Biotech Patents under Attack from Two More Angles

Judo FightTwo 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.

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Filed under Badges, Direct-to-Consumer Services, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

Duke Finds a Second Alzheimer’s Gene—What Does It Mean?

Genetic CodeThe recent discovery of a gene linked to Alzheimer’s disease provides a timely context for revisiting the significance of gene patents. Researchers at Duke University Medical Center recently announced that they have identified a second gene (called TOMM40) associated with an increased risk of late-onset Alzheimer’s, which affects people over the age of 65. A team of Duke gene hunters originally identified the first Alzheimer’s gene (APOE) in 1993. Although the announcement prompted warnings about the need for further confirmation, the Duke researchers hope that the analysis of which versions, or alleles, of the two genes that people carry will significantly sharpen geneticists’ ability to predict susceptibility to Alzheimer’s. Those predictions might prove especially useful in both diagnosing Alzheimer’s disease and in developing future Alzheimer’s drugs.

One of the first questions on everyone’s mind, particularly in light of the high-profile lawsuit by the ACLU and others against Myriad Genetics, is whether this newly discovered Alzheimer’s gene could be patented. In principle, yes.  Going back at least to the early 1980s, the U.S. Patent and Trademark Office (US PTO) and the federal courts have repeatedly taken the position that genes in isolation from their natural environment (that is, outside the body) are patentable subject matter, just like any other chemical compound. Individual cases have turned on such specifics as whether others had previously identified the gene, or whether and when the patent applicant or others had first disclosed the gene. But there is no general prohibition against patenting genes.

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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Uncategorized

Whole-Genome Sequencing and Gene Patents Coexist (For Now)

Test Tubes 80In a recent post, John Conley analyzed the ACLU’s lawsuit challenging Myriad Genetics’ patents on the BRCA-1 and BRCA-2 “breast and ovarian cancer susceptibility” genes. Several readers responded with the same general inquiry: if an individual undergoes a whole-genome sequence analysis, will the individual (or the company providing the sequence) be required to pay royalties to Myriad because the BRCA-1 and -2 loci will have been sequenced?

Although focused on the BRCA genes, the question is broadly applicable to the entire genome sequencing industry: when sequencing all or a portion (e.g., the exome) of an individual’s genome, are individual gene patents infringed upon by either the company providing the sequence or the individual purchasing or requesting it? The answer is not entirely clear, but, at least in the case of Myriad and the BRCA genes, it appears to be no. Or at least, not yet.

Let’s begin with what is not patented, which includes a majority of genes and the vast majority of the human genome. Genes—those stretches of DNA that encode for proteins—make up approximately 2% of the human genome. The estimate of the exact number of genes ranges from between roughly 20,000 to 30,000 and, of those, a 2005 study in the journal Science found that only 20% of human gene DNA sequences are patented (subscription). Although those numbers are certainly subject to change, the reality is that, today, it is likely that less than 1% of the entire human genome has been patented.

Of course, that very small number belies the fact that the genes which have been patented consist of some of the most important identified genes associated with the prediction or determination of human health and disease. The high-profile BRCA genes are an excellent example and thus make for a good case study.

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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation