Who should decide medical device patent infringementjudge or jury?

In a case that could have profound implications for all medical device patents, lawyers representing medical device manufacturer Medela have asked the U.S. Supreme Court to determine whether judges should have the power, rather than juries, to decide whether a patent should be invalidated on the grounds of obviousness.

In its petition for a writ of certiorari filed on Aug. 13, Medela posed the statement: “[W]hether a person accused of patent infringement has a right to independent judicial, as distinct from lay jury, determination of whether an asserted patent claim satisfies the 'on-obvious subject matter' condition for patentability."

The obviousness standard is the standard through which courts determine whether an invention is innovative enough to deserve patent protection. In the underlying case, Kinetic Concepts and Wake Forest University Health Services accused McHenry, Ill.-based Medela of infringing on two patents relating to wound treatment devices.

Medela claimed the patents were invalid under the obviousness standard, but a jury rejected its argument. The verdict was affirmed by a federal circuit, despite Medela’s argument that a judge should have made the legal determination as to the question of obviousness.

According to the petition, the action of the federal circuit court is “difficult or impossible to reconcile with this court’s precedents on obviousness.” The petitioners pointed to the recent case, KSR International v. Telefex, in which the court confirmed that the “ultimate judgment of obviousness is a legal determination.” They went on to point out that the court in KSR said “multiple times” that obviousness analysis should be undertaken by courts or patent examiners and that no mention was made of juries conducting this analysis.

“Under the Federal Circuit Court’s authorized procedure, lay juries with no legal training whatsoever are supposed to learn patent obviousness law on the basis of less than ten pages of text and, at most, a few minutes of oral instruction by the trial judge," the petitioners stated, adding that “the entire procedure seems to be a polar opposite from the explicit and careful process of legal analysis that KSR and this Court’s earlier precedents have mandated that courts should follow in analyzing the legal issues of obviousness.”