U.S. Federal Court Dismisses Challenge to Stem Cell Patent

CW and WARF logos

A U.S. federal appeals court has rejected an attempt to strike down a long-contested stem cell patent held by the Wisconsin Alumni Research Foundation (WARF). The Santa Monica, California–based Consumer Watchdog (CW) had hoped to invalidate the patent, which it says puts a burden on California’s taxpayer-funded research by requiring licensing agreements to use the cells, but on 4 June the U.S. Court of Appeals for the Federal Circuit ruled that CW isn’t involved in work on human embryonic stem cells and, thus, can’t challenge the patent in court.

The patent, awarded in 2006, involves creating an in vitro culture of human embryonic stem cells. CW challenged it and two other WARF stem cell patents, but the U.S. Patent and Trademark Office (PTO) upheld the patents in 2008. Last year, CW appealed its challenge to the federal circuit court, claiming that the isolation of these cells was an obvious, incremental step beyond existing techniques. In a brief to the court, CW’s attorney, Dan Ravicher of the Public Patent Foundation, also cited the Supreme Court’s June 2013 decision in the Myriad Genetics case that human genes are “products of nature” and cannot be patented.

The appellate court didn’t address either of those issues. Instead, Circuit Judge Randall Rader wrote in the decision that CW lacks the legal “standing” required to bring a case against WARF.

“We are very disappointed with and obviously disagree with the ruling,” Ravicher told ScienceInsider in an e-mail. He added that CW will “consider its options” for the next step. But time is running out, because the patent will expire in early 2015. 

The case was a test for a 2013 change in patent law specifying that anyone who gets an adverse judgment from the patent office has the right to appeal to the federal circuit. But the decision makes clear that the constitutional requirements for legal standing still apply, says Kevin Bastian, a patent attorney Kilpatrick Townsend & Stockton in San Francisco, California. “You have to have some skin in the game, as it were,” he says.

If it stands, the decision guarantees “a shorter and more certain resolution” for groups hoping to fight patents on political or ideological grounds, says Konstantin Linnik, a patent attorney at Nutter McClennen & Fish in Boston. Without a chance for such groups to appeal to the circuit court, “now it becomes a binary deal: You can win or you can lose at the patent office.”