v.
`
`
`FRESENIUS KABI USA, LLC,
`
`
`Defendant.
`
`
`
`)
`)
`)
`)
`) C.A. No. 14-914-GMS
`)
`)
`)
`)
`
`DEFENDANT FRESENIUS KABI USA, LLC’S ANSWER, AFFIRMATIVE
`DEFENSES AND COUNTERCLAIMS TO PLAINTIFF’S COMPLAINT
`
`Defendant Fresenius Kabi USA, LLC (“Fresenius”), by its attorneys, hereby responds to
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 1 of 32 PageID #: 129
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`CUBIST PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`
`
`
`
`the allegations of Plaintiff Cubist Pharmaceuticals, Inc. (“Cubist”) (D.I. 1) as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of Defendant Fresenius Kabi USA, LLC’s
`
`filing of Abbreviated New Drug Application (“ANDA”) No. 206077 seeking approval from the
`
`U.S. Food and Drug Administration (“FDA”) to manufacture and sell a generic version of
`
`CUBICIN® prior to the expiration of U.S. Patent Nos. 6,468,967, 6,852,689, 8,058,238, and
`
`8,129,342.
`
`ANSWER:
`
`
`
`Fresenius admits that the Complaint contains averments of patent infringement that arise
`
`under the patent laws of the United States, but denies that those averments have merit. Fresenius
`
`further admits that it has filed ANDA No. 206077 with the FDA seeking approval to
`
`manufacture and sell Daptomycin Intravenous Injection, 500 mg prior to the expiration of U.S.
`
`
`
`
`
`
`FRESENIUS KABI USA, LLC,
`
`
`Defendant.
`
`
`
`)
`)
`)
`)
`) C.A. No. 14-914-GMS
`)
`)
`)
`)
`
`DEFENDANT FRESENIUS KABI USA, LLC’S ANSWER, AFFIRMATIVE
`DEFENSES AND COUNTERCLAIMS TO PLAINTIFF’S COMPLAINT
`
`Defendant Fresenius Kabi USA, LLC (“Fresenius”), by its attorneys, hereby responds to
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 1 of 32 PageID #: 129
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`CUBIST PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`
`
`
`
`the allegations of Plaintiff Cubist Pharmaceuticals, Inc. (“Cubist”) (D.I. 1) as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of Defendant Fresenius Kabi USA, LLC’s
`
`filing of Abbreviated New Drug Application (“ANDA”) No. 206077 seeking approval from the
`
`U.S. Food and Drug Administration (“FDA”) to manufacture and sell a generic version of
`
`CUBICIN® prior to the expiration of U.S. Patent Nos. 6,468,967, 6,852,689, 8,058,238, and
`
`8,129,342.
`
`ANSWER:
`
`
`
`Fresenius admits that the Complaint contains averments of patent infringement that arise
`
`under the patent laws of the United States, but denies that those averments have merit. Fresenius
`
`further admits that it has filed ANDA No. 206077 with the FDA seeking approval to
`
`manufacture and sell Daptomycin Intravenous Injection, 500 mg prior to the expiration of U.S.
`
`
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 2 of 32 PageID #: 130
`
`Patent Nos. 6,468,967, 6,852,689, 8,058,238, and 8,129,342. To the extent that there are further
`
`averments in paragraph 1 not addressed by the foregoing, Fresenius denies them.
`
`PARTIES
`
`
`
`2.
`
`Plaintiff Cubist Pharmaceuticals, Inc. 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.
`
`ANSWER:
`
`
`
`Upon information and belief, Fresenius admits that Cubist is registered as a Delaware
`
`corporation, and has a principal place of business at 65 Hayden Avenue, Lexington,
`
`Massachusetts. Fresenius is without information sufficient to form a belief as to the truth of the
`
`remaining averments in paragraph 2 and therefore denies them.
`
`3.
`
`Upon information and belief, defendant Fresenius is a Delaware limited liability
`
`
`
`company with its principal place of business at Three Corporate Drive, Lake Zurich, Illinois
`
`60047.
