DOJ, PTO Question Groups' Standing in Stem Cell Case

, The Litigation Daily

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Young scientist works in modern biological lab

Government lawyers have weighed in on a case in front of the U.S. Court of Appeals for the Federal Circuit that could have repercussions for stem cell researchers and public interest groups challenging patent reexaminations.

In the brief submitted last week at the behest of a Federal Circuit panel, the U.S. Department of Justice and the U.S. Patent and Trademark Office responded to questions raised by the panel about whether the two public interest groups that brought the suit—Consumer Watchdog and the Public Patent Foundation—had standing.

"In the government’s view, Consumer Watchdog lacks standing and its appeal should be dismissed," the DOJ and the PTO wrote in their brief.

The case, Consumer Watchdog v. Wisconsin Alumni Research Foundation, dates back to 2006, when the public interest groups challenged a patent on human embryonic stem cells owned by Wisconsin Alumni Research Foundation (WARF). The PTO did not invalidate the patents, so the two groups—represented by attorney and Public Patent Foundation executive director Daniel Ravicher—appealed to the Federal Circuit.

Ravicher, together with the American Civil Liberties Union, represented the plaintiffs in a separate case brought before the U.S. Supreme Court, Association for Molecular Pathology v. Myriad Genetics Inc., in which the court ruled in June that merely isolating genes that are found in nature does not make them patentable. Ravicher wants the Federal Circuit to consider the high court’s ruling in the stem cells case since stem cells also are a natural material and therefore, he argues, should not be patentable.

Although PTO decisions can be appealed to the Federal Circuit, and third parties have the right to challenge PTO decisions on patent validity at the PTO, it is unclear whether third parties also have the right to appeal to the Federal Circuit. The government’s brief, written by DOJ appellate attorney Mark Freeman, suggests that the federal agencies believe third parties do not have that right if they cannot show they are directly harmed by the decision.

"Consumer Watchdog was free to petition PTO for inter partes reexamination," the government wrote in its brief. "But it cannot appeal the resulting administrative decision to this court [the Federal Circuit] unless it can identify some particularized, real-world consequence of that decision for Consumer Watchdog itself."

Ravicher maintains that Consumer Watchdog has been harmed because the government has not invalidated the patent—something it ought to do given the Supreme Court’s ruling in Myriad. He also says that since nonprofits, consumer groups and industry organizations do not have standing to bring declaratory judgment challenges to patents, there is no other avenue for them to bring challenges.

"Without a full and fair right to challenge patents at the PTO, including an equal right to appeal, these groups will have no avenue to rid the system of bogus patents and will be 100 percent reliant on purely commercial entities to do so," he told the Litigation Daily. "I believe this is a serious threat to the public interest."

Scientists are making great strides using embryonic stem cells in treatments for blindness, heart disease, severe injuries and even diabetes and cancer, and the case could determine who will profit from that research.

Consumer Watchdog will file a brief in response to the government. A hearing has not yet been scheduled. But Ravicher told the Litigation Daily that if the Federal Circuit denies him standing, he might seek a rehearing en banc or petition the Supreme Court for cert.

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