1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA BIOVAIL LABORATORIES INTERNATIONAL SRL, Plaintiff, v. PADDOCK LABORATORIES, INC. Defendant. C.A. No. 0:10-cv-01571 (MJD/JJK) ANSWER AND COUNTERCLAIM Paddock Laboratories, Inc. (“Paddock”) answers the Complaint of Biovail Laboratories International SRL (“Biovail”) as follows: PARTIES 1. Plaintiff Biovail is an international society with restricted liability organized and existing under the laws of Barbados having a principal place of business at Welches, Christ Church, Barbados, West Indies. Answer: Paddock lacks knowledge or information sufficient to form a belief as to the truth of the allegations in paragraph 1 of the Complaint and therefore denies them. 2. Upon information and belief, Defendant Paddock is a Minnesota corporation having a principal place of business at 3940 Quebec Avenue North, Minneapolis, Minnesota 55427. Answer: Paddock admits the allegations in paragraph 2 of the Complaint. JURISDICTION AND VENUE 3. This is an action for patent infringement arising under the patent laws of the United States, Title 35, United States Code, § 100 et seq., and in particular under 35 U.S.C. § 271, and 28 U.S.C. §§ 2201 and 2202. Case 0:10-cv-01571-MJD-JJK Document 6 Filed 05/05/10 Page 1 of 37
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA
BIOVAIL LABORATORIES INTERNATIONAL SRL,
Plaintiff,
v.
PADDOCK LABORATORIES, INC.
Defendant.
C.A. No. 0:10-cv-01571 (MJD/JJK)
ANSWER AND COUNTERCLAIM
Paddock Laboratories, Inc. (“Paddock”) answers the Complaint of Biovail
Laboratories International SRL (“Biovail”) as follows:
PARTIES
1. Plaintiff Biovail is an international society with restricted liability organized and existing under the laws of Barbados having a principal place of business at Welches, Christ Church, Barbados, West Indies.
Answer: Paddock lacks knowledge or information sufficient to form a belief as to
the truth of the allegations in paragraph 1 of the Complaint and therefore denies them.
2. Upon information and belief, Defendant Paddock is a Minnesota corporation having a principal place of business at 3940 Quebec Avenue North, Minneapolis, Minnesota 55427.
Answer: Paddock admits the allegations in paragraph 2 of the Complaint.
JURISDICTION AND VENUE
3. This is an action for patent infringement arising under the patent laws of the United States, Title 35, United States Code, § 100 et seq., and in particular under 35 U.S.C. § 271, and 28 U.S.C. §§ 2201 and 2202.
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Answer: Paddock admits that Biovail purports to bring this action under the
patent laws of the United States. Paddock denies that Biovail properly states a claim for
patent infringement.
4. This Court has subject matter jurisdiction over this action under 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202.
Answer: Paddock states that it does not contest subject matter jurisdiction.
5. This Court has personal jurisdiction over Paddock by virtue of its incorporation in Minnesota.
Answer: Paddock states that it does not contest this Court’s personal jurisdiction
over Paddock for the purposes of this action.
6. Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and § 1400(b).
Answer: Paddock states that it does not contest venue in this judicial district for
the purposes of this action.
7. An actual, substantial, and justiciable controversy exists between Biovail and Paddock as to the infringement and validity of United States Patent Numbers 7,569,610, 7,572,935, 7,649,019, 7,563,823, 7,553,992, and 7,671,094.
Answer: Paddock admits that an actual and justiciable controversy exists between
the parties with respect to U.S. Patent Nos. 7,569,610, 7,572,935, 7,649,019, 7,563,823,
7,553,992, and 7,671,094. Paddock denies any remaining allegations in paragraph 7 of
the Complaint. Paddock expressly denies any allegation of patent infringement and
denies that Plaintiff is entitled to any relief.
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PATENTS IN SUIT
8. Biovail is the lawful owner by assignment of exclusive rights to United States Patent Numbers 7,569,610, 7,572,935, 7,649,019, 7,563,823, 7,553,992, and 7,671,094, including all right to sue and recover for infringement.
Answer: Paddock lacks knowledge or information sufficient to form a belief as to
the truth of the allegations in paragraph 8 of the Complaint and therefore denies them.
9. United States Patent No. 7,569,610 (“’610 patent”), entitled “Modified Release Formulations of a Bupropion Salt,” duly and legally issued August 4, 2009, naming Werner Oberegger, Paul Maes, and Mohammad Ashty Saleh as inventors. The ’610 patent is a continuation of Application No. 11/475,252 filed on June 27, 2006, now United States Patent No. 7,241,805. A copy of the ’610 patent is attached as Exhibit A.
Answer: Paddock admits that the ’610 patent was issued on August 4, 2009, is
entitled “Modified Release Formulations of a Bupropion Salt,” and that what appears to
be a copy of the ’610 patent is attached as Exhibit A to the Complaint. Paddock denies
that the ’610 patent was duly and legally issued. Paddock lacks knowledge or
information sufficient to form a belief as to the truth of the remaining allegations in
paragraph 9 of the Complaint and therefore denies them.
10. United States Patent No. 7,572,935 (“’935 patent”), entitled “Modified Release Formulations of a Bupropion Salt,” duly and legally issued August 11, 2009, naming Werner Oberegger, Paul Maes, Stefano Turchetta, Pietro Massardo, and Mohammad Ashty Saleh as inventors. The ’935 patent is a continuation of Application No. 11/751,768, filed on May 22, 2007, which is a continuation of Application No. 11/475,252 filed on June 27, 2006, now United States Patent No. 7,241,805. A copy of the ’935 patent is attached as Exhibit B.
Answer: Paddock admits that the ’935 patent was issued on August 11, 2009, is
entitled “Modified Release Formulations of a Bupropion Salt,” and that what appears to
be a copy of the ’935 patent is attached as Exhibit B to the Complaint. Paddock denies
that the ’935 patent was duly and legally issued. Paddock lacks knowledge or
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information sufficient to form a belief as to the truth of the remaining allegations in
paragraph 10 of the Complaint and therefore denies them.
