Guest post by Lucia Tamayo Del Portillo*
In early 2012, a group of scientists from the University of California Berkeley (“UC”) led by Dr. Jennifer Doudna, in collaboration with the University of Vienna and fellow researcher Emmanuel Charpentier, filed the first patent application for a revolutionary gene-editing tool called Crispr Cas9. The Crispr and its associated protein Cas9 is a natural existing response to immunological hazard that can be found in bacteria. By a combination of complex biochemical interactions, bacteria is able to identify foreign DNA, cleave to it, and then induce a break on the DNA strand, causing its instant deactivation. UC’s first patent application was broad and mainly tested in rather simple living organisms such as bacteria. Few months after this application, the Broad Institute (“Broad”) along with the MIT and the Harvard College, filed another patent application over the Crispr Cas9. Dr. Feng Zhang commanded the main research team behind this invention. This subsequent application was limited to the use of the Crispr Cas9 method in eukaryotic organisms for example, plants and animals.
It is worth mentioning that under U.S. patent law, the Crispr Cas9 is not patentable as such due to the fact that it is a naturally existing phenomena. The only way to protect this invention was through the development of a method that combines different steps in order to enable gene editing while using this system.
By requesting fast-track examination, the Broad Institute managed to obtain a patent for the Crispr Cas9 before the UC. It was in these circumstances that the UC decided to take action requesting the USPTO to declare interference. By means of this procedure, an inventor having a later filing date can reclaim its invention by proving that he invented the subject matter. However, it also allows a patent application to challenge a granted patent with a later filing date subject that the applicant proves overlapping matter.
UC filing date goes back to pre-AIA. On the contrary, the Broads filing date falls within the new AIA rules. However, in order to overcome novelty and obviousness objections made by the examiner, Zhang swore that he was the one who first invented the subject matter, therefore, subjecting the patent to pre-AIA.
The United States Patent Office heard the claims of UC and appointed a three-judge panel to determine if there was interference in fact, and if so, who was the first to invent the Crispr Cas9 gene-editing method. The interference was declared on January 2016, and it was just a month ago, on 6th of December when the first and only oral hearing was held.
Even thought, the PTAB has not yet made officially available the records of what was discussed and presented by the counselors, commentators who attended the procedure are reporting that the main dialogue was gravitating towards two questions
- if the subject matter covered by the disputing patents is substantially the same, or if on the contrary, as Broad is arguing, they are separate inventions;
- if in light of the teaching of the first filed patent, the UC patent, it would have been obvious to a person skilled in the art to adapt the method to be workable in eukaryotic cells.
Broad presented strong evidence aiming to prove that the inventions are per se different, and that the UC failed to narrow down the claimed matter as to enable a person skilled in the art to perform the method in eukaryotic cells, therefore failing to reduce to practice, while UC took the defensive reinforcing its argument that Zhang’s lab used Doudna’s disclosures and simply adapted the teaching into eukaryotes. External sources are reporting that apparently the judges made more questions to the UC counsel in contrast to its opponent and they appeared to be more sympathetic towards Broad’s argumentation line than to the UC. However, there is no certainty about the outcome and a decision is only expected until late 2017.
Despite the outcome of this case that can significantly impact severely the biotech industry, the most challenging part for the Crispr Cas9 technology is to react in a responsible way to the Pandora box it is about to open by providing a remarkable tool for the so called genetic revolution.
*Lucia Tamayo Del Portillo has a law degree from Universidad de Los Andes, in Bogota, Colombia and holds an LL.M. on Intellectual Property and Competition Law from the Munich Intellectual Property Law Center in Germany. She has been practicing in IP for almost five years, and has practical experience in international firms such as Jones Day. Currently she works as an associate at the patent department of Colombian law firm Lloreda Camacho & Co.