Talk:Evergreening/Archives/2013

2008-10-20 "new patent ... prevents the manufacture of ... the product"

I can't follow the logic of the sentence

When the original patent expires, a new patent is in effect, which prevents the manufacture of generic versions of the product.

Won't the new patent only prevent manufacture of products that incorporate the new features of the new patent, and have no effect on products that only use prior art described in the lapsed patent? In this case, "prevents the manufacture of generic versions of the product" should be changed to "prevents the manufacture of generic versions of the updated product" --Yagibear (talk) 06:48, 20 October 2008 (UTC)

2007-10-5 Automated pywikipediabot message

--CopyToWiktionaryBot 07:43, 5 October 2007 (UTC)

Faunce is an academic expert on pharmaceutical evergreening, particularly in Australian context. Articles are appropriate. If an academic helps define a field is that a COI?217.41.235.6 (talk) 20:03, 11 June 2010 (UTC)

Possible copyvio

A significant part of the introduction is taken verbatim from http://law.anu.edu.au/StaffUploads/236-Art%20ANZHP%20Linkage%20Evergreening.pdf, without quotes. — Preceding unsigned comment added by Evanescent7 (talk • contribs) 23:19, 22 June 2011 (UTC)

I'm still confused...

Sorry, but I've just read the article and I don't feel informed about what evergreening actually is. I think it would be great if there were a section, near the top before the for and against explations, that spelled out (in a step-by-step manner perhaps?) how the process of evergreeing actually happens. All I know now is what the opening sentence says - that there are methods of doing it - but not what "it" specifically is. Wittylama 06:57, 3 April 2012 (UTC)

An example?

Is this what AstraZeneca did with Esomeprazole (Nexium) after the patent expired on Omeprazole (Prilosec)? Change up the chemical compound a bit, claim some differences in how it works, file a new patent and they're good for another 20 years. Who cares if any other drug company can make the old product because the new one is *better*. Bizzybody (talk) 02:33, 27 August 2012 (UTC)

Yes, I would take that to be one valid example.

This is a special case of evergreening, with some illuminating aspects. It is interesting to note that the "improved" version Nexium is actually "dis-improved" by comparison to the original Prilosec. This is because Prilosec contains both the left-hand and right-hand chiral molecular versions of the drug molecule (chiral versions are formed of the same elements arranged in very similar molecular structure, with the only difference being that the two versions of the molecule are a "mirror image" of each other) while the new version Nexium only contains one chiral version (I forget which is the "left-handed" version and which is the "right-handed" but it won't matter for this discussion). This forms the crux of the claims of improvement in the Nexium patent. I'll call these two chiral versions "A" and "B".

Proton-pump inhibition (the intended drug effect) is exhibited by only the chiral version in Nexium, version "A". However, the opposite chiral version "B" has a different, useful effect. "B" significantly slows or delays the elimination from the patient's body of "A", allowing a given amount to be active longer. Thus, for the new, chirally pure version containing only "A", a higher dose is required for the same theraputic response. Importantly, "B" has no negative effects on the body. In other drugs this is often not the case, as the un-theraputic chiral version can even have negative side effects in the body. Purifying the drug by removing the un-theraputic chiral version in this case represents an actual, measureable medical improvement. The Prilosec maker was banking on finding such an effect of "purity improvement" during his development of Nexium. The plan appeared to have backfired and handed them lemons. They were disappointed to find no measureable improvement. They decided to make lemonade for themselves.

The lemonade is Nexium, and it has extremely positive financial effects on profits, despite the questionable tactics of marketing a dis-improved product as NEW! and IMPROVED! The "dis-improvement" comes from at least two things. Firstly, when manufactured, Nexium starts as Prilosec, containing both "A" and "B". It is then "purified" to remove "B". This costs money and time, and is not perfectly efficient. Additionally, since a higher dose is required, (at least double the amount of "A") to achieve the same theraputic response, the material cost of the finished dose is more than doubled.

Not, of course, that the cost of manufacture is more than a minor fraction of the price, but I would dispute that there is any "improvement" to the world of medicine. The only "Improvement" I can see is the ability to now sell a patented version of a demonstrated therapy for big bucks, and prevent others from doing so. And in the world of patents, this IS a competetive improvement, though indisputibly not a technical or medical one. It plays on the ignorance of the public that the new version Nexium is no better for them, and in fact is less good: medically indifferent, probably, but financially worse for them and/or their insurer because Nexuim sells for more than Prilosec ever did, and theraputically it is at best, only equal. Because the company blows up a big smokescreen of marketing and technical obfuscsation, it takes a while for the world to catch on (if they ever really do - I have known about this since within a year of the introduction of Nexium, but how many others know or care?) Meanwhile, generic omeprazole, which is readily available at a much cheaper price and is theraputically as good or possibly better, is low-rated by the company's propaganda. Insurers take the advice of the doctors, who rely on the published smokescreen and on the (again, smokescreen propaganda) verbal education provided by the traveling sales reps. The patients and their doctors listen to the NEW! IMPROVED! marketing smokescreen and create (real or imagined) pressure on insurers to cover the latest version. The insurers have a lack of data to prove their suspicion of non-improvement, so do not fight it. This includes Medicare and Medicaid.

THAT is why I interpret this as an instance of Evergreening.

On another note, I have read the implication on numerous occasions that somehow the restriction on making and/or marketing the generic of any original drug (the "Prilosec" version - patent expired, older formulation, new version not demonstrably better) is due to something more than a perception of inferiority of the "Prilosec" version. It seems to be implied that there are somehow legal barriers, which I am not clear on. Can anyone out there clarify this? The article here seems to imply that later-issued patents on improvements to manufacturing or delivery systems or something else can somehow legally stymie such generics. What's up with that? Do these changes also hinge on perceptions of NEW! IMPROVED! only, or something more? Can't the generics compete on the basis of the original drug, delivery system and process? Or on the original drug and process, with a new delivery method (not patented by the original manufacturer) developed by a generics maker, which in such composition is now newly patentable by him?

On a third note, if a new drug is in fact a real incremental medical improvement and is patented, that does not make the original stop working. Are there any legal reasons to prevent the generics manufacturers from making and marketing the original drug, in original delivery system using whatever manufacturing process (including the original process; any of them not currently in patent) they can devise? And if other countries don't like it, is that merely a case of technology envy? And if they can't afford the patent-protected price, maybe they'll just have to wait for the patent to expire and get by on the older version, like we uninsured non-rich patients in the USA have to do? Jornadigan (talk) 18:38, 4 July 2013 (UTC)