throbber
Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 1 of 34 PageID #: 131
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`CUBIST PHARMACEUTICALS, INC.,
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`Plaintiff,
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` C.A. No. 13-1679-GMS
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`v.
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`STRIDES, INC. and AGILA
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`SPECIALTIES PRIVATE LIMITED,
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`Defendants.
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`DEFENDANTS’ STRIDES, INC.’S AND AGILA SPECIALTIES PRIVATE LIMITED’S
`ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS TO
`PLAINTIFF’S COMPLAINT
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`Defendants Strides, Inc. (“Strides”) and Agila Specialties Private Limited (“Agila”)
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`(collectively, “Defendants”) hereby respond to the complaint filed by plaintiff Cubist
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`Pharmaceuticals, Inc. (“Cubist” or “Plaintiff”) as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United States, Title
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`35 of the United States Code, that arises out of the filing by Defendants Strides, Inc. (“Strides”)
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`and Agila Specialties Private Limited (“Agila”) (collectively, “Defendants”) of Abbreviated New
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`Drug Application (“ANDA”) No. 205037 with the U.S. Food and Drug Administration (“FDA”)
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`seeking approval to manufacture and sell a generic version of CUBICIN® prior to the expiration
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`of U.S. Patent Nos. 6,468,967; 6,852,689; 8,058,238; and 8,129,342.
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`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 2 of 34 PageID #: 132
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`ANSWER:
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`Defendants admit that the Complaint contains averments of patent infringement that arise
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`under the patent laws of the United States, but deny that those averments have merit. Defendants
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`further admit that they have filed ANDA No. 205037 with the FDA seeking approval to
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`manufacture and sell a generic version of CUBICIN® prior to the expiration of U.S. Patent Nos.
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`6,468,967; 6,852,689; 8,058,238; and 8,129,342. To the extent that there are further averments
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`in paragraph 1 not addressed by the foregoing, Defendants deny those averments.
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`THE PARTIES
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`2.
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`Plaintiff Cubist Pharmaceuticals, Inc. (“Cubist”) is a corporation organized and existing
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`under the laws of the State of Delaware, with its principal place of business at 65 Hayden Avenue,
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`Lexington, Massachusetts.
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`ANSWER:
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`Upon information and belief, Defendants admit that Cubist has a place of business at 65
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`Hayden Avenue, Lexington, Massachusetts. Defendants are without information sufficient to form
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`a belief as to the truth of the remaining averments in paragraph 2 and therefore deny them.
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`3.
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`Upon information and belief, defendant Strides is a New Jersey corporation, with its
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`principal place of business at 201 South Main Street, Suite #3, Lambertville, NJ 08530.
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`ANSWER:
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`Admitted.
`
`-2-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 3 of 34 PageID #: 133
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`4.
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`Upon information and belief, defendant Agila is a corporation organized under the laws of
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`India, with its principal place of business at Strides House, Bilekahalli, Bannerghatta Road,
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`Bangalore 560076 India.
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`ANSWER:
`
`Admitted.
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`5.
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`Upon information and belief, defendant Strides is the U.S. agent for defendant Agila. Upon
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`information and belief, defendants Strides and Agila are wholly owned subsidiaries of Strides
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`Arcolab Ltd. that act in concert with respect to collaborating in the development, manufacturing,
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`and sale of generic copies of branded pharmaceutical products, including daptomycin for injection.
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`On information and belief, defendants Strides and Agila import, distribute, manufacture, market,
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`and/or sell generic versions of branded drugs in, and regularly conduct business throughout, the
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`United States, including in Delaware.
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`ANSWER:
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`Defendants admit that at the time of the filing of ANDA No. 205037, Strides filed the
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`ANDA on behalf of (alternatively, as the U.S. agent for) Agila. Paragraph 5 contains legal
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`conclusions to which no response is required. To the extent that there are further averments in
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`paragraph 5 not addressed by the foregoing, Defendants deny these averments.
