A “public use” of a claimed invention, by anyone, prior to the critical date will render the corresponding patent claims invalid (or unpatentable), if the invention, at the time of the public use, was ready for patenting. Under well established pre-AIA case law, an invention was deemed to have been “ready for patenting” if it had been reduced to practice or if drawings and/or descriptions of the invention had been prepared that were sufficiently specific to enable one of ordinary skill in the art to practice the claimed invention. Reduction to practice, however, requires that an invention be shown to work for its intended purposes. Courts consider the following factors when assessing whether or not a use is experimental: (1) the length of the test period; (2) any confidentiality agreement (though the presence or absence of a confidentiality agreement is generally not dispositive); (3) any records of testing; (4) any monitoring and control of the test results; (5) the number of tests; and (6) the length of the test period in relation to tests of similar inventions. One reason for this approach is to secure the earliest possible filing date thereby pre-dating as much would-be prior art as possible.
Accordingly, a proper analysis of whether a use constitutes a public use has always involved an inquiry into, first, whether the invention was “ready for patenting,” and secondly, whether the use was in fact public or not. Such would-be prior art, however, is not limited to that published or otherwise emanating from others but also includes time bars such as the public use bar.
While both the “ready for patenting” and the “public” prongs of the public use analysis are fact-intensive, case-specific analyses, adhering to the above guidance will unquestionably significantly increase the probability of side-stepping public use defenses based on a patentee’s own clinical trials.
Consistent with above, care should be taken not only with respect to design and implementation of the patentee’s clinical studies, but also with respect to decisions as the timing of the filing of patent applications directed to inventions that will be used in connection with carrying out the clinical studies.
 Specifically, the district court was persuaded by Merck’s expert who testified that, because MTHF was “a potentially dangerous new drug,” a standard offer for sale in the pharmaceutical industry for a product like MTHF would include “important safety and liability terms.”  The court noted, moreover, that there had been no legally binding sale because no agreement was reduced to writing and signed by both parties, as required by the Confidentiality Agreement. The sole issue on appeal was whether the Merck fax was an invalidating commercial offer to sell MTHF.
The information herein should not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer. The Federal Circuit also rejected Merck’s argument that the Confidentiality Agreement prevented the Merck fax from constituting an offer for sale.  The pre-AIA § 102(b) on-sale bar applied to the patent at issue in this case.It held that the Confidentiality Agreement, by its terms, did not apply to a stand-alone product purchase, and, even if it did, nothing in the Confidentiality Agreement required an ], The AIA § 102(a)(1) on-sale bar is different and is not discussed here.Any views expressed herein are those of the author(s) and not necessarily those of the law firm’s clients.
A connection pool is a standard technique used to maintain long running connections in memory for efficient re-use, as well as to provide management for the total number of connections an application might use simultaneously.
This behavior can be disabled using the The connection pool has the ability to refresh individual connections as well as its entire set of connections, setting the previously pooled connections as “invalid”.