Case 1:12-cv-00367-GMS Document 135 Filed 12/08/14 Page 1 of 47 PageID #: 4791
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CUBIST PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`)
`)
`)
`)
`)
`)
`)
`)
`Defendant.
`)
`~~~~~~~~~~~~~~~~~-)
`
`V.
`
`HOSPIRA, INC.,
`
`C.A. No. 12-367-GMS
`
`MEMORANDUM OPINION
`
`I.
`
`INTRODUCTION
`
`In this patent infringement action, plaintiff Cubist Pharmaceuticals, Inc. ("Cubist") alleges
`
`that pharmaceutical products proposed by defendant Hospira, Inc. ("Hospira") infringe the asserted
`
`claims of the patents-in-suit. (D.I. 1.) The court held a five-day bench trial in this matter on
`
`February 18 through February 24, 2014. (D.1. 121-125.) Presently before the court are the parties'
`
`post-trial proposed findings of fact and conclusions of law concerning the validity of the patents-
`
`in-suit and whether Hospira's proposed products infringe the patents-in-suit. (D.I. 126-28.)
`
`Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire
`
`record in this case and the applicable law, the court concludes that: (1) the Certificate of Correction
`
`issued for the RE'071 Patent is not invalid, and therefore Hospira's products infringe the RE'071
`
`Patent; (2) the RE'071 Patent is not invalid for lack of written description; (3) the RE'071 Patent is
`
`not invalid for improper recapture; (4) a revision to the court's claim construction of the term
`
`"daptomycin" in the '967, '689, '238, and '342 Patents is not warranted, and therefore Hospira's
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`products infringe the '967, '689, '238, and '342 Patents; (5) the '967, '689, '238, and '342 Patents
`
`are not invalid for lack of written description; (6) the asserted claims of the '967 Patent are invalid
`
`PETITIONER
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`EXHIBIT NO. 1045 1 of 47
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`due to anticipation; (7) the asserted claims of the '967 and '689 Patents are invalid due to
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`obviousness; (8) claim 98 of the '238 Patent is invalid due to anticipation; (9) the asserted claims
`
`of the '238 and '342 Patents are invalid due to obviousness; (10) Hospira's § 102(t) derivation
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`defense is untimely and precluded; and (11) each of the parties' Rule 52(c) motions are granted in
`
`part and denied in part. These findings of fact and conclusions of law are set forth in further detail
`
`below.
`
`II.
`
`FINDINGS OF FACT 1
`
`A.
`
`The Parties
`
`1. Plaintiff Cubist Pharmaceuticals Inc. ("Cubist") is a Delaware corporation having a
`principal place of business at 65 Hayden Avenue, Lexington, Massachusetts.
`
`2. Hospira, Inc. ("Hospira") is a Delaware corporation having a principal place of business at
`275 North Field Drive, Lake Forest, Illinois.
`
`3. The court has subject matter jurisdiction, as well as personal jurisdiction over all parties.
`
`B.
`
`Background
`
`4. Cubicin® (daptomycin for injection) is an intravenous bactericidal antibiotic approved by
`the Food and Drug Administration ("FDA") for the treatment of infections caused by certain
`Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant
`strains, also known as MRSA.
`
`5. Cubicin® was approved for the treatment of complicated skin and skin structure infections
`in 2003. It was approved for the treatment ofbloodstream infections (bacteremia), including
`right-sided infective endocarditis caused by MRSA, as well as by methicillin-susceptible
`Staphylococcus aureus, in 2006.
`
`6. The '967 Patent, the '689 Patent, the RE'071 Patent, the '238 Patent, and the '342 Patent
`(described below) have been listed in connection with Cubicin® in the FDA's publication,
`
`1 Prior to trial, the parties submitted an exhibit of uncontested facts in conjunction with their Pretrial Order.
`(D.1. 109, Ex. 1.) The court takes most of its findings of fact from the parties' uncontested facts. Where necessary, the
`court has overruled objections to the inclusion of these facts. The court has also reordered and renumbered some
`paragraphs, corrected some spelling and formatting errors, and made minor edits for the purpose of concision and
`clarity that it does not believe alters the meaning of the paragraphs from the Pretrial Order. Otherwise, any differences
`between this section and the parties' statement of uncontested facts are unintentional.
