Wednesday, January 03, 2007

Genetically modified pharming

The awful truth about evergreening by Thomas Faunce.
So what is evergreening and what should be done about it?

Patents allow the company that developed a drug to market it free from competition, in return for making public its original data. It is a system that balances reward of innovation in research and development with the public benefit of dispersed knowledge.

Drug patent evergreening is the single most important strategy that multinational pharmaceutical companies have been using since 1983 in the US (and since 1993 in Canada) to retain profits from "blockbuster" (high sales volume) drugs for as long as possible.

When the original patent over the active compound of a brand-name drug is due to expire, these drug companies often claim large numbers of complex and often highly speculative patents. Laws in the US and Canada require manufacturers to notify the original brand-name patent holders of their intention to market copies at the expiry of the original patent. The original patent holders can then threaten these potential generic competitors with breaching their now "evergreened" patents and seek a court order preventing their marketing approval.

The problem is a severe one in the US. In 2002, an extensive inquiry by the US Federal Trade Commission found that as many as 75 per cent of new drug applications by generic drug manufacturers were the subject of legal actions under patent laws by the original brand-name patent owner. These were driving up US drug costs by keeping the cheaper generic versions off the market.

The evergreening article in the Australia-US FTA (article 17.10.4) is far worse than the US or Canadian versions. For the first time it links the operations of our Therapeutic Drug Administration (the drug safety and efficacy body) with supervising patent law.

It requires that TGA drug marketing approval be "prevented" indefinitely (not for the 30-month and 24-month periods as in the US and Canada) whenever any type of patent (including a speculative evergreening patent) is merely "claimed".

Supreme Court rules against drug patent "evergreening" by Wayne Kondro
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."

[Canadian Generic Pharmaceutical Association president Jim] Keon 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."

Medicines patent loophole 'found'
Imperial College experts have developed a potentially cheaper version of an existing Hepatitis C drug by altering the molecular structure.

They have also called on other universities and charities to retain the rights to new discoveries, rather than sell them to big drugs companies.

The industry warned any such 'new' drug may need dedicated safety trials.

The work of Professor Sunil Shaunak, an expert on infectious diseases, and his colleague, Steve Brocchini, from the London School of Pharmacy, was funded by, among others, the Department of Trade and Industry and the Wellcome Trust.

The most effective drug treatment for the Hepatitis C virus is a version of a naturally-occurring molecule called interferon, which has been modified by coating it with sugar to allow it to remain in the body for longer.

The patent for the resulting drug - pegylated interferon - ruled out any other pharmaceutical which involved interferon coated with sugar.

However, the Imperial team found a way to place the necessary sugar elsewhere on the interferon molecule instead, effectively creating a new medicine not covered by the patent.

They plan to find a way to develop and market this alternative without involving pharmaceutical firms, at a fraction of the cost of the original medicine.

Professor Shaunak said: "As far as we're concerned, the end-game is the cure - you can get to the end-game in several different ways, and we have found a different way of doing it."

"What we have to recognise is that we have a real opportunity to cure infectious diseases in the developing world.

"At the current price, only a fraction of the number of people who could benefit from the drug will actually receive it."

Currently, many of the scientific advances which eventually lead to effective treatments are developed within universities or by researchers working for charities, but that 'intellectual property' is then sold to pharmaceutical companies who bring the product to market.

Professor Shaunak called for a different approach - for academic institutions to go into competition for cures with 'big pharma'.

"We in academic medicine can either choose to use our ideas to make large sums of money for small numbers of people, or to look outwards to the global community and make affordable medicines."

A spokesman for the Association of the British Pharmaceutical Industry said that should this prove to be a 'new' medicine, then the same costly and time-consuming safety trials would need to be undergone before the drug could be marketed.

The pharmaceutical company Roche, which produced the original version of pegylated interferon, said that it sought patents in order to guarantee the resources to re-invest in further 'cutting edge advances'.

A spokesman added: "Roche is committed to ensuring that as many people as possible can gain access to our medicines, many of which have transformed once deadly diseases into manageable and even curable conditions."

The Roche family is, of course, patently wealthy.


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