THE battle on Patent rights is now poised to spill out of laboratories dealing with chemical substances to human bodies. Biotech companies are involved in a furious scramble to patent every bit of the human genetic structure. What was merely a trickle a few years back has become a virtual deluge. Drugs companies are applying for patents on genes and their functions with unprecedented speed.  And some of these patents are so far-reaching that, if granted, they could prevent anyone else from touching those genes to create drugs that act on them or even to test the genes for mutations in a patient. GENE PATENTS GENERATE CONTROVERSY
 
A recent controversy has erupted over a Patent granted to an US company (New Scientist, July 13, 2002) - Myriad Genetics - for a genetic test to assess the risk of breast cancer or cancer of the ovaries. The patent granted to Myriad allows it exclusive rights over the use of two genes BRC41 and BRC42 for diagnostic or therapeutic purposes. Myriad is using this to prevent other research institutions and scientists from carrying out tests for ovarian and breast cancers.
 
The patent that Myriad is armed with allows it to stifle research by potential competitors. The floodgates are beginning to open and other companies are following in Myriad’s footsteps. Athena Diagnostics, a Massachusetts subsidiary of Ireland’s Elan Pharmaceuticals has exclusive patent rights to several genetic diagnostic tests for neurological diseases like Alzheimer’s disease. The New Scientist in its report on the issue quotes a letter from Athena that was sent to an university laboratory, which states that it is only by using Athena’s facilities that other laboratories can offer this patented diagnostic test without infringing the patent.
 
WARNING SIGNALS
 
The story of Myriad is a warning of sorts for future trends in research and the effect of patents. Soon after being granted the US patents in the mid-1990s, Myriad successfully halted most testing being done by laboratories in the US.  The company allows only laboratories to conduct limited tests on the patented genes when they are ready to pay a fee to Myriad. However if researchers want to conduct tests that involve a full sequencing of the patented genes, Myriad insists that all samples are sent to its headquarters in Salt Lake City, US.
 
While, in keeping with the liberal acceptance of absolute patent rights in the US, Myriad faced little opposition in the US, controversies erupted when it tried to extend its exclusive right to other parts of the globe. The company is being boycotted in Canada, Netherlands, Belgium and Germany. The Curie Institute in Paris with support from the French government has challenged Myriad’s patents with the European Patent Office (EPO), arguing that Myriad’s unwillingness to let anyone else do full testing would establish a monopoly, damaging scientific research and the welfare of patients. The patents have also been challenged in Germany, the Netherlands, Belgium and Denmark.
 
Research facilities in universities are particularly upset because, hitherto, they have been used to operating without restrictions. For years, whenever a gene for a disease was published in a scientific journal, researchers running university laboratories felt free to devise their own diagnostic test for it.  Since many of the first gene discoveries that led to diagnostic tests were not patented, labs could offer their homemade test without fear of infringing anyone’s intellectual property rights. Things started changing when, in the 1980s, the US passed the Bayh Dole Act to encourage universities to patent their research results.  Labs were now required to pay for their in-house tests. This still allowed laboratories to perform the tests themselves. The entry of companies like Myriad has changed the whole scenario, and laboratories are now being asked to stop doing all tests that involve patented genes.
 
IMPLICATIONS FOR DRUG DEVELOPMENT

The present situation has other frightening implications. It is entirely conceivable that pharmaceutical companies shall try to duplicate the methods used by Myriad and Athena. What we are looking at is, thus, not just restriction on doing research on genetic material but also on creation of huge monopolies in drug development. A large number of patent applications are pending in patent offices across the globe that involve different genetic sequences. The next generation of drugs are likely to target specific genetic sequences, and this is what pharmaceutical companies are targeting. These sequences will be vital in development of drugs that can revolutionise medical treatment. In a sense patent holders will hold the key to the “gateway” to developing new drugs.

At the heart of the whole controversy lies a core issue - what is patentable matter. Many have argued that genes should never be allowed to be patented in the first place as they already exist in nature and therefore do not satisfy the basic criteria of involving an “inventive step”. Till recently the US had led attempts to enlarge the definition of what constitutes an invention. This had resulted in a virtual frenzy of patenting in the 1990s when companies filed thousands of patent applications for genetic sequences, even though they frequently had no idea what the genes did.

In January 2001, the US Patent and Trademark Office (USPTO) has tried to be less liberal by stating that applicants must prove that they have a unique, non-obvious use for a claimed gene, such as a diagnostic tool for a specific disease. This still is a liberal interpretation of what constitutes an inventive step, as even if new uses are discovered for genes they still remain “discoveries” and not “inventions”. Classically discoveries were not supposed to have been patentable - or else Columbus could have patented America when he discovered it! Unfortunately there has been a gradual blurring of the line between discoveries and inventions. We may be looking at a situation soon where companies not only have a 20 year monopoly over a drug they have developed but also complete monopoly over all research in that area.

EFFECT ON RESEARCH
 
It is important to understand that the effects of gene patenting on research are not limited only to raising the costs. There is a real possibility that such patenting can harm research in many ways. Evidence is available that once someone patents a gene, researchers interested in finding diagnostic tests or therapies based on that gene will shy away from it for fear of infringing the patent. Tactics, as used by Myriad can also harm clinical studies because of the monopoly it would have on research data. It is widely known that, often, different trials conducted on human subjects for the same therapy can come up with differing results. Incremental progress is made regarding the usefulness of therapies once data from a large number of trials can be compared. But if a company like Myriad has complete control over data because no body else is allowed to do research, the possibility of conducting different trials is negated. Even more dangerous is the possibility that a company that has monopoly over data will be tempted to suppress data that is inimical to the commercial interests of the company - viz. data that shows that a company’s product has unacceptable side-effects.

Even in the US such concerns are beginning to be voiced. A bill to modify patent policy has just been introduced in Congress, which stipulates that any scientist doing non-commercial research that involves patented genes should be exempt from a patent.  The Bill also says that medical researchers would be free to create their own tests for a patented gene without having to pay royalties on that gene. Corporates are opposing the passage of the Bill and may well succeed. The other problem about allowing non-commercial use is the fact that Universities across the world are increasingly tying up with Industry to conduct research. Soon, it may become difficult to categorise research in terms of its commercial use.

The bottom line is obvious. Today there is no evidence that suggests that patents promote innovation and increase the pace of scientific and technological advances. If anything, evidence exists to the contrary. Yet we have a situation where hitherto untouched areas are being opened for patenting.   It is necessary today, than ever before, to question the whole concept of patents.