Case 1:17-cv-00389-RGA Document 72 Filed 06/29/18 Page 1 of 10 PageID #: 2763
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NOVARTIS PHARMACEUTICALS
`CORPORATIONS and NOV ARTIS AG,
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`Plaintiffs/Counterclaim Defendants
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`V.
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`Civil Action No. 17-389-RGA
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`MYLAN PHARMACEUTICALS INC.,
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`Defendant/Counterclaim Plaintiff.
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`MEMORANDUM OPI ION
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`Daniel M. Silver, MCCARTER & ENGLISH LLP, Wilmington, DE; Christina Schwarz
`(argued), Nicholas N. Kallas, Christopher E. Loh, Charlotte Jacobsen, Jared Stringham (argued),
`FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY.
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`Attorneys for Plaintiffs and Counterclaim Defendants.
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`James M. Lennon, DEVLIN LAW FIRM LLC, Wilmington, DE; Shannon M. Bloodworth,
`Brandon M. White, PERKINS COIE LLP, Washington, DE; Bryan D. Beel (argued), David
`Anstaett, PERKINS COIE LLP, Portland, OR.
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`Attorneys for Defendant and Counterclaim Plaintiff.
`
`JuneJf/.-, 2018
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`

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`Case 1:17-cv-00389-RGA Document 72 Filed 06/29/18 Page 2 of 10 PageID #: 2764
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`~fo
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`Presently before me is the issue of claim construction of multiple terms in U.S. Patent
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`Nos. 8,778,962 ("the ' 962 patent"), 8,617,598 ("the ' 598 patent"), and 7,297,703 ("the ' 703
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`patent"). I held oral argument on June 14, 2018. (D.I. 71 ("Tr.")).
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`I.
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`LEGAL STANDARD
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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. AWH 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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`SoftView 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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`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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`Case 1:17-cv-00389-RGA Document 72 Filed 06/29/18 Page 3 of 10 PageID #: 2765
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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-
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`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. Extrinsic evidence may assist
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`the court in understanding the underlying technology, the meaning of terms to one skilled in the
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`art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less
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`useful in claim construction than the patent and its 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 ' p er
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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 omitted).
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`II.
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`BACKGROUND
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`Novartis asserts the ' 962 and ' 598 patents against Mylan. (D.I. 1). Mylan seeks
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`declaratory judgments of non-infringement and invalidity of the ' 962, ' 598, and ' 703 patents.
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`(D.I. 15). The ' 962 patent "claims methods of inhibiting growth of non-malignant solid tumors
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`of the brain ... by administering therapeutically effective amounts of the active compound
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`everolimus." (D.I. 59 at 1 ). The ' 598 patent "claims novel pharmaceutical compositions of
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`Case 1:17-cv-00389-RGA Document 72 Filed 06/29/18 Page 4 of 10 PageID #: 2766
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`everolimus in the form of dispersible tablets, which tablets are dispersed in an ingestible liquid
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`before consumption." (Id. at 32). The '703 patent "discloses and describes mixtures of
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`stabilized pharmaceutical active ingredients, and methods for stabilizing the ingredients," where
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`the "active ingredient is preferably a poly-ene macrolide (a compound with a particular type of
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`ringed structure) having immunosuppressant properties." (Id. at 60).
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`The asserted claims of the '962 patent read as follows:
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`1. A method for inhibiting growth of non-malignant solid tumors of the brain in a subject,
`said method consisting of administering to said subject a therapeutically effective amount
`of a compound of formula I
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`41
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`4
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`5
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`6
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`36
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`35
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`33
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`i 34
`:;
`0
`
`N
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`8
`
`0
`
`OH
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`0
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`24
`
`19
`
`21
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`wherein
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`Xis=O.
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`2. The method of claim 1 wherein the compound of formula I is administered at a daily dose
`range of from about 0.1 to 25 mg, as a single dose or in divided doses.
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`3. The method of claim 1 wherein the compound of formula I is administered in a unit
`dosage form of from about 0.05 to 12.5 mg.
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`4
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`4. The method of claim 1 wherein the compound of formula I is administered in a unit
`dosage form of from about 0.25 to 10 mg.
