Five Questions for Personal Genomics in 2010
Death, taxes and January prediction columns: these things are inevitable. So what? A new year offers a convenient—if arbitrary—time to review the year that was and contemplate what lies ahead. Without further ado, here are five of the questions the Genomics Law Report is asking as we kick off 2010.
1. Will the $1,000 genome live up to the hype? Affordable whole-genome sequencing is coming, possibly as early as this year depending on whom you ask. But when the day inevitably arrives, after the media frenzy has subsided, will the $1,000 genome prove anti-climactic?
Whole-genome sequencing is a means to an end and not an end in itself. The understandable excitement surrounding Complete Genomics’ November announcement that it had sequenced three genomes for an average cost of $4,400 often neglected to focus on what the price tag did not cover: the substantial costs associated with interpreting the genomic data.
For genomics researchers, the falling cost of whole-genome sequencing is a continuing cause for celebration, enabling increasingly ambitious research projects. But the success of personal genomics, which is what really matters to consumers, patients and healthcare providers, requires more than inexpensive genomic data. The real breakthrough in personal genomics will come when we can offer individuals affordable access to their whole-genome sequence as well as to the genomic tools and knowledgebase necessary for those individuals to put that data to use.
Bilski and Biotechnology: The Supremes Speak Up
The Supreme Court heard oral argument in the Bilski case yesterday (pdf of full transcript). The Justices’ questions evinced unmitigated hostility to Bilski’s claim on a method of hedging commodities risks, and to business method patents generally. Detailed analysis of the oral argument is available from ScotusBlog, Patent Docs and Blawg IT. The decision in Bilski will have far-reaching consequences for patents on methods of analysis, data interpretation, and performing certain tasks, and at the GLR we have several times noted the potential significance of the case for biotechnology patent law.
The Justices may not be reading the GLR (or are they?), but they are well aware of Bilksi’s potential implications. In argument, Justice Sotomayor commented that if the Court upheld the Federal Circuit’s Bilski decision she would “have no idea what the limits of that ruling will impose in the computer world, in the biomedical,” but expressed concern that upholding Bilski’s machine or transformation test could “destroy industries” by “shoe-horning technologies that might be different.” And Justice Ginsburg, while remarking that Bilski “could be decided without making any bold steps,” conceded that “we know that things that we haven’t yet contemplated may be around the corner, and when they happen, we will deal with them.”
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Biotech Patents under Attack from Two More Angles
Two developments this month have underscored the breadth of dissatisfaction with the current state of biotechnology patenting, even as the court weighs a summary judgment motion in the pending ACLU-sponsored litigation against Myriad Genetics’ breast cancer gene patents. First, on October 2, 2009, the American Medical Association and four other medical organizations interested in genetic medicine filed an amicus brief in Bilski v. Kappos, which is now before the Supreme Court. In a decision in Bilski late last year, the Federal Circuit rejected a patent on a method of hedging in a commodities market because it was a nontransformative process consisting solely of mental steps. The Federal Circuit promulgated what has come to be known as the machine-or-transformation test, which limits patentable subject matter to processes that are either tied to a particular machine or transform the state of matter. The test has been attacked by various biotechnology and pharmaceutical interests because of its perceived limiting effect on patenting diagnostic techniques and tests.
Prometheus and Medical Methods Patents
On September 16 the Federal Circuit decided a patent case called Prometheus Laboratories Inc. v. Mayo Collaborative Services (pdf). Prometheus sued Mayo for infringing two patents on a method of optimizing drug therapy for autoimmune diseases. The question in the case was whether the method met the patentable subject matter standard of section 101 of the Patent Act, as interpreted in the Federal Circuit’s 2008 In re Bilski decision (pdf) (which is now before the Supreme Court). The patentable subject matter standard is an initial threshold that must be crossed on the way to patentability. To satisfy the standard, the claimed invention must be within the broad categories of things (machines, manufactures, compositions of matter, or processes/methods) that the Patent Act permits to be patented. If not, the inquiry ends; if so, the invention must still be shown to be novel, useful, and nonobvious. This is the standard that the ACLU has focused on in its motion for summary judgment in the Myriad Genetics case, which we have been following closely.
