Silence Therapeutics PLC’s (LON:SLN) decision to go down the legal route to protect a “fundamental chemical modification integral to the emerging science of RNA interference (RNAi)” has been well-received.
The value of Silence has soared since it started to explore ways to get paid for possible intellectual property infringements.
Since June, the shares have risen by more than 100% lifting the company’s value to almost £140mln.
US giant in cross-hairs
Silence has over the past year sought to shore up the patent protection around what it calls a “foundational innovation” that is core to the emerging RNAi industry.
It also believes a number of companies have been using its technology in drugs that silence genes and may be fundamental in the war against cancer.
Among those cited as using Silence’s tech is Alnylam, valued at US$12.7bn.
Silence has previously made claim for declaratory relief relating to its entitlement to Supplementary Protection Certificates on certain Alnylam products.
Declaratory relief is a court judgement that determines the rights of a person or a company without ordering anything to be done or awarding damages.
Supplementary Protection Certificates, as the name suggests, extend the protection of certain active ingredients in drugs.
Giants fight back
Alnylam UK Limited and The Medicines Company UK Limited have hit back by suing to revoke Silence’s European patent in the UK.
This also includes claims for declarations of non-infringement of this European patent by certain Alnylam products.
Silence said it regards the Alnylam counter-actions as simply the "normal course of business at the commencement of litigation”.
It added that it continues to believe that “certain Alnylam products require a licence under the Silence patent estate”.
Chief executive Ali Mortazavi told investors: "During 2017, both the European and US patent offices have continued to uphold the validity of our expanding patent estate with the granting of additional patents.
“We believe that our fundamental chemical modification technology is core foundational innovation for today's RNAi sector, and that therefore those companies using such modification technology within the scope of our intellectual property will require a licence.
“Silence is committed to defending its position and to securing the appropriate recognition and associated value for its IP."
What is RNA interference
Ali Mortazavi explains the underlining science behind Silence’s patents.
“Thanks to the Human Genome project we know the codes for every gene in the human genome.
“That’s really our starting point. Once we find a particular individual gene that we think is causing the disease we can very quickly create a short interfering RNA.”
“The short interfering RNA is the drug element and is the opposite code to the target genes.
“So when we know the code for the gene, we can synthesise a short interfering RNA and the journey starts from there.
“We add a delivery systems to the short interfering RNA, so there are linked to each other.
“The delivery system will take it to the specific organ or cell type that you want.
“In our case we are a liver-focused company through our GalNAc conjugates.
“Our delivery system is incredibly precise with almost no contamination of any other cell types.
In simple terms, the short interfering RNA will match the gene inside of the cell.
A natural process, RNA interference will spot this binding process and cut the gene up by shutting down protein production, hopefully shutting down the genes causing the disease
“Our IP covers the last extension of the delivery system or a linker,” says Mortavaza.
“Without it a short interfering RNA would be immediately degraded as soon as it was introduced to human body.
“Silence invented the concept of chemically modifying a short interfering RNA so we can basically be sure that will make its way into the target cell it safely and intact using the delivery system
“It won’t be degraded and will be highly stable and once it arrives will then trigger RNA interference.”
“Without that stability or chemical modification, no process of RNA interference could ever take place by definition because it would it would be degraded so fast.”
What else does Silence have?
Silence has a number of other potential revenue generators under development.
One licensee, US firm Quark, recently published encouraging Phase II trial results for acute kidney injury (AKI) and further milestone payments become due if its partner Novartis decides to take the drug further into development.
It also intends to file an application for its own proprietary GalNAc platform by the end of 2018, a move that would be first for a European company.