WASHINGTON, DC.— The Washington Legal Foundation (WLF) today urged the U.S. Court of Appeals for the Federal Circuit to reconsider a decision that shifted the burden of proof in certain patent infringement cases from the alleged infringer to the patent holder. In a brief filed in support of a petition for rehearing en banc filed by a company that holds patents on a skin care medication, WLF argued that the party challenging the validity of a patent should at all times bear the burden on demonstrating invalidity.
In December, a divided Federal Circuit panel overturned a district court decision that upheld the validity of patents on Differin Gel, a topical medication approved by FDA for treating acne. The panel held that the patents were invalid because they were obvious. The panel faulted the district court for imposing the burden of proof at all times on the alleged infringer. Rather, the panel held, in cases (as here) in which the alleged infringer demonstrates that the “prior art” appeared to disclose the product that was later patented, the burden falls on the patent holder to come forward with evidence demonstrating that the patents should nonetheless not be deemed obvious. The panel held that the patent holder had failed to make the required demonstration.
In urging the full Federal Circuit to rehear the case, WLF argued that the panel erred when it shifted the burden of proof to the patent holder — a shift that permitted the panel to ignore the district court’s detailed factual findings that the patents were not obvious. It argued that shifting the burden is inconsistent with the well-accepted presumption that a patent issued by the Patent and Trademark Office is valid. WLF also asserted that the panel decision decreases financial incentives for improving existing products; would-be inventors will be less likely to incur the costs and risks of research necessary to win FDA approval for product improvements if their patents are less likely to withstand judicial challenge.
After filing the brief, WLF issued the following statement by Chief Counsel Richard Samp:
“A patent is presumed to be valid. The Federal Circuit undercut that presumption when it ruled that in certain cases the burden of proof falls on the holder of a challenged patent to show that his patent is valid, rather than requiring the alleged infringer to demonstrate invalidity.”
WLF is a public interest law firm and policy center with supporters in all 50 states. WLF has appeared in numerous federal courts in cases raising issues related to the scope and validity of pharmaceutical patents.