Universities and biotech company smacked down in gene patent case

In a major reversal last week, a U.S. appeals court threw out a broad patent that covered a human gene that is central to many biological processes. The patent had been granted in 2002 to Harvard, MIT, and the Whitehead Institute for Biomedical Research, and until this week, it looked like a gold mine for Ariad Pharmaceuticals, which licensed the patent from the academic institutions.

I’ve made no secret of my opposition to patents on human genes. No one invented our genes, and no one should be given exclusive rights to any gene, or to all the drugs that might depend on a gene – by inhibiting or facilitating its action, for example. The patent in question is a “pathway” patent: it covers any drugs that modulate the gene NF-kB (nuclear factor kappa B), a protein that was discovered in 1986 by scientists at MIT and the Whitehead Institute for Biomedical Research, led by Nobel laureate David Baltimore.

NF-kB is an incredibly well-studied gene that is central to human biology. A search of the PubMed database reveals over 30,000 scientific articles on this gene. NF-kB controls the process by which DNA is copied to make genes (transcription), which means that it is critical to a wide variety of cellular processes. It also plays a key role in our immune system’s response to infections. So in effect, granting a patent on NF-kB is akin to granting a patent on all drugs that affect nearly any human gene. What a great patent! Control NF-kB, and you control the world – well, at least the pharmaceutical world.

The Chronicle of Higher Education reported on the latest decision this week, while most major media outlets missed it. Back in 2006, when Ariad won the original lawsuit, the New York Times and CNN (among others) both reported that a federal court ordered Eli Lilly & Co. to pay $65.2 million in royalties to Ariad Pharmaceuticals. In addition to this large cash award, Lilly was ordered to pay a 2.3% royalty on future sales of Evista, an osteoporosis drug, and Xigris, a drug for septic shock.

Ka-ching! This victory appeared to be a jackpot for Ariad. All it did was license the patent from the academic institutions – it didn’t actually produce any drugs based on the patent. Ariad and the academics filed a lawsuit against Eli Lilly on the day the patent was granted. Make no mistake, this patent was purely about greed.

The original ruling threatened many other companies besides Eli Lilly. For example, Amgen challenged the patent after the 2006 ruling, worried that its rheumatoid arthritis drugs Enbrel(R) and Kineret(R), would also be affected.

The patent itself, which can be found here, is incredibly broad. Its first claim, for example, is for any method “inhibiting expression, in a eukaryotic cell, of a gene whose transcription is regulated by NF-kB.” This language covers hundreds of other genes beyond NF-kB – and this is merely the first of 203 claims in the patent!

No, I am not a shill for Big Pharma, even though a big company is the winner here. (See some of my blogs attacking Big Pharma here and here, for example.) The NF-kB patent is a clear example of why we should not allow patents on human genes, and at the same time it illustrates how greedy university tech transfer offices are all too happy to apply for any patent they can, provided they see a profit in it. The presidents of Harvard, MIT, and the Whitehead Institute should never have filed this claim, and I’m delighted that the courts have done the right thing in striking it down.