Microsoft v i4i, the burden of proof and the pharma sector

If you think that shifting the burden
of proof is an uphill struggle, try
a few months of patent examination.

 In Microsoft Corp. v i4i Limited Partnership, 598 F.3d 831 (Fed. Cir. 2010) the United States Supreme Court has granted certiorari to address whether the statutory presumption of validity continues to apply when an issued patent is attacked based on prior art which was not on the record before the United States Patent Office (USPTO) during prosecution.

US legislation provides that, in infringement litigation, an issued patent shall be presumed valid. The burden of establishing invalidity of a patent or any of its claims thus lies with the party asserting invalidity. In Microsoft Corp. v i4i Limited Partnership the alleged infringer cited invalidity based on prior art which was not considered by the USPTO before issuance of the asserted patent. The Federal Circuit, noting that an issued patent is presumed valid, said that it was for the alleged infringer to prove invalidity under 35 U.S.C. l02(b) by clear and convincing evidence. However, the Supreme Court has agreed to hear an appeal on the issue of whether an invalidity defence based on newly-raised prior art must be proved by clear and convincing evidence.

According to Pharmaceutical Patent Attorneys LLP, the outcome of this appeal is of great significance in the pharma sector since it poses a potential advantage to generic drug makers, with a concomitant disadvantage to research based drug makers, if the burden of proof required to invalidate a patent in litigation is lowered. Says the organisation:

"Removing the presumption of validity when new prior art is relied on has some intuitive appeal, because the underlying reason for the statutory presumption – deference to administrative agency fact-finding – does not apply when the agency has not had the opportunity to review the relied-on references. On the other hand, deference should apply where the newly-cited reference is merely cumulative to, or redundant to, the art already of record during prosecution. Distinguishing the truly new from the merely cumulative requires a mini-trial; requiring district courts to adjudicate one for nearly every patent case does not help judicial efficiency".

Source: "Supreme Court May Change Burden of Proof", media release from Pharmaceutical Patent Attorneys, LLC


A more detailed appraisal of the certiorari in Microsoft v i4i has been written by the AmeriKat here and here