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`JURISDICTION AND VENUE
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`6.
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`This action arises under the patent laws of the United States of America and this Court has
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`jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and
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`2202.
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`-3-
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`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 4 of 34 PageID #: 134
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`ANSWER:
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`Admitted.
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`7.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`ANSWER:
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`Defendants do not contest venue by this Court in this civil action.
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`8.
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`Defendants are subject to personal jurisdiction in Delaware because of their continuous and
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`systematic contacts with Delaware. Upon information and belief, Defendants directly or indirectly
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`purposefully offer to sell, sell, market, distribute, and/or manufacture goods, including generic
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`pharmaceutical products, for sale in the United States and Delaware; derive substantial revenue
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`from things used or consumed in Delaware; regularly do business and solicit business in Delaware;
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`and have admitted, consented to, and/or not objected to jurisdiction in this Court, including, for
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`example, in Aventis Pharma S.A. et al. v. Strides, Inc. et al., C.A. No. 11-1121-GMS (D. Del.) and
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`Senju Pharmaceutical Co., Ltd. et al. v. Strides, Inc. et al., C.A. No. 13-851-SLR (D. Del.).
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`ANSWER:
`
`Defendants do not contest personal jurisdiction by this Court in this civil action. To the
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`extent that there are further averments in paragraph 8 not addressed by the foregoing, Defendants
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`deny those averments.
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`9.
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`Alternatively, Agila is subject to personal jurisdiction in Delaware pursuant to Fed. R. Civ.
`
`P. 4(k)(2). Agila has contacts with the United States through, among other things, its having filed
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`an ANDA with the FDA through its agent corporation, Strides, and its importation, distribution,
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`manufacture, marketing, and/or sale of generic versions of branded drugs in the United States.
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`-4-
`
`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 5 of 34 PageID #: 135
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`ANSWER:
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`Defendants do not contest personal jurisdiction by this Court in this civil action. To the
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`extent that there are further averments in paragraph 9 not addressed by the foregoing, Defendants
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`deny those averments.
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`BACKGROUND
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`10.
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`CUBICIN® (daptomycin for injection) is an intravenous bactericidal antibiotic approved
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`by the FDA for the treatment of complicated skin and skin structure infections caused by certain
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`Gram-positive microorganisms, such as Staphylococcus aureus, including methicillin-resistant
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`strains, also known as MRSA. CUBICIN® is also approved for the treatment of S. aureus
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`bloodstream infections (bacteremia), including right-sided infective endocarditis caused by
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`MRSA.
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`ANSWER:
`
`Defendants admit that the FDA label for CUBICIN® states that it is indicated for
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`“[c]omplicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the
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`following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant
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`isolates) Streptococcus pyogenes, Streptococcus agalactiae , Streptococcus dysgalactiae subsp.
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`equisimilis, and Enterococcus faecalis (vancomycin-suceptible isolates only).” Defendants
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`further admit that the FDA label for CUBICIN® states that it is indicated for “Staphylococcus
`
`aureus bloodstream infections (bacteremia), including those with right-sided infective
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`endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.” To the extent
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`that there are further averments in paragraph 10 not addressed by the foregoing, Defendants deny
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`those averments.
`
`-5-
`
`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 6 of 34 PageID #: 136
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`11.
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`Cubist sells CUBICIN® in the United States pursuant to a New Drug Application that
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`has been approved by the FDA.
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`ANSWER:
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`Upon information and belief, admitted.
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`12.
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`United States Patent No. 6,468,967 (“the ‘967 patent”), entitled “Methods for
`
`Administration of Antibiotics” (Exhibit A hereto), was duly and legally issued on October 22, 2002.
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`The ‘967 patent, which is owned by Cubist, will expire on September 24, 2019.
