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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.

Federal Circuit rules that eligibility for drug / diagnostic patent turns on distinction between manipulative steps and mental steps.

Patent claiming dose reduction for poor metabolizers affirmed at Federal Circuit.

Capital gains treatment is available only if the royalties are paid as consideration for all substantial rights to a patent.

Rejection of methyl homolog as prima facie obvious over old compound reversed under lead compound analysis.

Japanese patent laws allow applicants to extend patent protection an additional 18 months by following a simple filing sequence. 

Drug maker’s decision to list auto-injector patent was not unreasonable when FDA had declined to answer seven industry letters asking whether a drug delivery device patent could be listed in Orange Book.

Publication of clinical protocol on ClinicalTrials.gov might anticipate the underlying method of treatment, but not render the method of treatment obvious.