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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE


DARAVITA LIMITED,

Plaintiff and
Counterclaim-Defendant,
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)
)
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v. )
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C.A. No.: 14-1118 (GMS)
ACTAVIS LABORATORIES FL, INC.,

Defendant and
Counterclaim-Plaintiff.
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)
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ACTAVIS LABORATORIES FL, INCS ANSWER, SEPARATE
DEFENSES, AND COUNTERCLAIMS TO PLAINTIFFS COMPLAINT

Defendant Actavis Laboratories FL, Inc., (Actavis FL), submits the following Answer,
Separate Defenses, and Counterclaims to Plaintiffs Complaint (Complaint). Andrx
Corporation (Andrx), Actavis Pharma, Inc. (Actavis Pharma), and Actavis, Inc. (Actavis)
have been dismissed from this suit. This Answer is made on behalf of Actavis FL alone and not
on behalf of any of the dismissed entities. This Answer is based upon Actavis FLs knowledge
as to its own activities and upon information and belief as to the activities of others. The
numbered paragraphs below correspond to the paragraphs in the Complaint.
THE PARTIES
1. Actavis FL denies knowledge or information sufficient to form a belief as to the
truth of the allegations contained in Paragraph 1.
2. Actavis FL admits that Actavis FL is a corporation organized and existing under
the laws of Florida and is a wholly-owned subsidiary of Andrx. Actavis FL otherwise denies
the remaining allegations of this paragraph.
3. Actavis FL admits that it prepares and manufactures pharmaceutical products.
Actavis FL denies the remaining allegations of this paragraph.
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4. Andrx has been dismissed from this suit by Order of the Court and therefore no
answer is necessary.
5. Actavis Pharma Inc. has been dismissed from this suit by Order of the Court and
therefore no answer is necessary.
6. Actavis Pharma has been dismissed from this suit by Order of the Court and
therefore no answer is necessary.
7. Actavis, Inc. has been dismissed from this suit by Order of the Court and
therefore no answer is necessary.
NATURE OF ACTION
8. Actavis FL admits that this is a civil action for alleged infringement of United
States Patent Nos. 6,228,398 (the 398 patent) and 6,902,742 (the 742 patent) and that this
action purports to arise under the Patent Laws of the United States, 35 U.S.C. 100 et seq.
Actavis FL denies all allegations of infringement.
JURISDICTION AND VENUE
9. Paragraph 9 of the Complaint contains conclusions of law for which no response
is required. To the extent a response is required, Actavis FL will not contest subject matter
jurisdiction in this court solely for purposes of this action only.
10. Paragraph 10 of the Complaint contains conclusions of law for which no response
is required. To the extent a response is required, Actavis FL will not contest personal
jurisdiction in this court for purposes of this action only. Actavis FL denies the remaining
allegations of this paragraph.
11. Actavis FL admits that it shares at least one common officer and/or director with
one or more of the dismissed entities. Actavis FL will not contest personal jurisdiction in this
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court for purposes of this action only. Actavis FL denies the remaining allegations of this
paragraph.
12. Paragraph 12 of the Complaint contains conclusions of law for which no response
is required. To the extent a response is required, Actavis FL will not contest personal
jurisdiction in this court for purposes of this action only. The documents filed in the civil
actions identified in Paragraph 12 of the Complaint speak for themselves, and Actavis FL denies
any allegations to the extent they paraphrase, misstate, or are inconsistent with such documents.
Actavis FL denies the remaining allegations of this paragraph.
13. Paragraph 13 of the Complaint contains legal conclusions to which no response is
required. To the extent an answer is required, Actavis FL will not contest venue in this court
solely for the purpose of this action only.
FACTUAL BACKGROUND
14. Actavis FL admits that what purports to be a true copy of the 398 patent is
attached to the Complaint as Exhibit A, and that it on its face lists May 8, 2001 as the issue date
for the patent. Actavis FL lacks sufficient information or knowledge to admit or deny the other
allegations in Paragraph 14 of the Complaint and therefore denies the same.
