Case 1:17-cv-00116-IMK Document 25 Filed 08/07/17 Page 1 of 40 PageID #: 151
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`
`BIOGEN INTERNATIONAL GMBH and
`BIOGEN MA INC.,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`MYLAN PHARMACEUTICALS INC.
`
`
`Defendant.
`
`
`
`C.A. No. 1:17-cv-116-IMK
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`
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.’S
`ANSWER, SEPARATE DEFENSES AND COUNTERCLAIMS TO COMPLAINT
`
`Mylan Pharmaceuticals Inc. (“Mylan”) by its undersigned attorneys, answers and
`
`responds to the Complaint of plaintiffs Biogen International GmbH and Biogen MA Inc.
`
`(collectively, “Plaintiffs” or “Biogen”) on behalf of Mylan and no other parties, 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.
`
`ANSWER: Mylan is without knowledge or information sufficient to form a belief as to the
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`allegations set forth in paragraph 1 and, therefore, denies those allegations.
`
`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 Binney Street,
`Cambridge, Massachusetts 02142.
`
`ANSWER: Mylan is without knowledge or information sufficient to form a belief as to the
`
`allegations set forth in paragraph 2 and, therefore, denies those allegations.
`
`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
`and sold in this judicial district and throughout the United States for the treatment of relapsing
`forms of multiple sclerosis.
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`1
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`Page 1 of 40
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`Biogen Exhibit 2013
`Mylan v. Biogen
`IPR2018-01403
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`ANSWER: Mylan is without knowledge or information sufficient to form a belief as to the
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`allegations set forth in paragraph 3 and, therefore, denies those allegations.
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`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.
`
`ANSWER: Admitted.
`
`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.
`
`ANSWER: Mylan admits that it develops and manufactures certain generic drugs in West
`
`Virginia. Mylan denies any remaining allegations set forth in paragraph 5.
`
`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.
`
`ANSWER: Mylan admits that it filed an Abbreviated New Drug Application (“ANDA”),
`
`seeking approval by the United States Food and Drug Administration (“FDA”) for dimethyl
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`fumarate delayed-release capsules prior to the expiration of United States Patent Nos. 6,509,376
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`(“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”). Mylan is without
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`knowledge or information sufficient to form a belief as to the remaining allegations set forth in
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`paragraph 6 and, therefore, denies those allegations.
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`JURISDICTION AND VENUE
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`7.
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` This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`2
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`ANSWER: Paragraph 7 states a legal conclusion to which no answer is required. To the
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`extent an answer is required, Mylan admits that the Court has subject matter jurisdiction of any
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`civil action arising under any Act of Congress relating to patents under 28 U.S.C. §§ 1331 and
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`1338(a). Mylan denies any remaining allegations set forth in paragraph 7.
`
`8.
`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.
`
`ANSWER: Paragraph 8 states a legal conclusion to which no answer is required. To the
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`extent an answer is required, Mylan does not contest venue in this Judicial District. Mylan
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`denies any remaining allegations set forth in paragraph 8.
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`9.
`This Court has personal jurisdiction over Mylan because Mylan is incorporated in
`West Virginia.
`
`ANSWER: Paragraph 9 states a legal conclusion to which no answer is required. To the
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`extent an answer is required, Mylan does not contest personal jurisdiction in this Judicial
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`District. Mylan denies any remaining allegations set forth in paragraph 9.
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`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.
`
`ANSWER: To the extent that the allegation in paragraph 10 is directed to a “prime actor,” this
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`allegation is unclear and as such Mylan denies the allegations set forth in paragraph 10. To the
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`extent this allegation can be understood, Mylan admits that it developed, filed and is seeking
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`regulatory approval for ANDA No. 210531, for dimethyl fumarate delayed-release capsules.
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`Mylan denies any remaining allegations set forth in paragraph 10.
`
`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.
`
`ANSWER: Paragraph 11 states a legal conclusion to which no answer is required. To the
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`extent an answer is required, Mylan does not contest personal jurisdiction in this Judicial
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`District.
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`FIRST COUNT FOR PATENT INFRINGEMENT (’376 PATENT)
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`12.
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`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`ANSWER: Mylan hereby incorporates its responses to paragraphs 1–11 as if fully set forth
`
`herein.
`
`13.
`The U.S. Patent and Trademark Office (“PTO”) issued the ’376 patent on January
`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.
