Friday, November 16, 2007

Evergreening. How to extend drug patents and keep out competition

The evergreeners are also the people who feted Mulroney, not that the Liberals were any better. They both are in the pockets of the drug companies. It is amazing that we actually have a body that to some extent controls the prices of drugs and keeps us well below US prices. Even so we are nowhere near as progressive re drugs as such as Norway. At least evergreening has at last been stopped or at least I assume it has been. This is from the following site.
CMAJ • December 5, 2006; 175 (12). doi:10.1503/cmaj.061513.
© 2006 CMA Media Inc. or its licensors

Articles by Kondro, W.
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Medicine and the Law (including Forensic Medicine)


Supreme Court rules against drug patent "evergreening"
Wayne Kondro

It has become almost axiomatic in the pharmaceutical world that litigation has replaced innovation as the primary mode of operation, says the head of the Canadian Generic Pharmaceutical Association.

The Supreme Court of Canada tossed another salvo into that litiginous world Oct. 3 by ruling that the controversial practice of evergreening — which allowed brand-name pharmaceutical firms to obtain an automatic 2-year extension on the term of patent protection by filing new patents of an altogether marginal nature, such as the shape, dosing range or colour of a pill, and then claiming infringement on its original patent — should not have been allowed under Health Canada's old drug regulatory regime.

This latest decision overturned a lower-court ruling to quash Apotex Inc.'s notice of compliance to market a knock-off of the AstraZeneca proton-pump inhibitor, omeprazole, which was sold in Canada from 1989 to 1996. The drug was removed from the market and its patent expired in 1999 but AstraZeneca used the regulatory system to successfully trigger a series of successive 24-month "stays" to prevent Health Canada approval of a lower-cost generic equivalent.

In his October decision, Mr. Justice Ian Binnie wrote that "Given the evident (and entirely understandable) commercial strategy of the innovative drug companies to evergreen their products by adding bells and whistles to a pioneering product even after the original patent for that pioneering product has expired, the decision of the Federal Court of Appeal would reward evergreening even if the generic manufacturer (and thus the public) does not thereby derive any benefit from the subsequently listed patents."

Given that the government of Canada moved a month before the ruling with new regulations to limit evergreening to instances in which there is proof of actual infringement of the original patent, the decision was somewhat of a pyrrhic victory for the generic industry.

Nevertheless, Canadian Generic Pharmaceutical Association president Jim Keon was "very pleased. We've felt all along that these evergreening practices were problematic and costly for consumers."

Keon also argued consumers will bear the financial brunt of the Oct. 5 amendments to the Food and Drug Regulations to extend data protection on brand-name drugs from 5 to 8.5 years (including 6 months pediatric exclusivity), as well as eliminate the ability of generic firms to make damage claims for profits made by a brand-name company while it's using evergreening to delay competition.

If a generic product is now held off the market because of a protracted legal dispute, its' maker can now only seek redress for its own lost profits, Keon lamented. "Any disincentive is now gone. If I were the CEO of a brand name company, I'd be telling my legal people, let's see how many patents we can get, how many various aspects we can patent and then list every one of those and litigate to the maximum. If successful, fantastic. We get the extra profits. If the court later on finds against us, we'll pay a small fine for that because there's no other downside."

Canada's Research-Based Pharmaceutical Companies (Rx&D) spokesman Francois Lessard says they have no comment to make on the decision other than that it "is commercial in nature and applies to a single product. The association doesn't have a commercial mandate."

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