Since the passage of the America Invents Act in 2011, various changes to the patent litigation landscape have occurred. Perhaps the largest changes are a result of post-grant proceedings, including inter partes review (IPR), covered business method review (CBM) and post-grant review (PGR). These proceedings created an alternate forum and system for challenging the validity of issued U.S. patents. Their immediate effects were felt in places such as the Internet, software and electronics industries. However, these proceedings are also having a growing impact on life sciences litigation, particularly Hatch-Waxman litigation. It is very important for all companies involved in the pharmaceutical industry to keep in mind the impact of these post-grant proceedings when formulating their intellectual property strategies.

In Hatch-Waxman litigation, pharmaceutical companies are able to protect their branded drug products by initiating litigation prior to FDA approval of a generic drug. In this way, it is possible that patent issues can be resolved prior to the launch of a generic drug and its disruptive impact on the market. Within the bounds of forum and venue limitations, the branded company chooses where to enforce its patents. In district court, the branded company enjoys the presumption of validity mandating the presence of clear and convincing evidence to invalidate its patent. These advantages worked to the favor of the branded drug companies.

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