Medical Device Daily Correspondent and Staff Reports

A group of European clinical and medical research organizations, fighting to overturn three patents exploited by Myriad Genetics (Salt Lake City) covering the therapeutic and diagnostic applications of the BRCA1 gene, say they have won another round.

The European Patent Office reported last month that it would modify the terms of the second pair of patents, nos. EP 705902 and EP 705903. EP 705902 protected the composition of a specific portion of the BRCA1 gene, as well as the corresponding protein and the potential therapeutic applications (including gene therapy, drug screening and diagnostic kits), while EP 705903 covered 34 specific mutations of the gene associated with increased propensity to breast and/or ovarian cancer that could be used for diagnostic tests.

The EPO now has ruled that EP 705902 has no claims related to “therapeutic and diagnostic methods“ and that EP 705903 has no claims “relating to diagnostic methods.“ The latter now relates to only one mutation of the BRCA1 gene — 185delAG, the deletion of two nucleotides. The EPO has not gone as far this time as it did in the case of an earlier patent, EP 699754, which it revoked outright in May.

While the group of institutions led by the Curie Institute (Paris) proclaimed victory, Myriad issued a statement asserting that “two amended patents add to Myriad's existing intellectual property on BRACAnalysis test.“ It did acknowledge that EP 705903 now relates to a genetic probe for only one mutation of the gene, albeit describing it as the “single most common mutation that occurs in BRCA1 in the Ashkenazi Jewish population.“

Dominique Stoppa-Lyonnet, the head of the Curie Institute's genetics department, who led the European campaign, said she believes the EPO's modifications break the monopoly that Myriad has enjoyed over diagnostic tests for predisposition to breast and ovarian cancer. “We are going to be able to develop our screening tests and improve them without fear of being attacked for counterfeiting,“ she said.

The right to carry out genetics tests and the price charged for them have been the main commercial issues at stake in this long-running case. The Curie Institute said that Myriad charges EUR 2,744 for its initial test of a genetic mutation of the BRCA1 gene in a family, whereas the cost in French laboratories is only EUR 914.

The patent-holder has two months in which to lodge an appeal against the decision. While Myriad gave no indication of any plans to do so, it technically no longer owns the patents. Although it was originally granted them, last November the company handed over its rights to both the BRCA1 and BRCA2 genes to the University of Utah Research Foundation (also Salt Lake City), which already was the co-owner of the patents covering BRCA1.

Three French institutions — the Curie Institute, the Paris public hospital authority and the Institut Gustave Roussy (Villejuif) — jointly filed successive objections to the three patents covering the BRCA1 gene in October 2001, February 2002 and August 2002, respectively. They were supported by the French Hospital Federation, France's National Federation of Anti-Cancer Centers, the Dutch and Austrian health ministries, and human genetics companies and research organizations in 11 European countries.

Particle therapy solution coming to Europe

Siemens Medical Solutions (Concord, California) reported the upcoming installation at the University Clinic Heidelberg (Darmstadt, Germany) of the first Siemens particle therapy solution in Europe. The company said the system, which will be capable of treating tumors with both carbon ions and protons, is expected to begin treating patients in 2007.

The treatment facility will include space for three rooms that can treat patients with carbon ions and protons, as well as facilities for about 80 support staff who will handle patient care and logistics, as well as research and development. Siemens said the facility is expected to treat at least 1,000 patients each year, mostly on an outpatient basis, with the primary treatments involving tumors located in the brain and prostate, as well as soft-tissue sarcomas.

The use of particles such as carbon ions and protons provides treatments that are highly accurate and have a high biological effectiveness, according to Siemens. The particles are accelerated to a very high speed by a variable energy accelerator and then are deposited directly into the tumor, where they cause irreparable damage to the tumor cells while sparing the normal surrounding tissues.

“With this step, we have met the important technical prerequisites that allow us to begin treating patients with tumors that up to now have been considered to be incurable,“ said Imtraut Gurkan, director of administration of the University Clinic Heidelberg. “By using different particle therapies, a wider variety of tumor sites may be treated.“

New translational medicine partners

Affymetrix (Santa Clara, California) and the Karolinska Institute (Stockholm, Sweden) said they have entered into a strategic alliance designed to improve healthcare by accelerating the translation of basic genetic research into tools for better diagnosis, prognosis and treatment.

Over the next five years, the projects to be undertaken under the alliance — part of the Affymetrix Translational Medicine Initiative — include genetic analyses and measurement of gene expression in patients with atherosclerosis, breast cancer, rheumatoid arthritis, asthma and dyslexia.

Affymetrix and the institute said systematic use of the genomic information obtained would enable development of new and better clinical methods and drugs, thus reducing mortality and improving quality of life for patients suffering from these diseases.

The translational medicine research projects will use sufficiently large sample sizes to establish true clinical relevance of both gene expression and DNA sequence variation in key areas of unmet medical needs.