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Published online 3 September 2009 | Nature | doi:10.1038/news.2009.882
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India says no to HIV drug patents
Patent office rejects applications from two US drug companies.
India has rejected applications from two US companies for patents on two key AIDS drugs in a move that could mean more people in poor countries will have access to life-saving medicines.
The decisions are the latest in a string of legal victories for Cipla, India's largest generic drug maker.
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Pardon my ignorance, but I am unclear how "evergreening" actually works in practice.
For example, if drug (call the drug ARL) patent is close to expiration, then the owning company (call it Co.ARL) patents another development (an extension) of the original drug. Suppose drug ARL contains two optical isomers, Right & Left hand versions of ARL (A-R & A-L, respectively). The new patent covers "purified ARL" wherein the "inactive" A-R portion of ARL is removed, leaving only the "active" A-L version of A. The improvement according to the patent is that the so-called "inactive" A-R actually caused undesired side effects, so A-L in its now-pure form is a "better" drug than ARL (whether this is in fact true or not is another matter – for instance as with Prilosec, I believe). So all comers can legally make and sell ARL (the original mixed-isomer version) but the holder of the new patent controls the manufacture and sale of A-L until its patent expires.As I think I understand it, the original patent expires and the protections it afforded expire as well, but the COMBINATION of the original drug (now with an expired patent) plus the enhancement is still protected. So anyone can legally make and sell the original formulation, but not the new COMBINATION?
Is this a correct understanding? If not, what is the correct version?
And if my understanding is correct, then what is the problem? If everyone and anyone can now sell ARL unhindered after expiration of the original ARL patent, why the complaining?
And furthermore, some other company (say, Co.BRL), just as easily as Co.ARL have developed and patented the improvement to ARL, and prevented Co.ARL from selling the new combination. For example, Co.BRL, during the life of the ARL original patent, develops and patents (but does not market) A-L BEFORE Co.ARL does, then Co.ARL cannot freely make and sell A-L. Beyond that, Co.BRL could also develop and patent extended-release versions (X-ARL) and combinations with other drugs (ARL+1) and prevent Co.ARL from selling these, too. And when the original ARL patent expires, it would seem that Co.BRL could make, market and license A-L, X-ARL and ARL+1 to its heart's (and investors') content.
Right? Or not?
THANKS ! !
Thanks Keith
I'm not a patent lawyer, but evergreening covers a swathe of strategies used to extend the life of a patent, and is widely acknowledged as a problem; there is an extensive literature on the topic – see Google Scholar search for 'patents' + 'evergreening'
http://tinyurl.com/evergreening
As far as I understand it, revisions can be made to update the original patent, but in most cases the tactic is to apply for a thicket of patents on minor modifications of the drug just before the patent's expiry date. This deters generic makers, because it creates a significant risk of litigation for infringement as the drug is covered by multiple patents.
See also
The TRIPS Agreement, the Evergreening of Patents and Access to Medicines: Novartis v. India
See http://tinyurl.com/trips-evergreen
MSF describes evergreening as
"Patents are intended to protect "inventions," not medicines as such. In the pharmaceutical sector, an invention may for example relate to a product (e.g. a specific molecule), a process (e.g. the way the molecule is manufactured), a medical indication (e.g. the effect of this molecule on a human body), or a combination of products (e.g. a fixed-dose combination combining two molecules into a single pill). Formulations (including e.g. powders, tablets and capsules) can also be patented, as can the active pharmaceutical ingredients that are used to make a drug. Even a "new use" of an old molecule can sometimes be patented, if scientists subsequently discover that it works against another disease than the one for which it originally was granted a patent.
In other words, a single medicine can be protected by a large number of separate patents. This makes assessing which drugs are patented in which countries a complex task. It also means that the 20-year patent monopoly in practice can last much longer, as pharmaceutical companies usually extend that monopoly by filing for consecutive 20-year patents as new uses or new formulations or combinations are developed. This well-known process is known as 'ever-greening'"