James G. McEwen*
In the article included in the Stein McEwen Newsletter entitled Overview of the Leahy-Smith America Invents Act: What Is The Practical Effect of First-to-File for Patent Applicants (October 2011), the novelty portions of the American Invents Act were explored. However, as the America Invents Act was the result of pressures from diverse industries and groups, not all changes revolved directly around first to file issues. Specifically, in view of the high costs of litigation, there was pressure from electronics companies to reduce the uncertainties of litigation by clarifying the law in regards to willful infringement and inequitable conduct, eliminating “secret” prior art, and retaining the prior user defense. Additional issues included ensuring patent quality and reducing pendency by increasing third party participation in the issuance of patents, and increasing funding for the United States Patent and Trademark Office so that more examiners could be hired to deal with the increased number of patent applications being filed.
These pressures and issues have been at the forefront of the patent community since the American Inventors Protection Act was enacted on November 29, 1999 and amended by the Intellectual Property and High Technology Technical Amendments Act of 2002, and they have pitted different elements of the patent community against each other. Below is an overview of the more notable portions of the America Invents Act that relate to improving patent quality and third party participation, along with a discussion on potential pitfalls of each section.
As an offshoot of the move to first-to-file from first-to-invent, there was the issue of how to handle conflicts in inventorship. In theory, under a pure first-to-file system, inventorship is resolved by whichever inventor has filed first and there would be no need for any form of interference proceeding. However, in deference to concerns from inventors and small businesses, Congress only partially did away with interference proceedings and now allows inventors to contest whether one inventor derived an invention from another, which is also consistent with 35 U.S.C. § 102(b)(2). This new proceeding is called a derivation proceeding as will be explained below.
As background, under the old law, where there was a conflict in claimed subject matter under 35 U.S.C. § 102(g) between applications or patents, the conflict could be resolved using an interference
proceeding. Within an interference proceeding, there was a defense for derivation under 35 U.S.C. § 102(f) whereby a later filing invention could prove prior invention by showing that an earlier-filed invention should be invalid as it was stolen from the inventor of the later filed application. While interference proceedings were rare, the use of derivation as a defense during the proceedings was even rarer. As such, the restriction of interference to derivation should remain an extremely rare occurrence.
Under the America Invents Act, 35 U.S.C. §§ 291 & 135 replace interference law with derivation law. 35 U.S.C. § 291 governs proceedings in court between patents, and 35 U.S.C. § 135 governs proceedings at the USPTO between applications. The procedures are generally the same as the old interference law, including its odd timing requirements.
Specifically, as was also a problem in interferences, any derivation proceeding must be filed within 1 year. To bring a derivation proceeding in court, 35 U.S.C. § 291(b) requires the filing be within 1 year of issuance of the first patent with a derived claim. Of course, this assumes that both patents will issue with conflicting subject matter within the same year, which is a dubious assumption to say the least. There is nothing in the law which addresses what happens if the second patent is held up by USPTO delays, and therefore the use of the courts as a remedy, while available, is difficult to predict.
Similarly, if an inventor wants to file a derivation at the USPTO, 35 U.S.C. § 135 requires filing within 1 year of first publication of the “same or substantially the same” invention. This of course leaves open the question of how to proceed for unpublished claims, such as those added or amended after publication. And there is always the problem of how to file a derivation proceeding for national stage applications; an applicant will not generally know within 1 year of publication that the national stage has been filed, since PCT applications need not enter the national stage until the 30th month. Since the 18 month PCT publication qualifies as a U.S. patent publication, this 30th month entry literally leaves a day to file a derivation. Therefore, if a patent applicant is worried about derivation proceedings, the best course of action would be to use a PCT application and not enter the national stage until the 30th month.
However, these logistical problems also existed with interference proceedings, and therefore do not present new issues to an experienced interference practitioner. And given the rarity of these proceedings, it is not likely to affect the daily prosecution strategies of most applicants.
“New” Defense: Prior Commercial Use
The United States has not traditionally had an express prior user defense or experimental user defense, but such defenses have effectively always been present. Prior users could rely on two novelty provisions to invalidate a claim if the prior users could show they or someone else had previously been using the invention. Specifically, under the old law, 35 U.S.C. § 102(g)(2) could be used to invalidate a patent by showing another person first actually reduced the invention to practice and did not abandon, suppress or conceal the invention. Similarly, prior secret commercial use could be used to invalidate a claim under 35 U.S.C. § 102(b). These defenses, which had to be shown by clear and convincing evidence, protected not only the accused infringer but an entire industry, since the asserted claim was invalid and thus no longer usable.
