Case 1:12-cv-00654-GMS-MPT Document 77 Filed 05/07/13 Page 1 of 4 PageID #: 551

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

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PFIZER INC., WYETH LLC, and WYETH PHARMACEUTICALS INC., Plaintiffs, v. SANDOZ INC., Defendant.

Civil Action No. 12-654-GMS-MPT

ORDER CONSTRUING THE TERMS OF U.S. PATENT NO. 8,026,276

After having considered the submissions of the parties and hearing oral argument on the
1 matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted

claims of U.S. Patent No. 8,026,276 (the "'276 Patent"): 1. The term "CCI-779" is construed to mean "the compound corresponding to the

structure depicted in Exhibit A to the March 15, 2011 Declaration Under 37 C.F.R. 1.132, also known as rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2methylpropionic acid, and also known as temsirolimus."2

The transcript of the April 4, 2013 Markman hearing has not yet been entered on the docket for Civil Action No. 12-654-GMS-MPT. It is, however, available as D.l. 92 in Civil Action No. 11-1252-GMS-MPT. In referencing the transcript in this Order, the court will use the abbreviation "Tr." The parties sharply dispute the meaning of this claim term. The plaintiffs urge the court to adopt the following three-part construction: "CCI-779 means rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2methylpropionic acid, also known as rapamycin 42-ester with 2,2-bis(hydroxymethyl) propionic acid, and also known as temsirolimus." (D.I. 52 at 4.) Sandoz Inc. ("Sandoz"), on the other hand, acknowledges that CCI-779 has the structure set forth on page 3 of Exhibit A to the March 15, 2011 Declaration Under 37 C.F.R. 1.132 but resists assigning the compound any of the names offered by the plaintiffs. (D.l. 53 at 5.) The court first considers the structure offered by Sandoz. During the prosecution of the '276 Patent, the applicants submitted a declaration and attached a prior declaration made by one of the joint inventors, Dr. Joseph T. Rubino. (D.l. 60 at Tab 4, Ex. A.) In that earlier declaration, Dr. Rubino noted that "CCI-779 is a macrocylic ester" and then identified it using the structure now offered by Sandoz. (!d.) In light of this intrinsic evidence and the
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2.

The term "w/v," as used in Claim 20, refers to the mass of the constituent divided

by the volume of the respective mixture as made clear by the context of the claim, with w/v being measured in terms of g/mL. 3

