Tadalafil – USA

On Feb 28, 2017, The Federal Circuit ruled that the Patent Trial and Appeal Board incorrectly invalidated Los Angeles Biomedical Research Institute’s patent on drug Cialis (Tadalafil) for treating a condition related to erectile dysfunction based on obviousness. The patent-in-suit is U.S. Patent Number 8,133,903.

In two separate opinions (anticipation & obviousness) Federal Circuit affirmed the validity of US’903 patent challenged by Eli Lilly. With respect to obviousness court held that because the Board’s obviousness determination was predicated on an erroneous claim construction of two of the limitations of claim 1, and because the Board did not make factual findings as to whether there was an apparent reason to combine the prior art references to treat penile fibrosis and whether a person of skill in the art would have had a reasonable expectation of success from such a combination, we remand this case to the Board.

With respect to anticipation court  affirmed PTAB decision & said that the reference “Whitaker” may suggest” long term daily treatment by noting the beneficial effects of daily treatment (better erectile response and decreased side effects) in light of Example 6, but that is not enough. To anticipate, a reference must do more than “suggest” the claimed subject matter. Thus, we hold that substantial evidence supports the Board’s finding that Whitaker does not disclose the claimed treatment regimen with sufficient clarity to satisfy the demanding standard for anticipation.