Case 1:14-cv-01498-JBS-KMW Document 1 Filed 03/07/14 Page 1 of 12 PageID: 1
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`
`David C. Kistler
`BLANK ROME LLP
`301 Carnegie Center, 3rd Floor
`Princeton, New Jersey 08540
`(609) 750-2643-4444 (telephone)
`(609) 897-7291 (facsimile)
`
`Of Counsel:
`Christopher J. Harnett
`James F. Haley, Jr.
`Hassen A. Sayeed
`Jacqueline M. James
`Steven K. Mossey
`ROPES & GRAY LLP
`1211 Avenue of the Americas
`New York, New York 10036
`(212) 596-9000 (telephone)
`(212) 596-9090 (facsimile)
`
`Attorneys for Plaintiffs medac Pharma, Inc. and
`medac Gesellschaft für klinische Spezialpräparate mbH
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`
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`MEDAC PHARMA, INC. and MEDAC
`GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH,
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`JURY TRIAL DEMANDED
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`C.A. NO.: ________________
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`
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`Plaintiffs,
`
`v.
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`
`
`
`
`
`ANTARES PHARMA, INC., LEO
`PHARMA A/S and LEO PHARMA INC.,
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`
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`Defendants.
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`
`
`COMPLAINT
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`Plaintiffs medac Pharma, Inc. and medac Gesellschaft für klinische Spezialpräparate
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`
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`
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`mbH, by and through their undersigned counsel, file this Complaint against Antares Pharma,
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`Inc., LEO Pharma A/S and LEO Pharma Inc. (collectively, “Defendants”) and allege as follows:
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`KOIOS Exhibit 1016
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`Case 1:14-cv-01498-JBS-KMW Document 1 Filed 03/07/14 Page 2 of 12 PageID: 2
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`The Parties
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`1.
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`Plaintiff medac Pharma, Inc. (“medac Pharma”) is a corporation organized under
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`the laws of the State of Delaware, having its principal place of business at 29 North Wacker
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`Drive Suite 704, Chicago, Illinois 60606.
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`2.
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`Plaintiff medac Gesellschaft für klinische Spezialpräparate mbH (“medac”) is a
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`corporation organized under the laws of Germany, having its principal place of business at
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`Theaterstrasse 6, 22880 Wedel, Germany.
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`3.
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`4.
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`medac Pharma is a wholly-owned subsidiary of medac.
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`Upon information and belief, defendant Antares Pharma, Inc. is a corporation
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`organized under the laws of the State of Delaware, having its principal place of business at 100
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`Princeton South, Suite 300, Ewing, New Jersey 08628.
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`5.
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`Upon information and belief, defendant LEO Pharma A/S is a corporation
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`organized under the laws of Denmark, having its principal place of business at Industriparken 55,
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`DK-2750 Ballerup, Denmark.
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`6.
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`Upon information and belief, defendant LEO Pharma Inc. is an affiliate of LEO
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`Pharma A/S and is a corporation organized under the laws of the State of Delaware, having its
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`principal place of business at 1 Sylvan Way, Parsippany, New Jersey 07054.
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`7.
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`Upon information and belief, the acts of LEO Pharma Inc. are performed at the
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`direction and/or authorization of, and/or with the cooperation and/or assistance of LEO Pharma
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`A/S, and are performed at least in part for the benefit of LEO Pharma A/S.
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`Jurisdiction And Venue
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`8.
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`This is an action arising under the patent laws of the United States, 35 U.S.C. §§ 1
`
`et seq.
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`KOIOS Exhibit 1016
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`9.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
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`1338(a).
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`10.
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`This Court has personal jurisdiction over Antares Pharma, Inc. Upon information
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`and belief, Antares Pharma, Inc. maintains its principal place of business in the State of New
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`Jersey. Furthermore, upon information and belief, Antares Pharma, Inc. has engaged and
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`currently engages in continuous and systematic contacts with the State of New Jersey. Upon
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`information and belief, Antares Pharma, Inc. has marketed, placed and continues to place
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`medical products in the stream of commerce via established distribution channels, with the
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`knowledge and/or understanding that such products are marketed and/or sold within this District.
