Update on Gene Patents (June-Dec 2009)

Here’s an update by Rachel Goh, a medical student at Melbourne University  and who works at the Centre for Eye Research Australia. She helps us regularly on MBS & IPRIA research projects.

In the six months since June, a cornucopia of events urging both for and against gene patents have unfolded. Issues highlighted by IPRIA+CITE’s public forum in April continue to feature in government and media debate. Just last month, the Federal Circuit decided that the Supreme Court’s 2006 decision in eBay v. MercExchange eliminated the presumption of irreparable harm associated with the ongoing infringement of a patent. In the case of Prometheus v. Mayo, the Appeals Court ruled to restore diagnostic patent rights. This favors Myriad and the University of Utah; as of now, no party has prevailed in the BRCA1-2 gene patent lawsuit filed against the University of Utah and Myriad Genetics in May, and the District Court rejected a motion to dismiss the lawsuit. Bilski v. Kappos is still pending, expected to be decided by the Supreme Court in mid 2010. Until the crunch comes, we expect uncertainty to remain over the U.S. practice of granting patents on human genes.

Amidst fears that a rising number of human gene patents may be impeding medical advance as well as rights to their results, the Australian Parliament launched a Senate Inquiry. Up for examination in early August was the way companies have been filing “umbrella” patents and – allegedly – abusing the patent system in a bid to control the “blueprints of life”. While the Committee digests the Senate inquiry’s 75 submissions, the Biotechnology Industry Organization (BIO) took issue with the Secretary’s Advisory Committee’s (SACGHS) draft report examining how patenting and licensing affect access to clinical genetic testing in the US. The SACGHS reported that patents neither greatly hinder nor facilitate patient access to genetic testing, but added that problems do occur when patents are exclusively licensed to a single provider and no alternative is available. However, courts have been changing the thresholds for what can be patented, and how strongly patents can be enforced. Ultimately, the report may signal that the US government is taking action to foster beneficial uses of genetic testing while preserving intellectual property incentives. In claims contrary to this, BIO derided the report’s recommendations as over-reaching and restrictive, disregardful of research which shows that without patent protection, commercial investment in biotechnology research would falter and medical advances would be impeded. November came and went, along with the due date for the Senate report. The Committee has extended its reporting deadline to March 18, 2010.

Interviews with twenty researchers early last year showed divided opinions about the impact patents have on the research environment. In the last decade, studies have been similarly inconsistent about whether gene patents impede the development and availability of diagnostic testing. A recently published study by Murray and Huang provides the first large-scale systematic evidence for the negative impact of patent grant on downstream public knowledge; the negative impact is especially severe for disease-linked genes as they have greater commercial potential, stronger patent enforcement and exhibit ownership fragmentation. Since then, an empirical study by van Overwalle et al. on the granting for litigation of gene patents has reported that, though this is true, not many blocking gene patents exist and thus, a blanket ban on human genes is not a plausible solution. This view was supported by Holman in Science. These two studies, among others, suggest that reforming patent laws may be a better alternative. The most important change proposed is to ensure each patent is of appropriate scope and strength, rather than absolute patent protection, such as “patenting cures and not DNA” and exempting the use of naturally occurring genetic sequences for medical research from infringement liability. Thus far, research indicates that this may preserve commercial interests in biomedical research as well as availability of genomic diagnostics for public health.

Stay tuned for future updates.

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