Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 1 of 22 PageID #: 1
`
`FILED
`JUN 3 0 20
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`C.A.No. j i1W- I I
`
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`
`BIOGEN INTERNATIONAL GMBH
`and BIOGEN MA INC.,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Biogen International GmbH and Biogen MA Inc. (collectively, “Biogen” or
`
`“Plaintiffs”), by way of Complaint against Defendant Mylan Pharmaceuticals Inc. (“Mylan” or
`
`“Defendant”), allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Biogen International GmbH is a Swiss corporation with its principal
`
`place of business in Zug, Switzerland at Landis + Gyr-Strasse 3, 6300 Zug, Switzerland.
`
`2.
`
`Plaintiff Biogen MA Inc. is a corporation organized and existing under the laws of
`
`the Commonwealth of Massachusetts with its principal place of business at 225 Bimiey Street,
`
`Cambridge, Massachusetts 02142.
`
`3.
`
`Biogen is in the business of developing, manufacturing and marketing innovative
`
`therapies for patients living with serious neurological, autoimmune, and rare diseases, including
`
`therapies for multiple sclerosis. Biogen’ s asserted patents cover Tecfidera®, which is marketed
`
`1
`
`Page 1 of 22
`
`Biogen Exhibit 2040
`Mylan v. Biogen
`IPR2018-01403
`
`
`
`FILED
`JUN 3 0 20
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`C.A.No. j i1W- I I
`
`)
`)
`
`)
`
`)
`)
`
`))
`
`)
`
`BIOGEN INTERNATIONAL GMBH
`and BIOGEN MA INC.,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Biogen International GmbH and Biogen MA Inc. (collectively, “Biogen” or
`
`“Plaintiffs”), by way of Complaint against Defendant Mylan Pharmaceuticals Inc. (“Mylan” or
`
`“Defendant”), allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Biogen International GmbH is a Swiss corporation with its principal
`
`place of business in Zug, Switzerland at Landis + Gyr-Strasse 3, 6300 Zug, Switzerland.
`
`2.
`
`Plaintiff Biogen MA Inc. is a corporation organized and existing under the laws of
`
`the Commonwealth of Massachusetts with its principal place of business at 225 Bimiey Street,
`
`Cambridge, Massachusetts 02142.
`
`3.
`
`Biogen is in the business of developing, manufacturing and marketing innovative
`
`therapies for patients living with serious neurological, autoimmune, and rare diseases, including
`
`therapies for multiple sclerosis. Biogen’ s asserted patents cover Tecfidera®, which is marketed
`
`1
`
`Page 1 of 22
`
`Biogen Exhibit 2040
`Mylan v. Biogen
`IPR2018-01403
`
`
`
`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 2 of 22 PageID #: 2
`
`and sold in this judicial district and throughout the United States for the treatment of relapsing
`
`forms of multiple sclerosis.
`
`4.
`
`Upon information and belief, Mylan is a corporation organized under the laws of
`
`West Virginia, having a principal place of business at 781 Chestnut Ridge Road, Morgantown,
`
`West Virginia 26505.
`
`5.
`
`Upon information and belief, Mylan is a generic pharmaceutical company that
`
`develops, manufactures, markets, and distributes generic pharmaceutical products for sale in the
`
`State of West Virginia and throughout the United States.
`
`NATURE OF THE ACTION
`
`6.
`
`This is an action for patent infringement of U.S. Patent Nos. 6,509,376 (“the ‘376
`
`patent”), 7,320,999 (“the ‘999 patent”), 7,619,001 (“the ‘001 patent”), 7,803,840 (“the ‘840
`
`patent”), 8,759,393 (“the ‘393 patent”) and 8,399,514 (“the ‘514 patent”) arising under the patent
`
`laws of the United States, Title 35, United States Code, § 100 et seq., including 35 U.S.C. §
`
`271. This action relates to Mylan’s filing of Abbreviated New Drug Application (“ANDA”) No.
`
`210531 under Section 505(j) of the Federal Food, Drug and Cosmetic Act (“the Act”), 21 U.S.C.