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`11.
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`This Court has personal jurisdiction over LEO Pharma Inc. Upon information
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`and belief, LEO Pharma Inc. maintains its principal place of business in the State of New Jersey.
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`Furthermore, upon information and belief, LEO Pharma Inc. has engaged and currently engages
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`in continuous and systematic contacts with the State of New Jersey. Upon information and
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`belief, LEO Pharma, Inc. has marketed, placed and continues to place medical products in the
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`stream of commerce via established distribution channels, with the knowledge and/or
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`understanding that such products are marketed and/or sold within this District.
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`12.
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`This Court has personal jurisdiction over LEO Pharma A/S. Upon information
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`and belief, LEO Pharma A/S engages in continuous and systematic contacts with the State of
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`New Jersey through its affiliate, LEO Pharma Inc.
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`13.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(b), 1391(c) and 1400(b).
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`The Patent-In-Suit
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`14. medac is a global pharmaceutical company with products and services directed to
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`treatment, therapy and diagnosis of diseases in the fields of oncology, urology, autoimmune
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`KOIOS Exhibit 1016
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`diseases and fibrinolysis. medac Pharma is a wholly owned subsidiary of medac with products
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`and services directed to the commercialization of treatments for autoimmune diseases (including
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`the treatment of rheumatoid arthritis and psoriasis) and cancer. medac protects these products
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`and services through, inter alia, its intellectual property portfolio, including patents. medac has
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`expended significant resources to develop and acquire this intellectual property. medac Pharma
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`has expended significant resources to prepare to commercialize products related to this
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`intellectual property, should those products be approved for sale in the United States.
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`15. medac and medac Pharma are innovators and leaders in the field of subcutaneous
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`methotrexate administration, in particular for its use in the treatment of inflammatory
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`autoimmune diseases, including rheumatoid arthritis and psoriasis.
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`16. medac Pharma recently secured acceptance by the United States Food and Drug
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`Administration (“FDA”) of a new drug application (“NDA”) for a methotrexate-containing
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`autopen. This autopen contains a subcutaneous injectable form of methotrexate in a
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`concentration of more than 30 mg/mL that has the potential to improve bioavailability and to
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`overcome tolerability issues associated with methotrexate taken orally and is able to deliver
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`higher amounts of methotrexate at reduced drug volumes through subcutaneous injection,
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`addressing the stigmas associated with injectable medications, including methotrexate.
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`17. medac is the lawful owner of all right, title and interest in U.S. Patent 8,664,231
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`(“the ‘231 patent”), entitled “Concentrated Methotrexate Solutions.” medac Pharma is an
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`exclusive licensee of the ‘231 patent and has the right to use, supply, distribute, sell, offer for
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`sale, and import into the United States products for the use in methods claimed in the ‘231
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`patent.
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`KOIOS Exhibit 1016
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`18.
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`The ‘231 patent claims, among other things, a method for the treatment of
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`inflammatory autoimmune diseases in a patient in need thereof, comprising subcutaneously
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`administering to said patient a medicament comprising methotrexate in a pharmaceutically
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`acceptable solvent at a concentration of more than 30 mg/mL.
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`19.
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`The United States Patent and Trademark Office duly and legally issued the ‘231
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`patent on March 4, 2014. A true and correct copy of the ‘231 patent is attached to this
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`Complaint as Exhibit A.
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`Factual Background
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`20.
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`Upon information and belief, Antares Pharma, Inc. received FDA approval to
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`market OTREXUP™ (methotrexate) injection for subcutaneous use in the treatment of forms of
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`rheumatoid arthritis and psoriasis in adults and polyarticular idiopathic arthritis in children on
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`October 11, 2013, and announced the availability of OTREXUP™ (methotrexate) injection at
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`distribution centers throughout the United States in a Press Release, dated January 15, 2014,
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`which is attached to this Complaint as Exhibit B. It is available in four dosage strengths: 10
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`mg/0.4 mL methotrexate, 15 mg/0.4 mL methotrexate, 20 mg/0.4 mL methotrexate, and 25
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`mg/0.4 mL methotrexate. The latter three strengths are concentrations of more than 30 mg/mL
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`methotrexate, as recited in claims of the ‘231 patent.
