As many readers of this blog are by now aware, the Supreme Court today issued its much anticipated opinion in National Federation of Business et al v. Sebelius, regarding the constitutionality of the Patient Protection and Affordable Health Care Act (PL 111-148), more commonly refered to as "Obamacare". Because of the importance of this decision, we're attaching a link to another blog site maintained by Porter Wright Morris & Arthur LLP, "Employee Benefits Law Report", and to an entry , "Health Care Reform Survives Supreme Court Scrutiny - But Not Entirely Intact", authored by Rich McHugh, a partner in the Porter Wright DC office. Rich's practice focuses on employee benefits. A link to the decision is embedded within the article.
The Supreme Court’s decision in KSR v. Teleflex makes it easier to show that an invention is obvious. This case is likely to result in changes in the nanotechnology field and elsewhere, including:
?For patent applicants, fewer – but perhaps more valuable – allowed patents.
?For patent owners, a greater risk to patent claims that are challenged based on obviousness.
?For patent licensees, another factor to consider when evaluating existing license agreements in view of Medimmune v. Genentech.
Here’s what happened:
35 U.S.C. §103 requires that a patentable invention be nonobvious in view of the prior art. A finding of obviousness may be based on a single reference. For example, a claim for nanometer size aluminum oxide particles was found to be prima facie obvious in view of a reference that disclosed aluminum oxide particles with overlapping particle sizes and size distributions. In re Kumar, 418 F.3d 1361 (Fed. Cir. 2005). More often, though, a finding of obviousness is based on a combination of references that together disclose all elements of an invention, with elements “missing” from one reference being supplied by another reference. For example, a release agent comprising a stable emulsion of submicron size polysiloxane particles was held to be obvious in view of references that disclosed (1) a stable polysiloxane emulsion of similarly sized particles, and (2) an organopolysiloxane polymer used as a release agent. In re Ona, 38 U.S.P.Q.2d 1597 (Fed. Cir. 1995).
Before KSR, references could be combined only when there was teaching, suggestion, or motivation to combine the references at the time the invention was made (the “TSM” test). This avoided obviousness findings based on hindsight – an examiner or patent challenger could not rely on a combination of references unless the prior art pointed toward that combination. In the Ona case, above, the first reference taught numerous uses of the microemulsion and suggested its use where stability is desired. The court noted that this teaching would motivate one of ordinary skill in the art to use the microemulsion as a release agent, as taught by the second reference.
The Supreme Court concluded that the TSM test was too rigid and could preclude fact finders from applying common sense. The Court explained that “any need or problem known in the field . . . at the time of the invention . . . can provide a reason for combining the elements in the manner claimed” and that “familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” The Court did not abolish the TSM test but opened the door to a broader range of justifications for combination of references. In addition to increasing the difficulty of obtaining new patent claims, this new standard increases the likelihood that previously allowed claims will be held invalid, particularly if an obviousness rejection was overcome during prosecution by arguing that the TSM test was not satisfied.
[Editor's Note: Check back soon for an additional discussion on Medimmune]