Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 1 of 10 PageID #: 1522
`
`IN THE UNITED STATES DISTRICT COURT
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`FOR THE DISTRICT OF DELAWARE
`
`NOV ARTIS PHARMACEUTICALS
`NOV ARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
`CORPORATION and NOVARTIS AG,
`
`Plaintiffs,
`Plaintiffs,
`
`Civil Action No. 14-1494-RGA
`Civil Action No. 14-1494-RGA
`
`Civil Action No. 15-78-RGA
`Civil Action No. 15-78-RGA
`
`v.
`v.
`
`PAR PHARMACEUTICAL, INC.,
`PAR PHARMACEUTICAL, INC.,
`
`. Defendant.
`· Defendant.
`
`NOV ARTIS PHARMACEUTICALS
`NOV ARTIS PHARMACEUTICALS
`CORPORATION and NOV ARTIS AG,·
`CORPORATION and NOV ARTIS AG,·
`
`Plaintiffs,
`Plaintiffs,
`
`Civil Action No. 14-1508-RGA
`Civil Action No. 14-1508-RGA
`
`v.
`v.
`
`ROXANE LABORATORIES, INC.,
`ROXANE LABORATORIES, INC.,
`
`Defendant.
`Defendant.
`
`Civil Action No. 15-128-RGA
`Civil Action No. 15-128-RGA
`
`MEMORANDUM OPINION
`MEMORANDUM OPINION
`
`Daniel M. Silver, Esq., McCARTER & ENGLISH, LLP, Wilmington, DE; Nicholas N. Kallas,
`Daniel M. Silver, Esq., McCARTER & ENGLISH, LLP, Wilmington, DE; Nicholas N. Kallas,
`Esq., Christopher E. Loh, Esq. (argued), Charlotte Jacobsen, Esq., Christina Schwarz, Esq.,
`Esq., Christopher E. Loh, Esq. (argued), Charlotte Jacobsen, Esq., Christina Schwarz, Esq.,
`Laura K Fishwick, Esq., FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY,
`Laura K. Fishwick, Esq., FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY,
`attorneys for Plaintiffs.
`attorneys for Plaintiffs.
`
`Steven J. Fineman, Esq., Katharine C. Lester, Esq., RICHARDS LAYTON & FINGER, P.A.,
`Steven J. Fineman, Esq., Katharine C. Lester, Esq., RICHARDS LAYTON & FINGER, P.A.,
`Wilmington, DE; Daniel G. Brown, Esq. (argued), LATHAM & WATKINS LLP, New York,
`Wilmington, DE; Daniel G. Brown, Esq. (argued), LATHAM & WATKINS LLP, New York,
`NY; Roger J. Chin, Esq., LATHAM & WATKINS LLP, San Francisco, CA; Marc N. Zubick,
`NY; Roger J. Chin, Esq., LATHAM & WATKINS LLP, San Francisco, CA; Marc N. Zubick,
`Esq., Brenda L. Danek, Esq., LATHAM & WATKINS LLP, Chicago, IL; Parker M. Tresemer,
`Esq., Brenda L. Danek, E.sq., LATHAM & WATKINS LLP, Chicago, IL; Parker M. Tresemer,
`Esq., LATHAM & WATKINS LLP, Los Angeles, CA, attorneys for Defendant Par
`Esq., LATHAM & WATKINS LLP, Los Angeles, CA, attorneys for Defendant Par
`Pharmaceutical, Inc.
`Pharmaceutical, Inc.
`
`

`
`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 2 of 10 PageID #: 1523
`
`David E. Moore, Esq., Richard L. Horwitz, Esq., Bindu A. Palapura, Esq., POTTER
`David E. Moore, Esq., Richard L. Horwitz, Esq., Bindu A. Palapura, Esq., POTTER
`ANDERSON & CORROON LLP, Wilmmgton, DE; Marta E. Gross, Esq., Keith A. Zullow,
`ANDERSON & CORROON LLP, Wilmmgton, DE; Marta E. Gross, Esq., Keith A. Zullow,
`Esq., Michael B. CottIer, Esq., Steven J. Bernstein, Esq., GOODWIN PROCTER LLP, New
`Esq., Michael B. Cottler, Esq., Steven J. Bernstein, Esq., GOODWIN PROCTER LLP, New
`York, NY, attorneys for Defendant Roxane Laboratories, Inc.
`York, NY, attorneys for Defendant Roxane Laboratories, Inc.
