Homocysteine and Heart Disease - Patenting a Thought?

Patents are a double-edged sword. They can help a business make money on exclusive rights to commercialize a certain invention - a method of production, a drug, a machine. But they may also hinder progress (I have written earlier on how patents can tie up and discourage many an inventor) or they may re-direct human endeavors in a direction that is opposed to our long term survival. This is the case with genetic modification of plants and animals. The patenting of life forms is a boon to multinationals and a whole branch - life sciences - is being built on it. But it is also a controversial subject as the case of Percy Schmeiser and Monsanto's genetically modified canola seeds highlight.

Patenting life forms has been called "a dangerous step" and in 2003 the Canadian Supreme court rejected a patent for a genetically modified mouse.

Image credit: Catherine Jo Morgan

But now, it appears that even a thought could be the subject of a patent, such as the association of homocysteine levels and a deficiency of B vitamins, and consequently heart disease. This recent article in The Guardian discusses the issue, which has ended up before the U.S. Supreme court:

- - -

Supreme court to rule on patent for your thoughts

Oliver Burkeman in New York
Tuesday March 21, 2006
(Original in The Guardian)

The US supreme court is due to hear arguments in a case today that could overturn thousands of controversial patents, after a lower court ruled that doctors could infringe a drug company's ownership rights "merely by thinking" about the relationship between two chemicals in the human body.

The case concerns a patent granted in 1990 to scientists at the University of Colorado and Columbia in New York. They discovered that high levels of an amino acid, homocysteine, in the blood or urine tended to be associated with a deficiency of B vitamins. But their patent does not just relate to the test they invented. It asserts their ownership of the idea of correlating the two chemicals - leading to the charge that they have patented a law of nature, rather than a human invention.

"Unfortunately for the public, the Metabolite case is only one example of a much broader patent problem in this country," the bestselling novelist Michael Crichton wrote in the New York Times at the weekend. "We grant patents at a level of abstraction that is unwise, and it's gotten us into trouble in the past."

The idea that even thinking about a correlation could infringe a patent "smacks of thought control, to say nothing of unenforceability", he added.

Allowing the trend to continue could be disastrous, he warned. "Do you want to be told by your doctor, 'Oh, nobody studies your disease any more because the owner of the gene/enzyme/correlation has made it too expensive to do research'?"

The current dispute began in 1998 after LabCorp, a medical testing firm, stopped paying royalties to Metabolite Laboratories, which owns the patent. LabCorp said it had started using a different testing method for the same correlation, but Metabolite sued and won.

LabCorp was ordered to pay $7.8m (£4.5m) in damages, and is now asking the supreme court to overturn that judgment.

If the court finds in favour of LabCorp, thousands of patents could be at risk, including many of those granted in connection with the human genome.

A number of medical, software and financial companies are supporting Metabolite as "friends of the court", suggesting that they too see implications for their businesses if the court rules against the firm.

"The test itself is obvious when you have the correlation. It is the discovery of the correlation that is the real novelty here," Mark Lemley, a Stanford University law professor who is helping represent Metabolite, told the Washington Post.

But a pressure group called Patients Not Patents cited a recent patent application for "a method of evaluating a risk of occurrence of a medical condition in a patient, the method comprising: receiving a patient dataset for the patient; and evaluating the dataset with a model predictive of the medical condition" - which would, if granted, have patented the most basic aspects of being a doctor.

- - -

Here is the original Michael Chrichton piece as published in the New York Times:

This Essay Breaks the Law
By MICHAEL CRICHTON
Published: March 19, 2006

(Original in New York Times)

 The Earth revolves around the Sun.

 The speed of light is a constant.

 Apples fall to earth because of gravity.

 Elevated blood sugar is linked to diabetes.

 Elevated uric acid is linked to gout.

 Elevated homocysteine is linked to heart disease.

 Elevated homocysteine is linked to B-12 deficiency, so doctors should test homocysteine levels to see whether the patient needs vitamins.

ACTUALLY, I can't make that last statement. A corporation has patented that fact, and demands a royalty for its use. Anyone who makes the fact public and encourages doctors to test for the condition and treat it can be sued for royalty fees. Any doctor who reads a patient's test results and even thinks of vitamin deficiency infringes the patent. A federal circuit court held that mere thinking violates the patent.

All this may sound absurd, but it is the heart of a case that will be argued before the Supreme Court on Tuesday. In 1986 researchers filed a patent application for a method of testing the levels of homocysteine, an amino acid, in the blood. They went one step further and asked for a patent on the basic biological relationship between homocysteine and vitamin deficiency. A patent was granted that covered both the test and the scientific fact. Eventually, a company called Metabolite took over the license for the patent.

Although Metabolite does not have a monopoly on test methods - other companies make homocysteine tests, too - they assert licensing rights on the correlation of elevated homocysteine with vitamin deficiency. A company called LabCorp used a different test but published an article mentioning the patented fact. Metabolite sued on a number of grounds, and has won in court so far.

