On Tuesday, a divided panel of the Fed. Cir. found that Allergan’s claimed method of reducing the number of daily topical doses of brimonidine to treat glaucoma from 3 to 2 doses by administering a composition containing 0.2% brimonidine and 0.5% timolol, as unobvious, even though both drugs were known to be effective to treat glaucoma and the two drugs had been administered serially twice a day rather than three times a day. Allergan, Inc. v. Sandoz Inc., App. No. 2011-1619, -1620, -1635, -1639 (Fed. Cir. May 1, 2013). The majority of the panel reached this conclusion even after finding that the composition claims were obvious in view of the art, and after recognizing that an inherency doctrine may apply to an otherwise obvious claim, as well as to support an anticipation rejection.
In other words, the dissent (Dyk) “would find [the method claim] obvious on the grounds that it merely claims the result of treatment with an obvious composition.” The majority (Proust and O’Malley) distinguished decisions in which “patentee claimed either a previously unknown result or an undisclosed inherent property of an otherwise anticipated claim, citing Bristol-Myers Squibb v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir. 2001). In this decision, the court considered a claim to reduce the side-effects of a known anti-cancer drug by using a specific dosing regimen. The process, in its entirety, was found in the prior art, and the B-M court stated that “[i]n the context of anticipation, ‘[n]ewly discovered results of known process directed to the same purpose are not patentable because such results are inherent.’” Id. At 1376.
However, in this case, the question was whether or not the administration of an obvious composition would inherently yield the recited result (no loss of efficacy) and the panel found that Sandoz had only argued the obviousness of the method over the prior art and “does not argue that this efficacy limitation is inherent to fixed combination products [containing the two drugs], nor that a dose reduction without loss of efficacy would inherently flow from the obvious [composition].”
Although the court uses wobbly language at page 13 of the opinion, where it says that the prior art discloses “concomitant administration” of the two drugs multiple times a day – “concomitant” means “at the same time or almost at the same time,” the court clearly states that combinations with timolol and brimonidine were not in the prior art.
So the moral of this story is to get your “new use of an old compound/composition” into obviousness territory, so that inherent anticipation of your new use is not an issue. Once you are in obviousness-land you can show unexpected results – which did not help Allergan with its composition claims but saved its exclusivity with a single method-of-use claim. (Note: This also saved Perricone in Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005).) And just as a side bar, it is worth noting that in Mayo v. Prometheus, the Supreme Court endorsed “a new way of using an existing drug” as patentable subject matter. This may be indirectly influencing the Fed. Cir. to be more legally tolerant of such claims than it has been in the past.