Patent tactics in molecular diversity: Things that get around,come around (Or: There are always exceptions to the rule)

Certain activities which would constitute infringement of a U.S. patent can come within a statutory exemption when the activity is carried out to obtain FDA approval. Exemptions to infringement provided by 35 U.S.C. §271(e)(1) are discussed along with recent cases interpreting this statute. The evolution of the statute in providing an exemption to activities necessary to obtain FDA marketing approval is described to provide background, legislative intent and show a comparative of the law before and after 1984 when 271(e)(1) was enacted. By analyzing recent cases, criteria for qualifying an activity as exempt from infringement are described – as are activities that do not qualify for the 271(e)(1) exemption. Overall there appears to be a trend to more broadly allowing for activities to qualify as exempt from infringement. This trend may affect the value of patents and determine which technologies a company will seek patent protection on.