AbbVie v. Aurobindo Pharma Et. Al.
AbbVie v. Aurobindo Pharma Et. Al.
AbbVie v. Aurobindo Pharma Et. Al.
(ritonavir) tablets that are sold in the United States.
JURISDICTION AND VENUE
9. This is a civil action for patent infringement and declaratory judgment arising
under the patent laws of the United States, 35 U.S.C. 100 et seq., and the Declaratory Judgment
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Act, 28 U.S.C. 2201 and 2202. This Court has subject matter jurisdiction under 28 U.S.C.
1331 and 1338(a).
10. On information and belief, this Court has personal jurisdiction over Aurobindo
because of, among other things, its marketing and sales activities in this judicial district,
including but not limited to the substantial, continuous, and systematic distribution, marketing,
and/or sales of pharmaceutical products in this judicial district, and the fact that it has availed
itself of the rights afforded in this judicial district.
11. On information and belief, Aurobindo Limited develops, formulates,
manufactures, imports, markets, and sells various generic pharmaceutical drug products, and
regularly conducts business, throughout the United States, including in the State of Delaware,
through various directly or indirectly-owned subsidiaries, including for example Aurobindo
USA.
12. On information and belief, Aurobindo USA imports, markets, and sells various
generic pharmaceutical drug products, and regularly conducts business, through the United
States, including in the State of Delaware, for example on behalf of and at the direction of
Aurobindo Limited.
13. On information and belief, Aurobindo has purposefully conducted and continues
to conduct substantial business in this judicial district, from which it has derived, directly or
indirectly, substantially revenue.
14. Upon information and belief, Aurobindo Limited has, directly or through its agent
Aurobindo USA, filed an ANDA, and/or been actively involved in the preparation and
submission of an ANDA, for the purpose of seeking approval to engage in the commercial
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manufacture, use, offer for sale, sale, and/or importation of the generic drug product described in
ANDA No. 206614 in the United States, including Delaware.
15. Upon information and belief, Aurobindo USA has filed an ANDA, and/or been
actively involved in the preparation and submission of an ANDA, on behalf of Aurobindo
Limited for the purpose of seeking approval to engage in the commercial manufacture, use, offer
for sale, sale, and/or importation of the generic drug product described in ANDA No. 206614 in
the United States, including Delaware.
16. On information and belief, Aurobindo will act in concert, and intends to offer to
sell and sell in this judicial district, the generic drug product that will be manufactured as a result
of any FDA approval of Aurobindos ANDA No. 206614, and this judicial district is a likely
destination of products that will be manufactured and sold as a result of any FDA approval of
Aurobindos ANDA No. 206614.
17. On information and belief, Aurobindo USA is qualified and registered to do
business in the State of Delaware, has appointed a registered agent in Delaware, and holds
current and valid Pharmacy-Wholesale and Distributor/Manufacturer CSR Licenses in
Delaware.
18. On information and belief, Aurobindo Limited and/or Aurobindo USA have
previously submitted to the jurisdiction of this Court and asserted counterclaims arising under
the Patent Laws of the United States in other civil actions initiated in this Court. See, e.g.,
Answer at 5 & 1623, UCB, Inc. v. Aurobindo Pharma Ltd. & Aurobindo Pharma USA, Inc.,
No. 13-cv-1210 (D. Del. Oct. 4, 2013), ECF No. 14; Answer at 23 & 1016, Helsinn
Healthcare S.A. v. Aurobindo Pharma Ltd., No. 13-cv-688 (D. Del. Nov. 1, 2013), ECF No. 19.
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19. This Court also has personal jurisdiction over Aurobindo by virtue of the fact that,
among other things, Aurobindo has committed, or aided, abetted, contributed to, and/or
participated in the commission of the tortious act of patent infringement that has led to
foreseeable harm and injury to AbbVie, a Delaware corporation.
20. Venue is proper in this judicial district under 28 U.S.C. 1391 and 1400.
BACKGROUND
21. AbbVie is the holder of approved New Drug Application (NDA) No. 22-417
for ritonavir tablets, which AbbVie markets and sells under the trademark Norvir
. AbbVie
manufactures and sells Norvir
tablets.
23. Upon information and belief, Aurobindos ANDA No. 206614 seeks FDA
approval of a pharmaceutical composition comprising ritonavir in a 100mg dosage strength.
24. Upon information and belief, Aurobindos ANDA No. 206614 seeks FDA
approval to market Aurobindos generic ritonavir tablets in the United States.
25. On June 6, 2014, AbbVie received a letter on behalf of Aurobindo, dated June 5,
2014, purporting to be a Notice of Paragraph IV Certification for ANDA No. 206614 pursuant
to Section 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R.
