BIO's Reaction to KSR v. Teleflex

    By Christopher P. Singer --

Shortly after the Supreme Court released its opinion in KSR Int'l Co. v. Teleflex, Inc., Biotechnology Industry Organization (BIO) president and CEO Jim Greenwood commented on the decision, as well as on the amicus brief the organization had previously filed on behalf of Respondent, Teleflex, Inc. Mr. Greenwood stated that while the ultimate impact of the KSR decision on the biotech industry will not be known until District Courts and the Patent Office begin to apply the holding, he believed that the Supreme Court recognized the need for a "careful and deliberate analysis to the question of obviousness," which focuses on predictability of results.

In reviewing BIO's amicus brief in light of last week's decision, the organization had discussed the importance of investment dollars to the health and advancement of the biotech industry, and how a movement toward a more subjective analysis of obviousness would stem the flow of money into the industry.  The brief also argued strongly in favor of a consistent and predictable obviousness calculus, taking the position that the Federal Circuit's "TSM" test is consistent with the Supreme Court's earlier precedent, including its decisions in Hotchkiss v. Greenwood and Graham v. John Deere Co. BIO seemed to be particularly concerned that a more lenient test for obviousness would have allowed the dreaded "hindsight element" to infuse itself into the analysis and become more difficult to argue against successfully.  Indeed, hindsight bias logically arises more often in technologies and inventions that have a more prolonged prosecution (biotechnology).

BIO's amicus brief also set forth an argument against a separate obviousness test for combination inventions, which would include a "nebulous 'synergism' requirement[.]"  (Brief at 25).  The Supreme Court's KSR opinion does cite with approval to three post-Graham cases (U.S. v. Adams; Anderson's-Black Rock, Inc. v. Pavement Salvage Co.; and Sakraida v. Ag Pro, Inc.).  Each of these cases relates to combination inventions and stands (generally) for the proposition that in order for a combination of known elements to be non-obvious, the combination of elements must do more than function as they would individually.  Nevertheless, it remains to be seen whether this principle can be applied as readily to inventions in the pharmaceutical and biotechnology sectors.

For additional information regarding the KSR decision, please see:

• "Implications of the Supreme Court's KSR v. Teleflex Decision for Biotechnology," May 4, 2007
• "CLE's on KSR Int'l Co. v. Teleflex Inc.," May 4, 2007
• "The Patent Office Reacts to KSR: A First Look," May 3, 2007
• "KSR Int'l Co. v. Teleflex Inc. (2007)," April 30, 2007