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Gene patent decision on shaky ground

It sounds right yet defies natural logic

Can you patent genes? In Association for Molecular Pathology v. Myriad Genetics, the U.S. Supreme Court answered this imponderable question with a split decision: You can’t if they are naturally occurring, and you’ve simply discovered the gene; but if you’ve crafted a synthetic gene, you’ve invented it – and you can keep the patent. As sensible as this compromise sounds, it doesn’t reflect scientific logic. The court is trying to protect big pharma and our economy without offending basic principles of ethics and law. It may succeed in doing neither.

Thursday’s Solomonic decision is intuitive on the surface. On the one hand, as my 6-year-old daughter explained to me, “if you discover something, that means it was already there. And if it was already there, you couldn’t have invented it.” Patents are reserved for inventions, not naturally occurring phenomena.

On the other hand, the synthetic gene – in this case, a sequence of what is called “complementary DNA” that includes only those elements of the gene sequence that actually encode proteins – has some claim to having been invented, because it is not (exactly) naturally occurring.

Yet beneath the court’s formalist decision lies an attempt to reconcile the ethical principle that natural phenomena can’t be patented with the economic reality of the contemporary United States.

We increasingly rely on the products of intellectual property to produce goods that the rest of the world might want to buy.

If there were no patent available for gene identification, it would significantly reduce the incentive of big pharmaceutical companies to go after the basic science needed to identify genes and, potentially, create treatments for the diseases that those genes might cause.

The Supreme Court cut the genetic baby in half in the hopes of preserving that incentive.

The devil, as usual, lies in the details. Those details strongly suggest that the court’s distinction rests on very shaky scientific grounds – and can be explained more by political economy than by logic.

To simplify a modestly complex scientific process – as Justice Clarence Thomas skillfully did for a unanimous Supreme Court – the complementary DNA (or cDNA for short) is created by taking a naturally occurring messenger RNA molecule and, using ordinary nucleotide binding, turning it into cDNA.

The now patentable cDNA is different from the original DNA in that it omits those elements of the original sequence that do not code for protein formation (if you’re keeping score at home, these are called introns).

Notably, however, it is not the scientists who removed the introns from the officially unpatentable original DNA sequence to make the new, patentable cDNA sequence. It is nature itself, through the magic by which pre-RNA, which includes the introns, becomes messenger RNA, which does not.

The Supreme Court described this process by saying, “the pre-RNA is then naturally ‘spliced’ by the physical removal of the introns” – that is, the introns are removed as part of the ordinary process by which messenger RNA is created.

The role scientists then subsequently play is to take the messenger RNA and use it to synthesize the intron-free cDNA.

To put it much more simply, there is nothing that a 6-year- old would consider “invented” about the patentable cDNA. It is nothing more than the messenger RNA flipped into a DNA sequence that omits unnecessary elements that nature already excluded.

The sequence that codes the proteins is just as naturally occurring as the original DNA itself, which the court held couldn’t be patented because it was naturally occurring.

The distinction is, to put it bluntly, a lawyer’s distinction, not a scientist’s.

We are accustomed to disparaging law-office history. The Myriad Genetics case is giving us law-office biology.

But if the court’s formalism is a bit unconvincing, its desire to preserve something capable of being patented in genetic research makes a certain amount of sense.

For the Supreme Court to be too relaxed about defining intellectual property might send a global message that our government may not be vigilant about protecting intellectual property abroad.

It therefore makes sense for the Supreme Court to have found some mechanism for patent protection in genetic research, however tenuous or formalist the reasoning.

On the other side of the equation lie the concerns of ethics. It really would be too Orwellian if the court had allowed naturally occurring phenomena such as genes to be patented and thus owned, if only temporarily.

As philosophers Margaret Radin and Michael Sandel have argued, some things really shouldn’t be made into commodities, no matter what advantages might accrue from it – and our naturally occurring genes are surely such things. We should applaud the court for underscoring this basic principle.

At the same time, we should realize that the same court that produced an ethically appealing judgment also left room for private enterprise to play its role.

The baby has been split – or maybe spliced – in half. Let’s hope she survives, and that we do.

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