`
`ANSWER: Mylan admits that the ’376 patent states on its face that it was issued on January
`
`21, 2003, is entitled “Utilization of Dialkyfumarates,” and lists Rajendra Kumar Joshi and Hans-
`
`Peter Strebel as inventors. Mylan is without sufficient knowledge and information to form a
`
`belief as to whether Rajendra Kumar Joshi and Hans-Peter Strebel are the inventors of the ’376
`
`patent and, therefore, denies that allegation and any other remaining allegations of paragraph 13.
`
`Mylan acknowledges that what purports to be a copy of the ’376 patent was attached as Exhibit
`
`A to the Complaint.
`
`14.
`assignment.
`
`Biogen International GmbH is the owner of the ’376 patent by virtue of
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 14, and therefore, denies those allegations.
`
`15.
`The ’376 patent expires on October 29, 2019, excluding any pediatric exclusivity
`or patent term extension.
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 15, and therefore, denies those allegations.
`
`16.
`The ’376 patent is directed to and claims, inter alia, pharmaceutical preparations
`and compositions.
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`
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`ANSWER: Based on publicly-available information, Mylan admits that the ’376 patent
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`purports to claim certain pharmaceutical preparations and compositions. Mylan denies any
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`remaining allegations set forth in paragraph 16.
`
`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.
`
`ANSWER: Based on publicly-available information, Mylan admits that the ’376 patent
`
`appears to be listed in the Orange Book with respect to NDA No. 204063 for dimethyl fumarate
`
`delayed-release capsules. Mylan is without sufficient knowledge to form a belief as to the
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`propriety of that listing. Mylan denies any remaining allegations of paragraph 17.
`
`18.
`The FDA approved NDA No. 204063 on March 27, 2013, for the treatment of
`relapsing forms of multiple sclerosis.
`
`ANSWER: Based on publicly-available information, Mylan admits that NDA No. 204063
`
`appears to have been approved by FDA on March 27, 2013, related to the use of dimethyl
`
`fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
`
`Mylan denies any remaining allegations of paragraph 18.
`
`19.
`Dimethyl fumarate delayed-release capsules are marketed in the United States
`under the trademark Tecfidera®.
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations of paragraph 19, and therefore, denies those allegations.
`
`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.
`
`ANSWER: Mylan admits that it submitted ANDA No. 210531 to the FDA, under Section
`
`505(j) of the Act, 21 U.S.C. § 355(j), seeking approval for dimethyl fumarate delayed-release
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`
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`5
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`capsules containing 120 mg and 240 mg of dimethyl fumarate in the United States. Mylan
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`denies any remaining allegations of paragraph 20.
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`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.
`
`ANSWER: Mylan admits that the Notice Letter served by Mylan on Biogen was dated June 1,
`
`2017, included 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, and that it was received by
`
`Biogen. Mylan denies the remaining allegations of paragraph 21.
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`22. Mylan thus has actual knowledge of the ’376 patent.
`
`ANSWER: Mylan admits that it had knowledge of the ’376 patent at least as of the time it
`
`served Biogen with the Notice Letter dated June 1, 2017. Mylan denies the remaining allegation
`
`set forth in paragraph 22 as it states a legal conclusion for which no answer is required. To the
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`extent an answer is deemed required, Mylan denies the remaining allegation of paragraph 22.
`
`23.
`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).
`
`ANSWER: Mylan denies the allegations of paragraph 23.
`
`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).
`
`ANSWER: Mylan admits that it submitted ANDA No. 210531 seeking approval for dimethyl
`
`fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate. Mylan
`
`denies the remaining allegations of paragraph 24 as they state legal conclusions for which no
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`answer is required. To the extent an answer is deemed required, Mylan denies the allegations of
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`paragraph 24.
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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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 25.
`
`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
`ANDA No. 210531 upon approval.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 26.
`
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 27.
`
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 28.
`
`SECOND COUNT FOR PATENT INFRINGEMENT (’999 PATENT)
`
`29.
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`ANSWER: Mylan hereby incorporates its responses to paragraphs 1–28 as if fully set forth
`
`herein.
`
`30.
`The PTO issued the ’999 patent on January 22, 2008, entitled “Dimethyl
`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.
