UPC_CFI_187/2024

METHODS OF DETECTING NUCLEIC ACIDS IN INDIVIDUAL CELLS AND OF IDENTIFYING RARE CELLS FROM LARGE HETEROGENEOUS CELL POPULATIONS

InfringementMain Infringement ActionThe Hague LDInfringementCase Closed

Overview Decisions Reasoning Citations Documents Timeline

Plain-English summary

Advanced Cell Diagnostics (ACD) sued Molecular Instruments for infringement of its RNAscope in situ hybridisation patents EP 1 910 572 and EP 2 500 439 at The Hague Local Division. The court upheld both patents as valid (dismissing Molecular Instruments' revocation counterclaim) but found no infringement, either literal or by equivalence, because Molecular Instruments' HCR products use probes with a 1-4 nucleotide overlap rather than the strictly non-overlapping arrangement claimed, and that overlap serves an independent technical function that distinguishes the HCR approach from the patented invention.

Accepted arguments

What the court agreed with — by party.

Both EP 1 910 572 and EP 2 500 439 are valid (novelty and inventive step upheld); counterclaim for revocation dismissed
ClaimantLegal basis: Art. 54 EPC; Art. 56 EPC
Note: The court dismissed Molecular Instruments' counterclaim for revocation in its entirety, confirming both RNAscope patents are valid.
Equivalence arguments introduced in the reply to the statement of defence are admissible
ClaimantLegal basis: R. 7 RoP
Note: Court held the equivalence arguments were a legitimate response to the defence, directed to the same patent and same accused products, and the defendant had full opportunity to respond.

Rejected arguments

What the court did not agree with — and why.

Literal infringement of claim features 1(d)(iii), 1(h), 1(j) and 1(k)(iii) of EP 1 910 572 by HCR Products
ClaimantLegal basis: Art. 25 UPCA
Reason: Defendant's HCR products use probes that hybridise to partly overlapping regions of the hairpin initiator rather than to non-overlapping regions as claimed in feature 1(h); the product does not literally implement the 'non-overlapping' feature.
Infringement by equivalence for the missing 'non-overlapping' feature 1(h)
ClaimantLegal basis: Doctrine of equivalents
Reason: The court rejected equivalence on three grounds: (1) legal certainty for third parties makes it impossible to define how much overlap is still equivalent; (2) the patents are not a major inventive step so fair protection does not require equivalence; (3) the 1-4 nucleotide overlap in HCR has an independent technical function (kinetic barrier reduction) serving a different way of achieving the result, making it more than a mere work-around.

Key legal principles

Doctrines and rules cited in the reasoning.

Doctrine of equivalents: fair protection balanced against legal certainty for third parties Equivalence rejected where alternative design has an independent technical function of its own, not merely a work-around Patents representing modest inventive contribution do not demand broad equivalence scope Equivalence arguments first raised in reply are admissible where they respond to defence arguments and relate to the same features Counterclaim for revocation dismissed where both patents found valid

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Prior art relied on

References cited and the role they played.

WO 2007/001986 A2 (WO986) — EP572 priority documentBackground

Claim construction notes

The disputed claim feature was 'non-overlapping' regions in the probe/hairpin hybridisation scheme of EP 1 910 572 claim 1 (feature 1(h)). The court found that HCR products use probes hybridising to partly overlapping regions (1-4 nucleotide overlap), which does not literally meet the 'non-overlapping' requirement. On equivalence, the court held that the 1-4 nucleotide overlap is technically functional and not a mere cosmetic variant, relying heavily on the specific energy-relaxation mechanism that the overlap enables.