The U.S. Court of Appeals for the Federal Circuit smacked down Pfizer’s bid to get the court to reconsider a March 22 ruling that the patent on its hypertension drug Norvasc was invalid. See Pfizer v. Apotex (06-1261). The earlier ruling allowed Mylan Labs to make a generic version of Norvasc.

Mylan entered the market the day after a March 22 decision that invalidated the Norvasc patent but it lost in its efforts to prevent Apotex from entering the market before September. Apotex, the generic challenger that won the lawsuit over the patent’s validity, also may enter the market immediately. The patent expired March 25, three days after the court ruling. Pfizer had been given an additional six months of exclusivity for agreeing to test the drug for pediatric use.

Mylan was the first to challenge the patent and the only company to get FDA approval and so argued it has exclusive rights for six months. Apotex said that it should be the only generic company in the market because it won the appeals court decision. Teva claimed that since key provisions of the patent were invalidated, everyone should be allowed into the market.

The FDA came back and decided that, since the patent expired, Mylan wasn’t entitled to the six-months of exclusive rights for being the first to challenge the patent. However, the agency also ruled that, since only a portion of the Norvasc patent was invalidated, only Apotex could enter the market before Pfizer’s six-month exlusivity period ends in September — effectively shutting out Teva. Noteably, three of the 12 Fed Circuit judges, Judge Newman, Judge Lourie and Judge Rader, dissented.From Judge Newman:

Both sides acknowledge that the effects of chemical changes on properties of medicinal products is not predictable; the difference residing in the panel’s acceptance of the long-discredited “obvious to try” standard, on which the panel superimposes the theory that the skill of these inventors guided them to trial of the besylate salt (despite the prior art’s preference for the maleate salt), thereby negating patentability. The panel’s application of the obvious-to-try standard is in direct conflict with precedent; it has long been the law that “patentability shall not be negated by the manner in which the invention is made.”

From Judge Lourie:

… rather than give deference to the district court’s fact-findings, the panel substituted its own finding that a reasonable expectation of success existed in the art. See Pfizer, 480 F.3d at 1361, 1364-65 … Much public discussion has occurred, and even judicial comments in opinions, that we should defer to district court judges concerning certain aspects of claim construction, which we have held is a matter of law. Be that as it may, it is undisputed that we must defer to fact-findings by a district court, unless they are clearly erroneous, and I do not believe that they were here.

The panel concluded that the improvement of the invention, which related to drug formulation, viz., increased stability and decreased stickiness, was “insufficient” to meet the standards of patentability. … I read that conclusion as improperly requiring a compound to possess a specific type of improvement over the prior art—in this case, improved therapeutic properties—to be patentable, negating other important properties, a conclusion that is not compelled by our case law and not sound. Any useful and unexpected property should be eligible to overcome a prima facie obviousness determination.

Chemical and pharmaceutical compounds often can be found to be prima facie obvious, as they are based on prior work that could reasonably suggest them, see KSR Int’l Co. v. Teleflex Inc., — S.Ct. —, 2007 WL 1237837 (Apr. 30, 2007), but commercialization of such compounds may depend on their possession of unexpected properties. Such properties may be biological or physical. A failure to recognize all such properties that may be relevant to the value of such a compound may doom the compound to being poured down the drain rather than becoming an important therapeutic. The general public, innovative companies, and, ultimately, generic companies, depend upon faithful adherence to this principle. In addition, our cases hold that unexpected properties make for non-obviousness, see Papesch, 315 F.2d 381, and this decision disdains such properties if they are not biological. That is a conflict with our precedent that needs resolution.

From Judge Rader:

… ‘obvious to try’ jurisprudence has a very limited application in cases of this nature. With unpredictable pharmaceutical inventions, this court more wisely employs a reasonable expectation of success analysis. In this case, salt selection is unpredictable, thus rebutting, as most other courts found, any reasonable expectation of success. Although the panel gives “lip service” to the principle that ‘obvious to try’ does not work in this field, it nonetheless appears to be the basis for its decision in this case. In addition, the panel discerned a reasonable expectation of success by giving undue emphasis to the inventor’s subjective hopes for the outcome of his experiments.

The panel also found that amlodipine besylate was not patentable since it was made by a routine testing or a “well known problem solving strategy.” This clearly violates the statutory mandate that “patentability shall not be negatived by manner in which the invention was made.” 35 U.S.C. 103(a). Many if not most pharmaceutical inventions are discovered through a routine screening protocol or through an established trial and error process. Pharmaceutical inventions discovered by these routine screening methods include not only new formulations and salt forms, but also include the active pharmaceutical compounds themselves. Thus, this decision calls into question countless pharmaceutical patents, which in turn could have a profoundly negative effect on investments into the design and development of new life-saving pharmaceuticals.

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