`
`§ 355(j), seeking U.S. Food and Drug Administration (“FDA”) approval to manufacture, use,
`
`sell, offer to sell, and import dimethyl fumarate delayed-release capsules prior to the expiration
`
`of the asserted patents.
`
`JURISDICTION AND VENUE
`
`7.
`
`8.
`
`This Court has subject matter jurisdiction under 28 U.S.C. § 1331 and 1338(a).
`
`Venue is proper in this Court under 28 U.S.C. § 1391(b) and (c), and § 1400(b)
`
`because Mylan is incorporated in West Virginia.
`
`2
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`9.
`
`This Court has personal jurisdiction over Mylan because Mylan is incorporated in
`
`West Virginia.
`
`10.
`
`Upon information and belief, Mylan has been, and continues to be, the prime
`
`actor in the drafting, submission, approval and maintenance of ANDA No. 210531.
`
`11.
`
`For these reasons and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over Mylan.
`
`FIRST COUNT FOR PATENT INFRINGEMENT (‘376 PATENT)
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ‘376 patent on January
`
`12.
`
`13.
`
`21, 2003, entitled “Utilization of Dialkyfumarates.” The ‘376 patent identifies Rajendra Kumar
`
`Joshi and Hans-Peter Strebel as inventors of the claimed subject matter. A copy of the ‘376
`
`patent is attached hereto as Exhibit A.
`
`14.
`
`Biogen International GmbH is the owner of the ‘376 patent by virtue of
`
`assignment.
`
`15.
`
`The ‘376 patent expires on October 29, 2019, excluding any pediatric exclusivity
`
`or patent term extension.
`
`16.
`
`The ‘376 patent is directed to and claims, inter alia, pharmaceutical preparations
`
`and compositions.
`
`17.
`
`The
`
`‘376 patent
`
`is
`
`listed in Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (“the Orange Book”) for New Drug Application (“NDA”) No. 204063
`
`for dimethyl fumarate delayed-release capsules.
`
`18.
`
`The FDA approved NDA No. 204063 on March 27, 2013, for the treatment of
`
`relapsing forms of multiple sclerosis.
`
`3
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`19.
`
`Dimethyl fumarate delayed-release capsules are marketed in the United States
`
`under the trademark Tecfidera®.
`
`20.
`
`Upon information and belief, Mylan submitted ANDA No. 210531 to the FDA,
`
`under Section 505(j) of the Act, 21 U.S.C. § 355(j), seeking approval to manufacture, use,
`
`import, offer to sell and sell dimethyl fumarate delayed-release capsules containing 120 mg and
`
`240 mg of dimethyl fumarate (“Defendant’s generic products”) in the United States.
`
`21.
`
`Biogen received a letter from Mylan dated June 1, 2017 (“the Notice Letter”),
`
`purporting to include a Notice of Certification for ANDA No. 210531 under 21 U.S.C.
`
`§ 355(j)(2)(B)(ii) and 21 C.F.R. § 314.95(c) as to the ‘376 patent. The Notice Letter did not
`
`allege non-infringement as to at least one claim of the ‘376 patent.
`
`22.
`
`23.
`
`Mylan thus has actual knowledge of the ‘376 patent.
`
`Upon information and belief, Defendant’s generic products,
`
`if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
`
`including at least claim 1 of the ‘376 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`24.
`
`Upon information and belief, under 35 U.S.C.
`
`§ 271(e)(2)(A), Mylan has
`
`infringed at least one claim including at least claim 1 of the ‘376 patent by submitting, or causing
`
`to be submitted, to the FDA, ANDA No. 210531 seeking approval to manufacture, use, import,
`
`offer to sell or sell Defendant’s generic products before the expiration date of the ‘376 patent.
`
`Upon information and belief, the products described in ANDA No. 210531 would infringe, either
`
`literally or under the doctrine of equivalents, at least one claim including at least claim 1 of the
`
`‘376 patent under 35 U.S.C. § 271(e)(2)(A).
`
`4
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`25.
`
`Upon information and belief, Mylan will manufacture, market, import, use, sell
`
`and/or offer to sell Defendant’s generic products in the United States in connection with ANDA
`
`No. 210531 upon approval.
`
`26.
