Case 1:15-cv-00078-RGA Document 7 Filed 01/30/15 Page 1 of 15 PageID #: 54
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`Case 1:15-cv-00078—RGA Document 7 Filed 01/30/15 Page 1 of 15 PageID #: 54
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`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`NOVARTIS PHARMACEUTICALS
`
`CORPORATION and NOVARTIS AG,
`
`CA. No. 15—78—RGA
`
`Plaintiffs,
`
`PAR PHARMACEUTICAL, INC.
`
`Defendant.
`
`
`
`DEFENDANT PAR PHARMACEUTICAL, INC.’S ANSYYER AND COUNTERCLAIMS
`
`Par Pharmaceutical, Inc. (“Par”), answers the Complaint of Novartis Pharmaceuticals
`
`Corporation and Novartis AG (collectively “P1aintiffs”) as follows:
`
`NATURE OF ACTION
`
`1.
`
`This is an action for patent infringement.
`
`Answer: Par admits that Plaintiffs purport to bring an action for patent infringement
`
`against Par. Par denies that Plaintiffs properly state a claim for patent infringement.
`
`PARTIES
`
`Plaintiff Novartis Pharmaceuticals Corporation (“NPC”) is a corporation
`2.
`organized and existing under the laws of the State of Delaware, having a principal place of
`business at 59 Route 10, East Hanover, New Jersey 07936.
`
`Answer: Par lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in paragraph 2 of the Complaint and therefore denies them.
`’3
`Plaintiff Novartis AG (“Novartis AG”) is a corporation organized and existing
`3.
`under the laws of Switzerland, having an office and place of business at Lichtstrasse 35, CH-
`4056 Basel, Switzerland.
`
`

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`Answer: Par lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in paragraph 3 of the Complaint and therefore denies them.
`
`On information and belief, defendant Par Pharmaceutical, Inc. (“Par”) is a
`4.
`corporation organized and existing under the laws of the State of Delaware, and having
`designated its registered agent as The Corporation Trust Company, Corporation Trust Center,
`1209 Orange Street, Wilmington, Delaware 19801. Upon information and belief, defendant Par
`has its primary place of business at One Ram Ridge Road, Spring Valley, New York 10977.
`Upon information and belief, defendant Par develops, manufactures, markets and distributes
`numerous generic drugs for sale and use throughout the United States, including in this judicial
`district.
`
`Answer: Par admits the allegations in paragraph 4 of the Complaint.
`
`JURISDICTION AND VENUE
`
`This action arises under the patent laws of the United States of America. This
`5.
`Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331, 133 8(a),
`2201, and 2202.
`
`Answer: Par admits that Plaintiffs purport to bring this action under the patent laws of
`
`the United States of America. Par states that it does not contest this Court’s subject matter
`
`jurisdiction over this action.
`
`On information and belief, Par is in the business of developing, manufacturing,
`6.
`marketing, and selling pharmaceutical drug products, including generic drug products. On
`information and belief, Par directly or through its affiliates and agents markets and sells drug
`products throughout the United States and in this judicial district, is incorporated in Delaware,
`has a registered agent for service in Delaware, and has purposely availed itself of the rights and
`benefits of Delaware law and this Court. This Court has personal jurisdiction over Par by virtue
`of, inter alia, these above-mentioned facts.
`
`Answer: Par states that it does not contest this Court’s personal jurisdiction for purposes
`
`of this action.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b) and (c) and 28
`7.
`U.S.C. § 1400(b).
`
`Answer: Par states that it does not contest venue in this judicial district for purposes of
`
`this action.
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`