11. United States Patent No. 7,649,019 (“’019 patent”), entitled “Modified Release Formulations of a Bupropion Salt,” duly and legally issued January 19, 2010, naming Werner Oberegger, Fang Zhou, Paul Maes, Graham Jackson, and Mohammad Ashty Saleh as inventors. The ’019 patent is a continuation of Application No. 11/475,252 filed on June 27, 2006, now United States Patent No. 7,241,805. A copy of the ’019 patent is attached as Exhibit C.
Answer: Paddock admits that the ’019 patent was issued on January 19, 2010, is
entitled “Modified Release Formulations of a Bupropion Salt,” and that what appears to
be a copy of the ’019 patent is attached as Exhibit C to the Complaint. Paddock denies
that the ’019 patent was duly and legally issued. Paddock 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.
12. United States Patent No. 7,563,823 (“’823 patent”), entitled “Modified Release Formulations of a Bupropion Salt,” duly and legally issued June 21, 2009, naming Werner Oberegger, Paul Maes, Graham Jackson, and Mohammad Ashty Saleh as inventors. The ’823 patent is a continuation of Application No. 11/475,252 filed on June 27, 2006, now United States Patent No. 7,241,805. A copy of the ’823 patent is attached as Exhibit D.
Answer: Paddock admits that the ’823 patent was issued on June 21, 2009, is
entitled “Modified Release Formulations of a Bupropion Salt” and that what appears to
be a copy of the ’823 patent is attached as Exhibit D to the Complaint. Paddock denies
that the ’823 patent was duly and legally issued. Paddock lacks knowledge or
information sufficient to form a belief as to the truth of the remaining allegations in
paragraph 12 of the Complaint and therefore denies them.
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13. United States Patent No. 7,553,992 (“’992 patent”), entitled “Modified Release Formulations of a Bupropion Salt,” duly and legally issued June 30, 2009, naming Werner Oberegger, Paul Maes, Stefano Turchetta, Pietro Massardo, and Mohammad Ashty Saleh as inventors. The ’992 patent is a continuation of Application No. 11/475,252 filed on June 27, 2006, now United States Patent No. 7,241,805. A copy of the ’992 patent is attached as Exhibit E.
Answer: Paddock admits that the ’992 patent was issued on June 30, 2009, is
entitled “Modified Release Formulations of a Bupropion Salt,” and that what appears to
be a copy of the ’992 patent is attached as Exhibit E to the Complaint. Paddock denies
that the ’992 patent was duly and legally issued. Paddock 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.
14. United States Patent No. 7,671,094 (“’094 patent”), entitled “Bupropion Hydrobromide and Therapeutic Applications,” duly and legally issued March 2, 2010, naming Robert Perry Williams and Peter Harris Silverstone as inventors. The ’094 patent is a continuation-in-part of Application No. 11/751,768, filed May 22, 2007, now United States Patent No. 7,569,610; and a continuation-in-part of Application No. 11/755,946 filed on May 31, 2007, now United States Patent No. 7,553,992, both of which are continuations of Application No. 11/475,252, filed Jun. 27, 2006, now United States Patent No. 7,241,805. A copy of the ’094 patent is attached as Exhibit F.
Answer: Paddock admits that the ’094 patent was issued on March 2, 2010, is
entitled “Bupropion Hydrobromide and Therapeutic Applications,” and that what appears
to be a copy of the ’094 patent is attached as Exhibit F to the Complaint. Paddock denies
that the ’094 patent was duly and legally issued. Paddock lacks knowledge or
information sufficient to form a belief as to the truth of the remaining allegations in
paragraph 14 of the Complaint and therefore denies them.
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APLENZIN™ ER
15. Biovail is the holder of New Drug Application (“NDA”) No. 22-108 for Aplenzin™ (bupropion hydrobromide) ER Tablets, 174 mg, 348 mg, and 522 mg.
Answer: Paddock states that the Approved Drug Products with Therapeutic
Equivalence Evaluations (“the Orange Book”) entry for NDA No. 22-108 for Aplenzin
(bupropion hydrobromide) ER tablets 174 mg, 348 mg, and 522 mg lists “Biovail” as the
applicant. Paddock 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.
16. On April 23, 2008, the U.S. Food and Drug Administration (“FDA”) approved NDA No. 22-108 for the manufacture, marketing, and sale of a product containing the drug bupropion hydrobromide for treatment of depression. The drug bupropion hydrobromide with the trademark Aplenzin™ ER has been sold under NDA 22-108 since approval.
Answer: Paddock states that the Orange Book entry for NDA No. 22-108 lists the
FDA approval date as April 23, 2008. Paddock lacks knowledge or information
sufficient to form a belief as to the truth of the remaining allegations in paragraph 16 of
the Complaint and therefore denies them.
17. In compliance with 21 U.S.C. § 355(b)(1), Biovail certified to the FDA that the ’935, ’019, and ’094 patent claims cover Aplenzin™ ER. The ’935, ’019, and ’094 patents are accordingly listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”). The ’610 patent is also listed in the Orange Book covering methods of using Aplenzin™ ER.
Answer: Paddock states that the Orange Book entry for Aplenzin ER lists the
’935, ’019, ’094, and ’610 patents. Paddock lacks knowledge or information sufficient to
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form a belief as to the truth of the remaining allegations in paragraph 17 of the Complaint
and therefore denies them.
PADDOCK’S ANDA
18. Upon information and belief, Paddock submitted Abbreviated New Drug Application No. 20-1332 (“ANDA”) to the FDA, under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), seeking approval to engage in commercial manufacture, use, and/or sale of bupropion hydrobromide extended-release tablets (“Paddock’s Generic Product”), a generic version of Aplenzin™ ER, before expiration of the ’610, ’935, ’019, ’823, ’992, and ’094 patents. Paddock’s ANDA currently includes three dosage forms of Paddock’s Generic Product, 174 mg, 348 mg, and 522 mg.
