Steps that medical device companies can take to prepare for Patent Office Practice changes related to the new Leah-Smith American Invents Act.
Although President Obama signed the Leahy-Smith America Invents Act into law on September 16, 2011, most of the changes that will affect Patent Office Practice will not take effect until September 16, 2012 or March 16, 2013. Nevertheless, now is the time to prepare for these changes. This article highlights what will change in September and how medical device companies can prepare for the first-to-file changes that will take effect in March.
New Inventor Oath/Declaration Options
As of September 16, 2012, patent applicants will be able to satisfy the inventor oath/declaration requirement by submitting an assignment document that includes the mandated oath/declaration language. While this option may be convenient for inventors who will need to execute only a single document, medical device companies should approach this option with caution For example, while an assignment document may encompass future improvements of the invention (including those claimed in continuation-in-part applications), an inventor oath/declaration is tied to the text of a specific application (each inventor must acknowledge having reviewed and understood the application). Inventors may be more willing to execute additional oath/declaration documents for future applications than they would be to execute new combined assignment-oath/declaration documents, especially if they have changed employment.
Another change due to take effect in September relates to when the inventor oath/declaration must be submitted. The new law provides for submission before a Notice of Allowance is issued, but the Patent Office’s proposed rules still would require an executed inventor oath/declaration before substantive examination. The Patent Office is reconsidering its proposal in view of public comments opposing that approach, and may announce a different timeframe in the final rules. Even if the Patent Office permits applicants to satisfy the requirement later, medical device companies should strive to obtain executed inventor oath/declaration documents as soon as possible in case the inventor changes employment or otherwise becomes less willing to cooperate with the application process.
New Ability Of Third Parties To Submit Prior Art During Prosecution
As of September 16, 2012, third parties will be able to submit prior art in any pending patent application that has not yet received a Notice of Allowance, as long as the application was published within six months of the submission or has not yet received a first Office Action on the merits. As outlined in the proposed rules, the Patent Office will treat these submissions similar to an Information Disclosure Statement. Applicants will not have to respond to the submissions directly, but will have to respond to any examiner rejections based on information that was included in a submission. Offensively, medical device companies may want to monitor their competitors’ published applications and consider whether there is relevant prior art that they want to ensure is considered during prosecution. Defensively, medical device companies may want to consider expediting examination of important applications under the Track I program, to increase the odds that a Notice of Allowance will issue before a competitor has an opportunity to prepare a prior art submission. Medical device companies also may want to monitor the status of their own applications on the Patent Office’s PAIR Web site, because the Patent Office will not provide notice of a submission until a copy is provided with the first Office Action.
New Ability To Request Supplemental Examination Of A Patent
As of September 16, 2012, patent owners will be able to request a supplemental examination of any of their own patents to obtain consideration or reconsideration of any information believed to be relevant to the patent, or to correct any information believed to be relevant. Although the ultimate review process will be conducted under the reissue application framework, a request for supplemental examination will not have to aver any defect in the granted patent. Moreover, supplemental examination will shield the patent owner from charges of unenforceability (e.g., inequitable conduct) based on any information considered during a supplemental examination proceeding, as long as the request is filed before the charge is raised by a third party in litigation or in an Abbreviated New Drug Application paragraph IV filing.
New Ability To Request Inter Partes Review Of A Patent
On September 16, 2012, inter partes reexamination will be replaced with inter partes review. Although the proceedings will be similar, there are some significant differences, including explicit estoppel provisions and provisions governing the relative timing of inter partes review and district court litigation. Medical device companies may be particularly interested in the class of patents that can be challenged by inter partes review. While inter partes reexamination is only available for patents granted from applications filed on or after November 29, 1999, inter partes review will be available for patents granted from earlier applications. Medical device companies may want to consider whether this new opportunity to challenge an old patent is of strategic interest. On the other hand, the transition to inter partes review will impose a delay in challenging new patents because a request for inter partes review cannot be filed until nine months after the patent is granted. This time period will complement the time period during which post-grant review can be requested once post-grant review becomes available, but creates a gap in time for patents that are not subject to post-grant review (which only will be available against patents subject to the first-to-file changes, which do not take effect until March 16, 2013). If a medical device company is considering requesting ex parte reexamination of a recently issued patent, it may want to do so by September 15, 2012, in order to avoid the restrictions associated with the new inter partes review proceedings.