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`
`CLAIM FOR RELIEF — PATENT INFRINGEMENT
`
`Plaintiff NPC holds approved New Drug Application (“NDA”) No. 22—334 for
`8.
`AFINITOR® (everolimus) tablets for oral administration (2.5 mg, 5 mg, 7.5 mg and 10 mg
`dosage strengths), which contain the active ingredient everolimus. AFINITOR® tablets were
`approved by the United States Food and Drug Administration (“FDA”) on March 30, 2009 (5 mg
`and 10 mg dosage strengths), July 9, 2010 (2.5 mg dosage strength), and March 30, 2012 (7.5 mg
`dosage strength). AFINITOR® tablets are indicated for the treatment of: postmenopausal women
`with advanced hormone receptor-positive, HER2-negative breast cancer in combination with
`exemestane after failure of treatment with letrozole or anastrozole; adults with progressive
`neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic;
`adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib;
`adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate
`surgery; and pediatric and adult patients with tuberous sclerosis complex who have
`subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be
`curatively resected. AFINITOR® (everolimus) tablets for oral administration (2.5 mg, 5 mg, 7.5
`mg and 10 mg dosage strengths) are sold in the United States by Plaintiff NPC.
`
`Answer: Par states that the FDA website lists “Novartis” as the holder of NBA No. 22-
`
`334 for AFINITOR ® (everolimus) tablets (2.5 mg, 5 mg, 7.5 mg and 10 mg dosage strengths)
`
`and lists March 30, 2009 (5 mg and 10 mg dosage strengths), July 9, 2010 (2.5 mg dosage
`
`strength), and March 30, 2012 (7.5 mg dosage strength) as the approval dates for that NDA. Par
`
`further states that the FDA—approved labeling for AFINITOR ® states:
`
`AFINITOR is a kinase inhibitor indicated for the treatment of:
`
`o
`
`0
`
`0
`
`postmenopausal women with advanced hormone receptor—positive, HERZ-
`negative breast cancer (advanced HR+ BC) in combination with exemestane after
`failure of treatment with letrozole or anastrozole.
`
`adults with progressive neuroendocrine tumors of pancreatic origin (PNET) that
`are unresectable, locally advanced or metastatic. AFINITOR is not indicated for
`the treatment of patients with functional carcinoid tumors.
`adults with advanced renal cell carcinoma (RCC) after failure of treatment with
`sunitinib or sorafenib.
`
`0
`
`adults with renal angiomyolipoma and tuberous sclerosis complex (TS C), not
`requiring immediate surgery. The effectiveness of AFINITOR in the treatment of
`renal angiomyolipoma is based on an analysis of durable objective responses in
`patients treated for a median of 8.3 months. Further follow-up of patients is
`required to determine long-term outcomes.
`AFHQITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the
`treatment of:
`
`o
`
`pediatric and adult patients with tuberous sclerosis complex (TSC) who have
`subependymal giant cell astrocytoma (SEGA) that requires therapeutic
`
`

