Unigene Laboratories, Inc. and Upsher-Smith Laboratories, Inc. v. Apotex, Inc. and Apotex Corp.

Obviousness requires the showing that a person of ordinary skill at the time of the invention would have selected and combined prior art elements in the normal course of research and development to yield the claimed invention.

For full opinion:
2011 U.S.App.LEXIS 17762
2011 WL 3715557

Opinion (Rader): Apotex Inc. and Apotex Corp. (“Apotex”) challenged the validity of U.S. Patent No. RE40,812E (“’812E patent”), owned by Unigene Laboratories, Inc. and Upsher-Smith Laboratories, Inc. (“Unigene”), due to obviousness. The Court of Appeals GRANTED summary judgment for Unigene finding that the ‘812E patent was non-obvious. In order for an invention to be obvious, there needs to be a showing that “a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention.” The Court of Appeals applied the Graham factors (1. the scope and content of the prior art; 2. the level of ordinary skill in the art; 3. the differences between the claimed invention and the prior art; and 4. evidence of secondary factors) in determining that the ‘812E patent was non-obvious. Although the Court of Appeals found secondary factors of design need and market pressure to design around a prior invention, the Court found that the use of citric acid by the inventor was innovative due to being against the suggestions of prior art. The Court of Appeals also DISMISSED Apotex’s claims of criminal fraud and inequitable conduct finding that typographical mistakes in the ‘812E patent did not have the deceptive intent required for criminal fraud and inequitable conduct.