I too have wondered about this, and find the information from WCG about it too vague and unsatisfying.
The question also applies to other WCG projects such as DDDT, flu, etc.
Sorry, Lawrence, but your reply doesn't really help.

What kind of organisation, private company, charity, governmental, inter-governmental or other, would come up with the funding to develop a successful drug that has weak or no intellectual property protection? Are there examples from the past?*

As for the IP rights of us volunteer crunchers, I think we cancel those when we accept WCG's conditions that all research results must be placed in the public domain.

It might be interesting to read some opinions on this topic from the legal advisors to WCG and/or the Scripps Institute.
------
* An acquaintance has managed to develop and market one or more drugs that are based on a generic compound. He may have obtained some IP protection from the way his therapeutic product is formulated, as well as the results of the tests and trials that he conducted. His is AFAIK a one-man or small partnership business. Not big pharma, not even micro-pharma, more like nano-pharma. I suppose I shoud ask his opinion on this question (!)

Hi Steffen,

On FightAIDS@Home we are searching for "hits" (i.e., fairly small, moderately potent compounds that could potentially be developed into much more potent "leads," which could potentially be further developed into actual drugs). For additional details on this process, see the last Volume of the FightAIDS@Home newsletter (Volume 7, I believe).

For any promising "hits" that we discover on FAAH, we will publish the predicted structures and the data from follow-up "wet lab" experiments on these hits. Any interested members in the academic or industrial scientific community can then try to develop these hits into leads and then into drugs. We will also try to develop these hits into leads and then drugs at TSRI. But our main purpose is to discover new hits and to study how these hits work, in order to advance the basic science regarding the "structure-function" relationships that control (a) the potency of drugs against the normal, wild type versions of HIV and (b) the atomic mechanisms that allow drug-resistant mutant "super bugs" to evade the drugs.

Although our central goals are to discover and characterize new hits in order to advance the structural understanding of drug resistance and to test and further develop tools that can be used by the entire drug discovery community to help fight many diseases, we will also try to optimize the hits we discover into leads (and then into drugs). To make sure that we preserve the "patentability" of any leads or drugs that we subsequently develop, we perform the iterative process of optimization and analysis on our local computers at TSRI. Thus, we share the data on the hits we discover on FAAH with the public, so that other scientists can use that knowledge to help advance the fight against HIV/AIDS, but we use our local, secure computers when we dock the new compounds that we design, based upon the data on those hits. If/when we develop a potent lead (that medicinal chemists could then optimize, in order to try to produce an actual drug), the general, well-established process is to patent the discovery first, and then to share all of the details with the public.

Published, publicly-available data on hits is frequently used by corporations to help advance their discovery and development of actual drugs. The development of the HIV integrase drug called "raltegravir" is a recent example of this phenomenon. As pharmaceutical companies devote more and more of their "R & D" budgets to end-stage acquisition and development (and less and less of their budgets to the research part of R & D), scientists in the academic community need to pick up the slack and perform more and more of the research that advances the drug discovery process. It is certainly true that the Intellectual Property rights of potentially useful discoveries need to be protected (i.e., the patentability of discoveries needs to be preserved), or else useful discoveries will never be developed, mass produced, and delivered to patients. But sharing data on the hits discovered in the early stages of the drug discovery process will not impede the patentability of the leads and drugs developed from them. In fact, many pharmaceutical companies spend a lot of effort on "patent busting." Even though a current drug might be patented, if someone else can either (a) create a new, slightly different version of that drug that displays significant improvements in potency or (b) discover and demonstrate a new, previously unknown application of that drug, then they can still patent that new compound or that new "re-positioning" application.


Thank you all very much for your help,
Dr. Alex L. Perryman


PS--If someone from the patent law community can either confirm or correct these statements, that would be helpful. Although I have experience with a provisional patent (from my graduate work at UCSD) and now a full patent application (from my first postdoctoral position at Caltech), I am certainly not a lawyer. By the way, that full patent application (on engineered antiviral lectins for the prevention and treatment of enveloped viruses, including HIV) should be posted to the USPTO database and, thus, available to the public in December. As soon as this patent is available on the USPTO database, I will summarize that project for you.

Dr. Perryman

Thanks for your very informative post, however, it reveals a problem in the way WCG presents itself.

Namely, on the About Us page :

"As part of our commitment to advancing human welfare, all results will be in the public domain and made public to the global research community."

By reading it, we are misled to believe that, in exchange for using donated resources, **ALL** results derived from the projects will be donated to the public domain. If that was true, it would constitute prior art and prevent patenting of the active substances (or other results) isolated during research projects carried out using WCG, thus allowing low cost generic medication (or solar cells with the Clean Energy project) to be available much sooner.

You now tell us there is an intermediate step where, before the data is released to the public domain, you will patent all the interesting results. Since, as part of the patent process, all data regarding the patent and it's claims must be made public, the additional donation to the public domain promised by WCG is only about the remaining results you consider not good enough to be worth patenting. Put more bluntly, a few years later, the leftovers will be dumped in the public domain.