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`intervention but cannot be curatively resected. The effectiveness is based on
`demonstration of durable objective response, as evidenced by reduction in SEGA
`tumor volume. Improvement in disease-related symptoms and overall survival in
`patients with SEGA and TSC has not been demonstrated.
`
`Par lacks knowledge or information sufficient to form a belief as to the truth of the
`
`remaining allegations in paragraph 8 of the Complaint and therefore denies them.
`
`Everolimus is known chemically as (IR, 98, 128, 15R, 16E, 18R, 19R, 21R, 238,
`9.
`24E, 26E, 28B, 308, 328, 35R)—1, 18-dihydroxy—12—{(lR)—2-[(1S,3R,4R)—4-(2-hydroxyethoxy)-
`3-methoxycyclohexyl]—l—methylethyl}-19,30—dimethoxy~1 5, 17, 21, 23, 29, 35-hexamethyl-l 1,
`36—dioxa—4-aza-tricyclo[30.3.1.04’9] hexatriaconta—l6,24,26,28—tetraene-2, 3,10,14,20-pentaone
`and also as 40—0-(2-hydroxyethyl)-rapamycin. The chemical name 6‘(11R, 98, 128, 15R, 16E,
`18R, 19R, 21R, 23S, 24E, 26E, 28B, 308, 328, 35R)-1, 18-dihydroxy—12—{(lR)-2-[(1S,3R,4R)—4-
`(2—hydroxyethoxy)—3 -methoxycyclohexyl]-l—methylethyl}-19,30-dimethoxy—1 5, 17, 21, 23, 29,
`3 5—hexa1nethyl—1 1, 3 6—dioxa—4-aza—tricyclo[30.3 . 1 .04’9] hexatriaconta— 1 6,24,26,28-tetraene-2,
`3,10,14,20-pentaone” is equivalent to “40-0-(2—hydroxyethyl)—rapamycin.”
`
`Answer: On information and belief, Par admits the allegations in paragraph 9 of the
`
`Complaint.
`
`10.
`
`Everolimus is a 40-0-substituted rapamycin.
`
`Answer: On information and belief, Par admits the allegations in paragraph 10 of the
`
`Complaint.
`
`11.
`
`Plaintiff Novartis AG is the owner of United States Letters Patent No. 5,665,772
`
`(“the “772 patent”). The ‘772 patent was duly and legally issued on September 9, 1997.
`
`Answer: Par admits that the ’772 patent was issued on September 9, 1997. Par denies
`
`that the ’772 patent was duly and lawfully issued. Par further states that the PTO assignment
`
`database lists Novartis AG as the assignee of the ’772 patent. Par lacks knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations in paragraph 11
`
`of the Complaint and therefore denies them.
`
`The “772 patent claims, inter alia, the compound which is 40-0-(2—hydroxyethyl)-
`12,
`rapamycin and a pharmaceutical composition containing this compound. A true copy of the ‘772
`patent is attached as Exhibit A.
`
`

`

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`Answer: Par admits that what appears to be a copy of the ’772 patent is attached as
`
`Exhibit A to the Complaint. Par states that the ’772 patent speaks for itself. To the extent that
`
`the allegations in paragraph 12 of the Complaint vary therewith, Par denies them.
`
`13.
`
`Plaintiff Novartis AG is the owner of United States Letters Patent No. 7,297,703
`
`(“the ‘703 patent”). The ‘703 patent was duly and legally issued on November 20, 2007.
`
`Answer: Par admits that the ’703 patent was issued on November 20, 2007. Par denies
`
`that the ’703 patent was duly and lawfully issued. Par further states that the face of the ’703
`
`patent lists Novartis AG as the assignee. Par lacks knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations in paragraph 13 of the Complaint and therefore
`
`denies them.
`
`The ‘703 patent claims, inter alia, a solid mixture comprising a 40—0-substituted
`14.
`rapamycin and an antioxidant present in a catalytic amount, and pharmaceutical compositions
`comprising such solid mixture as active ingredient, admixed with one or more pharmaceutically
`acceptable carriers or diluents. A true copy of the ‘703 patent is attached as Exhibit B.
`
`Answer: Par admits that what appears to be a copy of the ’703 patent is attached as
`
`Exhibit B to the Complaint. Par states that the ’703 patent speaks for itself. To the extent that
`
`the allegations in paragraph 14 of the Complaint vary therewith, Par denies them.
`
`15.
`
`Plaintiff Novartis AG is the owner of United States Letters Patent No. 7,741,338
`
`(“the ‘338 patent”). The 6338 patent was duly and legally issued on June 22, 2010.
`
`Answer: Par admits that the ’338 patent was issued on June 22, 2010. Par denies that
`
`the ’338 patent was duly and lawfully issued. Par further states that the face of the ”338 patent
`
`lists Novartis AG as the assignee. Par lacks knowledge or information sufficient to form a belief
`
`as to the truth of the remaining allegations in paragraph 15 of the Complaint and therefore denies
`
`them.
`
`The ‘338 patent claims, inter alia, a solid mixture comprising 40-0—(2—
`16.
`hydroxy)ethyl—rapamycin and 2,6—di-tert—butyl—methylphenol (BHT), and pharmaceutical
`compositions comprising this solid mixture together with one or more pharmaceutically
`
`

