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PTAB provides two step road map for securing companion diagnostic and other biomarker-based patents.

PTAB reverses Examiner’s decision that intrathecal dose would have been arrived at by “routine optimization”

PTAB reverses obviousness rejection based on unpredictable results from site of deuteration

PTAB reverses Examiner’s finding of obviousness based on evidence distinguishing claimed insomnia population from insomnia population in the prior art.

Rosy predictions of cancer drug’s efficacy in a general review article did not impart reasonable expectation of success without data supporting the predictions.

Pharmacokinetic / dissolution claims save sustained release combination of naltrexone and bupropion from generic challenge.

Federal Circuit reversed district court decision to dismiss patent lawsuit at pleadings stage because dose adjustment required by claims was concrete application of natural law.

FDA clarifies requirements to be listed as the active ingredient in a drug product.

When will a preamble to a claimed method of treatment be given limiting effect? The answer might surprise you.

American patent rules seem to foreclose additional patent protection for new stereoisomers, while European patent rules offer some margin of hope.