It's the Law

The legal arm of the regulatory profession is fluid and changing. These articles attempt to explain some of the nuances of regulatory law and what should be considered when making decisions.

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1 December 2011

Considerations in View of the New US First-Inventor-to-File Patent System

By Shahnam Sharareh, PharmD, RAC, and Sarah Klosek, MS

The US patent system has a rendezvous with change. On 16 March 2013, it will officially change from a first-to-invent to a first-inventor-to-file system as authorized by the Leahy-Smith America Invents Act.

Under the current first-to-invent system, a patent is awarded to the inventive entity that invents first. In contrast, under a first-inventor-to-file system, a patent is awarded to the inventive entity that is the first one to file a patent application on its own invention.

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