The geographic expansion of unpublished "knowledge" as prior art does, however, raise a very important issue. Any new provisions in the patent statute implementing this change must be unmistakably clear as to what now will and what will not qualify as prior art. Unpublished foreign "knowledge" should not qualify as prior art to an invention unless it meets the same requirements for accessibility that have long applied when unpublished knowledge in the United States was determined to qualify as prior art. Under U.S. patent law today, only unpublished knowledge that has become reasonably and effectively accessible to persons skilled in the technology to which the invention relates could so qualify. Lilly notes that the "best practices" consensus view on defining what knowledge can qualify as prior art do not intend either to raise or to lower the existing public accessibility hurdle for qualification as prior art. As Congress changes to a global definition for this type of prior art, the definition should be in the statute and explicit – but not otherwise diminish or expand the qualifications for unpublished or knowledgebased prior art. A "best practices" patent statute should make clear that knowledge of an invention can arise from its sale or other use, just as current law provides. Further, knowledge can arise based upon whatever can be comprehended by persons skilled in the area of technology from any subject matter that is thereby made publicly accessible, precisely in accord with existing patent law principles. Equally importantly, knowledge can be either express or inherent and any action by Congress should make clear that inherent knowledge arising from subject matter that has become publicly accessible bars a later patent on anything thereby made inherently known.3 2 AIPLA has proposed - and Lilly supports – elimination of the so-called “forfeiture" aspect of the current patent law that prevents inventors (and only the inventors) from patenting subject matter that they themselves have placed or caused to be placed into non-public commercial use or made the subject of non-public offers for sale. Where an inventor has otherwise placed an invention in public use or on sale, including made offers for sale, it is clear that both the inventor (unless the inventor sought a patent before the end of the 1-year “grace period”) and any third parties ought to be barred from patenting such an invention. While this forfeiture provision makes sense under our current patent law, it is unnecessary, if not counterproductive, once a first-inventor-to-file rule is adopted. Under our current law, the forfeiture provision assists in securing that an inventor cannot wait to file for a patent until another inventor seeks a patent and then assert the right to patent the invention based upon an earlier date of invention. In a firstinventor-to-file system, this possibility does not exist. 3 By way of a simple example of what "inherent knowledge" means, if aspirin is sold for treating a headache and, subsequently, a later inventor attempts to patent the discovery of a method for treating headache through administration of a medicine that inhibits a COX enzyme, any patent that issues for this invention will be invalid if it can be shown that an Lilly Answers That Matter. The underlying requirement for "public accessibility" should apply regardless of the nature of the disclosure that is alleged to represent prior art. Thus, a disclosure based upon a use or other unpublished knowledge of the invention should be treated no differently from a disclosure appearing in a purported "printed publication" in assessing whether the requirement for public accessibility has been met. The courts have applied – and should continue to apply - the same "public accessibility" framework for assessing the prior art status to determining whether a disclosure of subject matter qualifies as prior art irrespective of the nature of the disclosure. "The statutory language, 'known or used ...' (35 U.S.C. §102(a)), means knowledge or use which is accessible to the public." See Carella v. Starlight Archery, 804 F2d 135 (Fed. Cir. 1986). “Thus, throughout our case law, public accessibility has been the criterion by which a prior art reference will be judged for the purposes of [35 U.S.C. ]§ 102(b). Oftentimes courts have found it helpful to rely on distribution and indexing as proxies for public accessibility [in the case of an alleged printed publication]. But when they have done so, it has not been to the exclusion of all other measures of public accessibility. In other words, distribution and indexing are not the only factors to be considered in a § 102(b) ‘printed publication' inquiry.” In re Klopfenstein, App. No. 03-1583 (Fed. Cir.), slip op. August 18, 2004. Again, because of the new global reach of all forms of prior art under a “best practices" approach, Congress should undertake an explicit codification of the longrecognized "public accessibility" criteria and, as noted above, break these criteria into their two established components, one relating to the reasonableness of the required efforts to secure access to the disclosure (i.e., a test to determine the extent to which the alleged public knowledge is capable of being physically located) and a second relating to the intellectual effectiveness of the access (i.e., a test to determine whether the