314.94(a)(12)(A)(i)(4) and 314.95(a) (Notice Letter). Aurobindos Notice Letter notified
AbbVie that Aurobindo had filed ANDA No. 206614, seeking approval to market Aurobindos
generic ritonavir tablets prior to the expiration of the 359, 752, and 015 Patents.
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THE PATENTS-IN-SUIT
26. The 359 Patent was duly and legally issued by the U.S. Patent and Trademark
Office (USPTO) on December 12, 2006. AbbVie is the owner by assignment of the 359
Patent and has the right to sue for infringement thereof. AbbVie lists the 359 Patent in the
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for NDA
No. 22-417, with an expiration date of January 19, 2020 (including pediatric exclusivity). The
359 Patent is currently the subject of a reexamination proceeding pending at the USPTO. A true
and correct copy of the 359 Patent is attached as Exhibit A.
27. The 752 Patent was duly and legally issued by the USPTO on April 29, 2008.
AbbVie is the owner by assignment of the 752 Patent and has the right to sue for infringement
thereof. AbbVie lists the 752 Patent in the Orange Book for NDA No. 22-417, with an
expiration date of May 10, 2021 (including pediatric exclusivity). The 752 Patent is currently
the subject of a reexamination proceeding pending at the USPTO. A true and correct copy of the
752 Patent is attached as Exhibit B.
28. The 015 Patent was duly and legally issued by the USPTO on March 19, 2013.
AbbVie is the owner by assignment of the 015 Patent and has the right to sue for infringement
thereof. AbbVie lists the 015 Patent in the Orange Book for NDA No. 22-417, with an
expiration date of February 25, 2025 (including pediatric exclusivity). A true and correct copy
of the 015 Patent is attached as Exhibit C.
29. The 878 Patent was duly and legally issued by the USPTO on April 8, 2014.
AbbVie is the owner by assignment of the 878 Patent and has the right to sue for infringement
thereof. AbbVie lists the 878 Patent in the Orange Book for NDA No. 22-417, with an
expiration date of February 25, 2025 (including pediatric exclusivity). A true and correct copy
of the 878 Patent is attached as Exhibit D.
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FIRST COUNT FOR PATENT INFRINGEMENT
U.S. PATENT NO. 7,148,359 B2
30. Paragraphs 129 are incorporated herein by reference.
31. On information and belief, Aurobindo filed ANDA No. 206614 in order to obtain
approval to market Aurobindos generic ritonavir tablets in the United States prior to the
expiration of the 359 Patent. On information and belief, Aurobindo filed with the FDA,
pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) and 21 C.F.R. 314.94(a)(12)(i)(A)(4), a
certification that the claims of the 359 Patent are purportedly invalid and/or not infringed.
32. Under 35 U.S.C. 271(e)(2)(A), the submission to the FDA of ANDA
No. 206614 seeking approval for the commercial marketing of Aurobindos generic ritonavir
tablets before the expiration date of the 359 Patent constitutes infringement of one or more
claims of the 359 Patent, either literally or under the doctrine of equivalents.
33. Upon FDA approval of ANDA No. 206614, Aurobindo will infringe one or more
claims of the 359 Patent, either literally or under the doctrine of equivalents, by making, using,
offering to sell, selling, and/or importing Aurobindos generic ritonavir tablets, and by actively
inducing others under 271(b), unless this Court orders that the effective date of any FDA
approval of ANDA No. 206614 shall be no earlier than the expiration date of the 359 Patent and
any additional periods of exclusivity.
34. The offering to sell, sale, making, and/or importation of Aurobindos generic
ritonavir tablets would actively induce infringement of at least one of the claims of the 359
Patent, either literally or under the doctrine of equivalents. Aurobindo has knowledge and is
aware of AbbVies 359 Patent, as evidenced by Aurobindos Notice Letter.
35. Aurobindo USA is jointly and severally liable for infringement of at least one
claim of the 359 Patent. On infringement and belief, Aurobindo USA participated in,
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contributed to, aided, abetted, and/or induced the submission of ANDA No. 206614 and its
505(j)(2)(A)(vii)(IV) allegations to the FDA.
36. AbbVie will be irreparably harmed if Aurobindo is not enjoined from infringing
or actively inducing infringement of at least one claim of the 359 Patent. Pursuant to 35 U.S.C.
283, AbbVie is entitled to a permanent injunction against further infringement. AbbVie does
not have an adequate remedy at law.
SECOND COUNT FOR PATENT INFRINGEMENT
U.S. PATENT NO. 7,364,752 B1
37. Paragraphs 136 are incorporated herein by reference.
38. On information and belief, Aurobindo filed ANDA No. 206614 in order to obtain
approval to market Aurobindos generic ritonavir tablets in the United States prior to the
expiration of the 752 Patent. On information and belief, Aurobindo filed with the FDA,
pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) and 21 C.F.R. 314.94(a)(12)(i)(A)(4), a
certification that the claims of the 752 Patent are purportedly invalid and/or not infringed.
