According to the FDA, Your Stem Cells Are Now Drugs

[CanOWorms]

Does this mean that companies can now patent your stemcells? I had read that there are already patents on genes or something that your body produces naturally. How the hell is this even remotely legit? Can we be forced to undergo medical procedures if company needs to get more of "their" property that your body naturally produces?

There are patents on gene sequences. Though naturally occurring, the gene sequences have been extracted, isolated, and purified from DNA. Another example is adrenalin, which naturally occurring in the human body, was patentable when extracted in a purified state.

I think that there are patents on stem cells, but no court has ruled on them yet.

 

[woolfe9999]

There are patents on gene sequences. Though naturally occurring, the gene sequences have been extracted, isolated, and purified from DNA. Another example is adrenalin, which naturally occurring in the human body, was patentable when extracted in a purified state.

I think that there are patents on stem cells, but no court has ruled on them yet.

Struck down.

http://investor.myriad.com/releasedetail.cfm?ReleaseID=455348

 

[CanOWorms]

Struck down.

http://investor.myriad.com/releasedetail.cfm?ReleaseID=455348

That's old news. The Federal Circuit struck down the District Court last summer. It's a highly-watched patent case. The Supreme Court will likely pick it up.

 

[CanOWorms]

Not all are. A drug is a substance which is administered. Technically injected insulin is a drug but it's not when endogenously produced by your pancreas yet insulin is a hormone.

I think that insulin is considered a biologic rather than a drug by the FDA. Same with hormones.

 

[woolfe9999]

That's old news. The Federal Circuit struck down the District Court last summer. It's a highly-watched patent case. The Supreme Court will likely pick it up.

You're right. I looked up the 11th circuit decision. However, that decision's rationale was that isolated genes were "markedly different" from naturally occurring DNA molecules because they had been subject to a chemical process that radically altered the original molecule. It's unclear how that sort of rationale could apply to stem cells.

 

[sandorski]

Why do some always criticize the Government/Government Agencies solely and completely ignore the Instigator Corporations? How long will it be before all realize the tangled web of this duplicity?

 

[CanOWorms]

You're right. I looked up the 11th circuit decision. However, that decision's rationale was that isolated genes were "markedly different" from naturally occurring DNA molecules because they had been subject to a chemical process that radically altered the original molecule. It's unclear how that sort of rationale could apply to stem cells.

An often used example is that purified batches of stem cells may provide properties that unpurified stem cells do not have.

 

[woolfe9999]

An often used example is that purified batches of stem cells may provide properties that unpurified stem cells do not have.

That may be the argument made, but under the case you bring up - which BTW is Association for Molecular Pathology v. USPTO, the court specifically disclaimed that argument, citing past precedent. They said that these isolated genes were not patentable because they were "purified," as that would not have been an adequate rationale for making them patentable. Rather, they were patentable because they were tiny pieces of DNA that had been cleaved from the DNA molecule. The court sites past precedent for why "purification" of a natural element does not, in and of itself, make it patentable.

- wolf

 

[Darwin333]

An often used example is that purified batches of stem cells may provide properties that unpurified stem cells do not have.

I may be way the hell offbase with my original statement on patents, it was more of a question that I was hoping to learn more about, which leads me to my next question.

Say a person had some weird condition in which their body produced the purified stem cells with the same properties and all that a company was granted a patent for. Would this person now be carrying property that belongs to another entity? Could the company legally prevent that person from donating blood, even to their own child, because their "property" was being distributed without compensation (lets just assume that the stem cells would be transferred in the blood, I have no clue).

 

[RabidMongoose]

Isn't Association for Molecular Pathology v. USPTO basically the Myriad case that is potentially going to be at the Supreme Court...the district court case that was overturned by the Federal Circuit and most likely going to have cert granted by the Supreme Court this month. The District said that it wasn't patentable, the federal circuit did, and I think that most patent experts feel that the Supreme Court will hold the federal circuit decision.

 

[woolfe9999]

I may be way the hell offbase with my original statement on patents, it was more of a question that I was hoping to learn more about, which leads me to my next question.

Say a person had some weird condition in which their body produced the purified stem cells with the same properties and all that a company was granted a patent for. Would this person now be carrying property that belongs to another entity? Could the company legally prevent that person from donating blood, even to their own child, because their "property" was being distributed without compensation (lets just assume that the stem cells would be transferred in the blood, I have no clue).