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`6. The method of claim 1 wherein the compound of formula I is administered orally.
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`('962 patent, claims 1, 2, 3, 4, 6).
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`The asserted claims of the ' 598 patent read as follows:
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`1. A pharmaceutical composition in the form of a dispersible tablet to be dispersed in an
`ingestible liquid before administration to a patient, comprising a solid dispersion of 40-O(cid:173)
`(2-hydroxy)ethyl-rapamycin, a disintegrant comprising cross-linked polyvinylpyrrolidone
`and colloidal silicon dioxide, wherein the composition comprises 1 to 5% colloidal
`silicon dioxide by weight and 10 to 30% of cross-linked polyvinylpyrrolidone by weight,
`and wherein the tablet has a disintegration time of 3 minutes or less and a hardness of 35
`to 80N.
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`2. The pharmaceutical composition according to claim 1, wherein 250 mg of the
`composition, when compressed using a force of 8 to 11 kN with a 9 mm die and standard
`flat punches, forms the dispersible tablet.
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`3. A method of administering the pharmaceutical composition of claim 1 to a patient in need
`of said composition which comprises (i) contacting the composition with an aqueous
`solution (ii) allowing the composition to disperse in the aqueous solution to form a
`dispersed mixture and (iii) ingesting the dispersed mixture.
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`4. A composition according to claim 1, wherein the tablet has a disintegration time of 90
`seconds or less.
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`6. A process for producing the pharmaceutical composition according to claim 1,
`comprising preparing the solid dispersion comprising 40-O-(2-hydroxy)ethyl-rapamycin,
`mixing the solid dispersion comprising 40-O-(2-hydroxy)ethyl-rapamycin with the
`disintegrant comprising cross-linked polyvinylpyrrolidone and colloidal silicon dioxide to
`form the pharmaceutical composition and compressing the pharmaceutical composition
`to form the dispersible tablet.
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`(' 598 patent, claims 1, 2, 3, 4, 6).
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`The asserted claims of the ' 703 patent read as follows:
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`1. A solid mixture comprising a poly-ene macrolide and an antioxidant wherein the poly(cid:173)
`ene macrolide is selected from the group consisting of rapamycin, a 16-O-substituted
`rapamycin, and a 40-O-substituted rapamycin and wherein the antioxidant is present in a
`catalytic amount.
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`5
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`6. A pharmaceutical composition comprising as active ingredient, a mixture according
`to claim 1 or 2, admixed with one or more pharmaceutically acceptable carriers or
`diluents.
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`7. A pharmaceutical composition according to claim 6 for oral administration.
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`('703 patent, claims 1, 6, 7). The parties agree that the claim term "admixed" in the ' 703 patent
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`means "together." (D.I. 59 at 1).
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`Novartis wrote to the Court stating, "Novartis has granted Mylan a covenant not to sue on
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`the '703 patent. As a result, Novartis believes that this Court no longer has jurisdiction over
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`Mylan's counterclaims concerning the '703 patent." (D.I. 64). However, Mylan stated at oral
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`argument, "[T]hat covenant is not sufficient to resolve the declaratory judgment claims and so in
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`our view those two terms are still live." (Tr. 64:22-65 :4). The parties indicated that they are
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`"discussing" the covenant, so I will not address the ' 703 patent terms at this time. (Tr. 65: 17-
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`24).
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`III.
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`TERMS FOR CONSTRUCTION
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`A. "Therapeutically effective amount" ('962 patent, claims 1, 2, 3, 4, 6)
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`1. Novartis 's proposed construction : "an amount that is safe and effective to produce the
`desired therapeutic effect, i.e., inhibiting growth (slowing the increase in size and/or
`reducing the size) of non-malignant solid tumors of the brain"
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`2. Mylan 's proposed construction: "amount effective for inhibiting growth of non(cid:173)
`malignant solid tumors of the brain in a patient"
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`3. Court 's construction: "amount effective for inhibiting growth of non-malignant solid
`tumors of the brain in a patient"
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`The sole dispute between the parties is whether my construction should include a "safe"
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`amount. (D.1. 59 at 1, 7). Novartis wrote to the Court, indicating that it "agrees to adopt
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`Mylan's construction of 'therapeutically effective amount. "' (D.I. 68). Accordingly, I will adopt
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`Mylan' s proposed construction as my own.
