Synthetic Biology & Process vrs Product - is this the Stem Cell sector's next big commercialization challenge?

It has been ruled on by the Supreme Court and Affirmed in Federal Appeals Court and at the USPTO that naturally occurring biological matter cannot be exclusively owned. This was today confirmed again in the matter of Roslin Institute's desire to Patent the "clones" of their SCNT cloning process. After years of examination rulings and a lengthy legal challenge, the Federal Appeals court upheld the decision of the USPTO that no Patents will be issued on the product of the process that created Dolly, as it produced a copy of a nature, and therefore "Dolly's genetic identity to her donor parent renders her unpatentable." Further, Judge Dyk stated that "There is nothing in the claims...that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies."

The issue at hand is pertinent and important to note in that cells themselves are natural biological products, aren't they? Therefore they themselves, if unaltered scientifically, wouldn't be Patentable themselves therefore. The Process yes but the cell itself, if identical to the naturally occurring original, wouldn't?

Processes in the stem cell field are seemingly never ending...

The "product-by-process" standards that have applied to determining patentability by limiting duplicate product patents will need to be revisited to narrow the "product" window to only unique synthetic constructs. This developing legal framework of patent scope now calls into question old technology product claims and may give rise to a freedom to operate latitude the Courts are indicating on natural biological ownership.... or am I missing something here?

Are cells which are innovatively derived also being pushed to be genetically altered as a synthetic variant of the original as a requirement to secure a firm path to market?

Is an RPE cell derived from different innovative methods, such as hESC, iPS, SCNT, hpESCs, subject to a novelty test against an existing natural RPE cell in order to secure product claims? Will there be a race to alter the cells to create genetically unique versions in relation to the natural standard and the competitive versions?



Dolly the Sheep-type clones ineligible for patent: appeals court
BY BERNARD VAUGHAN - Thu May 8, 2014 6:45pm EDT

(Reuters) - The method for cloning animals such as the famed Dolly the Sheep can be patented, but the resulting animals themselves cannot, a U.S. federal appeals court has ruled.

"Dolly's genetic identity to her donor parent renders her unpatentable," Judge Timothy Dyk wrote Thursday for the U.S. Court of Appeals for the Federal Circuit in Washington, D.C.

Pilar Ossorio, a professor of law and bioethics at the University of Wisconsin Law School, called the decision a victory for people who thought cloning animals was morally wrong.

"This ruling is taking away an incentive for research organizations to pursue more research into cloning, at least on the margins," she said.

Scientists Ian Wilmut and Keith Campbell of the Roslin Institute of Edinburgh, Scotland, generated international headlines and intense ethical debates in 1996 when they created Dolly the Sheep, the first mammal to be cloned from an adult cell.

Dolly, named after country singer Dolly Parton, was euthanized six years later after she was diagnosed with a progressive lung disease.

The institute, which owns a patent to a method of cloning called somatic cell nuclear transfer, applied for a patent over the clones themselves but was rejected by a U.S. Patent and Trademark Office examiner in 2008.

In February 2013, the USPTO affirmed the examiner's decision, saying the clones did not possess "markedly different characteristics than any found in nature."

In affirming the USPTO, the Federal Circuit said that nature, natural phenomena and abstract ideas were not eligible for patent protection.

Salvatore Arrigo, a lawyer for Roslin, said he was disappointed with the ruling.

"There's no doubt in anyone's mind that Dolly is man-made," he said.

Roslin had argued that its clones were distinguishable from their donor mammals, in part because environmental factors could make their shape, size, color and behaviors different than their donors.

The Federal Circuit disagreed, noting that Roslin itself had said that such differences were produced "quite independently of any effort of the patentee."

"There is nothing in the claims...that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies," Dyk wrote.

The USPTO declined to comment.

The case is In re Roslin Institute (Edinburgh), U.S. Court of Appeals for the Federal Circuit, No. 1407.