This past Thursday, the United States Supreme Court ruled that human genes cannot be patented in a case against the company Myriad Genetics. This decision will have many consequences on the pharmaceutical market worldwide since it sets a precedent for the holding of patents for rare and high risk diseases such as breast and ovarian cancer. Experts say that it will open up the market for competition which will reduce the costs of medication and improve human health.
But just how will this court ruling affect the pharmaceutical industry in Mexico? Mexico is an emerging market and one of its fastest growing sectors is on biocomparables. Although there are currently only about five companies that develop biocomparables in Mexico, the access to this niche market has been opened and is sure to expand rapidly in the coming years. Biocomparable drugs require the use of live cells to develop and engineer a molecule that could be the key active ingredient so a legal precedent that says companies cannot patent human, naturally occurring molecules can change the regulatory landscape in Mexico, affecting not only developing companies, but government and patients alike. As of now, the Mexican agency for the regulations and health risks, COFEPRIS, has been working in updating and speeding up trials for granting permissions to develop biotech molecules and biocomparables. Although there is still more to be done in this field, we have seen that there is a lot more leniency on topics such as autologous stem cells, which remains a highly debatable issue in the United States. So will regulations be more lenient towards patenting new molecules in the Mexican market? Or will companies in Mexico have to develop new strategies to increase understanding of their development protocols to avoid getting backtracked on obtaining a patent for a biocomparable drug?
To read the full article on the US Supreme Court ruling, go to: http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html