parties' agreement that this molecular structure represents CCI-779, (Tr. at 93, 100-01), the court incorporates it into its construction here. The plaintiffs, however, seek to expand that construction to include three alternative names for CCI-779. In Sandoz's view, such a construction would be improper as two of the three alternatives "are not mentioned anywhere in the specification or claims of the patent," (D.I. 53 at 5-6), and, while the term "rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2-methylpropionic acid" is found in the specification, using it to construe CCI-779 would leave that construction "vague, ambiguous, and subject to multiple interpretations," (!d. at 6). On the latter point, Sandoz argues that a construction of "rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2methylpropionic acid" would be "circular" and "tautolog[ical]," as that phrase "wouldn't have an independent meaning to one of ordinary skill in the art." (Tr. at 103.) The court first notes that, whether "circular" or not, construing CCI-779 as "rapamycin 42-ester with 3hydroxy-2-(hydroxymethyl)-2-methylpropionic acid" is proper in light of the express definitions provided in the specification. '276 Patent at 1:14-16, 1:50-55; see also Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009) ("When a patentee explicitly defines a claim term in the patent specification, the patentee's definition controls.") Moreover, since the court's construction already incorporates the structure agreed upon by the parties, there will be no harm if Sandoz is correct and the term "rapamycin 42-ester with 3-hydroxy-2(hydroxymethyl)-2-methylpropionic acid" fails to independently "advance the ball." (Tr. at 103.) Additionally, while the term "temsirolimus" may not appear in the '276 Patent, it is found in the intrinsic evidence. The Rubino declaration explicitly identifies CCI-779 and the structure offered by Sandoz as temsirolimus. (D.I. 60 at Tab 4, Ex. A.) Given this definition, the court finds no reason to omit the term from its construction. The court, however, will not include the remaining alternative name offered by the plaintiffs, "rapamycin 42-ester with 2,2-bis(hydroxymethyl) propionic acid." (D.I. 52 at 4.) While the '276 Patent specification does state that "[t]he preparation of and use of hydroxyesters of rapamycin, including CCI-779, are disclosed in U.S. Pat. No. 5,362,718," '276 Patent at 1:53-55, and U.S. Patent No. 5,362,718 (the "'718 Patent") does provide an example titled "Rapamycin 42-ester with 2,2-bis(hydroxymethyl) propionic acid," '718 Patent at 13:3-4, there is nothing in the '276 Patent to indicate that it is this particular example that discloses CCI-779. The court adopts the plaintiffs' proposed construction for this term. The parties' dispute centers on whether the volume denominator refers to the volume of the entire parenteral composition recited in Claim 20 or the volume of the mixtures-the concentrate and the diluent-that are listed in subsections (i) and (ii) of the claim. The court agrees with the plaintiffs that the proper volume is "the volume of the respective mixture as made clear by the context of the claim." (D.I. 70 at 4.) While Sandoz advances a plausible claim differentiation argument in support of its position, (Tr. At 115-16.), the court is also cognizant of its responsibility to avoid, whenever possible, a claim construction that produces a nonsensical result, see AlA Eng'g Ltd., v. Magotteaux Int'l SIA, 657 F.3d 1264, 1276 (Fed. Cir. 2011); Bd. of Regents of the Univ. of Tex. Sys. v. BENQ Am. Corp., 533 F.3d 1362, 1370 (Fed. Cir. 2008). Here, the court believes Sandoz's proposed construction would fall into that very trap. Claim 20 recites: "A parenteral composition comprising: (i) about 2.5% w/v of CCI-779, about 0.075% w/v of d, 1-a-tocopherol, about 0.0025% w/v of citric acid, about 40% w/v of dehydrated ethanol, and about 50% w/v of propylene glycol, and (ii) about 40% w/v of polysorbate 80, about 20% w/v of dehydrated ethanol, and about 43% w/v of polyethylene glycol400." '276 Patent at 10:4-11. If the court were to follow Sandoz's suggestion and treat the volume denominator as the volume of the entire composition, it would lead to an absurd reading of Claim 20 providing two separate
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3.

The term "w/v of citric acid," as used in Claim 20, refers to the mass of the citric

acid divided by the volume of the respective mixture as made clear by the context of the claim, with w/v being measured in terms of g/mL. 4 4. The term "parenteral composition" is construed to mean "a composition suitable

for immediate administration by either direct injection or by addition to sterile infusion fluids for intravenous infusion." 5

