Talk:Gene patents in the United States

Stupid!?

In the introduction one can read: "Patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism.[1]".

But later it says: "As of 2010, 40,000 patents exist on an estimated 2,000 human genes, or about 20 percent.[4][5]"

WTF!? —Preceding unsigned comment added by 217.24.58.160 (talk) 00:35, 28 June 2010 (UTC)

Dear unsigned person. The issues are complicated, not stupid. I wrote the sentence in the introduction, and it is true. The second sentence is sloppy and is where your confusion comes from. The second sentence should read: "As of 2010, approximately 40,000 patents have been issued that relate to an estimated 2,000 human genes, or about 20 percent of the genome.[4][5] As noted above, these patents do not cover the genes in any human body as these genes are indeed natural products and never have been patentable. The issued patents cover things like (i) isolated genes; (ii) methods of using the isolated genes (for instance, to manufacture protein drugs); (iii) methods to diagnose a disease based on an association between a gene and a disease." Does that help? I've made this change. —Preceding unsigned comment added by Jytdog (talk • contribs) 18:43, 28 September 2010 (UTC)

The line "As of 2010, 40,000 patents exist on an estimated 2,000 human genes, or about 20 percent.[4][5]" as since changed to ""As of 2010, 40,000 patents exist on an estimated 2,000 human genes, or about 20 percent.[4][5]""" why the wrong percent? The correct figure is 5% isn't it? — Preceding unsigned comment added by MrJosiahT (talk • contribs) 04:55, 24 February 2011 (UTC)

2,000 is indeed 5% of 40,000 if that's what you mean, but that's meaningless in this context. 40,000 is the number of patents, 2000 is the number of genes which have been (apparently) covered in patents, and the 20% bit means that 2,000 genes represents 20% of the total number of human genes - i.e. there are 10,000 human genes. Apparently. Destynova (talk) 16:35, 24 February 2011 (UTC)

Does this mean that eventually, someone could patent 100 % of my genes, and as a legal owner of my DNA, ask government to terminate me ? Mike.

NO. As the last sentence of the lead paragraph says, "Patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism.[1]" Patents are granted on ISOLATED genes - a little strip or circle of DNA all by itself. You can do things with that -- it is industrially useful. The genes in your body are (a) naturally occurring so therefore unpatentable; (b) not good for anything industrially (but very good for you of course). When I say that an isolated gene is useful, what I mean is the following. Let's say the gene makes a protein in a bacteria. The bacteria lives off oil and the protein's job in the cell is breaking down each oil molecule into little bits so that the bacteria can digest it. A scientist sees that the bacteria can do that, and figures out which strip of DNA in the bacteria = the gene for that protein. He snips it out. Now he has something useful. He can take that, put it in a different bacteria that is great at cranking out tons of protein, catch the protein and purify it, and then... put it in detergent for cleaning clothes, and have a product that can get oil stains out. This has actually happened - there are enzymes in laundry detergent, that are patented. Likewise, there is a gene that makes insulin in your body and mine. Scientists have been isolate it. That isolated gene can again be put into bacteria, and can crank out insulin, which is given to people with diabetes and save their lives. Get it? Isolated gene is useful to actually make things; the gene in your body is good only for keeping you alive. Jytdog (talk) 01:45, 9 August 2012 (UTC)

Removed Summary section

The section was both unnecessary, as the article was relatively short, and inappropriate, as it expressed a definite preferal on the subject of gene patents--something that wouldn't even be appropriate in a page specifically dedicated to the controversy, much less one dedicated to the general concepts of gene patents.

What have we narrowed our debate topic to?

What topic are we choosing? We need a specific topic...

Although the article presents an fairly unbiased approach to the topic, some of it is spoken in 1st/2nd person (...we are the primary source...) in the pro's section and the use of upper case words adds emotion, which in fact doesn't really have a place in an article about legal issues in modern genetics.

In addition, the last line of the 'pro' section ('it's critical that patents continue to be allowed...') implies emotion and unbiased approach. This article needs a cleanup. --Nushoin 20:30, 19 August 2006 (UTC)

I can't believe this is considered an encyclopedic entry

Since when have wikipedia articles turned into a debate? If this were an article about the debate on gene patents, that would be one thing, but this is not.

Here we will be discussing the pros and cons of genetic treatment technology patenting

Is this something you see in the ecyclopedia? No. This is more like an essay than an article. There are no references, and no in depth look at what gene patents are. glocks out 19:24, 21 September 2006 (UTC)

The article should have information on the genes patented till date and not the views of the world about patenting genes.US has patented more than 6000 genes till date .A list of these genes would make ideal content.I request anyone to please add the necessary information to the article.  —Preceding unsigned comment added by 219.64.138.69 (talk) 18:00, 22 November 2007 (UTC) 

Clean up...

I've made an attempt to clean up this article by basically starting from scratch.

I think it's rather easy to be biased on the subject when coming from any background. But all perspectives are welcome as long as you've referenced your sources!

-RT

"Next"

Ok, I'm no scientist, but I'm reading Crichton's newest book, "Next". In it he claims that the University of California holds more genetic patents than several major pharma companies combined. I tried to verify this on the internet and ended up here. It would help those of us with no background on this extremely compelx subject to know who is in on the money. I believe we are reaching a tipping point where the objectivity of supposedly unbiased research must be questioned. It is hilarious to me that the main criticisms of "State of Fear" were leveled at Crichton's criticism of the global warming proponents. That was not the thrust of the book! It was much more an indictment of a new and very powerful complex of supposed "non-profit" groups, universities, and other parties conventionally thought of as unbiased. I am as skeptical of claims from this bunch as I am of Exxon, et. al.

So, to make a long story short (too late, some would say) it would be useful to have a section on just who owns how many patents. The days of believing anything you hear or read have gone the way of 5 pound cellphones and 10 pound VCR cameras.

