Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 1 of 10 PageID #: 5753
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
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`PURDUE PHARMA L.P., PURDUE
`PHARMACEUTICALS L.P., THE P.F.
`LABORATORIES, INC., and RHODES
`TECHNOLOGIES,
`
`Plaintiffs,
`
`v.
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`AMNEAL PHARMACEUTICALS, LLC,
`
`Defendant.
`
`Civil Action No. 17-210-RGA
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`MEMORANDUM OPINION
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`Jack B. Blumenfeld, Rodger D. Smith II, MORRIS, NICHOLS, ARSHT & TUNNELL LLP,
`Wilmington, DE; John J. Normile, Pablo D. Hendler (argued), Kelsey I. Nix, Gasper J. LaRosa,
`Kenneth S. Canfield, Sarah A. Geers, Lisamarie LoGiudice, JONES DAY, New York, NY;
`Jason G. Winchester, JONES DAY, Chicago, IL.
`
`Attorneys for Plaintiffs
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`Anne Shea Gaza, Samantha G. Wilson, YOUNG CONAWAY STARGATT & TAYLOR, LLP,
`Wilmington, DE; Michael V. Ciresi, Jan M. Conlin, Katie Crosby Lehman (argued), Melissa A.
`Goodman, CIRESI CONLIN LLP, Minneapolis, MN; Barbara L. Mullin, Matthew A. Pearson,
`Angela Verrecchia, Jonathan J. Underwood, AKIN GUMP STRAUSS HAUER & FELD LLP,
`Philadelphia, PA.
`
`Attorneys for Defendant
`
`May~,2018
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`

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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 2 of 10 PageID #: 5754
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`Presently before the Court is the issue of claim construction of multiple terms in U.S.
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`Patent Nos. 9,492,392 ("the '392 patent"), 9,492,393 ("the '393 patent"), and 9,522,919 ("the
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`'919 patent"). The Court has considered the parties' joint claim construction brief. (D.I. 48).
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`The Court heard oral argument on February 14, 2018. (D.I. 80 ("Tr.")).
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`I.
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`BACKGROUND
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`This suit arises from Defendant's filing an Abbreviated New Drug Application
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`("ANDA"). Plaintiffs filed suit on March 1, 2017, alleging that the generic product that is the
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`subject of the ANDA filing would infringe a number of Plaintiffs' patents. (D.I. 1). The patents-
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`in-suit relate to OxyContin®, an extended-release pain medication. They are from two of the
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`same patent families asserted by Plaintiffs in an earlier related action, in which I issued a
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`Markman opinion. (No. 15-1152, D.I. 120). More specifically, the '392 and '393 patents are
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`related to and have the same specification as U.S. Patent Nos. 8,808,741 ("the '741 patent"),
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`8,894,987 ("the '987 patent), and 8,894,988 ("the '988 patent"). (D.I. 48 at 9). The '919 patent
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`is related to and has the same specification as U.S. Patent No. 9,073,933 ("the '933 patent").
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`(Id).
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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. AWHCorp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en bane). '"[T]here is no magic formula or catechism for conducting claim
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`construction.' Instead, the court is free to attach the appropriate weight to appropriate sources
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`'in light of the statutes and policies that inform patent law.'" SoftView LLC v. Apple Inc., 2013
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`WL 4758195, at* 1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324) (alteration in
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 3 of 10 PageID #: 5755
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`original). When construing patent claims, a court considers the literal language of the claim, the
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`patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52
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`F.3d 967, 979-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these sources, "the
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`specification is always highly relevant to the claim construction analysis. Usually, it is
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`dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at
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`1315.
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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. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan
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`after reading the entire patent." Id at 1321. "In some cases, the ordinary meaning of claim
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`language as understood by a person of skill in the art may be readily apparent even to lay judges,
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`and claim construction in such cases involves little more than the application of the widely
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`accepted 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 Pharms. 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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`2
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 4 of 10 PageID #: 5756
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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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`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 GMBHv. Int'! Trade
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`Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation omitted).