measurements for "dehydrated ethanol" over the same volume. As the plaintiffs noted at oral argument, such a construction would leave this claim "redundant and incomprehensible." (Tr. at 113.) The court also notes that Examples 2 and 8 of the '276 Patent disclose, respectively, cosolvent concentrate and diluent formulas corresponding with subsections (i) and (ii) of Claim 20. '276 Patent at 5:25-42, 7:5-24. This further recommends the plaintiffs' proposed construction. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) ("[C]laims 'must be read in view of the specification, of which they are a part.' ... [T]he 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 term."' (internal citations omitted)). Given this intrinsic evidence and the nonsensical result that would result from Sandoz's interpretation, the court adopts the plaintiffs' construction for this term. The parties' dispute as to this particular term is an offshoot of their disagreement regarding the meaning of"w/v." The court does not understand any additional construction to be necessary. The court largely adopts Sandoz's proposed construction for this term. The plaintiffs argue that "parenteral composition" should be construed as referring to "to a mixture, or more than one mixture combined or to be combined, to be administered parenterally." (D.I. 70 at 6.) In support of this position, they note that "the claims of the ['276 Patent] contemplate parenteral compositions where the parenteral composition exists as two separate mixtures," (Tr. at 130), and offer Claim 1 as an example. Claim 1 provides for "[a] parenteral composition comprising: (i) a first mixture ... and (ii) a second mixture .... " '276 Patent at 7:50-60. The court, however, notes that, while the plain language of the claim makes clear that two mixtures are included in the ultimate composition, there is no indication from the claim language as to when or how that composition is generated. Taken alone, the claim language fails to tell the reader whether a composition is created merely by placing two vials next to each other on a table or whether the mixtures must actually be physically combined first. Put differently, the court cannot accept the plaintiffs' position that the claims themselves "contemplate parenteral compositions where the parenteral composition exists as two separate mixtures"-they may simply contemplate compositions that include two mixtures. Fortunately, the specification does provide some evidence as to the proper understanding of this claim term. As Sandoz notes, "the Summary of the Invention" states that when separate 'concentrate' and 'diluent' solutions are made, preparing a 'parenteral formulation' requires 'mixing the cosolvent concentrate with the diluent."' (D.I. 53 at 19 (citing '276 Patent at 2:53-59).) The Detailed Description of the Invention also provides that, when the parenteral formulation is prepared from a concentrate and diluent, they are required to be mixed. '276 Patent at 4:26-48. The court reads these statements as suggesting that the parenteral composition must ultimately be a single composition. See Phillips, 415 F.3d at 1315. The plaintiffs, however, also claim to find support for their position in the specification language. In particular, they emphasize the very statement at column 4 also cited by the court and Sandoz:
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5. 6. 7.

The term "preparing" is construed to have its plain and ordinary meaning. 6 The term "combining" is construed to have its plain and ordinary meaning. 7 The court does not construe the term "ratio" at this time. 8

Dated: May

.L, 2013

The parenteral formulation can be prepared as a single solution or preferably can be prepared as a cosolvent containing CCI-779, an alcoholic solvent, and an antioxidant, which is subsequently combined with a diluent solvent and a surfactant. '276 Patent at 4:26-30. In the plaintiffs' view, this is an explicit assertion that "the parenteral composition can exist as two mixtures that can be combined." (Tr. at 130.) Again, however, the court must disagree with the plaintiffs' reading-this specification statement is most naturally read as indicating that the parenteral composition takes form when the "cosolvent ... is subsequently combined with a diluent solvent and a surfactant." As such, Sandoz's proposed construction would not exclude this preferred embodiment. The court, however, does agree with the plaintiffs in rejecting the part of Sandoz's construction that would require the parenteral composition to be administered "in a manner other than through the digestive tract, e.g., intravenous or intramuscular injection." (D.I. 59 at 17.) The plaintiffs contend that administration must occur via either direct injection or intravenous infusion, (id.), and cite to a specification statement providing that "[t]he parenteral formulations of this invention can be used to produce a dosage form that is suitable for administration by either direct injection or by addition to sterile infusion fluids for intravenous infusion," '276 Patent at 4:54-57. While the court recognizes that its "claim construction must not import limitations from the specification into the claims," Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1354 (Fed. Cir. 2012), it views this particular statement as an indication of the very scope of the invention rather than a mere description of two preferred embodiments, see Honeywell Int'l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006). The court finds that this term should be given its plain and ordinary meaning. "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 construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Phillips, 415 F.3d at 1314 (internal citations omitted). Moreover, Sandoz's attempt to "clarify" this ordinary meaning in support of its proposed construction of "parenteral composition," (Tr. at 136) is unnecessary in light of the court's above construction of that term. Likewise, the court believes the ordinary meaning of "combining," as understood by one of skill in the art, is apparent even to a lay audience and thus assigns this term its plain and ordinary meaning. See Phillips, 415 F.3d at 1314. During the Markman hearing, the court agreed to hear extrinsic evidence, including expert testimony, on the meaning of this claim term at trial. (Tr. at 127-28.)
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