University responds to DNA patent challenge
Madison, Wisconsin | 16 August 2013

Wisconsin Alumni Research Foundation (WARF) has issued a new response in its dispute with public interest groups over a patent covering human embryonic stem cells.

It has insisted that its patent is not undermined by the recent landmark decision in Association for Molecular Pathology v Myriad in the US Court of Appeals for the Federal Circuit, which states that naturally-human DNA can not be the subject matter of a patent even where isolated.

The patent in dispute (US7029913), which was assigned to WARF in 2006, covers in vitro cultures of human embryonic stem cells.

Consumer Watchdog and the Public Patent Foundation filed their brief challenging the patent with the Court of Appeals in June, days after the court’s ruling in the Myriad case.

The June claim asserted that “WARF's broad and aggressive assertion of the [disputed] patent has put a severe burden on taxpayer-funded research in the State of California”.

It went on to argue for revocation of the patent, explaining:“[T]he claims of the [patent] are invalid … for claiming subject matter that is not patent eligible. Specifically, the claimed human embryonic stem cell culture falls within the ‘product of nature’ exception to statutory subject matter.”

Referring to the Myriad decision, the June brief said: “The Supreme Court restated just last month that discovery and isolation of a product that occurs in nature does not render that product patent eligible … WARF did not create or alter the properties inherent in stem cells any more than Myriad created or altered the genetic information encoded in the DNA it claimed.”

The brief additionally claimed that the patents are invalid for obviousness and because the inventions it describes were anticipated by a researcher some years before the patent was issued to WARF.

However, in a response brief filed on 14 August, WARF has asked the court to throw out CW’s claim.

WARF claims that “the cultured embryonic stem cells are distinct from cells in an embryo in their cellular composition and properties,” so that the Myriad ruling does not apply to the patent covering the stem cells.

It also provides arguments against CW’s accusations of obviousness and anticipation.

The claim also asserts that “this court does not properly have jurisdiction to resolve this issue,” stating that the case to invalidate the patent can only be heard by the US Patent and Trademark Office (USPTO).

Author: Carri Swann

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