SOUTHEAST TEXAS RECORD

WASHINGTON (Legal Newsline) — In a brief filed with the U.S. Court of Appeals for the Federal Circuit Wednesday, a Washington D.C.-based legal foundation urged the court to reconsider its decision in a patent infringement case shifting the burden of proof to the patent holder.

The Washington Legal Foundation argues in its 10-page amicus brief that unless the Federal Circuit reverses its course in Galderma Laboratories LP v. Tolmar Inc., it will “undercut” a long-standing presumption that patents are valid.

WLF filed its brief in support of plaintiffs Galderma Laboratories LP’s petition for a panel rehearing and rehearing en banc.

“WLF is concerned that the panel majority’s decision in this case singles out improvement patents in the medicinal arts by presuming such patents obvious and shifting the burden to patentees at trial to prove otherwise, contrary to this court’s precedent precluding such burden shifting,” its counsel wrote.

The foundation contends that the party challenging the validity of a patent should bear the burden of demonstrating invalidity — at all times.

“Rehearing of the panel decision is warranted because the panel majority disregarded statute and Supreme Court precedent requiring patent challengers to prove invalidity of any patent — including improvement patents — by clear and convincing evidence,” WLF wrote.

“This conflicting precedent is likely to confuse the public, undermine the ability of businesses in the medical sector to fairly assess their intellectual property, and result in more costly and uncertain litigation.”

Originally filed in the U.S. District Court for the District of Delaware in January 2010, Galderma’s lawsuit alleges that Tolmar’s adapalene gel — a generic version of its own Differin gel — infringed on its patents.

In December, a divided Federal Circuit panel overturned the district court’s decision upholding Galderma’s patents on Differin, which is used to treat acne.

The panel determined the patents invalid because it deemed the purported innovation “obvious,” and it faulted the district court for imposing the burden of proof on the alleged infringer, Tolmar.

Rather, the panel held, in cases in which the alleged infringer demonstrates that prior art appeared to disclose the subsequently patented product, the burden must shift to the patent holder to demonstrate that the patents should not be deemed obvious.

“The relevant dispute in this case is thus not over whether the prior art discloses all of the claim elements or over the motivation to combine the prior art references. Rather, the dispute is whether there was motivation to select the claimed 0.3 percent adapalene composition in the disclosed range,” Circuit Judge Sharon Prost wrote in the panel’s Dec. 11 decision.

“In these circumstances, where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.”

The panel concluded that the patent holder — in this case, Galderma — failed to meet this burden.

WLF argues in its brief that the Federal Circuit’s decision could end up hurting innovators, the medical field and, ultimately, patients.

“Rehearing is warranted for the additional reason that, by shifting the burden to the patent owner to prove nonobviousness, the panel decision decreases the incentive for innovators of improvement inventions to incur the cost and risk of research and disclose information that would otherwise be kept secret,” the foundation wrote.

“These breakthroughs in drug dosing and formulation can alter how medications are given to patients, improve patient compliance with medicinal treatments, and substantially increase efficacy and reduce intolerable side effects.

“Because these improvement inventions are so important to the advancement of medicine, rehearing is warranted to review the panel’s erroneous determination that different patentability criteria should apply to inventions relating to improvements as opposed to those consisting of brand new products.”

From Legal Newsline: Reach Jessica Karmasek by email at patents@legalnewsline.com.