`
`Novemberd3 , 2015
`Novemberd3 ,2015
`
`2
`2
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`

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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 3 of 10 PageID #: 1524
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`~U~~GE:
`
`Presently before the Court is a supplemental claim construction of a tenn in U.S. Patent
`Presently before the Court is a supplemental claim construction of a term in U.S. Patent
`
`Nos. 7,297,703 ("the '703 patent") and 7,741,33<8 ("the '338 patent"). Plaintiffs Novartis
`Nos. 7,297,703 ("the '703 patent") and 7,741,33°8 ("the '338 patent"). Plaintiffs Novartis
`
`Phannaceuticals Corporation and Novartis AG assert claims of the '703 patent, the '338 patent,
`Pharmaceuticals Corporation and Novartis AG assert claims of the '703 patent, the '338 patent,
`
`and U.S. Patent No. 5,665,772 against Defendants Par Phannaceutieal, Inc. and Roxane
`and U.S. Patent No. 5,665,772 against Defendants Par Pharmaceutical, Inc. and Roxane
`
`Laboratories, Inc. in the above-captioned cases. I The Court previously construed another
`Laboratories, Inc. in the above-captioned cases. 1 The Court previously construed another
`
`disputed term submitted by the parties. (D.I. 80, 84).2 In the present matter, the Court has
`disputed tenn submitted by the parties. (D.I. 80, 84).2 In the present matter, the Court has
`
`considered the parties' Joint Claim Construction Brief. (D.I. 89). The Court heard oral
`considered the parties' Joint Claim Construction Brief. (D.I. 89). The Court heard oral
`
`argument on November 13, 2015 (D.!. 95 [hereinafter, "Tr."D.
`argument on November 13, 2015 (D.I. 95 [hereinafter, "Tr."]).
`
`I. LEGAL STANDARD
`I. LEGAL STANDARD
`
`"It is a bedrock principle of patent law that the claims of a patent define the invention to
`"It is a bedrock principle of patent law that the claims of a patent define the invention to
`
`which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
`which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
`
`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). "'[T]here is no magic fonnula or
`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). '" [T]here is no magic formula or
`
`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
`
`weight to appropriate sources 'in light of the statutes and policies that infonn patent law.'"
`weight to appropriate sources 'in light of the statutes and policies that inform patent law."'
`
`SoftViewLLCv. Apple Inc., 2013 WL4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
`SofiView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4,2013) (quoting Phillips,
`
`415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
`415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
`
`claim, the patent specification, and the prosecution history. lvlarkman v. Westview Instruments,
`claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
`
`Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these
`Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these
`
`sources, "the specification is always highly relevant to the claim construction analysis. Usually,
`sources, "the specification is always highly relevant to the claim construction analysis. Usually,
`
`it is dispositive; it is the single best guide to the meaning of a disputed tenn." Phillips, 415 F.3d
`it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d
`
`at 1315 (internal quotation marks and citations omitted).
`at 1315 (internal quotation marks and citations omitted).
`
`1 The claim terms of U.S. Patent No. 5,665,772 are not at issue in this proceeding.
`1 The claim terms of U.S. Patent No. 5,665,772 are not at issue in this proceeding.
`2 Citations to "D.I.
`"are citations to the docket in C.A. No. 14-1494.
`2 Citations to "D.I. _" are citations to the docket in C.A. No. 14-1494.
`
`3
`3
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`

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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 4 of 10 PageID #: 1525
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`"[T]he words of a claim are generally given their ordinary and customary
`"[T]he words of a claim are generally given their ordinary and customary
`meaning. . . . [Which is] the meaning that the term would have to a person of
`meaning.. .. [Which is] the meaning that the term would have to a person of
`ordinary skill in the art in question at the time of the invention, i.e., as of the
`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."
`effective filing date of the patent application."
`
`Id. at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary meaning of a
`ld. at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary meaning of a
`
`claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
`claim term is its meaning to [an] ordinary artisan after reading the entire patent." ld. at 1321
`
`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
`
`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
`
`construction in such cases involves little more than the application of the widely accepted
`construction in such cases involves little more than the application of the widely accepted
`
`meaning of commonly understood words." ld. at 1314 (internal citations omitted).
`meaning ofcommonly understood words." Id. at 1'314 (internal citations omitted).
