CONTENTS 6 News
10 Close to the edge Which patented drugs are losing their market exclusivity in 2015, and how will their makers cope? LSIPR takes a look at five of the biggest drugs to lose patent protection in the US this year.
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14 Better protection for big pharma? The battle between pharmaceutical and generics companies in India is once again in the spotlight, with a decision pending on another compulsory licence. The players this time are Novartis and Cipla, with the former already having drawn first blood. LSIPR investigates.
18 2015: year of the biosimilar The FDA could approve the US’s first biosimilar product any day now. But is the country ready for the wave of biosimilar applications that will surely follow, and how quickly can these cut-price drugs come to market? LSIPR reports.
22 New recipes for Tomatoes and Broccoli Controversial patents covering a fruit and a vegetable are awaiting their fate at the Enlarged Board of Appeal. LSIPR examines the likelihood of their succeeding.
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26 The race for market exclusivity Section 8 of Canada’s Patented Medicines (Notice of Compliance) Regulations is a unique provision under which an innovator can be liable for a generic’s losses that result from a delay in coming to market, as Gunars Gaikis explains.
30 Collision course Previously for LSIPR, Jane Wainwright of Potter Clarkson investigated the emergence of self-colliding patent filings in Europe and their relevance to the life sciences. As the European Patent Office begins to review this issue at the highest level, she revisits the concept and why it is now being reconsidered.
34 It’s easier being green Brazil’s pilot fast-track programme for green patents is now in its third phase. Priscila Kurdian Afonso of Di Blasi, Parente & Associados assesses whether it is meeting its goals.
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36 Further unravelling the Gordian Knot The CJEU’s decision in Forsgren has brought greater clarity to the scope of the SPC regulation, including whether a substance is an active ingredient, as Avi Toltzis and Penny Gilbert of Powell Gilbert explain.
38 Patents for plants
Genetically modified plants, hybrid seeds and plants obtained from such seeds are usually granted patent protection in Mexico as they are not created by ‘essentially biological’ processes, as Fernando Rincón of Becerril, Coca & Becerril reports.
40 A germ of comfort
The patentability of human embryonic stem cells is bound up with many ethical considerations, including the viability of the cells used. Laura von Hertzen and Robert Burrows of Bristows discuss the latest legal opinions.
40 4 Life Sciences Intellectual Property Review Volume 2, Issue 2
www.lifesciencesipreview.com
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