Policies & Legislation
Effect of patent filing and initiation of clinical trials on market exclusivity
The effect of the date of patent filing and the initiation of clinical trials can influence the expected duration of marketing exclusivity for originator companies.
Concerns of patent filing and approval date on market exclusivity
An understanding of the relationship between the date of patent filing and the marketing approval date on the expected duration of marketing exclusivity is critical for originator companies to maximise this period of exclusivity in order to recuperate their research and development costs before the advent of generic competition. Recent research has modelled the available duration of US market exclusivity for originator drugs at various times after the initial patent filing [1].
Patent filing and market exclusivity
The relationship between patent filing dates and the marketing authorisation date can change the duration of marketing exclusivity an originator pharmaceutical product can expect to enjoy [1].
Italy and Spain threaten legal action over EU patent
EU ministers have adopted a general approach to the two Commission proposals that provide for a European patent to protect inventions in the same way in all participating member countries. However, Italy and Spain are objecting to the ‘enhanced cooperation’ procedure and threatening legal action.
US caucus to promote generics and biosimilars
Two House members have established a group that they hope will produce legislation that leads to increased use of generic and biosimilar drugs and lower healthcare costs.
UK’s NICE issues first biosimilar recommendation
In a report published in May 2010 the UK’s National Institute for Health and Clinical Excellence (NICE) issued its first biosimilar recommendation, saying the biosimilar somatropin offers the same efficacy and safety as originator somatropins.
US patent reform legislation may delay generics
Generic drugmakers have been dealt a blow in Congress now that the Senate has passed patent-reform legislation despite efforts by the generics industry to remove a provision in the bill.
2012’s biggest patent expiries
Once the patent expiries set for 2011 are gone it is not over for the pharmaceutical industry, as 2012 looks set to be another bumper year for generics, with patents from more of the biggest selling drugs set to expire.
Change in Canadian exclusivity period may harm generics
The EU is in negotiations for a comprehensive economic and trade agreement (CETA) with Canada. As part of these negotiations the EU has proposed changes to the length of data exclusivity for originator drugs in Canada to bring them in line with time periods used in the EU.
2011’s biggest patent expiries
2011 looks set to be a bumper year for generics, with patents from some of the biggest selling drugs set to expire.