`
`ANSWER: Mylan admits that the ’999 patent states on its face that it was issued on January
`
`22, 2008, is entitled “Dimethyl Fumarate for the Treatment of Multiple Sclerosis,” and lists
`
`Rajendra Kumar Joshi and Hans-Peter Strebel as inventors. Mylan is without sufficient
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`knowledge and information to form a belief as to whether Rajendra Kumar Joshi and Hans-Peter
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`Strebel are the inventors of the ’999 patent and, therefore, denies that allegation and any other
`
`remaining allegations of paragraph 30. Mylan acknowledges that what purports to be a copy of
`
`the ’999 patent was attached as Exhibit B to the Complaint.
`
`31.
`assignment.
`
`Biogen International GmbH is the owner of the ’999 patent by virtue of
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 31, and therefore, denies those allegations.
`
`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.
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 32, and therefore, denies those allegations.
`
`33.
`sclerosis.
`
`The ’999 patent is directed to and claims, inter alia, methods of treating multiple
`
`ANSWER: Based on publicly-available information, Mylan admits that the ’999 patent
`
`purports to claim a method of treating multiple sclerosis. Mylan denies any remaining
`
`allegations set forth in paragraph 33.
`
`34.
`The ’999 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`fumarate delayed-release capsules.
`
`ANSWER: Based on publicly-available information, Mylan admits that the ’999 patent
`
`appears to be listed in the Orange Book with respect to NDA No. 204063 for dimethyl fumarate
`
`delayed-release capsules. Mylan is without sufficient knowledge to form a belief as to the
`
`propriety of that listing. Mylan denies any remaining allegations of paragraph 34.
`
`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.
`
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`ANSWER: Mylan admits that the Notice Letter served by Mylan on Biogen was dated June 1,
`
`2017 and included 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. Mylan denies the remaining
`
`allegations of paragraph 35.
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`36. Mylan thus has actual knowledge of the ’999 patent.
`
`ANSWER: Mylan admits that it had knowledge of the ’999 patent at least as of the time it
`
`served Biogen with the Notice Letter dated June 1, 2017. Mylan denies the remaining allegation
`
`set forth in paragraph 36 as it states a legal conclusion for which no answer is required. To the
`
`extent an answer is deemed required, Mylan denies the remaining allegation of paragraph 36.
`
`37.
`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).
`
`ANSWER: Mylan denies the allegations of paragraph 37.
`
`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).
`
`ANSWER: Mylan admits that it submitted ANDA No. 210531 seeking approval for dimethyl
`
`fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate. Mylan
`
`denies the remaining allegations of paragraph 38 as they state legal conclusions for which no
`
`answer is required. To the extent an answer is deemed required, Mylan denies the allegations of
`
`paragraph 38.
`
`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.
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`ANSWER: Mylan denies the allegations set forth in paragraph 39.
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`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 40.
`
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 41.
`
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 42.
`
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 43.
`
`THIRD COUNT FOR PATENT INFRINGEMENT (’001 PATENT)
`
`44.
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`ANSWER: Mylan hereby incorporates its responses to paragraphs 1–43 as if fully set forth
`
`herein.
`
`45.
`The PTO issued the ’001 patent on November 17, 2009, entitled “Utilization of
`Dialkyfumarates.” The ’001 patent identifies Rajendra Kumar Joshi and Hans-Peter Strebel as
`
`
`
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`inventors of the claimed subject matter. A copy of the ’001 patent is attached hereto as Exhibit
`C.
`
`ANSWER: Mylan admits that the ’001 patent states on its face that it was issued on
`
`November 17, 2009, is entitled “Utilization of Dialkyfumarates,” and lists Rajendra Kumar Joshi
`
`and Hans-Peter Strebel as inventors. Mylan is without sufficient knowledge and information to
`
`form a belief as to whether Rajendra Kumar Joshi and Hans-Peter Strebel are the inventors of the
`
`’001 patent and, therefore, denies that allegation and any other remaining allegations of
`
`paragraph 45. Mylan acknowledges that what purports to be a copy of the ’001 patent was
`
`attached as Exhibit C to the Complaint.
`
`46.
`assignment.
`
`Biogen International GmbH is the owner of the ’001 patent by virtue of
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 46, and therefore, denies those allegations.
`
`47.
`The ’001 patent expires on April 1, 2018, excluding any pediatric exclusivity or
`patent term extension.