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`B. "Inhibiting growth" ('962 patent, claims 1, 2, 3, 4, 6)
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`1. Novartis 's proposed construction: "slowing the increase in size and/or reducing the size,
`volume, mass, and/or weight"
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`2. Mylan 's proposed construction: "plain and ordinary meaning, which is slowing the
`increase in and/or reducing the growth, including but not limited to measures of volume,
`mass, or cell proliferation"
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`3. Court 's construction: "slowing the increase in and/or reducing the diameter, volume,
`mass, and/or weight"
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`Novartis wrote to the Court, indicating that the parties agree to a construction for
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`"inhibiting growth." (D.I. 64). Accordingly, I will adopt that construction as my own.
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`C. "Colloidal silicon dioxide" ('598 patent, claims 1, 2, 3, 4, 6)
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`1. Novartis 's proposed construction:
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`"colloidal silicon dioxide or colloidal silica"
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`OR, to the extent further construction is required,
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`"silicon dioxide forming small, insoluble, nondiffusible particles that remain in
`suspension"
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`4. Mylan 's proposed construction: "fumed silica"
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`5. Court 's construction: Plain and ordinary meaning: "colloidal silicon dioxide or colloidal
`silica"
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`Mylan contends that I should construe "colloidal silicon dioxide" as "fumed silica." (D.I.
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`59 at 40). Mylan makes two arguments to support its contention. First, Mylan argues that
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`Novartis made a "disavowal of claim scope, limiting the meaning of ' colloidal silicon dioxide' to
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`the form of silicon dioxide embodied in Aerosil®: fumed silica." (Id. at 41). Second, Mylan
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`argues that extrinsic evidence provides that "colloidal silicon dioxide" means "fumed silica."
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`(Id. at 41-42).
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`As to Mylan's disavowal argument, Mylan points to both the '598 patent specification
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`and prosecution history. 1 First, the specification states, "Colloidal silicon dioxide may be
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`obtained commercially ... as Aerosil®." ('598 patent, 3:30-31). Aerosil® is a fumed silica
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`product. (D.I. 59 at 40) (citing D.I. 60-2, Exh. 20 at 3:56-59)). But this provision in the
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`specification merely provides that "fumed silica" is "colloidal silicon dioxide." It does not limit
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`"colloidal silicon dioxide" to "fumed silica." Second, during prosecution, the patentee
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`responded to the Examiner's rejection of the pending claims, stating the "problem" of poor
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`disintegration times for the manufactured composition "was solved by adding Aerosil (silicon
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`dioxide)." (D.I. 60-6, Exh. 56 at 7). The patentee also referred to Aerosil® as "Aerosil:
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`Colloidal silicon dioxide." (Id. at 9). However, "for prosecution disclaimer to attach ... the
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`alleged disavowing actions or statements made during prosecution must be both clear and
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`unmistakable." Omega Eng 'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). The
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`patentee's statements do not amount to "clear and unmistakable" disclaimer. The patentee's
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`statements can be interpreted to mean that colloidal silicon dioxide provides a benefit, and
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`Aerosil® is but one form of colloidal silicon dioxide. Accordingly, I do not find any disavowal
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`based on the intrinsic record.
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`As to Mylan's extrinsic evidence argument, Mylan points to definitions of "colloidal
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`silicon dioxide" from two references, which it deems "authoritative."2 (D.I. 59 at 41-42). First,
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`the United States Pharmacopoeia defines "Colloidal Silicon Dioxide" as "a submicroscopic
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`fumed silica prepared by the vapor-phase hydrolysis of a silicon compound." (D.I. 60-5, Exh. 44
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`at 2514). Similarly, the Handbook of Pharmaceutical Excipients defines "colloidal silicon
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`1 As Novartis notes, the words "fumed silica" appear nowhere in the intrinsic record. (D.1. 59 at 45). As
`Mylan notes, the intrinsic record never provides a definition for "colloidal silicon dioxide." (Id. at 40, 45).
