PATENTING GENOMICS INNOVATIONS:POST-MYRIAD CHALLENGES AND POSSIBILITIES . (original) (raw)

The Future of Gene Patents and the Implications for Medicine

JAMA Internal Medicine, 2013

, in Association for Molecular Pathology v Myriad Genetics Inc, the US Supreme Court unanimously ruled that naturally occurring genes cannot be patented. Synthetic transcripts of genes, however, can be patented. 1 The case involved patent claims covering BRCA1 and BRCA2; mutations in these genes are linked to an increased risk for breast and ovarian cancer. Both sides quickly claimed victory. Harry Osterer, MD, a clinician and one of the plaintiffs, declared that the Court's decision would help society "feel more of the impact of the genomics revolution." 2 The Biotechnology Industry Organization claimed that the decision left intact patents on the synthetic transcripts, "the commercially most important form of DNA used in biotechnology." 3 On the day the decision was announced, Myriad Genetics stock initially jumped 12% but finished down 6%. So what does this decision really mean, for both patent law and medicine? The Myriad decision concerned one particular legal doctrine in patent law, termed "patentable subject matter" or "patent eligibility." Simply put, a patent can be granted only to someone who "invents or discovers" a "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." 4 Historically, courts and the US Patent and Trademark Office have interpreted these terms broadly to encompass "anything under the sun made by man." This has not included "laws of nature," "natural phenomena," "abstract ideas," or "products of nature." 5 Yet, a famous 1911 lower court decision concluded that "products of nature" may constitute patentable subject matter if they were "isolated and purified" from their surroundings. 6 Precisely what constitutes a "product of nature," or the propriety of this "isolated and purified" exception, has long been a puzzle. Nonetheless, human genes have been eligible for patent protection since at least 1982 under the theory that they were "isolated and purified" from their surrounding chromosomes. The Myriad case is the first time the Supreme Court addressed this practice. In Myriad, the Court considered 2 types of patent claims for human genes. The first type covered "isolated genomic DNA," that is, DNA fragments of various sizes that have simply been removed from the surrounding genome. The second type were claims directed to "complementary DNA" (cDNA), specifically, reverse transcripts of messenger RNAs (mRNAs). The Court ruled that claims on isolated genomic DNA were not patent eligible-even if the genomic DNA were "isolated and purified" from the surrounding chromosome. Claims for cDNA, however, were patent eligible. The Court's decision primarily focused on whether either type of DNA existed as such in nature. Because the Court viewed isolated genomic DNA as a stretch of DNA simply excised from a larger chromosomal region, it con-VIEWPOINT

Myriad's impact on gene patents

Nature Biotechnology, 2016

A new study examines the impact of the landmark Myriad US Supreme Court decision for gene patents at its threeyear anniversary. It identifies some striking and unforeseen implications. "The lawless science of the law, that codeless myriad of precedent, that wilderness of single instances…" (Lord A. Tennyson 1809-1892).

Patents in genomics and human genetics

Annual review of genomics and human genetics, 2010

Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts-and sometimes fails to adapt-to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive post-discovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted p...

Patents in the Era of Genomics: An Overview

Recent Patents on DNA & Gene Sequences, 2012

The recent developments in biotechnology are the emerging science of "omics"-genomics, proteomics, transcriptomics and metabolomics. The state of the art sequencing technology has led to the deciphering of whole genome sequences of various microbes, plant, human and animals. The outcomes of genomics in the form of various genes, gene fragments, single nucleotide polymorphism, promoters and other regulatory sequences are a subject matter for patents based on its applications spanning agricultural, biomedical and industrial sectors. The patenting of genes and sequences is a debatable issue which has led to several controversies over recent years. With the accumulation of huge amount of sequences in various databases as a result of various genome sequencing projects worldwide, there is an immediate need for clarification of patenting genes and sequences. This review article gives an insight into patents based on development of genomics highlighting some of the patents based on deoxyribonucleic acid, genes, sequences and other related genetic material and gene technologies. Patents on single nucleotide polymorphism, stem cells, biomarkers for cancer diagnosis and treatment, microbial genes and plant genes are also discussed.

Invisible genomes: the genomics revolution and patenting practice

Studies in History and Philosophy of Science Part C: …, 2008

In the mid-1990s, the company Human Genome Sciences submitted three potentially revolutionary patent applications to the US Patent and Trademark Office, each of which claimed the entire genome sequence of a microorganism. The patent examiners, however, objected to these applications, and after negotiation they were eventually re-written to resemble more traditional gene patents. In this paper, which is based on a study of the patent examination files, we examine the reasons why these patent applications were unsuccessful in their original form. We show that with respect to utility and novelty, the patent attorney’s case built on an understanding of the genome as a computer-related invention. The patent examiners did not object to the patenting of complete genome sequences as computer-related inventions on moral grounds or in terms of the distinction between a discovery and an invention. Instead, their objections were based on classification, rules and procedure. Rather than patent examiners having a notion of a genome that should not be patented, the notion of a ‘genome’, and the ways in which it may be different from a ‘gene’, played no role in these debates. We discuss the consequences of our findings for patenting in the biosciences.