`The court's findings of fact with respect to matters that were the subject of dispute between the parties are
`included in the Discussion and Conclusions of Law section ofthis opinion, preceded by the phrase "the court finds" or
`"the court concludes."
`
`2
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`PETITIONER
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`EXHIBIT NO. 1045 2 of 47
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`Approved Drug Products with Therapeutic Equivalence Evaluations, which is commonly
`referred to as the "Orange Book."
`
`C.
`
`The Patents-in-Suit
`
`7. U.S. Patent Number 6,468,967 ("the '967 Patent")-"Methods for Administration of
`Antibiotics"-issued on October 22, 2002. The '967 Patent is assigned to Cubist.
`
`8. The '967 purports to claim priority to Provisional Application Number 60/101,828, filed on
`September 25, 1998, and to Provisional Application Number 60/125,750, filed on March
`24, 1999.
`
`9. The '967 Patent lists Frederick B. Oleson, Jr. and Francis P. Tally as inventors.
`
`10. U.S. Patent Number 6,852,689 ("the '689 Patent")-"Methods for Administration of
`Antibiotics"-issued on February 8, 2005. The '689 Patent is assigned to Cubist.
`
`11. The '689 Patent is a continuation of U.S. Application Number 09/406,568, now the '967
`Patent, and purports to claim priority to Provisional Application Number 60/101,828, filed
`on September 25, 1998, and to Provisional Application No. 60/125,750, filed on March
`24, 1999. The '689 Patent is subject to a terminal disclaimer.
`
`12. The '689 Patent lists Frederick B. Oleson, Jr. and Francis P. Tally as inventors.
`
`13. U.S. Patent Number 8,058,238 ("the '238 Patent")-"High Purity Lipopeptides"-issued
`on November 15, 2011. The '238 Patent is assigned to Cubist.
`
`14. The '238 Patent claims priority to U.S. Application Number 10/747,485, filed on December
`29, 2003, which is a division of U.S. Application Number 09/735,191, filed on November
`28, 2000, now U.S. Patent Number 6,696,412, and Provisional Application Number
`60/177,170, filed on January 20, 2000.
`
`15. The '238 Patent lists Thomas Kelleher, Jan-Ji Lai, Joseph P. DeCourcey, Paul Lynch,
`Maurizio Zenoni, and Auro Tagliani as inventors.
`
`16. U.S. Patent Number 8,129,342 ("the '342 Patent")-"High Purity Lipopeptides"-issued
`on March 6, 2012. The '342 Patent is assigned to Cubist.
`
`17. The '342 Patent claims priority to U.S. Application Number 11/739,180, filed on April 24,
`2007, now the '238 Patent, which is a continuation of U.S. Application Number 10/747,485,
`filed on December 29, 2003, which is a division of U.S. Application Number 09/735,191,
`filed on November 28, 2000, now U.S. Patent Number 6,696,412, and Provisional
`Application Number 601177,170, filed on January 20, 2000. The '342 Patent is subject to a
`terminal disclaimer to the '238 Patent.
`
`3
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`PETITIONER
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`EXHIBIT NO. 1045 3 of 47
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`18. The '342 Patent lists Thomas Kelleher, Jan-Ji Lai, Joseph P. DeCourcey, Paul Lynch,
`Maurizio Zenoni, and Auro Tagliani as inventors.
`
`19. U.S. Patent Number RE39,071 ("the RE'071 Patent")-"Anhydro- and Isomer-A-21978C
`Cyclic Peptides"-issued on April 18, 2006. The RE'071 Patent is assigned to Cubist.
`
`20. The RE'071 Patent is a reissue of U.S. Patent Number 5,912,226 ("the '226 Patent").
`
`21. The RE'071 Patent is a continuation of U.S. Application Number 07/670,375, filed on
`March 14, 1991, which is a continuation of U.S. Application Number 07/060,148, filed
`June 10, 1987.