Lastly, while there was no express experimental use defense, patent owners would be reluctant to accuse laboratories for infringement if the use was de minimis and purely experimental; the legal expense would exceed the expected damages, as there would be no demonstrable sales. Further, there was always the specter that a court would decide that such uses fell within an experimental use exception. Thus, while these laboratories could be sued, such a threat was rare unless the suit also included use of equipment sold for use in experiments, in which case there was an impact on a commercial market.
Under the new prior user defense, where there is prior commercial use, the patent could possibly still be valid against others in the industry, assuming such use is not widespread. Furthermore, where there is prior experimental use, such use could continue to the extent it is ongoing, and therefore the defense is arguably broadened for long-standing and ongoing experiments and equipment. Thus, the new prior user defense will likely benefit those users who are performing experimental or pre-commercial uses as opposed to those users who are actually commercializing the invention.
35 U.S.C. § 273(a) allows the new defense when the infringing subject matter is “a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process” and where the defendant was “acting in good faith” and “commercially used” the subject matter in the United States. The use must also be internal use or commercial transfer, and have been ongoing for at least 1 year before the effective filing date or the disclosure date of 35 U.S.C. § 102(b). Further, the defendant must prove prior commercial use by clear and convincing evidence. Lastly, any abandonment of use or use through derivation from the inventor negates the prior user rights.
What qualifies as commercial use is not intuitive and is broader than any prior user rights under the prior 35 U.S.C. §§ 102(a), (b) or (g). Specifically, 35 U.S.C. § 273(c) states that commercial use includes FDA reviews of drug applications, as well as non-commercial use in “nonprofit” or university laboratory “for which the public is the intended beneficiary.” Where the use is in a university, the defense is only applicable to continued experimentation and does not extend to later commercial uses of the infringing subject matter.
Also, the defense is personal and does not extend to related entities and other locations. Specifically, under 35 U.S.C. § 273(e), only persons who have been using the invention commercially may take advantage of the defense. While the prior user defense extends to customers, the right itself can only be transferred with the sale of the business and such transfers have the effect of restricting the location at which the use can continue to occur.
A final twist on prior user rights relates to a somewhat confusing “university exception”. Under 35 U.S.C. § 273(e)(5), a person cannot claim prior commercial use if the invention being infringed was assigned to a university. Oddly, the exception applies only to U.S. universities since the statute references the definition contained in 20 U.S.C. § 1001(a). This restriction is potentially at odds with other definitions of universities, such as those contained in Bayh-Dole or the definition of small entity for purposes of fee calculation. However, some commentators, including the USPTO, appear to adopt the definition in 20 U.S.C. § 1001(a) despite the lack of express location requirements, such that it is arguable that there is no conflict.
Assuming that the invention being asserted is owned by a university such that prior use rights cannot be asserted by someone commercially using the invention, there is also an exception to the exception. Specifically, under 35 U.S.C. § 273(e)(5)(B), the University Exception does not apply where the claimed invention could not have been reduced to practice using Government funds. This exception to the exception is sure to create litigation problems as it is unclear as to when Government funds could not be used, or whether reduction to practice (actual or constructive) actually occurred. And since many universities utilize government funds in their research and are subject to the requirements of Bayh-Dole, it appears that many university inventions would be subject to this exception to the exception and thus be vulnerable to prior commercial use by third parties.
Lastly, while the prior user right is a possible defense, it should not be used lightly. Under 35 U.S.C. § 273(f), where the prior commercial use is raised as a defense and this defense is later found to be unreasonable, “the court shall find the case exceptional for the purpose of awarding attorney fees under section 285.” As such, a potential infringer needs to be aware that if the defense is asserted pro forma or without investigation, it can face a possible counterclaim of unreasonableness and an order to pay attorneys’ fees on top of any normal infringement damages. Given this risk, as well as the difficulty in showing prior commercial use over such a long time, it is likely that this defense will not be used often except in the pharmaceutical industry.
