Attack of the Clones

Dolly“The Sixth Day,” “Jurassic Park,” “Multiplicity,” and “The Island” are all popular movies that illustrate the real potential for cloning uses in our society. These movies were all released within the last twenty years and, at the time,  they were laughed at by many as being preposterous. After the recent scientific breakthroughs in the last few years, I assure you that less people are laughing now. Just as in “Jurassic Park,” where dinosaurs were brought back from extinction through reproductive cloning, in the not-too-distant future the main attraction at the zoo could be the once extinct wooly mammoth. In the future, a person in need of a liver, kidney, heart, or any other organ transplant could have spare body parts waiting for them, as in “The Island.” Maybe you just need six more of yourself to do the simple jobs in life like in “Multiplicity.” The potential for cloning is endless and scientists have only just begun to crack the surface. The possibilities stemming from cloning are limitless, but a giant roadblock may have recently been put in place when the United States Court of Appeals for the Federal Circuit ruled in  In re Roslin Institute genetic clones, such as Dolly, are ineligible for patent protection. 2014 WL 1814014 (Fed. Cir. 2014). The holding was based on the finding that the “claimed clones are exact genetic copies of patent ineligible subject matter.” Id.

The date was July 5, 1996 when Keith Henry Stockman Campbell and Ian Wilmut successfully developed the first ever cloned mammal, later known publicly as Dolly the Sheep. U.S. Patent No. 7,514,258 (the ’258 patent) for the somatic method of cloning mammals was granted to the Roslin Institute of Edinburgh in Scotland, but U.S. Patent Application No. 09/225,233 (the ’233 application), which claimed the products of the ‘258 patent, was rejected by the Patent Office under 35 U.S.C. § 101 for lack of patentable subject matter. The claims stated:

155. A live-born clone of a pre-existing, non- embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

Roslin appealed this decision to the Patent Trial and Appeal Board who affirmed the patent denial on Feb 7, 2013, but the decision was again appealed to the Federal Circuit. Roslin made a number of compelling arguments as this case was litigated. First, Roslin argued that the ‘233 application should be issued under Diamond v. Chakrabarty, where a patent for a genetically engineered bacterium was granted because it was not naturally occurring, was created under the sun, and was made by man. 100 S.Ct. 2204 (1980). Similarly, Dolly was not naturally occurring, instead being genetically created through the use of science and newly developed technology. The prevailing counterargument was that cloning a mammal constituted a natural phenomenon that did not possess markedly different characteristics from  the original organism it cloned. Therefore, the Court held that even if something can be said to be created by man, it is still not patentable the product is an exact copy of something that is naturally occurring. Roslin did not attempt to rebut this argument that the cloned products were not identical to the original organisms. Nothing is stated in the claims or specification that suggests the cloned products are distinct in anyway and the Court held that the ‘233 application failed under 35 U.S.C. § 101 because the claims were not patentable subject matter.

Although this landmark case was decided against allowing for the patents of cloned mammals, the overall purpose of a patent to “promote the Progress of Science and useful Arts” should not be hindered. U.S. Const. art. I, § 8, cl. 8. By still granting of patents on cloning methods, there will be many more breakthroughs in this ever-growing field and these discoveries will still be protected.

 

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