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The Paramus Post - Greater Paramus News and Lifestyle Webzine
Monday, December 10 2018 @ 05:44 AM EST
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The Paramus Post - Greater Paramus News and Lifestyle Webzine
Monday, December 10 2018 @ 05:44 AM EST
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The Paramus Post - Greater Paramus News and Lifestyle Webzine

Does legal ownership of genes, stem cells go beyond the pale?


PATENT OFFENDING
PATENT OFFENDING
In October 1976, an Alaska pipeline engineer named John Moore became seriously, mysteriously ill. Eventually, he found himself at the UCLA Medical Center, where he was diagnosed with a rare, progressive form of blood cancer called hairy cell leukemia.

To slow the disease and perhaps save his life, Moore's physician - Dr. David Golde - recommended removing Moore's spleen. The surgery was successful. Moore recovered and eventually returned to Alaska, with instructions to visit Golde for annual checkups.Over the next eight years, Moore did so. During each visit, Golde would extract samples of Moore's blood, skin, bone marrow and sperm. When Moore complained about the cost and hassle of the visits, he was told the UCLA visits were necessary and could be performed only under Golde's direction.

That was true, but not in the sense Moore initially presumed. Golde had discovered that Moore's diseased spleen had been overproducing lymphokines - a key chemical constituent of the body's immune system. The doctor and colleagues were using blood and tissue samples taken from Moore to develop a cell culture that produced lymphokines, which could then be marketed to companies working on cancer treatments and drugs.

Moore knew nothing of this research until 1984, when he was finally asked to sign a consent form and waive all rights to any product that might be developed from his cells. Moore refused and hired an attorney to investigate.

Not long after, Golde was granted U.S. Patent No. 4,438,032 for a "Unique T-Lymphocyte Line and Products Derived Therefrom."

In other words, the doctor and the university owned the rights to all biological material and knowledge gleaned from Moore's spleen. The patent was eventually sold to the Swiss pharmaceutical company Sandoz Laboratories for several million dollars in cash and stock.

Not surprisingly, Moore sued, alleging fraud and loss of financial benefit from his own body. He lost.

In 1990, the California Supreme Court ruled that Golde had erred in not getting Moore's research consent, but it also ruled that Moore had no proprietary right to blood and tissue removed from his body. To grant patients such a broad right, the split court said, would be to dampen scientific inquiry and medical progress.

PATENT RUSH

For the first 150 years or so of its existence, the nuts and bolts of the U.S. Patent Office was mostly nuts and bolts. Patent applications tended to be inorganic, describing tangible inventions, mechanical devices, better mousetraps.

A story like John Moore's was not really possible until the science of biotechnology emerged in the late 20th century. As researchers learned how to isolate and manipulate DNA and other genetic material, it became feasible to ask whether life or its products could be invented and patented.

In 1980, the U.S. Supreme Court ruled in a 5-4 decision that a bioengineered, oil-eating bacterium met the four basic requirements of a patent: It was novel, useful, non-obvious and "enabling," with fully disclosed details that allowed others to use it.

The case overturned "fairly long-standing law," said Richard Gold, director of the Centre for Intellectual Property Policy at McGill University in Quebec, and spurred a patent rush that today continues bigger than ever.

Thanks to continued scientific advancement, there are hundreds of patents on genetically modified organisms, from microbes to plants to mice. Almost one-fifth of the 23,688 genes in every human being is covered by a U.S. patent; 63 percent held by private companies, 28 percent assigned to universities.

The basic process for creating human embryonic stem cells - widely touted as the potential means for new medical treatments and cures - is patented. To use these human stem cells in research, one must first receive a license from the Wisconsin Alumni Research Foundation (WARF) and agree to meet designated royalties and other contractual obligations.

The question, of course, is whether any of this is a good thing. Do such patents, which promise intellectual property protection and potential reward, spur scientific innovation and medical progress? Or do they, in fact, hinder it?

"There's the economic argument that says somebody will be more likely to work harder on something if there's an opportunity to make a profit," said Michael Kalichman, a University of California San Diego professor of pathology and co-founder of the San Diego Center for Ethics in Science and Technology. "That motivation suggests new therapies and products appear sooner because there's a financial incentive to be first to market with something no one else has or can have without your permission.

"On the other hand, instead of science being conducted in an open fashion, with knowledge disseminated quickly and widely, people with patents can become more protective and proprietary. They want to protect their investment until they can cash in."

Unfortunately, there is little empirical proof to support either position, says Robert Cook-Deegan, director of the Center for Genome, Ethics, Law and Policy at Duke University.

"Nation by nation, laboratory by laboratory, regulation by regulation, we are still trying to figure out who 'owns' the genome, what the owners actually own, and how best to balance the pursuit of knowledge and the allocation of rewards," Cook-Deegan wrote in a recent essay with colleague Misha Angrist.

