Gene Patent Trial Begins: Biotech Researchers Sued Over Ownership Of Gene Discoveries

NEW YORK — A judge on Tuesday weighed whether a lawsuit should proceed that seeks to invalidate a company's patents on two genes linked to an increased risk of breast and ovarian cancer.

The case challenging whether anyone can hold patents on human genes has broad implications for the biotechnology industry and genetics-based medical research.

Last March, the American Civil Liberties Union and the Public Patent Foundation sued Myriad Genetics Inc., the University of Utah Research Foundation and the U.S. Patent and Trademark Office in U.S. District Court in Manhattan.

The ACLU and the patent foundation say Myriad's refusal to license the patents broadly has meant that women who fear they may be at risk of breast or ovarian cancer are prevented from having anyone but Myriad look at the genes in question.

During a lengthy hearing in a packed courtroom, U.S. District Judge Robert Sweet was asked by lawyers for the plaintiffs to strike down the validity of the patents, while a lawyer for the defendants called for the lawsuit to be tossed toss out. The judge did not immediately rule.

Christopher Hansen, an ACLU lawyer, told Sweet that researchers deserved praise but not patents for winning the race to isolate an important part of the body.

He said important medical research was being hampered because the patents for "BRCA1" and "BRCA2" genes prohibit the study of the genes by others.

"New forms and testing and new ways of using the gene have been inhibited," Hansen said. "That's not good for womens' health."

Hansen argued that the patents were awarded for the discovery of an "ancient secret of nature."

He added: "A patent is not a reward for effort."

Attorney Brian Poissant said Myriad Genetics, based in Salt Lake City, and the University of Utah Research Foundation have a right to the patents, especially since they pertain to the process that was developed to isolate chemical composition.

He said to disallow the patents would wreck the foundation of the entire biotechnology industry. Court precedent, he added, is on their side.

"But the information is not new?" the judge asked at one point.

Poissant responded that every invention in the history of man involves something to do with nature.

Poissant said a ruling against the company could lead to the invalidity of thousands of gene patents.

"This would unravel the foundation of the entire biotechnology industry," he said.

U.S. government attorneys have defended the patents, saying the groups do not have the right to even challenge them.

Comments

[Gena777]

07:33 PM on 02/07/2010

This is one of the most significant current patent law cases. Among many other issues, it tests the limits of the concept of monopoly. I'll continue to follow this case closely; please continue to keep us posted.
http://www.GeneralPatent.com

[Dr Manhattan]

05:04 PM on 02/03/2010

If anybody wants a peak at how this is going to go down check these out.

http://en.wikipedia.org/wiki/Moore_v._Regents_of_the_University_of_California

http://en.wikipedia.org/wiki/HeLa

[icposse2000]

06:58 PM on 02/03/2010

Interesting reads. I was struck in particular by this passage in Moore v. Regents:

"The opinion first looked at Moore's claim of a property interest under existing law. The court first rejected the argument that a person has an absolute right to the unique products of their body because his products were not unique. ("[the cells are] no more unique to Moore than the chemical formula for hemoglobin")."

As a scientist, I am struck by the lack of understanding of the court. Those cells are indeed unique to Moore. There is a simple way to prove this: if you were to inject these cells into anybody besides Moore (or an identical twin, if he had one), that person would reject those cells because their immune system would recognize them as different from their own cells. Hence, those cells ARE unique to Moore.

How that would influence the final decision I don't have the legal training to guess at, but it is frightening that the California Supreme Court would pass judgment on a such a critical issue when their understanding of the underlying biology is so incomplete.

[RTIII]

01:10 AM on 02/04/2010

Incomplete is a very friendly word-choice.

I would not have been so generous.
.

[Mike gordon]

01:23 PM on 02/03/2010

Myriad says if human genes can't be patented, discovery of new tests and drugs would be inhibited.

Someone who has the time should tabulate the genes discovered so far that are disease related,
who discovered them, did they have biotech company or other financial support?

I bet you would find most such discoveries were made by people with no financial stake.

Myriad is suing the other makers of tests to force them to stop. Now what was the incentive for
the other test makers who didn't have a patent? If you believe in free market competition,
you shouldn't be in favor of patents. They are a throwback to the mercantalism and government
granted monopolies of hundreds of years ago.

[RTIII]

01:13 AM on 02/04/2010

Your last two sentences are horribly misguided, but I do believe that nobody has the rights to patent what nature created. _They_ didn't discover how to do x y or z but rather discovered how nature does x y or z - and there's a HUGE difference there.
.

[abbienormal]

11:38 AM on 02/03/2010

This should go back to the Main Page. It is really important and only marginally relates to technology. It is a rights issue relating to health.

[pathos]

10:12 AM on 02/03/2010

"chemical composition" This is a joke.

They are patenting a "chemical composition" I already have what a joke. Furthermore, I suspect that large chunks of both Brca genes were already in sequence data bases before the patents were issued when gene boundaries were actually discovered. If they want to use the chemical composition as why they are entitled to the patent then they should only be allowed that on sequences not in some other PRIOR data base (prior art). Because those particular chemical compositions" have already been discovered.

