On August 16, 2012, the Federal Circuit again issued an opinion in the well-publicized case of Association for Molecular Pathology v. U.S. Patent and Trademark Office.

With the recent passage of H.R. 1249 by the U.S. House of Representatives, Congress is poised to enact the most sweeping reform of the patent laws since the Patent Act of 1952. A similar version of the "America Invents Act" was passed by the U.S. Senate earlier this year.

Development in the era of personalized medicine depends on invention of assay technologies that predict in a presenting patient the likely development or course of disease, or suggest which drug therapies are likely to be an effective treatment.