First-to-invent versus first-to-file: impact of the AIA.

On March 16, 2013, the USPTO switched from a 'first-to-invent' to a 'first-to-file' patent system. Under the 2011 America Invents Act, patents will be awarded to the first inventor to file a patent application as opposed to the date of invention. Now, over a year since the main provisions of the America Invents Act (AIA) came into effect, Pharmaceutical Patent Analyst has invited a selection of IP specialists and researchers from the US to discuss the implications of this new law and how it will affect future pharmaceutical and medical R&D. Interview conducted by Alexandra Sklan, Commissioning Editor.

How personalized medicine is changing the rules of drug life exclusivity.

Personalized medicine is premised on the notion that diagnostic techniques can improve safety or effectiveness of pharmaceutical therapies based upon individual genetic or proteomic make-ups. This article explains how diagnostic techniques and pharmaceutical therapies interact during the US Food & Drug Administration's approval of branded and generic drugs in the US, and how the same labeling requirement for generic drugs of the Hatch-Waxman Act can prevent generic drugs from entering the market when proprietary pharmacogenomic techniques are incorporated into the labeling of a branded drug.