Unless you began your winter hibernation early, you will have heard that, on September 16, 2011, the Leahy-Smith America Invents Act or (AIA), was signed into force by President Obama representing the first comprehensive overhaul to U.S. patent law in 60 years. So, do these changes have any significance to Canadian patent Applicants? Since most Canadian companies see the U.S. market as their biggest and most desirable, it is imperative that we all pay close attention to the changes that the AIA set in motion and that will continue to develop over the 18 month period following enactment.
Many comprehensive reviews of the AIA have been published since its enactment. Such a detailed review is beyond the scope of this newsletter. For a more in-depth review, we refer our readers to America Invents Act To Publish or Not To Publish? The purpose of this article is simply to highlight a few of the changes that should be of interest to Canadians, and the Biotech/Pharma community in particular.
Perhaps the most talked about change enacted by the AIA is the switch from a “first to invent” to a “first inventor to file” patent system. Since Canada has operated under a first to file system since 1989, the principle behind this new system will not be new to Canadian Applicants. However, there are some subtle, but significant differences between the two systems. For example, the U.S., like Canada, will retain a one-year grace period during which a patent application may be filed, by the inventor, after a disclosure made directly or indirectly by the inventor. Unlike Canadian law, however, the AIA introduces a new effect of such a disclosure by the inventor – if an inventor directly or indirectly discloses their invention and then subsequently files an application within the ensuing 12-month grace period, then any independent disclosure of the subject matter of that invention (i.e., by a third party) during the period between the publication and filing will not count as prior art.
The first inventor to file provisions will not take effect until March 16, 2013. Overall, these provisions completely re-write the novelty sections of the U.S. Patent Act and will result in more prior art being available for citation against a U.S. patent application (in fact, more prior art than can be cited against a corresponding Canadian application). Therefore, you will find many U.S. practitioners recommending that applicants try to get their applications filed prior to March 16, 2013. Keep in mind that U.S. or PCT applications based on a provisional application filed after March 16, 2012, that contain claims to subject matter added after March 16, 2013, will be subject to the new first inventor to file provisions.
Other significant changes include substantial alterations to the options for third parties to challenge the allowance and issuance of patents. For example, the new law makes it possible for third parties to submit prior art in a third party’s patent application in a much more effective manner. Also, a new post-grant review procedure, similar to the EP opposition procedure will be put into place, effective September 16, 2012.
With respect to changes specific to Biotech applicants, there are not many. As one example, effective as of the date of enactment, the banning of patent claims to human organisms has been specifically recited in the law, however this simply confirms current Patent Office practice. In fact the U.S. Patent Office recently released a memorandum stating that this provision of the AIA “does not change existing law or long-standing USPTO policy that a claim encompassing a human being is not patentable.” This statement put to rest any question as to whether this section might be interpreted more broadly, such as banning patents on isolated human stem cells or isolated human DNA.
Also effective as of the date of enactment, the AIA expanded the prior commercial use defenses to patent infringement. Like the previous version of the statute, the revised statute expressly includes pre-marketing regulatory review in the definition of “commercial use,” which is important to the Pharma industry to minimize infringement risks prior to drug approval.
The changes enacted by the AIA will impact U.S. patent prosecution and enforcement for years to come. Many provisions are not yet in effect and we are waiting for several guidance documents from the U.S. Patent Office before we will be able to provide more definitive guidance and instructions for our clients. However, as international applicants that desire strong patent protection in the U.S., it is imperative that we pay close attention to how the law is interpreted, implemented, and litigated.