`
`Upon information and belief, Mylan will directly infringe at
`
`least one claim
`
`including at least claim 1 of the ‘376 patent when it proceeds to manufacture, market, import,
`
`use, sell and/or offer to sell Defendant’s generic products in the United States in connection with
`
`ANDANo. 210531 upon approval.
`
`27.
`
`Upon information and belief, Mylan’s actions relating to Mylan’s ANDA No.
`
`210531 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Mylan.
`
`28.
`
`If Mylan’s marketing and sale of generic dimethyl fumarate delayed-release
`
`capsules prior to expiration of the ‘376 patent and all other relevant activities are not enjoined,
`
`Biogen will suffer substantial and irreparable harm for which there is no adequate remedy at law.
`
`SECOND COUNT FOR PATENT INFRINGEMENT (‘999 PATENT)
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`The PTO issued the ‘999 patent on January 22, 2008, entitled “Dimethyl
`
`29.
`
`30.
`
`Fumarate for the Treatment of Multiple Sclerosis.” The ‘999 patent identifies Rajendra Kumar
`
`Joshi and Hans-Peter Strebel as inventors of the claimed subject matter. A copy of the ‘999
`
`patent is attached hereto as Exhibit B.
`
`31.
`
`Biogen International GmbH is the owner of the ‘999 patent by virtue of
`
`assignment.
`
`5
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`Page 5 of 22
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`32.
`
`The ‘999 patent expires on May 18, 2020, which includes 202 days of Patent
`
`Term Adjustment under 35 U.S .C. § 154(b), excluding any pediatric exclusivity or patent term
`
`extension.
`
`33.
`
`The ‘999 patent is directed to and claims, inter alia, methods of treating multiple
`
`sclerosis.
`
`34.
`
`The ‘999 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`35.
`
`The Notice Letter dated June 1, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210531 under 21 U.S.C.
`
`§ 355(j)(2)(B)(ii) and 21 C.F.R.
`
`§ 314.95(c) as to the ‘999 patent. The Notice Letter did not allege non-infringement as to any
`
`claim of the ‘999 patent.
`
`36.
`
`37.
`
`Mylan thus has actual knowledge of the ‘999 patent.
`
`Upon information and belief, Defendant’s generic products,
`
`if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
`
`including at least claim 1 of the ‘999 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`38.
`
`Upon information and belief, under 35 U.S.C.
`
`§ 271(e)(2)(A), Mylan has
`
`infringed at least one claim including at least claim 1 of the ‘999 patent by submitting, or causing
`
`to be submitted, to the FDA, ANDA No. 210531 seeking approval to manufacture, use, import,
`
`offer to sell or sell Defendant’s generic products before the expiration date of the ‘999 patent.
`
`Upon information and belief, the products described in ANDA No. 210531 would infringe, either
`
`literally or under the doctrine of equivalents, at least one claim including at least claim 1 of the
`
`‘999 patent under 35 U.S.C. § 271(e)(2)(A).
`
`6
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`Page 6 of 22
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`
`39.
`
`Upon information and belief, physicians and/or patients will directly infringe at
`
`least one claim including at least claim 1 of the ‘999 patent by the use of Defendant’s generic
`
`products upon approval.
`
`40.
`
`Upon information and belief, upon approval, Mylan will take active steps to
`
`encourage the use of Defendant’s generic products by physicians and/or patients with the
`
`knowledge and intent that Defendant’s generic products will be used by physicians and/or
`
`patients, in a manner that infringes at least one claim including at least claim 1 of the ‘999 patent,
`
`for the pecuniary benefit of Mylan. Pursuant to 21 C.F.R. § 314.94, Mylan is required to copy
`
`the FDA approved Tecfidera® labeling. Upon information and belief Mylan will thus induce the
`
`infringement of at least one claim including at least claim 1 of the ‘999 patent.
`
`41.
`
`Upon information and belief, if the FDA approves ANDA No. 210531, Mylan
`
`will sell or offer to sell its generic products specifically labeled for use in practicing at least one
`
`claim including at least claim 1 of the ‘999 patent, wherein Defendant’s generic products are a
`
`material part of the claimed invention, wherein Mylan knows that physicians will prescribe and
`
`patients will use Defendant’s generic products in accordance with the instructions and/or label
`
`provided by Mylan in practicing at least one claim including at least claim 1 of the ‘999 patent,
`
`and wherein dimethyl fumarate delayed-release capsules are not staple articles or commodities of
`
`commerce suitable for substantial non-infringing use. Upon information and belief, Mylan will
`
`thus contribute to the infringement of at least one claim including at least claim 1 of the ‘999
`
`patent.
