For better, for worse? How shifting IP laws change the global life sciences regulatory chessboard
With IP laws around the world subject to frequent and sometimes unpredictable changes, it can be difficult to keep abreast of everything you need to know. Richard Gough and Jane Woodhouse take a look.
Building operative partnerships with law enforcement
There is a perfect storm brewing in the healthcare industry. Over the past few years, there has been an unprecedented rise in the trade of illicit healthcare products in the secondary market.
Clinical trials in BioPharma
A recent study revealed that biotechnology companies or universities discovered 42 percent of all innovative drugs approved by the US Food and Drug Administration (FDA) between 1998 and 2007.
Clinical trials and stratified medicine—maximising patent exclusivity
The traditional business model for a new drug relies on a substantial period of market exclusivity to recoup extensive research and development costs.
US Patent Law changes appear imminent
US patent reform looks like it may finally be coming. John Pegram and Mark Ellinger explain the proposed changes.
Patenting genes and diagnostics
As biotechnology patents continue to grow in importance, uncertainty remains on both sides of the Atlantic as to exactly what is patentable. Simon O’Brien and David Gass take a look.
Attacking the validity of selection patents
The Canadian Federal Court of Appeal recently considered whether ‘invalid selection’ can be an independent ground for invalidating selection patents. Katie Wang looks at the implications.
The Brazilian pharmaceutical sector: a year in review
Practitioners can take heart from recent developments in the Brazilian courts, say Otto Licks and Anderson Nascimento.
Recognising equivalence, reciprocity and respect
Homologation (recognition of equivalence) is a useful tool for simplifying administrative processes that are repeated in different countries. Nevertheless, it is not an end in itself.
Myriad issues for gene patents
A recent US district court ruling could significantly affect companies that patent genes and threaten the health of an entire industry. LSIPR investigates.