The patent dispute relating to the revolutionary CRISPR-Cas9 gene-editing technology between the Broad Institute (jointly operated by Harvard and MIT) on the one side and UC Berkeley on the other side is is heating up in Europe.

On January 17, the Broad Institue lost its first granted CRISPR EP patent in first instance opposition hearings. An appeal against this decision has immediately been filed on January 18 by the patent proprietor.

On the other hand, the University of Berkeley (together with the University of Vienna and Emmanuelle Charpentier) filed it´s first patent relating to CRISPR technology even before the Broad Institute already on March 15, 2013 claiming the earliest priority on May 25, 2012. The resullting patent EP 2 800 811 was granted with main patent claim 1 as follows:

“1. A method of modifying a target DNA, the method comprising contacting the target DNA with a complex comprising:

(a) a Cas9 polypeptide and
(b) a single-molecule DNA-targeting RNA comprising:

(i) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a sequence in the target DNA, and

(ii) a protein-binding segment that interacts with said Cas9 polypeptide, wherein
the protein-binding segment comprises two complementary stretches of nucleotides that
hybridize to form a double stranded RNA (dsRNA) duplex,

wherein said two complementary stretches of nucleotides are covalently linked
by intervening nucleotides,
wherein said contacting is in vitro or in a cell ex vivo; and
wherein said modifying is cleavage of the target DNA.”

A restriction to either eukaryotic or procaryotic cells (which played a major role in the parallel US interference proceedings) seems not to be present. The contacting of the target DNA to be modyfied by the method according to the claim, however, has to take place in vitro or in a cell ex vivo. 

The mention of grant of the patent was published on May 10, 2017.

Within the 9-month opposition term ending February 10, 2018 seven parties have filed an oppositions, namely:

Opponent 1: DF-MP Dörries Franck-Molnia & Pohlman
Opponent 2: Onno Griebling
Opponent 3: TL Brand & Co. Ltd.
Opponent 4: HGF Limited
Opponent 5: Jones Day
Opponent 6: Allergan Pharmaceutical International Ltd.
Opponent 7: Elkington & Fife LLP.

Of these opponents only one, Allergan Pharmaceutical International Ltd., is clearly identifiable, the other six oppositions are filed by IP firms acting as so-called “strawmen” for opponents which do not want to be identified. This practice explicitly allowed by the EPO is common in the pharmaceutical industry in Europe.

All opposition grounds are raised, namely lack of novelty and lack of inventive step, lack of enabling disclosure of the patented technical teaching, and extension beyond the content of the original application (added matter). Despite the huge amount of documents filed, a first instance decision in these opposition proceedings can be expected in approximately 18 months.

Disclaimer: Neither I myself nor the patent firm Betten & Resch, of which I am a partner, are representing clients involved in any patent cases relating to CRISPR-cas9 technology.

Twitter: @patentlyGerman