Dry Cleaning Your Genes
‘The good thing about science is that it’s true whether or not you believe in it’
- Dr. Neil deGrasse Tyson
During the early eighties, the member states of European Union recognized the importance of Biotechnology. Whilst the United States had long held a dominating position, the European Members States decided to strenghten the European Community's industrial growth by harmonizing their patent law thereby paving way for development and investment in the Biotechnology sector. Shruti Tiwari, Giulia Sibilla, George SK, and Ridwana Ahmed collectively present this interesting article on Biotechnology Laws with special emphasis on United States, European Union, Dubai (covering Dubiotech and other recent initiatives) and the law in UAE.
While human nature is steered towards fretting about daily challenges, what we actually fail to comprehend is the variety of solutions that biotechnology offers to mankind. Since the birth of Louise Brown, the first test tube baby in 1991, we have witnessed remarkable advances in the field of Biotechnology. However, such breakthroughs have raised significant questions on moral and ethical grounds. Ethicists, like John Harris, have pointed out numerous concerns on the imbalance that biotechnology causes on the nature. Think about a scenario where superheroes like Spiderman and Wonder-woman would be seen walking around in the streets of Dubai! This is most likely to cause large scale chaos and mayhem as they need not always be the good guys who fight the evil in the world.
Why hassle over the ‘tiny’ things?
The concept of ‘stem cells’ were first coined by renowned scientists, McCulloch and Till, in 1961. Presently, it is one of the most popular concepts in the field of biotechnology due to its potential applications and the legal and ethical issues that are associated with its usage. The evolution of the extensively funded industry of biotechnology has manifested itself to become one of the most dynamic branches of present day science and technology. Therefore, law regarding the patentability of stem cells mainly revolves around jurisprudence, biotechnology and regional moral or ethical standards. Morals are values that act as a guiding compass in our daily life as we face the complexities of the world around us. Law, on the other hand, is considered to be a vital instrument in regulating human conduct in the society. It is paramount to analyse how scientists, media and lawmakers have hyped the concept of stem-cells in order to understand the application of law and ethics in the field.
Stem cells have the capability of dividing and renewing themselves. However, the cardinal importance of stem cells lies in its ability to produce specialized custom cells as it helps in treating lethal diseases such as Parkinson’s, Diabetes, Arthritis and Cancer by using the specialized cells to revamp the affected tissues. Thus the progress in the field of stem cells has been stupendous, but the question is, if the progress is good enough for it to be made patentable? As biological advancement begin to take prominence, investors and innovators are compelled to turn to intellectual property rights with the objective of ensuring their exclusive rights over their investments. These rights work in unison with World Intellectual Property Organization (the WIPO). The patent system provides exclusive rights to inventors and innovators for a designated period of time In exchange for public disclosure of their inventions.
Patent Compatibility – A European View
European Patent Convention (the EPC) is a multilateral treaty which has laid down the legislations regarding patents in the European Union. The EU Biotech Directives (the Directives), issued by the European Commission, had been enacted for the purpose of protecting and promoting biotechnological inventions. Subsequently, the Directives were incorporated by EPC under its legislation. Thus the scheme for patentability of stem cells in Europe should be studied with the clauses under EPC simultaneously with the provisions of the Directives. Article 52 (1) of the EPC states that patentable inventions should:
· be novel;
· include an inventive step; and
· be capable of industrial use.
However, article 52 (2) of the EPC provides for an exclusion which states that discoveries, scientific theories and mathematical methods cannot be a subject matter of patent. It further states that inventions whose publication or exploitation is opposed to ‘ordre public’ or ‘morality’ cannot be patented. Therefore, one may argue on the basis of morality that the European Patent Office refrains from permitting patents for stem cells which are obtained though the destruction of human embryos. However, article 53 (a) explicitly states that the exploitation of an invention would not be deemed to be contrary merely because it is protected by the laws of any of the contracting states of the EU. This succours in blending the differences in moral beliefs that could be inspired by the domestic religion and traditions of the countries. This can be explained with the help of the following illustration: suppose a country has a law, ‘X’, which limits use of stem cells. It is not upon the law ‘X’ to determine if stem cells or invention made by the use of stem cells are patentable or not. Hence, a patent could be granted to an invention when it is capable of being exploited in the industry. Thus it is an attempt of harmonizing the patentability of inventions among various countries.
However, rule 23 (d) of the EPC specifically excludes the cloning of human beings, modifying germ line genetic identity of human beings, using of human embryos for industrial or commercial purposes and lastly modifying genetic identity of animals. This can be apprehended as an explicit exclusion to the patentability of biotechnological inventions as the inventions which result from the destruction or modification of human embryos cannot be patented in the EU. The infamous dispute in the patent application of Technion Research and Development Foundation Ltd. provides considerable insight on the position of the EU with regard to the patentability of human foreskin cells suitable for culturing stem cells. This dispute aided in explaining the status of patentability of ‘HES’ cells, as it was laid down that inventions which relied on commercially available ‘HES’ cells are excluded from patentability. The judges rejected the appellant’s claim that the inventions using commercially or publically available HES cells can be patented as it was obtained without the prior destruction of human embryos. Further, it was ruled that the appellant’s invention cannot be patented as the commercially available HES cell lines were also developed with the destruction of the human embryo.
