Thurgood Marshall Court House Seat of the United States District Court for the Southern District of New York Sheila, via Wikimedia Commons

In a move that could significantly alter the future of genetic medicine and the industry around it, a US District Court judge invalidated seven patents for human genes linked to breast and ovarian cancer, on the grounds that genes are discovered, not created. The ruling opens up challenges against the patents held by numerous companies on thousands of human genes, and jeopardizes an industry business model based on exclusive rights to gene treatment.

The case, Association for Molecular Pathology, et al. v U.S. Patent and Trademark Office, et al., reverses decades of rulings, including a 1980 Supreme Court decision upholding the patenting of artificial bacteria. In his opinion, Judge Robert Sweet decided that naturally occurring isolated genes are not legally distinct from entire genomes, which are protected from patent by law. Judge Sweet even went as far as calling the reasoning that deemed isolated genes legally distinct from entire genomes a "lawyer's trick".

Both sides acknowledge that this case, if upheld, will have a profound influence on the future of genetic medicine. For the Association for Molecular Pathology, the plaintiff in the case, and their allies like the American Civil Liberties Union and the American Medical Association, this ruling wins people back the rights to their own genetic blueprint. Conversely, those siding with the defense believe this case will retard the progress of potentially life-saving genetic treatments by invalidating the current business model, thus making it harder for start up companies to raise the capital needed for developing new technologies.

The ruling does not effect genes developed wholly in labs, and does not immediately void the hundreds of other patents held on human genes. However, this ruling is merely the beginning of a lengthy legal battle, with similar suits likely to pop up around the country targeting other gene patents, and with an appeal in the works.

[The New York Times]

16 Comments

YES! finally they get something right!

such a smart decision . This is the premise of Michael Chritons book "NEXT" , that a company could own genes , if those genes happen to exist only in your cells , a company could have exlusive right to you , and come harvest anytime they like . Im happy that the current patents have been invalidated aswell .

For arguments sake I can see why this is a good thing and a bad thing.

Genetic research has finally started to hit a real stride and become economical for smaller organizations. I can understand why they would definitely want to make it harder/next to impossible for much larger groups to come along and just copy their work.

On the other hand you can easily get trapped into Henrietta Lacks’ and the HeLa situation if they can just patent them. (source: smithsonianmag.com/science-nature/Henrietta-Lacks-Immortal-Cells.html)

This is only a good thing.

Another patenting my genes is comparable to repossessing my property without compensation.

Mother Nature owns the real patents... don't piss her off.

So our country is totally hopeless after all. If they patented my genes and I got a disease, I would sue their backsides off for faulty genes that caused me physical and emotional harm. They would be required to either fix my genes, at their cost, so that they didn't cause trouble or pay me.

if you wanted to patent a gene, would you have to make it from scratch, or could you use your own patented mutagen on an existing gene, making a new fuctup gene, and patent it?

nothing good comes from companies patenting genes . they are obviously smart companies and only patent useful genes , ones they can make money on through licensing , not actually making useful drugs , leave that to other people but make em pay you regardless . and the person who has the genes in their own cells gets nothing .

They have patents in some farm crops. I don't think genes should be patented as it's mother nature's doing.

I could understand if companies want to own the patent on a gene that they wholly created and doesn't resemble anything naturally occurring. Trying to patent some ones cancer gene is dumb and offensive to sensibility. Besides, patents aren't forever. By the time something useful could be made from these patented genes the patent would be close to expiration anyway. Way to go there business men.

There is some misunderstanding of what it means to have a gene patented. These companies have discovered genes that are related to specific traits or ailments. They don't "own" the gene. They own the "map" that shows where it is located and what it looks like. Ultimately they want to develop methods to treat the traits/ailments caused by this gene through targeted gene therapy or other methods. There is considerable time and expense in identifying this "map". Hence the attempt to "patent" the gene and protect their investment. I agree 100% with the ruling. They did not create the gene they discovered it.

This decision makes total sense, although Congress may want to grant some time limited license fee for the first discovery of the complete function of a gene or gene set in return for sharing the knowledge publicly soon after discovery in the interest of speeding medical research rather than knowledge hoarding.

It never made logical sense to patent the gene itself. Patents are not allowed on what was common technology at the time of patent application, since by definition it can't be new invention, and human genes have certainly have been around longer than both recorded time and patents.

Patents in any form never made sense.