`
`22. The RE'071 Patent lists Patrick J. Baker, Manuel Debono, Khadiga Z. Farid and R.
`Michael Molloy as inventors
`
`23. A Request for Certificate of Correction for the RE'071 Patent was filed on October 18,
`2007, and a Certificate of Correction issued for the RE'071 Patent on January 29, 2008.
`
`1. The Asserted Claims2
`
`24. Cubist is asserting claims 16, 17, 34, and 35 of the '967 Patent.
`
`25. Cubist is asserting claims 51 and 52 of the '689 Patent.
`
`26. Cubist is asserting claims 91, 98, and 187 of the '238 Patent.
`
`27. Cubist is asserting claims 23 and 53 of the '342 Patent.
`
`28. Cubist is asserting claims 18 and 26 of the RE'071 Patent.
`
`a.
`
`'967 Patent, Claim 16
`
`29. Claim 16 of the '967 Patent reads:
`
`The method according to claim 14, [comprising the step of
`administering to a human patient in need thereof a therapeutically
`effective amount of daptomycin . . . at a dosage interval that
`minimizes skeletal muscle toxicity], wherein the dose is 4 mg/kg
`[repeatedly] administered once every 24 hours.
`
`2 Several of the asserted claims are dependent claims. For clarity, the court has included language from the
`unasserted claims on which they depend to offer a more complete view of what the claims cover.
`
`4
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`PETITIONER
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`EXHIBIT NO. 1045 4 of 47
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`b.
`
`'967 Patent, Claim 17
`
`30. Claim 17 of the '967 Patent reads:
`
`The method according to claim 14, [comprising the step of
`administering to a human patient in need thereof a therapeutically
`effective amount of daptomycin . . . at a dosage interval that
`minimizes skeletal muscle toxicity], wherein the dose is 6 mg/kg
`[repeatedly] administered once every 24 hours.
`
`c.
`
`'967 Patent, Claim 34
`
`31. Claim 34 of the '967 Patent reads:
`
`The method according to claim 33 [for treating or eradicating a
`bacterial infection in a human patient in need thereof, comprising
`the step of administering a therapeutically effective amount of
`daptomycin ... to the patient at a dosage interval that minimizes
`skeletal muscle toxicity, wherein the daptomycin dose is repeatedly
`administered at the dosage interval of once every 24 hours ... until
`said bacterial infection is treated or eradicated], wherein the dose is
`4 mg/kg.
`
`d.
`
`'967 Patent, Claim 35
`
`32. Claim 35 of the '967 Patent reads:
`
`The method according to claim 33 [for treating or eradicating a
`bacterial infection in a human patient in need thereof, comprising
`the step of administering a therapeutically effective amount of
`daptomycin ... to the patient at a dosage interval that minimizes
`skeletal muscle toxicity, wherein the daptomycin dose is repeatedly
`administered at the dosage interval of once every 24 hours ... until
`said bacterial infection is treated or eradicated], wherein the dose is
`6 mg/kg.
`
`e.
`
`'689 Patent, Claim 51
`
`33. Claim 51 of the '689 Patent reads:
`
`The method according to claim 48 [for administering daptomycin,
`comprising the step of administering to a human patient in need
`thereof a therapeutically effective amount of daptomycin in a dose
`of at least 3 mg/kg of daptomycin at a dosage interval that minimizes
`skeletal muscle toxicity, wherein the dose is repeatedly administered
`
`5
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`PETITIONER
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`at a dosage interval of once every 48 hours], wherein the dose is 4
`mg/kg.
`
`f
`
`'689 Patent, Claim 52
`
`34. Claim 52 of the '689 Patent reads:
`
`The method according to claim 48 [for administering daptomycin,
`comprising the step of administering to a human patient in need
`thereof a therapeutically effective amount of daptomycin in a dose
`of at least 3 mg/kg of daptomycin at a dosage interval that minimizes
`skeletal muscle toxicity, wherein the dose is repeatedly administered
`at a dosage interval of once every 48 hours], wherein the dose is 6
`mg/kg.