15. Actavis FL admits that what purports to be a true copy of the 742 patent is
attached to the Complaint as Exhibit B, and that it on its face lists J une 7, 2005 as the issue date
for the patent. Actavis FL lacks sufficient information or knowledge to admit or deny the other
allegations in Paragraph 15 of the Complaint and therefore denies the same.
16. Actavis FL admits that on October 25, 2013, the FDA approved NDA 202880 for
capsules which contain hydrocodone bitartrate and that the 398 and 742 patents are listed in the
Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) for NDA
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No. 202880. Actavis FL lacks sufficient information or knowledge to admit or deny the other
allegations in Paragraph 16 of the Complaint and therefore denies the same.
17. Actavis FL admits that Actavis FL submitted ANDA No. 206952 to the FDA
seeking approval to manufacture, use, and/or sell hydrocodone bitartrate extended-release
capsules in 10, 15, 20, 30, 40 and 50 mg strengths. Actavis FL denies the remaining allegations
of this paragraph.
18. Actavis FL admits that a letter dated August 12, 2014 (the Notice Letter) was
sent to Plaintiff notifying it that Actavis FL filed ANDA No. 206952 with the FDA seeking
approval to manufacture, use, and/or sell a capsule product which contains hydrocodone
bitartrate. Actavis FL admits that the Notice Letter included paragraph IV certifications that
the 398 patent, and the 742 patents are invalid, unenforceable, and/or would not be infringed by
Actavis FLs product, which is the subject of ANDA No. 206952. Actavis FL denies the
remaining allegations of this paragraph.
19. Actavis FL admits that in the Notice Letter, it notified Plaintiff that its ANDA No.
206952 included paragraph IV certifications that the 398 patent, and the 742 patents are
invalid, unenforceable, and/or would not be infringed by Actavis FLs product, which is the
subject of ANDA No. 206952. Actavis FL denies the remaining allegations of this paragraph.
COUNT I
20. Actavis FL restates and incorporates by reference its responses to the allegations
of paragraphs 1-19 as though fully set forth herein.
21. Actavis FL admits it seeks the FDAs approval for the ANDA product that is the
subject of ANDA No. 206952. Actavis FL denies the remaining allegations of this paragraph.
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22. Actavis FL admits it seeks the FDAs approval for the ANDA product that is the
subject of the ANDA No. 206952. Actavis FL denies the remaining allegations of this
paragraph.
COUNT II
23. Actavis FL restates and incorporates by reference its responses to the allegations
of paragraphs 1-22 as though fully set forth herein.
24. Actavis FL admits it seeks the FDAs approval for the ANDA product that is the
subject of the ANDA No. 206952. Actavis FL denies the remaining allegations of this
paragraph.
25. Actavis FL admits it seeks the FDAs approval for the ANDA product that is the
subject of the ANDA No. 206952. Actavis FL denies the remaining allegations of this
paragraph.
PRAYER FOR RELIEF
A. Actavis FL denies that Plaintiff is entitled to the relief requested in paragraph A.
B. Actavis FL denies that Plaintiff is entitled to the relief requested in paragraph B.
C. Actavis FL denies that Plaintiff is entitled to the relief requested in paragraph C.
D. Actavis FL denies that Plaintiff is entitled to the relief requested in paragraph D.
E. Actavis FL denies that Plaintiff is entitled to the relief requested in paragraph E.
F. Actavis FL denies that Plaintiff is entitled to the relief requested in paragraph F.
DEFENSES
Without prejudice to the denials set forth in its Answer and without admitting any
allegations found in the Complaint not otherwise admitted, Actavis FL avers and asserts the
following defenses:
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FIRST SEPARATE DEFENSE
(Non-Infringement)
The manufacture, use, sale, offer for sale, or importation of the ANDA product has not,
does not, and would not infringe any valid and enforceable claim of the 398, or 742 patents
either directly or indirectly, contributorily and/or by inducement, literally or under the doctrine
of equivalents.
SECOND SEPARATE DEFENSE
(Invalidity)
The claims of the 398, or 742 patents are invalid for failure to comply with one or more
of the provisions of the United States Code, including but not limited to, 35 U.S.C. 102, 103,
and/or 112.
THIRD SEPARATE DEFENSE
(Failure to State a Claim)