New Opportunities for Third Party Examination
As noted above, one of the aims of patent reform has been to improve patent quality by reducing the number of invalid patents. One of the ways in which it is believed this improvement can occur is by increasing third party participation at the USPTO, thereby reducing the chances an invalid claim will issue in the first place, and also providing an alternative to court proceedings by allowing challenges in court. However, the prior patent law was limited in how third parties would be able to participate in challenging claims before and after issuance. As such, the new America Invents Act has provided additional and expanded mechanisms for third party challenges.
Under prior law, there were two mechanisms for submitting prior art to examiners during the pendency of the patent application: (1) a Protest under 37 CFR § 1.291, which is filed prior to publication of the application or before notice of allowance was mailed, and (2) a Third Party Submission under 37 CFR § 1.99, which is filed within two months after publication of the application or before the allowance was mailed. However, because both submissions have limited timeframes for submission, Congress revised the law to allow more post-publication participation.
Specifically, 35 U.S.C. § 122(e) was revised to allow submission of printed publications by third parties. Unlike post-publication practice under the former 37 CFR § 1.99, the submission includes an explanation of relevance, allowing the Examiner to understand the broader significance of a reference as context of the state of the art, adequacy of best mode, etc. Thus a submission is not limited to purely anticipatory references. The submitter is also required to pay a fee, and a statement that complies with 35 U.S.C. § 122(e). While unstated in the statute, it is likely that this procedure would be in addition to the existing pre-publication Protest, which is similar in many ways.
There are still temporal limitations. Specifically, the third party submission must be made prior to the earlier of either a Notice of Allowance or the later of one of two events: 6 months after publication, or issuance of a first office action. Given the existing pendency rates, where few office actions issue before 18 months, and given that few first actions are Notices of Allowance, for now it is likely that most submissions need merely be prior to a first office action. However, to be safe, a good rule of practice would be to ensure any submissions are filed within 6 months of publication, to prepare for the expected reduction in pendency as more examiners are hired due to improved funding (as discussed below).Thus, while there remains the need to act quickly, third parties will have an improved ability to submit prior art during examination under the new submission process.
Under the America Invents Act, Congress has created a new mechanism for challenging issued patents: post-grant review. This new mechanisms is in addition to comparatively well-known mechanisms, ex parte reexamination and inter partes reexamination, the latter of which has been renamed inter partes review. From a broad view, the new system allows ex parte challenges to exist throughout the life of the patent, but allows increased grounds for inter partes challenges for challengers who are able to file challenges closer to grant. This system will be explained below.
Under ex parte reexamination, 35 U.S.C. § 302 remains as it always has. A third party may request an ex parte reexamination, but the right of the third party to participate in the proceedings is very limited. The third party can only provide comments to initiate the reexamination, and then can only provide comments in response to an optional response by the patent owner subsequent to the initiation of the reexamination and prior to a first office action. The advantages to this method of initiating reexamination is that there is no time limit for response, no requirements to identify the real party in interest (thereby allowing anonymous challenges), fewer estoppel risks, and a comparatively small expense (the only charge is for the filing of the document). However, the disadvantage is large: the third party cannot participate in the examination.
In order to overcome these deficiencies without eliminating the existing ex parte reexamination system, Congress created an inter partes reexamination system in 1999 in Chapter 31 of Title 35. This procedure was mildly updated in the America Invents Act, which also re-titled the process as inter partes review. 35 U.S.C. § 313 establishes that the grounds for instituting the review does not depend on whether there is a significant new question of patentability as it had under the prior 35 U.S.C. § 312. Instead, the inter partes review is now dependent on whether the requester can show that the presented information “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least one claim” in the challenged patent. However, this change will likely have little practical effect since the USPTO interprets the standards for instituting the prior inter partes reexamination and the current inter partes review to be consistent.
A more substantive change is due to the introduction of post-grant review: inter partes review cannot be filed until 9 months after grant of the patent or termination of a post-grant review. Previously, inter partes reexamination was available immediately after grant without restriction. This change appears to be to ensure that a patent cannot be challenged by all three post-issuance challenge procedures at one time.
Another substantive timing change is that inter partes review is not available if the petitioner has already filed a declaratory judgment action in district court in which the validity of the patent has been challenged, since in theory the challenge could have instead been brought to the USPTO first. Conversely, should the petition be filed first and the court action filed second, the court action is to be stayed during the inter partes review. While this substantive timing issue will likely affect certain parties interested in filing declaratory judgment, a counterclaim defense of invalidity is not affected by this limitation. Other than the above distinctions, inter partes review is generally consistent with inter partes reexamination prior to the America Invents Act.
