Generic Challenge:. Martin a. Voet

period could allow the patent to be obtained in the U.S. if a patent application was filed within a year of the disclosure by the inventor on applications filed on or after March 16, 2013.

Experimental Use Exception

      An exception to this general rule on novelty is if the invention was being tested before completion (the so-called “experimental use” exception), but reliance on that exception could result in loss of patent rights if it is determined the invention was already perfected and was therefore a “public use”.

      In the pharma field, clinical trials have been held not to be a public use where the inventors did not know if their formulations would work for their intended purpose until after the clinical trial (In re Omiprazole Patent Litigation (Fed. Cir. 2008)). More recently, in Dey v. Sunovion (Fed. Cir. 2013), the Federal Circuit likewise held a clinical trial was not a public use due to confidentiality with the clinical trial administrator and the fact the subjects were given only a general description of the treatment formulations.

      However, in Pronova v. Teva (Fed. Cir. 2013), the Federal Circuit held a patent invalid as a public use where a shipment of the drug product that was claimed in the subject patent was sent to a skilled outside researcher for testing to confirm its content without any restrictions, and the product’s formulation was disclosed in detail to the researcher, and that the confirmatory testing was performed by the researcher, even though he did not test it for its indicated use to reduce triglyceride levels.

      Does the America Invents Act affect the foregoing? Effective March 16, 2013, clinical trials conducted outside the U.S. which do not meet the experimental use exception could be used to invalidate the patent if the clinical trial was found to be “available to the public”. As a result, the safest thing for an inventor to do is to file at least a provisional application in the U.S. before conducting any clinical trials to avoid making any inadvertent public disclosures of the invention.

Non-Obvious

      This is almost always the main question concerning patentability. Typically, an invention is new, useful and novel or no one would bother filing a patent on it. The law says non-obviousness must be viewed from the perspective of one of ordinary skill in the subject matter to which the invention pertains, with knowledge of all prior public uses and publications relating to such subject matter, taken as a whole. The law of non-obviousness fills whole libraries so thankfully this book is not intended to go into it in any detail. However, that is what patent attorneys spend most of their time and your money on: trying to convince patent examiners that the invention in front of them is not obvious, or in front of judges and juries trying to convince them that it is.

      In order to be rejected in the U.S. Patent Office on the grounds of non-obviousness (known in the trade as a “103 rejection” after the code section, 35 USC 103, which defines non-obviousness), an Examiner may combine any number of prior publications that relate to your invention and reject your claims as being obvious in light of the combination. This is in contrast to a rejection for lack of novelty that requires that the disclosure of the invention in the prior publication be contained within a single document.

      For example if you were claiming the first metal tennis racquet, the Examiner could reject you by combining one reference showing a conventional wooden racquet with a second reference showing that it was known to replace wood with metal in other sports equipment, such as skis. That would establish what the Patent Office would call a “prima facie” case of obviousness or obvious on its face. In order to overcome this rejection, the inventor would have to submit further argument as to why it would not be obvious to substitute metal for wood in a tennis racquet or that by doing so, one obtained certain unexpected results such as superior accuracy or faster ball speed off the racquet or whatever.

      A finding of unexpected results typically overcomes the prima facie case of obviousness. That is why patent lawyers are always looking for unexpected results as it is often the key to obtaining a patent. (A friend of mine, a pilot, once told me that actors were always looking for inspiration and pilots were always looking for a place to land. I asked what about lawyers? He said lawyers were always looking for a situation in which a great deal of money was about to change hands!)

      In 2007, the Supreme Court handed down its first new decision on obviousness in 40 years. The new case, KSR v. Teleflex concerned the validity of a patent covering a variable-height gas pedal. In holding the patent invalid, the Supreme Court made clear that “the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”. In other words, if common sense tells you something is obvious, and there are no unexpected results, then it is probably not patentable.

      The KSR case overturned an important line of cases which the Court of Appeals for the Federal Circuit (CAFC or Federal Circuit) had long advocated as the standard for determining obviousness, the so-called “teaching-suggestion-motivation” (“TSM”) test. The TSM test requires evidence of some teaching or suggestion or other motivation to combine prior art references to show obviousness, since otherwise any invention could be considered obvious by hindsight if all you had to do was find the parts of the invention in separate documents and simply say it would have been obvious to combine them to make the invention.

      The KSR case concerned the patentability of a variable-height gas pedal that substituted an electronic means for controlling speed for a conventional mechanical cable. In restating the law of obviousness, the Supreme Court did not say that the TSM test was necessarily always a bad test, (though Mr. Justice Scalia said in oral argument that he thought the test was “gobbledygook”), the Court concluded it was too rigid a test and it was certainly not the only test that should be applied, and although there had to be some reason articulated to combine references, that reason might even be just plain old common sense.

      In fact the Supreme Court suggested in KSR that one of the reasons for combining references could even be “obvious to try”. However, an “obvious to try” standard essentially substitutes hindsight for a more intellectually rigorous analysis to determine whether an invention would have been obvious to an ordinarily skilled artisan at the time the invention was made, a bit like Monday-morning quarterbacking. Since KSR, the Federal Circuit and the lower courts have been working out the modified standard for obviousness.