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`Answer: Par admits that what appears to be a copy of the ’338 patent is attached as
`
`Exhibit C to the Complaint. Par states that the ‘338 patent speaks for itself. To the extent that
`
`the allegations in paragraph 16 of the Complaint vary therewith, Par denies them.
`
`On information and belief, Par submitted to the FDA an abbreviated new drug
`17.
`application (“ANDA”) under the provisions of 21 U.S.C. § 3550) seeking approval to engage in
`the commercial manufacture, use, and sale of everolimus tablets (2.5 mg, 5 mg, and 7.5 mg
`dosage strengths) (“Par’s ANDA Products”) before the expiration of the ‘772, ‘703 and “338
`patents.
`
`Answer: Par admits the allegations in paragraph 17 of the Complaint.
`
`On information and belief, Par made and included in its ANDA a certification
`18.
`under 21 U.S.C. § 3550)(2)(A)(vii)(IV) that, in its opinion and to the best of its knowledge, the
`‘772 and ‘703 patent claims are invalid and/or will not be infringed. Par did not allege that any of
`the ‘772 and/or ‘703 patent claims were unenforceable.
`
`Answer: Par states that its ANDA No. 207934 speaks for itself. To the extent that the
`
`allegations in paragraph 18 of the Complaint vary therewith, Par denies them.
`
`Plaintiffs received written notification of Par’s ANDA and its accompanying §
`19.
`5050)(2)(A)(vii)(IV) certification by a letter dated December 10, 2014 (“Notice Letter”)
`informing Plaintiffs that Par had submitted to the FDA an ANDA under the provisions of 21
`U.S.C. § 3550) seeking approval to engage in the commercial manufacture, use and sale of 2.5
`mg, 5 mg, and 7.5 mg everolimus tablets.
`
`Answer: On information and belief, Par admits the allegations in paragraph 19 of the
`
`Complaint.
`
`20.
`
`This action was commenced within 45 days of receipt of the Par Notice Letter.
`
`Answer: On information and belief, Par admits the allegations in paragraph 20 of the
`
`Complaint.
`
`By filing its ANDA under 21 U.S.C. § 3550) for the purpose of obtaining
`21.
`approval to engage in the commercial manufacture, use, or sale of Par’s ANDA Products before
`the expiration of the ‘772, ‘703 and ‘338 patents, Par has committed an act of infringement under
`35 U.S.C. § 271(e)(2).
`
`Answer: Par denies the allegations in paragraph 21 of the Complaint.
`
`

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`‘703 and ‘338 patents and that the filing of its ANDA with the request for its approval prior to
`the expiration of the ‘772, ‘703 and ‘338 patents was an act of infringement of those patents.
`
`Answer: Par admits that it was aware of the ’772, ’703, and ’338 patents when it filed its
`
`ANDA No. 207934. Par denies the remaining allegations in paragraph 22 of the Complaint.
`
`On information and belief, the commercial manufacture, use, offer for sale, sale,
`23.
`and/or importation of Par’s ANDA Products will infringe one or more claims of the ‘772, ‘703
`and ‘338 patents.
`
`Answer: Par denies the allegations in paragraph 23 of the Complaint.
`
`On information and belief, Par’s ANDA Products, if approved, will contain 40—0—
`24.
`(2-hydroxyethyl)-rapamycin.
`
`Answer: Par admits the allegations in paragraph 24 of the Complaint.
`
`25. On information and belief, Par’s ANDA Products, if approved, will be
`pharmaceutical compositions containing a therapeutically effective amount of 40—0-(2-
`hydroxyethyl)—rapamycin and a pharmaceutically acceptable carrier.
`
`Answer: Par states that paragraph 25 of the Complaint requires legal conclusions to
`
`which no response is required. To the extent a response is required, Par states that its ANDA
`
`No. 207934 speaks for itself. To the extent that the allegations in paragraph 25 of the Complaint
`
`vary therewith, Par denies them.
`
`26. Par did not deny infringement of claims 1—3 and 7~10 of the ‘772 patent in its Notice
`
`Letter.
`
`Answer: Par denies the allegations in paragraph 26 of the Complaint.
`
`27. On information and belief, the commercial manufacture of Par’s ANDA Products will
`involve direct infringement of the ‘772 patent. On information and belief, this will occur at Par’s
`active behest, and with Par’s intent, knowledge, and encouragement.
`
`Answer: Par denies the allegations in paragraph 27 of the Complaint.
`
`28. On information and belief, Pat’s ANDA Products, if approved, will be
`pharmaceutical compositions comprising an active ingredient admixed with one or more
`pharmaceutically acceptable carriers or diluents. On information and belief, said active
`ingredient will be a solid mixture comprising a 40-0—substituted rapamycin and an antioxidant
`present in a catalytic amount.
`
`

