Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 1 of 26 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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`))))))))))
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`)
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Biogen International GmbH and Biogen MA Inc. (collectively, “Biogen” or
`
`“Plaintiffs”), by way of Complaint against Defendants Sawai USA, Inc. (“Sawai USA”) and
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`Sawai Pharmaceutical Co., Ltd.
`
`(“Sawai Pharmaceutical”)
`
`(collectively, “Sawai” or
`
`“Defendants”), allege as follows:
`
`THE PARTIES
`
`Plaintiff Biogen International GmbH is a Swiss corporation with its principal
`
`1.
`
`place of business in Zug, Switzerland at Landis + Gyr-Strasse 3, 6300 Zug, Switzerland.
`
`2.
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`Plaintiff Biogen MA Inc. is a corporation organized and existing under the laws of
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`the Commonwealth of Massachusetts with its principal place of business at 225 Binney Street,
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`Cambridge, Massachusetts 02142.
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`3.
`
`Biogen is in the business of developing, manufacturing and marketing innovative
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`therapies for patients living with serious neurological, autoimmune, and rare diseases, including
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`therapies for multiple sclerosis. Biogen’s asserted patents cover Tecfidera®, which is marketed
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`{01224971;v1 } 
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`1
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`BIOGEN INTERNATIONAL GMBH
`and BIOGEN MA INC.,
`
`Plaintiffs,
`
`v.
`
`SAWAI USA, INC. and
`SAWAI PHARMACEUTICAL CO., LTD.,
`
`
`Defendants.
`
`
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` 
`
`
`
`
`Biogen Exhibit 2016
`Sawai v. Biogen
`IPR2019-00789
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`Page 1 of 26
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`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 2 of 26 PageID #: 2
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`and sold in this judicial district and throughout the United States for the treatment of relapsing
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`forms of multiple sclerosis.
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`4.
`
`Upon information and belief, Sawai Pharmaceutical is a corporation organized
`
`under the laws of Japan, having a principal place of business in Osaka, Japan.
`
`5.
`
`Upon information and belief, Sawai Pharmaceutical is a generic pharmaceutical
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`company that develops, manufactures, markets, and distributes generic pharmaceutical products
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`for sale in the State of Delaware and throughout the United States.
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`6.
`
`Upon information and belief, Sawai USA is a corporation organized under the
`
`laws of Delaware, having a principal place of business at 11 Morgan, Irvine, CA 92618.
`
`7.
`
`Upon
`
`information and belief, Sawai USA
`
`is a subsidiary of Sawai
`
`Pharmaceutical.
`
`8.
`
`Upon information and belief, Sawai USA is a generic pharmaceutical company
`
`that develops, manufactures, markets and distributes generic pharmaceutical products for sale in
`
`the State of Delaware and throughout the United States in concert with Sawai Pharmaceutical.
`
`9.
`
`Biogen received a letter dated May 31, 2017 (“the Notice Letter”), purporting to
`
`include a Notice of Certification for ANDA No. 210285 under 21 U.S.C. § 355(j)(2)(B)(ii) and
`
`21 C.F.R. § 314.95(c). The Notice Letter states:
`
`Stason Pharmaceuticals, Inc., acting as the U.S. agent for Sawai USA,
`Inc. (collectively hereinafter “Sawai”) is providing . . . notice that Sawai
`has submitted . . . an Abbreviated New Drug Application.
`
` Biogen believes that this suit is properly placed in Delaware because Sawai USA
`
`
`10.
`
`is incorporated here. However, Biogen is concurrently filing a case in California out of an
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`abundance of caution given the confusing language in the Notice Letter suggesting that Stason
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`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 3 of 26 PageID #: 3
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`Pharmaceuticals, Inc., which is incorporated in California, participated in the filing of the noted
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`ANDA.
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`11.
`
`A press release by Sawai Pharmaceutical states that “Sawai Pharmaceutical Co.,
`
`Ltd. . . . through its subsidiary Sawai USA, Inc. (Headquarters: Delaware, USA), . . . submitted
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`Abbreviated New Drug Application (ANDA) with Paragraph IV certificate attached for the
`
`therapeutic agent ‘Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg.”
`
`(emphasis added).
`
`12.
`
`Upon information and belief, Stason provided the Notice Letter to Biogen, but
`
`Sawai Pharmaceutical submitted its ANDA through its Delaware subsidiary Sawai USA, Inc.
`
`13.
`
`Upon information and belief, the acts of Sawai Pharmaceutical complained of
`
`herein were done with the cooperation, participation and assistance of Sawai USA.
`
`NATURE OF THE ACTION 
`
`14.
`
