In This Issue:

1 - Obviousness of Pharmaceuticals - Patentability Over Known, Structurally Similar Compounds

1 - Post-Issuance Options: The Benefits and Risks of Reexamination and Reissue

11 - Stanford v. Roche, the Bayh-Dole Act, and the Possibility of Unintended Consequences

15 - MBHB is...

Excerpt from "Obviousness of Pharmaceuticals..."

Ethyl, methyl, butyl…futile – the running joke in grad school. Just try a different substituent until you find an active compound – or not. But while tweaking an alkyl substituent might seem “obvious” in the lab, when it comes to patent protection of small molecules, is it necessarily obvious? When examining a patent application with claims directed to novel chemical compounds, an examiner may reject those claims under 35 U.S.C. § 103 as obvious over structurally similar compounds in the prior art. Likewise, an accused infringer will often allege that the asserted claims to chemical compounds are “obvious” when challenging the validity of a patent. Successfully overcoming a charge of obviousness can be critical where the compound(s) in question are clinical candidates or are already highly successful commercial therapeutics. So how can you defeat those assertions?