By Crispin Hull

YVONNE D’Arcy’s win in the High Court against a pharmaceutical giant has been widely applauded.
But it may not be such a victory for the underdog as first portrayed.

It would be unfortunate if the case resulted in pharmaceutical companies contracting their gene-research programs. It would mean cures and treatments for sufferers of a great range of genetic disorders would be unnecessarily delayed.

In the case, patents held by Myriad Genetics were revoked. Myriad sought to patent the isolated parts of the BRCA1 and BRCA2 genes, defects in which are a sign of greater risk of breast cancer.

The court said that the isolated parts were not patentable because they were exactly the same as what is found in the human body and therefore not a “new manner of manufacture” as required by the Patents Act.

With a patent, Myriad would have the exclusive right to test for the BRCA gene or be able to charge others who do the test.

Mrs D’Arcy argued it was a “David and Goliath” battle. "I'm only a little person, but it's not the size of the dog in the fight, it's the size of the fight in the dog," she said.
And the media lapped it up.

Myriad had spent huge amounts of money and research effort in developing the process of isolating and testing for the gene. Its difficulty lay in the fact that none of the methods used in isolating the gene parts was new. So, although the method of isolating is a “manner of manufacture”, it is not a “NEW manner of manufacture”, and so not patentable.

Their only hope for a reward for their efforts was to seek a patent on the isolated genetic material itself. That hope is now lost.

Myriad and other genetics companies might well say we are not going to waste our money doing that sort of work again.

Mrs D’Arcy and others argued that it was not right for a company to have a patent over something which is part of the human body. The hint was that it was somehow unnatural. Again, the media lapped it up.

But the patent sought was for an isolated part of the gene – not a gene in the human body. It is not possible (at least at present) to test genes in the body.

The telling point against Myriad was that, if granted, a patent over the isolated genetic material itself might prevent its use in other unrelated medical treatments. It might be very difficult to determine what might be an infringement. 

It may well be that genetic research goes on because companies will find ways of getting patents for the uses to which they put the unpatentable genetic material.

But in the case of BRCA the critical use is in just knowing the sequence. 

Several legislative attempts to ensure genetic material was not patentable have failed. In committee hearings the evidence was that this would not cause research to dry up.

Even so, if a company puts in enormous cost and effort to do something really useful like testing for susceptibility to breast cancer, they should be rewarded.
But the High Court specifically ruled that out as one of the elements of the patent system.

It quoted with approval a statement that the Patents Act was “an act of economic policy the objectives of which were the encouragement of industry, employment and growth, rather than justice to the inventor for his intellectual percipience”.
It is as if reward for the inventor is a by-product of the system not an essential element.

The other side of this coin is that when pharmaceutical companies get a patent they exploit it mercilessly. And they try all sorts of tricks to extend the monopoly. One trick is to try to keep the research upon which the patent is based secret for as long as possible. That prevents competitors developing generics during the term of the patent so they are ready the moment the patent expires. It flies in the face of the public policy to make the invention public as the price for the period of the monopoly rights.

Research secrecy is one of the areas of dispute in the Trans-Pacific Free Trade Agreement.

The companies also try to build up a brand name for a drug so that patients, doctors and pharmacists use that name for the drug rather than a chemical name. That way it gets bought more often.

Another way is to seek further patents for different delivery systems for the same drug.

The best way to stop price gouging by patent holders is for government to use their market power when they buy in bulk for their universal health-insurance schemes like the Pharmaceutical Benefits Scheme in Australia. If there is no such scheme, patients are held to ransom – pay up or suffer and maybe die.

This is why drug prices are so much higher in the US, even if many of them were invent and manufactured there.

So the patents system, which began in 1624 with the English Statute of Monopolies, can be an all-or-nothing affair.

But the patents system is a bit like democracy -- the least worst way of encouraging innovation and making new technology available to all.

Its just that in medical cases when a company does research with such obvious major benefits it should get some reward even if it falls foul of nearly 400 years of jurisprudence in a system that otherwise holds up fairly well.