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 47, and therefore, denies those allegations.
`
`48.
`sclerosis.
`
`The ’001 patent is directed to and claims, inter alia, methods of treating multiple
`
`ANSWER: Based on publicly-available information, Mylan admits that the ’001 patent
`
`purports to claim a method of treating multiple sclerosis. Mylan denies any remaining
`
`allegations set forth in paragraph 48.
`
`49.
`The ’001 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`fumarate delayed-release capsules.
`
`ANSWER: Based on publicly-available information, Mylan admits that the ’001 patent
`
`appears to be listed in the Orange Book with respect to NDA No. 204063 for dimethyl fumarate
`
`
`
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`delayed-release capsules. Mylan is without sufficient knowledge to form a belief as to the
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`propriety of that listing. Mylan denies any remaining allegations of paragraph 49.
`
`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. §
`314.95(c) as to the ’001 patent. The Notice Letter did not allege non-infringement as to at least
`one claim of the ’001 patent.
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`ANSWER: Mylan admits that the Notice Letter served by Mylan on Biogen was dated June 1,
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`2017 and included a Notice of Certification for ANDA No. 210531 under 21 U.S.C. §
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`355(j)(2)(B)(ii) and 21 C.F.R. § 314.95(c) as to the ’001 patent. Mylan denies the remaining
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`allegations of paragraph 50.
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`51. Mylan thus has actual knowledge of the ’001 patent.
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`ANSWER: Mylan admits that it had knowledge of the ’001 patent at least as of the time it
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`served Biogen with the Notice Letter dated June 1, 2017. Mylan denies the remaining allegation
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`set forth in paragraph 51 as it states a legal conclusion for which no answer is required. To the
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`extent an answer is deemed required, Mylan denies the remaining allegation of paragraph 51.
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`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).
`
`ANSWER: Mylan denies the allegations of paragraph 52.
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`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).
`
`ANSWER: Mylan admits that it submitted ANDA No. 210531 seeking approval for dimethyl
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`fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate. Mylan
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`denies the remaining allegations of paragraph 53 as they state legal conclusions for which no
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`answer is required. To the extent an answer is deemed required, Mylan denies the allegations of
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`paragraph 53.
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`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.
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`ANSWER: Mylan denies the allegations of paragraph 54.
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`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.
`
`ANSWER: Mylan denies the allegations of paragraph 55.
`
`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
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 56.
`
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 57.
`
`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.
`
`ANSWER: Mylan denies the allegations set forth in paragraph 58.
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`FOURTH COUNT FOR PATENT INFRINGEMENT (’840 PATENT)
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`59.
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`Biogen realleges, and incorporates in full herein, each preceding paragraph.
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`ANSWER: Mylan hereby incorporates its responses to paragraphs 1–58 as if fully set forth
`
`herein.
`
`60.
`The PTO issued the ’840 patent on September 28, 2010, entitled “Utilization of
`Dialkyfumarates.” 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.
`
`ANSWER: Mylan admits that the ’840 patent states on its face that it was issued on
`
`September 28, 2010, is entitled “Utilization of Dialkyfumarates,” and lists Rajendra Kumar Joshi
`
`and Hans-Peter Strebel as inventors. Mylan is without sufficient knowledge and information to
`
`form a belief as to whether Rajendra Kumar Joshi and Hans-Peter Strebel are the inventors of the
`
`’840 patent and, therefore, denies that allegation and any other remaining allegations of
`
`paragraph 60. Mylan acknowledges that what purports to be a copy of the ’840 patent was
`
`attached as Exhibit D to the Complaint.
`
`61.
`assignment.
`
`Biogen International GmbH is the owner of the ’840 patent by virtue of
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 61, and therefore, denies those allegations.
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`62.
`The ’840 patent expires on April 1, 2018, excluding any pediatric exclusivity or
`patent term extension.
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as to the
`
`allegations set forth in paragraph 62, and therefore, denies those allegations.
`
`63.
`sclerosis.
`
`The ’840 patent is directed to and claims, inter alia, methods of treating multiple
`
`ANSWER: Based on publicly-available information, Mylan admits that the ’840 patent
`
`purports to claim a method of treating at least one autoimmune disease selected from
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`autoimmune polyarthritis and multiple sclerosis, but not treating psoriatic arthritis. Myl