Case 1:12-cv-00367-GMS Document 59 Filed 05/20/13 Page 1 of 4 PagelD #: 1522
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`W)
`Plaintiff,
`i
`v.
`i
`3
`i
`
`HOSPIRA, INC.,
`Defendant.
`
`___—)
`
`Civil Action No. 12-cv-367 (GMS)
`
`ORDER CONSTRUING THE TERMS OF US. PATENT NOS. 6,468,967; 8,852,689;
`8,129,342; and RE 39,071
`
`After having considered the submissions of the parties and hearing oral argument on the
`
`matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted
`
`claims of US. Patent Nos. 6,468,967 (“the ’967 Patent”), 8,852,689 (“the ’689 Patent”), 8,058,238
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`(“the ’238 Patent”), 8,129,342 (“the ’342 Patent”), and RE 39,071 (“RE ’071”) (collectively, “the
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`patents-in-suit”):
`
`The ’967 ’689 ’238 and ’342 Patents
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`1. The term “daptomycin” is construed to mean “the cyclic lipopeptide antibiotic derived
`
`from the fermentation of Streptomyces roseosporus, comprised of a decanoyl side chain
`
`linked to the N-terminal tryptophan of a cyclic 13-amino acid peptide, i.e.,
`
`CUBIST 2206
`AGILA v. CUBIST
`IPR2015-00143
`
`
`
`CUBIST 2206
`AGILA v. CUBIST
`IPR2015-00143
`
`

`

`Case 1:12-cv-00367-GMS Document 59 Filed 05/20/13 Page 2 of 4 PagelD #: 1523
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`(LY 146032) or a pharmaceutically acceptable salt thereof.”1
`
`‘ The court rejects the defendant’s proposed construction of this term, which the parties agrees should be
`construed the same for each of the patents-in-suit. The defendant’s proposed construction, “the compound described
`in the Baltz article at Fig. 1a (Biotechnology of Antibiotics, 2'Id Ed., ed. By Strohl, 415-435 (1997) and in the Tally
`article at Fig.
`1 (Exp. Opin. Invest. Drugs, 811223-1238 (1999)), (i.e., having the L-Asn configuration),” seeks to
`define daptomycin by the stereochemistry of the thirteen amino acids that comprise the compound. (D.I. 39 at 6; Bl.
`37 at 15-17.) Specifically, the defendant asserts that the stereochemistry of these amino acids should be construed as
`described in the prior art referenced in the patents and as depicted in a diagram illustrating the L-Asn and D-Asn
`structure of the claimed molecule. (D.I. 27 at 15-16.) Thus, the defendant contends that these amino acids should be
`defined by what was known of their stereochemistry at the time of the invention, despite the fact that scientists have
`since discovered, using new technology, that the stereochemistry of one of the thirteen amino acids was incorrect.
`The court finds the defendant’s proposed construction to be inconsistent with the claim language, the specification,
`and the intrinsic record for the reasons that follow.
`
`First, and as the plaintiff correctly highlights, neither the claim language nor the patent specification identifies
`the stereochemistry of daptomycin’s amino acids. Rather, the specification refers to daptomycin as the natural product
`obtained from fermentation of Streptomyces roseosporus, which is the fermentation of bacteria. See ’967 Patent at
`col. 1:42-47; ’238 Patent at col. 1:60-63; D.I. 39 at 5-6. Thus, while the defendant seeks to define daptomycin based
`exclusively on a diagram depicting stereochemical orientation, including the incorrect stereochemistry for one of the
`amino acids, the plaintiff’s proposed construction identifies daptomycin as a fermentation product with antibiotic
`activity and shows the thirteen amino acids that comprise daptomycin as they are presented in the high purity patents,
`without the specific stereochemical orientation of each.
`(D.I. 39 at 6.) The court finds this latter construction
`appropriate because it is consistent with the intrinsic record. As noted, at the time daptomycin was first discovered in
`the 1980s, scientists thought, based on scientific methods available at the time, that the asparagine amino acid was
`oriented in the “L” configuration.
`(Id. at 7.) Subsequently, in the early 20005, scientists using modern techniques
`were able to discover that daptomycin’s asparagine is, in fact, oriented in the “D” configuration. The defendants’
`attempt to construe daptomycin as defined by its stereochemistry—and the wrong stereochemistry for the asparagine
`amino acid~—when the claim language and specification does not do so, is inappropriate. See Phillips v. A WH Corp,
`415 F.3d 1303, 1313-14 (Fed. Cir. 2005) (“[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.”’ (citation omitted)).
