The exceptions to patent eligibility under 35 USC 101 always fell into three distinct categories: laws of nature, abstract ideas, and natural phenomena.  In deciding a case about whether claims of farm animals may be patented, according to some commentators, the U.S. Court of Appeals for the Federal Circuit may have created a fourth judicial exception to patent eligibility.  Ruling against the inventors of Dolly the sheep, the U.S. Court of Appeals for the Federal Circuit held that since the claimed clone had the same genetic information as its parent or donor, it is an exact genetic replica of another sheep, and because the parent exists in nature, the cloned copy is also a product of nature and is therefore unpatentable.  Essentially, the court seems to be stating that if the end product is a copy of something that exists in nature, it is not patentable, regardless of the human ingenuity involved.

The story began in 1996, when Dolly the Sheep, the first mammal to be cloned from an adult cell, generated international headlines and intense ethical debates.  Dolly was euthanized six years later due to complications of a progressive lung disease.  The Roslin Institute applied for and received a patent to the method of cloning, called somatic cell nuclear transfer, which created Dolly.  Roslin had also applied for a patent to the clones themselves.  The patent to the clones was rejected by a U.S. Patent and Trademark Office (USPTO) examiner in 2008 for a lack of patent-eligibility (§ 101), anticipation (§ 102), and obviousness (§ 103).  In February 2013, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the examiner’s decision.  On May 8th of this year, the U.S. Court of Appeals for the Federal Circuit affirmed the finding of the USPTO Patent Trial and Appeal Board (PTAB) that clones, although man-made, are non-patent eligible subject matter under 35 USC § 101 of the Patent law.  The Federal court decision cited the Supreme Court decisions in Myriad, Chakrabarty, and Funk Bros., as making it “clear that naturally occurring organisms are not patentable.”  The court held that only discoveries that possess “markedly different characteristics from any found in nature” . . . are eligible for patent protection.

Roslin argued that the claimed clones were not identical to donor parent because: (i) the clones had different mitochondrial DNA from the donor parent, since the method of cloning resulted in the mitochondrial DNA coming from the egg cell used to create the clone, and not the donor parent; (ii) the clones had observable differences in shape, size, color and behavior due to environmental factors, i.e., while genes help determine traits, environmental influences have a considerable impact on shaping the clone’s physical appearance and personality; and (iii) that clones are “time‐delayed versions” of the donor mammals.

The Federal court in rejecting all of Roslin’s arguments stated that the claims were written in term of genetic identity, not mitochondrial or phenotypic differences and 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.”  Further, the court stated that any phenotypic differences between Roslin’s donor mammals and its claimed clones are the result of ‘environmental factors,’ and that Roslin itself had conceded that such differences were produced “quite independently of any effort of the patentee.”  Additionally, the court stated that the argument that the clones are a time-delayed version of the donor mammals does not confer patent eligibility because the same is true of any copy.  In effect, Dolly is not patentable because she is too similar to her parent.

 In re Roslin Inst. (Edinburgh), No. 13-1407 (Fed. Cir. May 8, 2014).

Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).

Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).