`
`g.
`
`'238 Patent, Claim 91
`
`35. Claim 91 of the '238 Patent reads:
`
`The method of claim 85 [for preparing a pharmaceutical composition
`comprising combining ... a purified daptomycin composition comprising
`daptomycin of greater than or about 93% purity relative to impurities 1-14
`defined by peaks 1-14 shown in FIG. 12, the daptomycin being obtained by
`a process comprising the step of forming an aggregate comprising
`daptomycin
`.
`.
`. with a pharmaceutically acceptable carrier or
`excipient], wherein the composition is daptomycin that is essentially free of
`each of impurities 1 to 14 defined by peaks 1-14 shown in FIG. 12.
`
`h.
`
`'238 Patent, Claim 98
`
`36. Claim 98 of the '238 Patent reads:
`
`The composition of claim 97, [wherein the purity of daptomycin is
`at least 93% ... and the daptomycin is obtained by a process
`comprising:
`a) subjecting a daptomycin solution to conditions forming a
`daptomycin aggregate;
`b) separating the daptomycin aggregate from low molecular
`weight contaminants with ultrafiltration or size exclusion
`chromatography; and
`c) subjecting the daptomycin aggregate to conditions in
`which
`the daptomycin aggregate dissociates
`into
`daptomycin monomers;
`and further comprising separating the daptomycin monomers
`obtained from step c) from high molecular weight contaminants
`
`6
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`PETITIONER
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`with a size selection technique], wherein the size selection technique
`is ultrafiltration or size exclusion chromatography.
`
`i.
`
`'238 Patent, Claim 187
`
`37. Claim 187 of the '238 Patent reads:
`
`The composition of claim 183, [for a purified daptomycin
`composition of greater than or about 93% purity relative to
`impurities 1-14 defined by peaks 1-14 shown in FIG. 12, wherein
`the percent purity is measured by HPLC analysis, and the purified
`daptomycin composition is obtained from a lipopeptide aggregate
`comprising daptomycin], wherein the daptomycin composition is at
`least or about 97% pure.
`
`j.
`
`'342 Patent, Claim 23
`
`38. Claim 23 of the '342 Patent reads:
`
`The pharmaceutical composition of claim 22, [compatible with a
`pharmaceutically acceptable carrier for the treatment of an infection
`of the blood, skin or soft tissue in a daily dose of 1 to 12 mg/kg, of
`daptomycin in a reconstituted solution of the composition in the
`pharmaceutically acceptable carrier, selected from the group
`consisting of physiological saline and Ringer's solution for
`intravenous administration as a single daily dose to the subject,
`wherein the daptomycin has greater than 93% purity, less than 4%
`anhydro daptomycin and less than 4% ~-isomer of daptomycin; and
`is obtained by a
`the composition comprising daptomycin
`purification process comprising the steps of:
`a) subjecting daptomycin to anion exchange chromatography
`to obtain an enriched daptomycin preparation
`b) forming
`the daptomycin aggregate comprising a
`daptomycin micelle
`in
`the enriched daptomycin
`preparation or a composition obtained from the enriched
`daptomycin preparation; and
`c) obtaining the daptomycin from the daptomycin aggregate],
`wherein the daptomycin is obtained from the daptomycin aggregate
`by a method comprising the steps of
`a) filtering the daptomycin aggregate under conditions in
`which the daptomycin aggregate is retained on the filter;
`and
`b) collecting the daptomycin aggregate.
`
`7
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`PETITIONER
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`k.
`
`'352 Patent, Claim 53
`
`39. Claim 53 of the '342 Patent reads:
`
`The composition of claim 52 [obtained by a process comprising the
`steps of forming a daptomycin aggregate, converting
`the
`daptomycin aggregate to monomers and obtaining the daptomycin
`in the composition from the monomers by a process including one
`or more steps selected from the group consisting of anion exchange
`chromatography and hydrophobic interaction chromatography],
`wherein
`a) the composition is a lyophilized powder compatible with
`a pharmaceutically acceptable carrier for the treatment
`of an infection by a daily intravenous dose of 1 to 12
`mg/kg of the daptomycin in a reconstituted solution of
`the
`lyophilized powder
`in
`the pharmaceutically
`acceptable carrier; and
`b) the daptomycin has a purity of about 94 to 96% relative
`to impurities 1-14 defined by peaks 1-14 shown in FIG.
