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Americas
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. 3 March 2015
Americas
AstraZeneca has closed a deal that will see it acquire the rights to Actavis’s branded respiratory drugs business in the US and Canada, it was announced today. 3 March 2015
Big Pharma
The English High Court has ordered the country’s National Health Service to issue guidance to medical professionals so that they prescribe Pfizer’s branded product Lyrica—not the generic version—for neuropathic pain. 3 March 2015
Asia
India-based generic drug maker Natco Pharma has signed a non-exclusive licensing agreement with Gilead Sciences that allows Natco to make and sell generic versions of hepatitis C drugs including Sovaldi, it was announced yesterday. 3 March 2015
article
In 2014, LSIPR featured some of world’s top-selling drugs that were due to lose patent exclusivity that year. The list included the big hitters Copaxone, Nexium and Cymbalta, with Evista, Micardis, Restasis and Nasonex also included. This year we have profiled five drugs set to lose US patent protection in 2015. 3 March 2015
Biotechnology
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. 3 March 2015
Americas
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. 3 March 2015
article
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. 3 March 2015
Asia-Pacific
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. 3 March 2015
Americas
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 3 March 2015