lead compound : CAFC Alert

Post-filing recognition of a drug compound’s unexpected property may not be sufficient to establish the compound’s nonobviousness.

| July 24, 2014

Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA, Inc.

June 12, 2014

Summary

The Federal Circuit found that a patent claim directed to a drug compound for treating hepatitis B was invalid as an obvious modification to a structurally similar lead compound. In so finding, the Federal Circuit dismissed evidence of later discovery, after the time of invention, that the lead compound was highly toxic and therapeutically useless. The Federal Circuit then determined that evidence of the drug compound’s later-discovered unexpected lack of toxicity was insufficient to prove nonobviousness, despite additional evidence demonstrating the drug compound’s unexpectedly high potency and unexpectedly high barrier to resistance. The Federal Circuit’s decision may have taken some bite out of the court’s precedents that an invention’s properties and advantagesneed not be fully known as of the filing date of the patent application to be relevant to nonobviousness.


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