High Court Skeptical That Biotech Firm Can Patent Human Genes

Supreme Court justices seemed to express skepticism Monday that a biotech company can patent human genes isolated from the body that signal a greater likelihood of ovarian or breast cancer. The biotech industry has warned that a broad ruling against such patents could endanger billions of dollars in investment.

Los Angeles Times: Supreme Court Seems Opposed To Granting Patents On Human Genes
The Supreme Court took up a deceptively simple question in a case brought by breast cancer patients and medical researchers: Are human genes patentable? The answer appeared to be "no" during Monday's oral arguments. The justices signaled that they probably will bar any grants of exclusive and profitable patents on human genes that prevent other scientists from testing these pieces of DNA (Savage and Terhune, 4/16).

The Wall Street Journal: Justices Wary On Gene Patents
Monday arguments underscored the difficulty of distinguishing between those innovations that can be protected and scientifically significant discoveries that may not be eligible for patents -- even ones that seek to unlock the mystery of the human genome (Bravin, 4/16).

Reuters: Justices Wary Of Wide Human Gene Patent Ruling
The Supreme Court justices on Monday signaled reluctance to issue too broad a ruling about patents on human genes, and some indicated they might seek a compromise distinguishing between types of genetic material. The biotechnology industry has warned that an expansive ruling against Myriad Genetics Inc could threaten billions of dollars of investment (Hurley, 4/15).

Politico: SCOTUS Case: Can Genes Be Patented?
Several Supreme Court justices seemed sympathetic to claims that genes themselves do not warrant patent protection during arguments Monday in a landmark intellectual property case that could determine whether genes should be in the public domain. But during the arguments in Association for Molecular Pathology, et al. v. Myriad Genetics, the justices repeatedly took refuge in metaphors of baseball bats and chocolate-chip cookies rather than the hard science of DNA (Norman, 4/15).

Philadelphia Inquirer: A Patent On A Gene Stirs High-Court Musings
Molecules and chocolate-chip cookies, baseball bats, and Amazonian tree sap were all part of a spirited Supreme Court discussion Monday as the nine justices wrestled with the question of whether one should be able to get a patent for a human gene. If you slice up pieces of microscopic molecules, have you created new ones or just separated existing body parts, not unlike kidneys or livers, which are products of nature and not usually granted patents? And, more important in this matter, can you profit by preventing others from researching those molecules or providing lower-cost testing services? The justices seemed to be looking for a compromise in Association for Molecular Pathology v. Myriad Genetics Inc. AMP was part of the original group of plaintiffs that represented researchers, including two from the University of Pennsylvania, patient groups, and six women, including one from Williamsport, Pa., with breast or ovarian cancer or a family history of either (Sell, 4/16).

Medpage Today: Gene Patents Spark Debate In High Court
Supreme Court justices lobbed hard questions Monday about whether a company could patent isolated human genes in a case that looms large in the personalized medicine arena. During arguments before the court, several justices expressed doubt that Myriad Genetics could rightfully patent segments of human genes BRCA1 and BRCA2, genes in which mutations are indications of increased risk of breast and ovarian cancer. Products of nature aren't patentable. Only inventions are, but Salt Lake City-based Myriad argued that because the genes have been isolated from the body, they are no longer a product of nature and can be patented (Pittman, 4/15).

In the meantime, drugmakers are using an interpretation of safety laws to block generic versions of their drugs --

The New York Times: Drug Makers Use Safety Rule To Block Generics
For decades, pharmaceutical companies have deployed an array of tactics aimed at preventing low-cost copies of their drugs from entering the marketplace. But federal regulators contend the latest strategy -- which relies on a creative interpretation of drug safety laws -- is illegal. The Federal Trade Commission recently weighed in on a legal case over the tactic involving the drug maker Actelion, and earlier this month a federal suit was filed in another case in Florida (Thomas, 4/15).

In other drug industry news --

The Wall Street Journal: High Court Rejects Glaxo Appeal In Avandia Case
The U.S. Supreme Court on Monday cleared the way for health insurer Humana Inc. to sue GlaxoSmithKline for the recovery of health care expenses on some patients who were allegedly harmed by diabetes drug Avandia. The high court, in a short written order, said it wouldn't consider a Glaxo appeal of a lower-court ruling that allowed the Humana lawsuit to proceed (Kendall, 4/15).

Politico: Meningitis Deaths Fuel A Renewed FDA Debate
Food and Drug Administration Commissioner Margaret Hamburg will be on the hot seat Tuesday as she tries to defend the agency's failure to stop a fungal meningitis outbreak last year that killed more than 50 people. The episode mostly fell from the headlines as the deaths tapered off but is roaring back with the hearing on the Hill. Many Democrats in Congress want to give the FDA more authority to regulate compounding pharmacies like the one linked to this outbreak. But some Republicans question whether the agency failed to properly use the authority it already had, and the key House panel didn't put the issue on its list of legislative priorities for the year (Norman, 4/15).

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