Case 1:21-cv-00389-UNA Document 1 Filed 03/17/21 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. __________
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`COMPLAINT
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`BIOGEN INC., BIOGEN SWISS
`MANUFACTURING GMBH, and
`ALKERMES PHARMA IRELAND
`LIMITED,
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`
`Plaintiffs,
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`
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`v.
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`
`TEVA PHARMACEUTICALS
`DEVELOPMENT INC.,
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`Defendant.
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`Plaintiffs Biogen Inc. (“Biogen Inc.”), Biogen Swiss Manufacturing GmbH (“BSM”)
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`(collectively “Biogen”), and Alkermes Pharma Ireland Limited (“Alkermes Pharma”) (collectively
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`“Plaintiffs”), by their attorneys, hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United States,
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`Title 35, United States Code, that arises out of the submission by defendant Teva Pharmaceuticals
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`Development Inc. (“Teva”) of an Abbreviated New Drug Application (“ANDA”) No. 214206 to
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`the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a
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`generic version of Vumerity® (diroximel fumarate) delayed-release capsules for oral use, 231 mg
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`(“Teva’s ANDA Product”) prior to the expiration of U.S. Patent Nos. 8,669,281 (“the ’281
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`patent”); 9,090,558 (“the ’558 patent”); and 10,080,733 (“the ’733 patent”) (collectively “the
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`Asserted Patents”). Teva notified Plaintiffs that it had submitted this ANDA by a letter dated
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`February 2, 2021 (“Notice Letter”). Upon information and belief, Teva’s ANDA Product will be
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`marketed as a competing product to Vumerity®, a product developed by Plaintiffs for the treatment
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`1
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`of relapsing forms of multiple sclerosis (MS).
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`PARTIES
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`2.
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`Biogen Inc. is a corporation organized and existing under the laws of Delaware,
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`having its corporate offices and a place of business at 225 Binney Street, Cambridge, MA 02142.
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`3.
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`BSM is limited liability company organized and existing under the laws of
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`Switzerland, having a place of business at Landis & Gyr Strasse 3, CHR-6300 Zug, Switzerland.
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`4.
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`Alkermes Pharma is a corporation organized and existing under the laws of The
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`Republic of Ireland, having a place of business at 1 Burlington Road, Connaught House, Dublin,
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`Ireland. Alkermes Pharma is a wholly-owned subsidiary of Alkermes Ireland Holdings Limited,
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`which is a wholly-owned subsidiary of Alkermes Public Limited Company.
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`5.
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`Upon information and belief, Teva is a corporation organized and existing under
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`the laws of Delaware, having a place of business at 400 Interpace Parkway, Suite A1, Parsippany,
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`NJ 07054.
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`JURISDICTION AND VENUE
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`6.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`2201, and 2202.
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`7.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b), at least because
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`Teva is a corporation organized and existing under the laws of Delaware and therefore resides
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`there for purposes of venue.
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`8.
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`This Court has personal jurisdiction over Teva because, on information and belief,
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`Teva is a corporation organized and existing under the laws of the Delaware, has registered to do
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`business in Delaware (File No. 3960741), and has appointed a registered agent in Delaware to
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`accept service of process. Teva has thus consented to jurisdiction in Delaware. Upon information
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`2
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`and belief, Teva has appointed Corporate Creation Network Inc., located at Tatnall Building, 3411
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`Silverside Road, STE 104, Wilmington, DE 19801 as its registered agent.
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`9.
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`Upon information and belief, Teva is involved in developing, manufacturing,
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`marketing, selling, and/or distributing a broad range of generic pharmaceutical products in the
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`United States, including in Delaware.
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`10.
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`Upon information and belief, Teva has sought approval in ANDA No. 214206 to
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`distribute Teva’s ANDA Product in the United States, including in Delaware and will do so upon
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`approval of ANDA No. 214206. The filing of ANDA No. 214206 is therefore tightly tied, in
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`purpose and planned effect, to the deliberate making of sales in Delaware, and reliably indicates
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`that Teva plans to engage in the marketing of Teva’s ANDA Product in Delaware.
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`11.
