When the Bush administration came in and Todd Dickinson left his post as director of the US Patent and Trademark Office, there were approximately 10,000 outstanding gene-based patent applications. Early patents of this type tended to be full-length sequences; now, most focus on ESTs or SNPs. Since April, Dickinson hangs his shingle at the law firm Howrey Simon Arnold and White, where he’s a partner dealing with IP. GT’s Meredith Salisbury caught up with him to find out about guidelines, evaluations, and patent pooling.
In a Congressional statement, you said: “One of the key tenets of our patent system is that it is technology-neutral; from gearshifts to genomics, it applies the same norms to all inventions in all technologies.” Why is that important?
Dickinson: Because the standard of patentability — whether something is novel, whether it is fully disclosed — is something we can apply universally. In the legal sense, certainly in the last 50 years, that has benefited the system by keeping a standard approach; politics didn’t matter.
How does the patent office evaluate genomic patent applications? What are some of their challenges?
Dickinson: We have over 500 PhDs in the patent office; most examiners are or do become experts in their field of examination.The current application process takes just under 24 months.
The biggest challenge is in keeping up with the growth. So far, they’re keeping ahead of the patent applications. The office had one application recently filed that would have been 400,000 pages long if it were printed out. The fee revenue keeps being diverted — the Bush administration is proposing taking $207 million out of about $1.3 billion in revenue.
The time the patent office takes and the quality of the patents issued becomes compromised. Another recurring problem, for example, is that applicants fail to fully provide all of the sequence data. If people would take more care to submit the complete sequence data when they first file, that would significantly speed up the process.
The guidelines for gene-based patent applications were recently made more stringent. Why? Was it enough?
Dickinson: One of the key issues that was raised recently — on ESTs, for example — was whether the disclosed use was sufficient enough to meet the standard made under section 101. We had guidelines for the examiners which were revisited in view of some cases from the courts. We asked for public comment from the NIH and others. Many suggested that we take a more rigorous standard, which we did. Now, the use has to be substantial, specific, and credible.
There will also be test cases that will work their way up the system and through the courts to see whether these guidelines are sufficient. We raised the bar as far as we could based on case law. Utility is usually a low threshold.
From the patent perspective, what’s your outlook on this industry?
Dickinson: One possibility is patent pooling to ease the problem of patent layering, i.e. multiple licenses. The electronics industry has used that for a long time. There’s a real opportunity in the genomics industry to do the same thing, and I’m hopeful that that’ll happen. It’s usually led by the industry. If not, there may be room for the government itself to look into this.
I think genomics companies have to be very mindful of the public’s reaction. The public’s reaction — particularly in human genomics — is pretty visceral at this point. Fortunately, the major genomics players have been aware of this and have been very responsible. I’m more worried about the company that owns one or two patents that happen to be in a key area.