Thank you for your support,
Sarazen 00:15, 18 February 2007 (UTC)

Removed material

I took this out:

It is very difficult to separate the ethical, scientific and legal issues of patents on gene technologies and materials, because they often accompany one another in all sources of information.

1. It intimates the issues could be sorted out easily if the sources were structured differently.
2. In fact, it is a commonplace that science, ethics, and law are always and inherantly difficult to separate, because all three kinds of issue are deeply and inherantly involved with human intentions.
3. The statement makes most sense as OR, attempting to explain its author's difficulty with the subject, and concluding the structure of the materials is to blame. If the editor (who wrote this sentence that i removed) wrote most of the rest (of the revision that i found and changed) of that 'graph, then they are a "poor workman blaming their tools". There are plenty of issues here. But whoever would baldly write

   denied John the rights to his own spleen.

   must be innocent of any awareness of how many ways "his own spleen" differs from "his own house": it is a matter of legal fact, and AFAIK essentially uncontested ethical consensus, that no one may sell parts of the body of a living person (whether that person is themself or another). Similarly, the tone suggests an editor who would expect that when a student is allowed to use a generous corporation's laboratory equipment, and by dumb luck stumbles on the basis for a patent, the patent goes to the corporation. (In fact, any claim by the corporation would have to rest on an explicit contract mentioning resulting intellectual property.) And in the case of such an editor, i see them as suffering, on the contrary, the consequences of bringing a knife to an intellectual gunfight.

--Jerzy•t 18:40, 17 April 2007 (UTC)

History

We need to focus on the History of the gene patents and the legal and scientific milestones it achieves. The criticism and debate should not be the focus of this entry. glocks out 22:28, 14 August 2007 (UTC)

Proposed merge

I suggest to merge gene patents and biological patent. I am not sure however which title should prevail. Reason for the merge: major overlap/redundancy. --Edcolins (talk) 21:48, 14 February 2008 (UTC)

Actually, I was considering adding the idea of animal patents to this article, a controversial subject that warrants further discussion. Although those are technically gene patents in some sense of the word, that controversy centers around patenting discovered genes found in nature, especially humans. Animal patents center around inventions, not discoveries, especially through genetic manipulation.

I think we need a better way to discuss these distinct topics. While we could merge them, then distinguish between the two in the merged article, another approach would be to center one article around genetic creations and another around genetic discoveries, which maintaining two articles might allow. -Lciaccio (talk) 18:05, 5 March 2008 (UTC)

Since two years have passed with no support votes, I will remove the merge proposal. -SusanLesch (talk) 15:11, 30 March 2010 (UTC)

Patenting Genes violates 13th Amendment concerning Slavery?

Reading about this general topic isn't this true? I mean if you patent a gene you can not only force other researchers or hospitals to be unable to study about specific diseases, you may actually prohibit some people to reproduce have children. The following example related to Canavan disease shows that this is reality.

• Gene Patent: For Mankind's Good, or For Profit?

“ Neither slavery nor involuntary servitude, except as a punishment for crime where of the party shall have been duly convicted, shall exist within the United States, or any place subject to their jurisdiction.

Section 1. of the Thirteenth Amendment in the United States Constitution

”

More information.

• Patenting Life? - An Introduction to the Issues
• Patenting life is owning life

President Bush urges a ban on gene patents [1]

“ 'And as we explore promising avenues of research, we must also ensure that all life is treated with the dignity it deserves. And so I call on Congress to pass legislation that bans unethical practices such as the buying, selling, patenting, or cloning of human life.

President Bush, State of the Union, January 2008

”

—Preceding unsigned comment added by 83.233.234.230 (talk) 19:00, 19 August 2008 (UTC)

insight info

some interesting insights regarding gene patenting may be found in this slashdot discussion [2] —Preceding unsigned comment added by 217.10.60.85 (talk) 05:48, 14 May 2009 (UTC)

12 "not worldwide view" and "not neutral"?

Someone put two big alerts on the page, indicating that the article needs to be globalized and another indicating that it is biased in some way, and directed interested people to this page. I see nothing here raising a question about neutrality or globalization. I am deleting the alerts. If the person or persons who put up the alerts want(s) to re-put them that is great, but please do come here and state the concern! 140.251.150.42 (talk) 19:39, 28 September 2010 (UTC)

See my NPOV dispute. — Preceding unsigned comment added by MrJosiahT (talk • contribs) 05:35, 24 February 2011 (UTC)

U.S. Says Unmodified Genes Should Not Be Eligible for Patents

see NY Times, published October 29, 2010: U.S. Says Genes Should Not Be Eligible for Patents Gerhardvalentin (talk) 12:11, 30 October 2010 (UTC).

The US amicus brief (linked in the article cited above) makes a distinction, on the one hand, between DNA that is isolated and altered, and on the other hand, DNA that has simply been isolated. "... the district court erroneously cast doubt on the patent-eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA. Such compositions — e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules — are in every meaningful sense the fruits of human ingenuity and thus qualify as “‘human-made inventions’” eligible for patent protection .... The district court therefore erred in invalidating the challenged composition claims, such as claim 2 of the ‘282 patent, that are directed solely to cDNAs. The district court correctly held, however, that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible."

