Biowissenschaften

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  •  
    12/04/2024
    Europe

    Navigating clinical trial disclosures: No reasonable expectation of success in a patient sub-population in view of prior art reporting phase III clinical trial (T 1437/21)

    Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial. At a time when the European Medicines Agency (EMA) is requiring increased transparency for EU clinical trials, this case law is of increasing importance to those operating in the pharmaceutical space.In brief, this decision further supports the position that the disclosure of a clinical trial protocol does not always mean there is a reasonable expectation of success of achieving treatment. The...
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  •  
    08/04/2024
    Ungarn

    Hungary proposes ex-ante competition tool to regulate essential companies

    On 2 April 2024, the Hungarian Ministry of Justice submitted an omnibus act to the Hungarian parliament proposing the amendment of several Hungarian laws, including the Competition Act. This Proposal’s most noteworthy element is – based on the German example – expanding the Hungarian Competition Authority’s (HCA) toolbox by introducing a new ex-ante regime enabling the HCA to impose obligations on certain companies without first having to demonstrate a violation of the law.This following article summarises the Proposal’s new rules, potential consequences and next steps.PROPOSED...
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  •  
    03/04/2024
    Europe

    EP Case Law in Brief: Long-felt want and inventive step

    “Where the invention solves a technical problem which workers in the art have been attempting to solve for a long time, or otherwise fulfils a long-felt need, this may be regarded as an indication of inventive step.”The EPO Guidelines (G-VII, 10.3) describe the basic approach to the concept of long-felt want or long-felt need – terms that are used interchangeably. Long-felt want is an example of a secondary indicator of inventive step. Secondary indicators are factors which, although on their own may not be enough to indicate an inventive step, may be supportive of inventive step...
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  •  
    03/04/2024
    Ukraine

    Register of Damage for Ukraine is open for claims submission

    On 2 April 2024, the Register of Damage for Ukraine opened the claims submission process for compensation for damage, loss or injury caused by Russian aggression against Ukraine. The launch took place as part of the Ministerial Conference "Restoring Justice for Ukraine" co-hosted by the Netherlands, Ukraine and the European Commission at the World Forum in The Hague.As a reminder, the official website of the Register of Damage for Ukraine was launched on 4 March 2024. The website contains the following:documents governing the work of the Register;answers to frequently asked questions on the Register’s...
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  •  
    25/03/2024
    Europe

    Patentability of inventions relating to diagnostic methods at the EPO

    Under Article 53(c) of the European Patent Convention (EPC), diagnostic methods practised on the human or animal body are excluded from patentability. The purpose behind this exclusion is to avoid patent infringement by medical and veterinary practitioners when carrying out a medical diagnosis. How Article 53(c) EPC should be applied was discussed in detail in the Enlarged Board of Appeal decision G 1/04.In this decision, the Board held that the exclusion of diagnostic methods from patentability should be interpreted narrowly and sets out specific criteria for the assessment of this exclusion.The...
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    19/03/2024
    Ungarn

    Hungary adopts new regulations on occupational Safety and Health fines and administration

    The Hungarian parliament recently adopted amendments to certain government regulations on occupational matters, and new government regulations on the detailed rules for the amount and imposition of occupational safety and health (OSH) fines, which entered into force on 1 March 2024. The amendments to the government regulations were necessary to ensure consistency between the legislation.The following article summarises these changes.1. Government Decree No 24/2024 (II.14.) amending certain Government Decrees on employmentAmendment to Government Decree No. 320/2014 (XII.13.) on the designation of...
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