Case Analysis: In re Roslin Institute (Edinburgh)

Aastha Tushar Mehta & Bandhan Umesh Sheth ((Students of Law, GNLU, Gandhinagar)).

Cloning is seen as one of the marvels of scientific inventions, and a stride ahead in the field of biology.  First ever produced mammal clone was “DOLLY” the sheep which was created by Keith Henry Stockman Campbell and Ian Wilmut, by a process called somatic cell nuclear transfer, wherein the researchers took nucleus of an adult somatic mammary cell (A somatic cell is anybody cell other than gametes (egg or sperm) and enucleated oocyte (An oocyte is a female gametocyte (an egg cell prior to maturation). The basic question that came up before the court for adjudication was whether Patent and Trademark Officer (hereinafter referred as PTO) was correct in rejecting the plea of patenting the clone itself. It would be useful to clarify in the beginning itself that somatic process of cloning has been patented by the institution, so that has not come under discussion in this case.

One more point which is important before directing our attention to the key arguments is the reason why patent to the clone itself was rejected. The examiner of patent issued a non-final rejection to the plea of patenting the clone itself due to 35 U.S.C. § 101 which stipulate which inventions are patentable and it reads as follows

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title ((35 United States Code  § 101)).”

The statute uses the term “manufacture or composition of matter” which were relied by the Patent Board, and they acknowledged that the clones might fall within this category however, according to them it was ineligible for patent protection under §101 since it is naturally occurring phenomenon, resulting from nature, and so as to quote the words of the court “did not possess markedly different characteristics than any found in nature.” Nor did it comply with the statutory provisions of §102 ((Envisages concept of novelty, especially 35 U.S.C. §§ 102(a), (b).))and §103 ((Envisages concept of non-obviousness, see Gale Peterson, Understanding Biotechnology Law: Protection, Licensing, Intellectual Property Policies, CRC Press 1993, p.101))which deal with “conditions of patentability” and “non-obviousness criteria” respectively. However the main grounds for rejection remained §101 and that has been considered by the court. Court also clarified that they have jurisdiction 28 U.S.C § 1295(a) (4) (A), ((The United States Court of Appeals for the Federal Circuit shall have exclusive jurisdiction: of an appeal from a decision of — (A) the Patent Trial and Appeal Board of the United States Patent and Trademark Office with respect to a patent application, derivation proceeding, reexamination, post-grant review, or inter partes review under title 35, at the instance of a party who exercised that party’s right to participate in the applicable proceeding before or appeal to the Board, except that an applicant or a party to a derivation proceeding may also have remedy by civil action pursuant to section 145 or 146 of title 35; an appeal under this subparagraph of a decision of the Board with respect to an application or derivation proceeding shall waive the right of such applicant or party to proceed under section 145 or 146 of title 35))to review Patent Board’s order.

Arguments put forward

  1. The First point which Roslin Institute contended was copies (clones) are eligible for protection because they are “the product of human ingenuity” and “not nature’s handiwork, but their own.”
  2. Roslin argues, that Clones are patentable under §101 since they fall within the term “manufacture or composition of matter”.
  3. One more commendable argument put forward by the Institute, which happens to be their main argument is that claimed clones are patentable because they are distinguishable from donor mammals used to create them, and they rely on “environmental factors” which lead to “phenotypic differences ((Phenotype refers to all the observable characteristics of an organism such as shape, size, colour and behavior that, results from the interaction of organism’s genotype with its environment)),” between the clones and their donor mammals.
  4. From the same argument, they contend that there clones are distinguishable in colour from their original donors because of mitochondrial DNA, since in cloning process the clone inherits DNA from donor oocyte instead of donor somatic cell. Therefore differences in mitochondrial DNA render the clones patentable.
  5. Finally they argue that clones are time delayed versions of their donor mammals and therefore different from original mammals.

Decision of the Court

It would seem convenient from the point of view of understanding the ratio decidendi to go as per the above given arguments and the reasoning given by the Court in its answer.

