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The Genes Battle

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Can genes, which are present in nature, be patented? A US court recently ruled that they cannot. The outcome may be cheaper diagnostic kits, says Hari Pulakkat
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It’s a debate that will continue for a few years, and the dust is unlikely to settle down even after that. Are human genes patentable? While the world slowly seemed to move towards a grudging acceptance of human gene patents, an American judge suddenly springs a surprise, ruling they aren’t valid, providing new hope for those campaigning against them. If the higher courts uphold this judgment, patients around the world could expect cheaper diagnostic tests soon.

To summarise, the American Civil Liberties Union and the Public Patent Foundation, two non-profit organisations, filed a lawsuit against Myriad Genetics, a biotech company based in Salt Lake City, Utah. Myriad, along with the University of Utah Research Foundation, is the holder of several patents on two breast cancer genes, BRCA1 and BRCA2. Myriad has developed tests for breast cancer susceptibility, and no one else can do those tests. Now Judge Robert Sweet of the New York District Court has ruled that some claims of the patents are invalid, thus opening the door for competitors.

The US and Europe have been allowing human gene patents for over two decades, and this is the first time a judge has questioned their validity. In the last two decades, the US Patent Office granted patents to over 4,300 genes, which is about 20 per cent of active human genes.

Diagnostic tests based on these patented genes are expensive, and not within the reach of many. In the US, for example, testing for breast cancer susceptibility can cost as much as $3,000 for a full analysis of both genes. “Many patients will benefit from this judgment,” says Mark Stoler, president of the American Society for Clinical Pathology. The judge himself noted that the tests cost less than $1,000 in Canada, where the genes are not patented.

On the other hand, several biotech companies have built business models around those, and raise money based on their gene patents. “Some biotech companies will now find it more difficult to raise money,” says Lisa Haile, partner of life sciences practice at DLA Piper, a large law firm. In fact, as a way of buttressing this fact, the shares of Myriad fell 9.2 per cent immediately after the judgment. Myriad’s revenues had increased almost 50 per cent last year, mostly owing to BRCA gene testing.

So a fierce battle is on between two factions. On one side are the life sciences industry, venture capitalalists and other investors in life sciences companies. On the other side are a large number of doctors, scientists, patients and non-profit organisations. Each has its arguments and supporting evidence. Although the second faction is unlikely to win in a superior court, its victory will have far-reaching impact on the life sciences industry and the future of medicine. “This is very likely to go to the Supreme Court,” says Haile. That would take at least two to four years, and what happens in the US is also a good pointer to what will happen later in other countries.

Opponents of gene patents have more than one argument against them. One of the first is, of course, the principle itself: genes are present in nature and thus cannot be patented. Myriad and others have argued what is patented is a unique DNA sequence isolated in a lab. Judge Sweet in his judgment says genes are genes, whether inside or outside the body. However, there are even stronger arguments against gene patenting. They push up medical costs, stifle innovation and prevent patients from taking a second opinion. It is not just the patients who have to pay Myriad; even scientists who work on the BRCA gene have to pay the company.

“Myriad is just one example,” says Stoler. “Around 5,000 new tests are likely to be developed in the next 10 years.” These tests will be based on genes, and indiscriminate patenting can make them unaffordable except to a small fraction of the world population. Some of these products will be built by a research foundation funded by the public, and hence won’t be the exclusive property of private companies. For example, the BRCA gene was discovered in the University of California Berkeley by Marie-Claire King, now at the University of Washington. King herself is known to be averse to gene patents.

On the other hand, the life sciences industry argues gene patents are no different from drug patents, and a 20-year exclusivity is a small price to pay for treatments and diagnostics that would not exist otherwise.

Even an unfavourable ruling by the Supreme Court is unlikely to stop innovation or patents, as the industry is trying to tell the world. Many diagnostic tests are on multiple genes, and products based on unique combinations of genes may be patentable, even if single genes themselves are not. In any case, the next four years will see some interesting battles.


Source:
The Telegraph (Kolkata,India)

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Obesity Is Found to Make Ovarian Cancer Deadlier

 

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Ovarian cancer is fairly common. ”About one in 60 American women will develop ovarian cancer,” said Dr. Andrew J. Li, the senior author of the study, a faculty physician at the Cedars-Sinai Medical Center and an assistant professor of obstetrics and gynecology at the University of California, Los Angeles. Each year, about 20,000 new cases are diagnosed and about 15,000 women die of the disease, according to the American Cancer Society.

It is well known that obesity is associated with various malignancies, including kidney, throat, breast and colon cancers. Findings about obesity and ovarian cancer have been somewhat less clear, the researchers say, but evidence from previous studies suggests that obesity predicts a worse outcome for ovarian cancer patients as well.

The scientists wanted to know whether excess fat, apart from any other health problems it might cause, had direct effects on tumor growth. They reviewed the medical records of 216 patients at Cedars-Sinai who had surgery for epithelial ovarian cancer. The data included information on height, weight, age and any other diseases. The cause of death was presumed to be cancer related if the patient had advanced recurrent disease at the time of death.

Half the patients had ideal weight, with a body mass index from 18.5 to 24.9, and 8 percent had a B.M.I. of less than 18.5, considered underweight. Twenty-six percent were overweight, with indexes exceeding 25, and 16 percent were obese, with indexes higher than 30.

The overweight and obese differed little from normal and underweight people in age or in health status, except that they had more hypertension and diabetes.

But among patients with Stage III or Stage IV disease, the most advanced stages, those with B.M.I.’s greater than 25 survived disease free for an average of 17 months, compared with 25 months for people with indexes lower than 25.

For each increase of one unit in the index, the researchers found a 4 percent increase in the risk of recurrence and a 5 percent increase in the risk of death.

This ”dose response” effect strongly suggests that obesity alone is responsible for the decreased survival time, Dr. Li said.

The researchers acknowledge that their study, published yesterday in the journal Cancer, has certain weaknesses.

They found that a slightly lower dose of chemotherapy relative to body surface was given to obese patients, and it is possible that this underdosing may have had a role.

In addition, fluid in the body cavity, a symptom of the disease, may have artificially increased the B.M.I. of some patients. And it is possible that other diseases like hypertension and diabetes, more prevalent among the obese, could have decreased survival among those patients.

The study was also limited by its retrospective method and small sample population.

The researchers said they believed that it was unlikely that those factors could have accounted for the decreased overall survival time of obese women. More likely, they said, is that the presence of fat tissue encourages tumor growth or increases resistance to treatment.

”There may be some factor secreted by adipose tissue that makes tumors less sensitive to chemotherapy,” Dr. Li said, referring to fat tissue. ”We have some ideas, and we’re working on looking at those factors now.”

Dr. Li said obesity did not increase the risk of developing ovarian cancer, but did affect the chance of survival when a person developed it.

”Reducing obesity and maintaining an ideal body weight,” he said, ”is important for many reasons. This is just one more health problem in which obesity plays a role.”

Source:The New York Times