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Recent European Decisions on Breast Cancer Gene, hESC Patents Impact UURF, WARF

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A patent allowance and a patent rejection handed down in November by the European Patent Office directly affect a pair of prominent US research universities and, according to some industry insiders, may affect the availability of certain diagnostic tests and research tools based on the patents.
 
In the first decision, a technical board of appeal of the EPO has decided to allow a patent for diagnosing breast and ovarian cancer predisposition based on the BRCA1 gene — although in a severely limited form. The patent is based on discoveries made at the University of Utah and licensed exclusively to Myriad Genetics.
 
In the second verdict, the EPO’s Enlarged Board of Appeal has decided to disallow the claims of a patent owned by the Wisconsin Alumni Research Foundation related to the first isolation of human embryonic stem cells. The agency based its decision on the reasoning that European patent law prohibits the patenting of human stem-cell cultures whose preparation necessarily involves the destruction of human embryos.
 
Both decisions by the EPO are the agency’s final word on patent disputes begun years or even decades ago.
 
The BRCA1 decision involves EP 699754, which was granted in May 2001 to Myriad Genetics, the University of Utah Research Foundation, and the US government. The patent covers methods for using the BRCA1 and BRCA2 genes for diagnosing predisposition to breast and ovarian cancer.
 
The bulk of the claims of the patent, entitled "Method for diagnosing a predisposition for breast and ovarian cancer,” are based on research conducted at the University of Utah; thus, the school’s non-profit research foundation is the assignee. Myriad is the exclusive licensee of the patents.
 
Later in 2001, various research institutes national centers for human genetics in Europe filed an opposition to the patent, which led the EPO’s Opposition Division to revoke it. Myriad subsequently filed an appeal, requesting that its patent be maintained in a form that restricts its original claims.
 
Seven years later, the agency’s appeals unit handed down its decision by amending the patent. According to a statement issued by the EPO on Nov. 19, the patent will now relate to diagnostic methods for detecting a predisposition for breast and ovarian cancer caused by a specific group of mutations of the gene, so-called frame-shift mutations, but not missense mutations. It does not contain claims directed to the BRCA1 gene itself or to its mutated forms.
 
The patent cannot be further contested at the European level, the EPO said. The agency added that the full reasons for the decision will be published as soon as possible and made available online.
 
In a statement provided to BTW, Myriad said that it is “pleased with the [EPO] decision to uphold the European patents belonging to the University of Utah, related to the BRCA1 gene. The patents allow Myriad, as the licensee, further basis to invest in commercializing our molecular diagnostic product for breast and ovarian cancer in Europe, to bring these very important technologies to individuals with a history of breast or ovarian cancer.”
 

“The story is not over, I believe, but we support the licensee.”

It is unclear exactly how the patent decision will affect the University of Utah as details of any licensing agreements between the university and Myriad have not been disclosed.

 
However, Brent Edington, associate director of the University of Utah Technology Commercialization Office, told BTW that the university is “going to be supporting our licensee, Myriad. We’re going to be encouraging them to commercialize a product and reap the benefits of that.”
 
The university has not been directly involved with the ongoing EPO patent disputes, Edington said, but has been involved to the extent that it has “made sure the patents are prosecuted in Europe, the US,” and other regions of the world.
 
Edington added that as of now, the university is in a mode of “still watching. The story is not over, I believe, but we support the licensee.”
 
EP 699754 is not the only European patent in which Myriad or the University of Utah has a stake. A week before the EPO appeals division made its decision on the BRCA1 IP, its technical board of appeal decided to maintain in amended form European patent EP 705903, "Mutations in the 17q-linked breast and ovarian cancer susceptibility gene." The patent was granted in May 2001 and was considerably limited in 2005 after first-instance opposition proceedings.
 
Also, last year the board decided that EP 705902, relating to the BRCA1 gene itself, was to be maintained in a severely limited form. The patent is co-assigned to Myriad, the US government, and UURF, while EP 705903 is assigned to Myriad, Canada’s Centre de Recherche du Chul, and the Cancer Institute of Japan.
 