  1. As per the first argument, the court relied on the case of Funk Bros. Seed Co. v. Kalo Inoculant Co. ((333 U.S. 127 (1948).))which made crystal clear that naturally occurring organism are not patentable. In this case the court considered whether a mixture of naturally occurring strains of bacteria that helped leguminous plants extract nitrogen from the air and fix it in soil was patentable and decided that it cannot be subjected to patent protection and held as follows “The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end ((Id at 130)).” Therefore the court stated that the method of selecting the strains could be subject to patent, the mixture itself is not patentable. In order the reject the plea of patent to clones the courts also relied on one more landmark judgment wherein the criteria relied upon in order to know whether a new discovery had been made, independent from nature, was that of ““markedly different characteristics from any found in nature and one having the potential for significant utility ((Diamond v. Chakraborty 447 U.S 303 (1980) at 310)).” Court stated in this case as follows relying on Chakraborty case as follows “Dolly herself is an exact genetic replica of another sheep and does not possess “markedly different characteristics from any [farm animals] found in nature ((Case Judgment Copy, Available at” One more interesting thing on which court relies is the point laid down in the case of Association for Molecular Pathology v. Myriad Genetics, Inc. ((133 S. Ct. 2107 (2013).))wherein the court held that claims on two naturally occurring, isolated genes (BRCA1 and BRCA2), which can be examined to determine whether a person may develop breast cancer, were invalid under § 101., since they are products of nature, and court stated on the same basis that the institute did not alter or modify the genetic structure of the DNA, but all their innovation was the preservation of donor DNA, so that the clone was exact copy of mammal from which somatic cell was taken. Their role was not to change the DNA altogether. Therefore DOLLY being the exact genetic copy of her original donor, is not patentable.
  2. Considering the second point the court said there are three exception to §101 wherein even if the subject matter falls within one of the categories, it is rendered unpatentable, which are laws of nature, natural phenomenon and abstract ideas ((Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012); O’Reilly v. Morse, 56 U.S. (15 How.) 62, 112-20 (1854).)). Since clone itself is an exact genetic copy of original donor mammal, and has no much difference from any other farm animal, it falls within these exceptions.
  3. Addressing the question of “phenotypic differences”, court said that such differences are unclaimed. In the words of court “the word “cloned” in the pending claims connotes genetic identity, and the claims say nothing about a phenotypic difference between the claimed subject matter and the donor mammals. Moreover, Roslin acknowledges that any phenotypic differences came about or were produced “quite independently of any effort of the patentee ((Id at 8)).” Court further stated that the difference between clones and the mammals were the result of environmental factors not the result of patentee’s efforts. Institute explained how phonetically mammals and their offspring clones can never be same due to environmental factors, which shows expressly why the court held that clone itself was not patentable, as it had no specific characteristic attributed to the institute that did the cloning process, but was work of naturally occurring factors.
  4. Similarly, while discussing mitochondrial differences, the court stated that such differences were also unclaimed; Roslin’s patent application does not identify how differences in mitochondrial DNA influence or could influence the characteristics of cloned mammals. The patent application does not specifically put forward any different unique characteristics from their original donor cell; since the clones have their identity attached the nucleus of the DNA of their donor mammal cell. Therefore the court states in absence of any specification pointing out that there are marked difference between the donor cell and the receipt oocyte, the clones are not able to be given patent protection.
  5. Considering the last point of “time delayed version” court relied on the reasoning given by the Patent Board for rejection.  Board laid down the reason for not granting patent by saying “the difficulty of time-delayed characteristic is that it is true of any copy of an original”. Meaning thereby, that since clones are not very distinctly marked characteristic other than any their donor mammals, it is not subject to patent protection.

Impact of the judgment

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, and she stated “This ruling is taking away an incentive for research organizations to pursue more research into cloning, at least on the margins ((Bernard Vaughan, Dolly the sheep-type clones ineligible for patent: appeals court  (23rd October, 2014)” Personally, authors agree it will take off the commercial incentive, but the process itself is not rendered unpatentable, which still gives a scope to science researchers and academicians to endeavor such initiatives, by different processes, making the end product more useful. However it remains to be seen whether human cloning is something which would be ascertained as being allowed or prohibited on the same platform or not as that of “dolly-the-sheep” type of cloning. It remains to be seen what will be the stance taken by the Supreme Court if matter goes to appeal. There is a lot of debate as to pros and cons of such patenting of human genes and animals, since it goes against the philosophy of owning what is god-made, creation of the almighty and using it for commercial use. One side would be representing, human dignity is infringed, and human dignity in every human is internationally recognized feature, which does not allow patenting a human gene, genome, or even a cloned animal ((A.R Chapman, Patenting human genes: ethical and policy issues, In J.Bryant, L.B Velle and J.Searle (Eds.), Bioethics for Scientists (p.265-278) Hoboken: John Wiley and Sons)). Some believe it is an incentive for researchers, and science to have new dimension. Indian law has no specific clarity on this point, however it seems that patenting a cloned animal might have various problems in India, starting with Section 3(b) in Chapter II of Indian Patent Act 1970. Section 3 states what inventions which cannot be patented and clause b states as follows,

“an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment”.

In India, animals have a different place, cows are considered holy, camels a mode of transport, farm poultry a big industry, a cloned animal might be seen to be falling under any of the above categories. In 2002 Amendment, patents on living organism were granted ((Section 4(e), 2002 Amendment Act)). In the Calcutta High Court, Dimminaco A.G v. Controller of Patents Designs and Ors ((2002 IPLR 255 Cal H.C))wherein the Patent Office did not grant patent to process of creating live-vaccine for Buristis, and Calcutta High Court granted patent, by vendibility test, any claim of patent which leads to a vendible product is certainly a new product which undergoes a process of manufacture, and therefore is subject to patent protection. Even 2005 Amendment is not very clear as to the stance of the cloning, or patenting of human genes, however Ministry of Science and Technology in the text of Ethical Policies on the Human Genome, Genetic Research and Service, human cloning shall not be permitted ((Rosario M. Isasi, Bartha Knoppers, NATIONAL REGULATORY FRAMEWORKS REGARDING HUMAN CLONING FOR REPRODUCTIVE AND THERAPEUTIC/RESEARCH PURPOSES, (14 December 2014) In view of the authors, a specific legislation, or a particular provision in the patent law, in view of the upcoming genetic research, and in light of deciding the whether the view of the Dolly the Sheep judgment can be beneficial to Indian scenario, is a much needed requirement.