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CRISPR/Cas patent wars have begun at the European Patent Office

23 November 2015

By Dr James Legg

European Patent Attorney, Boult Wade Tennant

Appeared in BioNews 829

On 26 October this year the CRISPR/Cas patent wars truly began with the filing of European oppositions against what appears to be the first patent granted in Europe for this revolutionary gene-editing technology. The patent was granted to the Broad Institute, MIT and Harvard College on 11 February this year (1), and at least nine different opponents filed oppositions against it before the deadline this month. The European opposition procedure that will now follow could result in the amendment or even the revocation of the patent, but it is likely to be at least five years before the final outcome is known.

CRISPR/Cas is a gene-editing system derived from prokaryotic cells that uses a target-specific guide RNA to direct a nuclease (e.g. Cas9) to a specific sequence within cellular DNA, where it creates a precise cut. The speed at which the system has been adopted by both academic and industry groups since it was first published in 2012 is quite staggering (2). It is already used extensively across the drug discovery and development pipeline of major pharmaceutical companies. The potential applications extend well beyond biological research, however, and many companies are already exploring applications in industrial biotechnology, agricultural biotechnology and therapeutic use (e.g. based on gene and cell therapy). 

To provide some perspective on the patent landscape, the granting of the Broad Institute's patent was closely followed by the granting of two other European patents (3,4). These patents are still within the nine-month opposition period, and it seems likely that they too will be opposed by multiple parties. In the USA, the same patent family already includes at least 13 granted patents, the first of which was granted on 15 April 2014 (5). There are also many more European and US applications in this patent family that are currently pending.

One of the other important patent families directed to CRISPR/Cas currently includes a European patent application (6) and a US patent application (7). This patent family is in the name of the University of California, the University of Vienna and Emmanuelle Charpentier, and claims a priority date of 25 May 2012, which is more than six months earlier than the priority date claimed by the Broad Institute's patent family (i.e. 12 December 2012). The priority date of an invention is the date of filing of the patent application that discloses the invention or, if there is a valid priority claim, the date of filing of the priority application. It is an important date since the invention claimed in a patent must be novel and inventive over all public disclosures made before the priority date. 

Why then have patents been granted to the Broad Institute? The answer is a complicated one, but relevant considerations include the scope of the claims of the Broad Institute patents and the extent of the disclosure regarding CRISPR/Cas in the University of California cases. In addition, while the University of California family claims an earlier priority date, none of the applications were published until after the priority date claimed by the Broad Institute family. This means that – at least in Europe – if the priority claims of both cases are valid, the University of California cases will only be relevant to the assessment of novelty (and not inventive step) of the Broad Institute's patents.

The interplay between the factors mentioned above is complex, to put it mildly, but one clear question does emerge. Since Jinek and co-workers at the University of California published the details of the CRISPR/Cas9 system before the priority date of the Broad Institute patents, for the claims of those patents to be valid they must define subject matter that is novel and inventive over that publication (2). One consideration in this respect is whether it would have been obvious, based on the disclosure of Jinek et al, that the CRISPR/Cas system would work in vivo in eukaryotic cells.

In the USA there is also the potential for a patent interference to determine who was the first to invent the technology. This possibility exists because the patent families mentioned above have priority dates prior to 16 March 2013 (patents and applications with effective filing dates on or after this date in the USA are now governed by a first-to-file system under the America Invents Act).

To date, there appear to have been attempts to initiate interference proceedings in relation to the CRISPR/Cas technology based on an alleged overlap between the claims of an application that is part of the University of California's patent family (7) and the claims of the Broad Institute's US patents. However, a formal interference procedure has not yet begun. Moreover, even if a patent interference is initiated, it is likely to be many years before the victor is declared.

In summary, CRISPR/Cas already has a complex patent landscape with many overlapping patent rights. This landscape includes patents and applications covering the basic CRISPR/Cas system and methods for its use, improvements to the system (e.g. the new nuclease Cpf1 (8)) and specific applications for its use (e.g. therapeutic uses). In addition to the Broad Institute and the University of California, there are of course many other parties with patents and patent applications relevant to this technology, and the relevant patent rights extend well beyond Europe and the USA. Furthermore, with so many teams of researchers now working on the system, the complexity of the patent landscape will only increase with time.

Faced with such complexity, those using CRISPR/Cas (or planning to do so) will need to adopt a pragmatic approach to freedom-to-operate (FTO) analysis. FTO is best viewed as a risk assessment and, in the case of CRISPR/Cas, the risks of patent infringement will need to be carefully considered against the undoubted benefits of using this technology.

The Progress Educational Trust's public conference 'From Three-Person IVF to Genome Editing: The Science and Ethics of Engineering the Embryo' is taking place in central London on Wednesday 9 December 2015. Find out more here.

SOURCES & REFERENCES
1) EP 2 771 468, granted on 11 February 2015
| 
 
Science 337, 6069, 816-821 | 
 
3) EP 2 784 162, granted on 8 April 2015
| 
 
4) EP 2 896 697, granted on 2 September 2015
| 
 
5) US 8 697 359, granted on 15 April 201,4
| 
 
6) European Patent Application No. 13 793997
| 
 
7) US Patent Application No. 13/842859
| 
 
Cell. 2015, 163(3):759-71. | 
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

12 December 2016 - by Antony Blackburn-Starza 
Oral arguments from lawyers acting for the Broad Institute and the University of California, Berkeley, in the high-profile CRISPR/Cas9 patent dispute have been heard in Virginia...
22 August 2016 - by Chee Hoe Low 
A former MIT visiting student who worked in the Zhang lab for nine months in 2011 has claimed that patents over the CRISPR genome-editing technology were 'mis-patented'...
08 February 2016 - by Cait McDonagh 
A biotechnology company co-founded by two leading scientists involved in developing the genome-editing technology, CRISPR/Cas9, has gone public, raising over $94 million in its initial share offering...
25 January 2016 - by Antony Blackburn-Starza 
An article published in the journal Cell, providing an account of the discovery of the genome-editing technology CRISPR, has sparked fierce disagreement between the leading scientists involved in developing the technology....
18 January 2016 - by Antony Blackburn-Starza 
The CRISPR 'patent wars' have now officially kicked off in the USA, with formal proceedings to determine who controls key patents over the revolutionary genome-editing technology...

16 November 2015 - by Ari Haque 
A US biotechnology start-up co-founded by two pioneers of CRISPR technology intends to begin gene editing in humans as part of an experimental treatment to target a rare genetic eye disorder...
21 September 2015 - by Kirsty Oswald 
Researchers from London's Francis Crick Institute are seeking permission to edit the genome of human embryos...
18 May 2015 - by Ari Haque 
Patents for the gene-editing technology, CRISPR/Cas9, are the subject of a dispute between scientists at University of California, Berkeley and the Broad Institute of MIT and Harvard....
05 May 2015 - by Ayala Ochert 
The US National Institutes of Health has issued a firm statement that it will not fund any research involving gene-editing technologies in human embryos...

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