This post was published on May 2, 2011.
The debate with respect to genetic and stem cell patents is alive with the European Court of Justice’s (ECJ) preliminary opinion in March. According to the opinion, embryonic stem cells are not patentable because the use of totipotent stem cells amounts to the use of human embryos for industrial or commercial purposes. Since totipotent stem cells can develop into a human being and are derived from an embryo, they can be considered to be human embryos or based on the manipulation of human embryos. This opinion was an interpretation of Article 6(2) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, which prohibits patents that relate to the industrial or commercial use of human embryos as that would be against public order and morality.
While the final decision is expected in May, many scientists, attorneys, and scholars have raised concerns with respect to the preliminary opinion. They argue that the acquisition of stem cells and their development in the lab does not amount to the destruction or use of an embryo. Deriving embryonic stem cells from sources such as human embryos produced by in vitro fertilization, aborted fetuses, and asexually produced human embryos is not considered by scientists to be immoral or against public order because they are very valuable for developing treatments for many life-threatening diseases. According to them, preventing patents on such stem cells would hurt the progress of research, thereby preventing or slowing down treatments for dangerous diseases.
In India, stem cells are considered patentable, and many patents have been granted on stem cells. The Patents Act does not have any specific prohibition against the grant of patents over stem cells. Though the draft manual of 2008 stated that embryonic stem cell patents are against public order and morality, the latest Manual, published in 2011, does not mention anything about stem cell patentability. In the absence of any jurisprudence on the matter, embryonic stem cells can be considered patentable in India. Having said that, I am positive that the debate will come to life in India when an embryonic stem cell patent goes to court.
Authored by Dr. Kalyan C. Kankanala
