Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 1 of 9 PageID: 1
`
`John E. Flaherty
`MCCARTER & ENGLISH, LLP
`100 Mulberry Street
`Four Gateway Center
`Newark, NJ 07102
`Tel: (973) 639-7903
`Fax: (973) 297-3971
`Attorneys for Plaintiffs
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`Civil Action No.
`
`
`
`
`
`JANSSEN PRODUCTS, L.P.
`and JANSSEN R&D IRELAND,
`
`
`Plaintiffs,
`
`v.
`
`LUPIN LIMITED and
`LUPIN PHARMACEUTICALS INC.
`
`
`Defendants.
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Janssen Products, L.P. and Janssen R&D Ireland (collectively,
`
`"Janssen" or "Plaintiffs") for their Complaint against Lupin Limited ("Lupin Ltd.") and Lupin
`
`Pharmaceuticals Inc. ("Lupin Pharmaceuticals") (collectively "Lupin" or "Defendants") allege as
`
`
`
`follows:
`
`
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 2 of 9 PageID: 2
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for infringement by Lupin of U.S. Patent No.
`
`8,518,987 B2 ("the '987 Patent") arising under the patent laws of the United States, 35 U.S.C. §§
`
`1 et seq. This action arises out of Lupin's filing of Abbreviated New Drug Application
`
`("ANDA") seeking approval to sell generic versions of plaintiff Plaintiffs' highly successful
`
`PREZISTA® (darunavir) 75 mg, 150 mg, 300 mg, 400 mg, 600 mg, and 800 mg products prior
`
`to the expiration of the '987 Patent.
`
`THE PARTIES
`
`2.
`
`Plaintiff Janssen Products, L.P. is a partnership organized under the laws
`
`of the State of New Jersey, having its headquarters and principal place of business at 800/850
`
`Ridgeview Drive, Horsham, PA 19044.
`
`3.
`
`Plaintiff Janssen R&D Ireland is an Irish corporation having its principal
`
`place of business at Eastgate Village, Eastgate, Little Island, County Cork, Ireland.
`
`4.
`
`On information and belief, Lupin Ltd. is an Indian corporation having a
`
`place of business at B/4 Laxmi Towers, Bandra-Kurla Complex, Bandra (E), Mumbai 400 051,
`
`India, and having a registered office at 159 CST Road, Kalina, Santacruz (E), Mumbai 400 098,
`
`India. On information and belief, Lupin Ltd. is in the business of, among other things,
`
`manufacturing and selling generic versions of branded pharmaceutical products for the U.S.
`
`market through various operating subsidiaries, including Lupin Pharmaceuticals.
`
`5.
`
`On information and belief, Lupin Pharmaceuticals is a corporation
`
`organized and existing under the laws of the Commonwealth of Virginia, having a principal
`
`place of business at Harborplace Tower, 111 South Calvert Street, Baltimore, Maryland 21202.
`
`On information and belief, Lupin Pharmaceuticals is in the business of, among other things,
`
`
`
`2
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 3 of 9 PageID: 3
`
`manufacturing and selling generic versions of branded pharmaceutical products for the U.S.
`
`market. Lupin Pharmaceuticals is a wholly owned subsidiary of Lupin Ltd.
`
`JURISDICTION AND VENUE
`
`6.
`
`This Court has jurisdiction over the subject matter of this action pursuant
`
`to 28 U.S.C. §§ 1331 and 1338(a).
`
`7.
`
`On information and belief, this Court has personal jurisdiction over Lupin
`
`Ltd. because Lupin Ltd. has purposely availed itself of the benefits and protections of New
`
`Jersey's laws such that it should reasonably anticipate being haled into court here. On
`
`information and belief, Lupin Ltd. has had persistent and continuous contacts with this judicial
`
`district, including developing, manufacturing, and/or selling pharmaceutical products that are
`
`sold in this judicial district.
`
`8.
`
`On information and belief, this Court has personal jurisdiction over Lupin
`
`Pharmaceuticals because Lupin Pharmaceuticals has purposely availed itself of the benefits and
`
`protections of New Jersey's laws such that it should reasonably anticipate being haled into court
`
`here. On information and belief, Lupin Pharmaceuticals has had persistent and continuous
`
`contacts with this judicial district, including developing, manufacturing, and/or selling
`
`pharmaceutical products that are sold in this judicial district.
`
`9.
`
`On information and belief, Lupin Ltd. and Lupin Pharmaceuticals operate
`
`and act in concert as an integrated, unitary business. For example, Lupin Ltd. includes within its
`
`Annual Report the activities of Lupin Pharmaceuticals, including revenue earned.
`
`10.
`
`On information and belief, Lupin Pharmaceuticals is registered to do
`
`business in New Jersey.
`
`
`
`3
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 4 of 9 PageID: 4
`
`11.
`
`On information and belief, Lupin Pharmaceuticals retains a registered
`
`agent in this judicial district.
`
`12.
