The Case of Myriad Genetics (Vs. an array of National

Government Funded European Union Research Institutes)

Amir Zaher

UC Berkeley, Senior

Department of Mechanical Engineering

IEOR 190G Patents in Engineering

Center for Entrepreneurship and Technology

(In addition to addressing Patents in Technology, this presentation will also briefly discus Ethics in Patented Technology.)

Introduction to Myriad and its patents

• BRCA-1 and BRCA-2 are two genes linked to susceptibility for breast and ovarian cancer.

• The risk of falling ill increases if these genes show certain mutations.

• Myriad Genetics, in collaboration with the University of Utah, were the first to sequence the BRCA-1 gene, and applied for patent protection in 1994.

• In the mid-90’s, Myriad obtained nine US patents on the two genes, BRCA1 and BRCA2, and received right over a number of mutations in the genes.

• The Patent also applied to the use of diagnostics tools designed specifically to isolate mutations indicating a predisposition for breast/ovarian cancer.

• In Europe, they were granted three patents covering: • -cancer-related mutations• -different methods of testing for those mutations• -the gene itself.

Years Later…• The European Patent Office revoked the Patenting of the two

genes in 2004.

• Opposition was filed by, to name a few among others: • Switzerland’s Social Democratic Party; • Greenpeace Germany; • the French Institut Curie; • Assistance Publique-Hôpitaux de Paris; • the Belgian Society of Human Genetics; • the Netherlands, represented by the Ministry of Health; • and the Austrian Federal Ministry of Social Security

• The BRCA-2 patent was already filed for by the charity Cancer Research UK in the EU

• The BRCA-1 patent was deemed to lack novelty, inventive steps towards industrial application, and failed to disclose the “invention” sufficiently for a person skilled in the art to carry out the procedure (based on the European Patent Convention’s patentability criteria)

• Furthermore, errors in the original patent application had not been corrected until the gene sequences were in the public domain. Thus, the invention had not been fully disclosed, and was not novel by the time the invention was fully described in the amended application.

Screening Technology, Methods, and Implications

• Myriad’s diagnostics tools were designed to find so-called "frame shift" mutations showing a predisposition for breast and ovarian cancer.

• The company created different kinds of diagnostics tool kits, marketed first in the US then in Canada.

• The frame shift mutation tested for occurs when there are too few or too many DNA building blocks, or nucleotides, in a genetic sequence, throwing off the ability of a gene to produce proteins.

• The medical benefits of the cancer screening technology weren’t disputed. The controversy is about how patent systems should recognize such technology and how patents on such medical technology should be exercised.

The Myriad Case outcome in 2008

• The decision handed down by the European Patent Office, after Myriad’s appealing, granted a more restricted form on its previously granted patents.

• The patent only applies to diagnostics tools to find the “frame shift” mutations.

• To quote from the opposition, "The problem in the Myriad case is not that they have a patent, but that they abused their monopoly," said Dominique Stoppa-Lynnet, professor of genetics at the Institut Curie in Paris (who launched the legal challenge against the company in 2004).

Ethical Dilemmas

• The case highlights the ongoing policy debate on: -the patenting of human genes, -the patenting of genes used in diagnostics, • Because, such patents may constrain further

research on developing new tests and diagnostic methods

• And more specifically, can hinder access to testing.

Key Facts to bear in mind:• Biotech companies began patenting genes and genetic material in the 1980s.

• More than 20 percent of the 24,000 human gene patents granted since then have been in the United States.

• A gene inside the human body cannot be patented. However, once it is identified, removed and isolated, a company can apply for exclusive rights to exploit it for commercial purposes.

• Only a handful of countries -- including Brazil and Chile -- do not allow patents on genes in any form.

• (AFP, Physorg.com)

Class Question

• Let’s think about it together, what do we really need to look at when trying to solve issues related to patents in technology used for medical advancements and the pursuit of human health? Is this fundamentally a governmental or institutional responsibility?