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`ANSWER::
`
`Defendants admit that the ‘967 patent indicates on its face that it was issued on October
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`22, 2002, and that the ‘967 patent is titled “Methods for Administration of Antibiotics,” but deny
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`that the ‘967 patent was duly and legally issued. Defendants also admit that what purports to be
`
`a copy of the ‘967 patent was attached as Exhibit A to the Complaint. Defendants further admit
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`that the ‘967 patent indicates on its face that it is assigned to Cubist Pharmaceuticals,
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`Incorporated, and the FDA’s publication, Approved Drug Products with Therapeutic
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`Equivalence Evaluations (“Orange Book”) indicates that the ‘967 patent will expire September
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`24, 2019. To the extent that there are further averments in paragraph 12 not addressed by the
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`foregoing, Defendants deny those averments.
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`13.
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`United States Patent No. 6,852,689 (“the ‘689 patent”), entitled “Methods for
`
`Administration of Antibiotics” (Exhibit B hereto), was duly and legally issued on February 8,
`
`2005. The ‘689 patent, which is owned by Cubist, will expire on September 24, 2019.
`
`-6-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 7 of 34 PageID #: 137
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`ANSWER:
`
`Defendants admit that the ‘689 patent indicates on its face that it was issued on February
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`8, 2005, and that the ‘689 patent is titled “Methods for Administration of Antibiotics,” but deny
`
`that the ‘689 patent was duly and legally issued. Defendants also admit that what purports to be
`
`a copy of the ‘689 patent was attached as Exhibit B to the Complaint. Defendants further admit
`
`that the ‘689 patent indicates on its face that it is assigned to Cubist Pharmaceuticals, Inc., and
`
`the Orange Book indicates that the ‘689 patent will expire on September 24, 2019. To the extent
`
`that there are further averments in paragraph 13 not addressed by the foregoing, Defendants deny
`
`those averments.
`
`14.
`
`United States Patent No. 8,058,238 (“the ‘238 patent”), entitled “High Purity
`
`Lipopeptides” (Exhibit C hereto), was duly and legally issued on November 15, 2011. The ‘238
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`patent, which is owned by Cubist, will expire on November 28, 2020.
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`ANSWER:
`
`Defendants admit that the ‘238 patent indicates on its face that it was issued November
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`15, 2011, and that the ‘238 patent is titled “High Purity Lipopeptides,” but deny that the ‘238
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`patent was duly and legally issued. Defendants also admit that what purports to be a copy of the
`
`‘238 patent was attached as Exhibit C to the Complaint. Defendants further admit that the ‘238
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`patent indicates on its face that it is assigned to Cubist Pharmaceuticals, Inc., and the Orange
`
`Book indicates that the ‘238 patent will expire on November 28, 2020. To the extent that there
`
`are further averments in paragraph 14 not addressed by the foregoing, Defendants deny those
`
`averments.
`
`-7-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 8 of 34 PageID #: 138
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`15.
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`United States Patent No. 8,129,342 (“the ‘342 patent”), entitled “High Purity
`
`Lipopeptides” (Exhibit D hereto), was duly and legally issued on March 6, 2012. The ‘342
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`patent, which is owned by Cubist, will expire on November 28, 2020.
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`ANSWER:
`
`Defendants admit that the ‘342 patent indicates on its face that it was issued March 6,
`
`2012, and that the ‘342 patent is titled “High Purity Lipopeptides,” but deny that the ‘342 patent
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`was duly and legally issued. Defendants also admit that what purports to be a copy of the ‘342
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`patent was attached as Exhibit D to the Complaint. Defendants further admit that the ‘342 patent
`
`indicates on its face that it is assigned to Cubist Pharmaceuticals, Inc., and the Orange Book
`
`indicates that the ‘342 patent will expire on November 28, 2020. To the extent that there are
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`further averments in paragraph 15 not addressed by the foregoing, Defendants deny those
`
`averments.
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`16.
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`CUBICIN®, or its use, is covered by one or more claims of the ‘967, ‘689, ‘238, and
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`‘342 patents, which have been listed in connection with CUBICIN® in the FDA’s publication,
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`Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as the “Orange
`
`Book.”