However, inter partes review and ex parte reexamination are both limited in that only printed publications may be used for prior art invalidation. Thus, there was a need to increase the number of mechanisms usable to invalidate a patent. As such, the America Invents Act introduced the concept of a post-grant review. Found in the new Chapter 32, post-grant review has many of the procedures of inter partes review, but is far more expansive in its coverage. Specifically, unlike ex parte reexamination and inter partes review, post-grant review allows any defense otherwise usable in court to challenge a patent. In addition to anticipation through printed publications, petitioners can challenge claims based upon on sale and public use bars under 35 U.S.C. § 102, patentable subject matter exclusions under 35 U.S.C. § 101, and written description and enablement issues under 35 U.S.C. § 112. This presents a major advantage to post-grant review, and potentially provides a ready alternative to filing declaratory judgments in district court to challenge patents.
With the expansive scope of post-grant review, there would seemingly be no need for inter partes review. However, the two systems are designed to work in concert since post-grant review is only available within 9 months of a patent grant, whereas inter partes review only exists after this period. Therefore, while a seemingly superior system, post-grant review is only available to those willing to challenge patents on issuance. Thus, post-grant review is a reward for challengers to act rapidly to challenge patents as opposed to waiting to see whether the patent is actually enforced.
In looking at these three post-issuance challenges, if an inter partes process is desired, the best option is to file quickly after the grant so as to use the post-grant review process. If this process is not available, inter partes review should provide a modicum of relief. Where the cost of inter partes review or post-grant review is prohibitive, or where a declaratory action has already been filed, the challenger is best served by the existing ex parte reexamination system. Thus, with the America Invents Act, Congress has created a more robust challenge process with more options for potential challengers.
New Opportunity for Post-Issuance Correction
As with reexamination, the America Invents Act has added a new mechanism to correct patents. Under the prior law, where there was a defect in a patent, the patent owner had two choices for correction: reissue applications under 35 U.S.C. § 251 or ex parte reexamination under 35 U.S.C. § 302. Both mechanisms had their advantages. For instance, reissue applications are best where more extensive changes and flexibility is required. However, as the reissue application opens up the patent to any rejection by the examiner, reissue applications could take longer to complete. In contrast, ex parte reexamination is limited in scope and therefore can be, in theory, faster than a reissue application to complete. The problem with ex parte reexamination is that it is a cumbersome process where patent owners have little chance to amend the claims. Moreover, where there is a concern that information was not properly submitted such that the patent would be potentially unenforceable, neither reissue nor reexamination is usable to prevent such an unenforceability defense in later litigation. As such, there was a need for a quick mechanism by which claims of an issued patent could be tested against information which could form the basis of an unenforceability defense. Examples include where a corresponding foreign application considered a reference not submitted during prosecution of the patent, or where a patent applicant has made an incorrect interpretation of a reference which should be corrected. To correct these and other clouds on enforceability, Congress created Supplemental Examination in 35 U.S.C. § 257.
Under supplemental examination, a patent owner can ask the USPTO to consider new information, correct information already considered, and/or reexamine already-examined information. Where the USPTO finds that the submitted information does not present a substantial new question of patentability, a certificate will issue indicating this determination. Where the information does present a substantial new question of patentability, an ex parte reexamination commences without the opportunity for the patent owner statement normally allowed in ex parte reexamination. This supplemental examination will conclude with 3 months, thereby providing a quick mechanism for a patent owner to test their claims against any provided or corrected information.
The benefit of this process is that if a certificate issues, a third party may no longer use the submitted information to claim that the patent is unenforceable. However, this benefit does not apply when the supplemental examination is not concluded prior to the filing of a suit for the same patent, or where the information was previously asserted as being relevant to inequitable conduct. As such, the process is designed to ensure patent owners correct or submit information as soon as possible.
A potential risk is that, unlike reissue or reexamination, 35 U.S.C. § 257(e) has an antifraud provision. Specifically, where the submitted information leads the examiner to believe that there has been material fraud on the USPTO, the USPTO can order cancellation of all claims of the patent if the claims are found invalid, and refer the matter to the Attorney General for criminal proceedings. While seemingly a draconian solution, it is noted that it is unlikely that this provision will be used, given that the process is voluntary and patent owners who have committed material fraud are unlikely to participate. Instead, the process is designed to remove issues related to innocent misrepresentations that have led to a flood of charges of inequitable conduct and not to protect purposeful deceptions.