39. Under 35 U.S.C. 271(e)(2)(A), the submission to the FDA of ANDA
No. 206614 seeking approval for the commercial marketing of Aurobindos generic ritonavir
tablets before the expiration date of the 752 Patent constitutes infringement of one or more
claims of the 752 Patent, either literally or under the doctrine of equivalents.
40. Upon FDA approval of ANDA No. 206614, Aurobindo will infringe one or more
claims of the 752 Patent, either literally or under the doctrine of equivalents, by making, using,
offering to sell, selling, and/or importing Aurobindos generic ritonavir tablets, and by actively
inducing others under 271(b), unless this Court orders that the effective date of any FDA
approval of ANDA No. 206614 shall be no earlier than the expiration date of the 752 Patent and
any additional periods of exclusivity.
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41. On information and belief, Aurobindo knows and intends that medical
practitioners will prescribe, and patients will take, Aurobindos generic ritonavir tablets for
which approval is sought in ANDA No. 206614 to treat HIV infection, and therefore will
infringe at least one claim in the 752 Patent. The use of Aurobindos generic ritonavir tablets in
accordance with and as directed by Aurobindos proposed labeling would infringe at least one
claim of the 752 Patent.
42. On information and belief, Aurobindo had knowledge of the 752 Patent and, by
its promotional activities and proposed package insert for Aurobindos generic ritonavir tablets,
knows or should know that it will aid and abet anothers direct infringement of at least one of the
claims of the 752 Patent, either literally or under the doctrine of equivalents.
43. The offering to sell, sale, making, and/or importation of Aurobindos generic
ritonavir tablets would actively induce infringement of at least one of the claims of the 752
Patent, either literally or under the doctrine of equivalents. Aurobindo has knowledge and is
aware of AbbVies 752 Patent, as evidenced by Aurobindos Notice Letter.
44. AbbVie will be irreparably harmed if Aurobindo is not enjoined from infringing
and actively inducing infringement of at least one claim of the 752 Patent. Pursuant to 35
U.S.C. 283, AbbVie is entitled to a permanent injunction against further infringement. AbbVie
does not have an adequate remedy at law.
THIRD COUNT FOR PATENT INFRINGEMENT
U.S. PATENT NO. 8,399,015 B2
45. Paragraphs 144 are incorporated herein by reference.
46. On information and belief, Aurobindo filed ANDA No. 206614 in order to obtain
approval to market Aurobindos generic ritonavir tablets in the United States prior to the
expiration of the 015 Patent. On information and belief, Aurobindo filed with the FDA,
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pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) and 21 C.F.R. 314.94(a)(12)(i)(A)(4), a
certification that the claims of the 015 Patent are purportedly invalid and/or not infringed.
47. Under 35 U.S.C. 271(e)(2)(A), the submission to the FDA of ANDA
No. 206614 seeking approval for the commercial marketing of Aurobindos generic ritonavir
tablets before the expiration date of the 015 Patent constitutes infringement of one or more
claims of the 015 Patent, either literally or under the doctrine of equivalents.
48. Upon FDA approval of ANDA No. 206614, Aurobindo will infringe one or more
claims of the 015 Patent, either literally or under the doctrine of equivalents, by making, using,
offering to sell, selling, and/or importing Aurobindos generic ritonavir tablets, and by actively
inducing others under 271(b), unless this Court orders that the effective date of any FDA
approval of ANDA No. 206614 shall be no earlier than the expiration date of the 015 Patent and
any additional periods of exclusivity.
49. The offering to sell, sale, making, and/or importation of Aurobindos generic
ritonavir tablets would actively induce infringement of at least one of the claims of the 015
Patent, either literally or under the doctrine of equivalents. Aurobindo has knowledge and is
aware of AbbVies 015 Patent, as evidenced by Aurobindos Notice Letter.
50. AbbVie will be irreparably harmed if Aurobindo is not enjoined from infringing
or actively inducing infringement of at least one claim of the 015 Patent. Pursuant to 35 U.S.C.
283, AbbVie is entitled to a permanent injunction against further infringement. AbbVie does
not have an adequate remedy at law.
FOURTH COUNT FOR DECLARATORY JUDGMENT
AS TO THE 359 PATENT
51. Paragraphs 150 are incorporated herein by reference.
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52. On information and belief, Aurobindo is actively seeking FDA approval to sell its
generic ritonavir tablets labeled for the same indications, and the same dosage and methods of
use, as the Norvir