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`ANSWER:
`
`Defendants note that the ‘967, ‘689, ‘238, and ‘342 patents have been listed in the Orange
`
`Book in connection with CUBICIN®. To the extent that there are further averments in
`
`paragraph 16 not addressed by the foregoing, Defendants deny them.
`
`-8-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 9 of 34 PageID #: 139
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`17.
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`By letter dated August 26, 2013 (the “Notice Letter”), Defendants notified Cubist that
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`they had submitted to the FDA ANDA No. 205037 for Daptomycin for Injection, 500 mg/vial, a
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`generic version of CUBICIN® (“Strides’s ANDA Product”).
`
`
`
`ANSWER:
`
`Defendants admit that Strides sent Cubist a Notice Letter with an accompanying detailed
`
`statement on August 26, 2013. The Notice Letter and detailed statement speak for themselves.
`
`Accordingly, no further response is required.
`
`18.
`
`In the Notice Letter, Defendants stated that their ANDA included certifications pursuant
`
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ‘967, ‘689, ‘238, and ‘342 patents and
`
`alleged that the ‘967, ‘689, ‘238, and ‘342 patents are invalid, unenforceable, and/or will not be
`
`infringed by the commercial manufacture, use, offer for sale, or sale of Strides’s ANDA Product.
`
`ANSWER:
`
`Admitted.
`
`19.
`
`This action is being commenced before the expiration of forty-five days from the date of
`
`the receipt of the Notice Letter.
`
`ANSWER:
`
`Upon information and belief, Defendants admit that this action is being commenced
`
`before the expiration of forty-five days from the date of the receipt of the Notice Letter.
`
`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 6,468,967
`
`20.
`
`Plaintiff incorporates each of the proceeding paragraphs 1-19 as if fully set forth herein.
`
`-9-
`
`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 10 of 34 PageID #: 140
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`ANSWER:
`
`Defendants incorporate by reference their responses to paragraphs 1-19 of the Complaint
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`as if fully set forth herein.
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`21.
`
`The use of Strides’s ANDA Product is covered by one or more claims of the ‘967 patent.
`
`ANSWER:
`
`Denied.
`
`22.
`
`Defendants had knowledge of the ‘967 patent when they submitted their ANDA to the
`
`FDA.
`
`ANSWER:
`
`Admitted.
`
`23.
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`Defendants’ submission of ANDA No. 205037 for the purposes of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, and/or sale of Strides’s ANDA
`
`Product before the expiration of the ‘967 patent is an act of infringement of the ‘967 patent.
`
`ANSWER:
`
`Defendants admit that it is a technical act of infringement under 35 U.S.C. § 271(e)(2)(A)
`
`to submit “an application under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or
`
`described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is
`
`claimed in a patent,” but deny that the allegations of substantive infringement of the ‘967 patent
`
`have any merit. To the extent that there are further averments in paragraph 23 not addressed by
`
`the foregoing, Defendants deny those averments.
`
`-10-
`
`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 11 of 34 PageID #: 141
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`24.
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`The commercial manufacture, use, offer for sale, sale and/or importation of Stride’s
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`ANDA Product would infringe one or more claims of the ‘967 patent.
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`ANSWER:
`
`Denied.
`
`25.
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`Upon information and belief, use of Strides’s ANDA Product in accordance with and as
`
`directed by Defendants’ proposed labeling for that product would infringe one or more claims of
`
`the ‘967 patent.
`
`ANSWER:
`
`Denied.
`
`26.
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`Upon information and belief, Defendants intend to engage in the manufacture, use, offer
`
`for sale, sale, and/or importation of Strides’s ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 205037.
`
`ANSWER:
`
`Defendants admit that they intend to engage in the manufacture, use, offer for sale, sale,
`
`and/or importation of Strides’s ANDA Product with its proposed labeling upon approval of
`
`ANDA No. 205037. To the extent that there are further averments in paragraph 26 not addressed
`
`by the foregoing, Defendants deny those averments.