`
`42.
`
`Upon information and belief, Mylan’s actions relating to Mylan’s ANDA No.
`
`210531 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Mylan.
`
`7
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`
`43.
`
`If Mylan’s marketing and sale of generic dimethyl fumarate delayed-release
`
`capsules prior to expiration of the ‘999 patent and all other relevant activities are not enjoined,
`
`Biogen will suffer substantial and irreparable harm for which there is no adequate remedy at law.
`
`THIRD COUNT FOR PATENT INFRINGEMENT (‘001 PATENT)
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`The PTO issued the ‘001 patent on November 17, 2009, entitled “Utilization of
`
`44.
`
`45.
`
`Dialkylfumarates.” The ‘001 patent identifies Rajendra Kumar Joshi and Hans-Peter Strebel as
`
`inventors of the claimed subject matter. A copy of the ‘001 patent is attached hereto as Exhibit
`
`C.
`
`46.
`
`Biogen International GmbH is the owner of the ‘001 patent by virtue of
`
`assignment.
`
`47.
`
`The ‘001 patent expires on April 1, 2018, excluding any pediatric exclusivity or
`
`patent term extension.
`
`48.
`
`The ‘001 patent is directed to and claims, inter alia, methods of treating multiple
`
`sclerosis.
`
`49.
`
`The ‘001 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`50.
`
`The Notice Letter dated June 1, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210531 under 21 U.S.C.
`
`§ 355(j)(2)(B)(ii) and 21 C.F.R.
`
`§ 3 14.95(c) as to the ‘001 patent. The Notice Letter did not allege non-infringement as to at least
`
`one claim of the ‘001 patent.
`
`51.
`
`Mylan thus has actual knowledge of the ‘001 patent.
`
`8
`
`Page 8 of 22
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`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 9 of 22 PageID #: 9
`
`52.
`
`Upon information and belief, Defendant’s generic products,
`
`if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
`
`including at least claim 1 of the ‘001 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`53.
`
`Upon information and belief, under 35 U.S.C.
`
`§ 271(e)(2)(A), Mylan has
`
`infringed at least one claim including at least claim 1 of the ‘001 patent by submitting, or causing
`
`to be submitted, to the FDA, ANDA No. 210531 seeking approval to manufacture, use, import,
`
`offer to sell or sell Defendant’s generic products before the expiration date of the ‘001 patent.
`
`Upon information and belief, the products described in ANDA No. 210531 would infringe, either
`
`literally or under the doctrine of equivalents, at least one claim including at least claim 1 of the
`
`‘001 patent under 35 U.S.C. § 271(e)(2)(A).
`
`54.
`
`Upon information and belief, physicians and/or patients will directly infringe at
`
`least one claim including at least claim 1 of the ‘001 patent by the use of Defendant’s generic
`
`products upon approval.
`
`55.
`
`Upon information and belief, upon approval, Mylan will take active steps to
`
`encourage the use of Defendant’s generic products by physicians and/or patients with the
`
`knowledge and intent that Defendant’s generic products will be used by physicians and/or
`
`patients, in a manner that infringes at least one claim including at least claim 1 of the ‘001 patent,
`
`for the pecuniary benefit of Mylan. Pursuant to 21 C.F.R. § 314.94, Mylan is required to copy
`
`the FDA approved Tecfidera® labeling. Upon information and belief, Mylan will thus induce the
`
`infringement of at least one claim including at least claim 1 of the ‘001 patent.
`
`56.