`
`ANSWER:
`
`Admitted.
`
`4.
`
`Upon information and belief, defendant Fresenius engages in or collaborates in
`
`
`
`
`
`the development, manufacturing, marketing, and sale of generic copies of branded
`
`pharmaceutical products, including daptomycin for injection. On information and belief,
`
`defendant Fresenius imports, distributes, manufactures, markets, and/or sells generic versions of
`
`2
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 3 of 32 PageID #: 131
`
`branded drugs in, and regularly conducts business throughout, the United States, including in
`
`Delaware.
`
`ANSWER:
`
`
`
`Fresenius admits that it filed ANDA No. 206077 for Daptomycin Intravenous Injection,
`
`500 mg. Paragraph 4 contains legal conclusions to which no response is required. To the extent
`
`that there are further averments in paragraph 4 not addressed by the foregoing, Fresenius denies
`
`them.
`
`JURISDICTION AND VENUE
`
`
`
`5.
`
`This action arises under the patent laws of the United States of America and this
`
`Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 2201, and 2202.
`
`ANSWER:
`
`
`
`Paragraph 5 contains conclusions of law for which no response is required. To the extent
`
`that a response is required, Fresenius admits that this court has subject matter jurisdiction based
`
`upon the statutes cited solely for claims asserted against Fresenius under 35 U.S.C. §
`
`271(e)(2)(A).
`
`6.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`
`
`ANSWER:
`
`
`
`Paragraph 6 contains conclusions of law to which no response is required. To the extent a
`
`response is required, Fresenius does not contest venue solely for the limited purposes of this
`
`particular action.
`
`
`
`3
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 4 of 32 PageID #: 132
`
`
`
`7.
`
`Defendant Fresenius is subject to personal jurisdiction in Delaware because it is a
`
`Delaware corporation and has continuous and systematic contacts with the State of Delaware.
`
`Upon information and belief, Fresenius, directly or indirectly, purposefully offers to sell, sells,
`
`markets, distributes, and/or manufactures goods, including generic pharmaceutical products, for
`
`sale in the United States and Delaware; derives substantial revenue from things used or
`
`consumed in Delaware; and regularly does business and solicits business in Delaware. Fresenius
`
`has also repeatedly and purposely availed itself of this forum by filing numerous complaints in
`
`this Court over the past two years.
`
`ANSWER:
`
`
`
`Paragraph 7 contains conclusions of law for which no response is required. To the extent
`
`that a response is required, Fresenius does not contest personal jurisdiction solely for the limited
`
`purposes of this particular action. To the extent that there are further averments in paragraph 7
`
`not addressed by the foregoing, Fresenius denies them.
`
`BACKGROUND
`
`
`
`8.
`
`CUBICIN® (daptomycin for injection) is an intravenous bactericidal antibiotic
`
`approved by the FDA for the treatment of complicated skin and skin structure infections caused
`
`by certain Gram-positive microorganisms, such as Staphylococcus aureus, including methicillin-
`
`resistant strains, also known as MRSA. CUBICIN® is also approved for the treatment of S.
`
`aureus bloodstream infections (bacteremia), including right-sided infective endocarditis caused
`
`by MRSA.
`
`ANSWER:
`
`
`
`Fresenius admits that the current, approved package insert for CUBICIN® states that it is
`
`indicated for “[c]omplicated skin and skin structure infections (cSSSI) caused by susceptible
`
`4
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 5 of 32 PageID #: 133
`
`isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-
`
`resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae
`
`subsp. equisimilis, and Enterococcus faecalis (vancomycin-suceptible isolates only).” Fresenius
`
`further admits that the FDA label for CUBICIN® states that it is indicated for “Staphylococcus
`
`aureus bloodstream infections (bacteremia), including those with right-sided infective
`
`endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.” To the extent
`
`that there are further averments in paragraph 8 not addressed by the foregoing, Fresenius denies
`
`9.
`
`Cubist sells CUBICIN® in the United States pursuant to a New Drug Application
`
`them.
`
`
`
`that has been approved by the FDA.
