Cubist Pharmaceuticals Inc. v. Hospira Inc.
Filing
135
MEMORANDUM OPINION. Signed by Judge Gregory M. Sleet on 12/8/2014. (mdb)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
CUBIST PHARMACEUTICALS, INC.,
Plaintiff,
V.
HOSPIRA, INC.,
Defendant.
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C.A. No. 12-367-GMS
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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 patentsin-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
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(t) derivation
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
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
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 Claims 2
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
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
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
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
the composition comprising daptomycin is obtained by a
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
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
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; the
formula 2 compound is
FOll.\JUA 2
in which Risa 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 A2 l 978C cyclic peptide of
FORMULJ 3
i
t
-.,-/\..-=:.
- -;'..:[
t
~
_
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