`
`Upon information and belief, if the FDA approves ANDA No. 210531, Mylan
`
`will sell or offer to sell its generic products specifically labeled for use in practicing at least one
`9
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`Page 9 of 22
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`
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`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 10 of 22 PageID #: 10
`
`claim including at least claim 1 of the ‘001 patent, wherein Defendant’s generic products are a
`
`material part of the claimed invention, wherein Mylan knows that physicians will prescribe and
`
`patients will use Defendant’s generic products in accordance with the instructions and/or label
`
`provided by Mylan in practicing at least one claim including at least claim 1 of the ‘001 patent,
`
`and wherein dimethyl fumarate delayed-release capsules are not staple articles or commodities of
`
`commerce suitable for substantial non-infringing use. Upon information and belief, Mylan will
`
`thus contribute to the infringement of at least one claim including at least claim 1 of the ‘001
`
`patent.
`
`57.
`
`Upon information and belief, Mylan’s actions relating to Mylan’s ANDA No.
`
`210531 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Mylan.
`
`58.
`
`If Mylan’ s marketing and sale of generic dimethyl fumarate delayed-release
`
`capsules prior to expiration of the ‘001 patent and all other relevant activities are not enjoined,
`
`Biogen will suffer substantial and irreparable harm for which there is no adequate remedy at law.
`
`FOURTH COUNT FOR PATENT INFRINGEMENT (‘840 PATENT)
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`The PTO issued the ‘840 patent on September 28, 2010, entitled “Utilization of
`
`59.
`
`60.
`
`Dialkylfumarates.” The ‘840 patent identifies Rajendra Kumar Joshi and Hans-Peter Strebel as
`
`inventors of the claimed subject matter. A copy of the ‘840 patent is attached hereto as Exhibit
`
`D.
`
`61.
`
`Biogen International GmbH is the owner of the ‘840 patent by virtue of
`
`assignment.
`
`10
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`Page 10 of 22
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`
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`
`62.
`
`The ‘840 patent expires on April 1, 2018, excluding any pediatric exclusivity or
`
`patent term extension.
`
`63.
`
`The ‘840 patent is directed to and claims, inter alia, methods of treating multiple
`
`sclerosis.
`
`64.
`
`The ‘840 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`65.
`
`The Notice Letter dated June 1, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210531 under 21 U.S.C.
`
`§ 355(j)(2)(B)(ii) and 21 C.F.R.
`
`§ 3 14.95(c) as to the ‘840 patent. The Notice Letter did not allege non-infringement as to any
`
`claim of the ‘840 patent.
`
`66.
`
`67.
`
`Mylan thus has actual knowledge of the ‘840 patent.
`
`Upon information and belief, Defendant’s generic products,
`
`if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
`
`including at least claim 1 of the ‘840 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`68.
`
`Upon information and belief, under 35 U.S.C.
`
`§ 271(e)(2)(A), Mylan has
`
`infringed at least one claim including at least claim 1 of the ‘840 patent by submitting, or causing
`
`to be submitted, to the FDA, ANDA No. 210531 seeking approval to manufacture, use, import,
`
`offer to sell or sell Defendant’s generic products before the expiration date of the ‘840 patent.
`
`Upon information and belief, the products described in ANDA No. 210531 would infringe, either
`
`literally or under the doctrine of equivalents, at least one claim including at least claim 1 of the
`
`‘840 patent under 35 U.S.C. § 271(e)(2)(A).
`
`11
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`Page 11 of 22
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`
`69.
`
`Upon information and belief, physicians and/or patients will directly infringe at
`
`least one claim including at least claim 1 of the ‘840 patent by the use of Defendant’s generic
`
`products upon approval.
`
`70.
`
`Upon information and belief, upon approval, Mylan will
`
`take active steps to
`
`encourage the use of Defendant’s generic products by physicians andlor patients with the
`
`knowledge and intent that Defendant’s generic products will be used by physicians and/or
`
`patients, in a manner that infringes at least one claim including at least claim 1 of the ‘840 patent,
`
`for the pecuniary benefit of Mylan. Pursuant to 21 C.F.R. § 314.94, Mylan is required to copy
`
`the FDA approved Tecfidera® labeling. Upon information and belief, Mylan will thus induce the
`
`infringement of at least one claim including at least claim 1 of the ‘840 patent.
`
`71.
