Patentability of human stem cells

Stem cells have particular properties that allow them to differentiate into various types of mature cells found in all vertebrate animals, including human beings.

This ability to divide into identical or different types of cells is a feature of stem cells that, surprisingly, allows them to repair the necessary tissues to treat deteriorating diseases such as Parkinson’s, Alzheimer’s, Huntington’s and diabetes, as well as damage caused by strokes, spinal cord injuries, bone diseases and birth defects such as heart failure or congenital blindness.

These cells are also considered as key research tools for gaining important scientific insight into embryonic development and evaluating in vitro drugs, such as anticarcinogens, for the treatment of diseases.

Traditionally, stem cells have been classified in two types: embryonic stem cells and adult stem cells. Embryonic stem cells are cells that, in humans, are isolated from the inner cell mass of a four to five-day-old embryo post-fertilisation, with the capacity of forming all cell types from an adult organism.

On the other hand, adult stem cells exist in various parts of the body, such as the brain, bone marrow, liver, skin or blood. These are undifferentiated cells with the capacity to differentiate into some or all the specialised cell types of the tissue or organ in which they are found.

In Mexico, claims related to human stem cells were being rejected by the Mexican Institute of Industrial Property (IMPI) not so long ago. However, in a truly surprising and radical change on the subject, IMPI has indicated that adult stem cells can be considered patentable. Therefore, it can be concluded that IMPI rejects the patentability of embryonic stem cells, since these cells are obtained by the destruction of human embryos.

“In Mexico, claims related to human stem cells were being rejected by the Mexican Institute of Industrial Property (IMPI) not so long ago. However, in a truly surprising and radical change on the subject, IMPI has indicated that adult stem cells can be considered patentable.”

The above stance goes in tandem with that of the European Patent Office, which has issued three decisions on the patentability of human embryonic cells. One of these rulings was from the Opposition Division to the Edinburgh Patent, in which most of the claims were interpreted as relating to the use of human embryos for the production of embryonic cells, and human embryos would be destroyed in the process; the Opposition Division found that the invention was against article 53(a) and rule 23d(c) of the European Patent Convention.

Based on experience in the prosecution of these types of cases, it is safe to point out that inventions related to human embryonic stem cells are generally contested by IMPI, based on article 4 of the Industrial Property Law, which states:

“No patent, registration or authorization shall be granted, neither shall any publicity be given in the Gazette in respect of any of the legal devices or institutions regulated by this Law when their contents or form are contrary to public policy, morality or proper practice, or if they violate any legal provision.”

This provision is interpreted by IMPI as equivalent to the stipulations of article 327 of the General Health Law in Mexico, which states that:

“Trade of organs, tissues and cells is prohibited. Donation of the latter for transplant purposes shall be governed by principles of altruism, nonprofitness and confidentiality; therefore, obtention and use thereof shall be strictly gratuitous.”

Therefore, IMPI’s decision does not merely imply that the use of human embryos for commercial purposes cannot be patentable, but that human embryonic stem cells, their therapeutic uses and processes for obtaining them will face the same fate as well.

However, the above exclusion in no way encompasses adult human stem cells that have been isolated from the human body. So unless a contrary stance emerges, IMPI will continue granting patents to those inventions, provided they meet the universal requirements of patentability.

Fernando Antonio-Rincón is a department engineer at Becerril, Coca & Becerril, S.C. He can be contacted at: frincon@bcb.com.mx