WASHINGTON, DC – A patent on human embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF) “covers ineligible subject matter and was anticipated by and obvious” in view of earlier research, Consumer Watchdog and the Public Patent Foundation have told a federal appeals court.

In a reply brief filed late last week in the U.S. Court of Appeals for the Federal Circuit seeking to invalidate the ’913 patent issued by the Patent and Trademark Office, the two public interest groups said:

“The claims at issue here cover human embryonic stem (hES) cells that are not markedly different from those in our bodies. Thus, the claims are invalid under 35 U.S.C. § 101 for covering ineligible subject matter, an issue the Court may and, as a matter of judicial economy and public policy, should address.”

Read a copy of the groups’ response brief here: http://www.consumerwatchdog.org/resources/pubpatreplybrief082913.pdf

“Regarding anticipation and obviousness, WARF seeks to distract the Court (like it distracted the Board) with an after-the-fact, hindsight-filled declaration to contradict the plain language of the prior art,” the brief said. “When read directly, and not through Dr. [Colin] Stewart’s biased unchallenged one-sided vision, the plain language of Williams expressly taught the use of feeder cells for both derivation and maintenance of ES cells, including hES cells, and Bongso expressly taught selecting hES cells using the previously known way to select mouse ES cells …”

On the question of patent eligibility the brief noted that neither the PTO examiner or Board “had the benefit of the Supreme Court’s AMP v. Myriad decision, which was issued well after the Board’s decision.” That decision found that genes could not be patented because they exist in nature.

“WARF noticeably avoids directly discussing the prior art that anticipates and renders obvious its claims, instead preferring to distract the Court with a declaration from its hired-gun expert, Dr. Stewart, who opines in favor of upholding the claims using hindsight reasoning and reference to acclaim received by Dr. [James] Thomson,” the reply brief said. “When the prior art is viewed directly, without the broken lens of Dr. Stewart’s paid-for opinions, it is apparent that the claims here are anticipated and obvious and that the Board’s conclusion to the contrary was not supported by substantial evidence.”

Both Consumer Watchdog and the Public Patent Foundation stressed that while University of Wisconsin researcher James Thomson deserved acclaim for isolating human embryonic stem cells, important scientific accomplishments are not necessarily patentable. They said one of the main reasons he was able to derive a human stem cell line was because he had access to human embryos and financial support that other researchers did not have.

“Appellant also does not dispute that Dr. Thomson was the first to successfully isolate and maintain hES cells for an extended period of time or that he deserves acclaim for that accomplishment,” the reply brief said. “ Neil Armstrong was the first man to walk on the moon, and he deserves to be heralded as a national hero for doing so, but he did not invent the moon or even how to walk. As discussed above and in Appellants opening brief, the prior art fully taught how to achieve Dr. Thomson’s milestone, and while he deserves credit for getting there first, his achievement was not the result of his having created a patentable invention.”

“In this case, everyone knew what the problem was and no one skilled in the art was surprised by the way in which Dr. Thomson derived and maintained for an extended period of time hES cells. Rather, it was Thomson’s ability to overcome the pragmatic obstacles created by the scarcity of human embryos and funding for politically controversial hES cell research at the time of the ’913 patent that resulted in the acclaim he received,” the reply brief said.

Joining the two public interest groups in challenging WARF’s patent from the beginning was Dr. Jeanne Loring, now director of the Center for Regenerative Medicine at The Scripps Research Institute in La Jolla, CA. Later in the case Dr. Alan Trounson, then of Australia’s Monash University and now president of the California Institute for Regenerative Medicine, Dr. Douglas Melton of Harvard and Dr. Chad Cowan of Harvard filed affidavits supporting the challenge.

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Consumer Watchdog is a nonprofit, nonpartisan consumer advocacy organization with offices in Washington, DC, and Santa Monica, CA.  Our website is: www.consumerwatchdog.org.

The Public Patent Foundation at Benjamin N. Cardozo School of Law is a not-for-profit legal services organization that represents the public's interests against the harms caused by the patent system, particularly the harms caused by undeserved patents and unsound patent policy. For more information visit: www.pubpat.org.