The Complaint is subject to dismissal for failure to state a claim upon which relief may
be granted.
FOURTH SEPARATE DEFENSE
(Other Defenses)
Any additional defenses or counterclaims that discovery may reveal.
COUNTERCLAIMS
Counterclaim-Plaintiff Actavis Laboratories FL, Inc. (Counterclaim-Plaintiff) for its
Counterclaims against Daravita Limited (Counterclaim-Defendant) alleges as follows:
PARTIES
1. Actavis Laboratories FL, Inc. is a Florida corporation having its principal place of
business at 4955 Orange Dr., Davie, FL 33314.
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2. On information and belief, and based on Counterclaim-Defendants allegations in
its Complaint, Daravita Limited is an Irish corporation having its principal place of business at
Connaught House, 1 Burlington Road, Dublin 4, Ireland.
NATURE OF ACTION
3. This is an action for infringement of United States Patent Nos. 6,228,398
(the 398 patent) and 6,902,742 (the 742 patent). This action is based upon the Patent
Laws of the United States, 35 U.S.C. 100 et seq.
ACTUAL AND JUSTICIABLE CONTROVERSY
4. The United States Patent and Trademark Office purportedly issued the 398 patent
on May 8, 2001. The face of the patent lists Elan Corporation, PLC as assignee. Based upon
the allegations set forth in Counterclaim-Defendants Complaint, Daravita Limited is purportedly
now the assignee of all rights in the 398 Patent.
5. The United States Patent and Trademark Office purportedly issued the 742 patent
on J une 7, 2005. The face of the patent lists Elan Corporation, PLC as assignee. Based upon
the allegations set forth in Counterclaim-Defendants Complaint, Daravita Limited is purportedly
now the assignee of all rights in the 742 Patent.
6. Counterclaim-Plaintiff submitted to the FDA ANDA No. 206952 seeking
approval for the manufacture, use and sale of hydrocodone bitartrate capsules in 10, 15, 20, 30,
40, and 50 mg strengths prior to the expiration of the 398 and 742 Patents.
7. On September 3, 2014, Counterclaim-Defendant filed a Complaint alleging, inter
alia, infringement of the 398 and 742 Patents by Counterclaim-Plaintiff.
8. In its Complaint, Counterclaim-Defendant alleges that Counterclaim-Plaintiffs
submission of ANDA No. 206952, directly and indirectly infringes one or more claims of
the 398 and/or 742 Patents.
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9. No act committed by Counterclaim-Plaintiff, including its submission of ANDA
No. 206952, was or is an infringement of any valid and enforceable claim of the 398
and/or 742 Patent pursuant to 35 U.S.C. 271(e).
10. Each of the claims of the 398 and 742 Patent are invalid for failing to comply
with one or more provisions of Title 35 of the United States Code, including without limitation
102, 103, and 112.
11. Actual, substantial, and continuing justiciable cases and controversies exist
between Counterclaim-Plaintiff and Counterclaim-Defendant relating to the alleged infringement
of the 398 and 742 Patent under 35 U.S.C. 271(e), which is of sufficient immediacy and
reality to warrant the issuance of a declaratory judgment.
12. Actual, substantial, and continuing justiciable cases and controversies exist
between Counterclaim-Plaintiff and Counterclaim-Defendant relating to the validity of the 398
and 742 Patents under 35 U.S.C. 271(e), which is of sufficient immediacy and reality to
warrant the issuance of a declaratory judgment.
JURISDICTION AND VENUE
13. This counterclaim arises under the patent laws of the United States, 35 U.S.C.
100 et seq., and the Declaratory J udgment Act, 28 U.S.C. 2201 and 2202. This Court has
subject matter jurisdiction under 28 U.S.C. 1331, 1338(a), 2201, and 2202.
14. Personal jurisdiction over Counterclaim-Defendant exists because
Counterclaim-Defendant has submitted to the personal jurisdiction of the Court.
15. Venue is proper in this district pursuant to 28 U.S.C. 1391 and 1400 because
Counterclaim-Defendant has submitted to the personal jurisdiction of the Court and has asserted
the 398 and 742 Patents against Counterclaim-Plaintiff in this Court.
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COUNT I
(Declaratory Judgment of Invalidity of the 398 Patent)
16. Counterclaim-Plaintiff incorporates by reference the allegations set forth in
paragraphs 1-15 as though fully set forth herein.
17. One or more of the claims of the 398 patent are invalid for failure to comply with
one or more of the provisions of the United States Code, including but not limited to, 35 U.S.C.
102, 103, and 112.
18. Counterclaim-Defendant alleges ownership of the 398 patent and has brought