Answer: Paddock admits that it submitted Abbreviated New Drug Application
No. 20-1332 (“ANDA”) to the FDA, under § 505(j) of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. § 355(j)), seeking approval to engage in commercial
manufacture, use, and/or sale of bupropion hydrobromide extended-release tablets before
expiration of the ’610, ’935, ’019, ’823, ’992, and ’094 patents, and that the ANDA refers
to New Drug Application No. 22-108 for bupropion hydrobromide extended release
tablets as the reference listed drug. Paddock also admits that the ANDA currently
includes 174 mg, 348 mg, and 522 mg dosage forms. To the extent that paragraph 18 of
the Complaint contains additional allegations, Paddock denies them.
19. Upon information and belief, Paddock’s ANDA contains a “Paragraph IV” certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging at least the ’610, ’935, ’019, and ’094 patents listed in the FDA’s Orange Book as covering Aplenzin™ ER and its use are invalid and/or will not be infringed by commercial manufacture, use, or sale of Paddock’s Generic Product.
Answer: Paddock admits that Abbreviated New Drug Application No. 20-1332
contains a “Paragraph IV” certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging
the ’610, ’935, ’019, and ’094 patents are invalid, unenforceable, and/or will not be
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infringed by commercial manufacture, use, or sale of the bupropion hydrobromide
extended-release tablets that are the subject of Abbreviated New Drug Application No.
20-1332. To the extent that paragraph 19 of the Complaint contains additional
allegations, Paddock denies them.
20. On January 25, 2010, Biovail received written notification of ANDA No. 20-1332 under 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. 314.95 (“Paragraph IV letter”). Approximately a month later, Biovail received Paddock’s second Paragraph IV letter. The stated purpose of the letters was to notify Biovail that Paddock filed a certification with the FDA under 21 C.F.R. § 314.95 in conjunction with ANDA No. 20-1332 for approval to commercially manufacture and sell Paddock’s Generic Product before the expiration of several of Biovail’s Orange Book listed patents covering Aplenzin™ ER and its use. The Paragraph IV letters allege that those Biovail patents are invalid, unenforceable, and/or will not be infringed by commercial manufacture, use, or sale of Paddock’s Generic Product.
Answer: Paddock admits that it sent written notification of ANDA No. 20-1332
under 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. 314.95 (“Paragraph IV letter”) to
Biovail, stating that Paddock filed a certification with the FDA under 21 C.F.R. § 314.95
in conjunction with ANDA No. 20-1332 for approval to commercially manufacture and
sell bupropion hydrobromide extended-release tablets. Paddock also admits that the
written notification stated that the patents listed in the Orange Book in connection with
Aplenzin™ ER are invalid, unenforceable, and/or will not be infringed by commercial
manufacture, use, or sale of the bupropion hydrobromide extended-release tablets that are
the subject of ANDA No. 20-1332. To the extent that paragraph 20 of the Complaint
21. Biovail commenced its first action March 9, 2010 within 45 days of receiving Paddock’s first two Paragraph IV letters. That case is currently pending in this court (C.A. No. 10-cv-00687-MJD-JJK).
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Answer: Paddock lacks knowledge or information sufficient to form a belief as to
the truth of the allegations in paragraph 21 of the Complaint and therefore denies them.
22. Biovail received Paddock’s third Paragraph IV letter on April 7, 2010. The stated purpose of this letter was to notify Biovail that Paddock filed a certification with the FDA under 21 C.F.R. § 314.95 in conjunction with ANDA No. 20-1332 for approval to commercially manufacture and sell Paddock’s Generic Product before the expiration date of the ’094 patent. The Paragraph IV letters allege that Biovail’s patents listed in the Orange Book covering Aplenzin™ ER and its use are invalid, unenforceable, and/or will not be infringed by commercial manufacture, use, or sale of Paddock’s Generic Product.
Answer: Paddock admits that it sent written notification of ANDA No. 20-1332
under 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. 314.95 (“Paragraph IV letter”) to
Biovail, stating that Paddock filed a certification with the FDA under 21 C.F.R. § 314.95
in conjunction with ANDA No. 20-1332 for approval to commercially manufacture and
sell bupropion hydrobromide extended-release tablets. Paddock also admits that the
written notification stated that the patents listed in the Orange Book in connection with
Aplenzin™ ER are invalid, unenforceable, and/or will not be infringed by commercial
manufacture, use, or sale of the bupropion hydrobromide extended-release tablets that are
the subject of ANDA No. 20-1332. To the extent that paragraph 22 of the Complaint
23. Biovail commenced this action with 45 days of receiving Paddock’s third Paragraph IV letter.
Answer: Paddock lacks knowledge or information sufficient to form a belief as to
the truth of the allegations in paragraph 23 of the Complaint and therefore denies them.
24. This action is being filed in light of Paddock’s multiple Paragraph IV certifications.
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Answer: Paddock lacks knowledge or information sufficient to form a belief as to
the truth of the allegations in paragraph 24 of the Complaint and therefore denies them.
COUNT I (Infringement of the ’610 Patent Under 35 U.S.C. § 271(e)(2))
25. Biovail incorporates paragraphs 1-24. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-24
of the Complaint.
26. By seeking approval of its ANDA No. 20-1332 to engage in the commercial manufacture, use, or sale of a drug product claimed in the ’610 patent before its expiration, Paddock has infringed the ’610 patent under 35 U.S.C. § 271(e)(2)(A).
Answer: Paddock denies the allegations in paragraph 26 of the Complaint.
COUNT II (Declaratory Judgment of Infringement of the ’610 Patent
Under 35 U.S.C. § 271(a)-(c))
27. Biovail incorporates paragraphs 1-26. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-26
of the Complaint.
28. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Answer: Paddock admits that the Complaint purports to state a cause of action
under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Paddock denies that the Complaint properly states a cause of action under 35 U.S.C. §
271. To the extent that paragraph 28 of the Complaint contains additional allegations,
Paddock denies them.
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29. A concrete, real, and immediate dispute exists between the parties creating an actual case or controversy sufficient for the Court to entertain Biovail’s request for declaratory relief consistent with Article III of the United States Constitution because the actual case or controversy requires a declaration of rights by this Court.