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`Upon information and belief, if ANDA No. 214206 is approved, Teva will directly
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`or indirectly market and/or sell Teva’s ANDA Product within the United States, including in
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`Delaware, consistent with Teva’s practices for the marketing and distribution of other
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`pharmaceutical products on its own and/or through its affiliates.
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`12.
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`Upon information and belief, if ANDA No. 214206 is approved, Teva’s ANDA
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`Product, under the direction and control of physicians practicing in Delaware, will be administered
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`to patients of Delaware. These activities, as well as Teva’s and/or its affiliates marketing, selling,
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`and/or distributing of Teva’s ANDA Product, would have a substantial effect within Delaware and
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`would constitute infringement of the Asserted Patents in the event that Teva’s ANDA Product is
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`approved before the Asserted Patents expire.
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`13.
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`For the reasons described above, among others, the filing of ANDA No. 214206
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`was suit-related conduct with a substantial connection to Delaware and this District, the exercise
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`of personal jurisdiction over Teva does not offend traditional notions of fair play and substantial
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`3
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`justice, and this Court may properly exercise personal jurisdiction over Teva.
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`BACKGROUND
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`14.
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`Vumerity® is indicated for the treatment of relapsing forms of multiple sclerosis
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`(MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary
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`progressive disease, in adults.
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`15.
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`Biogen sells Vumerity® in the United States pursuant to New Drug Application
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`(“NDA”) No. 211855, which has been approved by the FDA.
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`16.
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`17.
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`Biogen Inc. is the holder of approved NDA No. 211855 for Vumerity®.
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`The ’281 patent, titled “Prodrugs of Fumarates and Their Use in Treating Various
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`Diseases,” was duly and legally issued on March 11, 2014. A copy of the ’281 patent is attached
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`as Exhibit A.
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`18.
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`19.
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`20.
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`Alkermes Pharma is the assignee of the ’281 patent.
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`BSM is the exclusive licensee of the ’281 patent.
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`There is an actual case or controversy between the parties regarding Teva’s liability
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`for its infringement of the ’281 patent.
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`21.
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`The ’558 patent, titled “Prodrugs of Fumarates and Their Use in Treating Various
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`Diseases,” was duly and legally issued on July 28, 2015. A copy of the ’558 patent is attached as
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`Exhibit B.
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`22.
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`23.
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`24.
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`Alkermes Pharma is the assignee of the ’558 patent.
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`BSM is the exclusive licensee of the ’558 patent.
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`There is an actual case or controversy between the parties regarding Teva’s liability
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`for its infringement of the ’558 patent.
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`25.
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`The ’733 patent, titled “Prodrugs of Fumarates and Their Use in Treating Various
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`4
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`Diseases,” was duly and legally issued on September 25, 2018. A copy of the ’733 patent is
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`attached as Exhibit C.
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`26.
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`27.
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`28.
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`Alkermes Pharma is the assignee of the ’733 patent.
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`BSM the exclusive licensee of the ’733 patent.
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`There is an actual case or controversy between the parties regarding Teva’s liability
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`for its infringement of the ’733 patent.
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`29.
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`This action is being filed within 45 days of Plaintiffs’ receipt of Teva’s Notice
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`Letter.
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`30.
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`31.
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`COUNT I
`(Infringement of the ’281 Patent)
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`Claim 1 of the ’281 patent covers “[a] compound having the formula:
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`or a pharmaceutically acceptable salt thereof.”
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`32.
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`Upon information and belief, Teva’s ANDA Product is covered by one or more
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`claims of the ’281 patent, including at least claim 1.
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`33.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Teva’s ANDA Product will infringe one or more claims of the ’281 patent,
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`including at least claim 1, either literally or under the doctrine of equivalents.
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`34.
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`Teva did not assert in its Notice Letter a basis for any assertion that Teva’s ANDA
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`Product would not infringe any claim of the ’281 patent.
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`5
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`35.
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`Upon information and belief, Teva filed as part of ANDA No. 214206 a
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`certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the Food, Drug & Cosmetic
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`Act (“FDCA”), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), asserting that the claims of the ’281 patent are
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`invalid, unenforceable, and/or not infringed by the manufacture, use, offer for sale, or sale of
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`Teva’s ANDA Product.