"The system works, but no one knows how well, because no one can address the crucial question: compared to what?"

John Wetherell, a San Diego-based intellectual property attorney with degrees in chemistry and molecular biology, says gene patents and the like have provided critical fuel to grow biotechnology. "Absent court decisions, industry would not be nearly as robust. We wouldn't be where we are today."

Others disagree.

"You hear that kind of talk all of the time from people in the industry and patent lawyers," said Gold, who also is the author of "Body Parts: Property Rights and the Ownership of Human Biological Materials."

"But the biotech industry is intelligent. Even without these patents and court decisions, researchers would have found a way to move ahead."

Gold and others contend that such biopatents have actually caused harm. In a 2002 paper in the journal Nature, Lori B. Andrews, director of the Institute for Science, Law and Technology at the Chicago-Kent College of Law, cited several cases where patent interests of biotech and pharmaceutical companies impinged upon scientific progress and medical treatment.

For example, the pharmaceutical giant GlaxoSmithKline filed for a patent on a genetic test to determine the effectiveness of one of its drugs. But Andrews says the company has no interest in developing the test - or letting anyone else develop it - because such a test might clarify exactly who benefits from the targeted drug. The company could lose customers.

Along similar lines, San Francisco-based Athena Neurosciences holds the patent on a gene associated with Alzheimer's disease. Athena will not allow any laboratory except its own to screen for mutations in that gene.

"Doctors and laboratories across the country face a lawsuit if they try to determine whether one of their patients carries this genetic predisposition to Alzheimer's disease, even though testing can easily be done by anyone who knows the sequence of the gene, without using any product or device made by the patent holder," wrote Andrews.

Such restrictions, she argues, inhibit research and degrade medical treatment because researchers and doctors cannot afford to purchase the necessary patent rights or pay the cost of either a lawsuit or a legal challenge.

Effects on research

There are other, subtler effects, according to Andrews and others. Most human gene patents cover sequences whose precise function and utility have yet to be determined. These isolated or purified gene products may lead to new drugs, treatments or medical breakthroughs, but perhaps not for decades.

"These patents are about control, about establishing boundaries for a product that doesn't yet exist, if it ever does exist," said Dr. Neil Thiese, a pathologist at Beth Israel Medical Center in New York and one of the nation's leading stem cell researchers.

In the meantime, critics suggest at least some patents impede research. One example is the search for the gene or genes related to autism. Two decades ago, scientists gathered DNA samples from affected children and families, but would not share them, fearing someone else might beat them to the patent.

Finally, in 1995, families of autistic patients founded their own group, Cure Autism Now, which independently raised millions of dollars to establish a DNA bank available to all interested scientists.

Patents can also scare away potential research interests, said Kalichman. Up-and-coming scientists tend to pursue areas of research where they can actually do research. If studying a particular topic means grappling with numerous, expensive patents and possible infringement lawsuits, they often choose to look elsewhere.

Wetherell, the attorney, said patent violations and related legal problems are not significant at the academic level, where much basic research is conducted. "Most companies with patents aren't going to go after the average professor doing research. There's just no profit in it. Where problems arise is between companies with competing commercial interests."

But Steven Briggs, a professor of biology at UCSD and former head of corporate research for Diversa, a San Diego-based biotech firm, said universities have become very savvy and aggressive about seeking patents for work done by their scientists. "I'd say the material transfer agreements we have are just as onerous as commercial versions. That's not being negative. UCSD is just as assertive about its patent rights."

THE FIX

Virtually everyone agrees that the U.S. patent system needs fixing. Virtually no one agrees on the scope of those fixes. There is legislation in Congress that would streamline the process and remodel it to be more in accord with patent systems elsewhere in the world. The U.S. Supreme Court has heard arguments on a potentially significant case involving two biotech companies that may or may not substantially reduce the scope of what's deemed patentable.

A couple of things, though, seem certain.

In Europe, patent policy includes consideration of "public ordre" or public morality. As a result, controversial scientific endeavors like human stem cell research, which are broadly opposed by Europeans, have been deemed unpatentable.

There is no similar clause in U.S. patent law, which has already ruled that human stem cells capable of differentiating into various kinds of cells (but not whole humans) may be subject to patent.

Also, whatever happens next, either in new court decisions or legislation, will not be radical. There will be no reversal of fortune.

"We're locked into this patent system," said Gold. "The question of whether genes should be patented was an issue 26 years ago. It's not practical to turn back the clock now because the whole system would have to be reinvented. The cost and disruption of doing so would be unacceptable."

Any change, Gold predicted, will be slow, tinkering and evolutionary.

A lot like life itself.
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