Answer: Paddock admits that an actual case or controversy exists between the
parties. Paddock expressly denies any allegation of patent infringement and denies that
Plaintiff is entitled to any relief.
30. Upon information and belief, Paddock intends, soon after the FDA has approved its ANDA No. 20-1332, to begin manufacturing, marketing, offering to sell, or selling within the United States Paddock’s Generic Product with a product insert directing physicians and patients in the use of Paddock’s Generic Product.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 30 of the Complaint at this time, and
therefore denies them.
31. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to manufacture, offer for sale, or selling within the United States, and/or import into the United States Paddock’s Generic Product before expiration of the ’610 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 31 of the Complaint at this time, and
therefore denies them.
32. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’610 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 32 of the Complaint at this time, and
therefore denies them.
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33. Paddock’s actions, including without limitation the filing of ANDA No. 201332, exhibit a refusal to change the course of its action despite Biovail’s patent rights.
Answer: Paddock denies the allegations in paragraph 33 of the Complaint.
34. Upon information and belief, commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’610 patent, and the active inducement of and/or contribution to any of those activities, will infringe the ’610 patent.
Answer: Paddock denies the allegations in paragraph 34 of the Complaint.
35. Biovail is entitled to a declaratory judgment that future commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Products before expiration of the ’610 patent by Paddock or its agents, will infringe the ’610 patent.
Answer: Paddock denies the allegations in paragraph 35 of the Complaint.
COUNT III (Infringement of the ’935 Patent Under 35 U.S.C. § 271(e)(2))
36. Biovail incorporates paragraphs 1-35. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-35
of the Complaint.
37. By seeking approval of its ANDA No. 20-1332 to engage in the commercial manufacture, use, or sale of a drug product claimed in the ’935 patent before its expiration, Paddock has infringed the ’935 patent under 35 U.S.C. § 271(e)(2)(A).
Answer: Paddock denies the allegations in paragraph 37 of the Complaint.
COUNT IV (Declaratory Judgment of Infringement of the ’935 Patent
Under 35 U.S.C. § 271(a)-(c))
38. Biovail incorporates paragraphs 1-37.
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Answer: Paddock incorporates its responses to the allegations in paragraphs 1-37
of the Complaint.
39. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Answer: Paddock admits that the Complaint purports to state a cause of action
under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Paddock denies that the Complaint properly states a cause of action under 35 U.S.C. §
271. To the extent that paragraph 39 of the Complaint contains additional allegations,
Paddock denies them.
40. A concrete, real, and immediate dispute exists between the parties creating an actual case or controversy sufficient for the Court to entertain Biovail’s request for declaratory relief consistent with Article III of the United States Constitution because the actual case or controversy requires a declaration of rights by this Court.
Answer: Paddock admits that an actual case or controversy exists between the
parties. Paddock expressly denies any allegation of patent infringement and denies that
Plaintiff is entitled to any relief.
41. Upon information and belief, Paddock intends, soon after the FDA has approved its ANDA No. 20-1332, to begin manufacturing, marketing, offering to sell, or selling within the United States Paddock’s Generic Product with a product insert directing physicians and patients in the use of Paddock’s Generic Product.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 41 of the Complaint at this time, and
therefore denies them.
42. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to manufacture, offer for sale, or sell within the United States, and/or import into the United States Paddock’s Generic Product before expiration of the ’935 patent.
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Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 42 of the Complaint at this time, and
therefore denies them.
43. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’935 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 43 of the Complaint at this time, and
therefore denies them.
44. Paddock’s actions, including without limitation the filing of ANDA No. 201332, exhibit a refusal to change the course of its action despite Biovail’s patent rights.
Answer: Paddock denies the allegations in paragraph 44 of the Complaint.
45. Upon information and belief, commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’935 patent, and the active inducement of and/or contribution to any of those activities, will infringe the ’935 patent.
Answer: Paddock denies the allegations in paragraph 45 of the Complaint.
46. Biovail is entitled to a declaratory judgment that future commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Products before expiration of the ’935 patent by Paddock or its agents, will infringe the ’935 patent.
Answer: Paddock denies the allegations in paragraph 46 of the Complaint.
COUNT V (Infringement of the ’019 Patent Under 35 U.S.C. § 271(e)(2))
47. Biovail incorporates paragraphs 1-46.
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Answer: Paddock incorporates its responses to the allegations in paragraphs 1-46
of the Complaint.
48. By seeking approval of its ANDA No. 20-1332 to engage in the commercial manufacture, use, or sale of a drug product claimed in the ’019 patent before its expiration, Paddock has infringed the ’019 patent under 35 U.S.C. § 271(e)(2)(A).
Answer: Paddock denies the allegations in paragraph 48 of the Complaint.
COUNT VI (Declaratory Judgment of Infringement of the ’019 Patent
Under 35 U.S.C. § 271(a)-(c))
49. Biovail incorporates paragraphs 1-48. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-48
of the Complaint.
50. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Answer: Paddock admits that the Complaint purports to state a cause of action
under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Paddock denies that the Complaint properly states a cause of action under 35 U.S.C. §
271. To the extent that paragraph 50 of the Complaint contains additional allegations,
Paddock denies them.
51. A concrete, real, and immediate dispute exists between the parties creating an actual case or controversy sufficient for the Court to entertain Biovail’s request for declaratory relief consistent with Article III of the United States Constitution because the actual case or controversy requires a declaration of rights by this Court.
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Answer: Paddock admits that an actual case or controversy exists between the
parties. Paddock expressly denies any allegation of patent infringement and denies that
Plaintiff is entitled to any relief.
52. Upon information and belief, Paddock intends, soon after the FDA has approved its ANDA No. 20-1332, to begin manufacturing, marketing, offering to sell, or selling within the United States Paddock’s Generic Product with a product insert directing physicians and patients in the use of Paddock’s Generic Product.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 52 of the Complaint at this time, and
therefore denies them.
53. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to manufacture, offer for sale, or sell within the United States, and/or import into the United States Paddock’s Generic Product before expiration of the ’019 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 53 of the Complaint at this time, and
therefore denies them.
54. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’019 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 54 of the Complaint at this time, and
therefore denies them.
55. Paddock’s actions, including without limitation the filing of ANDA No. 201332, exhibit a refusal to change the course of its action despite Biovail’s patent rights.
Answer: Paddock denies the allegations in paragraph 55 of the Complaint.
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56. Upon information and belief, commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’019 patent, and the active inducement of and/or contribution to any of those activities, will infringe the ’019 patent.
Answer: Paddock denies the allegations in paragraph 56 of the Complaint.
57. Biovail is entitled to a declaratory judgment that future commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Products before expiration of the ’019 patent by Paddock or its agents, will infringe the ’019 patent.
Answer: Paddock denies the allegations in paragraph 57 of the Complaint.
COUNT VII (Infringement of the ’823 Patent Under 35 U.S.C. § 271(e)(2))
58. Biovail incorporates paragraphs 1-57. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-57
of the Complaint.
59. By seeking approval of its ANDA No. 20-1332 to engage in the commercial manufacture, use, or sale of a drug product claimed in the ’823 patent before its expiration, Paddock has infringed the ’823 patent under 35 U.S.C. § 271(e)(2)(A).
Answer: Paddock denies the allegations in paragraph 59 of the Complaint.
COUNT VIII (Declaratory Judgment of Infringement of the ’823 Patent
Under 35 U.S.C. § 271(a)-(c))
60. Biovail incorporates paragraphs 1-59. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-59
of the Complaint.
61. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
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Answer: Paddock admits that the Complaint purports to state a cause of action
under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Paddock denies that the Complaint properly states a cause of action under 35 U.S.C. §
271. To the extent that paragraph 61 of the Complaint contains additional allegations,
Paddock denies them.
62. A concrete, real, and immediate dispute exists between the parties creating an actual case or controversy sufficient for the Court to entertain Biovail’s request for declaratory relief consistent with Article III of the United States Constitution because the actual case or controversy requires a declaration of rights by this Court.
Answer: Paddock admits that an actual case or controversy exists between the
parties. Paddock expressly denies any allegation of patent infringement and denies that
Plaintiff is entitled to any relief.
63. Upon information and belief, Paddock intends, soon after the FDA has approved its ANDA No. 20-1332, to begin manufacturing, marketing, offering to sell, or selling within the United States Paddock’s Generic Product with a product insert directing physicians and patients in the use of Paddock’s Generic Product.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 63 of the Complaint at this time, and
therefore denies them.
64. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to manufacture, offer for sale, or sell within the United States, and/or import into the United States Paddock’s Generic Product before expiration of the ’823 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 64 of the Complaint at this time, and
therefore denies them.
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65. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’823 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 65 of the Complaint at this time, and
therefore denies them.
66. Paddock’s actions, including without limitation the filing of ANDA No. 201332, exhibit a refusal to change the course of its action despite Biovail’s patent rights.
Answer: Paddock denies the allegations in paragraph 66 of the Complaint.
67. Upon information and belief, commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’823 patent, and the active inducement of and/or contribution to any of those activities, will infringe the ’823 patent.
Answer: Paddock denies the allegations in paragraph 67 of the Complaint.
68. Biovail is entitled to a declaratory judgment that future commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Products before expiration of the ’823 patent by Paddock or its agents, will infringe the ’823 patent.
Answer: Paddock denies the allegations in paragraph 68 of the Complaint.
COUNT IX (Infringement of the ’992 Patent Under 35 U.S.C. § 271(e)(2))
69. Biovail incorporates paragraphs 1-68. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-68
of the Complaint.
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70. By seeking approval of its ANDA No. 20-1332 to engage in the commercial manufacture, use, or sale of a drug product claimed in the ’992 patent before its expiration, Paddock has infringed the ’992 patent under 35 U.S.C. § 271(e)(2)(A).
Answer: Paddock denies the allegations in paragraph 70 of the Complaint.
COUNT X (Declaratory Judgment of Infringement of the ’992 Patent
Under 35 U.S.C. § 271(a)-(c))
71. Biovail incorporates paragraphs 1-70. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-70
of the Complaint.
72. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Answer: Paddock admits that the Complaint purports to state a cause of action
under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Paddock denies that the Complaint properly states a cause of action under 35 U.S.C. §
271. To the extent that paragraph 72 of the Complaint contains additional allegations,
Paddock denies them.
73. A concrete, real, and immediate dispute exists between the parties creating an actual case or controversy sufficient for the Court to entertain Biovail’s request for declaratory relief consistent with Article III of the United States Constitution because the actual case or controversy requires a declaration of rights by this Court.
Answer: Paddock admits that an actual case or controversy exists between the
parties. Paddock expressly denies any allegation of patent infringement and denies that
Plaintiff is entitled to any relief.
74. Upon information and belief, Paddock intends, soon after the FDA has approved its ANDA No. 20-1332, to begin manufacturing, marketing, offering to sell, or
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selling within the United States Paddock’s Generic Product with a product insert directing physicians and patients in the use of Paddock’s Generic Product.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 74 of the Complaint at this time, and
therefore denies them.
75. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to manufacture, offer for sale, or sell within the United States, and/or import into the United States Paddock’s Generic Product before expiration of the ’992 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 75 of the Complaint at this time, and
therefore denies them.
76. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’992 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 76 of the Complaint at this time, and
therefore denies them.
77. Paddock’s actions, including without limitation the filing of ANDA No. 201332, exhibit a refusal to change the course of its action despite Biovail’s patent rights.
Answer: Paddock denies the allegations in paragraph 77 of the Complaint.
78. Upon information and belief, commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’992 patent, and the active inducement of and/or contribution to any of those activities, will infringe the ’992 patent.
Answer: Paddock denies the allegations in paragraph 78 of the Complaint.
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79. Biovail is entitled to a declaratory judgment that future commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Products before expiration of the ’992 patent by Paddock or its agents, will infringe the ’992 patent.
Answer: Paddock denies the allegations in paragraph 79 of the Complaint.
