Published in The Hindu on April 8, 2010

Will purification of genes extracted from our body change their composition or character? Companies that are engaged in developing gene diagnostics believe so. Surprisingly, patent offices in the U.S. and Europe support this notion. That probably explains how thousands of genes making up nearly 20 per cent of the human genome have been patented.

Path breaking verdict

But a recent path breaking judgement by a New York City based District Court has set a precedent by invalidating or overturning all the seven patents that were named in the case on two genes BRCA1 and BRCA2.

Myriad Genetics, a Salt Lake City, Utah, based company along with the University of Utah, was holding 23 patents on the two genes. The number has been reduced to 16 following this judgement. The company has indicated its intention to appeal against the verdict.

Certain mutations in BRCA1 and BRCA2 genes can cause breast and ovarian cancers. This judgement has far-reaching implications for patients and researchers, and companies that are into gene diagnostics.

The Myriad was holding exclusive licence to sequence the two genes and study the sequences for mutations that cause breast and ovarian cancers. The monopoly meant that it limited both patients’ and doctors’ choice of an alternative test. Patients in the U.S., for instance, had to pay $3,000 for the test; it would have been cheaper had there been more players and more options.

Research stifled

Being an exclusive licence holder, the company had no incentive to invest in research to make tests more reliable and encompassing. That exclusive licences hamper research is well known. Researchers were hence a disgruntled lot.

For the above mentioned reasons, none was able to legally offer alternative tests using kits developed by other companies.

More choice

Apart from the implications for patients, doctors, researchers and companies, the judgement has set a precedent in invalidating gene patents. However, since the judgement was by a district court, its decision will not be binding on other federal courts.

The highlight of this judgement is the scientific way in which it went about to systematically reject each and every claim of Myriad’s.

Products of nature

For instance, since ‘products of nature’ cannot be patented, the company had to prove that the two genes were indeed different from those found inside our body. According to them, the mere act of isolating and purifying the gene taken from the body makes it very different from what is found in nature.

Interestingly, earlier judgments have clearly stated that “purification of a natural compound, without [doing anything] more, is insufficient to render a ‘product of nature’ patentable.”

In his verdict, Judge Robert Sweet cites the verdict of The American Wood-Paper company case. The American Wood-Paper had produced refined cellulose; it is nothing but purified pulp derived from wood and vegetable. The patent claim was hence turned down as it was seen to be a ‘product of nature.’

However, Parke-Davis was awarded a patent for its isolation of adrenaline which was in a salt form. Myriad had banked on this verdict to support its claim. While the verdict did clearly mention that purification alone is insufficient to become eligible for a patent, it awarded Parke-Davis a patent on the basis of “novelty;” adrenaline never occurs in a salt form in nature.

DNA molecule is unique

Another very significant outcome of the Myriad case is the rejection of Myriad’s claim that isolated DNA is “markedly different” from DNA found inside our body. The central premise of Myriad’s argument has been that isolated DNA molecules are much the same as any other chemical compounds. In other words, isolated DNA is the same as, say, oxygen.

“[Myriad] fails to acknowledge the unique characteristics of DNA that differentiates it from other chemical compounds,” Judge Sweet noted in his verdict. Explaining the uniqueness of DNA as a carrier of genetic information and for coding for proteins, the ruling notes: “…it would be erroneous to view DNA as no different from other chemicals.”

Undermined

These two observations have totally undermined the fundamental basis on which companies file a patent on isolated and purified genes. Even if this verdict is not binding on federal courts, the coming years will surely see more cases filed for invalidating gene patents.