`
`ANSWER:
`
`Upon information and belief, admitted.
`
`10. 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. The ’967 patent, which is owned by Cubist, will expire on September 24, 2019.
`
`ANSWER:
`
`
`
`Fresenius admits that the ’967 patent indicates on its face that it was issued on October
`
`22, 2002, and that the ’967 patent is titled “Methods for Administration of Antibiotics,” but
`
`denies that the ’967 patent was duly and legally issued. Fresenius also admits that what purports
`
`to be a copy of the ’967 patent was attached as Exhibit A to the Complaint. Fresenius further
`
`admits that the ’967 patent indicates on its face that it is assigned to Cubist Pharmaceuticals,
`
`5
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 6 of 32 PageID #: 134
`
`Incorporated, and the FDA’s publication, Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”) indicates that the ’967 patent will expire on
`
`September 24, 2019. To the extent that there are further averments in paragraph 10 not
`
`addressed by the foregoing, Fresenius denies them.
`
`11. 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.
`
`ANSWER:
`
`
`
`Fresenius admits that the ’689 patent indicates on its face that it was issued on February
`
`8, 2005, and that the ’689 patent is titled “Methods for Administration of Antibiotics,” but denies
`
`that the ’689 patent was duly and legally issued. Fresenius also admits that what purports to be a
`
`copy of the ’689 patent was attached as Exhibit B to the Complaint. Fresenius further admits
`
`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 11 not addressed by the foregoing, Fresenius denies
`
`12. United States Patent No. 8,058,238 (“the ’238 patent”), entitled “High Purity
`
`them.
`
`
`
`Lipopeptides” (Exhibit C hereto), was duly and legally issued on November 15, 2011. The ’238
`
`patent, which is owned by Cubist, will expire on November 28, 2020.
`
`6
`
`
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 7 of 32 PageID #: 135
`
`ANSWER:
`
`
`
`Fresenius admits that the ’238 patent indicates on its face that it was issued November 15,
`
`2011, and that the ’238 patent is titled “High Purity Lipopeptides,” but denies that the ’238
`
`patent was duly and legally issued. Fresenius also admits that what purports to be a copy of the
`
`’238 patent was attached as Exhibit C to the Complaint. Fresenius further admits that the ’238
`
`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 12 not addressed by the foregoing, Fresenius denies them.
`
`13. 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
`
`patent, which is owned by Cubist, will expire on November 28, 2020.
`
`ANSWER:
`
`
`
`Fresenius admits 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 denies that the ’342
`
`patent was duly and legally issued. Fresenius also admits that what purports to be a copy of the
`
`’342 patent was attached as Exhibit D to the Complaint. Fresenius further admits 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 further averments in paragraph 13 not addressed by the foregoing, Fresenius denies them.
`
`14. CUBICIN®, or its use, is covered by one or more claims of the ’967, ’689, ’238,
`
`
`
`and ’342 patents, which have been listed in connection with CUBICIN® in the FDA’s
`
`7
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 8 of 32 PageID #: 136
`
`publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as
`
`the “Orange Book.”
`
`ANSWER:
`
`
`
`Fresenius admits 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 14 not addressed by the foregoing, Fresenius denies them.
`
`15. By letter dated May 29, 2014 (the “Notice Letter”), Fresenius notified Cubist that
`
`
`
`it had submitted ANDA No. 206077 to the FDA for Daptomycin for Injection, 500mg/vial, a
`
`generic version of CUBICIN® (“Fresenius’s ANDA Product”).
`
`ANSWER:
`
`
`
`Fresenius admits that it sent Cubist a Notice Letter with an accompanying detailed
`
`statement on May 29, 2014. The Notice Letter and detailed statement speak for themselves.
`
`Accordingly, no further response is required.
`
`16.
`
`In the Notice Letter, Fresenius stated that its 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 Fresenius’s
`
`ANDA Product.
`
`ANSWER:
`
`Admitted.
`
`
`
`
`
`8
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 9 of 32 PageID #: 137
`
`
`
`17.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of the receipt of the Notice Letter.