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`Answer: Par states that paragraph 28 of the Complaint requires legal conclusions to
`
`which no response is required. To the extent a response is required, Par states that its ANDA
`
`No. 207934 speaks for itself. To the extent that the allegations in paragraph 28 of the Complaint
`
`vary therewith, Par denies them.
`
`29. On information and belief, the commercial manufacture of Par’s ANDA Products will
`involve direct infringement of the ‘703 patent. On information and belief, this will occur at Par’s
`active behest, and with Par’s intent, knowledge, and encouragement.
`
`Answer: Par denies the allegations in paragraph 29 of the Complaint.
`
`30. On information and belief, Par’s ANDA Products, if approved, will comprise a solid
`mixture comprising 40-O—(2—hydroxy)ethyl-rapamycin and 2,6-di—tert—butylmethylphenol (BHT).
`
`Answer: Par states that its ANDA No. 207934 speaks for itself. To the extent that the
`
`allegations in paragraph 30 of the Complaint vary therewith, Par denies them.
`
`31. On information and belief, Par’s ANDA Products, if approved, will be
`pharmaceutical compositions comprising a solid mixture comprising 40-0-(2-hydroxy)ethyl-
`rapamycin and 2,6—di-tert-butyl-methylphenol (BHT) together with one or more
`pharmaceutically acceptable diluents or carriers.
`
`Answer: Par states that paragraph 31 of the Complaint requires legal conclusions to
`
`which no response is required. To the extent a response is required, Par states that its ANDA
`
`No. 207934 speaks for itself. To the extent that the allegations in paragraph 31 of the Complaint
`
`vary therewith, Par denies them.
`
`On information and belief, the commercial manufacture of Par’s ANDA Products
`32.
`will involve direct infringement of the ‘338 patent. On information and belief, this will occur at
`Par’s active behest, and with Par’s intent, knowledge, and encouragement.
`
`Answer: Par denies the allegations in paragraph 32 of the Complaint.
`
`33. Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(c)(4), including an
`order of this Court that the effective date of any approval of the ANDA relating to Pat’s ANDA
`Products be a date that is no earlier than March 9, 2020, the expiration of the ‘772 patent’s
`pediatric exclusivity, and June 6, 2020, the expiration of the ‘703 and ‘338 patents’ pediatric
`exclusivity, and an award of damages for any commercial sale or use of Par’s ANDA Products
`and any act committed by Par with respect to the subject matter claimed in the ‘772, ‘703 and
`
`

