Pharmaceutical patent term extensions: federal court hears challenge to “absurd” Australian patent office ruling

    28 April, 2021
    Two major pharmaceutical companies have challenged Australia’s Commissioner of Patents in the Federal Court about the time limits within which an application can be made to extend a patent term. KEY TAKEAWAYS Ono Pharmaceutical and Bristol Myers Squibb have sought judicial review by the Federal Court of an Australian Patent Office (APO) ruling which rejected … Read more

    Change ahead? UKIPO publishes outcome of AI consultation and considers legislative reform

    07 April, 2021
    In September 2020 we reported that the UK Intellectual Property Office (‘UKIPO’) had launched a call for views on the relationship between artificial intelligence (‘AI’) and intellectual property rights. The outcome of that consultation has now been published. We summarise the key takeaways below. Key findings The majority of respondents agreed that: the law in … Read more

    EU Action Plan on IP – the challenge ahead

    30 March, 2021
    Herbert Smith Freehills' European IP team have had a feature article on the EU's IP Action Plan published in the April edition of PLC Magazine – see EU Action Plan on IP – the challenge ahead here. The article looks at the current challenges for the EU in relation to IP, its key focus areas and plans for future regulation and legislation, including: • The Unified Patent Court (UPC) • Supplementary Protection Certificates (SPCs) • Compulsory licensing • Standard Essential Patents (SEPs) • AI and emerging technologies • Counterfeiting • Designs • Geographical Indications • Data • The Pharmaceutical Strategy for Europe Read more

    Regulatory Disputes in the Consumer Sector: podcast & briefing

    30 March, 2021
    Businesses who deal with consumers will generally wish to have a good relationship with Government, regulators and other public authorities. However, there are times when a company’s interests are such that they come into conflict. At those times companies may wish to consider how that conflict might be resolved if it were to reach court. Last June, we created a guide to Regulatory Disputes in the Consumer Sector. Our guide and podcast are designed for businesses that interact with consumers, for example, selling products to the public direct or through retailers, who might have to consider how to proceed when regulatory matters become contentious, and indeed those who work at regulators themselves. Read more

    Judicial review – another weapon in Big Pharma’s disputes arsenal?

    23 March, 2021
    The life sciences and healthcare sector is subject to complex regulation and decisions of Government bodies can have a significant impact on the availability and production of pharmaceutical products.  Where Government bodies take decisions of this nature, and there is no other recourse available, judicial review provides an avenue to healthcare companies and others to challenge Government decisions. Herbert Smith Freehills has had a practice note published in Practical Law which considers the various grounds of judicial review, the application of these grounds to specific cases in the healthcare sector and some particular considerations to be taken into account when making a judicial review application. Read more

    High Court finds clause imposing harsh consequences for breach of term aimed at protecting IP rights was not an unenforceable penalty

    11 March, 2021
    In a recent decision, the High Court has found that a clause in a settlement agreement which was aimed at protecting a business’s IP rights was not penal, despite imposing “undoubtedly extremely harsh” consequences for breach of certain obligations in a settlement agreement. Under the clause, the relevant party would cease to receive any payment … Read more

    A ‘new normal’ when it comes to the TGA regulation of medical devices?

    11 March, 2021
    Key points: In Australia responding to the urgent need for COVID-related medical devices the TGA implemented a number of emergency measures to bring medical devices to market faster. The emergency regulatory measures have proven agile, flexible and successful with the potential risks to the public well managed. The regulatory measures have potential utility beyond the … Read more

    Patent pending: the law on AI inventorship

    09 March, 2021
    Last year the UK High Court decided that an AI system cannot be named as inventor on a patent application within the meaning of the Patents Act 1977, simply because an AI is not a person – but with the UKIPO recently calling for views on AI inventorship, could a change in law be on … Read more