Under current law, the answer is "no." To be patentable, it must be significantly altered from its natural form. If a person possesses such cells in his body that is per se proof that it is natural occurring in that form, and hence unpatentable. Even had a patent been previously granted in that case, it would be overturned.

 

[woolfe9999]

Isn't Association for Molecular Pathology v. USPTO basically the Myriad case that is potentially going to be at the Supreme Court...the district court case that was overturned by the Federal Circuit and most likely going to have cert granted by the Supreme Court this month. The District said that it wasn't patentable, the federal circuit did, and I think that most patent experts feel that the Supreme Court will hold the federal circuit decision.

As I read the case and legal opinions surrounding it, yes, the Appellate Court's ruling will likely be upheld. However, for the reasons I already explained, that case is distinguishable from the situation with stem cells, and it does not hold that "purified DNA" is patentable.

 

[CanOWorms]

That may be the argument made, but under the case you bring up - which BTW is Association for Molecular Pathology v. USPTO, the court specifically disclaimed that argument, citing past precedent. They said that these isolated genes were not patentable because they were "purified," as that would not have been an adequate rationale for making them patentable. Rather, they were patentable because they were tiny pieces of DNA that had been cleaved from the DNA molecule. The court sites past precedent for why "purification" of a natural element does not, in and of itself, make it patentable.

- wolf

The case tends to be referred to as Myriad Genetics, or merely Myriad. I believe that you're correct that the Federal Circuit didn't go the purification route for this particular case as it's irrelevant. However, it doesn't delve far into purification, perhaps a paragraph wherein nothing new was said (I believe it focused on the elements).

Moreover, I'm not a biotech person. Just replace "purify" with "process" or something else.

 

[RabidMongoose]

As I read the case and legal opinions surrounding it, yes, the Appellate Court's ruling will likely be upheld. However, for the reasons I already explained, that case is distinguishable from the situation with stem cells, and it does not hold that "purified DNA" is patentable.

Apologies, maybe I'm misreading your statement, but I believe that Association for Molecular Pathology v. USPTO as it is right now does not hold that "purified DNA" is non-statutory subject matter. The Federal Circuit overturned the District Court that held that the isolated gene sequence was non-statutory subject matter.

I'm not sure about stem cells, to be frank I have no idea about them, but I don't have the impression that Association for Molecular Pathology v. USPTO where it is right now says that purified DNA is non-statutory subject matter.

 

[CanOWorms]

Apologies, maybe I'm misreading your statement, but I believe that Association for Molecular Pathology v. USPTO as it is right now does not hold that "purified DNA" is non-statutory subject matter. The Federal Circuit overturned the District Court that held that the isolated gene sequence was non-statutory subject matter.

I'm not sure about stem cells, to be frank I have no idea about them, but I don't have the impression that Association for Molecular Pathology v. USPTO where it is right now says that purified DNA is non-statutory subject matter.

I agree with you. I don't believe that they held that "purified DNA" is non-statutory subject matter.

 

[RabidMongoose]

Maybe there is confusion on what everyone means by "purified DNA." I don't think that merely isolated DNA itself has been held to be statutory. But Myriad as it is right now has "purified DNA" as being statutory.

That was just my impression, feel free to correct me if I am wrong.

 

[BoberFett]

Why do some always criticize the Government/Government Agencies solely and completely ignore the Instigator Corporations? How long will it be before all realize the tangled web of this duplicity?

Because if a company tried to claim they owned an idea without the force of government backing up that claim, they'd be laughed at?

 

[frostedflakes]

That interpretation of the commerce clause actually isn't unprecedented, they've used the same cumulative effect argument in other cases to claim that the interstate commerce clause applies, even when nothing is crossing any state borders. Kind of overreaching IMO, but there's precedent for it. Here's a more recent example.

http://en.wikipedia.org/wiki/Gonzales_v._Raich

 

[CanOWorms]

Maybe there is confusion on what everyone means by "purified DNA." I don't think that merely isolated DNA itself has been held to be statutory. But Myriad as it is right now has "purified DNA" as being statutory.

That was just my impression, feel free to correct me if I am wrong.