`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. §
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`271. This action relates to Sawai’s filing of Abbreviated New Drug Application (“ANDA”) No.
`
`210285 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,
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`sell, offer to sell, and import dimethyl fumarate delayed-release capsules prior to the expiration
`
`of the asserted patents.
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`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 4 of 26 PageID #: 4
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`JURISDICTION AND VENUE
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`15.
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`16.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`Venue is proper in this Court under 28 U.S.C. § 1391(b) and (c), and § 1400(b)
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`because Sawai USA is incorporated in Delaware and Sawai Pharmaceutical is incorporated in
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`Japan and may be sued in any judicial district in the United States in which the defendant is
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`subject to the court’s personal jurisdiction.
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`17.
`
`This Court has personal jurisdiction over Sawai Pharmaceutical under Federal
`
`Rule of Civil Procedure 4(k)(2), because, upon information and belief, Sawai Pharmaceutical is
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`organized under the laws of Japan.
`
`18.
`
`This Court has personal jurisdiction over Sawai USA because Sawai USA is
`
`incorporated in Delaware.
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`19.
`
`This Court also has personal jurisdiction over Sawai because at least one
`
`provision of 10 Del. C. § 3104(c) is satisfied. Upon information and belief, Sawai satisfies at
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`least § 3104(c)(1) (“[t]ransacts any business or performs any character of work or service in the
`
`State), § 3104(c)(2) (“[c]ontracts to supply services or things in this State”), § 3104(c)(3)
`
`(“[c]auses tortious injury in the State by an act or omission in this State), § 3104(c)(4) “[c]auses
`
`tortious injury in the State or outside of the State by an act or omission outside the State if the
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`person regularly does or solicits business, engages in any other persistent course of conduct in
`
`the State or derives substantial revenue from services, or things used or consumed in the State”),
`
`and § 3104(c)(5) (“[h]as an interest in, uses or possesses real property in the State”).
`
`20.
`
`Sawai “has taken the costly, significant step of applying to the FDA for approval
`
`to engage in future activities—including the marketing of its generic drugs—that will be
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`purposefully directed at,” upon information and belief, the District of Delaware and elsewhere.
`4
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`See Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 759 (Fed. Cir. 2016), cert.
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`denied, 2017 WL 69716 (U.S. Jan. 9, 2017). Sawai’s “ANDA filings constitute formal acts that
`
`reliably indicate plans to engage in marketing of the proposed generic drugs.” Id. at 760. Upon
`
`information and belief, Sawai “intends to direct sales of its drugs into Delaware, among other
`
`places, once it has the requested FDA approval to market them.” Id. at 758. Upon information
`
`and belief, Sawai will engage in marketing of its proposed ANDA products in Delaware upon
`
`approval of its ANDA.
`
`21.
`
`This Court also has personal jurisdiction over Sawai because, inter alia, this
`
`action arises from activities of Sawai directed toward Delaware.
`
`22.
`
`Sawai’s ANDA filing regarding the ’376 patent, the ’999 patent, the ’001 patent,
`
`the ’840 patent, the ’393 patent and the ’514 patent, has a substantial connection with this district
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`because it reliably and non-speculatively predicts activities by Sawai in this district.
`
`23.
`
`Exercising personal jurisdiction over Sawai in this district would not be
`
`unreasonable given Sawai’s contacts in this district and the interest in this district of resolving
`
`disputes related to products to be sold herein.
`
`24.
`
`This Court also has personal jurisdiction over Sawai because, inter alia, Sawai
`
`has purposefully availed itself of the rights and benefits of Delaware law by engaging in
`
`systematic and continuous contacts with Delaware. Upon information and belief, Sawai, either
`
`directly or through affiliates, currently sells significant quantities of generic drug products in the
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`United
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`States
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`and
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`in
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`the
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`State
`
`of
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`Delaware.
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`
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`Sawai’s
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`website
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`https://www.sawai.co.jp/en/about/bases (accessed on June 30, 2017), the contents of which are
`
