The opinion of the court was delivered by: Pisano, District Judge.
This is a patent infringement action brought by plaintiffs Taro Pharmaceuticals North America, Inc., and Taro Pharmaceutical U.S.A. (together, "Taro" or "Plaintiffs"), Inc. against defendants Suven Life Sciences, Ltd. and Suven Life Sciences USA, LLC ("Suven USA" or "Defendant").*fn1 Presently before the Court is Taro's motion pursuant to Federal Rules of Civil Procedure 12(b)(6) and 12(f) to dismiss Suven USA's inequitable conduct counterclaims (Counterclaims V and VI) and strike Suven USA's inequitable conduct affirmative defenses (fifth and sixth affirmative defenses). The Court decides the motion without oral argument pursuant to Federal Rule of Civil Procedure 78. For the reasons below, Taro's motion is granted.
Taro holds approved New Drug Application ("NDA") No. 18-613 for malathion lotion, 0.5%, a pharmaceutical topical preparation which is marketed under the brand name Ovide. Ovide is approved by the Food and Drug Administration for the treatment of head lice. In early 2011, Suven USA submitted to the United States Food and Drug Administration ("FDA") abbreviated new drug application ("ANDA") No. 091559 seeking approval to engage in the commercial manufacture, use, or sale of a generic malathion lotion, 0.5%.
Taro brings the instant suit alleging that by filing its ANDA, Suven USA has infringed two of Taro's patents, United States Patent No. 7,560,445 (the "'445 patent") and United States Patent No. 7,977,324 (the "'324 patent"), both of which are entitled "Process for Preparing Malathion for Pharmaceutical Use." See Amended Complaint ("Compl")., Ex. A and Ex. B. The '445 patent covers methods of making highly pure malathion, and the '324 covers the purified formulation of malathion. Highly pure malathion is desirable because malathion's impurities are highly toxic to humans. Counterclaim ¶ 12.
In this action, Suven USA has asserted, inter alia, counterclaims and affirmative defenses alleging that the patents-in-suit are unenforceable based on inequitable conduct. Specifically, Suven USA alleges that Taro concealed and/or misrepresented material information in submissions to the Patent Office during prosecution.
According to Suven USA's counterclaim, malathion was first used as a pesticide in the 1950s. Counterclaim ¶ 8. In 1982, the FDA approved malathion for use in topical pharmaceutical compositions for the treatment of lice infestations. Id. ¶ 9. Since then, various companies have sold malathion lotion 0.5% under the brand name Ovide. Id. ¶ 10.
Taro obtained the exclusive right to market Ovide in 2003 from Medicis Pharmaceutical Corporation ("Medicis"). Id. ¶ 11.
Malathion's impurities, particularly isomalathion, are highly toxic. Consequently, even non-pharmaceutical grade malathion used in pesticides is 96% pure. Id. ¶ 14. Pharmaceutical-grade malathion, such as that found in Ovide, have a much higher purity. Id. Taro, and Medicis before it, obtained the malathion active pharmaceutical ingredient used in Ovide products from Cheminova A/S ("Cheminova"). Id. ¶ 12. According to Certificates of Analysis from Cheminova, stability test results, and product specifications contained in the prosecution history for the '445 patent (and submitted in the '324 patent prosecution history), the malathion produced by Cheminova and used in Ovide beginning in the late 1990s was of very high purity. Id. at ¶ 15, 16.
B. Prosecution of the '445 and '324 Patents
In 2006, U.S. Patent Application No. 11/427,863 (the "'863 application") was filed, which later issued as the '445 patent. Id. ¶ 17. In 2009, U.S. Patent Application No. 12/353,691 (the "'691 application") was filed as a continuation of the '863 application. The '691 application later issued as the '324 patent. Id. ¶ 62.
As noted above, the '445 patent covers methods of making highly pure malathion, and the '324 covers the purified formulation of malathion. In support of the patentability of the methods and compositions claimed, the ...