Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 1 of 10 PageID #: 1
`
`CUBIST PHARMACEUTICALS, INC.,
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`C.A. No. _______________
`
`
`
`
`
`
`
`
`
`
`
`Plaintiff,
`
`
`
`v.
`
`
`
`
`
`Defendant.
`
`
`FRESENIUS KABI USA, LLC,
`
`COMPLAINT
`
`Plaintiff Cubist Pharmaceuticals, Inc., by its attorneys, alleges 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.
`
`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.
`
`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.
`
`
`
`
`
`CUBIST PHARMACEUTICALS, INC.,
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`C.A. No. _______________
`
`
`
`
`
`
`
`
`
`
`
`Plaintiff,
`
`
`
`v.
`
`
`
`
`
`Defendant.
`
`
`FRESENIUS KABI USA, LLC,
`
`COMPLAINT
`
`Plaintiff Cubist Pharmaceuticals, Inc., by its attorneys, alleges 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.
`
`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.
`
`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.
`
`
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 2 of 10 PageID #: 2
`
`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
`
`branded drugs in, and regularly conduct business throughout, the United States, including in
`
`Delaware.
`
`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.
`
`6.
`
`7.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`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.
`
`BACKGROUND
`CUBICIN® (daptomycin for injection) is an intravenous bactericidal antibiotic
`
`8.
`
`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
`
`
`
`– 2 –
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 3 of 10 PageID #: 3
`
`S. aureus bloodstream infections (bacteremia), including right-sided infective endocarditis
`
`caused by MRSA.
`
`9.
`
`Cubist sells CUBICIN® in the United States pursuant to a New Drug Application
`
`that has been approved by the FDA.
`
`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.
`
`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.
`
`12.
`
` 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
`
`patent, which is owned by Cubist, will expire on November 28, 2020.
`
`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.
`
`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
`
`publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as
`
`the “Orange Book.”
`
`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”).
`
`
`
`– 3 –
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 4 of 10 PageID #: 4
`
`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.
`
`17.
`
`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
`
`18.
`
`Plaintiff incorporates each of the proceeding paragraphs 1–17 as if fully set forth
`
`herein.
`
`19.
`
`The use of Fresenius’s ANDA Product is covered by one or more claims of the
`
`’967 patent.
`
`20.
`
`Fresenius had knowledge of the ’967 patent when it submitted its ANDA to the
`
`FDA.
`
`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.
`
`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.
`
`
`
`– 4 –
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 5 of 10 PageID #: 5
`
`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.
`
`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.
`
`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.
`
`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
`
`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.
`
`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.
`
`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.
`
`
`
`– 5 –
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 6 of 10 PageID #: 6
`
`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.
`
`COUNT II
`
`INFRINGEMENT OF U.S. PATENT NO. 6,852,689
`
`30.
`
`Plaintiff incorporates each of the proceeding paragraphs 1–29 as if fully set forth
`
`herein.
`
`31.
`
`The use of Fresenius’s ANDA Product is covered by one or more claims of the
`
`’689 patent.
`
`32.
`
`Fresenius had knowledge of the ’689 patent when it submitted its ANDA to the
`
`FDA.
`
`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
`
`ANDA Product before the expiration of the ’689 patent is an act of infringement of the ’689
`
`patent.
`
`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.
`
`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.
`
`36.
`
`Upon information and belief, Fresenius intend 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.
`
`
`
`– 6 –
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 7 of 10 PageID #: 7
`
`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.
`
`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.
`
`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.
`
`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.
`
`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.
`
`COUNT III
`
`INFRINGEMENT OF U.S. PATENT NO. 8,058,238
`
`42.
`
`Plaintiff incorporates each of the proceeding paragraphs 1–41 as if fully set forth
`
`herein.
`
`
`
`43.
`
`Fresenius’s ANDA Product is covered by one or more claims of the ’238 patent.
`
`– 7 –
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 8 of 10 PageID #: 8
`
`44.
`
`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 ’238 patent is an act of infringement of the ’238
`
`patent.
`
`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.
`
`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.
`
`47.
`
`The foregoing actions by Fresenius constitute and/or would constitute
`
`infringement of the ’238 patent.
`
`48.
`
`Unless Fresenius is enjoined from infringing the ’238 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`COUNT IV
`
`INFRINGEMENT OF U.S. PATENT NO. 8,129,342
`
`49.
`
`Plaintiff incorporates each of the proceeding paragraphs 1–48 as if fully set forth
`
`herein.
`
`50.
`
`51.
`
`Fresenius’s ANDA Product is covered by one or more claims of the ’342 patent.
`
`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.
`
`
`
`– 8 –
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 9 of 10 PageID #: 9
`
`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.
`
`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.
`
`54.
`
`The foregoing actions by Fresenius constitute and/or would constitute
`
`infringement of the ’342 patent.
`
`55.
`
`Unless Fresenius is enjoined from infringing the ’342 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`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,
`
`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
`– 9 –
`
`
`
`
`
`Case 1:14-cv-00914-GMS Document 1 Filed 07/11/14 Page 10 of 10 PageID #: 10
`
`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;
`
`Plaintiff’s reasonable costs of suit incurred; and
`
`Such further and other relief as this Court deems proper and just.
`
`(e)
`
`(f)
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiff
`Cubist Pharmaceuticals, Inc.
`
`
`
`OF COUNSEL:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily Whelan
`Sean K. Thompson
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`July 11, 2014
`8380712
`
`
`
`– 10 –
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