`incorporated herein by reference, identifies its two corporate bases as Japan and the United
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`States. Further, Sawai notes that its product line is “around 680 prescription drugs.”
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`(https://www.sawai.co.jp/en/operation/products/, accessed June 30, 2017).
`
`25.
`
`Upon information and belief, Sawai Pharmaceutical maintains continuous and
`
`systematic contacts with Delaware through its U.S. subsidiary Sawai USA, incorporated in
`
`Delaware.
`
`26.
`
`Upon information and belief, Sawai USA is registered to do business in Delaware
`
`(File No. 5345305). See https://icis.corp.delaware.gov/Ecorp/EntitySearch /NameSearch.aspx.
`
`(Accessed June 29, 2017).
`
`27.
`
`Upon information and belief, Sawai USA maintains continuous and systematic
`
`contacts with Delaware through its authorized U.S. agent, Paracorp Incorporated, located at 2140
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`S Dupont Hwy, Camden, DE 19934.
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`28.
`
`Upon information and belief, Sawai USA has appointed Paracorp Incorporated,
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`located at 2140 S Dupont Hwy, Camden, DE 19934, for receipt and service of process as its
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`registered agent.
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`29.
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`Sawai has availed
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`itself of Delaware courts
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`through
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`the assertion of
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`counterclaims.
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`30.
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`Upon information and belief, Sawai Pharmaceutical and Sawai USA operate as a
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`single integrated business with respect to the regulatory approval, manufacturing, marketing, sale
`
`and distribution of generic pharmaceutical products throughout the United States including in
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`this judicial district.
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`31.
`
`Upon information and belief, the effort to seek approval for ANDA No. 210285
`
`and to manufacture, import, market, and/or sell Defendants’ generic products upon approval has
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`been a cooperative and joint enterprise and venture between Sawai Pharmaceutical and Sawai
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`USA.
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`32.
`
`Upon information and belief, Sawai Pharmaceutical and Sawai USA have an
`
`express and/or implied agreement to cooperate in the joint enterprise and venture of preparing,
`
`filing and maintaining ANDA No. 210285 and in commercializing Defendants’ generic products
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`in the United States, including in this judicial district, in accordance with ANDA No. 210285
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`upon approval.
`
`33.
`
`Upon information and belief, Sawai USA and Sawai Pharmaceutical have thus
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`been, and continue to be, the prime actors in the drafting, submission, approval and maintenance
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`of ANDA No. 210285.
`
`34.
`
`For these reasons and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over Defendants.
`
`FIRST COUNT FOR PATENT INFRINGEMENT (’376 PATENT)
`
`35.
`
`36.
`
`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`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.
`
`37.
`
`Biogen International GmbH is the owner of the ’376 patent by virtue of
`
`assignment.
`
`38.
`
`The ’376 patent expires on October 29, 2019, excluding any pediatric exclusivity
`
`or patent term extension.
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`{01224971;v1 } 
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`39.
`
`The ’376 patent is directed to and claims, inter alia, pharmaceutical preparations
`
`and compositions.
`
`40.
`
`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.
`
`41.
`
`The FDA approved NDA No. 204063 on March 27, 2013, for the treatment of
`
`relapsing forms of multiple sclerosis.
`
`42.
`
`Dimethyl fumarate delayed-release capsules are marketed in the United States
`
`under the trademark Tecfidera®.
`
`43.
`
`Upon information and belief, Sawai submitted ANDA No. 210285 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 (“Defendants’ generic products”) in the United States.
`
`44.
`
`Biogen received a letter from Sawai dated May 31, 2017 (“the Notice Letter”),
`
`purporting to include a Notice of Certification for ANDA No. 210285 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.
`
`45.
`
`46.
`
`Sawai thus has actual knowledge of the ’376 patent.
`
`Upon information and belief, Defendants’ 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).
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`{01224971;v1 } 
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`47.
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`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Sawai 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. 210285 seeking approval to manufacture, use, import, offer
`
`to sell or sell Defendants’ generic products before the expiration date of the ’376 patent. Upon
`
