The University of California Berkeley (UCB) has lost a CRISPR patent in Europe in the latest twist in the long-running IP saga over the gene-editing technology.
The European Patent Office (EPO) handed down its decision on April 13, revoking the EP3241902 patent on the grounds of an invalid priority claim and delivering a blow to UCB’s CRISPR patent rights in Europe.
The ruling comes after the EPO revoked the Broad Institute’s CRISPR patent EP2771468 in November 2020, after it found issues with its claimed ownership.
In the wake of breakthrough technological advances in 2012–2013, biotech and pharmaceutical companies have sought to patent CRISPR/Cas9, a gene-editing technique that can target and modify DNA with high accuracy.
This has prompted a spate of litigation proceedings worldwide, including in the US where the UCB and the Broad Institute are waging an ongoing legal dispute over which body first invented the breakthrough technology.
During the latest proceedings at the EPO, opponents argued the ‘902 patent was invalid because a UCB publication, “Jinek 2012”, provided relevant prior art.
They also argued that the patent’s priority claim was invalid because a skilled person faced an undue burden in carrying out the claimed invention.
“It can be dangerous to rely on a ‘thin’ initial patent filing with limited data to support a claim to priority.”
Anonymous source
The EPO found against the UCB, holding that their earliest priority filing on May 25, 2012, contained insufficient data and technical description to support the claims of the granted patent. This meant that the UCB’s own 2012 publication became prior art, leading to a revocation of the patent for lack of inventive step.
In Europe, the EPO has become a key battleground for patent challenges in this hotly contested field as opponents can challenge the validity of an issued European patent within a relatively short time frame of its being granted. In addition, the office enables parties to file an opposition via a third-party “straw man” to conceal their identity.
At present, the EPO’s opposed European CRISPR patents include those owned by the University of Vienna, Emmanuelle Charpentier, the Broad Institute, Massachusetts Institute of Technology, Harvard University, and Sigma-Aldrich.
A source involved in the proceedings who did not wish to be named told LSIPR that the latest development highlighted the EPO’s strict stance on the principle of “entitlement to priority”.
“This serves as a warning to patent applicants that it can be dangerous to rely on a ‘thin’ initial patent filing with limited data to support a claim to priority,” the source said.
The source added: “This latest revocation of UCB’s patent indicates that priority challenges, whether based on formal defects or the substantive content of the priority document, continue to be useful lines of challenge at the EPO.”
Image: Shutterstock.com / Yurchanka Siarhei
President Xi Jingping has announced his support for waiving IP rights for COVID-19 vaccines.
In a video call at the Global Health Summit in May, China’s president openly backed an early decision by the World Trade Organisation (WTO) to waive COVID-19 vaccine patents, an idea first pitched by India and South Africa in October last year.
In his speech, Xi called upon countries developing and producing treatments to provide vaccines to developing countries “in urgent need”, as well as support businesses in “joint research and authorised production with other countries having the relevant capacity”.
Multilateral financial institutions should also provide “inclusive financing support” for vaccine procurement in developing countries, including urging the World Health Organization to boost its COVID-19 Vaccine Global Access (COVAX) efforts.
The president concluded his speech saying: “It is important that we uphold the spirit of extensive consultation, joint contribution and shared benefits, fully heed the views of developing countries, and better reflect their legitimate concerns.”
Whether this open support from the biggest vaccine-developing country will sway other governments opposing the waiver remains to be seen.
“It is important that we uphold the spirit of extensive consultation, joint contribution and shared benefits, fully heed the views of developing countries, and better reflect their legitimate concerns.”
President Xi Jingping
Waiver support
Support for the waiver has grown in recent weeks, with the US and now China openly supporting the temporary waiving of IP rights for COVID vaccines.
In a letter from US trade representative Katherine Tai, President Biden’s administration announced its support for the waiver, saying it “believes strongly in IP protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines”.
Despite the backing of the two largest vaccine-producing countries in the world, the waiver will need a unanimous vote in order to pass, with countries such as Switzerland and the UK blocking the plan.
Pharmaceutical companies, in particular, have been critical of the waiver, claiming that it would not help provide more equitable access to vaccines for countries in need, but are looking for alternative plans to get more people vaccinated.
On May 19, several pharmaceutical companies joint-published an alternative plan to supply more vaccines to developing countries that would avoid waiving IP rights.
Image: Shutterstock.com / Gil Corzo
Illumina and Roche-owned Ariosa Diagnostics filed a joint stipulation asking the US Supreme Court to dismiss a case concerning the eligibility of Illumina’s DNA testing patents.
The joint stipulation of dismissal, submitted on May 21, 2021, claimed that all parties “respectively submit that this case can be dismissed”, that all fees have been paid, and that each party will bear its own costs.
The case was being decided at the US Supreme Court after a petition for a writ of certiorari was filed by Ariosa in December last year, following the Federal Circuits decision to not revisit a ruling that found both the patents eligible.
In dispute were US nos. 9,580,751 and 9,738,931, which cover a method of identifying foetal DNA in mothers.
Patent eligibility
Ariosa originally petitioned the court requesting that it overturn a Federal Circuit ruling that a pregnant woman’s DNA is typically larger than the foetal DNA in her bloodstream, therefore the process of separating the two was a patentable process.
Ariosa said in the petition: “While a method involving unconventional steps for separating DNA might plausibly survive section 101 review [of patent eligibility], no such method is at issue here. More importantly, the Federal Circuit did not even consider the question.”
The Supreme Court itself had previously ruled that isolated DNA is not patentable in Association for Molecular Pathology v Myriad Genetics.
Image: Shutterstock.com / Syda Productions
