Indianapolis, Indiana – Patent lawyers for Alcon Research, Ltd. and Alcon Laboratories, Inc., both of Fort Worth, TX, Alcon Pharmaceuticals, Ltd. of Fribourg, Switzerland, and Kyowa Hakko Kirin Co., Ltd. of Tokyo, Japan, filed a patent infringement suit alleging Sandoz Inc. of Princeton, NJ, has infringed, and will infringe, the following three patents, as issued by the U.S. Patent Office: Patent No. 5,641,805, titled TOPICAL OPHTHALMIC FORMULATIONS FOR TREATING ALLERGIC EYE DISEASES; Patent No. 6,995,186, titled OLOPATADINE FORMULATIONS FOR TOPICAL ADMINISTRATION; and Patent No. 7,402,609, titled OLOPATADINE FORMULATIONS FOR TOPICAL ADMINISTRATION.
The defendant allegedly submitted Abbreviated New Drug Application (“ANDA”) No. 200410 to the FDA, seeking permission to market a generic version of the plaintiffs’ PATADAY(R) topical ophthalmic solution. The ANDA filing apparently claimed a certification that the three asserted patents are invalid, unenforceable, and/or would not be infringed by the generic version of the drug. In their complaint, the plaintiffs allege that the ANDA filing itself is an act of infringement and the defendants’ proposed use of their generic drug prior to the patents’ expiration would be an infringement. Among other things, the plaintiffs seek a judgment of infringement, an order that the effective date of FDA approval for the generic drug may not be earlier that the expiration date of the ‘805 patent, and an injunction.
Practice Tip: It is possible for a generic drug developer to obtain a patent on its formulation, but not on the active ingredients, which must be the same as that in the original drug.Complaint – Alcon v. Sandoz
Further information about this case is as follows:
Filed: January 27, 2010 as 1:2010cv00106 Updated: March 24, 2010 14:26:23
Referring Judge:Magistrate Judge Debra McVicker Lynch
Cause Of Action: Patent Infringement