`12, the daptomycin having less than 1 % of the lactone
`hydrolysis product of daptomycin, less than 4% anhydro
`daptomycin and less than 4% of the ~-isomer of
`daptomycin.
`
`l.
`
`RE'071 Patent, Claim 18
`
`40. Claim 18 of the RE'071 Patent reads:
`
`An antibiotic composition comprised of a combination of a
`compound of formula 1, a compound of formula 2 and a compound
`of formula 3, or pharmaceutically acceptable salts thereof, wherein
`the formula 1 compound is
`
`FORAfCL1 I
`
`8
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`PETITIONER
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`EXHIBIT NO. 1045 8 of 47
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`, R4 and Rs are hydrogen, and
`in which R is a C10 alkanoyl; R 1, R2
`
`, R3
`wherein the alanine is D-alanine and the serine is D-serine; the
`formula 2 compound is
`
`FOll.\JUA 2
`
`, R4 and Rs are hydrogen, and
`in which Risa C10 alkanoyl; R 1
`, R3
`, R2
`wherein the alanine is D-alanine and the serine is D-serine; and the
`formula 3 compound is an A2 l 978C cyclic peptide of
`FORMULJ 3
`
`-.,-/\ .. -=:.
`
`i
`- -;' .. :[ t
`t
`A •··i I
`NH
`I
`Ri-;
`wherein RN is n-decanoyl; and wherein the total amount of the
`compound of formula I and the compound of formula 2, or salts
`thereof, in the combination is less than 6 weight percent.
`
`~ _<T .- ..
`_ ,
`
`9
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`PETITIONER
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`EXHIBIT NO. 1045 9 of 47
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`m.
`
`RE'071 Patent, Claim 26
`
`41. Claim 26 of the RE'071 Patent reads:
`
`A pharmaceutical formulation compnsmg a combination of a
`compound of formula 1, a compound of formula 2 and a compound
`of formula 3, or pharmaceutically acceptable salts thereof, wherein
`the formula 1 compound is [shown above] in which R is a
`C10 alkanoyl; R1 , R2 , R3 , R4 and Rs are hydrogen, and wherein the
`alanine is D-alanine and the serine is D-serine; the formula
`2 compound is [shown above] in which R is a C10 alkanoyl; R 1
`, R2,
`R3, R4 and Rs are hydrogen, and wherein the alanine is D-alanine
`and the serine is D-serine; and the formula 3 compound is an
`A21978C cyclic peptide of [shown above] wherein RN is n(cid:173)
`decanoyl; and wherein the total amount of the compound of
`formula 1 and the compound of formula 2, or salts thereof, in the
`combination is less than 6 weight percent, and the pharmaceutical
`formulation further comprises from about 0.1 to about 90 weight
`percent of the A21978C cyclic peptide of formula 3.
`
`D.
`
`Hospira's ANDA and NDA
`
`42. Hospira filed Abbreviated New Drug Application ("ANDA") No. 202857 with the FDA
`seeking approval for the commercial manufacture, use, and sale of daptomycin for injection,
`500 mg/vial ("Hospira's Daptomycin ANDA Product") prior to the expiration of the '967,
`'689, RE'071, '238, and '342 Patents.
`
`43. Hospira's ANDA includes a certification pursu~nt to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`asserting that, inter alia, the '967, '689, RE'071, '238, and '342 Patents are invalid, are
`unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of
`Hospira's Daptomycin ANDA Product.
`
`44. By letter dated February 7, 2012 (the "Notice Letter"), Hospira notified Cubist that it had
`submitted ANDA No. 202587 to obtain approval to engage in the commercial manufacture,
`use, and sale ofHospira's Daptomycin ANDA Product prior to the expiration of, inter alia,
`the '967, '689, RE'071, and '238 Patents.