`
`ANSWER:
`
`
`
`Fresenius admits that this action was commenced on July 11, 2014. Upon information
`
`and belief, Fresenius admits that this action was commenced before the expiration of forty-five
`
`days from the date of Cubist’s receipt of the May 29, 2014 Notice Letter.
`
`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 6,468,967
`
`Plaintiff incorporates each of the proceeding paragraphs 1–17 as if fully set forth
`
`18.
`
`
`
`
`
`herein.
`
`ANSWER:
`
`
`
`Fresenius incorporates by reference its responses to paragraphs 1–17 as if fully set forth
`
`19.
`
`The use of Fresenius’s ANDA Product is covered by one or more claims of the
`
`herein.
`
`
`
`’967 patent.
`
`ANSWER:
`
`Denied.
`
`20.
`
`Fresenius had knowledge of the ’967 patent when it submitted its ANDA to the
`
`
`
`
`
`FDA.
`
`
`
`9
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 10 of 32 PageID #: 138
`
`ANSWER:
`
`
`
`Paragraph 20 contains conclusions of law for which no response is required. To the
`
`extent an answer is required, Fresenius admits that its ANDA included certifications pursuant to
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’967 patent. To the extent that there are
`
`further averments in paragraph 20 not addressed by the foregoing, Fresenius denies them.
`
`21.
`
`Fresenius’s submission of ANDA No. 206077 for the purpose of obtaining
`
`
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Fresenius’s
`
`ANDA Product before the expiration of the ’967 patent is an act of infringement of the ’967
`
`patent.
`
`ANSWER:
`
`
`
`Paragraph 21 contains conclusions of law for which no response is required. To the
`
`extent an answer is required, Fresenius admits 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 denies that the allegations of substantive
`
`infringement of the ’967 patent have any merit. To the extent that there are further averments in
`
`paragraph 21 not addressed by the foregoing, Fresenius denies them.
`
`22.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of
`
`
`
`Fresenius’s ANDA Product would infringe one or more claims of the ’967 patent.
`
`ANSWER:
`
`
`
`Denied.
`
`10
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 11 of 32 PageID #: 139
`
`23. Upon information and belief, use of Fresenius’s ANDA Product in accordance
`
`
`
`with and as directed by Fresenius’s proposed labeling for that product would infringe one or
`
`more claims of the ’967 patent.
`
`ANSWER:
`
`Denied.
`
`24. Upon information and belief, Fresenius intends to engage in the manufacture, use,
`
`
`
`
`
`offer for sale, sale, and/or importation of Fresenius’s ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 206077.
`
`ANSWER:
`
`
`
`These allegations relate to future conduct as to which no final decision has been made
`
`and Fresenius therefore denies the allegations of paragraph 24.
`
`25. Upon information and belief, Fresenius will actively induce infringement of the
`
`
`
`’967 patent when its ANDA is approved, and plans and intends to, and will do so, immediately
`
`and imminently upon approval.
`
`ANSWER:
`
`Denied.
`
`26. Upon information and belief, Fresenius knows that Fresenius’s ANDA Product
`
`
`
`
`
`and its proposed labeling are especially made or adapted for use in infringing the ’967 patent,
`
`and that Fresenius’s ANDA Product and its proposed labeling are not suitable for substantial
`
`11
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 12 of 32 PageID #: 140
`
`noninfringing use. Upon information and belief, Fresenius plans and intends to, and will,
`
`contribute to the infringement of the ’967 patent immediately and imminently upon approval of
`
`ANDA No. 206077.
`
`ANSWER:
`
`Denied.
`
`27.
`
`The foregoing actions by Fresenius constitute and/or would constitute
`
`
`
`
`
`infringement of the ’967 patent, active inducement of infringement of the ’967 patent, and/or
`
`contributory infringement of the ’967 patent.
`
`ANSWER:
`
`Denied.
`
`28. Upon information and belief, Fresenius acted without a reasonable basis for
`
`
`
`
`
`believing that it would not be liable for infringing the ’967 patent, actively inducing infringement
`
`of the ’967 patent, and/or contributing to the infringement of the ’967 patent.