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`36.
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`The purpose of filing ANDA No. 214206 was to obtain approval under the FDCA
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`to engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product
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`prior to the expiration of the ’281 patent.
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`37.
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`Teva’s submission of ANDA No. 214206 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product
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`prior to the expiration of the ’281 patent is an act of infringement of the ’281 patent under 35
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`U.S.C. § 271(e)(2)(A).
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`38.
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`Upon information and belief, Teva intends to engage in the manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of Teva’s ANDA Product immediately
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`and imminently upon the approval of ANDA No. 214206 and any amendments thereto, i.e., prior
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`to the expiration of the ’281 patent.
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`39.
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`Upon information and belief, Teva has knowledge of the ’281 patent at least
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`because the ’281 patent is listed in the FDA’s Orange Book: Approved Drug Products with
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`Therapeutic Equivalence Evaluations for Biogen’s Vumerity® drug product. Notwithstanding this
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`knowledge, Teva continues to assert its intent to engage in the manufacture, use, offer for sale,
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`sale, marketing, distribution, and/or importation of Teva’s ANDA Product and the proposed
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`labeling therefor immediately and imminently upon the approval of ANDA No. 214206 and any
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`amendments thereto.
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`6
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`40.
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`Upon information and belief, Teva plans and intends to, and will, actively induce
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`infringement of the ’281 patent when ANDA No. 214206 and any amendments thereto are
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`approved, and will do so with specific intent to induce infringement of the ’281 patent. Further
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`upon information and belief, Teva plans and intends to, and will, do so immediately and
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`imminently upon approval.
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`41.
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`The foregoing actions by Teva constitute and/or will constitute infringement of the
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`’281 patent and active inducement of infringement of the ’281 patent, either literally or under the
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`doctrine of equivalents.
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`42.
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`Unless Teva is enjoined from infringing the ’281 patent and actively inducing
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`infringement of the ’281 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no
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`adequate remedy at law.
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`COUNT II
`(Infringement of the ’558 Patent)
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`43.
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`44.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`Claim 1 of the ’558 patent covers “[a] method of treating multiple sclerosis in a
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`subject in need thereof, comprising administering to the subject a therapeutically effective amount
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`of a compound having the formula:
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`or a pharmaceutically acceptable salt thereof.”
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`45.
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`Upon information and belief, use of Teva’s ANDA Product is covered by one or
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`more claims of the ’558 patent, including at least claim 1.
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`7
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`46.
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`Upon information and belief, the use of Teva’s ANDA Product in accordance with
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`and as directed by Teva’s proposed labeling for that product will infringe one or more claims of
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`the ’558 patent, including at least claim 1, either literally or under the doctrine of equivalents.
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`47.
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`Teva did not assert in its Notice Letter a basis for any assertion that the use of
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`Teva’s ANDA Product in accordance with and as directed by Teva’s proposed labeling for that
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`product would not infringe any claim of the ’558 patent.
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`48.
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`Upon information and belief, Teva filed as part of ANDA No. 214206 a
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`certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C.
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`355(j)(2)(A)(vii)(IV), asserting that the claims of the ’558 patent are invalid, unenforceable, and/or
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`not infringed by the manufacture, use, offer for sale, or sale of Teva’s ANDA Product.
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`49.
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`The purpose of filing ANDA No. 214206 was to obtain approval under the FDCA
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`to engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product
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`prior to the expiration of the ’558 patent.
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`50.
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`Teva’s submission of ANDA No. 214206 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product
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`prior to the expiration of the ’558 patent is an act of infringement of the ’558 patent under 35
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`U.S.C. § 271(e)(2)(A).
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`51.
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`Upon information and belief, Teva intends to engage in the manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of Teva’s ANDA Product and the
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`proposed labeling therefor immediately and imminently upon the approval of ANDA No. 214206
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`and any amendments thereto, i.e., prior to the expiration of the ’558 patent.
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`52.
