Janssen Wins Trial Verdict in Risperdal Case Against Mylan and Dr. Reddy's
Janssen Pharmaceutica, a division of Johnson & Johnson, won its patent infringement case against Mylan and Dr. Reddy's over generic Risperdal (risperidone), an antipsychotic medication with worldwide sales of $3 billion annually. Judge John C. Liflind of the U.S. District Court for the District of New Jersey held a four-day bench trial in June, and decided the case last week.
Judge Lifland's 79-page Opinion (part 1; part 2) held that Janssen's U.S. Patent No. 4,804,663 is not invalid as obvious. Mylan and Dr. Reddy's argued that the invention in the '663 patent, the claims of which cover both risperidone and "compound 11" (in Markush group form), would have been obvious. More specifically, the defendants argued that the claimed invention would have been obvious because compound 11 (though not risperidone) would have been obvious in view of the drug pirenperone, which is covered by U.S. Patent No. 4,342,870. The compounds are structurally similar: where risperidone has a ketone group, pirenperone has a benzisoxazole group.
Judge Lifland summarized the defendants' obviousness argument as follows:
First, Defendants claim that pirenperone would have been chosen as a lead compound by one looking for an antipsychotic with minimal side effects, including EPS, because it possessed indicators of those properties. Second, Defendants claim that once pirenperone was chosen, it would have been obvious to the person of ordinary skill in 1985 that its only problem was that it had a short half-life, and thus had to be administered to patients three times per day, which was a problem for schizophrenics. Third, given the prior art, Mylan and DRL believe it then would have been obvious that pirenperone's ketone group was responsible for this durational problem. Fourth, it then would have been obvious, Defendants assert, to the person of ordinary skill that the solution to this problem was to convert the ketone group to benzisoxazole, and that this change would permit the compound to retain its desired antipsychotic activity with low side effects.
The court found that the defendants failed to prove that any one of those steps would have been obvious. In particular, Judge Lifland found that one of ordinary skill in the art would not have chosen pirenperone as the lead compound because there was no teaching, suggestion, or motivation to do so. In fact, the court found evidence that defendants' experts admitted to using hindsight when they testified that pirenperone would have been selected as the lead compound.
Mylan (but not Dr. Reddy's) also argued that the '663 patent is unenforceable due to inequitable conduct, but that argument failed as well. The court found that Mylan failed to prove both materiality and intent to deceive.
Judge Lifland's Order enjoins Mylan and Dr. Reddy's from marketing their generic versions of Risperdal until the '663 patent expires, on December 29, 2007.
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