When and where should supplemental examination be used? As a general matter, supplemental examination is probably most useful where reissue under 35 U.S.C. § 251 is not available. The reissue process is a more thorough process, and will examine the information as well as the entire application for issues beyond 35 U.S.C. § 102, such as 35 U.S.C. § 101. Moreover, the reissue process is more flexible and allows for the patent applicant to file continuations, requests for continued examination, and any other device usable in normal ex parte prosecution. In contrast, ex parte reexamination only examines issues related to 35 U.S.C. §§ 102 and 103, and does not allow many opportunities for amendment. Thus, while supplemental examination would seemingly remove a charge of inequitable conduct, the reissue process is usable to clear a multitude of issues beyond inequitable conduct.
However, if reissue is not available and there is genuine concern that an innocent misrepresentation or failure to submit will prevent enforcement of a patent, supplemental examination presents an alternative which has advantages over regular patent-owner-initiated ex parte reexamination.
Eliminating Litigation Traps
Under current law, there are a number of traps for the unwary patent owner. Two such traps are the best mode requirement under 35 U.S.C. § 112 and false patent marking under 35 U.S.C. § 292. Both are based on well-meaning public policies. For instance, best mode provides an incentive to ensure that the inventor is more forthcoming about the invention and fully discloses the best way for the invention to be made. It is also hard to argue that society benefits where incorrect patent numbers are affixed to products, and the patent owner is in the best position to correct these markings. At the same time, whatever benefit is derived from best mode and false patent marking, the harm greatly outstrips the theoretical benefit.
By way of example, while best mode is designed to ensure that the inventor is forthcoming, there is little evidence that the inventors have an incentive to deceive the public by hiding the best mode while still providing enablement and written description to satisfy the remainder of 35 U.S.C. § 112. Moreover, during litigation, inventors are subjected to questioning about whether, 10 years after the fact, they actually disclosed the best mode. Such questions rarely lead to inventors actually admitting that they actually hid the best mode as the test is inherently subjective, and hard to demonstrate by clear and convincing evidence. At the same time, it does lead to an increase in deposition costs and discovery fishing expeditions, as litigators look for admissions that the inventor may not have fully disclosed the exact best mode known at the time of the filing of the invention.
Similarly, while false patent marking suits had been relatively rare, a cottage industry has grown up around 35 U.S.C. § 292, as this statute specifically allows third parties to assert false patent marking, and receive damages based upon each mismarked product. As these qui tam relators need not even be injured by the false marking behavior, there actions are less in the public interest than in the interest of obtaining large damages regardless of the harm actually visited by the incorrect markings.
Lastly, another problem facing some patent owners is not related to false markings in particular, but how to mark certain items. For instance, while marking a television might seem obvious, marking semiconductor chips or chemicals is not as intuitively easy. Since marking is one mechanism to provide notice (and hence start damages), the ability to mark hard-to-mark articles is a problem faced by certain industries.
In order to relieve these problems, Congress enacted Sections 15 and 16 of the American Invents Act, which eliminated the use of best mode as a defense to invalidity during litigation. Specifically, Section 15 amended 35 U.S.C. § 282 to indicate that a defendant can invalidate a patent for not complying with any portion of 35 U.S.C. § 112 “except that the failure to disclose the best mode shall not be a basis on which any claim of a patent may be canceled or held invalid or otherwise unenforceable”. Moreover, best mode also cannot be used to attack patent validity during reexamination or post-grant opposition. Notably, the best mode requirement remains a requirement for obtaining a patent, but the only mechanism available to check whether there is compliance lies with the patent examiner during ex parte examination. And since best mode is rarely asserted during ex parte examination, as the examiner lacks the evidence needed to initiate the inquiry, it is unlikely that best mode will ever prevent issuance of a patent outside of the most exotic of circumstances.
In order to address the marking problems, Congress enacted Section 16 which first alleviated the problem of marking hard-to-mark products. Specifically, 35 U.S.C. § 287 was revised to provide virtual marking products using webpages. Specifically, the marking requirement is satisfied where the product on the webpage has a description which includes the word “patent” and a link to actual patent or patents. As many companies already put information on their products on company webpages, this change would seemingly make it far simpler to use the Internet to convey the “patent pending” message, as compared to affixing the message to the product itself.
