High Court OKs ‘Broad Interpretation’ in Patent Reviews
In a decision that could hurt the drug and biologic industry over intellectual property rights, the U.S. Supreme Court has decided Cuozzo Speed Technologies, Inc. v. Lee, holding that, in an inter partes review, the Patent and Trademark Office (PTO) may give a patent claim its broadest reasonable interpretation in determining whether it is valid, and a patent holder may not appeal the issue of whether the PTO complied with the authorizing statute in deciding to initiate the review.
Both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) filed briefs urging the high court to “reign in” the PTO’s Patent Trial and Appeal Board’s invalidation of many patents under looser standards than would apply in federal court. “While we are disappointed in the court’s ruling, it is important to note that all the court decided today was the PTO could lawfully use the ‘broadest reasonable interpretation’ (BRI) claim construction standard because Congress had not spoken directly to this issue in the statute,” BIO said in a statement. “However, the court also made clear in its opinion that the PTO or Congress could choose to change that standard to address the policy concerns that have been raised by amici, such as BIO. We continue to urge the PTO and Congress to do just that. The powerful reasons to abandon the unfair BRI standard remain even after today’s decision, and the strong bipartisan votes to repeal BRI by both the House and Senate Judiciary Committees reinforce the breadth of support for that policy position.”
The BRI standard is one reason why the patent board has been invalidating patents at an alarming pace, BIO said in its brief. “That standard has no place in an IPR proceeding, and this court should review it now before many more patents fall before the scythe,” it argued. “The PTO’s main justification for the standard has been that patent reexaminations use it; patent reexaminations allow the patentee to amend the claims to fix any problems, and the PTO has emphasized that in theory IPRs permit amendment as well.”
In its brief, PhRMA said that leaving the BRI standard intact would “introduce considerable uncertainty in the construction of patent claims, increase the risk of conflicting invalidity decisions, and undercut a central reform that Congress enacted to strengthen the U.S. patent system. All of those consequences threaten the predictability and strength of protection that the patent system provides to innovators and the public alike.”