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`III.
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`PA TENTS-IN-SUIT
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`The '392 and '393 patents relate to a tamper resistant dosage form of OxyContin®.
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`Claim 1 of the '392 patent is representative and reads as follows:
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`1. A cured shaped pharmaceutical tablet comprising:
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`( 1) at least a first compression shaped and then air cured matrix, wherein
`said curing is without compression, by heated air having a temperature of
`at least about 62° C. for a duration of at least about 5 minutes, said matrix
`comprising oxycodone or a pharmaceutically acceptable salt thereof in
`combination with at least one high molecular weight polyethylene oxide
`having, based on rheological measurements, an approximate molecular
`weight selected from the group consisting of 4,000,000, 7,000,000, and a
`combination thereof, and optionally further comprising at least one low
`molecular weight polyethylene oxide having, based on rheological
`measurements, an approximate molecular weight of less than 1,000,000;
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`(2) optionally a second air cured matrix comprising oxycodone or a
`pharmaceutically acceptable salt thereof in combination with at least one
`low molecular weight polyethylene oxide having, based on rheological
`measurements, an approximate molecular weight of less than 1,000,000;
`and
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`(3) optionally a coating,
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`wherein, in said tablet:
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`(i) said oxycodone or pharmaceutically acceptable salt thereof is provided
`in a dose selected from the group consisting of 10 mg, 15 mg, 20 mg, and
`30mg;
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`the total combined weight of said low molecular weight polyethylene
`oxide, if present, and said high molecular weight polyethylene oxide is at
`least 79% by weight of the total weight of said tablet, excluding the weight
`of any coatings; and
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`3
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 5 of 10 PageID #: 5757
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`said low molecular weight polyethylene oxide, if present, is at least 10%
`by weight of the total weight of said tablet, excluding the weight of any
`coatings; or
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`(ii) said oxycodone or pharmaceutically acceptable salt thereof is provided
`in a dose selected from the group consisting of 40 mg, 60 mg, and 80 mg;
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`the total combined weight of said low molecular weight polyethylene
`oxide, if present, and said high molecular weight polyethylene oxide is at
`least 65% by weight of the total weight of said tablet, excluding the weight
`of any coatings; and
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`said low molecular weight polyethylene oxide, if present, is at least 10%
`by weight of the total weight of said tablet, excluding the weight of any
`coatings; and
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`said tablet provides a dosage form for twice-daily extended release
`administration of oxycodone or pharmaceutically acceptable salt thereof.
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`('392 patent, claim 1) (disputed terms italicized).
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`The '919 patent relates to a process for preparing an oxycodone hydrochloride
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`composition. The sole disputed term in the '919 patent appears in claims 3 and 17, which
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`depend from claims 1 and 12, respectively. Claims 1 and 3 read:
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`1. An oxycodone HCl composition comprising oxycodone HCl and 8a,14-dihydroxy-7,8-
`dihydrocodeinone, wherein the ratio of 8a, 14-dihydroxy-7 ,8-dihydrocodeinone to
`oxycodone HCl is 0.04% or less as measured by HPLC.
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`(' 919 patent, claim 1).
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`3. The oxycodone HCl composition of claim 1, wherein at least 1 kg of the oxycodone
`HCl is prepared.
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`(Id. at claim 3) (disputed term italicized).
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`IV.
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`CONSTRUCTION OF DISPUTED TERMS
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`1. "at least one high molecular weight polyethylene oxide having, based on
`rheological measurements, an approximate molecular weight selected from
`the group consisting of 4,000,000, 7,000,000, and a combination thereof'
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`a. Plaintiffs' proposed construction: "one or a combination of polyethylene
`oxides having an overall weight average molecular weight of
`approximately 4,000,000 daltons, 7,000,000 daltons, or a combination
`thereof based on rheological measurements"
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 6 of 10 PageID #: 5758
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`b. Defendant's proposed construction: "one or more high molecular weight
`polyethylene oxide supplied in a grade having an approximate molecular
`weight of 4,000,000 daltons, 7,000,000 daltons, or a combination of
`4,000,000 and 7 ,000,000 daltons based on rheological measurements"
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`c. Court's construction: "one or a combination of polyethylene oxides
`having an overall weight average molecular weight of approximately
`4,000,000 daltons, 7,000,000 daltons, or a combination thereof based on
`rheological measurements"
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`This term appears in claim 1 of the '392 and '393 patents.