But what the Supreme Court will focus on is the nature of the claimed correlation. On the one hand, courts have repeatedly held that basic bodily processes and "products of nature" are not patentable. That's why no one owns gravity, or the speed of light. But at the same time, courts have granted so-called correlation patents for many years. Powerful forces are arrayed on both sides of the issue.

In addition, there is the rather bizarre question of whether simply thinking about a patented fact infringes the patent. The idea smacks of thought control, to say nothing of unenforceability. It seems like something out of a novel by Philip K. Dick ˜ or Kafka. But it highlights the uncomfortable truth that the Patent Office and the courts have in recent decades ruled themselves into a corner from which they must somehow extricate themselves.

For example, the human genome exists in every one of us, and is therefore our shared heritage and an undoubted fact of nature. Nevertheless 20 percent of the genome is now privately owned. The gene for diabetes is owned, and its owner has something to say about any research you do, and what it will cost you. The entire genome of the hepatitis C virus is owned by a biotech company. Royalty costs now influence the direction of research in basic diseases, and often even the testing for diseases. Such barriers to medical testing and research are not in the public interest. Do you want to be told by your doctor, "Oh, nobody studies your disease any more because the owner of the gene/enzyme/correlation has made it too expensive to do
research?"

The question of whether basic truths of nature can be owned ought not to be confused with concerns about how we pay for biotech development, whether we will have drugs in the future, and so on. If you invent a new test, you may patent it and sell it for as much as you can, if that's your goal. Companies can certainly own a test they have invented. But they should not own the disease itself, or the gene that causes the disease, or essential underlying facts about the disease. The distinction is not difficult, even though patent lawyers attempt to blur it. And even if correlation patents have been granted, the overwhelming majority of medical correlations, including those listed above, are not owned. And shouldn't be.

 

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posted by Sepp Hasslberger on Wednesday March 22 2006
updated on Tuesday March 28 2006

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Readers' Comments

Homocysteine is an amino acid produced by the body, usually as a byproduct of consuming meat. The association between high levels of an amino acid, homocysteine, in the blood or urine tends to be associated with a deficiency of B vitamins is common knowledge that can be understood from free radical/antioxidant science and is hardly a discovery. It is an observation from population studies just like any other anthroplogical observation. hence the observation on the association between the Mediterranean Diet and cardiovascular disease or the association between the Polynesian diet and absence of heart diseae and these pieces of information cannot be the subject matter of a patent.

But their patent does not just relate to the test they invented. It asserts their ownership of the idea of correlating the two chemicals - leading to the charge that they have patented a law of nature, rather than a human invention. Patent laws are not designed to restrict thinking on correlations or links or associations. That is absurd.

The Court must understand that, in the first instance, there is no perfect correlation between these two molecules. High homocysteine blood levels do not perfectly correlate with the incidence of vitamin B deficiency like in a mathematical equation. Vitamin suplementation can reduce homocysteine levels.

High levels of homocysteine in the blood are also associated with with heart disease or heart attacks but people who eat food rich in antioxidants or have high intake of a broad range of antioxidants are at a lower risk of heart attacks compared with people with similar or even slightly lower levels of blood homocycteine.

High levels of blood homocysteine is not the direct cause of heart attackes or cardiovascular disease. Free radicals can damage homocysteine molecules and in large numbers, as in high blood levels of homocysteine, a large number of ree radical damaged circulating homocysteine molecules together with the excess free radicals can exert oxidative stress on the endothelium and cause endothelial dysfunction. Only when associated with free radical damage homocysteine molecules and when these exert sufficient oxidative stress to cause endothelial dysfunction leading to excess nitric oxide production will the resulting altered biochemical situation increase the risk of heart attacks. Now can I patent this information and later assert that doctors who think of this biochemical pathway are infringing my patent rights? LUDICROUS!

NAY, the object of such information lies in the public domain for its application and progress of science. And, it shows why there is only a tendency in the correlation between high blood homocysteine levels and vitamin B deficiency. Free radical damaged homocysteine molecules cause oxidative damage to phospholipids - ie they rob electrons from the lipid part of the molecules in cell membranes and when this happens in the heart there is arrythmia (as demonstrated by Dr. Leaf) that can be reversed by the carbonyl ion in omega-3 fish oil or by vitamin B because vitamin B works in lipid medium. Hence, the free radical stress caused by damaged homocysteine molecules to the cell membranes of the heart is removed by vitamin B and it gets depleted over time.

This means that the correlation between high homocysteine levels equates more properly to vitamin B deficiency only free radicals damage homocysteine molecules and hence otherwise there is only a tendency in the correlation with vitamin B. It also means that if there are other natural biomolecules such as omega-3 fish oil that also minimize or prevent lipid peroxidation, the correlation between high levels of blood homocysteine and vitamin B will become weaker. Now, can make this knowledge the subject matter of a patent. Of course, not. Simply because it is an explaination in science and aids the development of science and scientific thought. Knowledge, whether it is observation or a causal link or an explaination are not the type of information that is cirmcumscribed by patent laws.