NPOV dispute- Controversy

The section titled "Controversy" appears to have a strong bias toward the patenting of genes. Obvious examples include "The case that there are negative effects on basic research appears to be mostly driven by academic law professors, and not by practicing university scientists" There is no citation for this. — Preceding unsigned comment added by MrJosiahT (talk • contribs) 04:56, 24 February 2011 (UTC)

I thought the same when I read that bit so I've added a {{POV-section}} tag. Qwfp (talk) 17:14, 27 February 2011 (UTC)

I wrote that bit. I read a lot in the field and in the following sentence I provided two examples of academic law professors work and another citation showing that there is no impact of patenting on the actual practice of science in a university. What is the problem? thxJytdog (talk) 14:01, 2 March 2011 (UTC)

I am removing the POV flag as no one has responded in two months and I have responded to the stated concern. Jytdog (talk) 11:23, 3 May 2011 (UTC)

JosiahT -- You just flagged the article as potential POV, but when I responded to the query above back in Feb nobody picked up the discussion. Please state your issues here so they can be addressed! Jytdog (talk) 13:05, 27 May 2011 (UTC)

Am taking the possible POV flag off. Not fair to flag this without raising specific issues... Jytdog (talk) 13:07, 27 May 2011 (UTC)

I felt like this line: "The case that there are negative effects on basic research appears to be mostly driven by academic law professors, and not by practicing university scientists. See for example this page at The Hastings Center's website and this document at the journal, Academic Medicine. There is data showing that gene patents have little to no effect on basic university research provided at the Science Progress Blog." was attempting to reflect that a negative stance toward gene patenting was unscientific, and, though the editor cited several example pages once could also cite scientific pages that complain about this. I propose this line adn the one following it be removed, or at least rewritten. If you disagree with this please at the NPOV flag citing this talk page so other editors can collaborate on this issue. Thanks MrJosiahT (talk) 16:17, 28 May 2011 (UTC)

Thank you for fleshing out your concern, namely, that this section "was attempting to reflect that a negative stance toward gene patenting was unscientific..." this is not what I, who wrote the sentence, was attempting to say. My intention was to communicate this: "Group A says Group B has a problem; Group B sees no problem. " Group B happens to be scientists while Group A is not, but their fields of expertise are not the point. There was no intention to say that law professors are ignorant about science - just that the people the law professors are talking about (scientists) don't see themselves as having a problem. Basic scientists at universities, when interviewed, indicate that they are not hampered and that they don't think about patents when they are planning or doing work in their labs, and I am not aware of any publications by basic scientists who make the claim that patents get in the way of their basic research. (The situation is different for scientists at companies; companies pay for R&D with goal of creating, developing, and selling new products and of course are concerned about patents that could be used to block the company from selling those resulting products.. so of course corporate scientists consider patents in the fields in which they work. But university scientists do basic research with the intention of publishing it and moving on to the next set of questions and experiments and getting grants to continue working; their labs are not directed toward developing products like corporate research labs are. Patents are very relevant to commercial activity, but not to basic research activity) Again I am not sure how you are reading against the plain surface meaning, but please feel free to offer suggestions on how to avoid such misreadings.Jytdog (talk) 19:22, 28 May 2011 (UTC)

MrJosiahT -- I neglected to mention yesterday, that if you indeed have "scientific pages that complain about this" -- as in reliable sources in which basic researchers indicate that gene patents do hamper their work -- please edit the article and cite them! That would be very helpful. Jytdog (talk) 14:19, 29 May 2011 (UTC)

Jytdog, one of the big problems with this entry is that you include a lot of opinions in the narrative of the article, rather than attributing them to someone. You can cite opinions, from WP:RS, Wikipedia itself doesn't take sides or state opinions about controversies. WP:NPOV.

For example, when you say, "The case that there are negative effects on basic research appears to be mostly driven by academic law professors, and not by practicing university scientists," you're siding against the academic law professors, in the name of Wikipedia. There may be some people who believe that, but there are some people who disagree (including the academic law professors), and under Wikipedia WP:NPOV rules, we have to give both sides neutrally.

This is written like an essay or a college paper. It's perfectly proper to take a POV in a term paper, and sometimes it's desirable, but not in a WP article.

One of the problems is the citation format. Wikipedia doesn't have in-line links to the source article; it has in-line links to footnotes at the bottom, which link to the source article. I couldn't figure out at first what the nature.com link was referring to.

I don't have time to give a long critique right now; I just looked at this entry while I was preparing to go to a conference on biotechnology law. I'll have to get back to it. But I agree with much of what MrJosiahT said. --Nbauman (talk) 07:13, 9 June 2011 (UTC)

Thanks for your comment. I edited to make the citations into footnotes and replaced my synthetic comment with a quote in the section you referenced. Jytdog (talk) 11:58, 9 June 2011 (UTC)

I just went to a seminar on genetic patents, and talked to a couple of lawyers, so I understand this entry a little better now. I'm going to edit it as well as I can by sticking to the original sources, and eliminating stuff that doesn't follow Wikipedia rules, or is not directly on point. I should get some more WP:RS, but I don't have time to do it right now.

1. A 2001 guideline by the USPTO is not necessarily the position of the USPTO today, and not necessarily what the courts have decided since or will decide.

The lawyers told me that the question of whether a DNA sequence itself is patentable is controversial, and there are scholars on both sides. It may not hold up in the courts.

2. There may be data showing that gene patents have little effect on basic university research, but there's also data that they do. A lawyer told me that there were many scientists who felt that Myriad's patent on HER2 sequences was interfering with their research (and a couple of scientists at the seminar were also worried). One of the reasons Myriad wound up in court is that they sent letters to scientists forbidding them to use the HER2 sequence in their research without permission. In order to get permission, they would have to sign away rights to commercial results.

A blog is not usually a WP:RS, but it might be if it meets certain requirements. The Science Progress blog is run by The Center for American Progress, which is not a neutral source. It's run by John Podesta who has had (and may still have) corporate legal and lobbying clients. They seem to have cited all the evidence that supports their position, but none of the evidence against their position (which isn't science).

The whole discussion beginning, "While there is some controversy concerning the patenting of isolated genes..." is opinion without WP:RS to support them. Who says there is "little controversy"? --Nbauman (talk) 21:07, 9 June 2011 (UTC)

You went to a conference and talked to a couple of lawyers and now you think you understand this complex field? Anyway creative destruction here we come. I hope you are as open to be reverted as you are to reverting!Jytdog (talk) 00:33, 10 June 2011 (UTC)

No, I spent a few years writing articles about gene and other patents for lawyers, and I've been following it in the scientific journals and the newspapers. I went to a conference and talked to a couple of lawyers to make sure I understood their articles that I've already read.