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`21.
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`Upon information and belief, Antares Pharma, Inc. manufactures, sells and offers
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`to sell OTREXUP™ (methotrexate) injection for subcutaneous use to treat the approved forms of
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`rheumatoid arthritis and psoriasis in adults and polyarticular idiopathic arthritis in children. See
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`Exhibit B.
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`22.
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`Upon information and belief, Antares Pharma, Inc. is selling and offering to sell
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`and intends to continue selling and offering to sell its OTREXUP™ (methotrexate) injection for
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`treating the approved forms of psoriasis in adults through an exclusive promotion and marketing
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`agreement with LEO Pharma A/S. See November 14, 2013, Antares Pharma, Inc. Press Release
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`attached to this Complaint as Exhibit C.
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`23.
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`Upon information and belief, LEO Pharma Inc., an affiliate of LEO Pharma A/S,
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`carries out LEO Pharma A/S’s promotion and marketing responsibilities for the OTREXUP™
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`(methotrexate) injection in the United States.
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`COUNT I
`(INFRINGEMENT OF U.S. PATENT 8,664,231 BY DEFENDANTS)
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`24. medac and medac Pharma reallege and incorporate by reference paragraphs 1
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`through 23, inclusive, as if fully set forth in this paragraph.
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`25.
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`Upon information and belief, OTREXUP™ (methotrexate) injection is an
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`autoinjector for subcutaneous injection that administers a single 0.4 mL dose of methotrexate
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`solution in one of four dosage strengths (10 mg/0.4 mL methotrexate, 15 mg/0.4 mL
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`methotrexate, 20 mg/0.4 mL methotrexate, and 25 mg/0.4 mL methotrexate), the latter three of
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`which dosage strengths have a concentration of more than 30 mg/mL.
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`26.
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`Upon information and belief, the FDA approved OTREXUP™ (methotrexate)
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`injection for treatment of forms of rheumatoid arthritis and psoriasis in adults and polyarticular
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`idiopathic arthritis in children.
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`27.
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`Upon information and belief, rheumatoid arthritis, polyarticular idiopathic
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`arthritis and psoriasis, and the forms of those diseases for which the OTREXUP™ (methotrexate)
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`injection is approved, are autoimmune diseases.
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`28.
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`Upon
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`information and belief, Antares Pharma, Inc. represents
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`that
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`the
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`OTREXUP™ (methotrexate) injection will expand treatment options for rheumatoid arthritis,
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`polyarticular idiopathic arthritis and psoriasis patients in the United States.
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`KOIOS Exhibit 1016
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`29.
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`Upon information and belief, Antares Pharma, Inc. indicated the availability of
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`OTREXUP™ (methotrexate) injection as of January 15, 2014 at distribution centers throughout
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`the United States for the treatment of the approved forms of rheumatoid arthritis, polyarticular
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`idiopathic arthritis and psoriasis. See Exhibit B.
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`30.
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`Upon information and belief, one or more of the following entities are involved
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`with the promotion and marketing of OTREXUP™ (methotrexate) injection for the treatment of
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`the approved forms of psoriasis in the United States: LEO Pharma A/S and LEO Pharma Inc.
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`See Exhibit C and Antares Pharma, Inc.’s Cowen & Company 34th Annual Health Care
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`Conference Presentation “Overview of Recent Events,” attached to this Complaint as Exhibit D.
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`31.
