[olsen]

U.S. Says Genes Should Not Be Eligible for Patents
By ANDREW POLLACK
Published: October 29, 2010
Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature....The new position was declared in a friend-of-the-court brief filed by the Department of Justice late Friday in a case involving two human genes linked to breast and ovarian cancer.

“We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,” the brief said.

It is not clear if the position in the legal brief... will be put into effect by the Patent Office.

If it were, it is likely to draw protests from some biotechnology companies that say such patents are vital to the development of diagnostic tests, drugs and the emerging field of personalized medicine, in which drugs are tailored for individual patients based on their genes.


... Opponents say that genes are products of nature, not inventions, and should be the common heritage of mankind. They say that locking up basic genetic information in patents actually impedes medical progress. Proponents say genes isolated from the body are chemicals that are different from those found in the body and therefore are eligible for patents.

The Patent and Trademark Office has sided with the proponents and has issued thousands of patents on genes of various organisms, including on an estimated 20 percent of human genes.

... in its brief, the government said it now believed that the mere isolation of a gene, without further alteration or manipulation, does not change its nature...

http://www.nytimes.com/2010/10/30/bu...drug.html?_r=1

[paula_w]

Madelyn ,

Could you tell us anything that we should be reading between the lines? My first un-informed reaction is to think, ok that sounds really good. But is there something we should be looking for, like "who is in charge of genes?" and who will pay for the research and hire all the necessary people? Is this a good thing?

You watch issues that I don't know much about. No rush. Mahalo

[lurkingforacure]

My immediate thought is: if there is no patent or other protection of innovation to be pursued, no one, and I mean no one, will pursue research into this. Maybe this is an attempt to try to control innovation? Or perhaps make the market so hostile that no research can or will take place outside of the federal government umbrella.

Who will pour the millions/billions of dollars into gene research when everyone else can simply sit back, wait, and then when the discovery is made, reap the benefit for free? Has anyone in the government ever read "Little Red Hen?" Perhaps a "friend of the court" courtesy copy could be sent to the policy/decision makers who hold our lives in their hands.

[olsen]

Hi Paula, My interpretation concerning the downside of allowing patenting of genes is that if a researcher wishes to study a process that involves genes, he/she must first "lease" the genes from the patent owner. Depending upon the numbers of genes to be studied the costs could be prohibitive for the research to be done (patent attorney fees included). And since anyone may patent a gene or its fragments, will the entity owning that patent know how to use the gene in research endeavors? This will be owning genetic information for the sake of owning it and being able to lease it, not for the sake of researching with the information. A primary focus on making money, not perfroming scientific research. (I have strong opinions whether genes should be treated as other consumer commodities--actually I have strong opinions that drugs should not be treated as other commodities)
Having the private sector in charge of all aspects of research results in greater interest in studies that have the potential for large profits vs those that represent the public interest. The numbers of clinical trials for "me too"drugs is evidence of this in operation.
In 2000, Howard Brody wrote that a study of Pharma accounting (done by a firm, DiMasi ,hired by Pharma) noted approximately one third of all drugs abandoned by Pharma were not scientific failures, rather they were forecast to be economic failures: scientifically useful, though profitability such that these were deemed not worth pursuing. Thus much of what could be useful scientific information is just discarded (GDNF in action). (and remember pharma does not share its information as the public sector does, so this information is truly lost).
Brody also noted the accounting of clinical trials costs included "an opportunity cost for the use of capital". Thus cost estimates for clinical trials by Pharma listed trial costs at $169 million/trial, while Public Citizen noted costs of $75 million for Phases I, II and III. "opportunity costs" are explained as though you were accounting the cost of a book purchased at $9; the opportunity cost would be $18 because the $9 you paid for the book would be added to the "lost opportunity" to puchase something else at a cost of $9 with the same money. ( Makes perfect sense to me, though i definitely willnot be utilizing this accounting practice for my tax returns) (Brody, Howard, Hooked, 2007, Rowan & Littlefield, p 88-89). In addition, Pharma is taxed at a rate of 16% vs 27% for other industries.
The public sector does fund basic scientific research. Something akin to 84% of all useful, innovative drugs were first discovered in the public sector in 2006, which the govt then sold to the industry to be manufactured and marketed, because we should all be aware that the govt could not possibly perform those 2 tasks. and being unable to do so, must give away all rights, including drug pricing, to Industry.
Pharmaceutical industry is in the business to develop, manufacture and market drugs. The fear tactic that if the ability to patent compounds, genes, etc is taken away the companies will stop research is a disingenuous argument for an industry that is based upon developing and marketing new drugs. As long as there exists a finite period of exclusivity for drugs, pharma will be forced to continue finding newer compounds to replace those that can be copied and sold generically. The real blockbusters. whether these are truly useful to society is another topic. (these are my biases accompanied by info from howard Brody's book).
madelyn

In re-reading this, I did not really answer your question, Paula, but thank you for providing an opportunity for me to rant. out of sync lately. madelyn

[paula_w]

but there are just more questions. if the govt. 'owns' the genes - won't they screw it up? hold it up? Sorry to sound dismal but i don't want my genetic material being sold to China lol. i'm partly kidding...heh heh...sigh!

Anyway if you rant, I learn something. thanks!

[GregD]

Originally Posted by paula_w

but there are just more questions. if the govt. 'owns' the genes - won't they screw it up? hold it up? Sorry to sound dismal but i don't want my genetic material being sold to China lol. i'm partly kidding...heh heh...sigh!

Anyway if you rant, I learn something. thanks!

Please, please sell my genetic material to China! It will set them back thousands of years just trying to figure out what it is.