`information and belief, the products described in ANDA No. 210285 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).
`
`48.
`
`Upon information and belief, Sawai will manufacture, market, import, use, sell
`
`and/or offer to sell Defendants’ generic products in the United States in connection with ANDA
`
`No. 210285 upon approval.
`
`49.
`
`Upon information and belief, Sawai 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 Defendants’ generic products in the United States in connection with
`
`ANDA No. 210285 upon approval.
`
`50.
`
`Upon information and belief, Sawai’s actions relating to Sawai’s ANDA No.
`
`210285 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Sawai.
`
`51.
`
`If Sawai’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.
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`{01224971;v1 } 
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`SECOND COUNT FOR PATENT INFRINGEMENT (’999 PATENT)
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`Biogen realleges, and incorporates in full herein, each preceding paragraph.
`
`The PTO issued the ’999 patent on January 22, 2008, entitled “Dimethyl
`
`52.
`
`53.
`
`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.
`
`54.
`
`Biogen International GmbH is the owner of the ’999 patent by virtue of
`
`assignment.
`
`55.
`
`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.
`
`56.
`
`The ’999 patent is directed to and claims, inter alia, methods of treating multiple
`
`sclerosis.
`
`57.
`
`The ’999 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`58.
`
`The Notice Letter dated May 31, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210285 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.
`
`59.
`
`60.
`
`Sawai thus has actual knowledge of the ’999 patent.
`
`Upon information and belief, Defendants’ generic products, if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
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`{01224971;v1 } 
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`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 11 of 26 PageID #: 11
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`including at least claim 1 of the ’999 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`61.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Sawai 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. 210285 seeking approval to manufacture, use, import, offer
`
`to sell or sell Defendants’ generic products before the expiration date of the ’999 patent. Upon
`
`information and belief, the products described in ANDA No. 210285 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).
`
`62.
`
`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 Defendants’ generic
`
`products upon approval.
`
`63.
`
`Upon information and belief, upon approval, Sawai will take active steps to
`
`encourage the use of Defendants’ generic products by physicians and/or patients with the
`
`knowledge and intent that Defendants’ 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 Sawai. Pursuant to 21 C.F.R. § 314.94, Sawai is required to copy the
`
`FDA approved Tecfidera® labeling. Upon information and belief, Sawai will thus induce the
`
`infringement of at least one claim including at least claim 1 of the ’999 patent.
`
`64.
`
`Upon information and belief, if the FDA approves ANDA No. 210285, Sawai 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 Defendants’ generic products are a material
`
`part of the claimed invention, wherein Sawai knows that physicians will prescribe and patients
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`will use Defendants’ generic products in accordance with the instructions and/or label provided
`
`by Sawai 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, Sawai will
`
`thus contribute to the infringement of at least one claim including at least claim 1 of the ’999
`
`patent.
`
`65.
`
`Upon information and belief, Sawai’s actions relating to Sawai’s ANDA No.
`
`210285 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Sawai.
`
`66.
`
`If Sawai’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
`
`67.
`
`68.
`
`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.
`
`69.
`
`Biogen International GmbH is the owner of the ’001 patent by virtue of
`
`assignment.
`
`70.
`
`The ’001 patent expires on April 1, 2018 excluding any pediatric exclusivity or
`
`patent term extension.
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`{01224971;v1 } 
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`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 13 of 26 PageID #: 13
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`71.
`
`The ’001 patent is directed to and claims, inter alia, methods of treating multiple
`
`sclerosis.
`
`72.
`
`The ’001 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`73.
`
`The Notice Letter dated May 31, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210285 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.
`
`74.
`
`75.
`
`Sawai thus has actual knowledge of the ’001 patent.
`
`Upon information and belief, Defendants’ 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).
`
`76.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Sawai 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. 210285 seeking approval to manufacture, use, import, offer
`
`to sell or sell Defendants’ generic products before the expiration date of the ’001 patent. Upon
`
`information and belief, the products described in ANDA No. 210285 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).
`
`77.
`
`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 Defendants’ generic
`
`products upon approval.
`{01224971;v1 } 
` 
`
`13
`
`Page 13 of 26
`
`