`
`Lupin Ltd. and Lupin Pharmaceuticals have stipulated and/or consented to
`
`personal jurisdiction in this district in numerous prior patent cases, including in the related
`
`consolidated action, Janssen Products, L.P., et al. v. Lupin Limited, et al., 10-cv-5954 (WHW)
`
`(CLW).
`
`13.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`BACKGROUND
`
`14.
`
`On August 27, 2013, the United States Patent and Trademark Office ("the
`
`PTO") issued the '987 Patent, entitled "Pseudopolymorphic forms of a HIV protease inhibitor."
`
`A true and correct copy of the '987 Patent is attached hereto as Exhibit A.
`
`15.
`
`16.
`
`17.
`
`Plaintiff Janssen R&D Ireland holds title to the '987 Patent.
`
`The '987 Patent expires on February 16, 2024.
`
`The United States Food and Drug Administration ("FDA") has awarded 6
`
`months of pediatric exclusivity for PREZISTA®. The period of pediatric exclusivity applicable
`
`to the '987 Patent does not expire until August 16, 2024.
`
`18.
`
`Janssen Products L.P. is the holder of approved New Drug Application
`
`("NDA") No. 21-976 for PREZISTA®.
`
`19.
`
`PREZISTA® is included in FDA's list of "Approved Drug Products With
`
`Therapeutic Equivalence Evaluations" also known as the "Orange Book." Approved drugs may
`
`be used as the basis of a later applicant's ANDA to obtain approval of the ANDA applicant's
`
`drug product under the provisions of 21 U.S.C. § 355(j).
`
`
`
`4
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 5 of 9 PageID: 5
`
`20.
`
`The FDA's "Orange Book" also lists patents associated with approved
`
`drugs. The '987 Patent is listed in the "Orange Book" in association with PREZISTA®.
`
`21.
`
`On information and belief, Lupin Ltd., itself and/or through its subsidiary,
`
`agent and alter ego, Lupin Pharmaceuticals, submitted ANDA No. 202-073 to the FDA under
`
`§ 505(j) of the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 355(j), seeking
`
`approval to engage in the commercial manufacture, use, offer for sale, and sale of generic
`
`versions of PREZISTA® 75 mg, 150 mg, 300 mg, 400 mg, 600 mg and 800 mg tablets ("Lupin's
`
`Generic Tablets").
`
`22.
`
`On information and belief, Lupin Ltd. and Lupin Pharmaceuticals
`
`collaborated in the research, development, preparation and filing of ANDA No. 202-073 for
`
`Lupin's Generic Tablets.
`
`23.
`
`On information and belief, Lupin Pharmaceuticals will market and/or
`
`distribute Lupin's Generic Tablets if ANDA No. 202-073 is approved by the FDA.
`
`24.
`
`On information and belief, Lupin Ltd. participated in, contributed to,
`
`aided, abetted and/or induced the submission to the FDA of ANDA No. 202-073.
`
`25.
`
`On or about November 4, 2013, Plaintiffs received a letter dated
`
`November 1, 2013 ("the 2013 Lupin Paragraph IV Letter") stating that Lupin had submitted
`
`ANDA No. 202-073 seeking approval to manufacture, use and sell Lupin's Generic Tablets prior
`
`to the expiration of the '987 Patent.
`
`26.
`
`The 2013 Lupin Paragraph IV Letter also states that the Lupin ANDA No.
`
`202-073 included a certification, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that the claims of
`
`the '987 Patent are invalid and/or will not be infringed by the commercial manufacture, use and
`
`sale of Lupin's Generic Tablets.
`
`
`
`5
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 6 of 9 PageID: 6
`
`27.
`
`On information and belief, Lupin continues to seek approval of ANDA
`
`No. 202-073 from the FDA and intends to pursue the commercial manufacture, marketing and
`
`sale of Lupin's Generic Tablets (including the commercial marketing and sale of such products in
`
`the State of New Jersey) in the event that the FDA approves ANDA No. 202-073.
`
`COUNT I
`
`Infringement of the '987 Patent by Lupin
`
`28.
`
`Plaintiffs repeat and reallege each and every allegation contained in
`
`paragraphs 1 through 27 above, as if fully set forth here.
`
`29.
`
`Under 35 U.S.C. § 271(e)(2)(A), Lupin has infringed the '987 Patent by
`
`submitting ANDA No. 202-073 with a Paragraph IV certification and seeking FDA approval of
`
`ANDA No. 202-073 prior to the expiration of the '987 Patent.
`
`30.
`
`Plaintiffs have no adequate remedy at law to redress the infringement by
`
`Lupin.
`
`31.
`
`Plaintiffs will be irreparably harmed if Lupin is not enjoined from
`
`infringing or actively inducing or contributing to infringement of the '987 Patent.
