Thursday, August 27, 2009

Combining drugs -- "epitome of obviousness?"

Ortho-McNeil sells the pain reliever Ultracet®, which is a combination of acetaminophen (Tylenol®) and tramadol (an analgesic). Ortho sued Teva Pharmaceuticals and Caraco Pharmaceutical Laboratories for infringing U.S. Reissued Patent 39,221, which claims combinations of acetaminophen and tramadol in certain ratios.

The defendants prevailed at the trial level by arguing that the patent was invalid for anticipation and obviousness. Basically, the prior art disclosed a pain reliever made up of acetaminophen, tramadol, and 2 other compounds at varying ratios. The trial court agreed that this rendered the patent obvious and anticipated, and granted summary judgment in favor of the defendants. Ortho appealed.

Obviousness of combining only acetaminophen and tramadol

The Federal Circuit stated the law on obviousness:
Obviousness is ultimately a determination of law, though it is based on questions of fact. [Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc. 424 F.3d 1293, 1302 (Fed. Cir. 2005] Anticipation is a question of fact. Id. Because issued patents enjoy a presumption of validity, obviousness and anticipation must be proven by clear and convincing evidence. Impax Labs., Inc. v. Aventis Pharma., Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008). When the patent examiner has considered the asserted prior art and basis for the validity challenge during prosecution, the burden of proving invalidity is especially heavy. Id.; Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990). ...
Inventions in most instances rely upon building blocks long since uncovered, and combine elements that are in some sense already known. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418-19 (2007). The combination of familiar elements according to known methods is likely to be obvious, however, when it does no more than yield predictable results. Id. at 1739. Each case must be decided in its particular context, including the characteristics of the science or technology, the nature of the choices available to one skilled in the art, the specificity of the prior art, and the predictability of results in the area of interest. Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008).
The Court then relied upon Ortho's expert testimony in deciding that there is a question of fact as to whether or not the claimed combination was obvious, and thus the Court vacated summary judgment on this issue and remanded.

Anticipation of the claimed ratio

The district court improperly resolved disputed questions of fact in reaching this conclusion. What a reference discloses is a question of fact. Para-Ordnance Mfg., Inc. v. SGS Imps. Int’l, Inc., 73 F.3d 1085, 1088 (Fed. Cir. 1995).
Thus, because the parties don't agree as to what the prior art discloses, a question of fact remains.

Obviousness of the claimed ratio

Here, the Federal Circuit was not convinced by Ortho's expert, and agreed with the trial court that no genuine issue of fact existed as to whether or not the claimed ratio was obvious. As such, claim 6 remains invalid for being obvious in light of the prior art.

The dissent -- Judge Mayer

Most interesting in this case (to me at least) is Judge Mayer's dissent. A sampling of his language conveys his opinion this matter:

The claimed invention does nothing more than combine two well-known pain relievers—acetaminophen and tramadol—in a single tablet. Since the prior art clearly and unequivocally taught that these two analgesics could be combined for effective pain relief, the claimed invention is the epitome of obviousness. I therefore respectfully dissent.

Ortho-McNeil Pharmaceutical, Inc. (“Ortho”) did not invent acetaminophen and it did not invent tramadol. ...

* * *

[A]s here, it was manifestly obvious to combine two well-known drugs -- which had previously been administered together -- in a single table...

* * *

Expert opinions must be given short shriftwhen they fly in the face of explicit disclosures in the prior art....

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Simply put, there is nothing even arguably new about what Ortho claims to have invented. I would affirm.
(emphasis added, and citations omitted).

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