`
`When a court relies solely upon the intrinsic evidence----the patent claims, the
`When a court relies solely upon the intrinsic evidence--the patent claims, the
`
`specification, and the prosecution history-the court's construction is a determination oflaw.
`specification, and the prosecution history-the .court's construction is a determination of law.
`
`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
`
`make factual findings based upon consideration of extrinsic evidence, which "consists of all
`make factual findings based upon consideration of extrinsic evidence, which "consists of all
`
`evidence external to the patent and prosecution history, including expert and inventor testimony,
`evidence external to the patent and prosecution history, including expert and inventor testimony,
`
`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks and
`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks and
`
`,citations omitted). Extrinsic evidence may assist the court in understanding the underlying
`citations omitted). Extrinsic evidence may assist the court in understanding the underlying
`
`technology, the meaning of terms to one skilled in the art, and how the invention works. ld.
`technology, the meaning of terms to one skilled in the art, and how the invention works. Id.
`
`Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
`Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
`
`and its prosecution history. Id. "A claim construction is persuasive, not because it follows a
`and its prosecution history. ld. "A claim construction is persuasive, not because it follows a
`
`certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v.
`certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v.
`
`Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
`Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
`
`4
`4
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`

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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 5 of 10 PageID #: 1526
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`II. CONSTRUCTION OF DISPUTED TERM
`II. CONSTRUCTION OF DISPUTED TERM
`
`Claim 1 of the '703 patent and claim 1 ofthe '338 patent are each directed to the disputed
`Claim 1 of the '703 patent and claim 1 of the '338 patent are each directed to the disputed
`
`term "solid mixture." ('703 patent, col. 8, lL 37-41; '338 patent, coL 10,11. 12-13). The '703
`term "solid mixture." ('703 patent, col. 8, ll. 37-41; '338 patent, col. 10, 11. 12-13). The '703
`
`and '338 patents share the same specification.
`and '338 patents share the same specification.
`
`1.
`1.
`
`"solid mixture"
`"solid mixture"
`
`a.
`a.
`
`b.
`b.
`
`c.
`c.
`
`Plaintiffs' proposed construction: mixture in solid form of two or more
`Plaintiffs' proposed construction: mixture in solid form of two or more
`substances, which mixture is not a pharmaceutical composition
`substances, which mixture is not a pharmaceutical composition
`
`Defendants' proposed construction: a solid combination of two or more solid
`Defendants' proposed construction: a solid combination of two or more solid
`substances that are mixed, but not chemically combined
`substances that are mixed, but not chemically combined
`
`Court's construction: a solid combination of two or more solid substances that
`Court's construction: a solid combination of two or more solid substances that
`are mixed, but not chemically combined
`are mixed, but not chemically combined
`
`The parties agree that the claimed "solid mixture" is a combination of two or more solid
`The parties agree that the claimed "solid mixture" is a combination of two or more solid
`
`substances that are not chemically conibined. (D.L 89 at 6, 12). The dispute concerns whether
`substances that are not chemically corribined. (D.I. 89 at 6, 12). The dispute concerns whether
`
`the solid mixture can be a pharmaceutical composition. (Id.).
`the solid mixture can be a pharmaceutical composition. (Id.).
`
`Plaintiffs argue that the claimed "solid mixture" cannot be a pharmaceutical composition
`Plaintiffs argue that the claimed "solid mixture" cannot be a pharmaceutical composition
`
`because claims 1 and 6 of the '703 patent and claims 1 and 3 of the '338 patent draw.an "express
`because claims 1 and 6 of the '703 patent and claims 1 and 3 of the '338 patent draw.an "express
`
`distinction between (i) a solid mixture of a macrolide and an antioxidant, and (ii) a
`distinction between (i) a solid mixture of a macrolide and an antioxidant, and (ii) a
`
`pharmaceutical composition that incorporates a solid mixture of a macrolide and an antioxidant."
`pharmaceutical composition that incorporates a solid mixture of a macrolide and an antioxidant."
`
`(Id. at 7). Claims 1 and 6 of the '703 patent read:
`(Id. at 7). Claims 1 and 6 of the '703 patent read:
`
`1. A solid mixture comprising a poly-ene macrolide and an antioxidant wherein
`1. A solid mixture comprising a poly-ene macrolide and an antioxidant wherein
`the poly-ene macrolide is selected from the group consisting ofrapamycin, a
`the poly-ene macrolide is selected from the group consisting of rapamycin, a
`16-0-substituted rapamycin, and a40-0-substituted rapamycin and wherein
`16-0-substituted rapamycin, and a40-0-substituted rapamycin and wherein
`the antioxidant is present in a catalytic amount.
