35 USC §103 – Obviousness [U.S. Law]
Obviousness and the U.S. Supreme Court: The purpose of §103 is “to find a balance between promoting innovation and allowing the public to use and perfect the invention for the good of the economy.” KSR International Co. v. Teleflex Inc., et al., 550 U.S. 398 (2007).
KSR International Co. v. Teleflex Inc., et al., 550 U.S. 398 (2007)
KSR is the most important recent US Supreme Court case on obviousness because it directs the USPTO and courts to avoid applying a rigid test for obviousness. The Supreme Court denounced rigid tests for obviousness because such tests would inappropriately bar the use of “common sense.”
Obviousness for Small-Molecules:
Lead Compound Analysis
For small molecules, the courts & the USPTO apply a two-part Lead-Compound Analysis:
- Determine whether a chemist would have selected the prior art compound as a lead compound for further development;
- Determine whether the prior art gives motivation to modify the lead to make the claimed compound with a reasonable expectation of success.
The Court of Appeals for the Federal Circuit (CAFC) described the two-part inquiry of the lead compound analysis in its decision Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007) in the same year as KSR. More recently the CAFC backed up Takeda in its decision in Otsuka Pharmaceutical Co. v. Sandoz, Inc. (Fed. Cir. 2012) (No. 11-1126). The Lead compound analysis resembles the previous rigid use of the Teaching, Suggestion or Motivation (TSM) test, which was frowned upon by the Supreme Court. However, the CAFC allows for the flexibility required by KSR because, for example, the reason or motivation for a Person Having Ordinary Skill in the Art (PHOSITA) to modify a lead compound may come from a variety of sources, or not even be explicit in the prior art. Otsuka, Slip Op. at 19-20.
