The first-to-file provisions of the American Invents Act (AIA) take effect on March 16, 2013. Medical device companies have much at stake and are taking precautions now to prepare for this significant change in America’s patent system. Under the first-to-file rules, any patent application filed after March 16, 2013 containing even a single claim with a priority date of March 16, 2013 or later will fall under the first-to-file rules.
While there are many elements of these rules to be considered, one of the most critical is that the new first-to-file rules expand the amount of foreign prior art that is available to a patent examiner to reject a patent application. Claims of a patent application covered by the first-to-file rules can be rejected based on the additional foreign prior art, while this same art would not be available in rejecting the same claims of a patent application covered by the old first-to-invent rules. Medical device companies, therefore, may want to avoid the first-to-file rules for as long as possible to minimize exposure to the expanded universe of foreign prior art they make available to examiners.
To avoid the expanded breadth of foreign prior art under the first-to-file rules of the AIA, medical device companies can review invention disclosures and confer with inventors to identify inventions that can be described in patent applications filed prior to March 16, 2013. Time is of the essence. Once an application falls under the first-to-file system, only filing as early as possible will stop the growth of foreign prior art that will be available under the first-to-file system.
Under the old first-to-invent system, a PCT application that published in English and designated the United States could be used as prior art as of the PCT application filing date, even if it claimed priority to an earlier foreign patent application. The filing date of the foreign application was ignored for prior art purposes. In addition, because the statute required an English publication of the PCT application for it to be used as prior art, the PCT application was guaranteed to publish in English eighteen months from the earliest priority date. Unlike the date that a PCT application can be used as prior art, the earliest priority date takes into account any priority foreign applications. Accordingly, the PCT application would publish in English eighteen months after a priority foreign application was filed. Figure 1 represents the old first-to-invent rules for a PCT application claiming priority to a foreign application.
|Figure 1: The old first-to-invent rules will change on March 16, 2013.|
The new first-to-file rules expand the number of PCT applications that qualify as prior art for any application. PCT applications are no longer required to be published in English. Accordingly, a PCT application not published in English may take an additional twelve months to become readily available in English when a U.S. national stage application is filed, which requires an English translation. If a U.S. national stage application is not filed, an English version of the PCT application may not be readily available at all. Applications without an English translation may have less impact during prosecution of other applications because they are likely not to be found by a patent examiner. These applications, however, may prove valuable to a challenger of a first-to-file patent.
Another significant change is in regard to the prior art date afforded to PCT applications. The date a PCT application qualifies as prior art under the first-to-file rules will be the earliest effective filing date of the PCT application. The earliest effective filing date takes into account the filing date of any priority foreign application. For example, a PCT application claiming priority to a foreign application will be available as prior art as of the filing date of the foreign application, not the PCT filing date. PCT applications may therefore be available as prior art as much as twelve months earlier than under the old first-to-invent rules. Figure 2 highlights the changes to prior art date for PCT applications under the first-to-file rules.
|FIgure 2: Changes to prior art date reveal the serious stake medical device companies have in understanding the new rules.|
To eschew the expanded foreign prior art available under the first-to-file rules, medical device companies should take action now to ensure that any application are filed before the March 16, 2013. Filing patent applications prior to March 16, 2013 is the only way to avoid the expanded foreign prior art. After the March 16, 2013 date, medical device companies should strive to file applications as quickly as possible to halt the growth of available prior art.
Troy Smith is an associate with Foley & Lardner LLP and is a member of the firm’s Electronics Practice and the Emerging Technologies Industry Team. Smith has extensive experience in the areas of computer software and engineering. He was a senior software architect at CaseKnowledge, a founder and vice president of technology at Revisto, and a senior software engineer at Shoptalk and Motorola. Smith is also a registered patent agent. He received his law degree from Northwestern University School of Law and his master’s in computer science, with distinction, from DePaul University.
Michael Rechtin is a partner with Foley & Lardner LLP and a member of the firm's Mechanical & Electromechanical Technologies and Chemical, Biotechnology & Pharmaceutical Practices. Rechtin's technical background and training encompasses physics, chemistry, mechanical engineering, and biotechnology. He is also a member of the Emerging Technologies, Energy, and Nanotechnology Industry Teams. Rechtin graduated from Illinois Institute of Technology Chicago Kent College of Law and holds a PhD in solid-state science and materials science from Massachusetts Institute of Technology. He also was an IBM post-doctoral fellow at MIT.