COUNT XI (Infringement of the’094 Patents Under 35 U.S.C. § 271(e)(2))
80. Biovail incorporates paragraphs 1-79. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-79
of the Complaint.
81. By seeking approval of its ANDA No. 20-1332 to engage in the commercial manufacture, use, or sale of a drug product claimed in the ’094 patent before its expiration, Paddock has infringed the ’094 patent under 35 U.S.C. § 271(e)(2)(A).
Answer: Paddock denies the allegations in paragraph 81 of the Complaint.
COUNT XII (Declaratory Judgment of Infringement of the ’094 Patent
Under 35 U.S.C. § 271(a)-(c))
82. Biovail incorporates paragraphs 1-81. Answer: Paddock incorporates its responses to the allegations in paragraphs 1-81
of the Complaint.
83. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Answer: Paddock admits that the Complaint purports to state a cause of action
under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271.
Paddock denies that the Complaint properly states a cause of action under 35 U.S.C. §
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271. To the extent that paragraph 83 of the Complaint contains additional allegations,
Paddock denies them.
84. A concrete, real, and immediate dispute exists between the parties creating an actual case or controversy sufficient for the Court to entertain Biovail’s request for declaratory relief consistent with Article III of the United States Constitution because the actual case or controversy requires a declaration of rights by this Court.
Answer: Paddock admits that an actual case or controversy exists between the
parties. Paddock expressly denies any allegation of patent infringement and denies that
Plaintiff is entitled to any relief.
85. Upon information and belief, Paddock intends, soon after the FDA has approved its ANDA 20-1332, to begin manufacturing, marketing, offering to sell, or selling within the United States Paddock’s Generic Product with a product insert directing physicians and patients in the use of Paddock’s Generic Product.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 85 of the Complaint at this time, and
therefore denies them.
86. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to manufacture, offer for sale, or sell within the United States, and/or import into the United States Paddock’s Generic Product before expiration of the ’094 patent.
Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 86 of the Complaint at this time, and
therefore denies them.
87. Upon information and belief, Paddock has made, and will continue to make, substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’094 patent.
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Answer: Paddock is without knowledge or information sufficient to form a belief
as to the truth of the allegations in paragraph 87 of the Complaint at this time, and
therefore denies them.
88. Paddock’s actions, including without limitation the filing of ANDA No. 20332, exhibit a refusal to change the course of its action despite Biovail’s patent rights.
Answer: Paddock denies the allegations in paragraph 88 of the Complaint.
89. Upon information and belief, commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product before expiration of the ’094 patent, and the active inducement of and/or contribution to any of those activities, will infringe the ’094 patent.
Answer: Paddock denies the allegations in paragraph 89 of the Complaint.
90. Biovail is entitled to a declaratory judgment that future commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States of Paddock’s Generic Products before expiration of the ’094 patent by Paddock or its agents, will infringe the ’094 patent.
Answer: Paddock denies the allegations in paragraph 90 of the Complaint.
INJUNCTIVE RELIEF
91. Biovail will be substantially and irreparably damaged and harmed by Paddock’s infringing activities unless those activities are enjoined by this Court. Biovail does not have an adequate remedy at law.
Answer: Paddock denies the allegations in paragraph 91 of the Complaint.
PRAYER FOR RELIEF
Paddock denies that Biovail is entitled to any of the relief it seeks in its Complaint.
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SEPARATE DEFENSES
1. The ’610 patent is invalid under 35 U.S.C. § 1 et seq. and/or the doctrine of
obviousness-type double patenting.
2. No valid claims of the ’610 patent will be infringed by the manufacture,
use, offer for sale, sale, marketing, distribution, or importation of the proposed drug
products under ANDA No. 20-1332.
3. The ’935 patent is invalid under 35 U.S.C. § 1 et seq. and/or the doctrine of
obviousness-type double patenting.
4. No valid claims of the ’935 patent will be infringed by the manufacture,
use, offer for sale, sale, marketing, distribution, or importation of the proposed drug
products under ANDA No. 20-1332.
5. The ’019 patent is invalid under 35 U.S.C. § 1 et seq. and/or the doctrine of
obviousness-type double patenting.
6. No valid claims of the ’019 patent will be infringed by the manufacture,
use, offer for sale, sale, marketing, distribution, or importation of the proposed drug
products under ANDA No. 20-1332.
7. The ’823 patent is invalid under 35 U.S.C. § 1 et seq. and/or the doctrine of
obviousness-type double patenting.
8. No valid claims of the ’823 patent will be infringed by the manufacture,
use, offer for sale, sale, marketing, distribution, or importation of the proposed drug
products under ANDA No. 20-1332.
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9. The ’992 patent is invalid under 35 U.S.C. § 1 et seq. and/or the doctrine of
obviousness-type double patenting.
10. No valid claims of the ’992 patent will be infringed by the manufacture,
use, offer for sale, sale, marketing, distribution, or importation of the proposed drug
products under ANDA No. 20-1332.
11. The ’094 patent is invalid under 35 U.S.C. § 1 et seq. and/or the doctrine of
obviousness-type double patenting.
12. No valid claims of the ’094 patent will be infringed by the manufacture,
use, offer for sale, sale, marketing, distribution, or importation of the proposed drug
products under ANDA No. 20-1332.
13. The Complaint fails to state a claim for which relief can be granted.
14. The relief requested in the Complaint is barred by the doctrines of estoppel,
waiver, laches, or unclean hands.
COUNTERCLAIM
Paddock Laboratories, Inc. (“Paddock”) asserts the following counterclaims
against Biovail Laboratories International SRL (“Biovail”):
THE PARTIES
1. Paddock is a Minnesota corporation having a place of business at 3940
formulations of a bupropion salt,” issued on January 12, 2010.
14. On information and belief, Biovail is the assignee of the ’992, ’823, ’610,
’935, ’019, ’094, and ’901 patents.
15. On information and belief, Biovail is the holder of New Drug Application
No. 22-108 (“NDA 22-108”) for bupropion hydrobromide extended release tablets
marketed under the brand name AplenzinTM ER. In connection with NDA 22-108,
Biovail caused the U.S. Food and Drug Administration (“FDA”) to list the ’610, ’935,
’019, and ’094 patents in the Approved Drug Products with Therapeutic Equivalence
Evaluations (“Orange Book”), as well as U.S. Patent Nos. 7,241,805 (“’805 patent”),
7,585,897 (“’897 patent”), 7,645,802 (“’802 patent”), and 7,662,407 (“’407 patent”).
16. Paddock submitted Abbreviated New Drug Application No. 20-1332
(“ANDA 20-1332”) requesting regulatory approval to engage in the commercial
manufacture, use, or sale of bupropion hydrobromide extended release tablets
(“Paddock’s Bupropion Hydrobromide Extended Release Tablets”) before the expiration
of the Orange Book patents listed for AplenzinTM ER. Paddock made a certification
pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“paragraph IV certification”) that the ’805,
’610, ’935, ’897, ’802, ’019, ’407, and ’094 patents listed in the Orange Book for
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AplenzinTM ER are invalid, unenforceable, and/or will not be infringed by the
commercial manufacture, use, or sale of Paddock’s Bupropion Hydrobromide Extended
Release Tablets.
17. Pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), on January 22, 2010, Paddock
notified Biovail of Paddock’s paragraph IV certification filed with ANDA 20-1332 for
the ’805, ’610, ’935, ’897, ’802, and ’019 patents. The notice included an offer of
confidential access to ANDA 20-1332.
18. Pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), on February 23, 2010, Paddock
notified Biovail of Paddock’s paragraph IV certification filed with ANDA 20-1332 for
the ’805, ’610, ’935, ’897, ’802, ’019, and ’407 patents. The notice included an offer of
confidential access to ANDA 20-1332.
19. On March 9, 2010, Biovail filed a complaint in this Court alleging
infringement of the ’610, ’935, ’019, ’094, ’823, and ’992 patents by Paddock, which was
assigned Civil Action No. 0:10-cv-00687-MJD-JJK.
20. Pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), on April 2, 2010, Paddock notified
Biovail of Paddock’s paragraph IV certification filed with ANDA 20-1332 for the ’094
patent. The notice included an offer of confidential access to ANDA 20-1332.
21. Pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), on April 7, 2010, Paddock notified
Biovail of Paddock’s paragraph IV certification filed with ANDA 20-1332 for the ’805,
’610, ’935, ’897, ’802, ’019, ’407, and ’094 patents. The notice included an offer of
confidential access to ANDA 20-1332.
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22. On April 15, 2010, Biovail filed the instant Complaint alleging
infringement of the ’610, ’935, ’019, ’094, ’823, and ’992 patents by Paddock.
COUNT ONE
(Declaratory Judgment regarding U.S. Patent No. 7,553,992)
23. Paddock realleges paragraphs 1-22 of the Counterclaim as if fully set forth
herein.
24. The claims of the ’992 patent are invalid for failure to satisfy the
requirements of Title 35 of the United States Code, including without limitation one or
more of 35 U.S.C. §§ 101, 102, 103, and 112 and/or the doctrine of obviousness-type
double patenting.
25. Paddock’s Bupropion Hydrobromide Extended Release Tablets do not
infringe any valid claim of the ’992 patent.
26. The commercial manufacture, use, offer for sale, sale, or importation of
Paddock’s Bupropion Hydrobromide Extended Release Tablets would not infringe any
valid claim of the ’992 patent.
27. An actual and justiciable controversy exists between the parties with
respect to the ’992 patent, and Paddock is entitled to a declaratory judgment that the ’992
patent is invalid and not infringed.
COUNT TWO
(Declaratory Judgment regarding U.S. Patent No. 7,563,823)
28. Paddock realleges paragraphs 1-22 of the Counterclaim as if fully set forth
herein.
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29. The claims of the ’823 patent are invalid for failure to satisfy the
requirements of Title 35 of the United States Code, including without limitation one or
more of 35 U.S.C. §§ 101, 102, 103, and 112 and/or the doctrine of obviousness-type
double patenting.
30. Paddock’s Bupropion Hydrobromide Extended Release Tablets do not
infringe any valid claim of the ’823 patent.
31. The commercial manufacture, use, offer for sale, sale, or importation of
Paddock’s Bupropion Hydrobromide Extended Release Tablets would not infringe any
valid claim of the ’823 patent.
32. An actual and justiciable controversy exists between the parties with
respect to the ’823 patent, and Paddock is entitled to a declaratory judgment that the ’823
patent is invalid and not infringed.
COUNT THREE
(Declaratory Judgment regarding U.S. Patent No. 7,569,610)
33. Paddock realleges paragraphs 1-22 of the Counterclaim as if fully set forth
herein.
34. The claims of the ’610 patent are invalid for failure to satisfy the
requirements of Title 35 of the United States Code, including without limitation one or
more of 35 U.S.C. §§ 101, 102, 103, and 112 and/or the doctrine of obviousness-type
double patenting.
35. Paddock’s Bupropion Hydrobromide Extended Release Tablets do not
infringe any valid claim of the ’610 patent.
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36. The commercial manufacture, use, offer for sale, sale, or importation of
Paddock’s Bupropion Hydrobromide Extended Release Tablets would not infringe any
valid claim of the ’610 patent.
37. An actual and justiciable controversy exists between the parties with
respect to the ’610 patent, and Paddock is entitled to a declaratory judgment that the ’610
patent is invalid and not infringed.
COUNT FOUR
(Declaratory Judgment regarding U.S. Patent No. 7,572,935)
38. Paddock realleges paragraphs 1-22 of the Counterclaim as if fully set forth
herein.
39. The claims of the ’935 patent are invalid for failure to satisfy the
requirements of Title 35 of the United States Code, including without limitation one or
more of 35 U.S.C. §§ 101, 102, 103, and 112 and/or the doctrine of obviousness-type
double patenting.
40. Paddock’s Bupropion Hydrobromide Extended Release Tablets do not
infringe any valid claim of the ’935 patent.
41. The commercial manufacture, use, offer for sale, sale, or importation of
Paddock’s Bupropion Hydrobromide Extended Release Tablets would not infringe any
valid claim of the ’935 patent.
