Some exceptions to patentability and the New Mexican Industrial Property Law
Recently, a New Industrial Property Law in Mexico was approved, which will enter into force on 5 November 2020. Among the new amendments, there are some regarding the exclusion from patentability in relation to biotechnological inventions, as described below:
‘Article 49.- The following will not be patentable:
Inventions whose commercial exploitation is contrary to public order or contravene any legal provision, including those whose exploitation must be prevented to protect the health or life of people or animals or plants, or to avoid serious damage to the environment.
a) The cloning procedures of human beings and their products;
b) The procedures for modifying the germinal genetic identity of the human being and its products when these imply the possibility of developing a human being’.
In relation to the aforementioned, there have been some cases in which it is necessary to define that the use of embryonic cells does not always imply the destruction of embryos that have the possibility of developing a human being. For example, in our jurisdiction, a patent application related to the methods for improved embryonic stem cell-based therapies for retinal degeneration was objected to, because the patent examiner of the Mexican Patent Office (‘IMPI’) argued that the ‘embryonic stem cells’ referred to cells originating from an embryo, more specifically to cells isolated from the inner cell mass of a blastocyst or a morula (stages in the embryonic human development), and therefore those ‘embryonic stem cells’ protected by the claimed invention, implies the destruction of a human embryo.
However, during the examination procedure, the patent holder replied that the use of those embryonic cells did not imply the destruction of human embryos, since the embryonic cells were obtained by parthenogenetic activation. In this sense, this specialised technique is described as the ‘nuclear transfer into an oocyte to effect the reprogramming of the genetic material of a human somatic cell to form a diploid human pronucleus capable of directing a cell to generate the stem cells from which autologous, isogenic cells for transplantation therapy are derived’.
Because the claimed invention use embryonic cells by means of pharthenotes, also known as parthenogenetically activated oocytes, which are artificially activated unfertilised oocytes, and they cannot develop beyond the blastocyst stage, they are not considered embryos and therefore, they cannot develop into a human being.
In comparative law, the European Parliament has issued a Directive (case C-364/13) that clearly describes the parthenogenetic activation, as follows:
‘Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that an unfertilized human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being... .’
Thus, IMPI took into consideration the experience abroad and took a similar criteria, considering that the subject matter claimed by the invention did not contravene the provisions of the Industrial Property Law, and finally the patent was granted.
Similar cases regarding the exclusion of patentability of embryonic stem cells have been examined in other countries, in which the use of parthenotes avoid the destruction of human embryos, and therefore allows the possibility of applying for patent protection. In this regard, a more detailed article is still necessary in the Mexican IP Law to define the use of parthenotes.