Lebenswissenschaften - Regelung

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  •  
    13/06/2024
    Europe

    What’s in a name? The use of a product code in a clinical trial protocol fails to circumvent clinical trial prior art

    The use of product or sponsor codes in clinical trial related documents is common practice in the pharmaceutical space. However, such codes may not always be sufficient to disregard a publication as relevant prior art against patent claims.In recent decision T 1255/21, the EPO Board of Appeal finds that the use of a product code or sponsor code for a compound or composition in a clinical trial protocol does not affect the status of the protocol as prior art if the skilled person would have been able to identify the compound or composition based on the description of the components of the product...
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  •  
    04/06/2024
    Polen

    Poland’s Advertising Council amends Code of ethics to include advertising for food supplements

    GB PL
    In May 2024, the Union of Associations Advertising Council (Advertising Council), an NGO involved in corporate responsibility in advertising, developed a comprehensive self-regulation on ethical advertising of food supplements, which is now part of the Code of Ethics for Advertising, a set of rules defining what is acceptable and what is unethical in advertising. The Code of Ethics for Advertising is to be followed by entrepreneurs, especially advertisers and other entities engaged in advertising activities in Poland.Entities who advertise food supplements have so far relied on two sets of rules...
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  •  
    14/05/2024
    Ungarn

    EU introduces criminal offences and penalties for sanctions violations

    Criminal offencesUnder the Directive, the following conduct constitutes a criminal offence when committed intentionally and in violation of restrictive measures or a national provision implementing restrictive measures:making funds or economic resources available directly or indirectly to, or for the benefit of, a designated person, entity or body;failing to freeze funds or economic resources belonging to or owned, held or controlled by a designated person, entity or body;enabling designated natural persons to enter into, or transit through, the territory of a EU member state;entering into or continuing...
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  •  
    16/04/2024
    APAC region

    Top developments and predictions in the Life Sciences & Healthcare sector in Asia-Pacific

    In this round-up, we look back at the top developments over the last 12 months in the life sciences & healthcare (LSHC) sector, and we look to the future with our top predictions for the coming year for businesses operating in the Asia-Pacific region.In 2023, China enhanced rules for the management of human genetic resources. It also intensified regulatory oversight in the sales of pharmaceuticals, medical devices, and cosmetics, particularly in the realm of online sales. Meanwhile, the Hong Kong government is actively working on unlocking the city’s potential in the Life Sciences &...
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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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  •  
    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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