Up Next in Gene Patents: Waiting for a Ruling (Again) and SACGHS Meets (Again)
GenomeWeb has a recap of today’s hearing in the Myriad case, including the not-at-all-surprising decision that there was no summary judgment decision issued from the bench. From all accounts the case appears to have been argued along the lines set forward by the parties in their briefs, with no obvious surprises presented by either party during oral argument. As for a decision, according to GenomeWeb, “Judge Sweet did not say today when he expects to make a decision in the case.” Interested observers, including the Genomics Law Report, can expect to wait some time – at least several weeks, if not months – before a decision is handed down. That decision, no matter which way it falls, is likely to produce an appeal to the Second Circuit.
In the meantime, those that simply cannot get enough of the gene patent debate are reminded that the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) is convening again this week to finalize its report on biotechnology patent and licensing policy. As previously reported by the GLR, the last SACGHS meeting reviewed and approved several recommendations (pdf) from its Gene Patents and Licensing Task Force, including proposed exemptions from liability for infringing patents when (i) making, using, ordering, or selling tests for patient care purposes or (ii) “in the pursuit of research.”
While the SACGHS approved the recommendations, final review and approval of the Committee’s report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests was tabled until the February meeting. The recommendations and the draft report generated some pushback last fall so, Friday morning, the Committee will be reviewing those additional comments and “coming to closure” (pdf) on the report. The GLR will be listening in. Interested readers can find information about the SACGHS meeting here.
It seems to me that the ACLU could concede that isolated DNA is different from natural DNA and still have a strong case. The key would be to focus on utility. More specifically, there are three potentially patentable areas around isolated DNA:
1.) The process of isolating the DNA.
2.) The process of transforming the isolated DNA into bits (i.e. information).
3.) The process of transforming the bits into risk profiles (i.e. knowledge).
In this sense, patenting isolated DNA is equivalent to patenting patterns of bits. Both patterns of bits and isolated DNA really have no “specific, credible, and substantial utility” in and of themselves. From a public policy perspective, patenting isolated DNA would also retard investment in, and development of, the third type of process listed above (assuming that processes of the third type can surmount Bilski hurdles).
Matthew -
Thank you for the comment, but I disagree. First, isolated GENES (as opposed to, say, ESTs) clearly meet any historical utility standard. That’s a non-starter. Second, patent lawyers and their clients strongly prefer composition of matter claims to process claims (as a VC just emphasized to my biotechnology law class this morning). Third, of the three processes you identify below, only (3) would have any shot at novelty and nonobviousness. Finally, and most importantly, it’s highly unlikely in my view that the ACLU would make such a concession. They’re undertaking a radical frontal assault on gene patents–that’s the whole point of the litigation. To make the suggested concession would fatally undermine the case they’ve chosen to make.
- John
Yes, I agree that isolated GENES might have utility in so much as they are used in genetic engineering. For instance, one could easily claim that an artificial plasmid that codes for insulin is both novel and useful. In the Myriad case, though, the “isolated gene” is non-functional. Myriad makes no attempt to code a BRCA1 protein from the isolated gene and it is not even clear that the “gene”, as isolated by Myriad, even has any meaningful biological properties. Therefore, we are really dealing with isolated DNA from which inferences are made. I just hope that the ACLU is able to tease out these important distinctions.
One of the speakers at the Molecular Medicine Tri-Conference warned that limits on Gene patents for diagnostic purposes is a “slippery slope” for the Patent Office. The argument being “where do you draw the line, for example will image biomarkers be excluded from patent protection. Do you think there is any merit to this concern?