at 15) (quoting
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`35 U.S.C. § 112, paragraph 4 (2010)). I disagree. Claim 18 requires that the compound of claim
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`14 be incorporated into a pharmaceutical composition. This is quite clearly an additional limitation
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`4
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`Case 1:15-cv-00902-RGA Document 175 Filed 03/03/17 Page 7 of 7 PageID #: 2337
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`not present in claim 14. Furthermore, the only way to conclude that claim 18 does not incorporate
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`all of claim 14's limitations is to adopt Defendants' implied negative limitation that "isolated"
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`requires that the compound be separate from any other compounds or ingredients. This argument
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`fails, however, because the term must be construed in the context of the patent, including the other
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`claims, rather than in isolation as Defendants propose. I find no support for Defendants' argument
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`in the intrinsic evidence.
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`The specification additionally supports Plaintiffs' position. For example, the patent teaches
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`a method for preparing a compound, specifying that the product of the reaction "can be isolated
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`by silica gel chromatography" from "the reaction mixture." ('456 patent at 53:35-36). This usage
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`is inconsistent with Defendants' much more restrictive limitation that the compound must be kept
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`isolated and separate from any other compounds. Rather, it seems clear to me that the patent uses
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`the word "isolated" to mean separated from synthesis-related compounds existing in the reaction
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`mixture. Furthermore, the very same example uses the word "purified" in a similar context,
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`specifying that, "The product is purified by silica gel chromatography." (Id. at 53:5-6). It seems
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`to me that "purified and isolated" are used as a compound phrase in claim 14 and that, taken
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`together, the phrase simply means that the compound is free of impurities and synthesis related
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`compounds. The intrinsic evidence does not support giving the word "isolated" any additional
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`meaning as Defendants propose. Therefore, I will adopt Plaintiffs' proposed construction.
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`5
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