Interesting Battle Developing In Zetia® Patent Litigation

For quite a while now, I have been covering Glenmark Pharmaceuticals' efforts to bring a generic version of Zetia^® (ezetimibe) to the United States market.

Old Schering-Plough -- now New Merck -- has sued Glenmark to prevent that from happening, alleging patent infringement. However, the automatic 30-month stay period for an "at risk" generic launch expired in October 2009. So an at-risk Glenmark generic launch could occur at any time, now. Meanwhile, the final pretrial conference in the lawsuit has been dialed forward -- to early March 2010.

In any event, in the litigation proper, Glenmark has argued rather forcefully that the Zetia patents fail for two reasons -- first, the claimed-inventions are obvious (and thus not patentable, at all), and second they suffer from a fatal defect called double-patenting -- essentially an attempt to twice patent the same invention, and thus unfairly extend the life of the patent exclusivity.

This lawsuit will likely be scheduled for a trial date in late March 2010. Just today, Glenmark drove home the two reasons it ought to prevail, in a pre-trial brief, designed to keep New Merck from even putting on evidence of what Glenmark asserts is a carnival-barkers' "side-show" about the supposed-benefits of Zetia (as a largely irrelevant proof of its patentability, in this context):

. . . .Additionally, much like [in the] Merck and Sanofi [case-law opinion], there is a blocking position for Schering in this analysis that negates any probative value of this evidence. At the time that anyone outside of Schering would have first had access to the ‘365 invention, Schering had already developed the ezetimibe drug and filed a patent application for it (eventually maturing into the ‘721 Patent).

Any evidence of economic and motivational factors is rendered useless in this context. It simply cannot be presumed that the claimed subject matter in the ‘721 Patent would have been brought to the market sooner had it been obvious over the process claims of the ‘365 Patent. This is because the public did not learn of the ‘365 Patent until after the subject matter claimed in the ‘721 Patent had been developed. The public could not have been motivated to alter or otherwise use the process claimed in the ‘365 Patent to make ezetimibe or the other compounds claimed in the ‘721 Patent because these compounds had already been made, and a patent application filed on them.

Rule 403 directs courts to exclude evidence "if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues. . . or by consideration of undue delay, waste of time, or needless presentation of cumulative evidence." Fed. R. Evid. 403.

Here, Schering seeks to hold a separate trial on the greatness of its ezetimibe products which calls for testimony from three expert witnesses and a fact witness, which could cost the parties and the Court several days in the courtroom and substantial legal and expert fees. This waste of time and resources would all be to present evidence lacking any probative value. Rule 403 exists to prevent exactly this type of side show. . . .

Stay-tuned -- I'll keep you informed, right here. The case is Schering-Plough, et al. v. Glenmark Pharmaceuticals (Case No. 07-1334, U.S. Dist. Ct. NJ).