I don't take these things as seriously as I used to. As long as the article is reasonably understandable to a non-specialist, and gives some good links to sources like the NYT story and Genomics Law Report, I'm satisfied. --Nbauman (talk) 03:08, 10 June 2011 (UTC)

gotcha. Many of your changes were OK with me! Some went too far or oversimplified things so I have made changes. Happy to continue the discussion. Thanks for your edits, I do think overall you have improved the article. So thanks.Jytdog (talk) 13:37, 10 June 2011 (UTC)

Nbauman, above you wrote "there's also data that they (gene patents) do (interfere with basic science)" I do not believe this is true as I have looked and never found such data, and would be very interested for you to produce it -- I am happy to learn. I will also be happy for you to retract the statement if you cannot back it up! :) This is one of my big problems with Eisenberg's work -- she makes this point about the "anticommons" over and over but I have not seen that backed up with data from surveys of practicing basic scientists nor - more importantly - with ANY cases of basic scientists getting sued for infringement of gene patents in the course of their basic research. Additionally ( and I recognize this is anecdotal and not data) I work with basic biomedical researchers all day long and they do not think about patents when they plan, conduct, or publish their basic science nor when they write grants -- patents are about commercial activity not basic research. Some of them think about gene patents when they TURN and want to commercialize their work but I have never seen anybody talk about using gene patents to block basic science -- researchers get all horrified just to consider it Jytdog (talk) 02:21, 11 June 2011 (UTC)

rewrite of june 9 2011

well here we go!

so far, so far. First serious I have encountered going over reversions and revisions was deletion of this text,

While there is some controversy concerning the patenting of isolated genes and the way those patents are used, and there is controversy concerning patents on the diagnostic uses of genes (the real source of dispute in the Myriad court case), it is difficult to find controversy surrounding patents on genes that are used to manufacture therapeutic proteins (for an example of patents on therapeutic proteins, the drug candidate that is the subject of the early part of the movie 'Extraordinary Measures' was covered in part by a classic gene patent, US Patent 6,770,468.[3]) There is also little controversy concerning the role of gene patents in the chemical industry—for instance in the manufacture of enzymes used in consumer products or industrial processes.[4] In descriptions of the controversy over "gene patents", it is rare to find references to these everyday uses of genes and gene patents.

With this stated reason:

20:11, 9 June 2011 108.21.11.192 (talk) (13,233 bytes) (→Controversy: Gene patents were not an essential part of the movie Extraordinary Measures. Unless you can find some issue that makes gene patents significant, that general article on enzymes doesn't have much to do with gene patents either.)

I don't quite know what to say. If "108.21.11.192" understood that in biotechnology you make proteins (be they therapeutic proteins that are the entire goal of the movie "Extraordinary Measures" or industrial enzymes as are described on the bottom on the wiki enzyme page) by using genes, which in industrial contexts are usually covered by patents, perhaps he/she would understand why each are absolutely central to a discussion of gene patents and the controversy. Generally in a controversy -- especially very interesting ones -- there are serious issues at stake on both sides. What happens to development of therapeutic proteins if you make (some) pathologists happy and ban gene patents? Can we keep strong gene patents to support new drug development and keep (some) pathologists in the bad place they are in? How the heck are we gonna get our clothes cleaner if we cannot patent new industrial enzymes and the new genes we make theme with? There are real questions on both sides. Hence "controversy". Anyway I restored this; if "108.21.11.192" or anybody else wants to discuss I am happy to do so!Jytdog (talk) 01:15, 10 June 2011 (UTC)

For the record, my edits turned out to be 108.21.11.192 because WP logged me out after I left my computer for a few minutes. --Nbauman (talk) 17:42, 10 June 2011 (UTC)

After reading through these edits again, I have the following observations:

1. I think Myriad's $3,000 price should be kept in.

Most of the articles about the lawsuit, including the NYT story (and for example this one http://www.genomicslawreport.com/index.php/2011/01/18/government-refuses-to-march-in-under-bayh-dole-again/) mention the $3,000 price, and the price was an issue in the lawsuit, including many of the amicus filings.

It realistically makes a genetic screening panel impossible.

You listen to all the arguments for Bayh-Dole, and they sound good, and then somebody says, "Yeah, but Myriad is charging $3,000," and then Bayh-Dole doesn't sound so great anymore.

If they were licensing the test for $5, it probably wouldn't have gone to court.

2. I think the Alzheimer's Institute of America case is important and belongs in the article, since it's another case of someone claiming broad ownership rights over a gene sequence, and this time even for research purposes, which many defenders of gene patents said would be allowed under the patent laws. Nature, Science and The Scientist thought it was important.

I don't know what's distorted. I wrote what I thought was an accurate paraphrase of the Nature article. If you disagree, the procedure in Wikipedia is to correct it, or add a different view, or at least flag it with ^[Disputed] or something, not to delete it entirely.

3. I think the EST dispute is important, because it got a lot of debate in Science, and it shows the boundary of what *can't* be patented. The evolution of the law is important in understanding the current law.

4. Dan Vorhaus told me that there are two important claims being litigated in the Myriad case -- first, whether Myriad can own the original unaltered sequence, which Sweet rejected, a decision most lawyers expect to be upheld on appeal, and second, whether Myriad can own the use of the sequence in a test for breast and ovarian cancer, which Sweet also rejected but which most lawyers think is less likely to be upheld on appeal.

If Myriad owns the use of the sequence in a test for breast and ovarian cancer, then what happens when I get my $1,000 whole-genome sequence? Can I (if I were female) look up my BRCA1 and BRCA2 sequence and see whether I have an increased risk of breast cancer? Can my doctor? Or can Myriad stop us from doing that?