42. An actual and justiciable controversy exists between the parties with
respect to the ’935 patent, and Paddock is entitled to a declaratory judgment that the ’935
patent is invalid and not infringed.
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COUNT FIVE
(Declaratory Judgment regarding U.S. Patent No. 7,649,019)
43. Paddock realleges paragraphs 1-22 of the Counterclaim as if fully set forth
herein.
44. The claims of the ’019 patent are invalid for failure to satisfy the
requirements of Title 35 of the United States Code, including without limitation one or
more of 35 U.S.C. §§ 101, 102, 103, and 112 and/or the doctrine of obviousness-type
double patenting.
45. Paddock’s Bupropion Hydrobromide Extended Release Tablets do not
infringe any valid claim of the ’019 patent.
46. The commercial manufacture, use, offer for sale, sale, or importation of
Paddock’s Bupropion Hydrobromide Extended Release Tablets would not infringe any
valid claim of the ’019 patent.
47. An actual and justiciable controversy exists between the parties with
respect to the ’019 patent, and Paddock is entitled to a declaratory judgment that the ’019
patent is invalid and not infringed.
COUNT SIX
(Declaratory Judgment regarding U.S. Patent No. 7,671,094)
48. Paddock realleges paragraphs 1-22 of the Counterclaim as if fully set forth
herein.
49. The claims of the ’094 patent are invalid for failure to satisfy the
requirements of Title 35 of the United States Code, including without limitation one or
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34
more of 35 U.S.C. §§ 101, 102, 103, and 112 and/or the doctrine of obviousness-type
double patenting.
50. Paddock’s Bupropion Hydrobromide Extended Release Tablets do not
infringe any valid claim of the ’094 patent.
51. The commercial manufacture, use, offer for sale, sale, or importation of
Paddock’s Bupropion Hydrobromide Extended Release Tablets would not infringe any
valid claim of the ’094 patent.
52. An actual and justiciable controversy exists between the parties with
respect to the ’094 patent, and Paddock is entitled to a declaratory judgment that the ’094
patent is invalid and not infringed.
COUNT SEVEN
(Declaratory Judgment regarding U.S. Patent No. 7,645,901)
53. Paddock realleges paragraphs 1-22 of the Counterclaim as if fully set forth
herein.
54. The claims of the ’901 patent are invalid for failure to satisfy the
requirements of Title 35 of the United States Code, including without limitation one or
more of 35 U.S.C. §§ 101, 102, 103, and 112 and/or the doctrine of obviousness-type
double patenting.
55. Paddock’s Bupropion Hydrobromide Extended Release Tablets do not
infringe any valid claim of the ’901 patent.
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56. The commercial manufacture, use, offer for sale, sale, or importation of
Paddock’s Bupropion Hydrobromide Extended Release Tablets would not infringe any
valid claim of the ’901 patent.
57. An actual and justiciable controversy exists between the parties with
respect to the ’901 patent, and Paddock is entitled to a declaratory judgment that the ’901
patent is invalid and not infringed.
PRAYER FOR RELIEF
WHEREFORE, Paddock respectfully requests that this Court enter judgment in its
favor and against Biovail and grant the following relief:
A. Declare that the claims of the ’992 patent are invalid;
B. Declare that the manufacture, use, offer for sale, sale, marketing,
distribution, or importation of Paddock’s bupropion hydrobromide extended release
tablets would not infringe the claims of the ’992 patent;
C. Declare that the claims of the ’823 patent are invalid;
D. Declare that the manufacture, use, offer for sale, sale, marketing,
distribution, or importation of Paddock’s bupropion hydrobromide extended release
tablets would not infringe the claims of the ’823 patent;
E. Declare that the claims of the ’610 patent are invalid;
F. Declare that the manufacture, use, offer for sale, sale, marketing,
distribution, or importation of Paddock’s bupropion hydrobromide extended release
tablets would not infringe the claims of the ’610 patent;
G. Declare that the claims of the ’935 patent are invalid;
Case 0:10-cv-01571-MJD-JJK Document 6 Filed 05/05/10 Page 35 of 37
36
H. Declare that the manufacture, use, offer for sale, sale, marketing,
distribution, or importation of Paddock’s bupropion hydrobromide extended release
tablets would not infringe the claims of the ’935 patent;
I. Declare that the claims of the ’019 patent are invalid;
J. Declare that the manufacture, use, offer for sale, sale, marketing,
distribution, or importation of Paddock’s bupropion hydrobromide extended release
tablets would not infringe the claims of the ’019 patent;
K. Declare that the claims of the ’094 patent are invalid;
L. Declare that the manufacture, use, offer for sale, sale, marketing,
distribution, or importation of Paddock’s bupropion hydrobromide extended release
tablets would not infringe the claims of the ’094 patent;
M. Declare that the claims of the ’901 patent are invalid;
N. Declare that the manufacture, use, offer for sale, sale, marketing,
distribution, or importation of Paddock’s bupropion hydrobromide extended release
tablets would not infringe the claims of the ’901 patent;
O. Award Paddock its costs and reasonable attorney fees; and
P. Award Paddock such other and further relief as the Court deems just and
proper.
Case 0:10-cv-01571-MJD-JJK Document 6 Filed 05/05/10 Page 36 of 37
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Dated: May 5, 2010 KELLY & BERENS, P.A.
s/Justi Rae Miller
Barbara Podlucky Berens #209778 Justi Rae Miller #387330 80 S. 8th Street, Suite 3720 Minneapolis, MN 55402 Telephone: (612) 349-6171 Fax: (612) 349-6416
WILSON SONSINI GOODRICH & ROSATI, P.C. Daniel G. Brown Gina R. Gencarelli 1301 Avenue of the Americas, 40th Floor New York, NY 10019 Telephone: (212) 999-5800 Fax: (212) 999-5899
Attorneys for Defendant Paddock Laboratories, Inc.
Case 0:10-cv-01571-MJD-JJK Document 6 Filed 05/05/10 Page 37 of 37
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