Originally published in Pharmaceutical Outsourcing’s website on December 2012.
Patent law is changing rapidly. The changes are putting even greater pressure on patents as a tool for protecting a pharmaceutical or biotechnology company’s hard-won inventions. The Leahy-Smith America Invents Act (the “AIA”) has made it harder than ever to get a patent, and has also created new ways to challenge patents in the Patent Office before they can be asserted in court. The changes created by the AIA have started to go into effect, with major changes becoming effective in March 2013, and so now is the time to rethink how your company obtains and asserts patents to protect the products and services it has in development and on the shelves.
The AIA switched the United States from a “first to invent” system, to a “first inventor to file” system, to harmonize U.S. law with laws in other countries. As part of that change, the definition of “prior art” (i.e, all existing knowledge that is used to determine whether an invention is sufficiently new and non-obvious to merit a patent) was expanded to include all public uses or sales by third parties, anywhere in the world, that are accessible by the public at any time up until the day the patent application is filed. One example of these potential public uses is a clinical trial that uses the invention and provides information about it to patients and physicians without confidentiality restrictions. Under current law, a one-year grace period applies, so that only third party uses and sales occurring at least one year before the patent application is filed are considered prior art. In addition, under current law, only uses and sales in the United States could be considered prior art. These changes become effective March 16, 2013, for all patent applications filed on or after that date. Patent applications claiming inventions disclosed in an application filed before March 16, 2013, will continue to be judged based on the existing, more narrow definition of prior art.
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