`
`
`
`6
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 7 of 9 PageID: 7
`
`PRAYER
`
`
`
`
`
`WHEREFORE, Plaintiffs respectfully request relief and judgment as follows:
`
`(a)
`
`a judgment that Lupin has infringed the '987 Patent under 35 U.S.C. §
`
`271(e)(2)(A);
`
`(b)
`
`a judgment, pursuant to 35 U.S.C. § 271(e)(4)(A), that the effective date
`
`of any approval of Lupin's ANDA No. 202-073 under § 505(j) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. § 355(j)) is not earlier than the day after the expiration of the period of
`
`pediatric exclusivity applicable to the '987 Patent;
`
`(c)
`
`a judgment declaring that the making, using, selling, offering to sell, or
`
`importing of the generic darunavir tablets described in ANDA No. 202-073 would constitute
`
`infringement of the '987 Patent, or inducing or contributing to such conduct, by Lupin pursuant
`
`to 35 U.S.C. § 271(a), (b) and/or (c);
`
`(d)
`
`a judgment permanently enjoining Lupin and each of its officers, agents,
`
`servants and employees, and those persons in active concert or participation with them, from
`
`commercially manufacturing, selling or offering for sale, using, or importing the generic
`
`darunavir tablets described in ANDA No. 202-073 until the day after the expiration of the period
`
`of pediatric exclusivity applicable to the '987 Patent;
`
`(e)
`
`(f)
`
`a declaration that this case is exceptional;
`
`an award of Plaintiffs' costs, expenses, reasonable attorneys' fees and such
`
`other relief as the Court deems just and proper pursuant to 35 U.S.C. § 271(e)(4) and 35 U.S.C.
`
`§ 285; and
`
`(g)
`
`such other and further relief as the Court may deem just and proper.
`
`
`
`7
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 8 of 9 PageID: 8
`
`
`
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`
`s/ John E. Flaherty
`John E. Flaherty
`MCCARTER & ENGLISH, LLP
`100 Mulberry Street
`Four Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 639-7903
`Fax: (973) 297-3971
`Attorneys for Plaintiffs
`
`
`
`
`
`
`
`Of Counsel:
`Gregory L. Diskant
`Eugene M. Gelernter
`Irena Royzman
`PATTERSON BELKNAP
` WEBB & TYLER LLP
`1133 Avenue of the Americas
`New York, New York 10036
`Tel.: (212) 336-2000
`Fax: (212) 336-2222
`
`Dated: March 4, 2014
`
`
`
`8
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 1 Filed 03/04/14 Page 9 of 9 PageID: 9
`
`
`
`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`Plaintiffs, by their undersigned counsel, hereby certify pursuant to L. Civ. R. 11.2 that the
`
`matter in controversy is not the subject of any other action pending in any court, or of any
`
`pending arbitration or administrative proceeding. The matter in controversy is related to the
`
`subject matter of:
`
`(cid:1)
`
`Janssen Products L.P., et al. v. Lupin Limited, et al., Civil Action No. 10-cv-
`
`5954-WHW-CLW (D.N.J.);
`
`(cid:1)
`
`Janssen Products L.P., et al. v. Lupin Limited, et al., Civil Action No. 13-cv-
`
`03891-WHW-CLW (D.N.J.);
`
`(cid:1)
`
`Janssen Products L.P., et al. v. Teva Pharmaceuticals USA, Inc., et al., Civil
`
`Action No. 13-cv-7576-WHW-CLW (D.N.J.).
`
`
`
`
`
`
`
`
`
`
`
` Respectfully,
`
`
`s/ John E. Flaherty
`John E. Flaherty
`MCCARTER & ENGLISH, LLP
`100 Mulberry Street
`Four Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 639-7903
`Fax: (973) 297-3971
`Attorneys for Plaintiffs
`
`
`
`9
`
`
`
`
`
`Of Counsel:
`Gregory L. Diskant
`Eugene M. Gelernter
`Irena Royzman
`PATTERSON BELKNAP
` WEBB & TYLER LLP
`1133 Avenue of the Americas
`New York, New York 10036
`Tel.: (212) 336-2000
`Fax: (212) 336-2222
`
`Dated: March 4, 2014
`
`
`
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 6 Filed 04/11/14 Page 1 of 1 PageID: 54
`
`AO 399 (01/09) Waiver of the Service of Summons
`
`UNITED STATES DISTRICT COURT
`for the
` District of New Jersey
`__________ District of __________
`
`Civil Action No.
`
`2:14-cv-01370-WHW-CLW
`
`)))))
`
`JANSSEN PRODUCTS, L.P., et al.,
`Plaintiff
`v.
`LUPIN LIMITED, et al.
`Defendant
`
`WAIVER OF THE SERVICE OF SUMMONS
`
`To:
`
`Amy D. Brody
`(Name of the plaintiff’s attorney or unrepresented plaintiff)
`
`I have received your request to waive service of a summons in this action along with a copy of the complaint,
`two copies of this waiver form, and a prepaid means of returning one signed copy of the form to you.
`
`I, or the entity I represent, agree to save the expense of serving a summons and complaint in this case.