`the antioxidant is present in a catalytic amount.
`
`6. A pharmaceutical composition comprising as active ingredient, a mixture
`6. A pharmaceutical composition comprising as active ingredient, a mixture
`according to claim 1 or 2, admixed with one or more pharmaceutically
`according to claim 1 or 2, admixed with one or more pharmaceutically
`acceptable carriers or diluents.
`acceptable carriers or diluents.
`
`('703 patent, col. 8, 11. 37-41, 55-58).
`('703 patent, col. 8, 11. 37-41, 55-58).
`
`5
`5
`
`

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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 6 of 10 PageID #: 1527
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`Claims 1 and 3 of the '338 patent read:
`Claims 1 and 3 of the '338 patent read:
`
`1. A solid mixture comprising 40-0-(2-hydroxy)ethyl-rapamycin and 2,6-di(cid:173)
`1. A solid mixture comprising 40-0-(2-hydroxy)ethyl-rapamycin and 2,6-di(cid:173)
`tert-butyl-methylphenol (BHT).
`tert-butyl-methylphenol (BHT).
`
`3. A pharmaceutical composition comprising the solid mixture of claim 1
`3. A pharmaceutical composition comprising the solid mixture of claim 1
`together with one or more pharmaceutically acceptable diluent or carrier.
`together with one or more pharmaceutically acceptable diluent or carrier.
`
`('338 patent, col. 10,11. 12-13, 16-18). Plaintiffs contend that ifthe claimed solid mixture were
`('338 patent, col. 10, 11. 12-13, 16-18). Plaintiffs contend that ifthe claimed solid mixture were
`
`a pharmaceutical composition, "then claim 6 of the '703 patent and claim 3 of the '338 patent
`a pharmaceutical composition, ''then claim 6 of the '703 patent and claim 3 ofthe '338 patent
`
`would cover a pharmaceutical composition comprising, as an active ingredient or element
`would cover a pharmaceutical composition comprising, as an active ingredient or element
`
`thereof, a pharmaceutical composition." (D.I. 89 at 7). Plaintiffs argue that Defendants'
`thereof, a pharmaceutical composition." (D.I. 89 at 7). Plaintiffs argue that Defendants'
`
`construction is improper because it renders claim 6 of the '703 patent and claim 3 of the '338
`construction is improper because it renders claim 6 of the '703 patent and claim 3 of the '338
`
`patent nonsensical. (Id.). Plaintiffs further contend that, like the claims, the specification .
`patent nonsensical. (Id.). Plaintiffs further contend that, like the claims, the specification
`
`expressly distinguishes a solid mixture of a macrolide and an antioxidant from a pharmaceutical
`expressly distinguishes a solid mixture of a macrolide and an antioxidant from a pharmaceutical
`
`composition that incorporates a solid mixture of a macrolide and an antioxidant. (Id. at 9-10).
`composition that incorporates a solid mixture of a macrolide and an antioxidant. (Id. at 9-10).
`
`Defendants respond that a claim directed to a pharmaceutical composition comprising, as
`Defendants respond that a claim directed to a pharmaceutical composition comprising, as
`
`an active ingredient or element thereof, a pharmaceutical composition is not nonsensical. (Id. at
`an active ingredient or element thereof, a pharmaceutical composition is not nonsensical. (Id. at
`
`14). "A pharmaceutical composition comprising a ph~aceutical composition" makes sense
`14). "A pharmaceutical composition comprising a pharmaceutical composition" makes sense
`
`because a pharmaceutical composition can be one element of another pharmaceutical
`because a pharmaceutical composition can be one element of another pharmaceutical
`
`composition. (Tr. at 26). Defendants contend, for example, that replacing the term "mixture" in
`composition. (Tr. at 26). Defendants contend, for example, that replacing the term "mixture" in
`
`claim 6 of the '703 patent with the term "pharmaceutical composition" would not render the
`claim 6 of the '703 patent with the term "pharmaceutical composition" would not render the
`
`resulting claim nonsensical because claim 6 "would simply require admixing 'one or more
`resulting claim nonsensical because claim 6 "would simply require admixing 'one or more
`
`pharmaceutically acceptable carriers or diluents' in addition to whatever is already in the mixture
`pharmaceutically acceptable carriers or diluents' in addition to whatever is already in the mixture
`
`of claim 1." (D .I. 8 9 at 15). With respect to Plaintiffs' argument that the intrinsic evidence
`of claim I." (D.I. 89 at 15). With respect to Plaintiffs' argument that the intrinsic evidence
`
`repeatedly distinguishes solid mixtures from pharmaceutical compositions, Defendants' view is
`repeatedly distinguishes solid mixtures from pharmaceutical compositions, Defendants' view is
`
`that the fact that the claims and specification refer to "mixtures" in some instances and
`that the fact that the claims and specification refer to "mixtures" in some instances and
`
`6
`6
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`

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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 7 of 10 PageID #: 1528
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`· "phannaceutical compositions" in other instances suggests that "mixture" and "phannaceutical
`. "pharmaceutical compositions" in other instances suggests that "mixture" and "pharmaceutical
`
`composition" do not have identical scope, but does not preclude their having overlapping scope.