`2 Mylan' s expert describes the United States Pharmacopoeia as "the leading resource in the formulations
`industry for Food and Drug Administration-enforceable standards for drugs." (D.I. 60-6, Exh. 58 at 13).
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`dioxide" as "Aerosil; Cab-O Sil; colloidal silica; fumed silica; light anhydrous silicic acid; silicic
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`anhydridic; silicon dioxide fumed; Wacker HDK." (D.I. 60-5, Exh. 46 at 143).
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`However, Novartis responds with other extrinsic evidence, which it cites in support of its
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`own construction. (D.I. 59 at 48-50). For example, a chapter in a booked entitled Adsorption on
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`New and Modified Inorganic Sorbents states, "There are numerous industrial products of
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`colloidal silicas in various forms," including fumed silica like "aerosil" and non-fumed silica like
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`"precipitated silicas," "silica sol," "silica hydrogels," and "porous silica." 3 (D.I. 60-2, Exh. 17 at
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`93-94). Merriam Webster 's Medical Desk Dictionary defines "silica gel," which is non-fumed,
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`as "colloidal silica." (D.I. 60-2, Exh. 12 at 654). Novartis cites numerous United States patents,
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`which refer to "colloidal silica" as including "Syloid 44," which is non-fumed. (D.I. 60-2, Exh.
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`22 at 6:17-18; D.I. 60-2, Exh. 23 at 8:24-25; D.I. 60-2, Exh. 24 at 8:49-50; D.I. 60-2, Exh. 25 at
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`6:14-15; D.I. 60-2, Exh. 26 at 5:52; D.I. 60-2, Exh. 27 at 15:43 ; D.I. 60-2, Exh. 28 at 6:17-18).
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`Novartis' s expert argues, "A POSA would have understood that each of' these products,
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`including silica gels, porous silica, and Syloid 44, "was a 'colloidal silica' or 'colloidal silicon
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`dioxide."' (D.I. 60-1 , Exh. 10 at 11-13).
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`Mylan does not disagree that these references are inconsistent with the definition from
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`the United States Pharmacopoeia, stating that the references use language that "confuses the
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`issue." (Tr. at 52:2-8). However, Mylan' s expert opines that the references cited by Novartis are
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`not "extrinsic sources that a person in the art would ordinarily review." (D.I. 60-6, Exh. 56 at
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`15).
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`I agree with Mylan that the United States Pharmacopoeia is an authoritative reference.
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`However, I also agree with Novartis' s expert that several other pieces of extrinsic evidence
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`3 The parties agree that "colloidal silica" is synonymous with "colloidal silicon dioxide." (D.I. 59 at 3 1,
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`33).
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`provide that "colloidal silicon dioxide" includes more products than just "fumed silica," and that
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`a skilled artisan would have relied on those pieces of extrinsic evidence. Accordingly, I find that
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`a skilled artisan would understand "colloidal silicon dioxide" to be broader than "fumed silica,"
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`based on the extrinsic evidence as a whole. I decline to adopt Mylan's proposed construction.
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`I also decline to adopt Novartis's additional proposed language, "silicon dioxide forming
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`small, insoluble nondiffusible particles that remain in suspension."4 As discussed at oral
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`argument, I find Novartis's proposed language to be non-scientific and unhelpful in illuminating
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`the meaning of"colloidal silicon dioxide." (Tr. at 46:21-47:12). Novartis agrees that the
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`language is not necessary. (D.I. 59 at 35).
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`Instead, I adopt a plain and ordinary meaning construction, and specify that "colloidal
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`silicon dioxide" and "colloidal silica" are synonyms. Colloidal silicon dioxide is not limited to
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`fumed silica.
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`IV.
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`CONCLUSION
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`Within five days the parties shall submit a proposed order consistent with this
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`Memorandum Opinion.
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`4 Mylan argues that adopting this language would "create indefiniteness." (D.I. 59 at 42). Because I
`decline to adopt the language, I need not evaluate Mylan ' s argument.
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