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`Upon information and belief, Defendants knew or should have known of the
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`12/374,528 application that issued as the ‘231 patent as of at least December 14, 2012, the date
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`of the filing of the OTREXUP™ (methotrexate) injection NDA because, among other reasons, a
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`corporate entity that conducts intellectual property diligence on its planned products would have
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`been aware of the 12/374,528 application, the prosecution status of which was publicly available
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`via Patent Application Information Retrieval at the PTO website (http://portal.uspto.gov/
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`external/portal/pair) from the time that the PCT application, designating the United States, was
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`published in January 2008 and the U.S. application was published in January 2010; from the time
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`the claims, as issued in the ‘231 patent, were filed on March 21, 2012; and from the time those
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`claims were allowed on January 7, 2014. Defendants also knew or should have known of the
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`12/374,528 application as of at least January 27, 2014, the date of a Press Release issued by
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`medac Pharma announcing the allowance of a patent application directed to a method for the
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`treatment of inflammatory autoimmune diseases by subcutaneously administering methotrexate
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`at a concentration of more than 30 mg/mL. A copy of that Press Release is attached to this
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`Complaint as Exhibit E. The filing of this Complaint also constitutes actual notice of the ‘231
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`patent to Defendants under 35 U.S.C. § 287.
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`32.
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`Upon information and belief, Defendants directly infringe, contributorily infringe
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`and/or actively induce the infringement by others under 35 U.S.C. § 271, either literally or under
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`the doctrine of equivalents, at least claim 1 of the ‘231 patent, by activities including but not
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`limited to making, using, selling, importing and/or offering to sell FDA-approved OTREXUP™
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`(methotrexate) injection in the United States for the treatment of the approved forms of
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`rheumatoid arthritis, polyarticular idiopathic arthritis and psoriasis, together with instructing,
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`directing and/or advising others how to carry out such infringement using such OTREXUP™
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`(methotrexate) injection.
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`33.
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`Upon information and belief, Defendants sell, and offer for sale, FDA-approved
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`OTREXUP™ (methotrexate) injection with a package insert that includes instructions for a
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`method of treating the approved forms of rheumatoid arthritis, polyarticular idiopathic arthritis
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`and psoriasis using such OTREXUP™ (methotrexate) injection by subcutaneous injection.
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`34.
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`Upon information and belief, Defendants actively induce the infringement of at
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`least claim 1 of the ‘231 patent, either literally or under the doctrine of equivalents, by offering
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`for sale and/or selling FDA-approved OTREXUP™ (methotrexate) injection in the United States,
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`together with a package insert setting forth instructions for a method of treating the approved
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`forms of rheumatoid arthritis, polyarticular idiopathic arthritis and psoriasis using such
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`OTREXUP™ (methotrexate) injection by subcutaneous injection.
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`35.
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`Upon information and belief, when physicians or others use FDA-approved
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`OTREXUP™ (methotrexate) injection according to the method of treating the approved forms of
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`rheumatoid arthritis, polyarticular idiopathic arthritis and psoriasis set forth on the package insert
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`KOIOS Exhibit 1016
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`Case 1:14-cv-01498-JBS-KMW Document 1 Filed 03/07/14 Page 9 of 12 PageID: 9
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`provided by Defendants, those acts constitute direct infringement of at least claim 1 of the ‘231
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`patent, either literally or under the doctrine of equivalents.
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`36.
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`Upon information and belief, Defendants contributorily infringe, either literally or
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`under the doctrine of equivalents, at least claim 1 of the ‘231 patent by offering for sale and/or
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`selling FDA-approved OTREXUP™ (methotrexate) injection in the United States, while knowing
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`that such OTREXUP™ (methotrexate) injection is especially made or especially adapted for use
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`in the infringement of the ‘231 patent, and is not a staple article suitable for substantial non-
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`infringing use.
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`37.
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`As a result of Defendants’ acts of infringement, medac and medac Pharma have
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`been and will continue to be irreparably harmed and have and will continue to suffer damages in
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`an amount to be proved at trial.