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`The parties' dispute in regard to this term is twofold.
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`First, the parties seem to dispute whether, as Plaintiffs argue, the polyethylene oxide
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`("PEO") component of the "at least one high molecular weight polyethylene oxide" can include
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`more than one PEO, or whether, as Defendant maintains, the term is limited to a single grade of
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`PEO.
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`In support of their proposed construction, Plaintiffs submit that, "when either (or both) of
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`the ... PEO ingredients is a single grade, the molecular weight of that grade is in reality an
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`overall average of the molecular weights of different PEO molecules." (D.I. 48 at 27). Plaintiffs
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`further point to the claim construction hearing in the related civil action, No. 15-1152, during
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`which Plaintiffs "demonstrated" that a 4,000,000 PEO can be made by combining different PEOs
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`or different grades. (Id.). Contrary to Defendant's assertions, contend Plaintiffs, nothing in the
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`intrinsic record supports the requirement that a PEO component be limited to specific grades.
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`(Id at 29).
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`In response, Defendant acknowledges, and notes its disagreement with, my prior finding
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`in the 15-1152 action that, "at least one polyethylene oxide" in claim 1 of the related '987 patent,
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`which has the same specification as the '392 and '393 patents, is not limited to a single
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`commercial product grade. (See id at 33 n.11). Further, at oral argument, Defendant preserved
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 7 of 10 PageID #: 5759
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`its objection to my prior construction, in light of its understanding that I would adopt that
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`construction again. (See Tr. at 13:23-14:2).
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`I agree with Plaintiffs. Like the claims at issue in the 15-1152 action, the claims here in
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`which the disputed term appears are not so narrowly drawn that they limit the PEO components
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`to a single grade. I think the "at least one high molecular weight" PEO from claim 1 of the '392
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`and '393 patents is a PEO component that, whether it is a single grade or a blend of different
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`grades, meets the specifications' definitions of PEO with "an approximate molecular weight" of
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`4,000,000 or 7,000,000. (See '392 patent, 8:26-31, 36-41; '393 patent, 8:28-33, 38-43).
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`Second, the parties dispute whether the recited molecular weight is an "overall weight
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`average molecular weight." To support their position that "molecular weight" refers to "weight
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`average molecular weight," Plaintiffs again point to my Markman opinion in the 15-1152 action.
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`(See D.I. 48 at 29). Plaintiffs also point to information related to Dow POL YOX™ PEOs and a
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`patent application cited by the examiner during prosecution of the '988 and '741 patents, two
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`related patents with the same specification. (Id. at 9, 30-31 ).
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`Defendant responds by arguing that Plaintiffs' proposed "overall weight average"
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`language ignores my prior construction in the 15-1152 action. (Id. at 32-33, 36-40). More
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`specifically, Defendant maintains that Plaintiffs' attempt to add a weight average formula into
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`the construction for this term "renders the Court's rheological measurement requirement in the
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`claim construction moot." (Id. at 33). Instead, the rheology test should control, and the "overall
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`weight average molecular weight" language should be rejected. (Id. at 34). Further, according
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`to Defendant, Plaintiffs' proposal violates the Markush drafting requirement. (Id. at 36). More
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`specifically, Defendant contends that Plaintiffs' "construction adds uncertainty, ambiguity, and
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 8 of 10 PageID #: 5760
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`unnamed elements" into the claims. (Id.). Under Plaintiffs' proposal, maintains Defendant,
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`"unnamed PEO grades may be used even though not listed in the claim." (Id. at 39).
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`I am not persuaded by Defendant's arguments.
