What Makes Genes Patentable?

By Veronique Greenwood | August 5, 2011 12:39 pm

genes

What’s the News: Whether genes can be property is an ongoing controversy in the world of biotechnology, and last week saw the latest court battle in that war: Upon appeal, a suit brought by the ACLU charging that genes aren’t products of human ingenuity and thus cannot be patented was settled largely in favor of Myriad Genetics, the biotech company that has patents on two BRCA genes. The genes are linked to hereditary breast and ovarian cancer, and plaintiffs charged that Myriad’s exclusive test for the genes kept patients from getting second opinions.

A detailed description of the court’s reasoning can be found over at Ars Technica. But for those of you who are thinking, what? someone else can own my genes?, chew on this: About 20% of human genes are patented or have patents associated with them, according to a comprehensive analysis. Here’s why.

What Are the Rules for Patenting Genes?

  • The general description of what’s patentable lays out a few guidelines: (1) It’s got to be useful. (2) It’s got to have something new about it that’s not already known by experts in its field. (3) It can’t be obvious—it can’t be logically deduced by someone with average knowledge of the field—and (4) it can’t be naturally occurring. As far as exactly what items are considered patentable, intellectual property cases are constantly amending that.
  • Molecules and compounds from the human body or human cells, as long as they are altered somehow or took some ingenuity to extract, have been patentable for more than 100 years. A process for purifying human adrenaline, for example, was patented in 1906.
  • In 1980, the first living thing was patented, and the patent was upheld in the landmark Diamond v. Chakrabarty case. Chakrabarty, an engineer at General Electric, had bioengineered a bacterium that could eat oil spills, and the act of tinkering with an organism’s DNA, the court found, made his organism patentable. After that, patents on genes themselves weren’t too big of a leap.
  • Gene patents can consist of ways to isolate, synthesize, or alter a particular gene or gene product, as well as diagnostic tests that detect the gene’s presence. Notably, they can also consist of the sequence of the gene itself, if the patent office finds that it was arrived at through an act of ingenuity.
  • At least as far as the US patent authority is concerned, extracting a gene from a cell is ingenious enough to count, and to boot, once removed from its context, the gene is legally considered no longer in its “natural” state.

They’re Controversial Because:

  • It’s generally agreed that if you make a new version of a gene yourself, or come up with a process involving the gene that no one else would have thought of, you should certainly be able to patent it.
  • Where things gets fuzzier is when the act of isolating, synthesizing, or sequencing a gene, or the naturally occurring gene sequence itself, are the subjects of patents. What was once considered ingenious may no longer be, as isolating genes gets easier and more routine. And laying claim to an actual sequence of DNA that you’ve extracted from a cell, just on the grounds that getting it out is an act of invention, has come under fire as a legal game.

This Case is Important Because:

  • An earlier ruling on the case seemed to overturn decades of case law that upheld gene patents. In 2010, using precedent set by the Funk Brothers case, which found that just combining natural biological products wasn’t sufficient invention for a patent, the judge found that Myriad’s patents were without base (read our analysis here). It was worrisome for biotech companies, many of whom had built their businesses on gene patents.
  • This new ruling, by an appeals court, let Myriad keep the patents on the genes and on certain processes involving them, but held that the part of the test where a patient’s gene is compared to a control genome could be done by anyone with that information, and thus can’t be patented.
  • Although this ruling is mostly in Myriad’s favor, it’s worth noting it’s far from a unanimous support for gene patents. One of the three judges was very much against the ruling, and one who went along with it had serious qualms. Expect more gene patent lawsuits in the future.

The Future Holds: It’s likely that another round of appeals will follow, and you can bet biotech companies will be paying close attention. If this has piqued your interest, try following Genomics Law Report, a biotech trade blog with that keeps track of developments in gene-related cases.

Image: Wikimedia Commons

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