The patent challenge trial for Eli Lilly's Prozac is expected to run for two weeks after pre-trial rulings limited the issues Barr could bring against Lilly.

The trial, scheduled to begin Jan. 25 in Indianapolis federal court, was originally projected to last four to six weeks. Barr's case will proceed on the issues of anticipation and inequitable conduct, Judge Sarah Barker determined Jan. 12.

The inequitable conduct claim, concerning the requirement that patent holders disclose all relevant material without including any misleading information, is expected to be taken up first. A judge is required to decide the issue. Barr had also requested an advisory jury but was denied. The anticipation claim relates to Lilly's 2003 patent for the drug and will be heard by a jury. Lilly had attempted to strike Barr's jury demand.

The judge dismissed Barr's claims on best mode - that patent holders must disclose the best means of producing a product - and double patenting. The company can appeal after the completion of the trial. The best mode issue involves allegations of Lilly's "nondisclosure of methods of making the commercially available starting material p-trifluoromethylphenol," according to the court docket, as well as "nondisclosure of a recrystallization solvent for fluoxetine."

Lilly's motion to consolidate the case with recently filed cases involving Teva Pharmaceuticals and Zenith-Goldline (who are challenging the 2003 patent) was denied. The case against Geneva has been combined with Barr's case. Lilly's motion for a separate trial on each Prozac patent was also denied.

Lilly is being represented by Barnes & Thornburg, Indianapolis, and Barr is represented by Winston & Strawn, Chicago. The ruling is under seal because of the proprietary information it contains, and parties are prohibited from discussing the facts of the case.

Lilly's patents for fluoxetine expire in 2001 and 2003, and the company is banking on holding off generic competition on its flagship antidepressant while it develops a single isomer version of the drug with Sepracor ("The Pink Sheet" Dec. 14, 1998, p. 13). Barr filed an ANDA for fluoxetine in December 1995, and Lilly filed suit in April 1996.

Prozac Patent Challenge Trial To Last Two Weeks After Rulings Reduce Scope

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