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Infringement letter, prior demonstration and opposition strategy

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Infringement letter, prior demonstration and opposition strategy

It is now 1 March 2025. MedDevice Ltd receives a letter from Competitor GmbH alleging infringement of EP 2 987 654. Claim 1 recites a catheter comprising a shaft whose proximal portion has a flexural modulus of 0.5-1.5 GPa and a distal tip with a radiopaque marker, wherein the marker is an annular band embedded in the tip. MedDevice's current catheter has a proximal shaft modulus of 1.8 GPa and a radiopaque helical coil embedded in the tip. Competitor's patent was granted on 15 January 2025 and its priority date is 10 June 2022. MedDevice publicly demonstrated a catheter at a trade fair on 20 March 2022; the demonstrated catheter had a 1.2 GPa proximal shaft and an annular radiopaque band. MedDevice has photographs, a booth brochure, and three witness statements. It asks: 'Can we keep selling? Should we attack the patent?' It has no licence and wants a cost-effective strategy.

1. Analyse whether MedDevice's current catheter infringes claim 1 literally or by equivalents.

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Literal infringement requires every feature of claim 1. MedDevice's proximal shaft has a flexural modulus of 1.8 GPa, which is outside the claimed 0.5-1.5 GPa range. Its radiopaque marker is a helical coil, not an annular band embedded in the tip. On the stated facts there is no literal infringement. Equivalence must be assessed under Article 69 EPC and the Protocol on Interpretation. For a numerical range, the range is normally a strict limitation; a value of 1.8 GPa is 20% above the upper limit and is not a trivial rounding difference. The patentee would have to show that the range was not intended to be strict, which is unlikely without clear evidence. The helical coil is also structurally different from an annular band and may perform differently: a coil can provide flexibility and a different radiopaque profile, whereas an annular band is a discrete ring. The patentee may argue that both are embedded markers, but the claim requires an annular band. The overall conclusion is that infringement risk is low, but the client should confirm the product specifications and review the prosecution history for any statements that narrow or clarify the claim. Continue selling, but document the analysis.

2. Assess the validity attack based on the 20 March 2022 trade fair demonstration and advise on the opposition.

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The trade fair demonstration occurred before Competitor's priority date of 10 June 2022. If the demonstration was public and enabling, and if the demonstrated catheter had a proximal shaft modulus of 1.2 GPa and an annular radiopaque band as claimed, it is prior art under Article 54(2) EPC. A public demonstration at a trade fair is generally not confidential, but MedDevice must prove what was actually disclosed. The photographs, booth brochure and witness statements are useful, but they should be supported by dated material such as the fair catalogue, visitor records, invoices or contemporaneous emails. If the demonstration disclosed all features of claim 1, the patent lacks novelty and can be revoked. MedDevice can file opposition within nine months of grant; the grant date is 15 January 2025, so the opposition deadline is 15 October 2025. Opposition is likely the most cost-effective central attack. Alternatively, MedDevice can rely on the prior use in national infringement proceedings, but that is a defence, not a revocation of the patent. The client should preserve all evidence and obtain signed statements from the witnesses.

3. Draft a short legal opinion and strategy recommendation to the client.

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In the opinion, state that MedDevice's current catheter does not literally infringe claim 1 because the shaft modulus is 1.8 GPa rather than 0.5-1.5 GPa, and because the marker is a helical coil rather than an annular band. Equivalence is unlikely for the numerical range and for the different marker geometry, so the infringement allegation is weak. Recommend that MedDevice reply to Competitor denying infringement, setting out the claim features and asking for the factual basis of the allegation. At the same time, file an opposition before 15 October 2025 based on the 20 March 2022 trade fair demonstration. The opposition should include the photographs, brochure, witness statements and any independent evidence of the date and public availability. Argue lack of novelty under Article 54(2) EPC. If the opposition fails, consider national revocation proceedings or a prior-use defence. Continue selling the current product, but keep the product specifications and the legal analysis on file. Do not take a licence unless the commercial position changes. The strategy is: deny infringement, attack the patent centrally, and preserve the prior-use evidence.