[Mixpixlix]

09:55 AM on 02/03/2010

This is so wrong on so many levels I don't know where to start. While I u nderstand a company patenting the method used to map the gene, even the method used to identify the components that make up the gene, but NOT the gene itself.

This is one of the most aggregious examples of medicine for profit.

However, it is just one more example of an activist court that the Right so loudly decries, EXCEPT when the rulings favor business.

Among the other things I hope this Great Recession restores in America is basic common sense. It's been long gone in the greed rush that nealy destroyed this nation.

[darr]

09:46 AM on 02/03/2010

Let me clarify that I am not a scientist and am not very knowledgable about this subjet.
Something is bothering me about this. Maybe someone could shed some light for me.
I always thought that a patent was for something you or your company invented or an idea you had that has never been used before. If that's the case then this court case seems moot. How can you patent something like a gene? If the case is settled in the favor of the biotech company then does that mean that everything of a scienfific nature can be patented? For example; certain chains of DNA or even individual cells, could they be patented as a result?
I am not being smart. I am really confused over this. Anyone want to shed some light for me?

[spartanmom]

10:06 AM on 02/03/2010

your concerns are the crux of the matter.

Monsanto was granted a patent on the Neem tree by the US patent office even though Indians have been aware of and using the products of the tree for everything from dental hygiene to pest control for centuries (millennia?).—European courts refused but I haven't heard any more on the case.

It really makes no sense

[pathos]

10:23 AM on 02/03/2010

what they have patented was a specific chemical and that chemical happened to be the sequence for two genes called Brca.

What you are saying is addressing the problem clearly and with my explanation above you now see what exactly was patented. Personally I find this to be a absolutely LUDICROUS. First of all large chunks of the sequence had already been discovered. What I think is very patentable is to say a specific mutation that creates an enzyme with altered properties. But to broadly patent a gene is ludicrous. And the fact that I do not have to pay a user fee every time my body uses that sequence sort of points out the fact that not every use is covered under the patent LOL

[who38]

09:38 AM on 02/03/2010

Attorney Brian Poissant said Myriad Genetics, based in Salt Lake City, and the University of Utah Research Foundation have a right to the patents, especially since they pertain to the process that was developed to isolate chemical composition.

He said to disallow the patents would wreck the foundation of the entire biotechnology industry. Court precedent, he added, is on their side.

--------

Isn't this the best argument ever for a more socialistic approach to government? What this attorney's argument is saying to me is that we can't allow people's lives to interfere with company profits. Maybe the government should be spending more money on biotech research and less on missiles. BTW, I wonder if Myriad Industries and the U. of Utah received government grants to support their research; if so, the government should own these patents in partnership with those agencies.

[Julia Bailey]

11:51 AM on 02/03/2010

To expand your point... The US taxpayers paid for an awful lot of the research that was required prior to discovering this gene.

[DickTater]

08:48 AM on 02/03/2010

wrecking th biotech industry, or going against precedent are HORRIBLE reasons to argue that corporations can OWN human life and research and future treatments, etc.

How twisted and strange and inhumane we have become. All the glorious puffing and strutting and preening we do when we talk about our human prowess and science and the wonders of the future have all come to this. TV was supposed to be so great and it enslaved us. Radio has turned into Rush and Beck and selling rabid sports/hate talk and Enzyte commercials.

Half the people who espouse the corporate line on this are also against gene therapy and science in general. So, your corporate and money grubbing side trumps, yet again, your half-baked and insincere spiritual stand on issues. I'm not surprised

[Jamie Kowalski]

09:39 AM on 02/03/2010

I have a big scientific interest in biotech as well as some money invested in it, but I agree with you 100%.

Except I do still like my TV. :)

[icposse2000]

08:39 AM on 02/03/2010

Researchers who find a link between a gene (BRCA1) and a disease (Breast cancer) should be allowed to patent a test that would identify women at low or high risk for developing the disease. These patents should be protected as long as they are of reasonable cost and do not hinder medical care for the women.

However, isolating a link between a gene and a particular disease should not result in a blanket patent on that gene. If different researchers identify a link between BRCA1 and colon cancer, the original group of researchers should have absolutely no claim on that discovery. It's like saying that if you discover wood can be burned to make a fire, that you own all of the potential uses for wood (building ships, houses, fences, etc)...even if you never discovered those uses. That's an absurd position to take.

And the patents absolutely should not prevent other researchers from studying BRCA1 and other genes. To use the above analogy, that's basically the same as saying that you own all the wood in the world.

If the biotechnology laws in this country rest on that flimsy of a foundation that invalidating these patents would throw the industry into disarray then that is exactly what needs to happen. In the long run, the openness will result in far greater discovery and expansion of the entire industry with health benefits for everyone.

[ept]

08:42 AM on 02/03/2010

An excellent comment.

It would also extend to all patents, with the same consequences.

[who38]

09:40 AM on 02/03/2010

Fanned.

[3neuticals]

08:34 AM on 02/03/2010

I've actually followed this issue for quite some time and in the end, I keep coming back to the theme of Ayn Rand's Atlas Shrugged. This is not only about breast cancer. Gene patents are the modern day equivalent of prospecting for gold.