`
`ANSWER:
`
`Denied.
`
`29. Unless Fresenius is enjoined from infringing the ’967 patent, actively inducing
`
`
`
`
`
`infringement of the ’967 patent, and/or contributing to the infringement of the ’967 patent,
`
`Cubist will suffer irreparable injury. Cubist has no adequate remedy at law.
`
`ANSWER:
`
`
`
`Denied.
`
`12
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 13 of 32 PageID #: 141
`
`
`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 6,852,689
`
`Plaintiff incorporates each of the proceeding paragraphs 1–29 as if fully set forth
`
`
`
`30.
`
`herein.
`
`ANSWER:
`
`
`
`Fresenius incorporates by reference its responses to paragraphs 1–29 as if fully set forth
`
`31.
`
`The use of Fresenius’s ANDA Product is covered by one or more claims of the
`
`herein.
`
`
`
`’689 patent.
`
`ANSWER:
`
`Denied.
`
`32.
`
`Fresenius had knowledge of the ’689 patent when it submitted its ANDA to the
`
`
`
`
`
`FDA.
`
`ANSWER:
`
`
`
`Paragraph 32 contains conclusions of law for which no response is required. To the
`
`extent an answer is required, Fresenius admits that its ANDA included certifications pursuant to
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’689 patent. To the extent that there are
`
`further averments in paragraph 20 not addressed by the foregoing, Fresenius denies them.
`
`33.
`
`Fresenius’s submission of ANDA No. 206077 for the purpose of obtaining
`
`
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Fresenius’s
`
`13
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 14 of 32 PageID #: 142
`
`ANDA Product before the expiration of the ’689 patent is an act of infringement of the ’689
`
`patent.
`
`ANSWER:
`
`
`
`Paragraph 33 contains conclusions of law for which no response is required. To the
`
`extent an answer is required, Fresenius admits 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 denies that the allegations of substantive
`
`infringement of the ’689 patent have any merit. To the extent that there are further averments in
`
`paragraph 33 not addressed by the foregoing, Fresenius denies them.
`
`34.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of
`
`
`
`Fresenius’s ANDA Product would infringe one or more claims of the ’689 patent.
`
`ANSWER:
`
`Denied.
`
`35. Upon information and belief, use of Fresenius’s ANDA Product in accordance
`
`
`
`
`
`with and as directed by Fresenius’s proposed labeling for that product would infringe one or
`
`more claims of the ’689 patent.
`
`ANSWER:
`
`Denied.
`
`
`
`
`
`14
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 15 of 32 PageID #: 143
`
`
`
`36. Upon information and belief, Fresenius intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of Fresenius’s ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 206077.
`
`ANSWER:
`
`
`
`These allegations relate to future conduct as to which no final decision has been made
`
`and Fresenius therefore denies the allegations of paragraph 36.
`
`37. Upon information and belief, Fresenius will actively induce infringement of the
`
`
`
`’689 patent when its ANDA is approved, and plans and intends to, and will do so, immediately
`
`and imminently upon approval.
`
`ANSWER:
`
`Denied.
`
`38. Upon information and belief, Fresenius knows that Fresenius’s ANDA Product
`
`
`
`
`
`and its proposed labeling are especially made or adapted for use in infringing the ’689 patent,
`
`and that Fresenius’s ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. Upon information and belief, Fresenius plans and intends to, and will,
`
`contribute to the infringement of the ’689 patent immediately and imminently upon approval of
`
`ANDA No. 206077.
`
`ANSWER:
`
`Denied.
`
`
`
`
`
`15
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 16 of 32 PageID #: 144
`
`
`
`39.
`
`The foregoing actions by Fresenius constitute and/or would constitute
`
`infringement of the ’689 patent, active inducement of infringement of the ’689 patent, and/or
`
`contributory infringement of the ’689 patent.
`
`ANSWER:
`
`Denied.
`
`40. Upon information and belief, Fresenius acted without a reasonable basis for
`
`
`
`
`
`believing that it would not be liable for infringing the ’689 patent, actively inducing infringement
`
`of the ’689 patent, and/or contributing to the infringement of the ’689 patent.
