Hat tip to stockbettor on IHub for posting the meat of Momenta's complaint:
>>extracts from Momenta complaint
TEVA’S INFRINGING CONDUCT
22. On information and belief, Teva intends to market imminently an enoxaparin
product in the United States. In order to manufacture commercial quantities of generic enoxaparin in preparation for launch, Teva has engaged in, and/or is engaging in, activities that
infringed, or are infringing, the claims of the '886 and '466 patents.
23. In accordance with its announced plans to market a generic enoxaparin product in
the United States, Teva filed an ANDA and amendments thereto with the FDA.
24. Teva has stated that it intends, and is prepared, to sell its enoxaparin immediately
following FDA approval. In February 2010, the President and CEO of Teva North America
Pharmaceuticals, Bill Marth, stated: “[A]ll I can say is that when that approval [of generic
enoxaparin] comes, we’ll be ready.” A true copy of Teva’s Q4 2009 Earnings Conference
Transcript, dated February 16, 2010, is attached hereto as Exhibit C.
25. In May 2010, Teva stated its belief that FDA approval of its enoxaparin product
would occur shortly thereafter. Teva’s President and CEO, Shlomo Yanai, stated: “Again you
know, all the questioning we get from the FDA leads us to be fairly confident that [approval] will
come .... We’re just hopeful that it comes soon as we see the questioning. It just leads us to
believe that it is that we’re far down the path.” A true copy of Teva’s Q1 2010 Earnings Call,
dated May 4, 2010, is attached hereto as Exhibit D.
26. On July 23, 2010, the day that the FDA approved Sandoz and Momenta’s generic
enoxaparin sodium for commercial sale, Teva announced that “[it] believes it has demonstrated
to the FDA that its version of generic Lovenox® meets their criteria and that Teva’s pending
ANDA is approvable.” A true copy of Teva’s press release, dated July 23, 2010, is attached
hereto as Exhibit E. Later, in July 2010, Teva’s Mr. Marth stated: “As far as launch quantities
with respect to enoxaparin, the answer is yes we’re in good shape. So we just will need the
approval ....” A true copy of Teva’s Q2 2010 Earnings Conference Transcript, dated July 27,
2010, is attached hereto as Exhibit F.
27. In August 2010, Teva stated its belief that its enoxaparin product would be
approved by the FDA. Teva’s Research and Development Officer, Benzion Weiner, stated to
Israel’s Calcalist financial newspaper: “We are waiting to receive the approval soon and the
chances of receiving it is high.” A true copy of the article entitled, “Teva Copy of Lovenox®
May Be Close,” Reuters, dated August 5, 2010, is attached hereto as Exhibit G.
28. During an earnings call held on November 2, 2010, Teva’s President and CEO,
Mr. Yanai, reported that during a recent meeting with the FDA “we confirmed that our version of
generic Lovenox® meets the FDA’s criteria to demonstrate chemical sameness.” On the same
call, Teva’s Mr. Marth stated that Teva is “still hopeful” that it will obtain FDA approval this
year. A true copy of Teva’s Q3 2010 Earnings Conference Transcript, dated November 2, 2010,
is attached hereto as Exhibit H.
29. On information and belief, in order for Teva to have had a reasonable basis for its
statements that it believes that the FDA will approve its manufacture of generic enoxaparin, Teva
has included in its manufacturing process for each batch of enoxaparin sodium that it has
prepared, and will prepare, for commercial sale:
(a) a method for determining that its oligosaccharides contain the 1,6-anhydro
derivative. The use of such a method infringes the '886 patent; and
(b) a method for determining the presence, in the tetrasaccharide chains of its
enoxaparin, of particular chain sequences in particular relative amounts
that infringes the '466 patent.
30. On information and belief, in order to be prepared for immediate commercial
launch in the United States, Teva has manufactured and/or is in the process of manufacturing
commercial quantities of generic enoxaparin sodium using the methods claimed in the '886 and
'466 patents.
COUNT I
(Infringement of U.S. Patent No. 7,575,886)
31. Plaintiffs re-allege, and incorporate herein by reference, the allegations of
Paragraph 1-30 of this Complaint as if fully set forth herein.