`
`I understand that I, or the entity I represent, will keep all defenses or objections to the lawsuit, the court’s
`jurisdiction, and the venue of the action, but that I waive any objections to the absence of a summons or of service.
`
`I also understand that I, or the entity I represent, must file and serve an answer or a motion under Rule 12 within
`60 days from
`, the date when this request was sent (or 90 days if it was sent outside the
`03/14/2014
`United States). If I fail to do so, a default judgment will be entered against me or the entity I represent.
`
`Date:
`
`04/11/2014
`
`LUPIN LIMITED
`Printed name of party waiving service of summons
`
`/s Amy D. Brody
`Signature of the attorney or unrepresented party
`
`Amy D. Brody
`Printed name
`6 West Hubbard Street
`Suite 500
`Chicago, Illinois 60654
`Address
`
`abrody@rmmslegal.com
`E-mail address
`
`(312) 222-6344
`Telephone number
`
`Duty to Avoid Unnecessary Expenses of Serving a Summons
`
`Rule 4 of the Federal Rules of Civil Procedure requires certain defendants to cooperate in saving unnecessary expenses of serving a summons
`and complaint. A defendant who is located in the United States and who fails to return a signed waiver of service requested by a plaintiff located in
`the United States will be required to pay the expenses of service, unless the defendant shows good cause for the failure.
`
`“Good cause” does not include a belief that the lawsuit is groundless, or that it has been brought in an improper venue, or that the court has
`no jurisdiction over this matter or over the defendant or the defendant’s property.
`
`If the waiver is signed and returned, you can still make these and all other defenses and objections, but you cannot object to the absence of
`a summons or of service.
`
`If you waive service, then you must, within the time specified on the waiver form, serve an answer or a motion under Rule 12 on the plaintiff
`and file a copy with the court. By signing and returning the waiver form, you are allowed more time to respond than if a summons had been served.
`
`

`
`Case 2:14-cv-01370-WHW-CLW Document 7 Filed 04/11/14 Page 1 of 1 PageID: 55
`
`AO 399 (01/09) Waiver of the Service of Summons
`
`UNITED STATES DISTRICT COURT
`for the
` District of New Jersey
`__________ District of __________
`
`Civil Action No.
`
`2:14-cv-01370-WHW-CLW
`
`)))))
`
`JANSSEN PRODUCTS, L.P., et al.,
`Plaintiff
`v.
`LUPIN LIMITED, et al.
`Defendant
`
`WAIVER OF THE SERVICE OF SUMMONS
`
`To:
`
`Amy D. Brody
`(Name of the plaintiff’s attorney or unrepresented plaintiff)
`
`I have received your request to waive service of a summons in this action along with a copy of the complaint,
`two copies of this waiver form, and a prepaid means of returning one signed copy of the form to you.
`
`I, or the entity I represent, agree to save the expense of serving a summons and complaint in this case.
`
`I understand that I, or the entity I represent, will keep all defenses or objections to the lawsuit, the court’s
`jurisdiction, and the venue of the action, but that I waive any objections to the absence of a summons or of service.
`
`I also understand that I, or the entity I represent, must file and serve an answer or a motion under Rule 12 within
`60 days from
`, the date when this request was sent (or 90 days if it was sent outside the
`03/14/2014
`United States). If I fail to do so, a default judgment will be entered against me or the entity I represent.
`
`Date:
`
`04/11/2014
`
`LUPIN PHARMACEUTICALS, INC.
`Printed name of party waiving service of summons
`
`/s Amy D. Brody
`Signature of the attorney or unrepresented party
`
`Amy D. Brody
`Printed name
`6 West Hubbard Street
`Suite 500
`Chicago, Illinois 60654
`Address
`
`abrody@rmmslegal.com
`E-mail address
`
`(312) 222-6344
`Telephone number
`
`Duty to Avoid Unnecessary Expenses of Serving a Summons
`
`Rule 4 of the Federal Rules of Civil Procedure requires certain defendants to cooperate in saving unnecessary expenses of serving a summons
`and complaint. A defendant who is located in the United States and who fails to return a signed waiver of service requested by a plaintiff located in
`the United States will be required to pay the expenses of service, unless the defendant shows good cause for the failure.
`
`“Good cause” does not include a belief that the lawsuit is groundless, or that it has been brought in an improper venue, or that the court has
`no jurisdiction over this matter or over the defendant or the defendant’s property.
`
`If the waiver is signed and returned, you can still make these and all other defenses and objections, but you cannot object to the absence of
`a summons or of service.
`
`If you waive service, then you must, within the time specified on the waiver form, serve an answer or a motion under Rule 12 on the plaintiff
`and file a copy with the court. By signing and returning the waiver form, you are allowed more time to respond than if a summons had been served.