I don't have a WP:RS for this yet, but I'm sure there is one. --Nbauman (talk) 18:26, 10 June 2011 (UTC)

Hi nbauman -- thanks for clarifying who "108.21.11.192 " is! Responding point by point:
1) Hmmm. I struggled with this b/c there is no context. Would be OK with me, if there were context. Part of the context should be how that price compares to other patented tests, AND to unpatented ones. The other part should be that the price will only be this high during the life of the patents. One thing that gets lost in the debate over gene patents is that patents always expire. Innovators get to reap profits for "a limited period of time" as per the Constitution. Not forever. Part of the irony here is that the challenged Myriad patents almost all expire in 2015. So we have only four more years of $3000 tests anyway.

2) OK with me to include the AIA case if the description is not black and white. I added it in the first place because it is relevant and interesting! But I deleted your edited version because when I added it, I very carefully described what was happening to make it clear that AIA is absolutely NOT going after academic researchers who are infringing their patent while doing academic nonprofit science (they could of course, but the important point is that they are not). They are going after companies that are infringing their patent to develop products that they will sell and make money with (and the universities that work for/with or that spunout those companies) - in other words AIA is making a distinction between basic research and commercial research. The difference is enormous and is goes to the very heart of the ethics issues around gene patents. Your editing obliterated this which was frustrating. Also people who are ideologically opposed to gene patents don't seem to address this kind of thing - the way gene patents have no influence on basic scientists and the way patent holders use them 99% of the time.

3) The EST issue is a straw man. First it is waaaaay in the past and the "resolution" of the non-controversy is accepted law - you cannot patent a gene if you do not know its function and do not provide the sequence. Second, the patent office was never even considering granting the patent - the patent office was fighting this all the way. People can TRY To patent anything. Whether they have a ghost of a chance is another matter.

4) anybody who is informed who follows patent law would tell you that the challenged claims fall into two buckets -- patents on isolated gene sequences ("normal" and mutated) and the diagnostic methods. The first were challenged as being unpatentable as products of nature; the second also as unpatentable a la Bilsky. Most folks I know think the isolated gene ruling will be reversed and find the methods much more dicey.

As to your question: First you should know that the Myriad case never challenged Myriad's claims on the PCR primers. So anybody that wants to look for BRCA mutations using PCR is still going to infringe the remaining, unchallenged claims in Myriad patents. (which is kind of mind-blowing to me -- I don't know why these claims were not challenged). But to the extent somebody does, say single molecule sequencing like PacBio, and only provides sequence information, they would escape the Myriad claims for sure. So let's say you have Pacbio sequence you. You get the results. You bring them to your doctor, who interprets them for you. The best claim Myriad has is this one: claim 1 of the '441 patent which reads:"1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject. "

So if all Pacbio (or 23andMe) does is provide your sequence, they do not infringe. But your doctor would infringe. What about it? three things: a) no sane company (there are insane companies of course) would try to enforce their patent against every doctor who does this b) policing infringement would be just about impossible anyway (how would you know when a doctor did this comparison?) c) It is very likely that challenges would be brought under USC § 287(c) https://www.law.cornell.edu/uscode/text/35/287- - high risk of failure there.

It is different if a clinical path lab does the test. This is very police-able and it is this situation (this kind of infringer and this kind of claim AND a Myriad-like business plan of exclusive use and enforcement) that has pathologists (and I understand why!) up in arms.

But I would say Myriad wouldn't - and probably couldn't - touch the activity you describe.Jytdog (talk) 02:07, 11 June 2011 (UTC)

August 16 Decision

The paragraph about the August 16 decision needs some elaboration. Did they uphold the entire patent, or only the sections they approved before? — Preceding unsigned comment added by 216.136.13.242 (talk) 18:29, 14 September 2012 (UTC) Nevermind, copied it from the better description on the court case article. — Preceding unsigned comment added by 216.136.13.242 (talk) 18:49, 14 September 2012 (UTC)

Systemic bias towards situation in the USA

I think the article is biased towards the USA. It says that "Patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism." I do not know whether that sentence is factually correct, but the stated source is insufficient as it only covers the patenting criteria by the US patent office, while patent rules vary by country. The history section only covers the United States, the controversy section seems to be broader but actually only covers discussions about US law and US patents and the final section specifically covers a US lawsuit. From this I conclude that the entire article is about gene patenting in the USA and should be extended with the situation in other countries, there is already another article about the situation in Australia, and an article about an EU directive on gene patenting that may link to suitable sources. For now I will add 'in the USA' before the sentence I cited in the first two lines. PinkShinyRose (talk) 20:02, 21 September 2012 (UTC) PS From earlier discussion I assume this may be controversial. PinkShinyRose (talk) 20:06, 21 September 2012 (UTC)

I agree 100% that this is focused on the US. Let's change the title to Gene Patents in the United States.Jytdog (talk) 20:20, 21 September 2012 (UTC)

Made move as I suggested above.Jytdog (talk) 11:46, 9 October 2012 (UTC)

Add an "enforcement" section ?

I am currently working on adding an enforcement section to this page, similar to the one that is in the patents article. I think that it is a large, impartial edit that we can all add to in-order to further the page without much debate. The section will focus on examples from the Myriad case, detailing Myriad's "Cease and Desist" letters various BRCA screening clinics that offered BRCA screening, Myriad's lawsuit with U. Penn, and international refusal to adhere to Myriad's BRCA 1&2 patents. I will reveal my sources at the time of posting but,Jytdog I would appreciate your input. Jwalkfour (talk) 19:17, 7 December 2012 (UTC)

Thanks for asking! I am not sure this makes sense - especially with the focus of the proposed content on Myriad's activities, which would seem to violate WP:UNDUE in light of the thousands of gene patents that exist. The content might be useful to put into the background section of the article on the Myriad litgation, however. I also do not know what you mean by "similar to the one that is in the patents article". If you mean this section - Patents#Enforcement - it is very general, and does not have any specific examples. So I don't know how you think the proposed section would be similar to the that. To be frank, it sounds to me like your interest is in painting Myriad as some kind of bad actor, which, if it is the case, does not seem impartial.20:05, 7 December 2012 (UTC)

