Evergreen!

At the AAFP: http://www.nofreelunch.org/news.htm

"Evergreening” is when Big Pharma attempts to extend the patent monopoly on a product by seeking a new patent that “updates” the first one before its expiration. This is usually done by claiming things such as an “inventive” method for administering the pharmaceutical compound covered by the base patent. For pharmaceutical products, this means an extended monopoly that excludes generic drugs from the market.


Ambien CR :

The US approval of Ambien CR gives Sanofi a new story to tell doctors and consumers about Ambien, which has been subsisting on old advertising that promises a free trial to patients if they ask for it in doctors' offices. The trial is being advertised in TV spots running on CNN, among others. Sanofi spent $63 million on Ambien last year, per Nielsen Monitor-Plus.

Sanofi is under considerable pressure to pick up market share for Ambien CR, as the original formulation will start to face generic competition in October 2006.

Flomaxtra XL:

Astellas is looking to maintain its sales when Flomax MR's UK patent expires in February 2006. As part of this strategy, Astellas is withdrawing Flomax MR in October and replacing it with Flomaxtra XL.

http://www.pharmafocus.com/cda/focusH/1,2109,21-0-0-OCT_2005-focus_news_detail-0-364893,00.html


Evergreening is clearly anti-competitive, results in higher expenditure for financially burdened healthcare systems, and drives up patient co-payments. To evergreen their products, the originator company will often develop what are euphemistically called “life-cycle management plans“ composed not only of patent strategies, but an entire range of practices aimed at limiting or delaying the entry of a generic product onto the market.

In the words of Greg Perry, Director General of European Generic Manufacturers Association:

“These practices beg the question of whether they meet the intended purpose of pharmaceutical patent law. More importantly, society must ask itself how much longer it is willing to subsidise pharmaceutical companies through the high prices demanded for their products when lower-priced generic equivalents could be available.

The European generics pharmaceutical industry firmly believes that strong protection of intellectual property rights is essential to maintaining continued progress in the development of new treatments. It also believes that current rules must be constantly reviewed to eliminate the loopholes which undermine the fragile balance between legitimate IP rights and the imperative need to ensure a continuous supply of competitively-priced generic medicines.”

http://www.egagenerics.com/gen-evergrn.htm