In general, patent laws are designed to protect the maufacturer of products (icluding test kits) that find a commercial use especially when he discovers a new biomolecule or a new process. They cannot, by any extension of idea or any legal precept be extended to cover an observation from a population study because to patent pure knowledge is a perverse distortion of a law. The claim in the 1990 patent is obviously pure knowledge. If there is another way to test or a different method or tool to test, and the original test is not used, clearly there is no need to pay royalties because the patent protected only that original test and not the pure knowledge. Imagine if Newton patented his laws of motion or if Einstein patented his famous equation on energy, E = (mc)2.

Elevated plasma levels of homocysteine in association with endothelial dysfunction can also precipitate localized conditions such as preeclampsia.

Decreased antioxidant activity and increased lipid peroxidation in cell membranes are clearly the causative link in homocysteine linked heart attacks. Tests that use serum with high homocysteine levels to determine the extent of lipid peroxidation activity would be better for medical use than tests that would test for low levels of vitamin B in serum with high homocysteine levels.

High levels of free radical damaged homocysteine circulating molecules can also cause blood clots just like blood clot formation in older people with excess free radicals in the bloodstream but this constitutes a factor more commonly in older people whole blood antioxidant levels are low or below 30%. Again, the lipid peroxidation in the cell membranes of blood cells may result in agglutination.

Posted by: BELDEU SINGH on March 30, 2006 08:48 AM

 

with further research I would like to add to my comment above. Beatriz et al, 2001, conducted a study on hyperhomocysteinaemia which is an independent risk factor in cardiovascular diseases that are the leading cause of death in haemodialysis patients. (Homocysteine and lipid peroxidation in haemodialysis: role of folinic acid and vitamin E; Nephrol Dial Transplant (2001) 16: 2172-2175). Uraemic patients possess numerous factors that increase oxidative stress and favour LDL oxidation. These factors include increases in free radical production, decreases in primary antioxidant mechanisms (vitamins and enzymes), increases in the time LDL remains in the vascular wall, reductions in the antioxidant capacity of HDL, and accumulation of homocysteine.

This study was designed to determine the effect of folinic acid on hyperhomocysteinaemia and to assess the antioxidant efficacy of folinic acid. The antioxidant effect of folinic acid was compared with that of vitamin E.

Their results show that folinic acid reduced homocysteine by 44%, but vitamin E produced no effect on homocysteine levels. However, and more importantly, folinic acid reduced lipid peroxidation. They conclude that treatment with folinic acid lowers plasma homocysteine levels and, like vitamin E, affords antioxidant protection, which prevents lipid peroxidation. This lowering of lipid peroxidation may reduce the risk of atherosclerosis and prevent or delay cardiovascular complications in HD patients.

Interestingly, they also mention in their study the findings of other researchers that treatment with folinic acid lowers homocysteine levels and improves endothelial dysfunction in patients with hyperhomocysteinaemia.

Hence, a test to measure the extent of lipid peroxidation of serum obtained from patients with high serum homocysteine will serve as a better diagnostic tool for antioxidant administration or intake, not limited to vitamin B. It may include folinic acid as well as coconut oil and omega-3 fish oil and cruciferous vegetables and raw spinach.

Folinic acid is one of the forms of folate found naturally in foods such as spinach and green vegetables. Cooking in excessive heat may destroy the folate. This bioactive form of folic acid is one of the supplements used to promote higher levels of glutathione in the body and may benefit autistic children and people suffering from AIDS or fatigue. Naturally, better health results can be expected if taken together with other natural antioxidants.

This study supports the ideas and explainations in the readers' comments above and confirms that there is no clear or mathematical correlation between high homocysteine levels and depletion of vitamin B but the correlation may be produced by free radical damaged homocysteine molecules that can produce oxidative damage in the lipid part of cell membranes and deplete not just vitamin B but also other antioxidants that carry out free radical scavenging activity in lipid medium and cause a localized disease condition or heart attack, especially when there endothelial dysfunction (ie excess nitric oxide secretion from the endothelium). It is advisable to also test for serum glutathione levels if there is high lipid peroxidation. In patients with high serum homocysteine levels with high lipid peroxidation activity and glutathine levels that fall below 50%, it could be a better predictive indicator of heart attack but it could be reversed by proper natural antioxidant administration, including eating brazil nuts for increasing selenium intake. That puts things in a better medical and health perspective. And, it would be ridiculous to suggest that this info and the info on the treatment can be the subject of a patent.

BELDEU SINGH

Posted by: BELDEU SINGH on April 4, 2006 08:30 AM

 

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