The patent held for Zyprexa had been challenged by generics manufacturers Dr Reddy’s, Ivax Corp and Teva Pharmaceuticals. The ruling to uphold Lilly’s intellectual property, made in a US district court in Indiana, ensures that the Zyprexa will continue to enjoy patent protection until 2011.
The court ruled in favor of Lilly on all counts in the case, including the patent doctrines of obviousness, double patenting, inequitable conduct, novelty, and public use. This ruling had been generally anticipated, although delays in the judge’s decision had cast some doubt over the potential outcome in recent months.
Generating sales of $4.4 billion last year, Zyprexa represents more than one-third of Lilly’s annual revenue. The drug, which is the leading atypical antipsychotic on the market, was initially launched to treat schizophrenia, but has since gained approval in acute bipolar mania and bipolar maintenance.
While the decision provided a massive boost to Lilly, the global pharmaceutical industry is also likely to benefit. Invalidation of the Zyprexa patent could have had significant implications for other patent battles.