`
`

`
`4;‘9!2015
`
`CMIECF LIVE - U .8. District Court for the District of New Jersey
`
`ANDA,CLOSED
`
`U.S. District Court
`
`District of New Jersey [LIVE] (Newark)
`CIVIL DOCKET FOR CASE #2 2:14-cv-01370-WHW-CLW
`
`JANSSEN PRODUCTS, L.P. et al V. LUPIN LIMITED et al
`Assigned to: Judge William H. Walls
`Referred to: Magistrate Judge Cathy L. Waldor
`Lead case: 2: 13-cv-03891-WHW-CLW
`
`Date Filed: 03/04/2014
`Date Terminated: 01/08/2015
`Jury Demand: Defendant
`Nature of Suit: 830 Patent
`
`Member case: (View Member Case)
`Cause: 352271 Patent Infringement
`
`Plaintiff
`
`JANSSEN PRODUCTS, L.P.
`
`Jurisdiction: Federal Question
`
`represented by JOHN EDMUND FLAHERTY
`MCCARTER & ENGLISH, LLP
`FOUR GATEWAY CENTER
`
`100 MULBERRY STREET
`
`NEWARK, NJ 07102
`(973) 622-4444
`Email: jflaherty@mccarter.com
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`RAVIN R. PATEL
`
`MCCARTER & ENGLISH LLP
`
`FOUR GATEWAY CENTER
`
`100 MULBERRY STREET
`
`NEWARK, NJ 07102
`973-848-5312
`
`Email: rpatel@mccarter.com
`A TTORNE Y TO BE NOTICED
`
`Plaintiff
`
`JANSSEN R&D IRELAND
`TERMINA TED: 01/05/2015
`
`Li“
`
`JANSSEN SCIENCES IRELAND UC
`
`represented by JOHN EDMUND FLAHERTY
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`RAVIN R. PATEL
`
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by JOHN EDMUND FLAHERTY
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`http5:f!ecf.njd.uscourts.gow'cgi—bir1a’DktR pt.p|?1094-50-449285127— |__1_e1
`
`we
`
`

`
`41912015
`
`CIWECF LIVE - U.S. District Com for the District of New Jersey
`
`RAVIN R. PATEL
`
`(See above for address)
`LEAD A TTORNEY
`
`ATTORNEY TO BE NOTICED
`
`represented by MELISSA E. FLAX
`CARELLA BYRNE CECCHI OLSTEIN
`
`BRODY & AGNELLO, PC
`5 BECKER FARM ROAD
`
`ROSELAND, NJ 07068
`(973) 994-1700
`Email: mflax@care11abyrne.com
`LEAD A TTORNEY
`
`ATTORNEY TO BE NOTICED
`
`MICHAEL CROSS
`
`CARELLA, BYRNE, CECCHI,
`OLSTEIN, BRODY & AGNELLO, P.C.
`5 BECKER FARM ROAD
`
`ROSELAND, NJ 07068
`973-994-1700
`
`Email: mcross@care11abyrne.com
`LEAD A TTORNEY
`
`ATTORNEY TO BE NOTICED
`
`represented by MELISSA E. FLAX
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`MICHAEL CROSS
`
`(See above for address)
`LEAD A TTORNEY
`
`ATTORNEY TO BE NOTICED
`
`represented by JOHN EDMUND FLAHERTY
`(See above for address)
`LEAD A TTORNEY
`
`ATTORNEY TO BE NOTICED
`
`RAVIN R. PATEL
`
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`V.
`
`Defendant
`
`LUPIN LIMITED
`
`Defendant
`
`LUPIN PHARMACEUTICALS INC.
`
`Counter Defendant
`
`JANSSEN SCIENCES IRELAND UC
`
`flips1:‘ecf.njd.uscoLr13.gow'cgi-bina'DktRpt.pl?1O9450449285127-L_1_01
`
`

`
`4;‘9!2015
`
`CMIECF LIVE - U.S.
`
`District Court for the District of New Jersey
`
`Counter Claimant
`
`LUPIN PHARMACEUTICALS INC.
`
`Counter Claimant
`
`LUPIN LIMITED
`
`V.
`
`Counter Defendant
`
`JANSSEN PRODUCTS, L.P.
`
`Counter Defendant
`
`JANSSEN R&D IRELAND
`
`TERMINA TED: 01/05/2015
`
`represented by MELISSA E. FLAX
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`MICHAEL CROSS
`
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`represented by MELISSA E. FLAX
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`MICHAEL CROSS
`
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`represented by JOHN EDMUND FLAHERTY
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`RAVIN R. PATEL
`
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by JOHN EDMUND FLAHERTY
`(See above for address)
`LEAD ATTORNEY
`
`ATTORNEY TO BE NOTICED
`
`RAVIN R. PATEL
`
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Date Filed
`
`# Docket Text
`
`03/04/2014
`
`I
`
`COMPLAINT against LUPIN LIMITED, LUPIN PHARMACEUTICALS INC. (
`
`http5:f!ecf.njd.uscourts .gow'cgi—bI'r1a’D ktR pt.pI?109$')0449285127— L_1_O-1
`
`316
`
`

`
`4/9/2015
`
`CM/ECF LIVE - U .8. District Court for the District of New Jersey
`
`Filing and Admin fee $ 400 receipt number 5539970), filed by JANSSEN
`PRODUCTS, L.P., JANSSEN R&D IRELAND. (Attachments: # 1 exh a, # 2 Civil
`Cover Sheet)(dr, ) (Entered: 03/07/2014)
`
`A0120 Patent/Trademark Form filed. (Attachments: # 1 United States Patent No.
