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Medical devices new rules: the clock is ticking
A new EU regulation on implantable medical devices takes steps to acknowledge that patient outcomes and safety are primary goals, but the transition to the new system might not be easy for industry stakeholders, says Jo Emmett of Premier Research.
Plants, patents and political challenges
European developments surrounding the patentability of plants and animals have become rather political, but there are ways for patentees to mitigate the effects of political influence over the patenting process, writes Jane Wainwright of Potter Clarkson.
Biosimilars in Italy: a new regime
Several changes have been made to Italy’s regulatory landscape for biosimilars, as Luca Tosoni of Covington & Burling reports.
The pitfalls of second medical use patents
It appears necessary and perhaps inevitable that further guidance from the UK Court of Appeal will be provided on the issue of second medical use patents, following the high-profile dispute between Warner-Lambert and Actavis. Geoff Hussey and Christopher Burnett of AA Thornton & Co report.
The challenges of patenting cell therapies
A combination of patents, SPCs and regulatory exclusivities should be considered carefully in order to maximise the exclusivity available for cell therapies, as Glyn Truscott of Elkington + Fife explains.
Pharma collaboration in Russia: the dos and don’ts
Natalia Gulyaeva and Maria Sedykh of Hogan Lovells look at the main drivers of collaboration in the pharmaceutical sector and the legal issues to keep in mind when handling partnerships in Russia.
IP and investment: put your money where your mouth is
Intellectual property in the life sciences arena can be an attractive investment target, but a long process of evaluation must take place first, cautions Dimitar Georgiev, founder and CEO of Paralax Life Sciences.
Arrow declarations: striking at the heart of commercial uncertainty
To overcome a crowded patent market, a potential solution is to seek a declaration of obviousness, which has a basis in UK law stemming from Arrow Generics v Merck. Richard Roberts of Potter Clarkson reports.
IP Life Sciences Exchange: a preview
The IP Life Sciences Exchange, an event for senior IP decision-makers from the life sciences sector, will take place on November 15 and 16 in Munich, Germany. LSIPR previews some of the most interesting sessions.
Brexit: a fresh start for SPCs?
The UK’s vote to leave the EU may allow Britain to replace the SPC regulation—an often-criticised piece of law—and take a fresh approach to the system governing these rights, say Paul England and Matthew Royle of Taylor Wessing.