`
`45. This action was commenced on March 21, 2012, before the expiration of forty-five days
`from the date of the receipt of the Notice Letter.
`
`46. By letter dated May 31, 2012 (the "Second Notice Letter"), Hospira notified Cubist that it
`had submitted an amendment to the FDA for its previously submitted ANDA No. 202587
`to obtain approval to engage in the commercial manufacture, use, and sale of Hospira's
`Daptomycin ANDA Product prior to the expiration of the '342 Patent.
`
`10
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`PETITIONER
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`47. Civil Action No. 12-859-GMS was commenced on July 9, 2012, before the expiration of
`forty-five days from the date of the receipt of the Second Notice Letter. Civil Action No.
`12-859-GMS was consolidated with this action on August 31, 2012.
`
`48. Hospira filed New Drug Application ("NDA") No. 203797 with the FDA under Section
`505(b)(2) of the Federal Food, Drug, and Cosmetic Act, seeking approval for the
`commercial manufacture, use, and sale of Daptomycin for Injection, 350 mg/vial
`("Hospira's 505(b)(2) Product"), prior to the expiration of the '967, '689, RE'071, '238,
`and '342 Patents.
`
`49. By letter dated August 10, 2012 (the "505(b)(2) Notice Letter"), Hospira notified Cubist
`that it had submitted NDA No. 203797 to obtain approval to engage in the commercial
`manufacture, use, offer for sale, and/or sale of Hospira's 505(b)(2) Product prior to the
`expiration of, inter alia, the '967, '689, RE'071, '238, and '342 Patents.
`
`50. In the 505(b)(2) Notice Letter, Hospira alleged that the '967, '689, RE'071, '238, and '342
`Patents, inter alia, are invalid, are unenforceable, and/or will not be infringed by the
`commercial manufacture, use, offer for sale, or sale ofHospira's 505(b)(2) Product.
`
`51. Civil Action No. 12-1142-GMS was commenced on September 17, 2012, before the
`expiration of forty-five days from the date of the receipt of the 505(b)(2) Notice Letter.
`
`52. Civil Action No. 12-1142-GMS was consolidated with this action on October 19, 2012.
`
`E.
`
`Infringenient
`
`53. Under the court's current claim construction, Hospira stipulated to infringement (active or
`induced) of the assert:ed claims of the patents-in-suit.3
`
`F.
`
`Certificate of Correction
`
`54. The Certificate of Correction for RE'071 (noted above) changed one amino acid in the tail
`portion of Formula 3 from L-Asn to D-Asn (reflecting different stereoisomer configurations
`of the amino acid asparagine ).
`
`55. The Certificate of Correction does not correct a clerical or typographical error.4
`
`3 Hospira reserved the right to argue non-infringement in the event that the court revised its claim construction
`order, concerning the construction of the term "daptomycin" and "Formula 3 compound," (D.I. 59), or ifthe court ruled
`the Certificate of Correction for the RE'071 patent was invalid. (D.I. 109 at 6-7.) These matters are discussed in detail
`below.
`
`4 As such, the dispute, discussed below, concerns whether the Certificate of Correction corrects a mistake of
`"minor character." 35 U.S.C. § 255.
`
`11
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`PETITIONER
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`EXHIBIT NO. 1045 11 of 47
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`III.
