The US and China take very different approaches to the patentability of a range of inventions in the life sciences field, as Yu Guo of China Patent Agent reports.
Inter-partes reviews (IPRs) can be a powerful weapon against patents listed in the Orange Book. However, IPR practice favours a petitioner who has carefully thought about the issues and crafted the best strategy, says Mark Remus of Brinks Gilson & Lione.
In order to be well prepared before a generic or biosimilar marketing authorisation is approved, drugs companies in the EU may consider monitoring pending applications, says Ruth Franken of Hogan Lovells.
Everyone benefits from an efficiently run clinical drug study, including sponsors, contract research organisations, the investigator sites where patients are treated and observed, and most of all, patients, says Charlie Nicholson of Premier Research.
For many of the key questions relating to the grant of SPCs, there is some variance in the practice of national patent offices, even where there is guidance from the CJEU, as Simon Spink and Adrian Chew of Bristows explain.
Several legislative changes affecting data exclusivity of biologic drugs in Vietnam are poised to come into effect, and companies operating in this sector should take note now, as Hien Thi Thu Vu and Huong Lan Nguyen of Tilleke & Gibbins explain.
Legislative developments surrounding supplementary protection certificates in the EU are moving fast, and may be catching on as far afield as Australia. Gareth Morgan of Olswang explains more.
Following the UK’s vote to leave the EU, it is business as usual for life sciences companies working with intellectual property, at least for now, says Claire Phipps-Jones of Bristows.
The UK’s vote to leave the EU has triggered an immediate need for innovative life sciences companies to evaluate the impact on their patent strategies, argues Laetitia Benard of Allen & Overy.
Is it time for healthcare regulators and patent offices to limit the strategies used by existing biologic manufacturers and allow new suppliers to reach some of the world’s most lucrative healthcare systems? Elizabeth Ward of Virtuoso Legal investigates.