`composition" do not have identical scope, but does not preclude their having overlapping scope.
`
`(ld. at 15, 17). Defendants argue that their proposed construction simply gives the tenn"solid
`(Id. at 15, 17). Defendants argue that their proposed construction simply gives the term "solid
`
`mixture" "the full scope of its plain meaning, which would not exclude 'pharmaceutical
`mixture" "the full scope of its plain meaning, which would not exclude 'pharmaceutical
`
`compositions. '" (ld. at 15). I agree that Defendants' proposed construction does not render the
`compositions."' (Id. at 15). I agree that Defendants' proposed construction does not render the
`
`dependent claims facially nonsensical and is consistent with the patents' distinguishing
`dependent claims facially nonsensical and is consistent with the patents' distinguishing
`
`"mixture" from "pharmaceutical composition:"
`"mixture" from "pharmaceutical composition:"
`
`Defendants argue that Plaintiffs' proposed negative limitation violates the principle that
`Defendants argue that Plaintiffs' proposed negative limitation violates the principle that
`
`dependent claims must fall within the scope of the independent claims from which they depend.
`dependent claims must fall within the scope of the independent claims from which they depend.
`
`(ld. at 23 (citing Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006».
`(Id. at 23 (citing Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)).
`
`The parties agree that claim 6 ofthe '703 patent depends from claim 1 ofthe '703 patent and
`The parties agree that claim 6 of the '703 patent depends from claim 1 of the '703 patent and
`
`claim 3 of the '338 patent depends from claim 1 of the '338 patent. (ld. at 23-24; Tr. at 6).
`claim 3 of the '338 patent depends from claim 1 of the '338 patent. (Id. at 23-24; Tr. at 6).
`
`Defendants.argue that under Plaintiffs' proposed construction claim 1 of the '703 patent cannot
`Defendants argue that under Plaintiffs' proposed construction claim 1 of the '703 patent cannot
`
`include claim 6 of the '703 patent within its scope and claim 1 of the '338 patent cannot include
`include claim 6 of the '703 patent within its scope and claim 1 of the '338 patent cannot include
`
`claim 3 of the '338 patent within its scope. (D.L 89 at 23).
`claim 3 of the '338 patent within its scope. (D.I. 89 at 23).
`
`Relying on Forest Laboratories, Inc. v. Abbott Laboratories, 239 F.3d 1305 (Fed. Cir.
`Relying on Forest Laboratories, Inc. v. Abbott Laboratories, 239 F.3d 1305 (Fed. Cir.