`
`27.
`
`Upon information and belief, Defendants will actively induce infringement of the ‘967
`
`patent when their ANDA is approved, and plan and intend to, and will do so, immediately and
`
`imminently upon approval.
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`-11-
`
`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 12 of 34 PageID #: 142
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`ANSWER:
`
`Denied.
`
`28.
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`Upon information and belief, Defendants know that Strides’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ‘967 patent, and that
`
`Strides’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. Upon information and belief, Defendants plan and intend to, and will, contribute to the
`
`infringement of the ‘967 patent immediately and imminently upon approval of ANDA No.
`
`205037.
`
`ANSWER:
`
`Denied.
`
`29.
`
`The foregoing actions by Defendants constitute and/or would constitute infringement of
`
`the ‘967 patent, active inducement of infringement of the ‘967 patent, and/or contribution to the
`
`infringement by others of the ‘967 patent.
`
`ANSWER:
`
`Denied.
`
`30.
`
`Upon information and belief, Defendants acted without a reasonable basis for believing
`
`that they would not be liable for infringing the ‘967 patent, actively inducing infringement of the
`
`‘967 patent, and/or contributing to the infringement by others of the ‘967 patent.
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`ANSWER:
`
`Denied.
`
`-12-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 13 of 34 PageID #: 143
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`31.
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`Unless Defendants are enjoined from infringing the ‘967 patent, actively inducing
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`infringement of the ‘967 patent, and/or contributing to the infringement by others of the ‘967
`
`patent, Cubist will suffer irreparable injury. Cubist has no adequate remedy at law.
`
`ANSWER:
`
`Denied.
`
`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 6,852,689
`
`32.
`
`Plaintiff incorporates each of the proceeding paragraphs 1-31 as if fully set forth herein.
`
`ANSWER:
`
`Defendants incorporate by reference their responses to paragraphs 1-31 of the Complaint
`
`as if fully set forth herein.
`
`33.
`
`The use of Strides’s ANDA Product is covered by one or more claims of the ‘689 patent.
`
`ANSWER:
`
`Denied.
`
`34.
`
`Defendants had knowledge of the ‘689 patent when they submitted their ANDA to the
`
`FDA.
`
`ANSWER:
`
`Admitted.
`
`35.
`
`Defendants’ submission of ANDA No. 205037 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, and/or sale of Strides’s ANDA
`
`Product before the expiration of the ‘689 patent is an act of infringement of the ‘689 patent.
`
`-13-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 14 of 34 PageID #: 144
`
`ANSWER:
`
`Defendants admit that it is a technical act of infringement under 35 U.S.C. § 271(e)(2)(A)
`
`to submit “an application under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or
`
`described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is
`
`claimed in a patent,” but deny that the allegations of substantive infringement of the ‘689 patent
`
`have any merit. To the extent that there are further averments in paragraph 35 not addressed by
`
`the foregoing, Defendants deny those averments.
`
`36.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Stride’s
`
`ANDA Product would infringe one or more claims of the ‘689 patent.
`
`ANSWER:
`
`Denied.
`
`37.
`
`Upon information and belief, use of Strides’s ANDA Product in accordance with and as
`
`directed by Defendants’ proposed labeling for that product would infringe one or more claims of
`
`the ‘689 patent.
`
`ANSWER:
`
`Denied.
`
`38.
`
`Upon information and belief, Defendants intend to engage in the manufacture, use, offer
`
`for sale, sale, and/or importation of Strides’s ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 205037.
`
`-14-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 15 of 34 PageID #: 145
`
`ANSWER:
`
`Defendants admit that they intend to engage in the manufacture, use, offer for sale, sale,
`
`and/or importation of Strides’s ANDA Product with its proposed labeling upon approval of
`
`ANDA No. 205037. To the extent that there are further averments in paragraph 38 not addressed
`
`by the foregoing, Defendants deny those averments.