`

` 
`
`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 14 of 26 PageID #: 14
`
`78.
`
`Upon information and belief, upon approval, Sawai will take active steps to
`
`encourage the use of Defendants’ generic products by physicians and/or patients with the
`
`knowledge and intent that Defendants’ 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 Sawai. Pursuant to 21 C.F.R. § 314.94, Sawai is required to copy the
`
`FDA approved Tecfidera® labeling. Upon information and belief, Sawai will thus induce the
`
`infringement of at least one claim including at least claim 1 of the ’001 patent.
`
`79.
`
`Upon information and belief, if the FDA approves ANDA No. 210285, Sawai 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 Defendants’ generic products are a material
`
`part of the claimed invention, wherein Sawai knows that physicians will prescribe and patients
`
`will use Defendants’ generic products in accordance with the instructions and/or label provided
`
`by Sawai 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, Sawai will
`
`thus contribute to the infringement of at least one claim including at least claim 1 of the ’001
`
`patent.
`
`80.
`
`Upon information and belief, Sawai’s actions relating to Sawai’s ANDA No.
`
`210285 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Sawai.
`
`81.
`
`If Sawai’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.
`14
`{01224971;v1 } 
` 
`
`Page 14 of 26
`
`

`

` 
`
`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 15 of 26 PageID #: 15
`
`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
`
`82.
`
`83.
`
`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.
`
`84.
`
`Biogen International GmbH is the owner of the ’840 patent by virtue of
`
`assignment.
`
`85.
`
`The ’840 patent expires on April 1, 2018 excluding any pediatric exclusivity or
`
`patent term extension.
`
`86.
`
`The ’840 patent is directed to and claims, inter alia, methods of treating multiple
`
`sclerosis.
`
`87.
`
`The ’840 patent is listed in the Orange Book for NDA No. 204063 for dimethyl
`
`fumarate delayed-release capsules.
`
`88.
`
`The Notice Letter dated May 31, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210285 under 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R.
`
`§ 314.95(c) as to the ’840 patent. The Notice Letter did not allege non-infringement as to any
`
`claim of the ’840 patent.
`
`89.
`
`90.
`
`Sawai thus has actual knowledge of the ’840 patent.
`
`Upon information and belief, Defendants’ 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).
`{01224971;v1 } 
` 
`
`15
`
`Page 15 of 26
`
`

`

` 
`
`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 16 of 26 PageID #: 16
`
`91.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Sawai 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. 210285 seeking approval to manufacture, use, import, offer
`
`to sell or sell Defendants’ generic products before the expiration date of the ’840 patent. Upon
`
`information and belief, the products described in ANDA No. 210285 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).
`
`92.
`
`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 Defendants’ generic
`
`products upon approval.
`
`93.
`
`Upon information and belief, upon approval, Sawai will take active steps to
`
`encourage the use of Defendants’ generic products by physicians and/or patients with the
`
`knowledge and intent that Defendants’ 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 Sawai. Pursuant to 21 C.F.R. § 314.94, Sawai is required to copy the
`
`FDA approved Tecfidera® labeling. Upon information and belief, Sawai will thus induce the
`
`infringement of at least one claim including at least claim 1 of the ’840 patent.
`
`94.
`
`Upon information and belief, if the FDA approves ANDA No. 210285, Sawai 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 Defendants’ generic products are a material
`
`part of the claimed invention, wherein Sawai knows that physicians will prescribe and patients
`
`will use Defendants’ generic products in accordance with the instructions and/or label provided
`
`by Sawai in practicing at least one claim including at least claim 1 of the ’840 patent, and
`16
`{01224971;v1 } 
` 
`
`Page 16 of 26
`
`

`

` 
`
`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 17 of 26 PageID #: 17
`
`wherein dimethyl fumarate delayed-release capsules are not staple articles or commodities of
`
`commerce suitable for substantial non-infringing use. Upon information and belief, Sawai will
`
`thus contribute to the infringement of at least one claim including at least claim 1 of the ’840
`
`patent.
`
`95.
`
`Upon information and belief, Sawai’s actions relating to Sawai’s ANDA No.
`
`210285 complained of herein were done with the cooperation, participation, assistance, and for
`
`the benefit of Sawai.
`
`96.
`
`If Sawai’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
`
`97.
`
`98.
`
`Dialkylfumarates.” 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.
`
`99.
`
`Biogen International GmbH is the owner of the ’393 patent by virtue of
`
`assignment.
`
`100.
`
`101.
`
`102.
`
`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.
`
`{01224971;v1 } 
` 
`
`17
`
`Page 17 of 26
`
`

`

` 
`
`Case 1:17-cv-00875-UNA Document 1 Filed 06/30/17 Page 18 of 26 PageID #: 18
`
`103.
`
`The Notice Letter dated May 31, 2017, purported to include a Notice of
`
`Certification for ANDA No. 210285 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.
`
`104.
`
`105.
`
`Sawai thus has actual knowledge of the ’393 patent.
`
`Upon information and belief, Defendants’ 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 ’393 patent under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`106.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Sawai 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. 210285 seeking approval to manufacture, use, import, offer
`
`to sell or sell Defendants’ generic products before the expiration date of the ’393 patent. Upon
`
`information and belief, the products described in ANDA No. 210285 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).
`
`107.
`
`Upon information and belief, Sawai 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/o