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Patenting Dolly

No. You may not patent Dolly the cloned sheep. Dolly and other animal clones like her are too geneticially identical to her naturally occurring donors to be patented as human creations, the US Court of Appeals for the Federal Circuit in Washington said yesterday.

In a decision that could impact the genetic engineering and biomedical fields, the court upheld the ruling of the Patent Trial and Appeal Board, which said that the Roslin Institute researchers seeking to patent the Dolly clone, which was the world's first cloned mammal when she was unveiled in 1996.

“This is a very important and fascinating opinion,” said Arthur Caplan, head of the division of medical ethics at NYU Langone Medical School tells Bloomberg. “They’ve just ruled one of the most novel, innovative ways to create new living things is nothing more than copying.”

PatentDocs provides some helpful background on the legal case. Dolly's inventors, Keith Campbell and Ian Wilmut, have already obtained a patent for the method they used to produce her – somatic cell nuclear transfer – but they have further applied to patent the products created via this cloning method. That claim was rejected by the patent examiner, that ruling was affirmed by the patent board, and now the Federal Circuit court has agreed with the patent board, ruling that the claimed subject matter here is ineligible for patent because it does not possess "markedly different characteristic than any found in nature."

Why is Roslin not content with having a patent on the process alone?

The advantage to patenting the product of this method, the clone, is that Roslin would have maintained ownership of the animal no matter what method was used to create it, Roslin's lawyer, Salvatore Arrigo, tells Bloomberg.

IP Watchdog's President and Founder Glenn Quinn says the reverberations of this ruling will be felt far beyond the domain of this Scottish sheep.

"Sadly, until further notice, personalized medicine is dead," Quinn writes – it is unclear with how much intentional hyperbole – saying that the ruling will lead to "a near complete cessation in many areas of personalized medicine." At least in respect to the organ transplantation field, he says.

When you add this ruling to the IP landscape in the wake of the Supreme Court's AMP v Myriad decision, he says, you get a scenario in which many "fledgling and potentially promising technologies to grow organs will shrivel up and die."

Why would any company want to spend billions of dollars in this branch of personalized medicine without the possibility of having exclusive rights to the product it creates, Quinn asks.

"Sure, some universities will continue to use grant money to pursue as much as they can, but without the private sector working to engage in commercialization research it simply won’t happen, and no company is ever going to spend the money required to make this a reality without an expectation of recouping their investment in R&D plus a suitable return on that investment."