`
`39.
`
`Upon information and belief, Defendants will actively induce infringement of the ‘689
`
`patent when their ANDA is approved, and plan and intend to, and will do so, immediately and
`
`imminently upon approval.
`
`ANSWER:
`
`Denied.
`
`40.
`
`Upon information and belief, Defendants know that Strides’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ‘689 patent, and that
`
`Strides’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. Upon information and belief, Defendants plan and intend to, and will, contribute to the
`
`infringement of the ‘689 patent immediately and imminently upon approval of ANDA No.
`
`205037.
`
`ANSWER:
`
`Denied.
`
`41.
`
`The foregoing actions by Defendants constitute and/or would constitute infringement of
`
`the ‘689 patent, active inducement of infringement of the ‘689 patent, and/or contribution to the
`
`infringement by others of the ‘689 patent.
`
`-15-
`
`

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`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 16 of 34 PageID #: 146
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`ANSWER:
`
`Denied.
`
`42.
`
`Upon information and belief, Defendants acted without a reasonable basis for believing
`
`that they would not be liable for infringing the ‘689 patent, actively inducing infringement of the
`
`‘689 patent, and/or contributing to the infringement by others of the ‘689 patent.
`
`ANSWER:
`
`Denied.
`
`43.
`
`Unless Defendants are enjoined from infringing the ‘689 patent, actively inducing
`
`infringement of the ‘689 patent, and/or contributing to the infringement by others of the ‘689
`
`patent, Cubist will suffer irreparable injury. Cubist has no adequate remedy at law.
`
`ANSWER:
`
`Denied.
`
`COUNT III
`INFRINGEMENT OF U.S. PATENT NO. 8,058,238
`
`44.
`
`Plaintiff incorporates each of the proceeding paragraphs 1-43 as if fully set forth herein.
`
`ANSWER:
`
`Defendants incorporate by reference their responses to paragraphs 1-43 of the Complaint
`
`as if fully set forth herein.
`
`45.
`
`Strides’s ANDA Product is covered by one or more claims of the ‘238 patent.
`
`-16-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 17 of 34 PageID #: 147
`
`ANSWER:
`
`Denied.
`
`46.
`
`Defendants’ submission of ANDA No. 205037 for the purposes of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Strides’s
`
`ANDA Product before the expiration of the ‘238 patent is an act of infringement of the ‘238
`
`patent.
`
`ANSWER:
`
`Defendants admit that it is a technical act of infringement under 35 U.S.C. § 271(e)(2)(A)
`
`to submit “an application under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or
`
`described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is
`
`claimed in a patent,” but deny that the allegations of substantive infringement of the ‘238 patent
`
`have any merit. To the extent that there are further averments in paragraph 46 not addressed by
`
`the foregoing, Defendants deny those averments.
`
`47.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Stride’s
`
`ANDA Product would infringe one or more claims of the ‘238 patent.
`
`ANSWER:
`
`Denied.
`
`48.
`
`Upon information and belief, Defendants intend to engage in the manufacture, use, offer
`
`for sale, sale, and/or importation of Strides’s ANDA Product immediately and imminently upon
`
`approval of ANDA No. 205037.
`
`-17-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 18 of 34 PageID #: 148
`
`ANSWER:
`
`Defendants admit that they intend to engage in the manufacture, use, offer for sale, sale,
`
`and/or importation of Strides’s ANDA Product upon approval of ANDA no. 205037. To the
`
`extent that there are further averments in paragraph 48 not addressed by the foregoing,
`
`Defendants deny those averments.
`
`49.
`
`The foregoing actions by Defendants constitute and/or would constitute infringement of
`
`the ‘238 patent.
`
`ANSWER:
`
`Denied.
`
`50.
`
`Unless Defendants are enjoined from infringing the ‘238 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`ANSWER:
`
`Denied.
