Bio-Techne loses UK patent bid and heads to UPC
UK High Court invalidates two patents due to “overwhelming evidence” supplied by defendant | Biotech firm files same claims in Netherlands division of UPC on same day.
The UK High Court has declared two patents held by Advanced Cell Diagnostics (ACD), a Bio-Techne brand invalid, following a dispute with Molecular Instruments.
ACD alleged in 2022 that Molecular Instruments’ HCR 3.0 technology infringed two of its European (UK) patents (EP 2,500,439 and EP 1,910,572).
The patents describe methods, kits and products for “detecting nucleic acids in individual cells and…identifying rare cells from large heterogeneous cell populations”, and underpin ACD’s ‘RNAscope in-situ hybridisation’ (ISH) technology.
ACD owns patents covering various features of its RNAscope technology, which it says is the “gold standard” for ISH technology.
According to Bio-Techne, ISH technology “leverages dynamic nanotechnology to enable small amplification components to first penetrate a biological sample without interacting, and then autonomously grow bright amplification polymers at the site of RNA targets within the sample”.
But in his judgment delivered in the UK Patents Court on Wednesday, April 23, Justice Richard Meade rejected ACD’s claim of infringement, ruling that both of ACD’s patents are invalid and obvious and finding that Molecular Instruments’ primary evidence is “really overwhelming in this case”.
He also said: “Had the patents been valid, EP572 but not EP439 would have been infringed by the acts to be considered at this trial.”
Molecular Instruments’ CEO Harry Choi said in a statement: “Our goal is to empower biologists, bioengineers, drug developers, and diagnostics developers by providing them with next-generation molecular tools that enable breakthroughs in their projects.
“We felt compelled to fight this lawsuit to protect the ability of our customers to continue their research, as many customers working in challenging imaging settings cannot perform their experiments with any other technology.
“This judgment in our favour ensures that UK researchers will not be denied access to our game-changing HCR imaging platform.”
In a statement, a spokesperson for Bio-Techne said: “ACD disagrees with this decision and is considering its options for appeal," as reported by GenomeWeb.
“It’s worth noting that the Patents Court of the High Court of England and Wales did in fact find that Molecular Instruments would have infringed ACD’s intellectual property had it been found valid.
“ACD will continue to protect its intellectual property and commercial investments and, to that effect, has just filed an additional lawsuit against Molecular Instruments in Europe’s Unified Patent Court."
Bio-Techne also noted that the UPC covers multiple countries within the EU and that the UK decision will not be precedential.
Parallel EU suit
On the same day as the UK judgment, Bio-Techne filed a lawsuit at the Unified Patent Court (UPC), alleging infringement of the same two patents by Molecular Instruments.
The lawsuit was filed at the Local Division of the Court of First Instance in The Hague, Netherlands, “to halt the infringement of its patented RNAscope ISH technology by Molecular Instruments” in “key European markets”.
Bio-Techne describes itself as “a pioneer in spatial biology, with its broad portfolio of more than 50,000 unique RNAscope ISH probes across more than 400 species.
Kim Kelderman, president and CEO of Bio-Techne, said in a statement that the company “has made substantial investments to become the global leader in the rapidly growing spatial biology industry, including the development and application of its RNAscope technology”.
He added that the company had also acquired Lunaphore, “which added the fully automated, high-throughput, hyperplex COMET platform to the portfolio.
“We will continue to diligently monitor the spatial biology industry, as well as all of the areas where we operate, for violators of our intellectual property and vigorously defend our position against any potential offenders.”
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