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Adult stem cells can be considered perfectly patentable at Mexican Institute of Industrial Property (IMPI)

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

The discovery of stem cells can be considered as one of the major breakthroughs in life sciences of the last decade. To appreciate their significance, it is worthy to briefly point out that stem cells have particular properties that allow them to differentiate into a variety of types of mature cells that constitute all vertebrate animals, including human beings.

The ability of stem cells to divide into identical or different types of cells is considered a feature that, surprisingly, allows them to repair the vital tissues affected by deteriorating diseases like Parkinson's, Alzheimer's, Huntington's, diabetes. These cells are critical in the treatment of other diseases such as stroke, spinal cord injuries, bone diseases as well as birth defects such as heart failure or congenital blindness, thalassemia major or Cooley's anemia to name some of them. This type of cells is also considered as a key research tool that helps to gain important scientific insight on embryonic development, for the treatment of diseases, and it also helps to evaluate in vitro drugs, such as anticarcinogens.

Traditionally, human stem cells have been classified in two types: embryonic stem cells and adult stem cells. On the one hand, embryonic stem cells are isolated from the inner cell mass of 4 to 5-day old embryos post-fertilization. Embryonic cells are capable of forming every cell type 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 of the specialized 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, such institute, in a truly surprising and radical change on the subject, has indicated that adult stem cells can be considered perfectly patentable. Therefore, it can be concluded that what the IMPI rejects is the patentability of embryonic stem cells, since these cells are obtained by the destruction of human embryos.

The above stance goes in tandem with that of the European Patent Office (EPO), which has ruled three decisions regarding the patentability of human embryonic cells. One of these rulings was from the Opposition Division to the Edinburgh Patent (T1079/03), in which most of the claims were interpreted as relating to the use of human embryos for the production of embryonic cells, wherein human embryos would be destroyed in the process to obtain the same. This was the rationale argumented by the Opposition Division to consider that the invention was against Article 53(a) and Rule 23d(c) from the European Patent Convention (EPC).

Now, based on experience in the prosecution of this type of cases, it is safe to point out that inventions related with human embryonic stem cells are generally contested by the IMPI, based on the grounds of Article 4 from the Industrial Property Law (LPI), 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”.

The above provision is interpreted by the IMPI as equivalent to the stipulations of Article 327 from 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, non-profitness and confidentiality; therefore, obtention and use thereof shall be strictly gratuitous”.

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

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

In conclusion, it can be considered that this opens a new perspective on the scope that patent applications must consider when applicants plan to file them in Mexico.

Source: http://www.marcasurmi.com/en/articles/mexico/_Patentability_of_human_stem_cells.html

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