Presumed valid but rebuttable

All issued United States patents are presumed valid but this presumption is rebuttable with clear and convincing evidence. During prosecution of a patent application, the examiner looks for prior art references to see if the invention being claimed is novel and non obvious.  If no prior art reference is found that is on point, then the patent will mature into a patent.  It is more difficult to use those prior art references found by the examiner which are similar but not on point to rebut the presumption of validity.The following case explains and illustrates how to treat evidence that was considered by the Patent Office during prosecution of the patent application.

Facts of case

In Lupin v. Sciele, the patent owner Shinogi obtained allowance for some but not all of its originally submitted claims for an extended time-release pharmaceutical product.  During prosecution, the patentee cancelled the rejected claims so that the allowed claims would mature into a patent.  To the patentee’s surprise, the rejected and cancelled claims found its way into the issued patent.  The Patent Office had made a mistake.

The defendant attempted to market a competitive pharmaceutical formulation alleged to infringe those claims that were cancelled but nonetheless appeared in the issued patent.  During litigation, the defendant argued that those claims at issue were invalid due to the prior art already considered by the examiner during prosecution of the patent application. The Federal Circuit held that regardless of whether the evidence submitted to rebut the presumption of a patent’s validity was previously considered by the Patent Office, the standard to rebut the presumption of validity always remains a the same level, namely, the clear and convincing standard.  What changes is the weight of the evidence.  If evidence was already considered by the Patent Office, then the trier of fact should afford this previously considered evidence less weight.  But, if it was not considered, then the trier of fact is allowed to afford more weight to the evidence in rebutting the evidence.

Holding of case

In the present case, the prior art references were already considered by the Patent Office and is given less weight. Nonetheless, the Federal Circuit held that in light of the prosecution history and the Examiner’s finding that these prior art references established obviousness of the claims, the presumption of validity of the patent at issue was rebutted.  Thus, the Patent Office errors did not save the validity of claims that the Examiner found were unpatentable.

All issued United States patents are presumed valid but this presumption is rebuttable with clear and convincing evidence. During prosecution of a patent application, the examiner looks for prior art references to see if the invention being claimed is novel and non obvious.  If no prior art reference is found that is on point, then the patent will mature into a patent.  It is more difficult to use those prior art references found by the examiner which are similar but not on point to rebut the presumption of validity.The following case explains and illustrates how to treat evidence that was considered by the Patent Office during prosecution of the patent application.

I invite you to contact me with your patent questions at (949) 433-0900 or James@OCPatentLawyer.com. Please feel free to forward this article to your friends. As an Orange County Patent Attorney, I serve Orange County, Irvine, Los Angeles, San Diego and surrounding cities.