Lastly, to address the false marking issues, Congress also revised 35 U.S.C. § 292 to limit who can bring False Marking suits to the United States Government or Persons actually harmed by false marking. As such, qui tam relators are no longer able to bring such suits. And even where a competitive injury can be shown, the suit cannot be based on expired patents. In effect, the changes to 35 U.S.C. § 292 should eliminate the threat once posed by false marking charges.
Eliminating Patent Backlog
A chronic problem faced by patent applicants is the continued delay in the issuance of patents. One factor in this backlog is the continued problem of USPTO underfunding. The America Invents Act attempts to address this problem in three sections: Sections 10, 11, and 22. These sections give the USPTO fee-setting authority, and automatically increase other fees. These sections also allow the director to create a new category of entity: the microentity, which is entitled to reduced USPTO fees.
However, what these sections do not provide is a mechanism by which the fees, once collected, remain in the USPTO. Instead, the situation remains largely the same as it is now, where the patent fees are collected and Congress returns whatever portion they believe is adequate to run the agency. Under the new system, any difference between what is collected and what is appropriated to the USPTO goes into a new Patent and Trademark Fee Reserve Fund. Thus, the USPTO will be able to calculate with certainty how much money has not been given back to the Agency using this new Reserve Fund, but will not be able to access these funds unless Congress specifically allows for it. This Reserve Fund has caused quite a bit of controversy since one of the main draws for supporting the America Invents Act had been the possibility that the USPTO’s collected fees would be used to reduce the patent backlog and improve quality, whereas the enacted America Invents Act does not allow this power. While defective in at least this one respect, the granting of additional control over their fees is a first step in ensuring that the USPTO is able to match its needs with the fees it charges.
Exceptions to Patentable Subject Matter
Recently, there has been a great deal of attention drawn to what is patentable subject matter. This attention is normally focused on requiring the courts to interpret 35 U.S.C. § 101, which provides the statutory basis for patent eligibility. As a result, the Supreme Court has interpreted what methods are patentable in Bilski v. Kappos, 130 S.Ct. 3218, 95 USPQ2d 1001 (U.S. 2010). Following this decision, the Federal Circuit has issued Classen Immunotherapies Inc. v. Biogen Idec, 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011), which found that methods including physical step are patentable subject matter, and CyberSource Corp. v. Retail Decisions Inc., 654 F.3d 1366, 99 USPQ2d 1690 (Fed. Cir. 2011), which found that software is not patentable subject matter if it is implementing a method which is itself not patentable subject matter. It is fair to state that the state of the law is in flux, and that the courts have not helped in alleviating this confusion.
It is also fair to state that Congress is not helping clarify the situation since the America Invents Act further removes from patentability two different classes of inventions. The first class of inventions is eliminated in Section 33 of the America Invents Act, which prevents patents to the “human organism”. The second class of invention is eliminated in Section 14 of the America Invents Act, which automatically places tax avoidance strategies within the prior art so as to prevent patents from issuing based purely on these strategies. However, it is apparent that these exceptions are being narrowly construed and it is uncertain as to whether either of these provisions will impact an appreciable amount of patent applicants.
Effective Dates for Implementation
Lastly, while the America Invents Act has made a multitude of changes, the changes are not all implemented at once. The changes implemented immediately (on September 16, 2011) include the USPTO’s Fee Setting Authority, prior user rights, the elimination of best mode defense, and the changes to the marking law. Indeed, the changes to best mode and marking law are retroactive, which resulted in at least one case in which a false marking case was dismissed solely due to enactment of the American Invents Act.
Other provisions go into effect 1 year after the enactment: September 16, 2012. These changes largely relate to improving the quality of patent examination by allowing improved third party participation, and thus include post-grant review, inter partes review, and pre-issuance submissions. While not directly related to third party participation, supplemental examination will also go into effect on this date. However, for post-grant review, these provisions are only available to patent applications having an effective filing date after the implementation of the first-to-file changes. Thus, for post-grant review, there is a dead zone where the process is in effect but no applications are available for said review.
Lastly, the changes relating to the first-to-file system will take effect 18 Months after enactment of the America Invents Act: March 16, 2013. Thus, while the changes are dramatic, there will be ample time to prepare for these changes and to adjust filing strategies accordingly.
