Molecular Medicine: Send in the lawyers (3 of 3)

One of the most interesting aspects of this conference on molecular medicine was a couple of sessions about intellectual property (IP). IP is the mother’s milk of the life science industry. What they have that is really of value is what they know and know how to do. Those intangibles are the gold assets of the industry just as the formula for Coke is for the Coca-Cola Co. Since know-how has the evanescence of all information, the way it is protected, locked-up, and allocated is through patents and other intellectual property laws. Biotech companies need to understand and manipulate the law and economics of IP as much as they need to understand the dynamics of macromolecules. They hire patent attorneys the way movie stars hire bodyguards.

It turns out that there is a controversy—perhaps “conflict” would not be too strong a word—about how to frame patent laws in the life science field. The opposing positions were on display in the sessions of this conference. As the old saying goes: “Where you stand depends on where you sit.”

Starting more than a decade ago the US Patent and Trademark Office (PTO) began issuing patents that, in effect, allowed the patenting of genes. There was controversy from the beginning about whether or not the discovery of a molecule found is nature was something that ought to be patentable. One objection was the principle of the thing: should we allow the patenting and exclusive use of a piece of nature, a piece of life? But the PTO, after rulings by the US Supreme Court, decided that grating patents for gene sequences and similar cellular products was a way to stimulate the discovery of more genes and gene technology, consistent with the purpose of patents.

The practice is still in place, but it has never stopped being controversial. At this time there’s significant debate within the life science industry itself. One reason is because of someting I referred to in an earlier post: the industry is now dealing with polygenic diseases. It was one thing when the assumption was that most diseases were related to one or two genes. A company could license the gene from the patent holder at reasonable price and move on with development. It’s another thing when trying to unravel and affect ever more complex biological systems. If it’s necessary to look at dozens of genes and perhaps produce products that involve many of them, then things become both more complicated and more expensive. The charge has been made that the fragmentation of gene ownership is “strangling” research and is strangling the development of products to deal with complex diseases such as cancer.

One viewpoint is that genes and naturally occurring molecular products found in cells should not be patented but that any tools, techniques and drugs that make use of those things should be patentable. This position was argued by an attorney from a large company that makes gene chips—arrays of molecules on a chip-like surface that can detect evidence of the presence of specific genes. This company now makes a single chip that contains indicators for all 30,000 known human genes. But for them to make a chip that can survey the whole genome—without doubt a great asset to genomic research and drug development—they have to deal with a quagmire of legal and financial arrangements. To make this product they have to do what is called “patent stacking.” They liken patenting genes to patenting the elements of the periodic table to the first discoverers. What if every time you wanted to make a product with iron or hydrogen or even do chemical research using those elements you had to pay a royalty to the holders of the iron and hydrogen patents? They say there is more than enough money for everybody to get rich in making products that use the genes. They propose that genes, haplotypes, SNPs, gene expression sequences, and other naturally occurring molecules not be patentable, or, if patented, they should be put into a “patent pool” for easy and reasonably priced patenting.

Of course, there’s another position. There are those who say that to incent the discovery of yet unknown basic molecules the PTO has been doing the right thing. Guess who they are? Yes, the pharmaceutical companies and biotechs who got on the bandwagon early and already own such things. It’s unfair to pull the rug out from under them, they say. Also researchers who think they can discover additional important natural molecules want to be able to cash in on their finds. They say that unless they can lock in the intellectual property of future discoveries, they can’t get investors to back their research.

After the debate about this at the conference, something interesting happened. I went up to the woman from the gene chip company and told her I thought she had made an excellent, understandable presentation and that I’d like her card in case the ACS was interested in hearing about the effect of IP matters on cancer research. She said she’d be glad to meet with me or to make a presentation to the ACS. After I wandered away, a patent attorney for a large pharmaceutical company with the opposing view who had evidently overheard my previous conversation cornered me and said she too would be pleased to talk with me about the issue. With two business cards in-hand I promised to talk with both of them to be able to present both sides of the story. Fair and balanced, that’s my policy.

IP is a very complex issue and the description above is over-simplified. What’s more, it grows more important daily in this world where knowledge is increasingly what’s of value. What is good IP? How do you give incentive to create it? How to you protect it so people get compensated for it? How do you run the system so that progress doesn’t grind to a halt in a litigious battle over IP? (If this sounds vaguely familiar it’s possibly because the recording industry has been fighting Internet music users tooth-and-nail over similar issues for years now. Let’s hear it for disruptive technologies!)

Regardless of which position you favor, it is evident that intellectual property law plays a very real role in the process of researching the basis of cancer and of bringing the results of that research to the world.