Additional note. If the section is called something like "examples of enforcement" and you had a wide range of examples -- universities suing companies, companies suing each other, and sure some examples like Myriad (and Athena) of companies sending letters to clinical diagnostic labs...it would be OK, I think... and also since licensing is a form of enforcement and recognition -- it should also have examples of widely licensed gene patents like Stanford licensing the Cohen Boyer patents, Columbia licensing its Axel patents and patents in the monoclonal antibody spaced owned by the likes of Genentech and CAT.... Jytdog (talk) 20:30, 7 December 2012 (UTC)

No, I don't wish to "paint (Myriad) a bad actor at all," but I appreciate your commitment to integrity. I merely wish to add the enforcement section to highlight recent trends in Gene Patent litigation which is an important aspect of patents in general. I use Myriad Genetics because their BRCA 1&2 patents are prolific in a way that other gene patents are not, and that their case Vs. Association for Molecular Pathology is specifically mentioned in the article. Moreover, I feel an enforcement section is not only beneficial, but crucial to this article because "A patent generally has no legal effect until successfully asserted in court," (Holman, C. (2008). Trends in human gene patent litigation. Science, 322(5899), 198-199. doi: 10.1126) and therefore has large implications for how we understand Gene Patents in the U.S.

I am sorry but I very strongly object to any section on enforcement that focuses solely on providing many examples of Myriad's activities. As I wrote above, it would violate WP:UNDUE. You do not respond to that point -- please respond to it. I tried to point out above that there are thousands of gene patents that have been enforced in many ways, by many different sorts of parties. You are right that the article discusses Myriad directly - because that court case (not the prior enforcement activities by Myriad) is going to culminate with a ruling on whether (or maybe, to what extent) genes are patentable. Prior enforcement activity has nothing to do with that. There is nothing particularly "prolific" about Myriad's enforcement activity. I think you are saying that because you do not understand the issues very well. Myriad is certainly in the news, yes. They are not particularly prolific though. More importantly there is no need to have a section about enforcement here... as you point out a gene patent is a patent like any other and the general process described in the patents article covers it. A section teaching about how gene patents are enforced that is actually general and impartial would be mere duplication with no added value.Jytdog (talk) 21:40, 7 December 2012 (UTC)

I feel my proposed section is impartial and fair, which you can read below. Where I have placed "(Cite)" I have a citation that I have that I simply haven't added yet because this is the talk page. Feel free to discuss what you would like to keep or remove:

As above, focusing solely on Myriad is WP:UNDUE. The draft article also has several inaccuracies Jytdog (talk) 21:40, 7 December 2012 (UTC)

I feel my proposed section is impartial and fair, which you can read below. Where I have placed "(Cite)" I have a citation that I have that I simply haven't added yet because this is the talk page. Feel free to discuss what you would like to keep or remove:

Enforcing gene patents has proved difficult for companies like Myriad Genetics, largely due to the international controversy gene patents have raised.

In the case of the BRCA 1 & 2 patents, Myriad Genetics began enforcing their patents by sending “Cease and Desist” letters to various cancer research facilities in North America asking them to stop BRCA screening for new patients, citing each specific clinic’s apparent copyright infringement. For many cancer research facilities, as was the case for the Hereditary Cancer Program (HCP) in Vancouver, British Columbia, this was enough to convince them to comply with Myriad’s demands and direct all new patients for the HCP to Myriad Genetics or MDS Laboratories (a Myriad Genetics Licensee in Toronto) for testing. (Cite) Still, the HCP provides free Genetic Counseling to those at risk for hereditary breast cancer, but ask that the BRACAnalysis test be paid for by the patient. Other “Cease and Desist” letters were sent to Yale and U. Penn barring their clinics from returning BRCA screening results to patients, but allowing them to use the BRCA genes for research. (Cite)

In spite of the threat of legal action on behalf of Myriad Genetics (well within Myriad’s legal rights), many clinics in Canada, Europe, and even within the United States, continue to offer BRCA screening for patients. (Cite) A paper published in Nature in June, 2012, noted that despite the recent trend of “Cease and Desist” letters sent by a variety of companies to various clinics, “in clinical practice, studies indicate that human genetic testing is largely unaffected by patents at present.” (Cite) Jwalkfour (talk) 20:34, 7 December 2012 (UTC)

Also, if you have additional information you can add about"gene patents like Stanford licensing the Cohen Boyer patents, Columbia licensing its Axel patents and patents in the monoclonal antibody space owned by the likes of Genentech and CAT" please feel free to add it! — Preceding unsigned comment added by Jwalkfour (talk • contribs) 20:47, 7 December 2012 (UTC)

I gave specific examples on purpose -- they are very famous and there is tons of information on the internet about them. If you really care about this issue and want to understand it, please google these examples and learn more about the issues. Myriad is a tiny drop in the bucket of gene patents.21:40, 7 December 2012 (UTC)

--- comments on your draft:Jytdog (talk) 21:40, 7 December 2012 (UTC)

Enforcing gene patents has proved difficult for companies like Myriad Genetics, largely due to the international controversy gene patents have raised.

This is a false statement and is original research. IMO Myriad (until very recently) has had an easy time enforcing its patents. Jytdog (talk) 21:40, 7 December 2012 (UTC)

In the case of the BRCA 1 & 2 patents, Myriad Genetics began enforcing their patents by sending “Cease and Desist” letters to various cancer research facilities

This is false/misleading. Letters were sent to clinical diagnostic testing labs at universities and elsewhere, which operate like or are businesses. You state it more accurately belowJytdog (talk) 21:40, 7 December 2012 (UTC)

in North America asking them to stop BRCA screening for new patients, citing each specific clinic’s apparent copyright infringement.

