Case 1:11-cv-01077-RGA Document 250 Filed 06/21/13 Page 1 of 3 PageID #: 2975
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`NOV ARTIS PHARMACEUTICALS
`CORP., et al.,
`Plaintiffs,
`
`V.
`
`Civil Action No. 11-1077-RGA
`
`WATSON LABORATORIES, INC.,
`et al.,
`
`Defendants.
`
`ORDER
`
`The Court having considered the Parties' Joint Claim Construction Brief (D.I. 224) and
`
`appendix (D.I. 225), Plaintiffs' additional submission (D.I. 240), and oral argument on June 13,
`
`2013 (D.I. 244), IT IS HEREBY ORDERED that the terms below, as used in U.S. Patent Nos.
`
`6,335,031 and 6,316,023 1 are construed as follows:
`
`A "antioxidant"
`
`The term "antioxidant" is construed to mean "agent that reduces oxidative degradation."
`
`Over the course ofbriefing and oral argument, the parties' substantive disputes over the
`
`construction of this term narrowed to whether the antioxidant must reduce oxidative degradation
`
`"of Compound A," as Defendants propose. Defendants point to disclosure in the specifications
`
`and prosecution histories that Compound A is problematically susceptible to degradation, and to
`
`the disclosed solution of pairing it with an antioxidant. E.g., '031 Patent, col.lll.22-24, 29-33;
`
`D.I. 225-1 at 20.
`
`Plaintiffs characterize these disclosures as providing three classes of embodiments: a)
`
`1 The patents share the same specification, and claim terms are construed consistently
`between them.
`
`NOVARTIS EXHIBIT 2003
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 1 of 3
`
`

`
`Case 1:11-cv-01077-RGA Document 250 Filed 06/21/13 Page 2 of 3 PageID #: 2976
`
`compositions containing Compound A and an antioxidant, b) transdermal devices containing
`
`Compound A and an antioxidant, and c) a method of using an antioxidant to stabilize Compound
`
`A. Plaintiffs note that the disclosures for the compositions and the transdermal devices disclose
`
`the presence of the antioxidant, without specifically referring to any reduction in the degradation
`
`of Compound A. See '031 Patent, Abst.; col.111.34-36; col.3 1.61 - col.41.4; col.411.5-7; col.7
`
`1.55 - col.8 1.1 0. The claims for a method for stabilizing Compound A require the antioxidant be
`
`present in an amount effective to stabilize Compound A, whereas the claims for the composition
`
`and some of the claims for the transdermal device do not explicitly limit the antioxidant's
`
`amount or effect. Compare '031 Patent, col.9 11.10-15 (claim 15) and col.8 11.59-67 (claim 11)
`
`with col.811.14-21 (claim 1) and col.811.49-51 (claim 7).
`
`The patents repeatedly disclose the combination of Compound A and the antioxidant
`
`without specifically requiring that the antioxidant affect Compound A. '031 Patent, Abst.; col. I
`
`11.34-36; col.3 1.61 - col.4 1.4; col.4 11.5-7; col. 7 1.55 - col.8 1.1 0. It would be improper to
`
`preclude those embodiments by limiting "antioxidant" to require that interaction. It is also
`
`improper to impute the antioxidant's stabilizing effect on Compound A, explicitly claimed in
`
`some claims, into claims that do not contain that explicit limitation. See Phillips v. A WH Corp.,
`
`415 F.3d 1303, 1314-15 (Fed. Cir. 2005)(en bane). The flip side ofthat coin is that it is also
`
`improper to construe "antioxidant" to require that it reduce degradation of Compound A, and
`
`therefore render superfluous or redundant the explicit limitation in some claims that the
`
`antioxidant stabilize Compound A.
`
`B. "an amount of antioxidant effective to stabilize Compound A from degradation"
`
`The term "an amount of antioxidant effective to stabilize Compound A from degradation"
`
`2
`
`NOVARTIS EXHIBIT 2003
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 2 of 3
`
`

`
`Case 1:11-cv-01077-RGA Document 250 Filed 06/21/13 Page 3 of 3 PageID #: 2977
`
`is construed to mean "an amount of antioxidant that will significantly reduce degradation of
`
`Compound A over a prolonged period of time." Claim language of an "effective amount" has a
`
`customary usage: the amount that will achieve the claimed effect. Abbott Labs v. Baxter Pharm.
`
`Prods., Inc., 334 F.3d 1274, 1277-78 (Fed. Cir. 2003). The patentee here did not deviate from
`
`that customary usage.
`
`Of the remaining term language, only "stabilize" requires construction. The specification
`
`provides that "stable pharmaceutical compositions comprising compound A can now be
`
`obtained, which show insignificant degradation of compound A over a prolonged time period,
`
`e.g. 2 years, as indicated by standard tests, e.g. stress tests." '031 Patent, col.l 11.29-33 (emphasis
`
`added). While the "can" language is permissive, such that the pharmaceutical compositions
`
`comprising compound A need not always be stable, the language "show insignificant degradation
`
`of compound A over a prolonged time period, e.g. 2 years, as indicated by standard tests, e.g.
`
`stress tests" indicates what the patentee meant by "stable." The patentee went on to describe "an
`
`effective stabilizing effect" in terms of a reduction of degradation products in two and three
`
`month stress tests. Id. col.4 11.11-30. Examples 1-3 describe "insignificant degradation" after
`
`storage for certain periods. !d. col. 7 11.16-51. This disclosure indicates that "stabilizing" means
`
`"significantly reducing degradation over a prolonged period of time."
`
`C. "stabilizing"
`
`The term "stabilizing" means "significantly reducing degradation over a prolonged
`
`period of time."
`
`s+
`
`Entered thisdJ: day of June, 2013.
`
`3
`
`NOVARTIS EXHIBIT 2003
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 3 of 3