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`Answer: Par denies the allegations in paragraph 33 of the Complaint.
`
`34. On information and belief, Par has taken and continues to take active steps towards
`the commercial manufacture, use, offer for sale, sale, and/or importation of Par’s ANDA
`Products, including seeking approval of those products under Par’s ANDA.
`
`Answer: Par admits that it prepared and submitted its ANDA No. 207934 to the FDA,
`
`and seeks approval thereof. Par denies the remaining allegations in Paragraph 34 of the
`
`Complaint.
`
`35. There is a substantial and immediate controversy between Plaintiffs and Par
`concerning the ‘772, ‘703 and ‘338 patents. Plaintiffs are entitled to declaratory judgment under
`28 U.S.C. §§ 2201 and 2202 that Par will infringe and/or induce infringement of one or more
`claims of the ‘772, ‘703 and “338 patents.
`
`Answer: Par states that paragraph 35 of the Complaint requires a legal conclusion to
`
`which no response is required. To the extent a response is required, Par states that it does not
`
`contest subject matter jurisdiction concerning the ’772, ’703, and ’338 patents. Par denies the
`
`allegations in the second sentence of paragraph 35 of the Complaint.
`
`PRAYER FOR RELIEF
`
`Par denies that Plaintiffs are entitled to any of the relief they seek in the Complaint.
`
`AFFIRMATIVE DEFENSES
`
`1.
`
`The claims of the ’772 patent, ”703 patent, and ”338 patent are invalid under 35
`
`U.S.C. § et seq. (including, inter alia, 35 U.S.C. §§ 102, 103, and/or 112) and/or the doctrine of
`
`obviousness—type double patenting.
`
`2.
`
`Par’s filing of its ANDA No. 207934 was not an act of infringement of any valid
`
`claim of the ’772 patent, ’703 patent, or ’338 patent.
`
`3.
`
`The manufacture, use, offer for sale, sale, marketing, distribution, or importation
`
`of the products that are the subject of Par’s ANDA No. 207934 would not infringe any valid
`
`claim of the ”772 patent, ’703 patent, or ’338 patent.
`
`

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`4.
`
`The Complaint fails to state a claim for which relief can be granted.
`
`COUNTERCLAIMS
`
`Par Pharmaceutical, Inc. (“Par”) asserts the following Counterclaims against Novartis
`
`Pharmaceuticals Corporation and Novartis AG (collectively “‘Plaintiffs”):
`
`THE PARTIES
`
`1.
`
`Par is a corporation organized and existing under the laws of the State of
`
`Delaware, with a principal place of business at One Ram Ridge Road, Spring Valley, New York
`
`10977.
`
`2.
`
`Novartis Pharmaceuticals Corporation asserts in its Complaint that it is a
`
`corporation organized and existing under the laws of the State of Delaware, having a principal
`
`place of business at 59 Route 10, East Hanover, New Jersey 07936.
`
`3.
`
`Novartis AG asserts in its Complaint that it is a corporation organized and
`
`existing under the laws of Switzerland, having an office and place of business at Lichtstrasse 35,
`
`CPI-4056 Basel, Switzerland.
`
`NATURE OF THE ACTION
`
`4.
`
`Par seeks a declaratory judgment under the Patent Laws of the United States, 35
`
`U.S.C. § 100 et seq., and the Declaratory Judgment Act, 28 U.S.C. § 2201 et seq, that Par does
`
`not infringe any valid claim of US. Patent Nos. 5,665,772 (“the ’772 patent”), 7,297,703 (“the
`
`”703 Patent”), or 7,741,338 (“the ’338 Patent) and that the ’772 patent, the ”703 patent, and the
`
`’3382 patent are invalid.
`
`JURISDICTION
`
`5.
`
`This Court has original jurisdiction over the subject matter of these claims under
`
`28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`