`
`DISCUSSION AND CONCLUSIONS OF LAW
`
`The court has subject matter jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331,
`
`1338, and 2201. Venue is proper in this court under 28 U.S.C. §§ 1391 and 1400(b). After having
`
`considered the entire record in this case, the substantial evidence in the record, the parties' post(cid:173)
`
`trial submissions, and the applicable law, the court concludes that: (1) the Certificate of Correction
`
`issued for the RE'071 Patent is not invalid, and therefore Hospira's products infringe the RE'071
`
`Patent; (2) the RE'071 Patent is not invalid for lack of written description; (3) the RE'071 Patent is
`
`not invalid for improper recapture; (4) a revision to the court's claim construction of the term
`
`"daptomycin" in the '967, '689, '238, and '342 Patents is not warranted, and therefore Hospira's
`
`products infringe the '967, '689, '238, and '342 Patents; (5) the '967, '689, '238, and '342 Patents
`
`-are not invalid for lack of written description; (6) the asserted claims of the '967 Patent are invalid
`
`due to anticipation; (7) the asserted claims of the '967 and '689 Patents are invalid due to
`
`obviousness; (8) claim 98 of the '238 Patent is invalid due to anticipation; (9) the asserted claims
`
`of the '238 and '342 Patents are invalid due to obviousness; (10) Hospira's § 102(f) derivation
`
`defense is untimely and precluded; and (11) each of the parties' Rule 52(c) motions are granted in
`
`part and denied in part. The court's reasoning follows.
`
`A. The RE '071 Patent
`
`1. Certificate of Correction
`
`Hospira argues that the Certificate of Correction filed in 2007 for the RE'071 Patent is
`
`invalid because it did not correct a mistake of "minor character." See 35 U.S.C. § 255. Thus,
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`Hospira contends that the asserted claims of the RE'071 Patent only cover compounds of"Formula
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`3" as it was originally identified, prior to correction, having an L-asparagine amino acid in the tail
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`portion of the chemical structure. 5 Because its proposed products possess D-asparagine instead,
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`Hospira argues it does not infringe the RE'071 Patent. 6
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`"[A] mistake the correction of which broadens a claim is not a 'mistake of .
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`. mmor
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`character."' Superior Fireplace Co. v. Majestic Prods. Co., 270 F.3d 1358, 1376 (Fed. Cir. 2001).
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`And determining whether a claim is "broadened through correction requires interpreting the old and
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`new versions of that claim, and then determining whether the new version covers territory the old
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`one did not." Cent. Admixture Pharmacy Servs., Inc. v. Advanced Cardiac Solutions, P.C., 482 F.3d
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`1347, 1353 (Fed. Cir. 2007). Indeed, a certificate of correction is invalid if the corrected claim
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`"contains within its scope any conceivable apparatus or process which would not have infringed
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`the original patent." Tillotson, Ltd. v. Walbro Corp., 831 F.2d 1033, 1037 n.2 (Fed. Cir. 1987)
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`(emphasis added) (discussing broadening in the context of patent reissue applications). A certificate
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`of correction is part of a duly issued patent; therefore, "the party seeking invalidation must meet
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`the clear and convincing standard of persuasion." Cent. Admixture, 482 F.3d at 1353 (internal
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`quotation marks omitted). 7
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`Both parties offer compelling arguments. On the one hand, Hospira is certainly correct that
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`Formula 3 in the corrected RE'071 Patent is different from the pre-correction Formula 3. Focusing
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`solely on the chemical structure identified in the claims, the court is presented with a clear case of
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`claim broadening. On the other hand, as Cubist emphasizes, the court's focus is not limited to the
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`5 To avoid confusion, the court refrains from referring to these "Formula 3" compounds as "daptomycin,"
`which, as discussed below, is known to possess D-asparagine.
`6 In the parties' Proposed Pretrial Order, Hospira stipulated that:
`Making, using, offering to sell, selling, or importing Hospira's Daptomycin
`ANDA and 505(b)(2) Products in/into the United States would directly infringe
`claims 18, 19, 26, and 28 of the RE'071 patent, unless such claims are found to
`be invalid, the Certificate of Correction is found to be invalid, or the Court's
`construction of"Formula 3 compound" is reversed.
`(D.1. 109 at 8 (emphasis added).)
`7 "Clear and convincing evidence is evidence that places in the fact finder 'an abiding conviction that the truth
`of [the] factual contentions are 'highly probable."' Alza Corp v. Andrx Pharms., LLC, 607 F. Supp. 2d 614, 631 (D.
`Del. 2009) (quoting Colorado v. New Mexico, 467 U.S. 310, 316 (1984)).