This is false. The issue was patent infringement, not copyright infringement.Jytdog (talk) 21:40, 7 December 2012 (UTC)

For many cancer research facilities, as was the case for the Hereditary Cancer Program (HCP) in Vancouver, British Columbia, this was enough to convince them to comply with Myriad’s demands and direct all new patients for the HCP to Myriad Genetics or MDS Laboratories (a Myriad Genetics Licensee in Toronto) for testing. (Cite)

This borders on orginal research - would be interested in what the source actually says. But this is what I meant above when I said enforcement was easy. These clinics did not fight back but complied with the cease and desist letters.Jytdog (talk) 21:40, 7 December 2012 (UTC)

Still, the HCP provides free Genetic Counseling to those at risk for hereditary breast cancer, but ask that the BRACAnalysis test be paid for by the patient.

Citation needed. I also don't see how this is relevant - why is HCP important enough to give all this weight to? Jytdog (talk) 21:40, 7 December 2012 (UTC)

Other “Cease and Desist” letters were sent to Yale and U. Penn barring their clinics from returning BRCA screening results to patients, but allowing them to use the BRCA genes for research. (Cite)

In spite of the threat of legal action on behalf of Myriad Genetics (well within Myriad’s legal rights), many clinics in Canada, Europe, and even within the United States, continue to offer BRCA screening for patients. (Cite)

Very interested to see your source for this.Jytdog (talk) 21:40, 7 December 2012 (UTC)

A paper published in Nature in June, 2012, noted that despite the recent trend of “Cease and Desist” letters sent by a variety of companies to various clinics, “in clinical practice, studies indicate that human genetic testing is largely unaffected by patents at present.”

There are literally hundreds of tests offered by clinical path labs. This statement is completely unsurprising. Again, it is not clear that you understand how diagnostic labs operate nor how gene patents are actually used in business....Jytdog (talk) 21:40, 7 December 2012 (UTC)

--- In general, as I wrote above, this content belongs in the background section of the article on the litigation -- and much of it is already there. I don't want to repeat myself, but there are literally thousands of patents on genes and they are enforced all kinds of ways. And gene patents cover many kinds of things -- yes, diagnostics, but also protein therapeutics, gene therapies, industrial enzymes, recombinant bacteria and other micro-organisms, recombinant plants, and tools used in research. The field of gene patents is far broader than diagnostics, and even in the field of diagnostics, Myriad's enforcement activity is one example among hundreds. This is not a Good Article example of "Enforcement" for an article on gene patents. Thanks again for asking my opinion.Jytdog (talk) 21:40, 7 December 2012 (UTC)

With all that said, I do like the idea of a section on "Examples of Enforcement and Licensing" -- this could be very informative and interesting. But it should provide many examples and not focus on Myriad. Some of the text you propose could be useful for a brief discussion of Myriad -- Myriad clearly used its patents both to prevent some parties from practicing the inventions but also licensed their patents, at least to MDS.Jytdog (talk) 22:09, 7 December 2012 (UTC)

--- Sorry for late response, just adding some proof below to a couple comments you made. We don't have to do an enforcement article, just an idea. — Preceding unsigned comment added by Jwalkfour (talk • contribs) 23:10, 7 December 2012 (UTC)

Enforcing gene patents has proved difficult for companies like Myriad Genetics, largely due to the international controversy gene patents have raised.

This is a false statement. Myriad (until very recently) has had an easy time enforcing its patents. Jytdog (talk) 21:40, 7 December 2012 (UTC)

Not a false statement, how can you account for the company being in and out of court since their patents became valid in 1994, Lawsuits filed on behalf of OncorMED in 1997, Myriad having to sue UPenn in 1998, having lost their original Association for Molecular Pathology v. Myriad Genetics court case only to be back in court in the appeal, which will now be reconsidered by the supreme court? Hardly an easy go of it considering the rest of the world refuses to pay attention to the patent anyways. As stated in http://jnci.oxfordjournals.org/content/95/1/8.full "Patents notwithstanding, most European laboratories continue to use their own genetic tests rather than pay expensive fees to Myriad."

Can you please provide a source for your statement that Myriad sued UPenn in 1998? (sending a cease and desist letter is not the same as suing) With respect to Oncormed and Myriad -- they sued each other for infringement, as they had slightly different patents on BRCA, and ended up settling. This is common in the biotechnology industry. Myriad succeeded pretty easily in the US with enforcing its patents -- as far as I know the only suit it actually had to bring was the one against Oncormed - that is remarkably easy. Their business model has worked well in the US - that is where they have put their energy for the most part. It is true that they have had a more difficult time outside the US - I am not denying that.00:30, 8 December 2012 (UTC)

In the case of the BRCA 1 & 2 patents, Myriad Genetics began enforcing their patents by sending “Cease and Desist” letters to various cancer research facilities

This is false/misleading. Letters were sent to clinical diagnostic testing labs at universities, which operate like businesses. You state it more accurately belowJytdog (talk) 21:40, 7 December 2012 (UTC)

That's cool, we can reword it. I did ask for your opinion.

in North America asking them to stop BRCA screening for new patients, citing each specific clinic’s apparent patent infringement.

This is false. The issue was patent infringement, not copyright infringement.Jytdog (talk) 21:40, 7 December 2012 (UTC)

edited

For many cancer research facilities, as was the case for the Hereditary Cancer Program (HCP) in Vancouver, British Columbia, this was enough to convince them to comply with Myriad’s demands and direct all new patients for the HCP to Myriad Genetics or MDS Laboratories (a Myriad Genetics Licensee in Toronto) for testing. (Cite)

This borders on orginal research - would be interested in what the source actually says. But this is what I meant above when I said enforcement was easy. These clinics did not fight back but complied with the cease and desist letters.Jytdog (talk) 21:40, 7 December 2012 (UTC)

Citation: Genetic testing for sale : implications of commercial BRCA testing in Canada. Willaims-Jones, Bryn. URL: https://circle.ubc.ca/handle/2429/13580 page 38. "To date only British Columbia has complied with the myriad patents and ceased to provide in-house testing..." Ergo, enforcement is not as easy as you claim

See above...Jytdog (talk) 00:30, 8 December 2012 (UTC)

Still, the HCP provides free Genetic Counseling to those at risk for hereditary breast cancer, but ask that the BRACAnalysis test be paid for by the patient.