It is important to realize that America Invents Act is first significant change in U.S. patent law in 50 years. Its passage was based, not just on the belief that the changes improve efficiency and encourage innovation, but that the changes by themselves create new jobs. While the changes themselves will likely not increase jobs outside of the hiring of new patent examiners, these changes were long sought and represent an important step in harmonizing U.S. law with international standards. These changes will have certain benefits as noted above, but will also create a great deal of uncertainty which will take years to sort out in court. Therefore, it is important for applicants and patent owners to recognize the need, now more than ever, to engage competent U.S. counsel to ensure that their inventions survive and thrive in a first-to-file environment.
* Partner, Stein McEwen, LLP, Washington, D.C.; B.S.A.E, University of Texas; J.D. with honors, The George Washington University; admitted to practice in the Commonwealth of Virginia and the District of Columbia; registered to practice before the U.S. Patent and Trademark Office. His biography is online at http://www.smiplaw.com/pro_mcewen.cfm; he may be reached at 202-216-9505 or firstname.lastname@example.org. The opinions expressed in this article do not represent the official position of Stein McEwen, LLP or the author’s former employers.
 Patent Reform Act of 2005, H.R. 2795, 109th Cong. §§ 3, 6 (2005).
 American Inventors Protection Act of 1999, Pub. L. No. 106-113, 113 Stat. 1501 (2000).
 High Technology Technical Amendments Act of 2002, Pub. L. No. 107-273, 116 Stat. 1758 (2000).
 35 U.S.C. § 371 (referring to Article 22 of the Patent Cooperation Treaty).
 35 U.S.C. § 374.
 Thomson S.A. v. Quixote Corp., 166 F.3d 1172, 49 USPQ2d 1530 (Fed. Cir. 1999).
 Invitrogen Corp. v. Biocrest Manufacturing L.P., 424 F.3d 1374, 76 USPQ2d 1741 (Fed. Cir. 2005).
 See generally Note, Sealing The Coffin On The Experimental Use Exception, 2003 Duke L. & Tech. Rev. 0012 (2003).
 35 U.S.C. § 273(b).
 35 U.S.C. § 273(e)(2) & (4).
 35 U.S.C. § 201(i).
 37 CFR § 1.27.
 MPEP 509.02.
 35 U.S.C. § 200 et seq.
 37 CFR §§ 1.291, 1.99 (2005).
 For instance, according to September 2011 statistics, first actions are issued within 28 months. USPTO Data Visualization Center Patents Dashboard (September 2011 Patents Data, at a Glance (October 25, 2011), available at http://www.uspto.gov/dashboards/patents/main.dashxml.
 37 CFR § 1.535.
 35 U.S.C. § 314(a).
 Under MPEP 2642, a significant new question of patentability exists “where there is a substantial likelihood that a reasonable examiner would consider the prior art patent or printed publication important.”
 35 U.S.C. § 311(c).
 35 U.S.C. § 315(a).
 35 U.S.C. § 315(a)(3).
 35 U.S.C. §§ 301(a) & 311(b).
 35 U.S.C. § 321(b).
 35 U.S.C. § 321(c).
 35 U.S.C. § 311(c).
 35 U.S.C. § 257(a).
 35 U.S.C. § 257(b).
 35 U.S.C. § 257 (c)(1).
 35 U.S.C. § 257(c)(2).
 MPEP 1445.
 MPEP 1451 & 1452.
 MPEP 2271.
 MPEP 2165.
 MPEP 2163.03.
 Henry R. Nothhaft and Paul R. Michel, Both parties stifle job creation, The Hill’s Congress Blog (June 14, 2011), available at http://thehill.com/blogs/congress-blog/campaign/166367-both-parties-stifle-job-creation (last visited November 22, 2011).
 See Robert W. Bahr, Acting Associate Commissioner for Patent Examination Policy, Memorandum to Examiners Regarding Claims Directed to or Encompassing a Human Organism (Sept. 20, 2011) (arguing that Section 33 only codifies existing law), Robert W. Bahr, Acting Associate Commissioner for Patent Examination Policy, Memo to Examiners Regarding Tax Strategies Are Deemed to Be Within the Prior Art (Sept. 20, 2011) (noting that Section 14 does not affect all financial transaction patents, and does not affect the software elements of systems which provide tax avoidance strategies).
 Kilts Resources LLC v. Uniden Direct In USA Inc., 100 USPQ2d 1088 (E.D. Tex. 2011).
 See Section 6(f)(2) (referring to Section 3(n)(1) of the America Invents Act).