license for TAQ

Bill Alexander alexanderw at cber.cber.fda.gov
Wed Apr 17 14:05:06 EST 1996


In Article <4l142t$cbp at ox.mc.edu>, "Robert G. Hamilton" <rhamilto at mc.edu> wrote:
>DNA polymerase could have been patented. In vitro DNA synthesis, just 
>primer extension, a opposed to cycles of primer extention, denaturation 
>and annealing, could have been patented. The recipie for bread could be 
>patented. Simple protocols like plasmid preps could have been patented. 
>Given the Roche example, we can expect such protocols to be patented in 
>the future..unless something is done. 

Take it easy.  A patent on bread would have expired long ago and would not
have applied to crackers ;-).  

What is wrong with people getting payed for their novel time saving ideas? 
Or should people only be paid for their manual labor?  A patent only lasts
17 years (20 soon?) and doesn't prevent rival methods from becoming
available.  I think it also spurs research into rival methods.

Some plasmid prep methods ARE patented.  Do you wish you were still doing
CsCl preps?  There are also a number of other amplification methods.

>
>While from a business perspective, one would expect Roche, or anyone else 
>to try and "cash in" wherever possible, patenting every novel method 
>would cause research to become outrageously expensive. Note that this is 
>different than paying a royalty. Roche restricts the use of PCR through 
>licensing. Roche is not providing any physical product of any sort.  
>Imagine if bread were sold in this manner!

Roche is selling a TIME (read $$$) saving method.  It really speeds up your
research.  You can also lose money patenting everything.

>
>There is a difference between a company investing into areas such as DNA 
>polymerase, and developing modified polymerases like sequenase. This is a 
>case where an investment was made, and patents allow the company to sell 
>a product and profit from that investment. The patent on PCR is not 
>providing a return on an investment other than the purchase of the 
>patent. "Discovering" PCR cost Cetus very little to nothing.

So what.  Have you heard of intellectual property?  If someone invests their
time and energy thinking up useful methods shouldn't they be rewarded?  A
patent is an incentive for the disclosure of new ideas.  In return the
patentee gets a "short" monopoly on the use of their invention.  If the
price of their license is too high their company will not be successful. 
You could also have trade secrets where a company keeps their methods secret
in hopes of extending their monopoly (much worse for research).  You can
really lose it this way if someone else figures out your methods.  This
almost cost the Wright brothers their patent.

>
>Just because someone got a Nobel prize for something doesn't make it 
>particularly novel, it only means that the protocols (as in the case of 
>PCR) came to be widely used. If no-one used PCR, there would have been no 
>Nobel for it.

You are partly right here.  It got a patent because it was novel.  It got a
Nobel for the way it has changed molecular biology so quickly.  Remember
primer extension is NOT the same as PCR.  No one taught the use of primer
extension using two primers to create a specific product before Mullis et
al.  PCR filled a great need in molecular biology.

>
>While it is a narrow issue, the patenting of simple protocols like PCR in 
>a manner that allows a company to exclusively control the use of that 
>protocol restricts scientific research by funneling research dollars 
>into private companies that are not actually providing any service. There 
>are no jobs created. In fact, by reducing the amount of actual work done 
>for a given amount of research funding, jobs are likely lost. Less PCR 
>means fewer thermal cyclers, fewer technicians doing the research, etc.

Simple but very powerful (You are very wrong here).  I hope I don't have to
list all the areas where PCR has incredibly speed up research.  Also please
remember the exemption for research (in the US).  Check the Perkin Elmer
catalog for the lack of any services (I think they created a few jobs and
products).   Yes, these are not all research jobs but they are jobs.  What
about their human identification kits (among others).  The Unabomer may be
identified by cells left behind on stamps and envelope seals.  HIV viral
load is also tough to measure without PCR.  Also one person can get MORE
research done than before.  You could, for example, make your own site
directed mutations or knock outs, check your constructs for the correct
integration events, and sequence the resulting single colonies without
growing large amounts of each colony.
>
>As this practice becomes more rampant, with every inventor of every 
>protocol trying to "cash in", the effects will be more widely felt. 
>Research will become more expensive..fewer researchers will have the 
>funds available to compolete projects (and this is independent of 
>reductions in funding...this is increase in costs).

If these methods cost you more in money than they save in time, then don't
use them.  

>
>As a scientist, I am opposed to the concept of a patent presented by 
>Roche. If I were a businessman, I would probably support Roche..or be 
>more likely to support Roche. To me the issue is: do you believe in 
>promoting research, or are you more interested in discovering some trick 
>and "cashing in"? 

If it is only a "trick" then no one will use it and the inventor will lose
money by seeking a patent.

>If I want to enhance the capacity of myself and my 
>students to conduct scientific research, patents on simple protocols like 
>PCR must be opposed. (This is much different than a patent on a product 
>like sequenase, which is a product that a private company developed for 
>sale). 
>
I don't think it was so simple.  To move from primer extension to DNA
amplification takes a few steps.  You need a second primer (not always). You
need multiple rounds of annealing of you primers followed by extension. 
Your product serves as a new template in the following rounds of
amplification (not so for primer extension).

Regards, 
Bill Alexander
alexanderw at cber.cber.fda.gov
Regards,

Bill Alexander
alexanderw at cber.cber.fda.gov

     "640K ought to be enough for anybody." -- Bill Gates, 1981



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