A subsidiary of German pharmaceuticals giant Merck has petitioned US patent authorities to consider its claims to ownership of rights in gene-editing technology CRISPR.
The move, by US-based life sciences company Sigma-Aldrich, comes after the US Patent and Trademark Office (USPTO) reopened the debate over who has the right to control the use of CRISPR earlier this summer. The USPTO declared that rival academic institutions hold overlapping patents applicable to CRISPR and has opened proceedings to consider the matter in more detail.
That intervention followed a US Court of Appeal ruling last year which found that that the Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard University were entitled to patents covering the use of the CRISPR gene editing technology in eukaryotes despite claims from the University of California, Berkeley (UCB), the University of Vienna and French genetics professor Emmanuelle Charpentier that they own the rights in the invention as a result of research undertaken in respect of CRISPR's use in prokaryotes.
Eukaryotes and prokaryotes are different types of organisms. Prokaryotes are simple cells that are commonly associated with bacteria, while eukaryotes are more complex cells that are mostly associated with animals and plants. Use of CRISPR in eukaryotes is considered to have the greatest commercial value.
Now, with its petition seen by Out-Law, Sigma-Aldrich has urged the director of the USPTO and chief administrative patent judge of the US Patent Trial and Appeal Board (PTAB) to consider its claims to CRISPR patent rights at the same time as they consider the institutions' dispute.
Sigma-Aldrich has recently been granted a patent pertinent to the use of CRISPR. It has a number of pending patent applications in relation to use of CRISPR in eukaryotes which it has claimed concern innovations that pre-date the priority dates applicable to the patent rights asserted by the two competing groups of academic institutions.
A patent's priority date is the date at which its validity is assessed. Usually this is the filing date of the relevant patent application, though sometimes an earlier date from a previous disclosure of the invention may be claimed.
Sigma-Aldrich acknowledged its petition for a parallel patent interference declaration would ordinarily be considered "premature", but cited reasons of "effective administration of justice, efficiencies of the USPTO and the parties, conservation of considerable valuable resources, and the public interest" for why the USPTO should take on its case.
Sigma-Aldrich said: "Not surprisingly, the scientific community is keenly interested in the allocation of patent rights to the several competition entities… Moreover, given the commercial potential for the CRISPR technology, the investment community is also intensely interested in learning, as soon as possible, how the landscape of legal rights will ultimately 'shake out'. Still further, companies and research institutions are in a constant state of confusion regarding which party or parties they need to take licenses from in order to practice the CRISPR-Cas9 eukaryotic technology."
"This ongoing uncertainty in the patent landscape provides a significant chilling effect on the funding of both research efforts and commercial endeavours. And of course, some scientific and marketplace potential actors may choose to sit on the sidelines and observe the ongoing IP battle until the smoke clears. All of this uncertainty and trepidation inures to the detriment of the public, who could potentially benefit greatly from the treatments and therapies that CRISPR-based gene-editing therapies promise. Allowing Sigma-Aldrich's patent applications to languish with an intransigent examiner ... provides a profound disservice to the public interest," the company said in its petition.
Asawari Churi, a member of the life sciences team at Pinsent Masons, the law firm behind Out-Law, said: "If the USPTO accepts Sigma-Aldrich's petition, it will have to decide who between the three parties first invented CRISPR in eukaryotes. Of course, its decision is only applicable in the US. The fight over CRISPR is also ongoing in Europe and other jurisdictions where the outcome may be different."
Gene editing has been the subject of controversy in recent times. Chinese state media reported earlier this year that an investigation in the country had found that a scientist who claimed to have used gene-editing technology to alter the DNA of two new babies in China had done so illegally.
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