`
`2001), Plaintiffs respond that claim 6 of the '703 patent and claim 3 of the '338 patent properly
`2001), Plaintiffs respond that claim 6 ofthe '703 patent and claim 3 of the '338 patent properly
`
`depend on the first claims of their respective patents. (Tr. at 15-17). In Forest Laboratories, the
`depend on the first claims of their respective patents. (Tr. at 15-17). In Forest Laboratories, the
`
`court held that a claim to a "phannaceutical composition ... comprising ... [the] surface active
`court h.eld that a claim to a "pharmaceutical composition ... comprising ... [the] surface active
`
`material ... in claim I" properly depended on claim 1, which recited a "surface active material
`material ... in claim 1" properly depended on claim 1, which recited a "surface active material
`
`comprising [certainmaterialJ." Forest Labs., Inc., 239 F.3d at 1310, 1311 n.3. In reaching that
`comprising [certain material]." Forest Labs., Inc., 239 F.3d at 1310, 1311 n.3. In reaching that
`
`conclusion, the court recounted the test for proper dependency in the Manual of Patent
`conclusion, the court recounted the test for proper dependency in the Manual of Patent
`
`Examining Procedure, which provides: "The test [of proper dependency] is not whether the
`Examining Procedure, which provides: "The test [of proper dependency] is not whether the
`
`7
`7
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`

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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 8 of 10 PageID #: 1529
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`claims differ in scope. A proper dependent claim shall not conceivably be infringed by anything
`claims differ in scope. A proper dependent claim shall not conceivably be infringed by anything
`
`which would not also infringe the basic claim." Id. at 1311 n.3. Relying on that test, the court
`which would not also infringe the basic claim." Id. at 1311 n.3. Relying on that test, the court
`
`_ concluded that the claims to a pharmaceutical composition properly depended on the claims to
`. concluded that the claims to a pharmaceutical composition properly depended on the claims to
`
`surface active material because "[a]ny pharmaceutical composition that would infringe the
`surface active material because "[a]ny pharmaceutical composition that would infringe the
`
`dependent claims must necessarily contain a surface active material that would also infringe the
`dependent claims must necessarily contain a surface active material that would also infringe the
`
`independent claims." Id.
`independent claims." Id.
`
`Forest Laboratories does not support Plaintiffs' construction that "solid mixture"
`Forest Laboratories does not support Plaintiffs' construction that "solid mixture"
`
`excludes pharmaceutical compositions. In Forest Laboratories, the court did not adopt a
`excludes pharmaceutical compositions. In Forest Laboratories, the court did not adopt a
`
`construction of "surface active material" that excluded from it "pharmaceutical compositions."
`construction of "surface active material" that excluded from it "pharmaceutical compositions."
`
`To the contrary, the court held that "[w]hen the surface active material is combined with a
`To the contrary, the court held that "[w]hen the surface active material is combined with a
`
`pharmaceutically acceptable carrier, it does not necessarily cease to be the claimed surface active
`pharmaceutically acceptable carrier, it does not necessarily cease to be the claimed surface active
`
`material." Id. at 1310. Applying the Forest Laboratories reasoning to the claims at issue in this
`material." Id. at 1310. Applying the Forest Laboratories reasoning to the claims at issue in this
`
`case, the conclusion would be that when the solid mixture is combined with one or more
`case, the conclusion would be that when the solid mixture is combined with one or more
`
`pharmaceutically acceptable carriers or diluents, it would not necessarily cease to be the claimed
`pharmaceutically acceptable carriers or diluents, it would not necessarily cease to be the claimed
`
`solid mixture. That solid mixture, combined with one or more pharmaceutically acceptable
`solid mixture. That solid mixture, combined with one or more pharmaceutically acceptable
`
`carriers or diluents, would be the pharmaceutical composition claimed in the dependent claims.
`carriers or diluents, would be the pharmaceutical composition claimed in the dependent claims.
`
`Thus, Forest Laboratories does not support Plaintiffs' construction.
`Thus, Forest Laboratories does not support Plaintiffs' construction.
`
`More generally, it is simply not possible for both (1) "solid mixture" to exclude
`More generally, it is simply not possible for both (1) "solid mixture" to exclude
`
`pharmaceutical compositions and (2) the dependent claims to properly depend on their respective
`pharmaceutical compositions and (2) the dependent claims to properly depend on their respective
`
`independent claims. By the terms of the claims themselves, a substance that would infringe
`independent claims. By the terms of the claims themselves, a substance that would infringe
`
`claim 6 of the '703 patent or claim 3 of the "338 patent would be a "pharmaceutical
`claim 6 of the '703 patent or claim 3 of the '338 patent would be a "pharmaceutical
`
`composition." ('703 patent, col. 8, lL 55-58; '338 patent, coL 10,11. 16-18). For that substance
`composition." ('703 patent, col. 8, 11. 55-58; '338 patent, col. 10, 11. 16-18). For that substance
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`to also infringe claim 1 of either patent, according to the claims themselves, it would have to be a
`to also infringe claim 1 of either patent, according to the claims themselves, it would have to be a
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`8
`8
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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 9 of 10 PageID #: 1530
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`"solid mixture." ('703 patent, col. 8, 11. 37-41; '338 patent, col. 10, 11. 12-13). Thus, the
`"solid mixture." ('703 patent, col. 8,11.37-41; '338 patent, coL 10, lL 12-13). Thus, the
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`pharmaceutical composition would have to be a solid mixture. Alternatively, if one accepted that
`pharmaceutical composition would have to be a solid mixture. Alternatively, if one accepted that
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`"solid mixture" excludes pharmaceutical compositions, then claim 6 of the '703 patent and claim
`"solid mixture" excludes pharmaceutical compositions, then claim 6 of the '703 patent and claim
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`3 of the '3 3 8 patent would not properly depend on their respective independent claims because
`3 of the '338 patent would not properly depend on their respective independent claims because
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`the pharmaceutical composition that would infringe claim 6 of the '703 patent or claim 3 of the
`the pharmaceutical composition that would infringe claim 6 of the '703 patent or claim 3 of the
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`'338 patent could not infringe the independent claims.