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`Upon information and belief, Teva has knowledge of the ’558 patent at least
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`because the ’558 patent is listed in the FDA’s Orange Book: Approved Drug Products with
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`8
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`Therapeutic Equivalence Evaluations for Biogen’s Vumerity® drug product. Notwithstanding this
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`knowledge, Teva continues to assert its intent to engage in the manufacture, use, offer for sale,
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`sale, marketing, distribution, and/or importation of Teva’s ANDA Product and the proposed
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`labeling therefor immediately and imminently upon the approval of ANDA No. 214206 and any
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`amendments thereto.
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`53.
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`Upon information and belief, Teva plans and intends to, and will, actively induce
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`infringement of the ’558 patent when ANDA No. 214206 and any amendments thereto are
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`approved, and will do so with specific intent to induce infringement of the ’558 patent. Further
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`upon information and belief, Teva plans and intends to, and will, do so immediately and
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`imminently upon approval.
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`54.
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`Upon information and belief, Teva knows that Teva’s ANDA Product is especially
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`made or adapted for use in infringing the ’558 patent, and that Teva’s ANDA Product is not
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`suitable for substantial noninfringing use. Upon information and belief, Teva plans and intends
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`to, and will, contribute to infringement of the ’558 patent immediately and imminently upon
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`approval of ANDA No. 214206 and any amendments thereto.
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`55.
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`The foregoing actions by Teva constitute and/or will constitute infringement of the
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`’558 patent, active inducement of infringement of the ’558 patent, and contribution to the
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`infringement by others of the ’558 patent, either literally or under the doctrine of equivalents.
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`56.
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`Unless Teva is enjoined from actively inducing infringement of the ’558 patent and
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`contributing to the infringement by others of the ’558 patent, Plaintiffs will suffer irreparable
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`injury. Plaintiffs have no adequate remedy at law.
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`COUNT III
`(Infringement of the ’733 Patent)
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`57.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`9
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`58.
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`Claim 1 of the ’733 patent covers “[a] crystalline form of a compound having the
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`formula:
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`having an X-ray powder diffraction pattern comprising peaks, in terms of degrees 2-theta±0.2
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`degrees, at 11.6, 21.0, 24.3, 27.4, and 27.9 when using a Cu X-ray source.”
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`59.
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`Upon information and belief, Teva’s ANDA Product is covered by one or more
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`claims of the ’733 patent, including at least claim 1.
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`60.
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`Upon information and belief, the manufacture, sale, offer for sale, or importation
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`of Teva’s ANDA Product, or the use of Teva’s ANDA Product in accordance with and as directed
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`by Teva’s proposed labeling for that product, will infringe one or more claims of the ’733 patent,
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`including at least claim 1, either literally or under the doctrine of equivalents.
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`61.
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`Teva did not assert in its Notice Letter a basis for any assertion that Teva’s ANDA
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`Product, or the use of Teva’s ANDA Product in accordance with and as directed by Teva’s
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`proposed labeling for that product, would not infringe any claim of the ’733 patent.
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`62.
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`Upon information and belief, Teva filed as part of ANDA No. 214206 a
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`certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV), asserting that the claims of the ’733 patent are invalid, unenforceable,
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`and/or not infringed by the manufacture, use, offer for sale, or sale of Teva’s ANDA Product.
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`63.
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`The purpose of filing ANDA No. 214206 was to obtain approval under the FDCA
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`to engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product
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`prior to the expiration of the ’733 patent.
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`10
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`64.
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`Teva’s submission of ANDA No. 214206 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product
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`prior to the expiration of the ’733 patent is an act of infringement of the ’733 patent under 35
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`U.S.C. § 271(e)(2)(A).
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`65.
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`Upon information and belief, Teva intends to engage in the manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of Teva’s ANDA Product and the
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`proposed labeling therefor immediately and imminently upon the approval of ANDA No. 214206
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`and any amendments thereto, i.e., prior to the expiration of the ’733 patent.
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`66.