As a result, the main effect of our contribution is to lower your costs, but it will not result in any significant change in the availability of exploitable results in the public domain, and as a consequence, it will not enable lower cost, more accessible treatments, and it won't speed up the availability of generic drugs that would be required to stop this worldwide pandemic. It won't alter the overwhelmingly unbalanced weight of patent based pharmaceutical corporate profits and the little value put on human life, and even worse if those humans live in already poor nations.

honestly, this is a big disappointment, even if I suspected there somehow was a twist in this seemingly altruistic way WCG present itself and the convoluted answers given in the past when the patent issue have been raised in these forums.

The statement in the "About Us" page would be more fair and accurate if it included the sentence :
"Researchers involved in the projects retain the right to patent the discoveries made using the World Community grid before the data is made public."

However, thanks for making the whole process slightly more transparent. If I decide to keep participating, I will now do so in a more informed manner.

------


Thanks for using quotes when talking about R&D and pharmaceutical companies. From a scientist, this is priceless !

Increasingly, their only "R&D" (what you call "end-stage acquisition and development") is about buying on the cheap exclusive rights to scientific research patents from publicly funded R&D institutions such as SCRIPPS (mostly from NIH grants) and then patenting all practical ways to use it to lock out their competitors and sell the drugs at the highest price the market will bear without consideration for the manufacturing cost or the emergency of the humanitarian situation.

What they develop is mainly so called compound patents, that is the union of 2 or more elements that are either impossible to patent by themselves or already patented. The 10 years old frenzy about patenting (anything)+"on the internet" is a good illustration. In pharmaceutical industry "R&D", that means combining the active substance + (in a pill, in a gel, in a syrup, in child dose, in injectable solution, in combination with another active ingredient, etc ...)
Those are very low value added patents, but they are the ones reaping indecent financial reward.

This is not new. SCRIPPS (but it's an industry wide issue) already found itself in an intense controversy regarding this issue 15 years ago :
Scripps' Latest Deal Sparks Debate

Those patent based pharmaceutical mammoths are increasingly becoming as irrelevant middlemen in the drug elaboration process as record labels are in the distribution of music, except, in the case of drugs, we're talking about life and death.

Just like record labels are lobbying hard to expand copyright with legal tools such as DMCA, the pharmaceutical lobby can be expected to increasingly resort to hardball tactics to maintain their patent based privileges.

However, in some countries, a backlash is starting to occur, due to the unwillingness of the pharmaceutical industry to do any significant effort and the emergency created by the massive death toll and the need to react fast to the worst pandemic in mankind history :
Brazil breaks patent on HIV/AIDS drug


Generic pharmaceutical companies do not rely primarily on patents, yet they do at least as much "r&d" as patent based ones, and they make a handsome profit. One example, here in Canada is Apotex, with it's CEO being the #10 richest Canadian, and the 2nd highest pharmaceutical "R&D" budget in the country. Yet, they can sell "APO-TRIAVIR", their generic HIV treatment in Rwanda for 38 cents a day, while the same active substances are sold domestically for more than 50$ a day (131x more).
http://www.apotex.com/apotriavir/default.asp

Patents are not needed to yield good ROI and healthy profits, however, they are absolutely required to make the indecent level of profit the Patent based pharmaceutical industry is having right now. For HIV drugs, we're talking at least 25000% profit, a cost to end user price ratio of more than 250:1
If car manufacturers had the same profit level, an average familly car would cost 1M$ !
A very informative page about generic HIV treatment, the issues & costs can be found here : http://www.avert.org/generic.htm

With so much money floating around, scientists at the core of this business should get paid accordingly. Instead, you are requesting computer time donations from us because your financing is too low, while those using the results of your work and the work of your colleagues are reaping billions in profits, allocating you as little as they need to keep scientific progress on a short leash. Is this the best way to achieve scientific progress and new discoveries ? Is it the best way to attract the brightest students ?

Once scientists have isolated the active substance, putting it in a pill is trivial. Why don't publicly funded institutions like SCRIPPS go the proverbial "extra mile", all the way to the final pill patents and be the ones who subcontract their manufacture & distribution instead of being used as cheap labour paid largely with taxpayer's money by the pharmaceutical industry ?

Even within the current patent system, there are models that prevent those abuses, such as the RAND (Reasonable and non discriminatory) model designed to allow a level playing field and fair competition between manufacturers.


Sharks eating sharks. I would be curious to know the ratio of scientists versus lawyers and it's evolution in recent years at Pfizer, GlaxoSmithKline, Bayer, etc ...


What you describe is the frowned upon practice known as "Evergreening", specifically designed to prevent drugs whose patent is about to expire from entering the public domain by adding mostly frivolous new claims, or, much worse, intentionally delaying improvements to existing drugs and only releasing them years later, when the original patent is about to expire, even if this delay is known to cause harm to the patients.

Some techniques used for evergreening :
http://www.egagenerics.com/gen-evergrn.htm


Feel free to correct me if I got anything wrong.

i am so happy that you explained all of this to me... makes me glad to be here and doing my part... mind you i have only completed 1 year towards fightAids so far but it lets me see behind the jargon and the actual reserch leads me to more hope for people with Aids as well as other diseases.

- to the people who dont think they are being fair: remember the scientists have to be able to make a profit of some sort or at least pay the bills.

and if i had a few spair terabits of free space on hard drives i might also ask for the data to quench my curiosity but unfortunatly i dont have the data space or really the reason to ask eithor.

good luck and please keep those posts comming Dr. Alex L. Perryman they help me at least

V/R Nasher