`'338 patent could not infringe the independent claims.
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`Defendants also argue that Plaintiffs' "proposed construction does not meet the Federal
`Defendants also argue that Plaintiffs' "proposed construction does not meet the Federal
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`Circuit's high bar for adopting a negative limitation." (D.I. 89 at 13). Negative limitations will
`Circuit's high bar for adopting a negative limitation." (D.!. 89 at 13). Negative limitations will
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`generally not be added to claim terms without "express disclaimer or independent lexicography
`generally not be added to claim terms without "express disclaimer or independent lexicography
`
`in the intrinsic record that justifies including the negative limitation." Vehicle IP, LLC v. AT & T
`in the intrinsic record that justifies including the negative limitation." Vehicle IP, LLC v. AT & T
`
`Mobility, LLC, 594 F. App'x 636, 642 (Fed. Cir. 2014). Although the claims and specification
`Mobility, LLC, 594 F. App'x 636, 642 (Fed. Cir. 2014). Although the claims and specification
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`distinguish "solid mixture" from "pharmaceutical composition," Plaintiffs do not dispute that
`distinguish "solid mixture" from "pharmaceutical composition," Plaintiffs do not dispute that
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`patentees did not expressly disavow or disclaim "pharmaceutical compositions" from the scope
`patentees did not expressly disavow or disclaim "pharmaceutical compositions" from the scope
`ofthe term "solid mixture" in the specification or during prosecution. (D.I. 89 at 14, 18-19).
`of the term "solid mixture" in the specification or during prosecution. (D.I. 89 at 14, 18-19).
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`Patentees did not act as their own lexicographers by clearly setting forth a definition of "solid
`Patentees did not act as their own lexicographers by clearly setting forth a definition of "solid
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`mixture" that excluded "pharmaceutical compositions" from its scope. In fact, the specification
`mixture" that excluded "pharmaceutical compositions" from its scope. In fact, the specification
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`does not use the term "solid mixture."
`does not use the term "solid mixture."
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`Plaintiffs maintain that express disavowal and lexicography are not the sole means by
`Plaintiffs maintain that express disavowal and lexicography are not the sole means by
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`which claim terms can be limited. (ld. at 19). As Plaintiffs point out, claim terms are sometimes
`which claim terms can be limited. (Id. at 19). As Plaintiffs point out, claim terms are sometimes
`
`limited in view of intrinsic evidence even absent express disavowal and lexicography. (Id. at
`limited in view ofintrinsic evidence even absent express disavowal and lexicography. (Ia. at
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`19); see, e.g., Cephalon, Inc. v. Barr Labs., Inc., 389 F. Supp. 2d 602, 606 (D. Del. 2005). Still,
`19); see, e.g., Cephalon, Inc. v. Barr Labs., Inc., 389 F. Supp. 2d 602,606 (D. DeL 2005). Still,
`
`the intrinsic evidence Plaintiffs cite here is insufficient to support their proposed negative
`the intrinsic evidence Plaintiffs cite here is insufficient to support their proposed negative
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`limitation in light of the lack of express disavowal and lexicography.
`limitation in light of the lack of express disavowal and lexicography.
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`Case 1:14-cv-01494-RGA Document 97 Filed 11/24/15 Page 10 of 10 PageID #: 1531
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`Further, Defendants argue that the prosecution history of the '338 patent supports their
`Further, Defendants argue that the prosecution history of the '338 patent supports their
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`construction. (OJ. 89 at 24-25). In rejecting patentees' amendment to add as claim 3 "[a]
`construction. (D.I. 89 at 24--25). In rejecting patentees' amendment to add