Claiming Metabolites: Federal Circuit Poses New Challenges to Patent Applicants

After they are administered, or taken by the patient, many drugs are converted into other chemical compounds or other physical forms, as the drugs are processed within the body of the patient. Often these compounds, known as metabolites, are the "active ingredient" that is responsible for the desired result, such as lowering blood pressure or cholesterol levels. The Court of Appeals for the Federal Circuit has also long recognized this effect and has held that the ingested form of a drug or its "metabolites" can be patented. Thus, an optimal patent strategy would require an inventor to patent both the pre-ingested form of the drug and its new physical forms or metabolites, as formed in the body ("<i>in vivo</i>"). However, the <i>in vivo</i> fate of the drug may not be learned until long after the "parent" drug has been tested and patented.

13 minute read September 09, 2004 at 02:29 PM

By

Warren D. Woessner, Ph.d.