alleged public knowledge is capable of being understood by a human being). These two components arise from longstanding judicial precedent. The gist of the public accessibility criteria based upon these two components was described though a five-part analytical paradigm in Philips Electronic and Pharmaceutical Industries Corp. v. Thermal and Electronics Industries, Inc. 450 F2d 1164 (3rd Cir. 1971), as applied to a purported printed publication. “[A] proponent of a microfilm as a 'printed publication' under the statute should produce sufficient proof of its dissemination or that it has otherwise been made available and [1] accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents. He should be able to make a satisfactory showing that a person interested in and [2] ordinarily skilled in the art [3] can locate it, and [4] understand the essentials of the claimed invention [5] without further research or experimentation." Emphasis added. inherent property or characteristic of aspirin in treating headache was the inhibition of the COX enzyme. Lilly Answers That Matter. As to element four of this five-part analysis, the "effective accessibility" component, the Court of Customs and Patent Appeals has cogently noted the basis for effective accessibility component (as distinct from the requirement for reasonable accessibility in the sense of physical access), stating that, "if the publication [asserted to be prior art] were illegible, whether 'printed' or handwritten, no one would argue that it would constitute a statutory bar" i.e., a basis for denying a patent for an invention. See In re Tenney, 254 F.2d 619 (C.C.P.A. 1958). Moreover, as is clear from the Philips decision, these components are to be objectively applied, i.e., the reference point employed for assessing the accessibility criteria is the hypothetical person of ordinary skill in the art to which the claimed invention pertains. This objective focus is intended to assure that the criteria for assessing public accessibility do not turn on whether information was disclosed to the inventor — or whether the inventor was entirely ignorant of such information. A congressionally codified standard should incorporate the same general – and objective - five part analytical paradigm used in the Philips decision. However, on the fifth of the five criteria in Philips, it would be appropriate to refine the level of permissible effort set out in the Philips decision (i.e., the passage in Philips referencing the standard, "without further research or experimentation"). We would support an “undue efforts” principle. The "undue efforts" standard would be intended to allow subject matter that can be accessed without undue effort to qualify as prior art. This standard could be applied analogously to the "undue experimentation" standard that has been used in assessing the enablement of a claimed invention under 35 U.S.C. §112, first paragraph. Thus, the "undue effort" standard could draw a clear distinction between (1) knowledge that, while not categorically secret, is insufficiently accessible to be regarded as public and (2) knowledge that, because of its sufficient accessibility, can advance progress in the useful arts to which it relates. We would further urge that Congress expressly reject the concept applied in some foreign patent systems that any non-confidential disclosure of the invention is sufficient to create prior art as to the subject matter that is non-confidentially disclosed. Indeed, it is appropriate to require something more than a mere reasonable possibility that persons of ordinary skill in the art could achieve meaningful access to a disclosure. Lilly realizes the importance of making these "best practices" changes with extreme care. With any legislation, there is a risk of unintended consequences. By codifying existing principles for determining prior art as part of the expansion of the definition to include foreign knowledge of an invention, Congress can assure that it is not otherwise making changes that go beyond what is needed to normalize our laws with those of other countries under the "best practices framework. In doing so, Congress can make clear that any statutory changes that are made do not call in to question decades of established case law on prior art, including the cases previously cited. It is vitally important, therefore, to tie statutory changes to the language from decades of case law both in statutory language and appropriate legislative history. By doing so, Congress can avoid spurring unnecessary litigation that can otherwise result from reformulated standards of prior art. Specifically, Congress needs to exercise the greatest care to assure that subject matter that was already being used and commercialized within the United States that would not be patentable by a third party today does not become patentable under a “best practices" formulation of the patent law. For all these reasons, we are particularly supportive of the AIPLA's detailed proposal that proposes to codify what the courts have decreed is the inquiry mandated under the current "known or used” and “in public use” standards, i.e., whether subject matter was "readily and effectively accessible." This standard, as we understand it, contemplates that subject matter, once widely deployed, will be available as prior art, both for what is expressly used or otherwise