- Posted in Legal, Clinical & Regulatory | June 06, 2013 | Comments (0)
- Tags: intellectual property, government regulation, medical device innovation
- By: John W. Boger and Kristian E. Ziegler
On March 16, 2013, the final two critical provisions of the patent reform law, The Leahy-Smith America Invents Act, went into effect. The first was the implementation of derivation proceedings, which would be applicable to any application that was filed on or after March 16, 2013. The second, and the most significant reform to the U.S. patent law system in nearly 60 years, was conversion from a “first-to-invent” to a “first-inventor-to-file” (FITF) system.
The new law under the FITF system has many uncertain twists and turns because of the changes to how prior art may be used against you when filing a patent application. Much of the uncertainty lies in how courts will interpret the new language that is contained in the revised law.
Briefly, the FITF system now includes:
- Providing a one-year grace period for inventors to safeguard patent rights against disclosures made by inventors and, in limited scenarios, by third parties;
- A redefinition of prior art to include public uses, sales, offers for sale and other public activity without geographic limitations of the invention if done before the inventor’s effective filing date;
- Further changes to what qualifies as prior art to include U.S. patents and patent application publications, as well as PCT (International) publications designating the U.S. (in any language) if the effective filing date for these predates the inventor’s effective filing date; and
- Allowing common ownership and joint research agreements to overcome obviousness (§103) and anticipation (§102) rejections.
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First-Inventor-to-File System Some opponents of the FITF system believe the system incentivizes inventors to race to the USPTO to protect as many of their ideas as soon as possible. They identify independent inventors, startups and small businesses as those potentially most harmed by such a system because they lack the resources to compete with large corporations in such a filing race. Other commenters share a different concern and contend that the FITF system harms inventors who work in collaborative environments, publish in journals and present at conferences before filing patent applications. These opponents identify large corporations and universities as most negatively-affected by the FITF system, because inventors at these institutions typically engage in such activity. Only time will tell which group of critics, if either, are right. |
The Leahy-Smith America Invents Act was signed into law on September 16, 2011 and provided for various provisions to become effective during an 18-month period. Here is a reminder of ten previous provisions that went into effect upon the date of signature of the law and in the year following. The key sections of the law covered: |