`
`Upon information and belief, if the FDA approves ANDA No. 210531, Mylan
`
`will sell or offer to sell its generic products specifically labeled for use in practicing at least one
`
`claim including at least claim 1 of the ‘840 patent, wherein Defendant’s generic products are a
`
`material part of the claimed invention, wherein Mylan knows that physicians will prescribe and
`
`patients will use Defendant’s generic products in accordance with the instructions and/or label
`
`provided by Mylan in practicing at least one claim including at least claim 1 of the ‘840 patent,
`
`and wherein dimethyl fumarate delayed-release capsules are not staple articles or commodities of
`
`commerce suitable for substantial non-infringing use. Upon information and belief, Mylan will
`
`thus contribute to the infringement of at least one claim including at least claim 1 of the ‘840
`
`patent.
`
`72.
`
`Upon information and belief, Mylan’s actions relating to Mylan’s ANDA No.
`
`210531 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Mylan.
`
`12
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`Page 12 of 22
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`
`73.
`
`If Mylan’s marketing and sale of generic dimethyl fumarate delayed-release
`
`capsules prior to expiration of the ‘840 patent and all other relevant activities are not enjoined,
`
`Biogen will suffer substantial and irreparable harm for which there is no adequate remedy at law.
`
`FIFTH COUNT FOR PATENT INFRINGEMENT (‘393 PATENT)
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`The PTO issued the ‘393 patent on June 24, 2014, entitled “Utilization of
`
`74.
`
`75.
`
`Dialkyiflimarates.” The ‘393 patent identifies Rajendra Kumar Joshi and Hans-Peter Strebel as
`
`inventors of the claimed subject matter. A copy of the ‘393 patent is attached hereto as Exhibit
`
`E.
`
`76.
`
`Biogen International GmbH is the owner of the ‘393 patent by virtue of
`
`assignment.
`
`77.
`
`78.
`
`79.
`
`The ‘393 patent expires on October 29, 2019, excluding any pediatric exclusivity.
`
`The ‘393 patent is directed to and claims, inter alia, pharmaceutical preparations.
`
`The ‘393 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`80.
`
`The Notice Letter dated June 1, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210531 under 21 U.S.C.
`
`§ 355(j)(2)(B)(ii) and 21 C.F.R.
`
`§ 314.95(c) as to the ‘393 patent. The Notice Letter did not allege non-infringement as to any
`
`claim of the ‘393 patent.
`
`81.
`
`82.
`
`Mylan thus has actual knowledge of the ‘393 patent.
`
`Upon information and belief Defendant’s generic products,
`
`if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
`
`13
`
`Page 13 of 22
`
`
`
`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 14 of 22 PageID #: 14
`
`including at least claim 1 of the ‘393 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`83.
`
`Upon information and belief, under 35 U.S.C.
`
`§ 271(e)(2)(A), Mylan has
`
`infringed at least one claim including at least claim 1 of the ‘393 patent by submitting, or causing
`
`to be submitted, to the FDA, ANDA No. 210531 seeking approval to manufacture, use, import,
`
`offer to sell or sell Defendant’s generic products before the expiration date of the ‘393 patent.
`
`Upon information and belief, the products described in ANDA No. 210531 would infringe, either
`
`literally or under the doctrine of equivalents, at least one claim including at least claim 1 of the
`
`‘393 patent under 35 U.S.C. § 271(e)(2)(A).
`
`84.
`
`Upon information and belief, Mylan will directly infringe at
`
`least one claim
`
`including at least claim 1 of the ‘393 patent when it proceeds to manufacture, market, import,
`
`use, sell and/or offer to sell Defendant’s generic products in the United States in connection with
`
`ANDANo. 210531 upon approval.
`
`85.
`
`Upon information and belief, Mylan’s actions relating to Mylan’s ANDA No.
`
`210531 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Mylan.
`
`86.
`
`If Mylan’ s marketing and sale of generic dimethyl fumarate delayed-release
`
`capsules prior to expiration of the ‘393 patent and all other relevant activities are not enjoined,
`
`Biogen will suffer substantial and irreparable harm for which there is no adequate remedy at law.
`
`SIXTH COUNT FOR PATENT INFRINGEMENT (‘514 PATENT)
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`The PTO issued the ‘514 patent on March 19, 2013, entitled “Treatment for
`
`87.
`
`88.
