In The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit held that the patent covering the active ingredient of ACTONEL was not obvious. Teva had argued that the claim covering the compound (risedronate) was obvious in view of an expired patent also owned by Procter. The previous patent did not claim or disclose the specific compound. The previous patent only disclosed a an intermittent dosing method for treating osteoporosis and listed 36 polyphosphonate compounds and Teva contended that the structural similarities between ACTONEL and one of the listed compounds rendered the claim covering ACTONEL obvious. The district court concluded that the earlier patent would not have led a person of skill in the art to identify the specific compound as the lead compound. The district court also found that due to the extremely unpredictable nature of bisphosphonates at the time of the invention there would not have been any motivation to make the specific modifications. The district court also found that the unexpected results of the potency of ACTONEL and the low toxicity rebutted any alleged obviousness and that the secondary considerations also supported its conclusions.
The court agreed with the district court explaining that "an obviousness argument based on structural similarity between claimed and prior art compounds 'clearly depends on a preliminary finding that one of ordinary skill in the art would have selected [the prior art compound] as a lead compound.'"
The CAFC framed the issue as stating that to decide whether residronate was obvious the court must determine whether there would have been a "reason to attempt to make the composition" known as risedronate and "a reasonable expectation of success in doing so." The court explained that even if a lead compound had been identified there was no factual support to find the reason to make the composition or that would have been a reasonable expectation of success. The CAFC and the district court relied upon Procter's expert witnesses that testified to the unpredictable nature of bisphosphonates and an article by the "preeminent authority on bisphosphonates that stated that "to infer one compound the effects in another is dangerous and can be misleading." The federal circuit agreed that the field was unpredictable and and that the district court had properly found that Teval failed "clear [the] hurdle, establishing insufficient motivation for a person of ordinary skill to synthesize and test risedronate."
The CAFC also agreed that there was no reasonable expectation of success. The court emphasized that there where there are a finite number of identified predictable solutions it is likely that the invention is obvious, but that where there are numerous possible choices "where the prior art [gives] either no indication of which parameters are critical or no direction as to which of many possible choices is likely to be successful" the "courts should not succumb to hindsight claims of obviousness." The court explained that "patents are not barred just because it was obvious "to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it." Here, the CAFC found that it was not routine to make the structural modification. Therefore, the claims were not obvious.
The court also found that Proctor had provided sufficient evidence of unexpected results and secondary considerations of non-obviousness to rebut any prima facie obviousness even if it had been properly made. The court found that Proctor had satisfied a long-felt need at the time the application was filed. Teva had argued that the long-felt need must be unmet at the time the invention becomes available on the market, when it can actually satisfy that need. Actonel came on the market after Fosamax so it couldn't fill any need because it had already been met. The CAFC disagreed finding that they look to the filing date to asses the presence of a long-felt and unmet need.
As an alternative ground Proctor had attempted to show that the patent used by Teva to show obviousness was not prior art. Proctor only had a notebook page that was dated but was unwitnessed and was not corroborated by any other evidence. Since there was no other corroboration other than the dated page it was not sufficient to disqualify the patent as prior art.
The full opinion can be found here.
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