This is the updated complaint: I started where they left off!
On June 18, 2014, Plaintiff notified Defendants that it intended to file this case asa new action and dismiss the First Action in an effort to expedite the progress of this litigation on
the merits.
26. On information and belief, Omthera and AstraZeneca, working in concert, are currently making substantial preparations to commercially launch Epanova™ in the United
States, including in this judicial district.
Case 1:14-cv-00791-UNA Document 1 Filed 06/20/14 Page 4 of 10 PageID #: 45
27. Defendants have launched a website, www.epanovahcp.com, which is dedicated to the promotion of Epanova™. On the website, Defendants advertise Epanova™,
display the FDA-approved label for Epanova™ and provide prescribing information for Epanova™.
28. Omthera notes on its website, excerpts of which are attached hereto as Exhibit C, that “We expect to build a U.S.-based sales and marketing infrastructure to support a launch of Epanova in patients with severe hypertriglyceridemia and anticipate to initially target specialists, cardiologists and primary care physicians who are the top prescribers of lipid regulating
therapies.” [Ex. C.]
29. Omthera also states on its website that it will seek additional indications for Epanova “n addition to commercially launching Epanova in the severe hypertriglyceridemia indication.” [Ex. C.]
COUNT I
(Declaratory Judgment of Infringement
of the ’662 Patent under 35 U.S.C. § 271(b) and (c))
30. Paragraphs 1 to 29 are incorporated herein as set forth above.
31. The commercial manufacture, sale, offer for sale, and/or importation of Epanova™ will induce the direct infringement of at least claim 1 of the ’662 patent under 35 U.S.C. § 271(b).
32. Defendants have had actual knowledge of the ’662 patent since at least March 4, 2014, the date that Plaintiff filed the First Action.
33. The use of Epanova™ by patients and/or doctors will directly infringe at least claim 1 of the ’662 patent.
Case 1:14-cv-00791-UNA Document 1 Filed 06/20/14 Page 5 of 10 PageID #: 56
34. Defendants will encourage the direct infringement of at least claim 1 of the ’662 patent by and through the commercial manufacture, sale, offer for sale, and/or importation of Epanova™.
35. On information and belief, Defendants know or should know that their commercial manufacture, sale, offer for sale, and/or importation of Epanova™ will actively induce direct infringement of at least claim 1 of the ’662 patent.
36. At a minimum, the approved label for Epanova™ indicates that Epanova™ is “as an adjunct to diet to reduce triglyceride levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia. ” A copy of the approved label for Epanova™ is attached to this
Complaint as Exhibit D.
37. The approved label for Epanova™ further encourages doctors that “the dosage of Epanova™ is 2 grams (2 capsules) or 4 grams (4 capsules) once daily. Individualize therapy according to patient response and tolerability.”
38. The approved label for Epanova™ further encourages patients to “[t]ake Epanova™ exactly as your doctor tells you to take it.”
39. The approved label for Epanova™ further cites clinical studies which indicate that treatment with Epanova™ in individuals with severe hypertriglyceridemia led to “increased
LDL-C levels” that were 13 percent higher than a placebo group for the 2 gram dose, and 15 percent higher than a placebo group for the 4-gram dose.
40. Defendants’ inducing acts, including those described in Paragraphs 36 through 39, are done with knowledge of the ’662 patent, with the intent to encourage infringement, and with
the knowledge that patients administering Epanova™ will directly infringe the ’662 Patent.Case 1:14-cv-00791-UNA Document 1 Filed 06/20/14 Page 6 of 10 PageID #: 67
41. Upon information and belief, patients will follow the label instructions provided by Omthera, and taking Epanova™ per the label instructions will result in the patients directly
infringing the ’662 Patent.
42. The commercial manufacture, sale, offer for sale, and/or importation of Epanova™ will contribute to the direct infringement of at least claim 1 of the ’662 patent under
35 U.S.C § 271(c).
43. On information and belief, Defendants know or should know Epanova™ is especially made or especially adapted for use in an infringement of the ’662 patent, and is not a staple article or commodity of commerce suitable for substantial non-infringing use.
44. Upon information and belief, there are no substantial noninfringing uses for Epanova™. At a minimum, the label for Epanova™ states that Epanova™ is indicated “as an adjunct to diet to reduce triglyceride levels in adult patients with severe (= 500 mg/dL)hypertriglyceridemia.” There are no indications for other patient populations.
45. The approved label for Epanova™ further cites clinical studies which indicate that treatment with Epanova™ in individuals with severe hypertriglyceridemia led to “increased
LDL-C levels” that were 13 percent higher than a placebo group for the 2 gram dose, and 15 percent higher than a placebo group for the 4-gram dose. On the approved label for Epanova™, there are no clinical studies cited for patients in which there was an increase of LDL-C levels of more than 20 percent against a placebo group.
46. On information and belief, Defendants know or should know that their offer for sale, sale and/or importation of Epanova™ will contribute to the direct infringement of the ’662
patent.
Case 1:14-cv-00791-UNA Document 1 Filed 06/20/14 Page 7 of 10 PageID #: 78
47. Plaintiff is entitled to a declaratory judgment that future commercial manufacture, offer for sale, sale, and/or importation of Epanova™ by Defendants will induce and/or contribute to infringement of the ’662 patent under 35 U.S.C. §§ 271(b) and (c).
48. The commercial manufacture, offer for sale, sale and/or importation of Epanova™ in violation of Plaintiff’s patent rights will cause harm to Plaintiff for which damages are inadequate.
49. Unless Defendants are enjoined from actively inducing and contributing to the infringement of the ’662 patent, sales of Epanova™ by Defendants will cause Plaintiff irreparable injury for which damages are an inadequate remedy.
PRAYER FOR RELIEF
Plaintiff respectfully prays for the following relief:
(1) That this Court issue a declaration under 28 U.S.C. § 2201 that if Defendants, their officers, agents, servants, employees, licensees, representatives, and attorneys, and all other
persons acting or attempting to act in active concert or participation with them or acting on their behalf engage in the commercial manufacture, offer for sale, sale and/or importation of
Epanova™, it will constitute infringement of the ’662 patent under 35 U.S.C. §§ 271(b) and (c);
(2) That this Court enter judgment that Defendants’ manufacture, use, offer for sale and/or importation of Epanova™ infringes the ’662 Patent under 35 U.S.C. §§ 271(b) and (c);(3) That following the launch of Epanova™, this Court enter judgment against
Defendants for money damages under 35 U.S.C. § 287 sustained as a result of Defendants’ infringement of the ’662 Patent and order an accounting of any infringing sales not presented at trial and an award of any additional damages for any such infringing acts;
Case 1:14-cv-00791-UNA Document 1 Filed 06/20/14 Page 8 of 10 PageID #: 89
(4) That this Count find that this is an exceptional case under 35 U.S.C. § 285, and that Plaintiff be awarded its reasonable attorneys’ fees and costs;
(5) That this Court award such other and further relief as it may deem just and proper.
JURY DEMAND
Pursuant to Federal Rule of Civil Procedure 38(b), Plaintiff hereby requests a trial by jury on all issues so triable.
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