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`6.
`
`This Court has personal jurisdiction over Plaintiffs based, inter alia, on the filing
`
`by Plaintiffs of this lawsuit in this jurisdiction.
`
`VENUE
`
`7.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b)—(d), 1400(b),
`
`and Plaintiffs” choice of forum.
`
`BACKGROUND
`
`8.
`
`Par submitted to the FDA Abbreviated New Drug Application No. 207934
`
`(“ANDA No. 207934”) requesting regulatory approval to commercially market in the United
`
`States everolimus tablets (2.5 mg, 5 mg, and 7.5 mg dosage strengths), before the expiration of
`
`the ’772 patent and the ’703 patent.
`
`9.
`
`Par included within its ANDA No. 207934 a certification pursuant to 21 U.S.C. §
`
`35 5(j)(2)(A)(vii)(IV) (“paragraph IV certification”).
`
`10.
`
`Pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), Par provided notice to Plaintiffs of the
`
`paragraph IV certification filed in connection with ANDA No. 207934 for the ”772 patent and
`
`the ’703 patent.
`
`11.
`
`On January 23, 2015, Plaintiffs filed the Complaint alleging infringement of the
`
`’772 patent, the ’703 patent, and the ’338 patent by Par.
`
`COUNT I
`
`(Declaratory Judgment of Non-Infringement of US. Patent No. 5,665,772)
`
`Par re-alleges paragraphs 1—11 of the Counterclaims as if fully set forth herein.
`
`Par’s filing of ANDA No. 207934 did not infringe any valid claim of the ’772
`
`12.
`
`13.
`
`patent.
`
`

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`14.
`
`The commercial manufacture, use, offer for sale, sale, or importation of Par’s
`
`everolimus products would not infringe any valid claim of the ”772 patent.
`
`15.
`
`An actual and justiciable controversy exists between the parties with respect to the
`
`”772 patent, and Par is entitled to a declaratory judgment that the ”772 patent is not infringed.
`
`new
`
`(Declaratory Judgment of Invalidity of US. Patent No. 5,665,772)
`
`Par re—alleges paragraphs 1—15 of the Counterclaims as if fully set forth herein.
`
`Par”s filing of ANDA No. 207934 did not infringe any valid claim of the ”772
`
`16.
`
`17.
`
`patent.
`
`18.
`
`The ”772 patent and the claims thereof are invalid under one or more of 35 U.S.C.
`
`§§ 102, 103, and/or 112 and/or the doctrine of obviousness-type double patenting.
`
`19.
`
`An actual and justiciable controversy exists between the parties with respect to the
`
`”772 patent, and Par is entitled to a declaratory judgment that the ”772 patent is invalid.
`
`COUNT III
`
`(Declaratory Judgment of Non-Infringement of US. Patent No. 7,297,703)
`
`20.
`
`Par re-alleges paragraphs 1—19 of the Counterclaims as if fully set forth herein.
`
`21.
`
`Pat’s filing of ANDA No. 207934 did not infringe any valid claim of the ’703
`
`patent.
`
`22.
`
`The commercial manufacture, use, offer for sale, sale, or importation of Par’s
`
`everolimus products would not infringe any valid claim of the ”703 patent.
`
`23.
`
`An actual and justiciable controversy exists between the parties with respect to the
`
`”703 patent, and Par is entitled to a declaratory judgment that the ’703 patent is not infringed.
`
`

`

`Case 1:15-cv-00078-RGA Document 7 Filed 01/30/15 Page 13 of 15 PageID #: 66
`
`Case 1:15-cv-00078-RGA Document 7 Filed 01/30/15 Page 13 of 15 PageID #: 66
`
`COUNT IV
`
`(Declaratory Judgment of Invalidity of US. Patent No. 7,297,703)
`
`24.
`
`Par re-alleges paragraphs 1-23 of the Counterclaims as if fully set forth herein.
`
`25.
`
`Par”s filing of ANDA No. 207934 did not infringe any valid claim of the ”703
`
`patent.
`
`26.
`
`The ’703 patent and the claims thereof are invalid under one or more of 35 U.S.C.
`
`§§ 102, 103, and/or 112 and/or the doctrine of obviousness-type double patenting.
`
`27.
`
`An actual and justiciable controversy exists between the parties with respect to the
`
`”703 patent, and Par is entitled to a declaratory judgment that the ”703 patent is invalid.
`
`COUNT V
`
`(Declaratory Judgment of Non—Infringement of US. Patent No. 7,741,338)
`
`28.
`
`Par re-alleges paragraphs 1—27 of the Counterclaims as if fully set forth herein.
`
`29.
`
`Par”s filing of ANDA No. 207934 did not infringe any valid claim of the ”338
`
`patent.
`
`30.
`
`The commercial manufacture, use, offer for sale, sale, or importation of Par’s
`
`everolirnus products would not infringe any valid claim of the ”338 patent.
`
`31.
`
`An actual and justiciable controversy exists between the parties with respect to the
`
`”338 patent, and Par is entitled to a declaratory judgment that the ”338 patent is not infringed.
`
`w
`
`(Declaratory Judgment of Invalidity of US. Patent No. 7,741,338)
`
`32.
`
`Par re-alleges paragraphs 1-31 of the Counterclaims as if fully set forth herein.
`
`33.
`
`Par’s filing of ANDA No. 207934 did not infringe any valid claim of the ”338
`
`patent.
`
`