`
`ANSWER:
`
`Denied.
`
`41. Unless Fresenius is enjoined from infringing the ’689 patent, actively inducing
`
`
`
`
`
`infringement of the ’689 patent, and/or contributing to the infringement 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
`
`Plaintiff incorporates each of the proceeding paragraphs 1–41 as if fully set forth
`
`42.
`
`
`
`
`
`herein.
`
`
`
`16
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 17 of 32 PageID #: 145
`
`ANSWER:
`
`
`
`Fresenius incorporates by reference its responses to paragraphs 1–41 as if fully set forth
`
`43.
`
`Fresenius’s ANDA Product is covered by one or more claims of the ’238 patent.
`
`herein.
`
`
`
`ANSWER:
`
`Denied.
`
`44.
`
`Fresenius’s submission of ANDA No. 206077 for the purpose of obtaining
`
`
`
`
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Fresenius’s
`
`ANDA Product before the expiration of the ’238 patent is an act of infringement of the ’238
`
`patent.
`
`ANSWER:
`
`
`
`Paragraph 44 contains conclusions of law for which no response is required. To the
`
`extent an answer is required, Fresenius admits 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 denies that the allegations of substantive
`
`infringement of the ’238 patent have any merit. To the extent that there are further averments in
`
`paragraph 44 not addressed by the foregoing, Fresenius denies them.
`
`45.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`
`
`Fresenius’s ANDA Product would infringe one or more claims of the ’238 patent.
`
`17
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 18 of 32 PageID #: 146
`
`ANSWER:
`
`Denied.
`
`46. Upon information and belief, Fresenius intends to engage in the manufacture, use,
`
`
`
`
`
`offer for sale, sale, and/or importation of Fresenius’s ANDA Product immediately and
`
`imminently upon approval of ANDA No. 206077.
`
`ANSWER:
`
`
`
`These allegations relate to future conduct as to which no final decision has been made
`
`and Fresenius therefore denies the allegations of paragraph 46.
`
`47.
`
`The foregoing actions by Fresenius constitute and/or would constitute
`
`
`
`infringement of the ’238 patent.
`
`ANSWER:
`
`Denied.
`
`48. Unless Fresenius is 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
`
`Plaintiff incorporates each of the proceeding paragraphs 1–48 as if fully set forth
`
`49.
`
`
`
`
`
`herein.
`
`18
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 19 of 32 PageID #: 147
`
`ANSWER:
`
`
`
`Fresenius incorporates by reference its responses to paragraphs 1–48 as if fully set forth
`
`50.
`
`Fresenius’s ANDA Product is covered by one or more claims of the ’342 patent.
`
`herein.
`
`
`
`ANSWER:
`
`Denied.
`
`51.
`
`Fresenius’s submission of ANDA No. 206077 for the purpose of the obtaining
`
`
`
`
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Fresenius’s
`
`ANDA Product before the expiration of the ’342 patent is an act of infringement of the ’342
`
`patent.
`
`ANSWER:
`
`
`
`Paragraph 51 contains conclusions of law for which no response is required. To the
`
`extent an answer is required, Fresenius admits 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 denies that the allegations of substantive
`
`infringement of the ’342 patent have any merit. To the extent that there are further averments in
`
`paragraph 51 not addressed by the foregoing, Fresenius denies them.
`
`52.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`
`
`Fresenius’s ANDA Product would infringe one or more claims of the ’342 patent.
`
`19
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 20 of 32 PageID #: 148
`
`ANSWER:
`
`Denied.
`
`53. Upon information and belief, Fresenius intends to engage in the manufacture, use,
`
`
`
`
`
`offer for sale, sale, and/or importation of Fresenius’s ANDA Product immediately and
`
`imminently upon approval of ANDA No. 206077.
`
`ANSWER:
`
`
`
`These allegations relate to future conduct as to which no final decision has been made
`
`and Fresenius therefore denies the allegations of paragraph 53.
