On 16 September 2011, President Barack Obama signed into law HR1249, the Leahy-Smith America Invents Act , which has been described as the most important change in U.S. patent legislation since 1952, when the structure of modern patent law was established. Given the significance of the changes, we wondered: Are any of them important for scientists -- academic scientists in particular -- who may wish to commercialize the research arising from their labs or the technologies they develop?
We interviewed Erich E. Veitenheimer by e-mail to find out. He is a senior partner in the intellectual property (IP) law firm Cooley LLP. Veitenheimer earned a Ph.D. in plant breeding and genetics, with a minor in statistics, from the University of Wisconsin, Madison and, later, a law degree from Georgetown University in Washington, D.C. The Cooley firm represents Montana State University, New York University, Yale University, the University of Miami, Regents of the University of California, the Howard Hughes Medical Institute, and other academic and non-profit universities and institutions in IP matters. They also handle university intellectual property that has been in-licensed by a large number of small to mid-size companies, particularly in the life sciences, biotechnology, and pharmaceuticals space.
Q: The Leahy-Smith America Invents Act (AIA) has been called the biggest change to U.S. patent law in 60 years. Please explain the changes most important to academic scientists who may wish to commercialize their science.
Next, the new law creates a "micro-entity" status that will result in lower patenting fees on qualifying individuals and academic institutions. While this provision was due to be effective upon enactment (16 September 2011), the U.S. Patent & Trademark Office has up to 18 months to develop the regulations to identify exactly which fees will be eligible for the reduction. The U.S. Patent & Trademark Office has issued a timetable that shows they expect to promulgate the regulations by February 2013.
In a third major change, the AIA provides for a new 9-month opening after a patent issues in which any third party may initiate a post-grant review of the patent. This review is somewhat similar to the patent-opposition procedures available in other countries, such as the EPO, and possibly allows for a less costly way of challenging patents than through an
Under the AIA, academic scientists (and others) will now have 6 months from the publication of a patent application (by others) to submit prior art (e.g., disclosures, publications) that they believe the examiner should consider. Previously, this time period was 3 months. In addition, third parties can now provide comments on the relevance of the prior art they submit; no such comments were permitted prior to the AIA. Of course, taking advantage of this option will require becoming aware of the published application before the end of the 6-month window. So it's more important than ever to monitor the databases of published patent applications for patents on work that's similar to yours.
Q: It sounds like the most important change is the change from first-to-invent system to first-inventor-to-file system with a grace period. What are the implications of this change for how academic scientists and their institutions should think about issues such as disclosure?
However, the AIA still allows for such a grace period for disclosures by the inventor himself or herself, a joint inventor, or any third party who obtained the invention from them. So, if you disclose the invention yourself (in a journal article, for example), you then have 12 months to file your patent application, as long as you're the first to describe that invention in a publication.
Some have said that because of this grace period, the new law effectively creates a hybrid “first to file or publish” rule that encourages publication of inventions, particularly by academics. This conclusion appears to be substantiated by the following pre-passage legislative history:
An inventor who publishes his invention retains an absolute right to priority if he files an application within one year of his disclosure. No application effectively filed after his disclosure, and no prior art disclosed after his disclosure, can defeat his patent application. 157 Cong. Rec. 1348, 1365-66 (8 March 2011)
Historically, academic technology transfer offices (TTOs) have trained their academic scientists
Of course, as was also true before the AIA, publishing also eliminates the ability to maintain the invention as a trade secret or proceed in secrecy after filing a patent application and before it publishes as such 18 months later. Another potential problem with publishing first is that often publications are not as complete as a patent application filing would be, so it's not as effective in protecting your IP even in places where there is a grace period.
If there is interest in patenting the invention in countries without an applicable grace period, then an application should be filed prior to publishing it. Given the confusion being generated by the FITF system, it will be even harder for TTOs to reign in publication-hungry academic researchers.
Q: It sounds like international differences in patent law are important, even under the new law.
But -- and this is the most important point -- the European Patent Office does NOT have a grace period. So, while U.S. law still provides an incentive to publish as a way of establishing an invention, under European patent law people who publish before they file a patent application aren't protected. Someone else could file the patent before you and gain priority in Europe. Publishing, then, can be a good strategy for United States patents but if you want to protect your invention in Europe, you still should file your patent application before publishing.
Q: In practical terms, doesn't an inventor -- including an academic scientist -- always care about Europe, too, these days? Is there ever a case where an inventor only cares about patenting in the United States?
Individual inventors and their institutions reluctantly settle for patenting only in the United States where budgets dictate -- i.e., when there is no potential licensee in sight -- and/or where we are successful in convincing them that some disclosing activity they did within the past year (a poster session, public talk, etc.) precludes them from getting patents anywhere of economic usefulness except for the United States.
Q: So, to summarize, in most cases, in practical terms, the publishing-versus-patenting calculation of a U.S. scientist at an academic institution probably won't change as a result of the new law. They should still file first and publish later. Correct?
Q: Are there other important differences between United States and European patent law?
Q: Help us understand the timing. When do people need to start thinking about these changes?
Q: One thing academic scientists hear a lot about is the importance of good record keeping for protecting intellectual property. In my experience, this is an area where academic laboratories often fall short. Does the new system change the way we should think about keeping records?
Now, with the FITF system and elimination of the patent interference option, academics may falsely believe they no longer need to maintain such records. In fact, they need to maintain even more complete records under the AIA, since it provides procedures for them to allege that an invention claimed by another was actually derived from their own invention. “Substantial evidence” of such derivation is necessary under the AIA to prevail on such a claim, so it is now even more important to maintain a complete record of any correspondence with third parties regarding their research and findings.