known and for what inherent knowledge is created. In summary, Lilly encourages Congress to take an approach towards harmonization that brings the United States into alignment with certain aspects of other countries' laws without, however, diminishing or expanding the scope of existing prior art (other than the expansion inherent in the removal of geographic limitations on unpublished knowledge). This can be done by carefully crafting the standard along existing patent law principles for defining what is and is not publicly available. Carefully legislating, such as AIPLA has proposed to in its "best practices" implementation, should preclude the otherwise serious concerns over unintended gamesmanship of patenting concepts already in deployment commercially--whether in the United States or elsewhere. Stop the “Inequitable Conduct” Defense From Crippling the Effectiveness of the "Duty of Candor” by Adopting AIPLA and ABA IPL Section Reforms Since 1979 - the patent office has had a very explicit "duty of candor and good faith" in its rules designed to assure that patent examiners get all the information they need to make the right decisions in deciding whether to allow a patent to issue. The office undertook a major effort in the early 1990s to retool the duty to make certain that it was fully comprehensive with the needs of patent examiners. The only meaningful * Patent applicants in the United States face a unique requirement that other patent systems outside the United States do not impose: they are obligated under the "duty of candor and good faith" to refrain from misrepresenting information and to affirmatively disclose all information of known materiality to the patent examiner. As we look to greater international harmonization of patenting processes, Lilly would urge the Congress effort to reaffirm the role of duty of candor, actually give the patent office greater statutory authority to manage and strengthen the duty, and make clear that a duty of candor should play a central role in fostering the integrity of the U.S. patent system irrespective of other efforts at pursuing more harmonized approaches to patenting. enforcement of the duty of candor today is in the courts in the context of patent infringement litigation, where violation of the duty of candor with the intent to deceive the patent examiner automatically renders the patent permanently unenforceable. Despite decades of work at perfecting the duty of candor and good faith, Director Dudas appeared today to lament the need for "increased applicant responsibility" as he termed it. He cited a common concern among those within the patent office: “Applications filed with large numbers of prior art references, without any guidance as to which references the applicants believes to be most relevant, have an impact on efficient examination.” The root cause of the problems that the patent office today faces with deriving the expected value from the duty of candor does not lie in deficient patent office rules. The problem is not that the patent office has not set the standard for conduct high enough. It is not that patent applicants are unwilling to act with full and complete candor in dealings with the patent office. As Lilly assess the current dilemma, the root cause lies rather in the perverse incentives that are created because of the manner in which the "inequitable conduct" defense is applied in the courts. Applicants getting patents need to act defensively – in order to blunt the “inequitable conduct” charges that are almost inevitably leveled once the patent is litigated. Even though the "inequitable conduct" defense undeniably operates as an incentive for patent applicants to make the fullest imaginable disclosure of information to the patent office, it has a glaring deficiency. The "inequitable defense" provides no incentive for patent applicants to work with patent examiners to secure the issuance of a completely valid patent. Completely valid patents are the target of "inequitable conduct" charges with the same frequency as patent containing invalid claims. Instead of creating an incentive to procure entirely valid patents, the "inequitable conduct" defense encourages patent applicants to do exactly what Director Dudas finds to problematic - submit large numbers of prior art references without any guidance as to relevance or content. In short, to blunt later charges of concealment of known information, patent applicants are forced to make the work of the patent examiner more difficult, not more efficient or accurate. We have seen one proposal that reaffirms the duty of candor and would actual strengthen the duty and the authority of the patent office to mold and reinforce. This proposal, authored by the AIPLA, further operates to address the chief deficiency with the "inequitable conduct" defense. The AIPLA proposal would provide an incentive to obtain a wholly valid patent -- and an incentive to work with the patent examiner to see that was done. We would urge Congress to give it careful consideration. The proposal of AIPLA, which is quite similar to a parallel position of the ABA IPL Section, provides this incentive in an utterly simple and elegant fashion- do not allow the defense of inequitable conduct to be pled in a case where the patent at issue is entirely valid. In such a case where no actual fraud can exist because only a wholly valid |