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`My claim construction in the 15-1152 action referred to "overall weight average
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`molecular weight" and "rheological measurements." Thus, I do not see how including "overall
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`weight average molecular weight" in this construction would conflict with my prior ruling.
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`Further, I do not think, as Defendant contends, that including "overall weight average molecular
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`weight" "avoid[s] the inventor's express rheological test." (Id. at 39). The construction I
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`previously adopted and Plaintiffs' proposal here both require a PEO or combination of PEOs
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`having an "overall weight average molecular weight ... based on rheological measurements." In
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`any event, it seems to me that, as I stated in the 15-1152 action, the intrinsic evidence indicates
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`that the inventors were referring to weight average molecular weight. (See No. 15-1152, DJ.
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`120 at 9).
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`Finally, I find Defendant's argument in regard to Markush drafting requirements
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`unconvincing. As an initial matter, I note that my Markman opinion in the 15-1152 action did
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`not involve Markush claims. Here, on the other hand, the disputed claims are written in Markush
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`form. They denote a Markush group by listing three alternatives for the "at least one high
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`molecular weight" PEO component--4,000,000, 7,000,000, and a combination thereof. See
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`Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1357 (Fed.
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`Cir. 2016) ("Markush claims create a customized 'Markush group' ... [which] lists specified
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`alternatives in a patent claim, typically in the form: a member selected from the group consisting
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`of A, B, and C."). The claims use the transitional phrase, "consisting of," indicating that the
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`group is "closed." See id. at 1358 ("Use of the transitional phrase 'consisting of to set off a
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 9 of 10 PageID #: 5761
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`patent claim element creates a very strong presumption that that claim element is 'closed' and
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`therefore 'exclude[s] any elements, steps, or ingredients not specified in the claim.'" (alteration
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`in original)).
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`I do not agree with Defendant that Plaintiffs' proposed "overall weight average molecular
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`weight" language violates Markush drafting requirements by adding unnamed elements into the
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`claims. The Markush group lists alternatives for the "approximate molecular weight[s]" of the
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`PEO component. They are 4,000,000, 7,000,000, and a combination thereof. The Markush
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`group does not appear to relate to how the molecular weight is calculated nor does it appear to
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`limit the PEO component to a single grade of PEO. Thus, I do not see how including Plaintiffs'
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`proposed language would conflict with the closed nature of the Markush group in the claims.
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`For the reasons stated above, I will construe this term to mean, "one or a combination of
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`polyethylene oxides having an overall weight average molecular weight of approximately
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`4,000,000 daltons, 7 ,000,000 daltons, or a combination thereof based on rheological
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`measurements."
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`2. "at least one low molecular weight polyethylene oxide having, based on
`rheological measurements, an approximate molecular weight of less than
`1,000,000"
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`a. Plaintiffs' proposed construction: "one or a combination of polyethylene
`oxides having an overall weight average molecular weight of less than
`approximately 1,000,000 daltons based on rheological measurements"
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`b. Defendant's proposed construction: "one or more low molecular weight
`polyethylene oxides supplied in a grade having an approximate molecular
`weight of less than 1,000,000 daltons based on rheological measurements"
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`c. Court's construction: "one or a combination of polyethylene oxides
`having an overall weight average molecular weight of less than
`approximately 1,000,000 daltons based on rheological measurements"
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`This term appears in claim 1 of the '392 and '393 patents.
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`Case 1:17-cv-00210-RGA Document 97 Filed 05/21/18 Page 10 of 10 PageID #: 5762
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`The parties' dispute in regard to this term is essentially the same as the previous term.
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`For the reasons stated above, I will adopt Plaintiffs' proposed construction.
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`3. "at least 1 kg of the oxycodone HCl is prepared"
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`This term appears in dependent claims 3 and 17 in the '919 patent. Those claims are no
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`longer a part of the case. (See Tr. at 30: 14-18, 31: 11-20). Accordingly, there is no reason for
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`the Court to construe this term.
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`V.
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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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