`
`54.
`
`The foregoing actions by Fresenius constitute and/or would constitute
`
`
`
`infringement of the ’342 patent.
`
`ANSWER:
`
`Denied.
`
`55. Unless Fresenius is 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 Fresenius’s submission of ANDA No. 206077 was an act of
`
`infringement of the ’967, ’689, ’238, and ’342 patents, and that Fresenius’s manufacture, use,
`
`20
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 21 of 32 PageID #: 149
`
`offer to sell, sale, or importation of Fresenius’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;
`
`
`
`(b) An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
`
`any FDA approval of Fresenius’s ANDA No. 206077, 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 Fresenius, and its affiliates and subsidiaries, and
`
`each of their officers, agents, servants and employees, from making, using, offering to sell,
`
`selling, marketing, distributing, or importing Fresenius’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)
`
`(f)
`
`Plaintiff’s reasonable costs of suit incurred; and
`
`Such further and other relief as this Court deems proper and just.
`
`RESPONSE TO PRAYER FOR RELIEF:
`
`
`
`Fresenius denies that Cubist is entitled to any of the relief requested in its Complaint.
`
`
`
`
`
`
`
`21
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 22 of 32 PageID #: 150
`
`AFFIRMATIVE DEFENSES
`
`Fresenius asserts following defenses:
`
`
`DEFENSE NO. 1
`(Non-Infringement of the ’967, ’689, ’238, and ’342 Patents)
`
`Cubist has failed to aver any facts supporting its allegations of infringement by
`
`
`
`
`
`Fresenius’s proposed ANDA product. Fresenius’s proposed ANDA product, which may be
`
`marketed upon approval of its 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)
`
`Cubist has failed to aver any facts supporting its allegations of inducement of
`
`
`
`infringement by Fresenius’s proposed ANDA product. Fresenius has not, does 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)
`
`Cubist has failed to aver any facts supporting its allegations of contributory infringement
`
`by Fresenius’s proposed ANDA product. Fresenius has not, does 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 35 U.S.C. §§ 101, 102,
`
`103, and 112.
`
`22
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 23 of 32 PageID #: 151
`
`
`
`
`
`
`
`
`
`
`DEFENSE NO. 5
`(Failure to State a Claim)
`
`The Complaint fails to state a claim against Fresenius upon which relief may be granted.
`
`
`DEFENSE NO. 6
`(No Willful Infringement or Declaration of Exceptional Case)
`
`The Complaint fails to state a claim for willful infringement and/or exceptional case.
`
`
`DEFENSE NO. 7
`(Other Defenses)
`
`Any additional defenses or counterclaims that discovery may reveal, including
`
`unenforceability.
`
`COUNTERCLAIMS
`
`
`
`For its counterclaims against Plaintiff/Counterclaim-Defendant Cubist Pharmaceuticals,
`
`Inc. (“Cubist”), Defendant/Counterclaim-Plaintiff Fresenius Kabi USA, LLC (“Fresenius”) states
`
`as follows:
`
`
`
`
`
`
`
`1.
`
`PARTIES
`
`Fresenius is a Delaware limited liability company with its principal place of
`
`business at Three Corporate Drive, Lake Zurich, Illinois 60047.
`
`
`
`2.
`
`Cubist has alleged that it is a Delaware corporation, with its principal place of
`
`business at 65 Hayden Avenue, Lexington, Massachusetts.
`
`
`
`
`
`23
`
`
`
`Case 1:14-cv-00914-GMS Document 7 Filed 08/01/14 Page 24 of 32 PageID #: 152
`
`JURISDICTION AND VENUE
`
`These counterclaims arise under the Patent Laws of the United States, 35 U.S.C.
`
`
`
`3.
`
`§§ 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`
`
`4.
`
`This Court has original jurisdiction over the subject matter of these counterclaims
`
`pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`
`
`5.
`
`This Court has personal jurisdiction over Cubist because Cubist has availed itself
`
`of the rights and privileges of this forum by bringing this civil action in this judicial district and
`
`because, upon information and belief, Cubist
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