They're not a kind of property right; they're a government granted right to infringe on other people's property rights.

E.g. it is illegal for me to machine certain shapes out of a block of aluminium. It's my block of aluminium and my tools, so it is my property right that is being infringed upon by the patent holder.

The claim is that infringing on other people's property rights is necessary to spur innovation. This is a falsifiable claim and it very much appears to be false. Almost all inventions are developed concurrently by many different people and companies; as soon as a couple of major patents are granted everyone else stops trying to develop the idea further because there is no point. History is replete with examples of patents being used to block technological progress; James Watt's steam engine, the Wright brother's airplane(in world war I the US airplane industry was so backwards thanks to patents that the US military had to simply ignore patent law as a matter of national security).

The claim that patents are a net benefit to society needs to be examined in detail and rejected if found wanting.

there is merit in a patent system as long as the patents are narrowly defined. The machined block of aluminum is a contrived example that does not reflect truly what patents are about. Patents are intended to protect "non-obvious" innovation. Many times the innovation comes at considerable expense. These expenses need to be recouped. Is the term of protection too long? Perhaps. Are there many patents that should not have been issued? Yes! This does not mean that there should be no protection at all. Let's just let everyone copy everything at will and watch ALL our manufacturing and wealth generation shift to the lowest cost manufacturing nations. But wait! That is already happening! China has little respect for intellectual property and will outright copy anything it deems necessary to furthering it's own self interest.
Finally one can argue that patents drive innovation. If I have a process that that uses patented technology and I don't want to license this technology, I have to find a different and possibly better way of doing it.

rbrjr, in a way I see your point in bringing up the fact that companies patent the maps of genes' locations. However, an analogy is in order.

If, say, Rand McNally is the first to a new highway connecting A and B (A and B being genes) and its employees map it first, should RM be allowed to *patent* it? Now other outfits such as Google Earth, Yahoo! Maps, etc. can't send their own people out to make the same map?

I don't think so.

Now, if RM comes up with something novel in its presentation of the information, then the folks there can file a copyright application, the print world's equivalent of a patent (in case someone doesn't know, though I'm sure you do).

Back to companies dealing with genes. If they come up with novel ways to *travel* the route, perhaps with nano-stuff, I think perhaps they would have a valid right to file for a patent, as long as they can show they were the first to do so. Of course, if they have developed a gene entirely in a lab and it doesn't duplicate or nearly so another gene already in existence -- whether natural or lab-created by yet another company earlier (and patented by the earlier company) --then fine, file away.

Sometimes these companies shoot themselves in the foot, in PR terms. I remember a case in which an Indian drug maker reverse-engineered a patented product and figured out the chemical formula. Aware it was protected by patent, including in India, they made some changes in the chemical structure that didn't alter the effects of the drug whatsoever -- but which did, legally, make it a different chemical soup from the patented stuff. They marketed it -- and the patent holder raised the roof in Indian courts.

Where they screwed up, at least in PR terms and maybe in legal terms, was arguing that "the law in my country" -- not India, in this case, but a Western country -- "patents protect the effects if the formula is fundamentally the same and the chemical causes the same effects as ours."

Unfortunately for the patent holder, that test didn't apply under Indian law. The holder could block the Indian company from marketing in its home country and any other country with the same or nearly the same laws -- but not in India nor in any other country the same as or similar to India, in terms of laws.

This is an oversimplification, of course, but as someone who isn't an attorney at all, much less one specializing in patent law in *any* jurisdiction, it's the clearest I can make it. As a writer, I follow copyright law closely, and my attorney for that actually specializes in trademark law, primarily, but he's also very strong in patent law, which his firm also handles -- and which he sometimes handles. I've had the benefit of listening to him over cold ones describe his cases, how different countries laws can make things very, very murky and difficult, etc., I've got a fair amount of "shade tree law school," so to speak!

You're right that a company has to spend a great deal of money to develop stuff, and I do believe they deserve the opportunity to recover their investment AND to make a profit. I remember a case in which a photographer tried to argue in a U.S. court that his copyrighted photo taken from a particular vantage point meant he "owned" that vantage point for the life of the copyright. In other words, he was saying neither you nor I nor anyone else could take even a holiday snapshot from that particular spot, which is bull crap. And that's the kind of crap some of these companies working with genes try to pull, though I do hasten to add they're scarcely alone.



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