Policies & Legislation

US President approves patent reform

Home/Policies & Legislation | Posted 23/09/2011

On 16 September 2011, US President Barack Obama signed into law a patent-reform bill that has been backed by brand-name drugmakers but opposed by generics companies.

US Senate approves patent reform

Home/Policies & Legislation | Posted 16/09/2011

On 8 September 2011, the US Senate passed a patent-reform bill that has been backed by brand-name drugmakers but opposed by generic companies.

European Commission publishes new rules on falsified medicines

Home/Policies & Legislation | Posted 26/08/2011

A new directive on falsified medicines was published in the Official Journal of the European Union 1 July 2011.

Effect of patent filing and initiation of clinical trials on market exclusivity

Home/Policies & Legislation | Posted 05/08/2011

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

Home/Policies & Legislation | Posted 29/07/2011

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

Home/Policies & Legislation | Posted 08/07/2011

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

Home/Policies & Legislation | Posted 01/07/2011

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

Home/Policies & Legislation | Posted 27/05/2011

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

Home/Policies & Legislation | Posted 29/10/2010

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

Home/Policies & Legislation | Posted 06/05/2011

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

Home/Policies & Legislation | Posted 29/04/2011

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

Home/Policies & Legislation | Posted 29/04/2011

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

Home/Policies & Legislation | Posted 22/04/2011

2011 looks set to be a bumper year for generics, with patents from some of the biggest selling drugs set to expire.

Still no word from FDA on generic user fees

Home/Policies & Legislation | Posted 22/04/2011

Well the FDA finally held its long-awaited meeting on generic user fees on 23 February 2011. However, since then there has been no news from the FDA as to when and how these user fees will be implemented, and more importantly how much they will cost and what will the review timelines be?

European Council gives go-ahead for EU patent – but is it legal

Home/Policies & Legislation | Posted 15/04/2011

The European Council announced that it had given the go-ahead on 10 March 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation’ to launch a common EU patent system without Italy and Spain on board.

Falsified medicines law approved by European Parliament

Home/Policies & Legislation | Posted 01/04/2011

Following many months of negotiations, a new law to prevent fake medicines from entering the supply chain was finally approved by the European Parliament on 16 February 2011. Internet sales will also be covered by the law, which introduces new safety and traceability measures as well as sanctions against counterfeiters. The law, which has been in the pipeline for over two years, still needs to be formally approved by the Council of Ministers.

Negotiations on generic drug user fees

Home/Policies & Legislation | Posted 25/03/2011

Things seem to be finally moving ahead with the FDA’s long-awaited attempt to create a system of user fees for assessing generic drugs. The US Agency [FDA], which has a backlog of more than 2,000 products to review and has been short of funds for years, will launch negotiations with generic drug manufacturers by the end of February 2011.