The introduction of an SPC manufacturing waiver in the European Union is now all but a done deal. Following the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal products (COM(2018) 317 final) issued on 28 May 2018, the European Parliament’s Committee on Legal Affairs (JURI) adopted its final…

Visser’s Annotated Patent Convention, the 2018 Edition, previously known as the Annotated European Patent Convention, was published on 15 December 2018. The new 2018 edition of this preeminent work – the only regularly updated authoritative article-by-article commentary in English on the European Patent Convention (EPC), its implementing regulations, and associated case law – provides the complete text of the…

The introduction of an SPC “manufacturing waiver” in the European Union, aimed at boosting the competitiveness of EU-based generics and biosimilar industry, gains momentum as the current EU legislative period draws to a close. Under the EU’s legislative procedure, the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal…

A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were the ambitious aims set out in the European Union’s single market strategy adopted in 2015. This was followed by a comprehensive evaluation of the legal aspects…

In order to provide adequate incentives for the research and development of high-quality medicinal products adapted for paediatric needs, special rewards, such as a 6-month paediatric extension of the term of a Supplementary Protection Certificate (SPC) have been made available in the EU since 2007. Switzerland, which participates in the EU’s single market and traditionally…

On 20 September 2018, the Treasury Laws Amendment (2018 Measures No. 5) Bill 2018 (Bill) was tabled in Australia’s House of Representatives. Among the amendments proposed was the repeal of Section 51(3) of the Competition and Consumer Act 2010 (Cth) (CCA), a change that could significantly impact IP licensing and assignment arrangements within Australia. The…