32. Teva has infringed, and continues to infringe, or has induced others to infringe,
the '886 patent, either literally or under the doctrine of equivalents, by, inter alia, manufacturing
generic enoxaparin for commercial sale using the methods claimed in the '886 patent and
offering those products for sale in the United States.
33. Teva has not obtained a license to use the methods claimed in the '886 patent or to
offer for sale in the United States products made by that process.
34. Unless Teva is preliminarily and permanently enjoined by this Court from
offering to sell, and selling, its generic enoxaparin product made using methods that infringe the
'886 patent, Momenta and Sandoz will be substantially and irreparably harmed by Teva’s
infringing conduct.
35. Upon information and belief, Teva’s direct or indirect infringement of the '886
patent has been, and continues to be, willful, deliberate, and objectively reckless. Teva’s
conduct provides a basis for this Court to award enhanced damages pursuant to 35 U.S.C. § 284,
and makes this an exceptional case within the meaning of 35 U.S.C. § 285.
COUNT II
(Infringement of U.S. Patent No. 7,790,466)
36. Plaintiffs re-allege, and incorporate herein by reference, the allegations of
Paragraph 1-35 of this Complaint as if fully set forth herein.
37. Teva has infringed, and continues to infringe, or has induced others to infringe,
the '466 patent, either literally or under the doctrine of equivalents, by, inter alia, manufacturing
generic enoxaparin for commercial sale using the methods claimed in the '466 patent and
offering those products for sale in the United States.
38. Teva has not obtained a license to use the methods claimed in the '466 patent or to
offer for sale in the United States products made by that process.
39. Unless Teva is preliminarily and permanently enjoined by this Court from
offering to sell, and selling, its generic enoxaparin product made using methods that infringe the
'466 patent, Momenta and Sandoz will be substantially and irreparably harmed by Teva’s
infringing conduct.
40. Upon information and belief, Teva’s direct or indirect infringement of the '466
patent has been, and continues to be, willful, deliberate, and objectively reckless. Teva’s
conduct provides a basis for this Court to award enhanced damages pursuant to 35 U.S.C. § 284
and makes this an exceptional case within the meaning of 35 U.S.C. § 285.
*****************
PRAYER FOR RELIEF
WHEREFORE, the plaintiffs respectfully request:
(a) That the Court determine that Teva has infringed, is infringing, or will
infringe, one or more claims of United States Patent No. 7,575,886;
(b) That the Court determine that Teva has infringed, is infringing, or will
infringe, one or more claims of United States Patent No. 7,790,466;
(c) That the Court enter a preliminary injunction restraining Teva, its officers,
agents, attorneys, servants, employees, and all persons in active concert or
participation with them, from selling, offering to sell, or importing into the
United States an enoxaparin product made using a method that infringes
one or more claims of either United States Patent No. 7,575,886 or U.S.
Patent No. 7,790,466;
(d) That the Court enter a permanent injunction precluding Teva, its officers,
agents, attorneys, servants, employees, and all persons in active concert or
participation with them, from selling, offering to sell, or importing into the
United States an enoxaparin product made using a method that infringes
one or more claims of either United States Patent No. 7,575,886 or U.S.
Patent No. 7,790,466;
(e) That the Court determine the amount of damage caused to Momenta and
Sandoz by Teva’s infringing conduct and enter judgment for Momenta and
Sandoz in the amount of their damages, plus interest and the costs of this
action;
(f) That the Court determine that Teva’s infringement has been willful and
deliberate and award up to treble damages to Momenta and Sandoz
pursuant to 35 U.S.C. § 284;
(g) That the Court determine that this case is exceptional, within the meaning
of 35 U.S.C. § 285, and order Teva to pay plaintiffs’ reasonable attorneys’
fees pursuant to 35 U.S.C. § 285; and
(h) That the Court grant such other and further relief as it deems appropriate.<<
I didn't think Momenta could do this before Teva got approval and launched. Shows what I know. Perhaps we'll eventually find out what T-enox is: if Lupenox, Momenta might lose the suit, but Teva will never get it approved. If something closer to what m_enox is, then Teva might actually be infringing. I like it.
Cheers, Tuck |