`
`Multiple Sclerosis.” The ‘514 patent identifies Matvey E. Lukashev and Gilmore O’Neill as
`14
`
`Page 14 of 22
`
`
`
`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 15 of 22 PageID #: 15
`
`inventors of the claimed subject matter. A copy of the ‘514 patent is attached hereto as Exhibit
`
`F.
`
`89.
`
`90.
`
`91.
`
`sclerosis.
`
`Biogen MA Inc. is the owner of the ‘514 patent by virtue of assignment.
`
`The ‘514 patent expires on February 7, 2028, excluding any pediatric exclusivity.
`
`The ‘514 patent is directed to and claims, inter alia, methods of treating multiple
`
`92.
`
`The ‘514 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`93.
`
`The Notice Letter dated June 1, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210531 under 21 U.S.C.
`
`§ 355(j)(2)(B)(ii) and 21 C.F.R.
`
`§ 314.95(c) as to the ‘514 patent. The Notice Letter did not allege non-infringement as to at least
`
`one claim of the ‘514 patent.
`
`94.
`
`95.
`
`Mylan thus has actual knowledge of the ‘514 patent.
`
`Upon information and belief, Defendant’s generic products,
`
`if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
`
`including at least claim 1 of the ‘514 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`96.
`
`Upon information and belief, under 35 U.S.C.
`
`§ 271(e)(2)(A), Mylan has
`
`infringed at least one claim including at least claim 1 of the ‘514 patent by submitting, or causing
`
`to be submitted, to the FDA, ANDA No. 210531 seeking approval to manufacture, use, import,
`
`offer to sell or sell Defendant’s generic products before the expiration date of the ‘514 patent.
`
`Upon information and belief, the products described in ANDA No. 210531 would infringe, either
`
`15
`
`Page 15 of 22
`
`
`
`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 16 of 22 PageID #: 16
`
`literally or under the doctrine of equivalents, at least one claim including at least claim 1 of the
`
`‘514 patent under 35 U.S.C. § 271(e)(2)(A).
`
`97.
`
`Upon information and belief, physicians and/or patients will directly infringe at
`
`least one claim including at least claim 1
`
`the ‘514 patent by the use of Defendant’s generic
`
`products upon approval.
`
`98.
`
`Upon information and belief, upon approval, Mylan will take active steps to
`
`encourage the use of Defendant’s generic products by physicians and/or patients with the
`
`knowledge and intent that Defendant’s generic products will be used by physicians and/or
`
`patients, in a manner that infringes at least one claim including at least claim 1 of the ‘514 patent,
`
`for the pecuniary benefit of Mylan. Pursuant to 21 C.F.R. § 314.94, Mylan is required to copy
`
`the FDA approved Tecfidera® labeling. Upon information and belief, Mylan will thus induce the
`
`infringement of at least one claim including at least claim 1 of the ‘514 patent.
`
`99.
`
`Upon information and belief, if the FDA approves ANDA No. 210531, Mylan
`
`will sell or offer to sell its generic products specifically labeled for use in practicing at least one
`
`claim including at least claim 1 of the ‘514 patent, wherein Defendant’s generic products are a
`
`material part of the claimed invention, wherein Mylan knows that physicians will prescribe and
`
`patients will use Defendant’s generic products in accordance with the instructions and/or label
`
`provided by Mylan in practicing at least one claim including at least claim 1 of the ‘514 patent,
`
`and wherein dimethyl fumarate delayed-release capsules are not staple articles or commodities of
`
`conirnerce suitable for substantial non-infringing use. Upon information and belief, Mylan will
`
`thus contribute to the infringement of at least one claim including at least claim 1 of the ‘514
`
`patent.
`
`16
`
`Page 16 of 22
`
`
`
`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 17 of 22 PageID #: 17
`
`100.
`
`Upon information and belief, Mylan’s actions relating to Mylan’s ANDA No.
`
`210531 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Mylan.
`
`101.
`
`If Mylan’s marketing and sale of generic dimethyl fumarate delayed-release
`
`capsules prior to expiration of the ‘514 patent and all other relevant activities are not enjoined,
`
`Biogen will suffer substantial and irreparable harm for which there is no adequate remedy at law.