`Second, the claims, specifications, and file histories of the relevant dosing patents make clear that daptomycin
`is a fermentation product with antibiotic properties. Specifically, all of the asserted claims of the dosing patents use
`the term daptomycin to refer to a clinical product that is “therapeutically effective” and is to be “administer[ed] to a
`human patient.” See, e.g., ’967 Patent at col. 14:50-56, Claim 1. The dosing patents’ claims do not recite the chemical
`structure of daptomycin or its stereochemistry, such that a person of ordinary skill in the art reading the claims would
`understand that daptomycin refers to the highly potent antibacterial Streptomyces roseosporus fermentation product,
`because that fermentation product was the therapeutically active antibiotic developed for clinical use.
`Instead, the
`patent specifications consistently state that daptomycin: is a fermentation product antibiotic; has a highly potent
`antibiotic that has been demonstrated to have clinical efficacy in pre-clinical and clinical studies conducted prior to
`
`2
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`
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`

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`Case 1:12-cv-00367-GMS Document 59 Filed 05/20/13 Page 3 of 4 PagelD #: 1524
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`The RE ’071 Patent
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`2. The term “Formula 3 compound” is construed to mean “an A21978C cyclic peptide
`
`of Formula 3
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`the discovery of the claimed dosing methods; and, as shown through the examples and embodiments, is therapeutically
`effective, such that “[d]aptomycin may be administered .
`.
`. until the bacterial infection is eradicated or reduced.” See,
`e.g., ’967 Patent at col. 1:42-47; id. at col. 1:63-67; id at col. 2:31-33; id. at col. 6:19-30. Therefore, the court finds
`that the defendant’s proposed construction is incorrect because this construction, which includes the flawed
`stereochemistry for the asparagine amino acid,
`is not a compound that has ever been shown to result from
`Streptomyces roseosporus fermentation and does not have antibiotic properties.
`Finally, the court concludes that the defendant’s proposed construction would, by focusing exclusively on
`stereochemistry, inappropriately exclude the preferred embodiments of the dosing patents. See Vitronics Corp. v.
`Conceptronic, Inc, 90 F.3d 1576, 1583 (Fed. Cir. 1996) (noting that a construction that excludes the preferred
`embodiment “is rarely, if ever, correct”). The sole support for the defendant’s proposed construction appears in
`figures that are not presented in the dosing patents and,
`instead, come from two articles cited in the patents’
`specifications: Baltz, BIOTECHNOLOGY OF ANTIBIOTICS, 415-35 (Strohl, 2nd ed. 1997) and Francis P. Tally et al.,
`Daptomycin: A Novel Agent for Gram-Positive Infections, 8 EXP. OPIN. INVST. DRUGS, 1223-1238 (1999). To this
`end, a person of ordinary skill in the art reading the dosing patents would not understand the claim term daptomycin
`to be limited by the figures in those articles depicting stereochemistry, particularly when doing so would exclude the
`detailed discussions of daptomycin’s properties in the specifications themselves. See id.; see also Phillips, 415 F.3d
`at 1313-14.
`Indeed, even the Baltz and Tally articles, read as a whole, describe daptomycin as a “highly active”
`“potent antibiotic” produced by fermentation of Streptomyces roseosporus and summarizes testing where daptomycin
`was administered to various patients. (D1. 39 at 10-11.)
`Thus, in view of the foregoing, the court concludes that the defendant’s proposed construction is inconsistent
`with the claim language, the specification, and the intrinsic evidence and adopts the plaintiff‘s proposed construction
`of the term.
`
`
`
`

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`Case 1:12-cv-00367-GMS Document 59 Filed 05/20/13 Page 4 of 4 PagelD #: 1525
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`wherein RN is n-decanoyl (i.e., LY 146032).2
`
` Dated: May 332, 2013
`
`2 The court rejects the defendants’ proposed construction. The parties do not dispute that, on October 18,
`2007, the plaintiff filed a request with the Patent and Trademark Office (“the PTO”) to correct the stereochemistry of
`daptomycin in the claims and specification of the RE ’071 Patent.
`(DJ. 48 at 2.) This request attached a paper by
`Vivian Miao et al., Daptomycin Biosynthesis in Streptomyces roseosporus, 151 MICROBIOLOGY 1507 (2005), which
`explained the error in daptomycin’s stereochemistry and how the error had been discovered. (Id. (citing RE ’071 File
`History, 10/18/2007 Request for Certificate of Correction (J.A. at 362-64)).) The PTO issued a Certificate of
`Correction that changed all instances of L-Asn in the RE ’071 Patent to D-Asn.