`
`COUNT IV
`INFRINGEMENT OF U.S. PATENT NO. 8,129,342
`
`51.
`
`Plaintiff incorporates each of the proceeding paragraphs 1-50 as if fully set forth herein.
`
`ANSWER:
`
`Defendants incorporate by reference their responses to paragraphs 1-50 of the Complaint
`
`as if fully set forth herein.
`
`
`
`-18-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 19 of 34 PageID #: 149
`
`52.
`
`Strides’s ANDA Product is covered by one or more claims of the ‘342 patent.
`
`ANSWER:
`
`Denied.
`
`53.
`
`Defendants’ submission of ANDA No. 205037 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, and/or sale of Strides’s ANDA
`
`Product before the expiration of the ‘342 patent is an act of infringement of the ‘342 patent.
`
`ANSWER:
`
`Defendants admit that it is a technical act of infringement under 35 U.S.C. § 271(e)(2)(A)
`
`to submit “an application under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or
`
`described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is
`
`claimed in a patent,” but deny that the allegations of substantive infringement of the ‘342 patent
`
`have any merit. To the extent that there are further averments in paragraph 53 not addressed by
`
`the foregoing, Defendants deny those averments.
`
`54.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Stride’s
`
`ANDA Product would infringe one or more claims of the ‘342 patent.
`
`ANSWER:
`
`Denied.
`
`55.
`
`Upon information and belief, Defendants intend to engage in the manufacture, use, offer
`
`for sale, sale, and/or importation of Strides’s ANDA Product immediately and imminently upon
`
`approval of ANDA No. 205037.
`
`-19-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 20 of 34 PageID #: 150
`
`ANSWER:
`
`Defendants admit that they intend to engage in the manufacture, use, offer for sale, sale,
`
`and/or importation of Strides’s ANDA Product upon approval of ANDA no. 205037. To the
`
`extent that there are further averments in paragraph 55 not addressed by the foregoing,
`
`Defendants deny those averments.
`
`56.
`
`The foregoing actions by Defendants constitute and/or would constitute infringement of
`
`the ‘342 patent.
`
`ANSWER:
`
`Denied.
`
`57.
`
`Unless Defendants are enjoined from infringing the ‘342 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`ANSWER:
`
`Denied.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff prays that this Court grant the following relief:
`
`(a)
`
`A judgment that Defendants’ submission of ANDA No. 205037 was an act of
`
`infringement of the ‘967, ‘689, ‘238, and ‘342 patents, and that Defendants’ manufacture, use,
`
`offer to sell, sale, or importation of Strides’s ANDA Product prior to the expiration of the ‘967,
`
`‘689, ‘238, and ‘342 patents, will infringe, actively induce infringement, and/or contribute to the
`
`infringement of the ‘967, ‘689, ‘238, and ‘342 patents;
`
`-20-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 21 of 34 PageID #: 151
`
`(b)
`
`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
`
`any FDA approval of Strides’s ANDA No. 205037, or any product or compound that infringes
`
`the ‘967, ‘689, ‘238, and ‘342 patents, shall not be earlier than the expiration of the ‘967, ‘689,
`
`‘238 and ‘342 patents;
`
`(c)
`
`An Order permanently enjoining Defendants, and their affiliates and subsidiaries,
`
`and each of their officers, agents, servants and employees from making, using, offering to sell,
`
`selling, marketing, distributing, or importing Strides’s ANDA Product, or any product or
`
`compound that infringes the ‘967, ‘689, ‘238, and ‘342 patents, or inducing or contributing to the
`
`infringement of the ‘967, ‘689, ‘238, and ‘342 patents until after the expiration of the ‘967, ‘689,
`
`‘238, and ‘342 patents;
`
`(d)
`
`A declaration that this is an exceptional case and an award of attorneys’ fees to
`
`plaintiff pursuant to 35 U.S.C. § 285;
`
`(e)
`
`Plaintiff’s reasonable costs of suit incurred; and
`
`(f)
`
`Such further and other relief as this Court deems proper and just.
