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What makes an invention obvious and not patentable? This spring the Supreme Court aimed to expand the grounds on which obviousness can be demonstrated. Another decision this spring, from the nation’s second most important patent bench, is further roiling the water — especially for the life science arts. In its April 30 decision in KSR International Co. v. Teleflex Inc., the high court stated that an invention is likely obvious “[i]f a person of ordinary skill in the art can implement a predictable variation, and would see the benefit of doing so.” A lower court considering patent validity must therefore ask whether the improvement produced by the invention “is more than the predictable use of prior-art elements.” Nowhere is that latter query more critical than in the chemical, pharmaceutical, and life science arts, where oftentimes all the elements of an invention are previously known (in some fashion) and the decision on obviousness comes down to so-called secondary considerations — such as unexpected results, long-felt needs, and commercial success. A recent decision by the U.S. Court of Appeals for the Federal Circuit, however, has raised a cloud of confusion as to the value of secondary considerations. On May 21, the Federal Circuit refused to grant rehearing en banc in Pfizer Inc. v. Apotex Inc., despite the numerous questions raised by the panel opinion, including key inconsistencies with existing precedent. Judges Pauline Newman, Alan Lourie, and Randall Rader each dissented from the denial. One statement from Judge Lourie’s dissent crystallizes the issue: “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 . . . but commercialization of such compounds may depend on their possession of unexpected properties.” OBVIOUS TO TRY? Last year the district court found that Pfizer’s patent on Norvasc, a hypertension drug, was valid and enforceable. On March 22, 2007, the Federal Circuit panel reversed the lower court, holding that Pfizer’s patent was invalid under 35 U.S.C. �103(a) because it was obvious in view of the prior art. Unfortunately, the panel reached the wrong conclusion. The judges made two specific mistakes: They ignored unexpected properties of the claimed compound (amlodipine besylate, which is an acid addition salt form of amlodipine). And, overruling the trial judge, they substituted their own finding that a “skilled artisan would have had a reasonable expectation of success” under an obvious-to-try scenario. In reaching its conclusion, the panel adopted a new approach to prima facie obviousness that runs counter to a long list of established cases. Back in 1963, the predecessor court to the Federal Circuit stated in In re Papesch that “a compound and all of its properties are inseparable; they are one and the same thing,” and the court thus found “no basis for ignoring any property” in adjudging patent validity. Nearly three decades later, sitting en banc in In re Dillion (1990), the Federal Circuit held that a patent can be challenged on the basis of “test data showing that the claimed compositions possess unexpectedly improved properties or properties that the prior art does not have.” In Pfizer, the experts for both parties agreed that there is “no reliable way of predicting the influence” of a particular salt on the behavior of a chemical compound. Moreover, Pfizer presented evidence that its salt form proved to have a superior combination of properties — namely, increased stability and decreased stickiness — as compared with the prior art. Greater stability and less stickiness are highly useful factors in developing a commercially viable version of a pharmaceutical compound. Moreover, the panel stated, “We cannot reject the district court’s finding that in 1986 [when Pfizer filed its initial patent application], it was generally unpredictable as to whether a particular salt would form and what its exact properties would be.” But then the panel focused its analysis narrowly on whether one of ordinary skill in the art could reasonably expect to make amlodipine besylate and whether it would work for its intended purpose. The court found that a skilled artisan had a reasonable, albeit not guaranteed, expectation that amlodipine besylate would form when the known ingredients were put together. It pointed out that Pfizer had conceded in prior litigation — Pfizer Inc. v. Dr. Reddy’s Laboratories (Fed. Cir. 2004) — that the type of salt did not affect the therapeutic value of the active ingredient, amlodipine, and that various types of salts were practically interchangeable for this purpose. And the court noted that “numerous other publications” had directed skilled artisans toward this salt form. UNEXPECTED OUTCOME Focusing on the drug’s therapeutic effects, the panel gave little if any consideration to the other beneficial properties of amlodipine besylate — that it is more shelf-stable, less likely to absorb moisture, and easier to process than other amlodipine salt forms. In fact, the panel went to great lengths to discount these secondary considerations: “Pfizer has simply failed to prove that the results are unexpected.” It is this singular focus on therapeutic value over other physical properties that is misplaced. The record clearly shows that Pfizer had identified superior properties of the besylate form of amlodipine. Yet the panel decision strains to discount these unexpected properties, thereby flying counter both to established case law that all properties of a compound must be considered and to the panel’s own acknowledgement that “it was generally unpredictable” what properties a particular salt might demonstrate. Having gone through an obvious-to-try analysis and found that the “routine testing” of various salt forms by Pfizer was within the prior art, the panel then gave mere lip service to well-accepted patent law principles: “In coming to this conclusion, we have not ignored the fact that �[p]atentability shall not be negatived by the manner in which the invention was made.’ . . . Nor are we ignorant of the fact that reference to �routine testing’ or �routine experimentation’ is disfavored.” Fine words, but they didn’t change the outcome. In the end, the panel simply discounted the value of secondary considerations altogether, raising process over result: “[E]ven if Pfizer showed that amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.” A month later, the full Federal Circuit refused to rehear the case en banc. CONFUSION AHEAD The panel decision in Pfizer may have been subtly influenced by the then-pending outcome of KSR at the Supreme Court. Most patent practitioners envisioned that a change in the law would be coming, and many predicted that the high court would expand the law on obviousness, making it harder both to obtain patents and to defend them on the ground of nonobviousness. But few patent practitioners would have predicted the confused state of the law in regards to obviousness in the chemical and pharmaceutical fields. To put it simply, the life sciences remain more mysterious than the better-developed mechanical arts. When the Supreme Court suggested in KSR that the case law was overlooking the obvious, the justices themselves were looking at an innovation combining an electronic sensor with a brake pedal. Modern scientists are much better at predicting how such things might work than they are at predicting what will happen when various chemical and biological substances come together. The life science arts are rife with “unexpected properties” and “unexpectedly superior results.” After KSR, we would expect future patent applicants to provide less information in the way of background and less discussion of the purpose or object of the invention, thus avoiding setting forth a “need or problem” that a court could later point to as “a reason for combining the elements in the manner claimed.” Because KSR makes prima facie obviousness easier to demonstrate, we might also expect patent defenders to rely more on unexpected results and secondary considerations, especially in the chemical and pharmaceutical fields. But with the Federal Circuit’s decision in Pfizer comes new confusion about the value of secondary considerations. Given the previously well-established precedent, as well as the arguments and tone of the dissenting opinions (Judge Rader warned ominously that Pfizer “calls into question countless pharmaceutical patents”), this issue is ripe to become not only fact-dependent but also panel-dependent at the Federal Circuit.
John W. Ryan is a partner at the D.C. office of Crowell & Moring, where he focuses on intellectual property issues in the chemical, pharmaceutical, biotechnology, and medical device industries. Thomas M. Haas is an associate in the firm’s intellectual property practice.

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