claims against Counterclaim-Plaintiff alleging infringement of the 398 patent.
19. The 398 patent describes and claims an alleged invention, the making of which
did not involve the inventive faculty but only the obvious judgment, knowledge, and mechanical
skill possessed by persons having ordinary skill in the art to which the alleged invention pertains.
20. The alleged invention of the 398 patent does no more than combine familiar
elements according to known methods to yield predictable results. Any alleged improvement
over the prior art set forth in the 398 patent is no more than the predictable use of prior art
elements according to their established functions. A person of skill in the art would have been
motivated to combine the teachings of the prior art to achieve the alleged invention of the 398
patent and would have had a reasonable expectation of success in doing so.
21. The subject matter claimed in the 398 patent fails to comply with 35 U.S.C.
102 and/or 103 in that the differences between the subject matter claimed in the patent and the
prior art are such that the subject matter as a whole was either fully anticipated by the prior art or
would have been obvious at the time the alleged invention was made to a person having
knowledge of such prior art and having ordinary skill in the art to which the claimed subject
matter pertains.
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22. The 398 patent does not contain a written description of the invention, and of the
manner and process of making and using it, in such full, clear, concise and exact terms as
required by the statutes of the United States to enable any person having skill in the art to
practice the invention purported to be covered thereby.
23. The claims of the 398 patent are invalid and void because they do not inform
those skilled in the art about the scope of the invention with reasonable certainty and they do not
particularly point out and distinctly claim the subject matter of the alleged invention, as required
by 35 U.S.C. 112.
24. There is an actual and justiciable controversy between the parties concerning
whether the 398 patent claims are invalid.
25. Counterclaim-Plaintiff is entitled to a judicial declaration that the claims of
the 398 patent are invalid.
COUNT II
(Declaratory Judgment of Non-Infringement of the 398 Patent)
26. Counterclaim-Plaintiff incorporates by reference each of the preceding Paragraphs
1-25 as if fully stated herein.
27. Counterclaim-Defendant alleges ownership of the 398 patent and has brought
claims against Counterclaim-Plaintiff alleging infringement of the 398 patent.
28. The manufacture, use, sale, offer for sale, and/or importation of the
Counterclaim-Plaintiffs ANDA product will not infringe any valid or enforceable claim of the
398 patent either directly or indirectly, either literally or under the doctrine of equivalents.
29. There is an actual and justiciable controversy between the parties concerning
whether the manufacture, use, offering for sale, or importation of the Counterclaim-Plaintiffs
ANDA product will infringe the 398 patent.
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30. Counterclaim-Plaintiff is entitled to a judicial declaration that it has not infringed
and does not infringeliterally or under the doctrine of equivalents, directly or indirectly, by
inducement or contributionany valid claim of the 398 patent.
COUNT III
(Declaratory Judgment of Invalidity of the 742 Patent)
31. Counterclaim-Plaintiff incorporates by reference the allegations set forth in
paragraphs 1-30 as though fully set forth herein.
32. One or more of the claims of the 742 patent are invalid for failure to comply with
one or more of the provisions of the United States Code, including but not limited to, 35 U.S.C.
102, 103, and 112.
33. Counterclaim-Defendant alleges ownership of the 742 patent and has brought
claims against Counterclaim-Plaintiff alleging infringement of the 742 patent.
34. The 742 patent describes and claims an alleged invention, the making of which
did not involve the inventive faculty but only the obvious judgment, knowledge, and mechanical
skill possessed by persons having ordinary skill in the art to which the alleged invention pertains.
35. The alleged invention of the 742 patent does no more than combine familiar
elements according to known methods to yield predictable results. Any alleged improvement
over the prior art set forth in the 742 patent is no more than the predictable use of prior art