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`chemical structure. Cubist argues that the particular chemical structure of Formula 3 is just one of
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`three ways the RE'071 Patent describes the compound of interest, as evidenced by the references
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`to L Y-14603 2 (Eli Lilly's codename for daptomycin) and A-21978C cyclic peptides (the byproduct
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`of the Streptomyces roseosporus fermentation process). (D.I. 126 at 44.)
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`Ultimately the court finds that Hospira has not satisfied its heavy burden to show by clear
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`and convincing evidence that the Certificate of Correction is invalid. Although the asserted claims
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`of the RE'071 Patent make no explicit reference to a method of manufacture or source for the
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`compound, there is mention of "an A21978C cyclic peptide of [Formula 3] wherein RN is n-
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`decanoyl." Indeed the court's claim construction order confirmed that a "Formula 3 compound" is
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`defined not just by the chemical structure but by this additional language as well. 8 (D.I. 59 at 3-4.)
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`At the very least, the inclusion of both "an A21978C cyclic peptide ... " and the chemical structure
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`created an ambiguity requiring additional analysis of the specification. See Merck & Co. v. Teva
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`Pharm. USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003) ("[C]laims must be construed so as to be
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`consistent with the specification, of which they are a part."); see also Regents of Univ. of NM. v.
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`Knight, 321 F.3d 1111, 1122 (Fed. Cir. 2003) ("[A] chemical structure is simply a means of
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`describing a compound; it is not the invention itself.") Hospira has not shown that one skilled in
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`the art, after examining the specification, still would have focused solely on the chemical structure
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`identified in Formula 3-indeed, Hospira's expert Dr. Ganem did not consider the specification at
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`all. (Tr. at 164 (Ganem).) Thus, even assuming that there was no excuse for why the incorrect
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`stereochemistry was included in the original patent, the court applies the established legal standard
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`8 The court's claim construction order assumed the validity of the Certificate of Correction and construed
`"Formula 3 compound" as having the corrected Formula 3, i.e., with D-asparagine. (D.1. 59 at 3-4 & n.2.) The court
`deferred ruling on the question of the Certificate of Correction's validity until summary judgment. (Id. at 4 n.2.) Then,
`in its order denying Hospira's letter request to file summary judgment, the court stated that the issue would be best
`addressed at trial. (D.I. 107 at 2.)
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`that one skilled in the art would look to the entire specification to determine what was covered by
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`the claims. See Phillips v. AWH Corp., 415 F.3d 1303, 1313-14 (Fed. Cir. 2005); Merck,
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`347 F.3d at 1371. The specification confirms that the Formula 3 compound identified in the claims
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`is truly D-asparagine daptomycin, the byproduct of the fermentation process. Substituting L(cid:173)
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`asparagine for D-asparagine in the Formula 3 chemical structure was therefore a correction of minor
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`character because it did not result in ''the new version cover[ing] territory the old one did not." See
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`Cent. Admixture, 482 F.3d at 1353. D-asparagine daptomycin was covered both before and after
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`correction. The court finds the Certificate of Correction is valid, and Hospira infringes the RE'071
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`Patent.
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`2. Written Description
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`Hospira argues that, ifthe Certificate of Correction is valid, the RE'071 Patent is still invalid
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`for failing the written description requirement imposed by § 112.
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`To satisfy the written description requirement, the application must show that, as of the
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`filing date, the applicants were "in possession of the invention'·' in question. See Vas-Cath Inc. v.
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`Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). "[T]he test for sufficiency is whether the
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`disclosure of the application relied upon reasonably conveys to those skilled in the art that the
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`inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc. v.
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`Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (emphasis added). Although an exact
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`definition of "possession" can be elusive, in essence, "the specification must describe an invention
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`understandable to [a] skilled artisan and show that the inventor actually invented the invention
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`claimed." Id. To this end, support in the written description must be based on what actually is
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`disclosed, and not on an obvious variant of what is disclosed. See id. at 1352 (citing Lockwood v.
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`Am. Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997)). Whether the written description
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`requirement is met is a question of fact.
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`Id. at 1351 (citing Ralston Purina Co. v. Far-Mar-Co,
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`Inc., 772 F.2d 1570, 1