Upon reconsideration as directed by the Federal Court of Appeal, the Federal Court upheld the validity of the 630 Patent concerning the co-administration of infliximab and methotrexate for the treatment of rheumatoid arthritis.
The Court concluded that the 1994 Kennedy Report and the Higgins publication did not anticipate the invention as they lacked full disclosure of the essential elements and did not enable a person of ordinary skill in the art without undue experimentation.
The Court further found that the invention was neither obvious nor obvious to try in light of the prior art, including the FDA Workshop, affirming the original trial decision.