Correct DNA sequences: the patent conflict

One of the great objectives of the scientific community involved in biotechnology, in the broadest possible sense of the term, has been to "repair" DNA breaks precisely, producing a single cut in the genome in the exact place where you want to alter the initial sequence, either to correct a mutation or to introduce variants. In microorganisms, such as S. cerevisiae yeast, it is possible to achieve this “edition” precisely, but not in plants and animals, including human cells.

The Spanish scientist Francisco J. Martínez Mojica of the University of Alicante identified in 1993 these CRISPR sequences in the DNA of microorganisms (archaea and bacteria) with a high salt tolerance, isolated on the coast of Santa Pola (Alicante). It was suggested that they served as an immune defense mechanism against viruses, so that the bacteria that survive the viral attack keep the aggressor's information, allowing them to identify undesirable genes thanks to previously stored information and destroy the virus.

CRISPR is an acronym for the English expression "Clustered Regularly Interspaced Short Palindromic Repeats", ie Short Palindromic Repeats Grouped and Regularly Spaced in Spanish. Cas9 is an endonuclease enzyme associated with CRISPR that acts as “molecular scissors” to edit or correct DNA in a cell, being directed by a guide RNA to the exact place to be modified.

As can be deduced from the previous paragraphs, CRISPR-Cas9 technology is a tool capable of modifying or correcting DNA sequences in a precise, economical and simple way and can even allow chromatin modifications to be made at specific sites, which implies enormous potential in medicine. , food, agriculture or environment. This is a disruptive innovation initially generated by two research groups in the United States and Sweden that filed patent applications, whose processing and exploitation is leading to a bitter conflict between the incumbent institutions.

The objective facts are:

- On May 25, 2012, the first patent application for this technology, shared between the University of California - Berkeley and the University of Vienna with Jennifer Doudna and Emmanuelle Charpentier, is filed with the US Patent and Trademark Office (USPTO) as principal investigators in Berkeley and Vienna respectively.

- This initial application, together with subsequent ones of October 2012, January 2013 and February 2013, filed by the same institutions, gave rise to an international patent application, filed under the Patent Cooperation Treaty (PCT) and It has continued in many countries and territories: Australia, Canada, China, Korea, Europe (38 countries), Hong Kong, Japan, Mexico ...

- Feng Zhang and his Broad Institute group - MIT (Boston MA, USA) proved that genetic editing technology could work in eukaryotic living things, even in humans. Applying a protection strategy that took advantage of the USPTO's accelerated examination options, they submitted a plurality of patent applications, the oldest being on December 12, 2012; Some of these applications have already been granted in various countries and territories.

- Institutions with ownership rights, particularly the University of California and the Broad Institute have licensed the exploitation of technology in various fields of application to large companies such as Bayer, Dow Dupont, Monsanto or Thermo Fischer, either directly or through spin companies -off as ERS Genomics, CRISPR Therapeutics, Intelia Therapeutics, Caribou Biosciences (arising from Berkeley and / or Vienna) or EDITAS Medicine (Broad)

It is clear that the impact of CRISPR-Cas9 technology far exceeds the experimental and research field with a huge social and economic impact, which makes interested parties use all the resources for patent offices to decide in favor of their respective interests. It would be the object of an in-depth analysis, rather than an entry in this blog, detailing the status of each patent.

However, the tendency seems to be, at least in the United States, to allow the coexistence of the Berkeley / Vienna and Broad-MIT patents, assuming the application of CRISPR-Cas9 in beings as non-obvious and therefore inventive. live eukaryotes, Broad - MIT's argument against the more generic statement of the initial Berkeley / Vienna patent. In other jurisdictions, such as the European Patent Office, cross-opposition proceedings are open in the processing of several applications, so “the swords remain high.”

As expected, the progress in research is being vertiginous, so there are numerous presentations of patent applications with various applications and variants of technology. They continue to stand out as frequent holders Harvard - MIT - Broad and UC-Berkeley, but companies such as DowDuPont, Caribou or EDITAS already mentioned in previous paragraphs appear.

As a conclusion, without a doubt, this technology has enormous potential, in which there is still much to move forward and develop, making it clear that companies and institutions with strong investments and interests in the field should redouble efforts to collaborate, rather than wear out in endless and very expensive patent litigation.


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