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The patent system has contributed greatly to genomics. More than 25,000 DNA-based patents were issued by the end of 2000 (1), covering purified and cloned gene fragments and full-length genes, [...]

A 2004 REPORT, BIOTECHNOLOGY RESEARCH in an Age of Terrorism, recommended that Institutional Biosafety Committees (IBCs) review research for biosecurity and 'dual use' potential, to prevent nefarious applications such as [...]

The article 'NIH invites activists into the inner sanctum' by Bruce Agnew (News Focus, 26 Mar., p. 1999) brings to mind the wisdom of the National Science Foundation in abandoning [...]

The author discusses an August 2012 decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) on the Association of Molecular Pathology (AMP) vs. U.S. Patent and Trademark Office (USPTO) and Myriad Genetics lawsuit regarding the patenting of BRCA cancer genes. The CAFC ruled that engineered DNA could be patented, but the judges disagreed about the patentibility of isolated DNA molecules found in nature. The author also looks at the pending appeal to the U.S. Supreme Court.

The article discusses the implications for research, innovation, business, and patients of a U.S. Supreme Court decision that the breast cancer (BRCA) gene is not patentable. Topics include the Court's unanimous decision on June 13, 2013, in the case of the Association of Molecular Pathology (AMP) v. Myriad Genetics, that genes and the information contained within them, called genomic DNA (gDNA), are not patent-eligible subject matter, the patent eligibility of complementary DNA (cDNA), which are DNA molecules synthesized in a laboratory, and the impact of the Court's ruling on diagnostic service monopoly models, such as Myriad Genetics'. Also discussed is Myriad Genetics' genetic test for mutations of BRCA 1 and 2.

The article discusses health services research in the U.S. The author notes that the U.S. spends more money per capita on health care than any other nation and argues that despite the criticism of the metrics used by the World Health Organization (WHO) to rank global health care, health care in the U.S. is expensive, unfairly distributed, and inefficient in comparison to other developed economies. Topics include a discussion on ways to address problems within the U.S. health care system without affecting areas of health research infrastructure that are working well, such a restructuring the U.S. National Institutes of Health (NIH), who should take charge, and how health services research will be funded.