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`Upon information and belief, Teva has knowledge of the ’733 patent at least
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`because the ’733 patent is listed in the FDA’s Orange Book: Approved Drug Products with
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`Therapeutic Equivalence Evaluations for Biogen’s Vumerity® drug product. Notwithstanding this
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`knowledge, Teva continues to assert its intent to engage in the manufacture, use, offer for sale,
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`sale, marketing, distribution, and/or importation of Teva’s ANDA Product and the proposed
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`labeling therefor immediately and imminently upon the approval of ANDA No. 214206 and any
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`amendments thereto.
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`67.
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`Upon information and belief, Teva plans and intends to, and will, actively induce
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`infringement of the ’733 patent when ANDA No. 214206 and any amendments thereto are
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`approved, and will do so with specific intent to induce infringement of the ’733 patent. Further
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`upon information and belief, Teva plans and intends to, and will, do so immediately and
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`imminently upon approval.
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`68.
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`Upon information and belief, Teva knows that Teva’s ANDA Product is especially
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`made or adapted for use in infringing the ’733 patent, and that Teva’s ANDA Product is not
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`suitable for substantial noninfringing use. Upon information and belief, Teva plans and intends
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`11
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`to, and will, contribute to infringement of the ’733 patent immediately and imminently upon
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`approval of ANDA No. 214206 and any amendments thereto.
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`69.
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`The foregoing actions by Teva constitute and/or will constitute infringement of the
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`’733 patent, active inducement of infringement of the ’733 patent, and contribution to the
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`infringement by others of the ’733 patent, either literally or under the doctrine of equivalents.
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`70.
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`Unless Teva is enjoined from infringing the ’733 patent, actively inducing
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`infringement of the ’733 patent, and contributing to the infringement by others of the ’733 patent,
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`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
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`
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`WHEREFORE, Plaintiffs request the following relief:
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`REQUEST FOR RELIEF
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`(a)
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`A judgment that Teva has infringed the Asserted Patents and/or will infringe,
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`actively induce infringement of, and/or contribute to infringement by others of the Asserted
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`Patents;
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`(b)
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`A judgment ordering that the effective date of any FDA approval for Teva to make,
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`use, offer for sale, sell, market, distribute, or import Teva’s ANDA Product, or any product the use
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`of which infringes the Asserted Patents, be not earlier than the expiration date of the Asserted
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`Patents, inclusive of any extension(s) and additional period(s) of exclusivity;
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`(c)
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`A permanent injunction enjoining Teva, and all persons acting in concert with Teva,
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`from making, using, selling, offering for sale, marketing, distributing, or importing Teva’s ANDA
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`Product, or any product the use of which infringes the Asserted Patents, or the inducement of or
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`contribution to any of the foregoing, prior to the expiration date of the Asserted Patents, inclusive
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`of any extension(s) and additional period(s) of exclusivity;
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`(d)
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`A judgment declaring that making, using, selling, offering for sale, marketing,
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`distributing, or importing of Teva’s ANDA Product, or any product the use of which infringes the
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`Asserted Patents, prior to the expiration date of the Asserted Patents, infringes, will infringe, will
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`actively induce infringement of, and/or will contribute to the infringement by others of the
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`Asserted Patents;
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’ fees
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`pursuant to 35 U.S.C. § 285;
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`(f)
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`(g)
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`An award of Plaintiffs’ costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`OF COUNSEL:
`
`Arlene L. Chow
`Ernest Yakob
`Michelle L. Ernst
`Jacob Whitt
`LATHAM & WATKINS LLP
`885 Third Avenue
`New York, NY 10022
`(212) 906-1200
`
`Adam L. Perlman
`Benjamin J. Behrendt
`David J. Lehr
`LATHAM & WATKINS LLP
`555 Eleventh Street, NW, Suite 1000
`Washington, D.C. 20004-1304
`(202) 637-2200
`
`March 17, 2021
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Jack B. Blumenfeld
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`
`
`Jack B. Blumenfeld (#1014)
`Jeremy A. Tigan (#5239)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`jtigan@morrisnichols.com
`
`Attorneys for Plaintiffs Biogen Inc., Biogen
`Swiss Manufacturing GmbH, and Alkermes
`Pharma Ireland Limited
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