Bacterium creator's patent opens legal can of worms

Bacterium creator's patent opens legal can of worms

Critics argue that patenting of genetic material and higher forms of life should not be allowed.

Throughout history, people have patented a range of unusual items, from light bulbs to lasers. But a bacterium?

A landmark 1972 case, in which a young General Electric researcher was eventually awarded the patent for an oil-eating bacterium, set a precedent for patenting other forms of life that are human-made or modified.

Four decades later, the creator of the genetically-modified bacterium will speak here on Wednesday at a conference by the Intellectual Property Office of Singapore (Ipos). It is about current trends in life sciences patents - and whether patentable biological inventions can treat or even prevent cancer.

In 1971, Dr Ananda Chakrabarty, then 33, was hired by General Electric's research centre in New York State to work on ways of turning cow manure into protein-rich animal feed, using bacteria to break down compounds in the manure.

But he was also interested in getting bacteria to break down hydrocarbons, long carbon-and-hydrogen chains found in many organic substances such as petroleum.

Catastrophic oil spills such as the Torrey Canyon spill off the coast of the UK in 1967 caused severe environmental harm and were hard to clean up.

So after hours and on weekends, Dr Chakrabarty would work on his hydrocarbon project, and by 1972, had cobbled together a bacterium whose genes produced enzymes that broke down oil.

"We applied for a patent because GE management thought that all useful and novel inventions should be patentable. Since GE was not a biological company, it did not take into consideration the fact that living things, like bacteria, could not be patented as living things were considered products of nature and therefore not patent eligible," Prof Chakrabarty said.

The company's lawyers argued that the bacterium, though alive, had been significantly altered through genetic engineering techniques to improve their oil-consuming characteristics.

The US Supreme Court agreed and granted Dr Chakrabarty a patent in 1981. But as the scientist had left GE by then, the firm did not try to market the bacterium.

However, the ruling gave a boost to the fast-developing fields of genetic engineering and other biotechnology - and opened up a legal and ethical can of worms.

On one hand, patents provide incentives for firms and scientists to carry out research and development, and their inventions can potentially help many people.

And Prof Chakrabarty, now at the University of Illinois, argues that stronger patent regimes can boost developing nations' economic growth.

He founded Indian cancer-drug firm Amrita Therapeutics, whose goal, he said, "is not so much to make the drug affordable, but so effective that people worldwide will buy them, even at a high price, so that (Amrita) will make money and pay appropriate taxes to the Indian government".

On the other hand, not everyone agrees that something existing in nature, even if modified, can be patented.

"It is not clear how much modification is required to make something sufficiently different from its 'natural' state," said intellectual property law scholar Burton Ong of the National University of Singapore.

So the most sensible way out is to permit patents on processes or methods, such as testing for diseases, rather than asserting patent rights of the genes themselves, he said.

But what if the genetic material is hard to distinguish from the test used to find it?

Take for example the Myriad gene test. US firm Myriad Genetics developed tests for two gene variants which carry high risks of breast cancer. Until the US Supreme Court overturned its patent last year, the only test available for these gene variants was its proprietary US$4,000 (S$5,000) one.

Prof Chakrabarty disagreed with the ruling. While the genes themselves should not be patentable, he said, testing for those specific mutations is "not only novel but of great utility", and should be patentable.

There are more issues: If a patented drug is very expensive, how will low-income patients or those in poorer countries access it?

What if biological samples are collected from developing countries, used by developed ones for drug or vaccine development, then sold back to those developing nations at a premium?

Even different regions have different patent regimes. For instance, in the US, anything made by man is patent eligible, making genetically modified foods, plants and animals patentable inventions, while the EU forbids patenting of higher forms of life under a public order or morality clause.

In any case, said Associate Professor Ong, patents are only one part of a legal framework.

"The patent grant itself does not give you positive rights to exploit your patented invention. For example, if you have a patent over a weapon, you might be prohibited by firearms control laws from selling or using your weapon."

So countries' biomedical ethics regulation plays a role in determining how patents are exploited, he said.

In Singapore, overall patent filings have risen by 20 per cent in the last decade, from 7,908 in 2003 to 9,722 in 2013.

While Ipos did not give numbers for biotechnology-related patents, it said there was roughly a ten-fold increase in the number from 2001 to last year.

"This is a strategic industry sector that Singapore is focused on and intends to grow," a spokesman said.

Firms here typically apply also for patents in larger markets such as the US or Europe.

Prof Chakrabarty remains optimistic about patents' potential here as well as abroad.

"I... believe that certain intelligently designed bacterial proteins with both cancer therapeutic and cancer preventive activities can be further developed in Singapore in a way that will be very different than the currently used highly toxic chemotherapeutic drugs," he said.

"To quote US President Abraham Lincoln, the holder of a patent, 'the patent system provides the fuel of interest to the fire of genius'."

This article was first published on Aug 24, 2014.
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