`
`RESPONSE TO PRAYER FOR RELIEF:
`
`Defendants deny that Plaintiff is entitled to any of the relief requested in their Complaint.
`
`AFFIRMATIVE DEFENSES
`
`Defendants assert the following defenses:
`
`-21-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 22 of 34 PageID #: 152
`
`DEFENSE NO. 1
`(Non-Infringement of the ‘967, ‘689, ‘238, and ‘342 Patents)
`
`Plaintiff has failed to aver any facts which support its allegations of infringement by
`
`Defendants’ proposed ANDA product. Defendants’ proposed ANDA product, which would be
`
`marketed upon approval of their ANDA, would not infringe any valid claim of the ‘967, ‘689,
`
`‘238, and ‘342 patents literally or under the doctrine of equivalents.
`
`DEFENSE NO. 2
`(No Inducement of Infringement of the ‘967, ‘689, ‘238, and ‘342 Patents)
`
`Plaintiff has failed to aver any facts which support is allegations of inducement of
`
`infringement by Defendants’ proposed ANDA product. Defendants have not, do not, and will
`
`not induce infringement of any valid claim of the ‘967, ‘689, ‘238, and ‘342 patents.
`
`DEFENSE NO. 3
`(No Contributory Infringement of the ‘967, ‘689, ‘238, and ‘342 Patents)
`
`Plaintiff has failed to aver any facts which support its allegations of contributory
`
`infringement by Defendants’ proposed ANDA product. Defendants have not, do not, and will
`
`not contribute to the infringement of any valid claim of the ‘967, ‘689, ‘238, and ‘342 patents.
`
`DEFENSE NO. 4
`(Invalidity of the ‘967, ‘689, ‘238, and ‘342 Patents Based on Title 35 of the U.S. Code)
`
`One or more claims of the ‘967, ‘689, ‘238, and ‘342 patents are invalid for failure to
`
`comply with one or more of the requirements for patentability set forth in Title 35 of the U.S.
`
`Code, including failure to comply with one or more of 35 U.S.C. §§ 101, 102, 103, and 112.
`
`-22-
`
`

`

`Case 1:13-cv-01679-GMS Document 8 Filed 11/13/13 Page 23 of 34 PageID #: 153
`
`DEFENSE NO. 5
`(Failure to State a Claim)
`
`The Complaint fails to state a claim against Defendants upon which relief may be
`
`granted.
`
`COUNTERCLAIMS
`
`For their counterclaims against Plaintiff/Counterclaim-Defendant Cubist
`
`Pharmaceuticals, Inc. (“Cubist”), Defendants/Counterclaim-Plaintiffs Strides, Inc. and Agila
`
`Specialties Private Limited (“Agila”) (collectively, “Counterclaim-Plaintiffs”) state as follows:
`
`Parties
`
`1.
`
`Counterclaim-Plaintiff Strides, Inc. (“Strides”) is a New Jersey corporation, with
`
`its principal place of business at 201 South Main Street, Suite #3, Lambertville, NJ 08530.
`
`2.
`
`Counterclaim-Plaintiff Agila Specialties Private Limited (“Agila”) is a
`
`corporation organized under the laws of India, with its principal place of business at Strides
`
`House, Bilekahalli, Bannerghatta Road, Bangalore 560076 India.
`
`3.
`
`Counterclaim-Defendant Cubist Pharmaceuticals, Inc. (“Cubist”) has alleged that
`
`it is a corporation organized and existing under the laws of the State of Delaware, with its
`
`principal place of business at 65 Hayden Avenue, Lexington, Massachusetts.
`
`Jurisdiction and Venue
`
`4.
`
`These counterclaims arise under the Patent Laws of the United States, 35 U.S.C.
`
`§§ 1 et seq., the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`5.
`
`This Court has original jurisdiction over the subject matt

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