22/01/2016
The discovery of an accurate, programmable and potentially valuable gene editing system known as the CRISPR-Cas system was announced to the public in the journal Science in 2012 by a group led by Jennifer Doudna at the University of California, Berkeley, and Emmanuelle Charpentier, then at Umeå University in Sweden. Corresponding patent applications relating to the CRISPR-Cas system were filed by the Doudna group from 25 May 2012 onwards. A rival group led by Feng Zhang at the Broad Institute has filed patent applications to foundational CRISPR-Cas technology since 12 December 2012. However, while no patents in key jurisdictions appear to have issued to date from the Doudna group applications, the Zhang group has been successful in expediting examination before patent offices such as the US Patent & Trademark Office (USPTO) and the European Patent Office (EPO), leading so far to thirteen granted US patents and four granted European patents.
Although the Zhang group has won the race to patent first, the CRISPR patent war between the Zhang and Doudna groups has only just begun. In the US, an interference has been declared this month by the USPTO in respect of Doudna’s first US patent application (published as US2014/068797). The aim of the interference proceedings is to determine whether the Doudna or Zhang groups have the earliest date of invention for specific claimed inventions. Under old first-to-invent US patent law, whichever party is awarded the earliest date of invention will be deemed by the USPTO to be entitled to one or more patents for those inventions.
US interference proceedings can be declared only on US patent applications filed before, or claiming valid priority to another patent application filed before 16 March 2013. For applications filed on or after 16 March 2013, the US applies a first-to-file system which broadly harmonises this aspect of US patent law with patent laws around the world. However, patent proprietors under the first-to-file system cannot simply rely on having the earliest patent application filing date. Rather, a detailed analysis of the content of the or each earlier-filed patent application is required to ascertain whether there is valid priority entitlement to the ultimate claims of the final application. A valid priority date will determine the cut-off point for identifying prior art, including co-pending patent applications, which can be used in the assessment of patentability requirements such as novelty and/or inventive step.
Determination of priority entitlement will be important for the European battle in the CRISPR patent war, and elsewhere. The validity of Zhang’s first and second granted European patents have been contested on several grounds, including novelty and inventive step, by several parties who have filed oppositions against the patents at the EPO. Oppositions against the Zhang group’s remaining two granted European patents are likely to be filed before the deadline for doing so expires.
Both in the US and Europe (and no doubt elsewhere), the CRISPR patent war is likely to continue for many years. The USPTO’s interference decision, when it eventually issues, can be appealed to the US Court of Appeals for the Federal Circuit. Similarly, EPO opposition decisions are appealable to the Boards of Appeal of the EPO. Post-grant EPO proceedings are currently delayed by several years due to workload and backlogs.
Meanwhile, while the CRISPR patent war rages, those wishing to exploit CRISPR-Cas technology should still consider seeking licences from relevant patent proprietors. When the patent war is over, it is reasonable to assume that there will likely still be winner(s) of valid patent protection for aspects of the underlying CRISPR-Cas technology.
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.
