Generic Ultracet® Clears Another Patent Hurdle
2008-1549, 1550 Ortho-McNeil v. Kali
D/NJ 06-3533
Judge Dennis Cavanaugh
Ortho-McNeil appeals from the grant of summary judgment to defedants by Judge Dennis Cavanaugh finding that the claims of RE39,221 (formerly 5,336,691) are invalid as obvious.
Ultracet® is a pain relief drug combining tramadol hydrochloride and acetaminophen in a 1:8.67 ratio by weight. The claims of the '221 cover ratios of 1:5 to 1:19. In a related action (D/NJ 02-5707), Judge Liflind previously found that claim 6 of the '691--the only claim to make it into the '221, and covering a ratio of "about 1:5"--was anticipated and obvious.
The instant decision was nicely covered in The Orange Book Blog.
The so-called Flick patent, 3,652,589, described combining tramadol with other active ingredients, including with an analgesic in a two-agent tablet. Flick also described a four-agent tablet containing both tramadol and acetaminophen.
Ortho-McNeil argued that Flick didn't disclose, and taught away from, its claimed two-agent tramadol and acetaminophen combination because the '589 uses "consisting of" which, in patent-speak, is a closed-ended term conveying limitation and exclusion. Thus, Ortho-McNeil argued, Flick suggested the combination only in a four-agent combination. The court disagreed:
Plaintiff argues that the “consisting of” language contained in the Flick Patent would not instruct a person of ordinary skill in the art to combine only acetaminophen and tramadol into a two-agent tablet. A person of ordinary skill in the art, however, is also a person of “ordinary creativity, not an automaton.” KSR Int’l Co., 127 S. Ct. at 1742. Here, a person of ordinary skill in the art would not be misled by the “consisting of” language. One of Plaintiff’s own clinical research fellows, Dr. Minn, stated that he “can’t think of anybody who didn’t think of [combining tramadol with acetaminophen].” (Dep. of Dr. Minn at p. 23, l. 8-11). Additionally, as previously determined by Judge Lifland – and undisputed by Plaintiff – the Flick Patent discloses a pharmaceutical composition of tramadol and acetaminophen in the proportions claimed in the ‘221 patent. See Ortho-McNeil Pharm., Inc. v. Kali Labs., Inc., 482 F. Supp. 2d 478, 523 (D.N.J. 2007).
The court also looked at other references that suggested combining tramadol with acetaminophen, each time teaching or suggesting likely synergistic effects. The court, citing Judge Lifland, noted that Ortho-McNeil "failed to demonstrate that [Ultracet's] ''synergism is an unexpected result'" relative to the Flick and other references.
The court also considered, but rejected, Ortho-McNeil's secondary considerations, finding that, while relevant, were secondary and could not defeat or overcome clear invalidity.
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