Preparing For First-To-File
The first-to-file system (embodied in a new version of 35 USC § 102) will not take effect until March 16, 2013, but medical device companies should understand the complicated effective date and applicability provisions of the revised statute and begin preparing now for patenting under the first-to-file system.
There are several reasons why medical device companies will want to shield their patent applications from the first-to-file system for as long as possible. For example, applications under the first-to-file system will be subject to more secret prior art because published U.S. patent applications and PCT applications that designate the United States will qualify as prior art as of the filing date of any earlier priority application “that describes the subject matter at issue,” potentially reaching back an additional 12 months. Unlike other first-to-file countries, like Europe and Japan, where such secret prior art only can be used in a novelty rejection, U.S. examiners are likely to continue to retroactively cite patent applications in obviousness rejections as well.
Of course, applications subject to the first-to-file system will not be able to avoid third-party prior art by establishing an earlier date of invention. Although limited exceptions will be available under new 35 USC § 102(b), those will require evidence establishing that the disclosure at issue “was obtained directly or indirectly” from an inventor or previously had been disclosed by an inventor or another who obtained the subject matter directly or indirectly from an inventor. Additionally, applications subject to the first-to-file system will not be able to avoid the prior art effect of an earlier-filed third party application by establishing priority in an interference proceeding. Instead, the only possible recourse against an earlier-filed copending application will be in a derivation proceeding, which will require proof that the other inventor “derived the claimed invention from an inventor named in the petitioner’s application.”
Another reason to avoid the first-to-file system is that only patents granted from first-to-file applications will be subject to the new post-grant review proceedings. Third parties will be able to request a post-grant review within nine months of a patent’s grant date or reissue date in order to challenge the validity of a first-to-file patent under a preponderance of the evidence standard “on any ground that could be raised” under 35 USC § 282(b)(2) or (3). This includes issues pertaining to 35 USC § 101 and 35 USC § 112, which cannot be raised in reexamination or inter partes review proceedings.
Despite these important reasons to file new U.S. patent applications by March 15, 2013, medical device companies need not file all planned patent applications by that date. For example, continuation and divisional applications filed on or after March 16, 2013 will remain under the current first-to-invent system, as will new U.S. applications that claim priority to earlier filed foreign or PCT applications, as long as all claims are entitled to a priority date of March 15, 2013 or earlier. On the other hand, brand new application, continuation-in-part applications, and new non-provisional applications may fall under the first-to-file system.
To ensure the availability of the current first-to-file system for as many inventions as possible, medical device companies should confer with their inventors and mine their invention disclosures to identify inventions that may be ready for patenting so that patent applications can be filed by March 15, 2013. Looking ahead, once the first-to-file system takes effect medical device companies should exercise care when filing an application that adds disclosure to a previously filed application, and should consider strategies that could preserve the applicability of the current first-to-invent system to the earlier subject matter. For example, original and new subject matter could be segregated in different applications, with one application claiming only original subject matter (and thus remaining under the first-to-invent system) and the other application claiming new subject matter (and thus falling under the first-to-file system). Medical device companies also should ensure that their inventors and business development teams understand the importance of filing a patent application before any disclosure or offer for sale of technology embodying a new invention because the new grace period exceptions will be both narrower and more difficult to establish than options currently available under the first-to-invent system.
Ready For Take-Off
There are a number of steps medical device companies should consider taking before September 16, 2013, with more to do before March 16, 2013. By understanding the different provisions of the America Invents Act, medical device companies can identify which changes are most relevant to their intellectual property programs and business objectives, and take appropriate measures. Savvy medical device companies will be able to position themselves to mitigate the impact of unfavorable provisions of the new law, while preparing to take advantage of the new opportunities that the law has to offer.
Courtenay C. Brinckerhoff is a partner of Foley & Lardner LLP, Chair of the firm’s IP Law & Practice, and editor of PharmaPatentsBlog.com. The views expressed herein are the author’s own, and may not represent those of Foley & Lardner LLP or its clients.
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