FDA clarifies requirements to be listed as the active ingredient in a drug product.
January 06, 2019
When will a preamble to a claimed method of treatment be given limiting effect? The answer might surprise you.
November 27, 2018
American patent rules seem to foreclose additional patent protection for new stereoisomers, while European patent rules offer some margin of hope.
June 24, 2018
Federal Circuit rules that eligibility for drug / diagnostic patent turns on distinction between manipulative steps and mental steps.
May 22, 2018
Patent claiming dose reduction for poor metabolizers affirmed at Federal Circuit.
April 22, 2018
Capital gains treatment is available only if the royalties are paid as consideration for all substantial rights to a patent.
April 03, 2018
Rejection of methyl homolog as prima facie obvious over old compound reversed under lead compound analysis.
February 27, 2018
Japanese patent laws allow applicants to extend patent protection an additional 18 months by following a simple filing sequence.
February 05, 2018
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.
January 23, 2018
Publication of clinical protocol on ClinicalTrials.gov might anticipate the underlying method of treatment, but not render the method of treatment obvious.
December 19, 2017