“Dolly the sheep” clones cannot be patented

The US Court of Appeals for the Federal Circuit has  ruled that mammals made using the cloning method that created Dolly the sheep are not patent eligible.

Affirming a decision by the US Patent Trial and Appeal Board (PTAB), on May 8, the appeals court found that while the method for creating genetic clones may be protected by patents, the products of the process are not patent eligible.

It also rejected the three disputed claims of the patent as “anticipated and obvious”.

The patent at issue, ‘233, covers “quiescent cell populations for nuclear transfer”. It is held by the Roslin Institute of Edinburgh, which in 1996 saw the creation Dolly the sheep – the first animal to be cloned from an adult somatic, or non-sex, cell.

The US Patent and Trademark Office, while granting a patent for the method of cloning, rejected the inventors’ claims covering the clones themselves.

In November 2008, the patent examiner issued a non-final rejection of the patent claims, finding that they were directed to non-statutory subject matter, and that they are anticipated and obvious. By February 2013, the PTAB had affirmed the examiner’s rejection of those claims.

The appeals court acknowledged the claimed clones “may be called a composition of matter or a manufacture”, but concluded that the subject matter is not eligible for patenting, as it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature”.

Referencing Myriad, in which it was ruled that patent claims covering “naturally occurring” genes were invalid, Judge Timothy Dyk said in the decision: “Here, as in Myriad, Roslin ‘did not create or alter any of the genetic information’ of its claimed clones, ‘[n]or did [Roslin] create or alter the genetic structure of [the] DNA’ used to make the clones.

“Roslin’s chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection.”

Nabeela Rasheed, shareholder at McAndrews, Held & Malloy Ltd in Chicago, said: “The court has effectively ruled that the product of one of the most novel and innovative methods of creating a new living creature is nothing more than making a Xerox copy.”

Describing the decision as a direct extension of Myriad, Rasheed said it would be “perplexing if it were not for the very real impression that there is now a well-established war on gene-based patents at the Federal Circuit.”

The exceptions to patent eligibility under 35 USC 101 always fell into three distinct categories, she explained: laws of nature, abstract ideas, and natural phenomena.

“Clearly, a clone of a living animal is not an abstract idea, nor is it a law of nature,” she said.

“It seems that nothing can be farther from being a natural phenomenon than a cloned animal, an exact copy of a previously living organism.”

The courts and patent office appear to be creating a “fourth category” of patent ineligibility, she said: “Where the product has ‘genetic identity’ with something already found in nature, then that product is an exception to patent eligibility, regardless of the level of ingenuity involved in the creation of that product or the fact that such a product simply does not exist in nature.”

Rasheed said there seem to be very few workarounds to this position, though she suggests patentees focus on the method: “Perhaps a product by process claim would pass muster under the more stringent 35 USC 101 world?

“That obviously would place the patentee back on the familiar ground of dealing with anticipation of the claim to Dolly by her parent donor. That being said, the product by process claim analysis also is a murky area and has only been clarified with respect to interpretation of such claims in an infringement analysis and not specifically with respect to patentability.”

This story was first published on  LSIPR.