`8,518,987 B2) (dr, ) (Entered: 03/07/2014)
`
`Corporate Disclosure Statement by JANSSEN PRODUCTS, L.P. identifying
`JOHNSON & JOHNSON as Corporate Parent.. (dr, ) (Entered: 03/07/2014)
`
`Corporate Disclosure Statement by JANS SEN R&D IRELAND identifying
`JOHNSON & JOHNSON as Corporate Parent.. (dr, ) (Entered: 03/07/2014)
`
`SUMMONS ISSUED as to LUPIN LIMITED, LUPIN PHARMACEUTICALS
`INC. Attached is the official court Summons, please fill out Defendant and
`Plaintiffs attorney information and serve. Issued By *Dianne C. Richards* (dr, )
`(Entered: 03/07/2014)
`
`WAIVER OF SERVICE Returned Executed by JANS SEN PRODUCTS, L.P.,
`JANS SEN R&D IRELAND. LUPIN LIMITED waiver sent on 3/ 14/2014, answer
`due 6/12/2014. (FLAHERTY, JOHN) (Entered: 04/11/2014)
`
`WAIVER OF SERVICE Returned Executed by JANS SEN PRODUCTS, L.P.,
`JANS SEN R&D IRELAND. LUPIN PHARMACEUTICALS INC. waiver sent on
`
`3/14/2014, answer due 5/13/2014. (FLAHERTY, JOHN) (Entered: 04/11/2014)
`
`NOTICE of Appearance by MELISSA E. FLAX on behalf of LUPIN LIMITED,
`LUPIN PHARMACEUTICALS INC. (FLAX, MELISSA) (Entered: 04/15/2014)
`
`NOTICE of Appearance by MICHAEL CROSS on behalf of LUPIN LIMITED,
`LUPIN PHARMACEUTICALS INC. (CROSS, MICHAEL) (Entered: 04/ 15/2014)
`
`|l\)
`
`IUJ
`
`I-JR
`
`I<./1
`
`ION
`
`|\]
`
`loo
`
`|\O
`
`03/04/2014
`
`03/04/2014
`
`03/04/2014
`
`03/07/2014
`
`04/11/2014
`
`04/11/2014
`
`04/15/2014
`
`04/15/2014
`
`04/29/2014
`
`l8
`
`NOTICE of Appearance by RAVIN R. PATEL on behalf of JANS SEN
`PRODUCTS, L.P., JANS SEN R&D IRELAND (PATEL, RAVIN) (Entered:
`04/29/2014)
`
`04/29/2014
`
`Letter from Melissa E. Flax to Hon. Cathy L. Waldor, U.S.M.J.. (Attachments: # 1
`Declaration of Melissa E. Flax in Support of Pro Hac Vice Admission of Counsel, #
`2 Declaration of Deanne M. Mazzochi in Support of Pro Hac Vice Admission of
`Counsel, # 3 Declaration of Amy D. Brody in Support of Pro Hac Vice Admission
`of Counsel, # 4 Declaration of Theodore J . Chiacchio in Support of Pro Hac Vice
`Admission of Counsel, # 5 Declaration of Luke T. Shannon in Support of Pro Hac
`Vice Admission of Counsel, # Q Declaration of Matthew V. Anderson in Support of
`Pro Hac Vice Admission of Counsel, # 1 Declaration of Cynthia H. Sun in Support
`of Pro Hac Vice Admission of Counsel, # 8 Text of Proposed Order)(FLAX,
`MELISSA) (Entered: 04/29/2014)
`
`05/01/2014
`
`2
`
`CONSENT ORDER permitting Deanne M. Mazzochi, Amy D. Brody, Theodore J .
`Chiacchio, Luke T. Shannon, Matthew V. Anderson, Cynthia H. Sun to appear pro
`hac vice. Signed by Magistrate Judge Cathy L. Waldor on 5/1/14. (sr, ) (Entered:
`05/01/2014)
`
`05/02/2014
`
`E
`
`Notice of Request by Pro Hac Vice Deanne M. Mazzochi to receive Notices of
`Electronic Filings. ( Pro Hac Vice fee 35 150 receipt number 0312-5665951.)
