Abstract
The America Invents Act (“AIA”) was signed into law in September 2011 although it will not be fully implemented until March 2013. This law enacts the most comprehensive changes to the American Patent System since the enactment of the 1952 Patent Act. Taking into account that the United States is the largest pharmaceutical market in the world, this new law promises to have a direct effect on generic companies selling in this market.
The AIA will obviously have a significant impact on originator companies by requiring them, for instance, to adjust to a “first inventor to file” system instead of the previous “first to invent” system. It will also have a significant impact on the generic pharmaceutical industry that will likewise need to adjust to the new law and make critical strategic decisions. For instance, the AIA will allow patent validity challenges through post-grant review in the U.S. Patent and Trademark Office although use of such a process will limit subsequent validity challenges.
Generic companies selling in the United States will need to understand the contours of the new law in order to make reasoned decisions regarding how to best challenge the validity or enforceability of a patent.
Due to the importance of the AIA for the generic industry, we have included two articles in this issue. One provides a general review of aspects of the AIA that generic companies should be familiar with, and the other provides a more in-depth discussion of post-grant review, which is one of the new aspects of the AIA. The articles present complementary reviews and strategic analyses of the new law to help generic companies in their transition to the new legal framework.