He Said/She Said
Stanford maintains that it owns the patents because Bayh-Dole awards patent ownership first to universities and other entities receiving federal funding, then to the federal government, and finally to inventors. Under the measure, universities were granted top-priority in patent ownership under the idea that they would then commercialize their discoveries for the benefit of the public.
Roche contends that it can apply the patents without paying royalties to Stanford or Dr. Holodniy because he signed away his inventor rights to Cetus. “The whole thing that was wrong here is that Stanford, instead of drafting the agreement as ‘I agree to assign,’ should have said ‘I hereby assign,’ and then there would be no case,” pointed out Justice Ruth Bader Ginsburg during the oral arguments.
The Supreme Court is expected to decide the case by early summer. Its last scheduled meeting day of the term is a June 27 nonargument session.
Stanford, U.S. Acting Solicitor General Neal Katyal, and several academic groups along with Bayh-Dole’s co-author, former Senator Birch Bayh, argue that the ability of universities to commercialize discoveries in the life sciences and other fields under Bayh-Dole is being threatened. “The issues presented here have widespread and profound implications for billions of dollars provided annually for government-sponsored research throughout the nation,” Stanford argued in its reply brief.
Stanford and its allies argued that their tech transfer efforts would be damaged significantly if the Supreme Court were to side with Roche, as the U.S. Court of Appeals for the Federal Circuit did in 2009. Roche disagreed, stating in its brief for respondents, filed in January, “Congress did not enact the Bayh-Dole Act to create a new class of nonpracticing entities to tax commercial development by American industry and increase expenses to patients and the healthcare system.”
Siding with Roche are a coalition of pharma companies, the Intellectual Property Owners Association, and the trade groups for the pharmaceutical and biotechnology industries. They say Stanford’s interpretation of Bayh-Dole in this case would upend the longstanding legal principle that the original owner of an invention is its inventor. “Absent a clear statement from Congress requiring such upheaval, which simply does not exist, the Court should maintain the status quo, which has served the interests of all affected parties and the nation’s economy well.”