Recoiling from a lengthy court fight with Kinetic Concepts Inc, medical instruments firm Medela has filed a petition in the Supreme Court calling for judges, rather than juries, to rule on obviousness cases.
Medela argues that 'widely varying legal rationales' confronting lay juries in patent cases make for outcomes detached from 'valid reasoning'. The company's bid for systemic change follows its failure this year to prove obviousness on appeal, after Kinetic alleged that Medela had infringed on its patented wound-therapy gauze.
'One of the most important conditions for patent validity is the requirement set forth in [Section 103(a) of the US Patent Act] that a claimed invention must have been "non-obvious subject matter" at the time of its making by a patent applicant,' says Medela's petition.
As such, it is asking the Supreme Court to rule on the question of: 'Whether 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 "non-obvious subject matter" condition for patentability.'
Filed on Medela's behalf by high-profile IP lawyer James Dabney – who took KSR v Teleflex to the Supreme Court in 2007 – the petition fills out the background of lay jury involvement in patent suits. It recounts that, from 1982, 'appeals from judgments in civil actions arising under federal patent law were diverted from the regional circuits to a then newly-created … Court of Appeals for the Federal Circuit [CAFC].
'In sharp contrast with Seventh and Ninth Circuit precedent,' adds the document, 'the Federal Circuit took the position that lay juries can render verdicts that preclude independent judicial determination of the ultimate question of patent validity under Section 103 [petition's emphasis]'.
While Medela credits the Federal Circuit for acknowledging that a test of obviousness may rest on a host of variables, it argues that the Circuit's means of addressing this, via post-trial or post-appeal reviews of jury decisions, is unsatisfactory. According to the petition, these reviews – which re-create the facts of a case in the form that the jury may have interpreted them – determine only 'whether such hypothetical facts would be sufficient to support a legal conclusion of validity on any theory [petition's emphasis]'.
Medela argues that, in practice, the effect of this 'is to eliminate any requirement that valid reasoning or analysis' will back a legal determination on obviousness. The petition's future at the Supreme Court has yet to be decided.
The action coincides with a move by the US Patent and Trademark Office (USPTO) to issue interim guidance on patentable subject matter to its examiners. The USPTO says that the guidance is a direct reaction to questions posed by Bilski, admitting that the state of the law over subject matter eligibility 'is in flux'. Aiming to steer examiners towards the legal basics, the guidance reinforces central tenets of eligibility, such as the classic categories of Process, Machine, Manufacture and Composition of Matter.