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`Prayer For Relief
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`
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`WHEREFORE, medac and medac Pharma request the Court to enter judgment in its
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`favor and grant the following relief:
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`(a)
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`A judgment that Defendants directly infringe, contribute to and/or actively induce
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`the infringement of the ‘231 patent by making, using, selling, importing and/or offering to sell
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`FDA-approved OTREXUP™ (methotrexate) injection in the United States;
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`(b)
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`A judgment and order permanently restraining and enjoining Defendants and their
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`directors, officers, agents, servants, employees, attorneys, parents, subsidiaries, divisions,
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`affiliate corporations, other related business entities, and all persons in active concert or privity
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`with them, and their successors and assigns, from infringing the ‘231 patent by making, using,
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`selling, importing or offering for sale FDA-approved OTREXUP™ (methotrexate) injection in
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`the United States;
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`KOIOS Exhibit 1016
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`(c)
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`A judgment and order requiring the Defendants to pay all available and legally
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`permissible damages to compensate medac and medac Pharma for Defendants’ infringing acts,
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`but in no event less than a reasonable royalty in accordance with 35 U.S.C. § 284;
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`(d)
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`A finding that the complained-of conduct by the Defendants has been willful,
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`warranting an award of treble damages under 35 U.S.C. § 284;
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`(e)
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`A finding that this case is exceptional under 35 U.S.C. § 285, warranting an award
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`to medac and medac Pharma of their costs, including attorney fees and other expenses incurred
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`in connection with this action;
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`(f)
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`A judgment and order requiring Defendants to pay medac and medac Pharma pre-
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`judgment interest and post-judgment interest on all damages awarded; and
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`(g)
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`Such further relief as this Court deems just and appropriate.
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`Demand For Jury Trial
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`
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`Pursuant to Fed. R. Civ. P. 38, medac and medac Pharma demand a trial by jury of all
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`issues so triable.
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`KOIOS Exhibit 1016
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`Case 1:14-cv-01498-JBS-KMW Document 1 Filed 03/07/14 Page 11 of 12 PageID: 11
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`Respectfully submitted,
`
`By: s/ David C. Kistler
`
`David C. Kistler
`BLANK ROME LLP
`301 Carnegie Center, 3rd Floor
`Princeton, NJ 08540
`(609) 750-2643 (telephone)
`(609) 897-7291 (facsimile)
`kistler@blankrome.com
`
`Of Counsel:
`Christopher J. Harnett
`James F. Haley, Jr.
`Hassen A. Sayeed
`Jacqueline M. James
`Steven K. Mossey
`ROPES & GRAY LLP
`1211 Avenue of the Americas
`New York, New York 10036
`(212) 596-9000 (telephone)
`(212) 596-9090 (facsimile)
`james.haley@ropesgray.com
`christopher.harnett@ropesgray.com
`hassen.sayeed@ropesgray.com
`jacqueline.james@ropesgray.com
`steven.mossey@ropesgray.com
`
`Attorneys for Plaintiffs medac Pharma, Inc.
`and medac Gesellschaft für klinische
`Spezialpräparate mbH
`
`
`
`Dated: March 7, 2014
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`KOIOS Exhibit 1016
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`Case 1:14-cv-01498-JBS-KMW Document 1 Filed 03/07/14 Page 12 of 12 PageID: 12
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`LOCAL CIVIL RULE 11.2 CERTIFICATION
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`Plaintiffs medac and medac Pharma hereby certify that, to their knowledge, the matter in
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`controversy in this action is not the subject of any other pending lawsuit, arbitration, or
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`Respectfully submitted,
`
`By: s/ David C. Kistler
`
`David C. Kistler
`BLANK ROME LLP
`301 Carnegie Center, 3rd Floor
`Princeton, NJ 08540
`(609) 750-2643 (telephone)
`(609) 897-7291 (facsimile)
`kistler@blankrome.com
`
`
`
`Of Counsel:
`Christopher J. Harnett
`James F. Haley, Jr.
`Hassen A. Sayeed
`Jacqueline M. James
`Steven K. Mossey
`ROPES & GRAY LLP
`1211 Avenue of the Americas
`New York, New York 10036
`(212) 596-9000 (telephone)
`(212) 596-9090 (facsimile)
`james.haley@ropesgray.com
`christopher.harnett@ropesgray.com
`hassen.sayeed@ropesgray.com
`jacqueline.james@ropesgray.com
`steven.mossey@ropesgray.com
`
`Attorneys for Plaintiffs medac Pharma, Inc.
`and medac Gesellschaft für klinische
`Spezialpräparate mbH
`
`
`administrative proceeding.
`
`Dated: March 7, 2014
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`Page 12 of 12
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`KOIOS Exhibit 1016