Citation needed.Jytdog (talk) 21:40, 7 December 2012 (UTC)'

Citation: https://circle.ubc.ca/handle/2429/13580 page.7-9

You ignored my comment here about undue weight.Jytdog (talk) 00:30, 8 December 2012 (UTC)

Other “Cease and Desist” letters were sent to Yale and U. Penn barring their clinics from returning BRCA screening results to patients, but allowing them to use the BRCA genes for research. (Cite)

In spite of the threat of legal action on behalf of Myriad Genetics (well within Myriad’s legal rights), many clinics in Canada, Europe, and even within the United States, continue to offer BRCA screening for patients. (Cite)

Very interested to see your source for this.Jytdog (talk) 21:40, 7 December 2012 (UTC)

Citations: http://jnci.oxfordjournals.org/content/95/1/8.full and for Canada Williams-Jones, 2002 38.

A paper published in Nature in June, 2012, noted that despite the recent trend of “Cease and Desist” letters sent by a variety of companies to various clinics, “in clinical practice, studies indicate that human genetic testing is largely unaffected by patents at present.”

There are literally hundreds of tests offered by clinical path labs. This statement is completely unsurprising.Jytdog (talk) 21:40, 7 December 2012 (UTC)

My attempt to move away from the Myriad Case specifically.

I hear you but that is not clear, and you are still sticking to the subset of gene patents that are at play in the diagnostics space and ignoring the rest of the economic world where gene patents are relevant.00:30, 8 December 2012 (UTC)

--- — Preceding unsigned comment added by Jwalkfour (talk • contribs) 23:08, 7 December 2012 (UTC)

thx for providing the citation. it does not support your statement that "many clinics in Canada, Europe, and even within the United States, continue to offer BRCA screening for patients". That is not good faith editing and citing, my friend... the article says "Patents notwithstanding, most European laboratories continue to use their own genetic tests rather than pay expensive fees to Myriad, said Matthijs". If you were being a careful editor, you would have done more reading and thinking, and realized that a) Matthijs is an opponent of gene patents and of Myriad's practices so he is not a very reliable source; b) the author of the JNCI article was careful to put that statement in a quote from Matthijs -- if the author had put it in his own words he would have been responsible to make sure it is true -- but putting it in quote relieves him of that duty. However you took the statement out of the quote and stated it as raw fact - you see how dangerous this is? c) you went even further and expanded the statement beyond what Matthijs actually said which is even worse scholarship - maybe you misunderstood something in the article, or maybe you were being dishonest... I have no way to know -- but this kind of bad scholarship hurts readers of Wikipedia by telling them something is true which has no basis in fact. This is really a terrible thing to do to people. d) you didn't do more research to see if Myriad was even trying to enforce its patents in Europe. If you had done that extra step you would see that Myriad has so far chosen not to enforce their patents in the EU. (see "A Change in Myriad’s Patent Policy" section in this article: http://www.genomicslawreport.com/index.php/2011/03/01/how-will-myriad-respond-to-the-next-generation-of-brca-testing/). In general, the JNCI article is not balanced and neutral -- almost all the quotes are from people who oppose gene patenting, and I would not have chosen to use it as a source for factual statements --- I would use it to support statements about opposition to gene patents, but not for factual information about gene patents. I appreciate that you want to make Wikipedia better but you have to hold yourself to high standards of scholarship if you want to do it - and make sure you that you follow Wikipedia's policies. Otherwise you will hurt people by giving them inaccurate or biased information.Jytdog (talk) 00:08, 8 December 2012 (UTC)

I see that we won't agree on this one, but do not insult me on my research abilities. A) Simply because Gert Matthjs is an opponent of gene patents doesn't make him an unreliable source. He is a well published doctor of clinical molecular genetics, so yes, he'll have an opinion on what goes on in the world of Genetic Patenting, an opinion I'll trust over yours; especially when his points are also cited in one one of the worlds most prestigious science journals. B)Yes, the author, Steve Benowitz, gave that specific quote to Gert Matthijs because Matthijs was the person who said it at the "American Society of Human Genetics meeting in Baltimore" otherwise its called plagiarism. C)No I'm not being dishonest, and no I am not mistaken, the fact that numerous clinics in Canada and Europe are disregarding Myriad's patents reflects a larger global pattern that demonstrates the patents ineffectiveness; thus proving the point that I had made originally, enforcing gene patent has proved difficult! D)Although Myriad hasn't yet tried to enforce their EU patents via litigation, it hasn't stopped other EU institutions from challenging their patents (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=897741). Jwalkfour (talk) 01:51, 8 December 2012 (UTC)

RIght, he has an opinion, and you a) presented it as fact, and b) expanded it beyond what he actually said. Those were my issues. I am not asking anybody to trust my opinion - -wikipedia is not about anyone's opinion, it is about presenting reliably sourced facts. I'm sorry that you think this is about opinion -- it is not. I am glad the wrong information was not presented on purpose -- I was hoping that. But I am sorry that you don't see the mistake. And yes, Europe has a system (which the US will soon have too) under which a patent, just after it issues, can be opposed. After seeing what happened in the US, it is only natural that folks would have used that system to oppose the EU patents. Finally, I have hard time seeing how you can justify a blanket statement about the ineffectiveness of Myriad's patents -- they began as a startup (just a few employees and no income) in 1994 and last year they had ~1200 employees and annual revenue of ~$500M -- and its business model has been based on its patents. That speaks to some effectiveness. I am not saying this is good or bad - those are just the facts. Have a good night!Jytdog (talk) 04:09, 8 December 2012 (UTC)

Moved your approved information into Association for Molecular Pathology v. Myriad Genetics Background. Check it out if you like. Jwalkfour (talk) 12:32, 8 December 2012 (UTC)

today i merged the this article into biological patent. they had a great deal of duplicated content and both were relatively short. merged gene patents into the other, as the biological patent article was broader. Jytdog (talk) 17:16, 9 February 2013 (UTC)