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