Further, the judgment by the High Court of Justice (England and Wales) in the case of International Stem Cells vs. Comptroller General of Patents [i], Designs and Trademarks provides a substantial insight on the scope of term ‘human embryo’. The court held that an unfertilized human ovum does not fall under the ambit of the term ‘human embryo’ if it does not have the inherent capacity of developing itself into a human being. This means that a stem cell could be patentable if it has been developed from a cell which does not have the capability to transform itself into a human being over a period of time. In the light of these cases, it can be comprehended that an invention involving the use of stem cells can be protected by the European Patent Office only if the cells used for inventing them are obtained without destructing or modifying a human embryo.
The American Approach
The patentability scheme in the United States is relaxed, compared to that of Europe. Title 35 of the United States Code (the Code) has laid down the provisions regarding the patentability of inventions in the US. The Code has explicitly provided for the eligibility of the inventions or discoveries that could be protected under the jurisdiction of the United States Patent and Trademark Office. An invention or a discovery would be eligible to be patented only if:
· it is a new and useful process, machine, manufacture, composition of matter or any improvement thereof (article 101);
· it is novel (article 102); and
· it is non-obvious (article 103).
Politics has broadly affected the patentability in the industry of biotechnology as there are no specific regulations in the US that deals with the patentability of stem cells. However, the US has emerged as a global leader in its spending towards research and development in the biotechnological industry. The decision of the US Supreme Court decided the celebrated case of Diamond vs. Chakrabarty has helped in determining the patentability of stem cells in the US. A living micro organism was modified by the defendant in order to develop a bacterium that had wide usage in treating oil spills. Subsequently, the employer of the defendant applied for the patent of:
2. the process/ method of producing the bacteria; and
3. claims for an inoculum which comprised of a carrier material floating on water.
Subsequently, the patent examiner granted patents for items 2 and 3 but rejected the application for patenting the bacteria. He contended that living micro organisms which were found in the nature could not be attended under the Code. However, the defendant claimed that the genetic engineering which he performed on the micro organism was a manufacturing process and it had covered the objects of patentability of the Code. The apex court took the view that a human-made micro organism is patentable under the Code. Further, the court also stated that the genetic engineering which the defendant had performed on the micro organism would constitute the ‘manufacture’ and the bacterium would fall under the ambit of the term ‘composition of matter’ for the purpose of interpretation.
Whereas, the landmark case of Association for Molecular Pathology vs. Myriad Genetics [ii] aided in further establishing the patentability of stem cells in the US. The main issue in this case was whether the genes of DNA and CDNA were eligible for patent protection? Myriad Genetics, a foremost player in the biotechnology industry, had found the precise sequence and location of genome genes called BRCAI 1 and BRCAI 2. A detailed study on these genes proved that it increased the risk of breast and ovarian cancer. They subsequently obtained patents on these genes. The validity of these patents was challenged by the plaintiff on the ground that genes were naturally occurring components in human body and the mere discovery of their location cannot be a subject matter of patent. Therefore, the court held that DNA was not admissible to be patented. However, the court observed that CDNA was eligible for patent protection as it was not a product of nature completely.
The regulations on legality and patentability of stem cells in Europe are highly influenced by socio-ethical factors. While USA has a laid back policy and does not exclude the patentability of stem cells exclusively while it also provides federal funding. Although members of EU are gaining pace in the industry, it continues to struggle in harmonizing the regulations governing stem cells among the various contracting states.
With advances in Biotechnology taking its stand on the platform of many international pedestals today, it is an honour to note that the UAE is regarded as the leading stand of the Arab world in Biotechnology. Recently, UAE has witnessed tremendous growth in the industry as it has been included in the Scientific American Worldview Report and the Bio Innovation Scorecard. UAE has also successfully incorporated the Khalifa Center for Biotechnology and Genetic Engineering (KCBGE) at the UAE University in Al Ain which aims at increasing agricultural production by developing genetic fertilization of plants., This centre facilitates in dealing with the issue of healthier food consumption, sustainability and food security as the growing number of food disorders amongst the youth today has an adverse effect on the society.
The commencement of operations at the Dubai Biotechnology and Research Park (DuBiotech) provides the Arab nation with substantial investment into the development of biotechnological industry. The park includes a bio headquarter towers, a nucleotide lab complex and warehousing facilities to support a growing body of research, development, manufacturing, distribution and services amongst others.
If we ought not to fear mortal truth, still less should we dread scientific truth. In the first place it cannot conflict with ethics? But if science is feared, it is above all because it can give no happiness? Man, then, cannot be happy through science but today he can much less be happy without it- Henri Poincare!
[i]  EWHC 807 (Ch)
[ii] Assciation for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 186 L. Ed. 2d 124 (2013)