I have mixed feelings about patents on genes and for anyone who wants to know what the hell they are talking about instead of simply spewing off their Marxist pap about how women have a "right" to this research, whether they can afford it or not- simply google for awhile. But don't just look into patented genes, try to find some of the stories of the joys of the aftermath of the Communist revolution in China- in what particular ways that people suffered when it came to health care.

The idea of government funding this research is offensive. Keep government OUT of the investment AND the profits. Keep government OUT of the failures. Keep companies OUT of the government. People have bargaining power only so long as government and industry do not collude against them.

[Caru]

08:42 AM on 02/03/2010

An objectivist... Great!

[amdezurik]

09:51 AM on 02/03/2010

so to you ONLY women who can pay deserve to live?

[Caru]

08:18 AM on 02/03/2010

On the record, I'm all for China ignoring these patents.

[Rumplestiltskin]

08:33 AM on 02/03/2010

They ignore all intellectual property rights for software, file, music, etc, already. Why would this be any different?

[Caru]

08:34 AM on 02/03/2010

Did I say it would be?

[who38]

09:42 AM on 02/03/2010

Israel is proud that it applies for more patents each year than any other country. Must their patents be honored by other countries?

[Caru]

10:13 AM on 02/03/2010

Depends, is there an clear international concensus on patents?

[ept]

12:39 PM on 02/03/2010

No. Patents are territorial beasts. You have to (excepting the EPO) have a patent in each country in which you would like to enforce your rights. This can run into big bucks if you file all over the place as you have to also pay maintenance costs generally each year in each country.

[toxicbrainpoison]

08:18 AM on 02/03/2010

you cannot patent genes despite all the effort.

[GRAycon]

08:20 AM on 02/03/2010

Why not?

[Caru]

08:22 AM on 02/03/2010

Did you make the genes? Do you own all people carrying these genes?

[ept]

08:02 AM on 02/03/2010

Besides the legal ramifications (the plantiffs have no apparent standing to sue), this is very problematic. A better argument would be about what the company is charging.

Just like anything produced by the government (and, society in general), there are good and bad patents. As the article does not specify the patents, it is impossible to comment on the patent quality. However, I suspect that the patent does not actually cover the gene itself but as indicated in the article instead covers one method of isolating the gene. Other methods may exist. In addition, the patent may cover the isolated gene, which does not appear in nature.

It is important to find a balance between allowing a company to recover its costs/profit from its research and the general public good. Other countries sometimes set the boundaries differently from in the US. Remember, however, that companies generally do not perform research without an incentive such as profit and patents are a fundamental source of protection for a company's hard work and innovation. Patents also serve to crossbreed ideas/techniques to allow companies in the same or perhaps other fields to take advantage of the innovations.

Patents in biotechnology (and in general) are neither good nor bad, but in their absence there would be less incentive to innovate and share the newly discovered knowledge (which would be kept as a trade secret, if discovered at all).

The lawsuit is a bad idea.

Full disclosure - I deal with patents for a living.

[SevTT]

09:24 PM on 02/03/2010

Patents are designed to give advantage to innovators. Unfortunately, genetic patents, as they stand, don't do this; they give advantage to discoverers. Patenting a gene which existed in nature is like patenting the X-ray, the laws of thermodynamics, or the speed of light in a vacuum.

Furthermore, the existence of a gene in nature is proof of Prior Art.

There's also the rather dystopian and ridiculous, though seemingly 'legal' implication that companies could use genetic patents to extort money out of people. "Hey! You're producing hemoglobin without paying your licensing fees!"

Now, I have no problems with patenting synthetic genes or genomes. In that kind of situation, innovation has actually occurred.

The idea that this will 'wreck' the biotech industry is absurd -- if it's wrecked by this, it should be. However, there's nothing to keep companies from patenting genetic testing methods, treatments, etc.

[spartanmom]

07:58 AM on 02/03/2010

So, whenever you have any procedure done that involves collecting tissue, black out the part of the consent form that says they can use the material for research purposes.

If everyone did this biotech would be screvved and the public would have some leverage.

Alternately, I'd like to see a law that lets them patent anything they like but they have to share the patent with everyone whose tissue was used in the research.

[GRAycon]

08:19 AM on 02/03/2010

And should that apply to abortion? should those women whose aborted fetuses were used in the research get a cut of the profits (after all, they clearly didn't want the fetus)?

[who38]

09:45 AM on 02/03/2010

Do abortion clinics routinely ask the woman to donate the fetus for research purposes?

[GRAycon]

08:22 AM on 02/03/2010

What about discoveries made from @bort!ed fe.tal tissue? Should the bearers of that t!ssue get a cut of the profits? After all, the tissue certainly wasnt wanted by them.....

[spartanmom]

09:36 AM on 02/03/2010

Public domain

[who38]

09:48 AM on 02/03/2010

Most people don't want the cancerous tissue removed from their bodies either; however, if a bio-med company will profit from the use of that tissue, yes, the person should receive compensation unless it was a voluntary donation. An option might be for the bio-med company to cover the cost of the medical procedure that resulted in the tissue donation.