Lilly Wins Appeal Protecting Attention-Deficit Disorder Drug Patent

Washington, D.C. – Indianapolis-based Eli Lilly & Co. won a lawsuit against seven other pharmaceutical companies that sought FDA approval to sell competing drugs that would have utilized Lilly’s patented drug formula. The seven defendants, Actavis Elizabeth LLC, Sun Pharmaceuticals, Sandoz Inc., Mylan Pharmaceuticals, Apotex Inc., Aurobindo Pharma Ltd., and Teva Pharmaceuticals, had filed an Abbreviated New Drug Application (ANDA) seeking to utilize Lilly’s patented formula and claiming invalidity of Lilly’s patent, No. 5,658,590, Treatment of attention-deficit/hyperactivity disorder, which has been issued by the US Patent Office. The patented drug is marketed under the name Strattera and is used to treat Attention-Deficit Disorder.

Upon the filing of the ADNA, Lilly’s patent attorneys immediately filed this patent infringement lawsuit in the United States District Court of New Jersey. The district court sustained the ‘590 patent against the defendants’ challenges on the grounds of inequitable conduct, anticipation, obviousness, and non-enablement. However, the court held the claims invalid for lack of utility, which the court called “enablement/utility.” The Federal Circuit Court went further in protecting Lilly’s patent and upheld the patent in its entirety. The ruling ensures that Lilly’s patent will be fully enforceable through its expiration in 2017.

According to the Indianapolis Business Journal, the drug generated $577 million in sales for Lilly last year.

The case is Eli Lilly & Co. v. Actavis Elizabeth LLC et al, Case No. 2010-1500 in the Court of Appeals for the Federal Circuit, decided July 29, 2011. The opinion notes it is “nonprecedential.”

Opinion