elements according to their established functions. A person of skill in the art would have been
motivated to combine the teachings of the prior art to achieve the alleged invention of the 742
patent and would have had a reasonable expectation of success in doing so.
36. The subject matter claimed in the 742 patent fails to comply with 35 U.S.C.
102 and/or 103 in that the differences between the subject matter claimed in the patent and the
prior art are such that the subject matter as a whole was either fully anticipated by the prior art or
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would have been obvious at the time the alleged invention was made to a person having
knowledge of such prior art and having ordinary skill in the art to which the claimed subject
matter pertains.
37. The 742 patent does not contain a written description of the invention, and of the
manner and process of making and using it, in such full, clear, concise, and exact terms as
required by the statutes of the United States to enable any person having skill in the art to
practice the invention purported to be covered thereby.
38. The claims of the 742 patent are invalid and void because they do not inform
those skilled in the art about the scope of the invention with reasonable certainty and they do not
particularly point out and distinctly claim the subject matter of the alleged invention, as required
by 35 U.S.C. 112.
39. There is an actual and justiciable controversy between the parties concerning
whether the 742 patent claims are invalid.
40. Counterclaim-Plaintiff is entitled to a judicial declaration that the claims of
the 742 patent are invalid.
COUNT IV
(Declaratory Judgment of Non-Infringement of the 742 Patent)
41. Counterclaim-Plaintiff incorporates by reference each of the preceding Paragraphs
1-40 as if fully stated herein.
42. Counterclaim-Defendant alleges ownership of the 742 patent and has brought
claims against Counterclaim-Plaintiff alleging infringement of the 742 patent.
43. The manufacture, use, sale, offer for sale, and/or importation of the
Counterclaim-Plaintiffs ANDA product will not infringe any valid or enforceable claim of the
742 patent either directly or indirectly, either literally or under the doctrine of equivalents.
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44. There is an actual and justiciable controversy between the parties concerning
whether the manufacture, use, offering for sale, or importation of the Counterclaim-Plaintiffs
ANDA product will infringe the 742 patent.
45. Counterclaim-Plaintiff is entitled to a judicial declaration that it has not infringed
and does not infringeliterally or under the doctrine of equivalents, directly or indirectly, by
inducement or contributionany valid claim of the 742 patent.
PRAYER FOR RELIEF
WHEREFORE, Counterclaim-Plaintiff respectfully requests that the Court enter an
Order:
A. Dismissing the Counterclaim-Defendants Complaint with prejudice;
B. Declaring the claims of the 398 and 742 patents are invalid for failure to comply
with one or more of the provisions of 35 U.S.C. 102, 103, and/or 112;
C. Declaring that Counterclaim-Plaintiffs filing of ANDA No. 206952 would not
directly, indirectly, contributorily and/or induce infringement, either literally or under the
doctrine of equivalents, any valid and enforceable claim of the 398 and 742 patents under 35
U.S.C. 271;
D. Declaring that the manufacture, use, sale, offer for sell, and/or importation in the
United States of Actavis FLs products that are the subject of ANDA No. 206952 do not, and
will not, infringe any valid and enforceable claim of the 398 and 742 patents;
E. Declaring this case exceptional under 35 U.S.C. 285;
F. Awarding Counterclaim-Plaintiff its reasonable attorneys fees and costs pursuant
to 35 U.S.C. 285, other statutes or rule, or general power of the Court; and
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G. Awarding Counterclaim-Plaintiff such other further relief as the Court deems just
and equitable.

Dated: October 24, 2014 /s/ Kelly E. Farnan
Kelly E. Farnan (#4395)
farnan@rlf.com
Richards, Layton & Finger, P.A.
One Rodney Square
920 N. King St
Wilmington, DE 19801
(302) 651-7700

Attorneys For Defendant
Actavis Laboratories FL, Inc.,

OF COUNSEL:

B. J efferson Boggs
Matthew L. Fedowitz
MERCHANT & GOULD PC
1701 Duke Street, Suite 310
Alexandria, VA 22314
(703) 684-2500

Christopher J . Sorenson
Rachel C. Hughey
Aaron M. J ohnson
MERCHANT & GOULD PC
3200 IDS Center
80 South Eighth Street
Minneapolis, MN 55402
(612) 332-5300

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