`(Id. (citing RE ’071 File History,
`1/29/2008 Certificate of Correction (J .A. at 365)).) Despite this correction, the defendant argues that this claim term
`should be construed to include the pre-Certificate of Correction incorrect stereochemistry because: ( 1) “even after the
`correction, a skilled artisan faced with conflicting evidence would still have concluded that the claimed compound
`was L-Asn daptomycin, not D-Asn datomycin” because “looking at the entire specification, and through the lens of
`the relevant prior art,” that skilled artisan would find “no teaching in the patent specification or other intrinsic evidence
`that a D-Asn antibiotic drug was what the inventors thought they had discovered” (DJ. 37 at l l); and (2) the plaintiffs
`Certificate of Correction is “ineffective and, thus, the Court should be construing the original claims, not the corrected
`claims” as the “allegedly corrected mistake is not a clerical or typographical error” and, therefore, is not effective (id
`at 11-12). The court disagrees.
`First, and with regard to the defendant’s contention that a skilled artisan “would simply not believe” the
`corrected claims of the RE ’07] Patent, the court does not find support for this argument. Specifically, the plaintiff
`submitted the Miao paper to the PTO in conjunction with its request for a Certificate of Correction, which discloses
`the correct structure and the scientific studies and experimental evidence to support the revised structure. (DJ. 48 at
`4 (citing RE ’071 File History, 10/ 18/2007 Request for Certificate of Correction at 1-2 (J.A. at 362-63)).) The
`defendant has not presented support for its assertion that a person of ordinary skill in the art would disbelieve the
`teachings in Miao in favor of earlier references depicting the erroneous stereochemistry. Second, the court agrees
`with the plaintiff that the defendant’s contention that the Certificate of Correction is ineffective, is a matter to be
`resolved on summary judgment or at trial, rather than at the claim construction stage. See Eon Corp. IP Holdings,
`LLC v. T-Mobile USA, Inc., No. lO-cv-0379, 2012 WL 405492, at *19 (ED. Tex. Feb. 8, 2012) (“[W]hether the CoC
`is valid .
`.
`. is not a claim construction issue, but rather an issue for summary judgment”). While the defendant argues
`that it “is not presently seeking summary judgment of .
`.
`. invalidity of any of the asserted patents,” it does request
`that the court determine whether the Certificate of Correct is indeed valid. A challenge to the validity of a certificate
`of correction is often a challenge to the validity of the patent’s claims. See Superior Fireplace Co. v. Majestic
`Products. Co., 270 F.3d 1358, 1366-67 (Fed. Cir. 2001) (“Because [the] certificate of correction became part of the
`’534 patent and changed claim language, [the alleged infringer’s] challenge to the certificate amounted to a challenge
`to the corrected claim itself”). Here, the court agrees with the plaintiff that the determination of whether the
`stereochemistry correction is properly considered a correction of “minor character” presents questions requiring expert
`testimony regarding the nature of the error and its correction. See AT&T Corp. v. Microsoft Corp., No. 01—cv-4872,
`2004 WL 292321, at *8 (S.D.N.Y. Feb. 17, 2004) (citing Tillotson, Ltd. v. Walbro Corp., 831 F.2d 1033, 1039 (Fed.
`Cir. 1987)).
`In fact, both parties’ arguments regarding the Certificate of Correction rely on facts the court will need
`to determine. See, e. g., Cent. Admixture Pharmacy Servs., Inc. v. Advanced Cardiac Solutions PC, 482 F.3d 1347,
`1354 (Fed. Cir. 2007) (“[W]hether the error and its correction would both be clearly evident to one of skill in the art[]
`has been treated as a factual question”).
`In consideration of the record before it, the court concludes that the
`defendants have failed to present clear and convincing evidence that the Certificate of Correction is invalid. See
`Superior Fireplace, 270 F.3d at 1367. The defendant also has not presented evidence that the correction was not of
`minor characteristic. Consequently, the court concludes that the plaintiffs proposed construction, which reflects the
`stereochemistry change allowed by the Certificate of Correction, is appropriate.
`The court recognizes that the parties did not include a paragraph in their Scheduling Order providing the
`opportunity to file letters requesting permission to file a motion for summary judgment. As a result, the court will
`issue an Amended Scheduling Order providing the parties with this opportunity and a deadline for such submissions.
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`4
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