I think that it's the opposite. Isolated DNA was held to be statutory, but nothing on purified DNA... if purified DNA is even a thing? I'm in no way knowledgeable on the biotech industry.

 

[bradley]

Classifying stem cells as drugs ensures big pharma profitability by strong-arming North American competition.

This will give the US a quick path to catching up with the rest of the world. Then US scientists and researchers proudly can pound their chests due to discovering something already being practiced successfully in Asia and Europe over the last 30+ years.

This is a win-win for American corporations & multi-nationals, Western medicine, big govt, and the Commerce Clause (almost more make-believe than Santa himself.)

 

[CanOWorms]

Classifying stem cells as drugs ensures big pharma profitability by strong-arming North American competition.

This will give the US a quick path to catching up with the rest of the world. Then US scientists and researchers proudly can pound their chests due to discovering something already being practiced successfully in Asia and Europe over the last 30+ years.

This is a win-win for American corporations & multi-nationals, Western medicine, big govt, and the Commerce Clause (almost more make-believe than Santa himself.)

The Europeans have explicitly stated that stem cells aren't patentable in a decision last year. That, combined with US issues with funding stem cell research, has led China to becoming a leader in the field. I don't think that the US and Europe have an issue with catching up with the other one.

 

[GoSharks]

I think that it's the opposite. Isolated DNA was held to be statutory, but nothing on purified DNA... if purified DNA is even a thing? I'm in no way knowledgeable on the biotech industry.

To me, they mean the same. I have a few years experience in both academic and industrial cell and molecular biology labs.

 

[sandorski]

Because if a company tried to claim they owned an idea without the force of government backing up that claim, they'd be laughed at?

Perhaps, but it still ignore the intertwining of the 2. Government has not come up with this idea, it was/is Corporations pushing for it.

 

[woolfe9999]

The Europeans have explicitly stated that stem cells aren't patentable in a decision last year. That, combined with US issues with funding stem cell research, has led China to becoming a leader in the field. I don't think that the US and Europe have an issue with catching up with the other one.

Are you sure China is leading in stem cell research? I know they are emerging and growing fast, but as of 2008, the U.S. was responsible for 36% of the world's publications on stem cell research (China=5%). And that was before Bush's limitation on federal funding got lifted in early 2009, and before the State of California decided to dump $3 billion into it.

http://download.cell.com/cell-stem-cell/pdf/PIIS1934590908002221.pdf?intermediate=true

This paper shows that the U.S. "under performs" in the sense that it puts less into stem cell research compared to other areas of molecular biology than do many other countries, but in absolute terms we are (or were) far and away the largest contributor. Then again, when the article was written, Bush's restrictions were still in place.

Also, according to Wiki, the State of California alone is putting an order of magnitude more money into stem cell research than is the Chinese government.

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

This assertion is, however, unfootnoted.

If you have better or more current information please link it.

- wolf

 

[CanOWorms]

Are you sure China is leading in stem cell research? I know they are emerging and growing fast, but as of 2008, the U.S. was responsible for 36% of the world's publications on stem cell research (China=5%). And that was before Bush's limitation on federal funding got lifted in early 2009, and before the State of California decided to dump $3 billion into it.

http://download.cell.com/cell-stem-cell/pdf/PIIS1934590908002221.pdf?intermediate=true

This paper shows that the U.S. "under performs" in the sense that it puts less into stem cell research compared to other areas of molecular biology than do many other countries, but in absolute terms we are (or were) far and away the largest contributor. Then again, when the article was written, Bush's restrictions were still in place.

Also, according to Wiki, the State of California alone is putting an order of magnitude more money into stem cell research than is the Chinese government.

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

This assertion is, however, unfootnoted.

If you have better or more current information please link it.

- wolf

My info isn't really from a link, but attending some speeches with Chinese and Europeans in the field.

China is not the leader, but a leader. I'm not sure who the current leader is, but a lot of stem cell research is going to China. From what I understand, this is because of many reasons. One is the patent situation in Europe is unfavorable, particularly after last year where even getting patents for research purposes was found to be in violation of their morality considerations. Another was the US funding issues (also, aren't some types of stem cells still not fundable?). Another issue is that regulatory review and clinical trials are easier in China. They of course have some problems in China (many IP issues), so they're not a utopia for stem cell research. But they are becoming a powerhouse.