Opinion ID: 208134
Heading Depth: 2
Heading Rank: 1

Heading: Validity of the Reissue Claims

Text: Each of claims 43-48, 51, 54, 67, 69, 72, and 74 recites a pharmaceutical composition with active ingredients consisting of tramadol and acetaminophen in a ratio of about 1:5 to about 1:19. A single tablet containing only tramadol and acetaminophen in a fixed dose ratio within the claimed range is not disclosed in the cited prior art. Flick discloses a four-compound combination comprising tramadol, acetaminophen, and two other active ingredients. Flick does not suggest that the pentobarbital sodium and ethoxy benzamide are merely optional for the combination to work as desired. The parties dispute whether Flick suggests that the composition in example 23 exhibits a synergistic effect. Ortho submitted uncontroverted expert testimony that one of ordinary skill in the art would not find it obvious to try to remove two of the four active ingredients disclosed in Flick example 23 to arrive at the claimed composition. The expert explained that drug interactions are complicated and unpredictable. He testified that the interactions of tramadol and acetaminophen were especially poorly understood in 1990. The expert testified that one of skill in the art would not expect the combination of solely tramadol 2008-1549, -1550 6 and acetaminophen to have any particular advantage unless Flick or some other reference specifically identified one. The expert testified that Flick’s broad statement that tramadol “often” displays synergistic affects when combined with other analgesics would not be enough give one of ordinary skill any expectations whether tramadol combined only with acetaminophen in a 1:5 to 1:19 ratio would exhibit the synergistic effects discovered by Ortho. Ortho’s expert also testified that no combination of the German references and Flick would suggest the claimed combination of tramadol and acetaminophen. The expert explained that the German references actually teach away from the claimed composition because they emphasize the importance of flexibility in choosing combinations and doses of medications based on individual needs. The expert testified that the claimed fixed-dosage combination tablet was disparaged in the German references and disfavored in the art at the time. Ortho’s proffered reading of Flick and the German references, as well as expert testimony regarding the understanding of one skilled in the art, raises material questions of fact as to whether a skilled artisan would have found the claimed combination of tramadol and acetaminophen to be obvious. We therefore vacate the district court’s summary judgment invalidating RE’221 claims 43-48, 51, 54, 67, 69, 72, and 74 based on obviousness and remand the case for a trial on the merits.