Obtaining a patent for an improved composition or method of use of known materials can bring substantial rewards. For example, this type of patent can provide leverage in licensing negotiations with the owner of an early, broad, blocking patent. It can also make the difference as to whether a pharmaceutical innovator's drug will become exposed to generic competition as soon as the original patent on the drug molecule expires, regardless of inventive work that continued beyond the original filing. Prosecuting and defending such patents can be difficult, however. Two Federal Circuit opinions highlight the role that result-oriented claim language can play in defeating an obviousness challenge. Innovators might consider including such language in their patent claims, either as a primary or a backup strategy.
Reducing the number of daily doses of a medicine without loss of efficacy may sound like something one would prove as an unexpected result, rather than include explicitly in a claim. But in one recent case, this result-oriented limitation did appear in a claim, and it likely saved the day for the patentee. See Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1289 (Fed. Cir. 2013). The Allergan court considered obviousness challenges to both a method claim explicitly reciting the effective, reduced dosing—twice a day instead of three times a day—and a claim to the composition used in the method that did not have result-oriented language. Id. The medicine at issue treats glaucoma or high eye pressure and comprises 0.2 percent brimonidine and 0.5 percent timolol. Id. The method claim survived the obviousness challenge, but the composition claim did not. Id. at 1295.
The reasoning underlying these divergent outcomes in Allergan shows the importance of the result-oriented claim language. The prior art taught administering 0.2 percent brimonidine and 0.5 percent timolol five minutes apart, and that achieving better patient compliance would have motivated one to combine brimonidine and timolol into a single formulation. Id. at 1293. Reversing the trial court regarding the composition claim, the Federal Circuit found that the evidence of obviousness outweighed secondary considerations—including unexpected efficacy. Id.
Turning to the method claim, the court did not explicitly weigh secondary considerations against the evidence of obviousness. Instead, it noted that the method "contains the additional limitation that the daily number of doses of brimonidine be reduced from 3 to 2 times a day without loss of efficacy," id. at 1293, and reasoned that "while it is true that the prior art shows concomitant administration of brimonidine and timolol . . . twice per day, this art does not show that there was no loss of efficacy associated with that treatment . . . ," id. at 1294 (emphasis added). Loss of efficacy had been observed with brimonidine when given alone twice a day. Id. Thus, the claim survived because it recited a result—efficacy from a twice-daily administration no less than from a three-times-daily administration—unexpected in light of the prior art, even though twice-daily administration was not new and the composition used in the claimed method had been held obvious.
Since the result was an explicit limitation of the method claim, the result had to be proven obvious by clear and convincing evidence as an essential element of the challenger's prima facie case. In contrast, if the result had not been recited in the claim, the patentee would have had to prove it as a secondary consideration and it would have needed to outweigh the challenger's 35 U.S.C. § 103 case—evidently a strong one given the composition claim's demise. Thus, in a validity contest, it can be an advantage to the patentee having a result limitation in a method claim. In prosecution, result-oriented claim language might keep the burden of production on the examiner and avoid possible downsides of showing unexpected results, such as costs, delays, and risks that may be associated with using declaration evidence to rebut an obviousness rejection. Of course, in cases where claims without result-oriented language are patentable, such claims may be preferable since the result need not be shown to prove infringement. And including method-of-use claims both with and without a result limitation might be a good general strategy, as it provides the patent holder with more flexible enforcement options.
Another recent case, when read with Allergan, further highlights the potential importance of result-oriented language. The Federal Circuit held obvious a claim to an anti-acne pharmaceutical composition comprising certain inactive ingredients and 0.3 percent adapalene as the sole active ingredient. Galderma Labs., L.P. v. Tolmar, Inc., __ F.3d __, 108 U.S.P.Q.2d 1929, No. 13-1034 (Fed. Cir. Dec. 11, 2013). The prior art taught acne medications containing adapalene from 0.01 percent to 1 percent, and the obviousness of the inactive ingredients was undisputed. 108 U.S.P.Q.2d at 1931-32. The key difference between the prior art and the patentee's claimed composition, therefore, was selection of the specific 0.3 percent adapalene concentration. The patentee prevailed at trial based in part on evidence that 0.1 percent was considered the optimum adapalene concentration, and although one would have expected a "clinically significant increase in side effects" from using a higher concentration, the claimed 0.3 percent composition unexpectedly provided comparable tolerability to the 0.1 percent composition. Id. at 1933-34.
The Federal Circuit reversed, holding that the tolerability "does not constitute an unexpected result that is probative of non-obviousness," despite agreeing with the district court that it was unexpected. Id. at 1934. The panel majority explained that unexpected results "probative of non-obviousness . . . differ[] in kind and not merely in degree," and that results "which differ by percentages are differences in degree . . . , where the modification . . . is within" ordinary skill. Id. (emphasis added) (internal citations and quotation marks omitted). Here, "skilled artisans were capable" of making the necessary modification, and "the expected result was an increase, by some percentage, in the prevalence of certain side effects. The failure of that percent increase to materialize, though unexpected, constitutes only a difference in degree from the prior art results." Id. (emphases added). In other words, the majority found that, in this case, a change in a parameter that turns out to be lower than expected was not sufficient for a legal showing of unexpected results, and had no effect against the evidence of obviousness. The claim was held obvious—despite its novelty and the ability of the claimed composition to provide a likely nonobvious result, judging from the court's acknowledgement that it was factually unexpected.
In dissent, Judge Newman sharply criticized the majority for "applying flawed procedural and substantive law" and "rely[ing] on their own factual determinations and creative theories of law [to] eradicate the patent." Id. at 1935 (Newman, J., dissenting). Judge Newman further stated that "refusing to credit any of the demonstrated 'secondary considerations'" would "foreclose patentability to a vast body of improvement patents." Id. at 1936. Despite these criticisms, innovators should prepare to live with the Galderma precedent unless and until it is either overruled or limited in future cases to its particular facts.
It seems prudent for innovators seeking to patent an improvement to follow the lesson of Allergan about the potential benefits of result-oriented language, either using independent or dependent claims. That is, where a composition or method can provide a result that is unexpected, that result should appear explicitly in one or more claims—it may be easier to win on validity since the challenger needs to prove its obviousness. This consideration may have particular relevance with a result potentially vulnerable to a "degree, not kind" challenge (see Galderma) that prevents the result from acting as a secondary consideration at all. Additionally, a reissue application to add or amend claims may be worth considering for some issued patents with no pending child application, e.g., if unexpected results were relied upon in prosecution or all claims may be vulnerable to a Galderma challenge. In conclusion, including result-oriented language in a claim can be advantageous because an examiner or challenger would have to prove obviousness for the claim as a whole, including the result—and the result may increase the burden of proof substantially.
This article previously appeared in Full Disclosure Patent Prosecution Update, January 2014.
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