`(FLAX, MELISSA) (Entered: 05/02/2014)
`
`htlp5:a'!ecf.njd.uscourts .gow'cgi—bI'r1/DktR pl.pI?109$')0449285127— L_1_O-1
`
`4/6
`
`

`
`4/9/2015
`
`05/02/2014
`
`l2
`
`05/02/2014
`
`05/02/2014
`
`l3
`
`05/02/2014
`
`l3
`
`05/02/2014
`
`05/13/2014
`
`CMIECF LIVE - U .8. District Court for the District of New Jersey
`
`Notice of Request by Pro Hac Vice Amy D. Brody to receive Notices of Electronic
`Filings. ( Pro Hac Vice fee 33 150 receipt number 0312-5665968.) (FLAX,
`MELISSA) (Entered: 05/02/2014)
`
`Notice of Request by Pro Hac Vice Theodore J. Chiacchio to receive Notices of
`Electronic Filings. ( Pro Hac Vice fee 35 150 receipt number 0312-5665974.)
`(FLAX, MELISSA) (Entered: 05/02/2014)
`
`Notice of Request by Pro Hac Vice Luke T. Shannon to receive Notices of
`Electronic Filings. ( Pro Hac Vice fee $ 150 receipt number 0312-5665978.)
`(FLAX, MELISSA) (Entered: 05/02/2014)
`
`Notice of Request by Pro Hac Vice Matthew V. Anderson to receive Notices of
`Electronic Filings. ( Pro Hac Vice fee $ 150 receipt number 0312-5665982.)
`(FLAX, MELISSA) (Entered: 05/02/2014)
`
`Notice of Request by Pro Hac Vice Cynthia H. Sun to receive Notices of Electronic
`Filings. ( Pro Hac Vice fee $5 150 receipt number 0312-5665992.) (FLAX,
`MELISSA) (Entered: 05/02/2014)
`
`ANSWER to Complaint with JURY DEMAND , COUNTERCLAIM against
`JANSSEN PRODUCTS, L.P., JANSSEN R&D IRELAND by LUPIN
`PHARMACEUTICALS INC., LUPIN LIMITED. (Attachments: # 1 Certificate of
`Service)(FLAX, MELISSA) (Entered: 05/13/2014)
`
`05/13/2014
`
`Corporate Disclosure Statement by LUPIN LIMITED. (FLAX, MELISSA)
`(Entered: 05/ 13/2014)
`
`05/13/2014
`
`l8
`
`Corporate Disclosure Statement by LUPIN PHARMACEUTICALS INC.. (FLAX,
`MELISSA) (Entered: 05/ 13/2014)
`
`05/14/2014
`
`22
`
`TEXT ORDER: The Court will hold an initial conference (rule 16) before U.S.M.J.
`C. Waldor in courtroom 4C on 10/20/14 at 10:00 AM. Parties are to submit a Joint
`
`05/28/2014
`
`10/13/2014
`
`10/14/2014
`
`12/29/2014
`
`Discovery Plan no later than 3 days before the scheduled conference. Please contact
`chambers with any questions or concerns at (973) 776 7862. Ordered by Magistrate
`Judge Cathy L. Waldor on 5/14/14. (tjg, ) (Entered: 05/14/2014)
`
`Plaintiffs’ ANSWER to Counterclaim ofDefendants by JANS SEN PRODUCTS,
`L.P., JANSSEN R&D IRELAND.(FLAHERTY, JOHN) (Entered: 05/28/2014)
`
`Letter from M. Flax to Hon. Cathy L. Waldor, U.S.M.J.. (FLAX, MELISSA)
`(Entered: 10/13/2014)
`
`TEXT ORDER: The Court will cancel the 10/20/ 14 conference. Ordered by
`Magistrate Judge Cathy L. Waldor on 10/14/14. (tj g, ) (Entered: 10/14/2014)
`
`Letter from John E. Flaherty to the Hon. Cathy L. Waldor, U.S.M.J., enclosing a
`Stipulation and Order Substituting Plaintiff. (Attachments: # 1 Stipulation and
`Order Substituting Plaintiff)(FLAHERTY, JOHN) (Entered: 12/29/2014)
`
`01/05/2015
`
`STIPULATION AND ORDER that Janssen Sciences Ireland UC is substituted for
`
`Janssen R&D Ireland as a plaintiff in this action. Janssen R&D Ireland will provide
`discovery, to the extent necessary, in this action as if it were a party to the action
`for all purposes, claims, defenses, and counterclaims. Signed by Magistrate Judge
`
`http5:a'!ecf.njd.uscourts .gow'cgi—bI'r1/DktR pt.pI?109$')0449285127— L_1_0-1
`
`5/6
`
`

`
`419/2015
`
`CMIECF LIVE - U.S. District Gout for the District of New Jersey
`
`Cathy L. Waldor on 1/5/15. (sr, ) (Entered: 01/05/2015)
`
`01/06/2015
`
`STIPULATION AND ORDER consolidating action with Civil No. 13-3891 for all
`purposes and staying Civil No. 13-3891 pending resolution of Lupin's appeal.
