Groups seek Supreme Court ruling on stem cell patent
This article was originally published in Scrip
Two nonprofit organizations want the US Supreme Court to overturn a lower court's ruling involving a patent on human embryonic stem cells (hESCs) in a case being watched closely by the biopharmaceutical industry.
This past June, the US Court of Appeals for the Federal Circuit ruled that the groups, the Consumer Watchdog, previously known as the Foundation for Taxpayer and Consumer Rights, and the Public Patent Foundation (PubPat), lacked legal standing to challenge a decision by the US Patent & Trademark Office (US PTO), which upheld an hESC patent it granted in 2006 to stem cell pioneer Dr James Thomson of the University of Wisconsin and the Wisconsin Alumni Research Foundation (WARF).
WiCell Research Institute, a non-profit institution established in 1999 to advance research in the area of stem cells, holds a license from the WARF on the hESCs.
Several of the WiCell lines are eligible for funding from the National Institutes of Health.
PubPat, which was one of the groups that brought the lawsuit – and won – against Myriad Genetics involving its patents on the BRCA gene, had filed a request through the inter partes reexamination process with the US PTO in September 2006 to revoke three WARF hESC patents (scripintelligence.com, 14 June 2013, 16 April 2013).
The US PTO initially sided with PubPat. But WARF amended its claims and the agency reissued the patents.
Consumer Watchdog and PubPat were permitted to pursue a case against one of the hESC patents, known as '913, declaring it failed the novelty and non-obviousness tests of Sections 102 and 103, respectively, of the US Patent Act.
But the Federal Circuit rules that PubPat and Consumer Watchdog could not appeal US PTO's administrative decision because the groups were not directly harmed by the patent.
Dan Ravicher, executive director of PubPat and Consumer Watchdog's counsel in the case, said the appeals court's refusal to allow the groups to appeal the US PTO's ruling was a "clear violation of the express language of statutes passed by Congress and signed by the president."
"It also conflicts with the clear intent of Congress and the president to empower the public to seek revocation of invalid patents," he charged.
In addition to claiming the WARF hESC patent failed to satisfied Sections 102 and 103 of the Patent Act, PubPat and Consumer Watchdog claimed in their petition to the Supreme Court the patent missed the mark for Section 101 – the provision that describes patentable subject matter.
Consumer Watchdog and PubPat are arguing the WARF patent is invalid because hESCs are products of nature.
Even if the Supreme Court were to hear the case and reverse the Federal Circuit's dismissal, the groups may not be able to challenge the WARF patent on the grounds the WARF patent fails to satisfy Section 101, said Antoinette Konski, a partner and intellectual property lawyer at Foley & Lardner.
Historically, only questions related to novelty and non-obviousness based on prior art patents and printed publications, or compliance with section 112 requirements for new or deleted matter, are allowed by statute or regulation in such a proceeding, she said.
In addition, the groups may be barred from raising a Section 101 challenge because they did not raise it during the US PTO reexamination proceedings, Ms Konski said.