16/02/2017
In a previous article, I wrote about US interference proceedings at the US Patent & Trademark Office (USPTO) involving US patents and applications covering the programmable and potentially valuable gene editing tool called the CRISPR-Cas system. The Patent Trial and Appeal Board (PTAB) of the USPTO has now decided in favour of the Broad Institute, ruling that their contested granted US patents claimed patentably distinct subject-matter over the subject-matter claimed in a pending US patent application of the University of California (UC), Berkeley.
In a judgment issued on 15 February 2017, the PTAB stated:
“Broad has persuaded us that the parties claim patentably distinct subject matter, rebutting the presumption created by declaration of this interference. Broad provided sufficient evidence to show that its claims, which are all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as UC’s claims, which are all directed to CRISPR-Cas9 systems not restricted to any environment. Specifically, the evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRISPR-Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in an eukaryotic environment. This evidence shows that the parties’ claims do not interfere. Accordingly, we terminate the interference”.
The parties involved in the interference naturally have different perspectives on the decision. The Broad Institute has stated on its website that “We agree with the decision by the patent office, which confirms that the patents and applications of Broad Institute and UC Berkeley are about different subjects and do not interfere with each other”. The Broad Institute also notes the following:
“CRISPR research is a very large field that involves contributions from talented scientists around the world. We have deep respect for all of these scientific contributions, including the work from Emmanuelle Charpentier, Jennifer Doudna, and their teams, as well as all of those who continue to advance the field and educate the public about this important technology.
Over the next few years there will be many patents issued in the CRISPR field to many institutions. As of February, 2017 the USPTO has issued 50 patents with claims to CRISPR and/or Cas9, including a robust portfolio of 14 CRISPR patents to the Broad Institute, MIT and affiliated groups for inventions from Dr. Feng Zhang and the Zhang lab”.
Meanwhile, the UC has commented on its website that the USPTO’s decision rules that “the inventions claimed in the pending U.S. patent application filed by the Doudna/Charpentier research group and the patents and applications filed by the Broad Institute are separately patentable from one another, thereby moving the Doudna/Charpentier group’s application closer to issuance as a U.S. patent”. Paul Alivisatos, UC Berkeley vice chancellor for research and professor of chemistry, is quoted on the UC website as saying:
“UC respects today’s ‘no-interference-in-fact’ decision by the PTAB and is pleased that its patent application covering the use of CRISPR-Cas9 gene editing technology for all cell types can now move closer to issuance. Nevertheless, the university continues to believe that the use of the CRISPR-Cas9 system in eukaryotic cells is not separately patentable from the general application of the CRISPR-Cas9 system in any cell type, as invented and claimed by the Doudna/Charpentier group. As such, we will be carefully considering all possible legal options at this juncture”.
It thus remains to be seen whether the UC will appeal the USPTO interference decision, so there will continue to be uncertainty on which party or parties will ultimately be deemed to hold valid US patents for the underlying CRISPR-Cas technology applicable in eukaryotic cells and/or prokaryotic cells.
As we reported previously, there are separate pending EPO opposition proceedings contesting the validity of the Broad Institute’s granted European patents. The outcome of the opposition proceedings may turn on different facts to the USPTO interference proceedings, given that the ‘first to invent’ interference factor is irrelevant under Europe’s first to file patent system.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