`Signed by Magistrate Judge Cathy L. Waldor on 1/6/2015. (nr, ) (Entered:
`01/08/2015)
`01/08/2015 - ***c1v11 Case Terminated. (nr, ) (Entered: 01/08/2015)
`01/08/2015 I Cases associated: Create association to 2:13-cv-0389l—WHW-CLW. (nr, )
`
`(Entered: 01/08/2015)
`
`
`
`
`
`PACER Service Center
`
`Transaction Receipt
`
`04/09/2015 18:32:29
`
`
`PAQER
`Loglnz
`
`rrnl794:2830l78:0 Client
`Code:
`
`0106-0039
`
`Description: Docket Report
`
`2:14-cv-0l370-WHW-
`Search
`Cl_iteria_ CLW Start date: 1/1/1970
`' End date: 4/9/2015
`
`Pages:
`
`
`
`
`
`https:1/ecf.njd.uscouts.gov/cgi—bir1.r'DktRpt.pI?10945O449285127-L_1_(} 1
`
`6/6
`
`

`
`Case 2:13-cv-07576-WHW-CLW Document 1 Filed 11/27/13 Page 1 of 8 PageID: 1
`
`
`
`John E. Flaherty
`MCCARTER & ENGLISH, LLP
`100 Mulberry Street
`Four Gateway Center
`Newark, NJ 07102
`Tel: (973) 639-7903
`Fax: (973) 297-3971
`Attorneys for Plaintiffs
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`Civil Action No.
`
`
`JANSSEN PRODUCTS, L.P.
`and JANSSEN R&D IRELAND,
`
`
`Plaintiffs,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.
`and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.
`
`
`
`
`Defendants.
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Janssen Products, L.P. and Janssen R&D Ireland (collectively,
`
`"Janssen" or "Plaintiffs") for their Complaint against defendants Teva Pharmaceuticals USA, Inc.
`
`("Teva USA") and Teva Pharmaceutical Industries, Ltd. ("Teva Industries") (collectively, "Teva"
`
`or "Defendants") allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for infringement by Teva of U.S. Patent No.
`
`8,518,987 B2 ("the '987 Patent") arising under the patent laws of the United States, 35 U.S.C. §§
`
`1 et seq. This action arises out of Teva's filing of Abbreviated New Drug Application ("ANDA")
`
`seeking approval to sell generic versions of plaintiff Plaintiffs' highly successful PREZISTA®
`
`
`6562041v.1
`
`

`
`Case 2:13-cv-07576-WHW-CLW Document 1 Filed 11/27/13 Page 2 of 8 PageID: 2
`
`
`
`(darunavir) 75 mg, 150 mg, 400 mg, and 600 mg products prior to the expiration of the '987
`
`Patent.
`
`THE PARTIES
`
`2.
`
`Plaintiff Janssen Products, L.P. is a partnership organized under the laws
`
`of the State of New Jersey, having its headquarters and principal place of business at 800/850
`
`Ridgeview Drive, Horsham, PA 19044.
`
`3.
`
`Plaintiff Janssen R&D Ireland is an Irish corporation having its principal
`
`place of business at Eastgate Village, Eastgate, Little Island, County Cork, Ireland.
`
`4.
`
`On information and belief, Teva Industries is an Israeli corporation having
`
`a principal place of business located at 5 Basel St., Petach Tikva 49131, Israel. On information
`
`and belief, Teva Industries is in the business of, among other things, manufacturing and selling
`
`generic versions of branded pharmaceutical products for the U.S. market through various
`
`operating subsidiaries, including Teva USA.
`
`5.
`
`On information and belief, Teva USA is a Delaware corporation having a
`
`principal place of business at 1090 Horsham Road, North Wales, Pennsylvania, 19454. On
`
`information and belief, Teva USA is in the business of manufacturing and selling generic
`
`versions of branded pharmaceutical products for the U.S. market. Teva USA is a wholly owned
`
`subsidiary of Teva Industries.
`
`JURISDICTION AND VENUE
`
`6.
`
`This Court has jurisdiction over the subject matter of this action pursuant
`
`to 28 U.S.C. §§ 1331 and 1338(a).
`
`7.
`
`On information and belief, this Court has personal jurisdiction over Teva
`
`USA because Teva USA has purposely availed itself of the benefits and protections of New
`
`
`6562041v.1
`
`2
`
`

`
`Case 2:13-cv-07576-WHW-CLW Document 1 Filed 11/27/13 Page 3 of 8 PageID: 3
`
`
`
`Jersey's laws such that it should reasonably anticipate being haled into court here. On
`
`information and belief, Teva USA has had persistent and continuous contacts with this judicial
`
`district, including developing, manufacturing and/or selling pharmaceutical products that are sold
`
`in this judicial district.
`
`8.
`
`On information and belief, this Court has personal jurisdiction over Teva
`
`Industries because Teva Industries has purposely availed itself of the benefits and protections of
`
`New Jersey's l