`

`Case 1:15-cv-00078-RGA Document 7 Filed 01/30/15 Page 14 of 15 PageID #: 67
`
`Case 1:15-cv-00078-RGA Document 7 Filed 01/30/15 Page 14 of 15 PageID #: 67
`
`34.
`
`The ’338 patent and the claims thereof are invalid under one or more of 35 U.S.C.
`
`§§ 102, 1035 and/or 112 and/or the doctrine of obviousness—type double patenting.
`
`35.
`
`An actual and justiciable controversy exists between the parties with respect to the
`
`”338 patent, and Par is entitled to a declaratory judgment that the ’338 patent is invalid.
`
`
`
`
`WHEREFOR 4‘, Par respectfully requests that this Court enter judgment in its favor and against
`
`PRAYER FOR RELIEF
`
`Plaintiffs and grant the following relief:
`
`A.
`
`B.
`
`Dismiss Plaintiffs’ Complaint with prejudice;
`
`Declare that Par’s filing of ANDA No. 207934 was not an act of infringement of
`
`any valid claim of the ’772 patent, the ”703 patent, or the ’338 patent;
`
`C.
`
`Declare that the manufacture, use, offer for sale, sale, marketing, distribution, or
`
`importation of Par’s everolimus products as specified in ANDA No. 207934 would not infringe
`
`any valid claims of the ”772 patent, the ’703 patent, or the ’338 patent;
`
`D.
`
`Declare that each claim of the ’772 patent, the ’703 patent, and the ’338 patent is
`
`invalid;
`
`E.
`
`F.
`
`Declare that this case is exceptional under 35 U.S.C. § 285;
`
`Award Par its costs and reasonable attorney fees to the extent permitted by law;
`
`G.
`
`Award Par such other and further relief as the Court deems just and proper.
`
`

`

`Case 1:15-cv-00078-RGA Document 7 Filed 01/30/15 Page 15 of 15 PageID #: 68
`
`Case 1:15-cv-00078-RGA Document 7 Filed 01/30/15 Page 15 of 15 PageID #: 68
`
`OfCoansel:
`
`)anie1 G. Brown
`LATHAM & WATKINS LLP
`
`885 Third Avenue
`New York, NY 10022
`(212) 906—1200
`
`Roger J. Chin
`LATHAM & WATKINS LLP
`
`
`/s/ Steven J. Fineman
`Steven J. Fineman (#4025)
`Katharine C. Lester (#5629)
`RICHARDS LAYTON & FINGER, PA.
`
`920 North King Street
`Wilmington, DE 19801
`(302) 651—7700
`fineman@rlf. com
`1ester@r1f.con1
`
`505 Montgomery Street, Suite 2000
`San Francisco, CA 94111
`
`Attorneysfor Defendant Par Pharmaceutical,
`Inc.
`
`(415) 391—0600
`
`Marc N. Zubick
`
`LATHAM & WATKINS LLP
`
`330 North Wabash Avenue, Suite 2800
`
`Chicago, IL 60611
`(312) 876-7700
`
`Parker M. Tresemer
`
`LATHAM & WATKINS LLP
`
`3 55 South Grand Avenue
`
`Los Angeles, CA 90071
`(213) 891—8052
`
`Dated: January 30, 2015
`
`