`
`REQUEST FOR RELIEF
`
`WHEREFORE, Biogen respectfully requests that the Court enter judgment in its favor
`
`and against Defendant Mylan on the patent infringement claims set forth above and respectfully
`
`requests that this Court:
`
`1.
`
`enter judgment under 35 U.S.C. § 271(e)(2)(A) that Mylan has infringed at least
`
`one claim including at least claim 1 of the ‘376 patent through Mylan’s submission of ANDA
`
`No. 210531 to the FDA to obtain approval to manufacture, use, import, offer to sell and sell
`
`Defendant’s generic products in the United States before the expiration of the ‘376 patent;
`
`2.
`
`enter judgment under 35 U.S.C. § 271(a) that Mylan’ s commercial manufacture,
`
`use, offer for sale, or sale within the United States, or importation into the United States of
`
`Defendant’s generic products prior to the expiration of the ‘376 patent constitutes infringement
`
`of one or more claims of said patent under 35 U.S.C. § 271(a);
`
`3.
`
`order that the effective date of any approval by the FDA of Defendant’s generic
`
`products be a date that is not earlier than the expiration date of the ‘376 patent, or such later date
`
`as the Court may determine;
`
`17
`
`Page 17 of 22
`
`
`
`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 18 of 22 PageID #: 18
`
`4.
`
`enjoin Mylan, and all persons acting in concert with Mylan,
`
`from the
`
`manufacture, use,
`
`import, offer for sale and sale of Defendant’s generic products until
`
`the
`
`expiration of the ‘376 patent, or such later date as the Court may determine;
`
`5.
`
`enjoin Mylan, and all persons acting in concert with Mylan,
`
`from seeking,
`
`obtaining or maintaining approval of Mylan’ s ANDA No. 210531 until the expiration of the ‘376
`
`patent, or such later date as the Court may determine;
`
`6.
`
`enter judgment under 35 U.S.C. § 271(e)(2)(A) that Mylan has infringed at least
`
`one claim including at least claim 1 of the ‘999 patent through Mylan’s submission of ANDA
`
`No. 210531 to the FDA to obtain approval to manufacture, use, import, offer to sell and sell
`
`Defendant’s generic products in the United States before the expiration of the ‘999 patent;
`
`7.
`
`enter judgment under 35 U.S.C. § 271(b) and/or (c) that Mylan’s commercial
`
`manufacture, use, offer for sale, or sale within the United States, or importation into the United
`
`States of Defendant’s generic products prior to the expiration of the ‘999 patent constitutes
`
`infringement of one or more claims of said patent under 35 U.S.C. § 27 1(b) and/or (c);
`
`8.
`
`order that the effective date of any approval by the FDA of Defendant’s generic
`
`products be a date that is not earlier than the expiration date of the ‘999 patent, or such later date
`
`as the Court may determine;
`
`9.
`
`enjoin Mylan, and all persons acting in concert with Mylan,
`
`from the
`
`manufacture, use,
`
`import, offer for sale and sale of Defendant’s generic products until
`
`the
`
`expiration of the ‘999 patent, or such later date as the Court may determine;
`
`10.
`
`enjoin Mylan, and all persons acting in concert with Mylan,
`
`from seeking,
`
`obtaining or maintaining approval of Mylan’s ANDA No. 210531 until the expiration of the ‘999
`
`patent, or such later date as the Court may determine;
`18
`
`Page 18 of 22
`
`
`
`Case 1:17-cv-00116-IMK Document 1 Filed 06/30/17 Page 19 of 22 PageID #: 19
`
`11.
`
`enter judgment under 35 U.S.C. § 271(e)(2)(A) that Mylan has infringed at least
`
`one claim including at least claim 1 of the ‘001 patent through Mylan’s submission of ANDA
`
`No. 210531 to the FDA to obtain approval to manufacture, use, import, offer to sell and sell
`
`Defendant’s generic products in the United States before the expiration of the ‘001 patent;
`
`12.
`
`enter judgment under 35 U.S.C. § 271(b) and/or (c) that Mylan’s commercial
`
`manufacture, use, offer for sale, or sale within the United States, or importation into the United
`
`States of Defendant’s g
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