Reacting to the EPO’s BRCA1 decision, a group of geneticists from the Center for Human Genetics at the University of Leuven in Belgium and the Institut Curie in Paris said that “for a molecular geneticist, the latest decisions hardly make sense. Also, after seven years of discussing the content of these patents, the latest decisions do not appear to make it any clearer at all how the claimed inventions, which are limited to certain mutations and exclude other mutations, will have to be interpreted in practice.”
 
In its e-mail to BTW, Myriad said that it “welcomes the opportunity to speak with representatives of the national health systems in order to relate the ways in which Myriad's products can improve health care through offering potentially life-saving technology to their members while saving costs to the healthcare systems.
 
“It is important for us to point out that research activities with the patented technologies are not limited in any way by Myriad and are in fact encouraged through subsidized costs for testing from the company to researchers,” Myriad added.
 
‘Morality Issues’
 
In its second decision, handed down on Nov. 27, the EPO invalidated patents owned by the Wisconsin Alumni Research Foundation related to the isolation of human embryonic stem cells discovered by James Thomson of the University of Wisconsin. The agency said it based its decision on moral guidance dictated by European patent law.
 
The patent dispute began in July 2004 when the examining division of the EPO refused WARF’s European patent application No. 96903521.1 on the basis that certain claims — specifically those that dealt with isolating human stem cells from embryos — did not comply with a morality exclusion contained within the European Patent Convention of 1973, which provides a single, legal framework for granting patents.
 
WARF appealed the decision, and the dispute has traveled through several levels of the EPO. Last week, the organization issued its final word through the EPO Enlarged Board of Appeal, which decided that WARF’s patent application could not be awarded due to the fact that European patent law “prohibits the patenting of human stem cell cultures whose preparation necessarily involves the destruction of human embryos,” the EPO said in a statement.
 
The decision hurts WARF’s ability to generate revenue in Europe based on that IP, but the damage to the foundation will be minimal because the ruling is based on European patent rules that “are peculiar to Europe,” and there is no counterpart in US patent law; “therefore, the decision does not affect in any way WARF’s patent rights in the US,” WARF said in a statement.
 
Janet Kelly, WARF’s director of communications, added that the “vast majority of WARF’s licensing revenues” stem from commercial sales in the US, so the EPO decision will not impact revenues from the organization’s largest market. “And since this decision is just for one case filed in 1995, there should be no impact on patent applications for later-developed hESC technologies,” Kelly said.
 
Indeed, Geron, which licenses several related US patents from WARF, and has many other similar patent applications pending with the EPO based on its own internal research, said in a statement that that the EPO’s decision has a minimal impact on Geron, as well.
 
In a statement, the company said that the Enlarged Board of Appeals emphasized the fact that in 1995, when WARF filed the priority patent application, the only method of obtaining hESCs required the use of a human embryo. Since then, the company said, many hESC lines became available through stem-cell banks; therefore, the decision should not affect patent applications for later-developed hESC technologies, including those developed by Geron.
 
“While this result is not unexpected given the language of the EPC rule, given the narrow basis for the decision, it should have very limited impact on Geron’s ability to protect our hESC technologies in Europe,” David Earp, Geron’s chief patent counsel and senior vice president of business development, said in a statement.
 
“Importantly, the EPO did not rule that hESC technologies in general are not patentable in Europe,” Earp added. “We are optimistic that the EPO will now move to allow the backlog of Geron’s European patent applications that have been on hold pending this decision.”
 
For its part, WARF would rather see the patent allowed in the European Union, and Kelly said that the organization’s attorneys are “currently studying our options as we consider next steps. Until we decide upon what action to take, it is too early for us to discuss these options.”
 

One option is for WARF to pursue the patent in various countries within the EU or even outside of the EU, as not all countries in the union subscribe to the “morality issues” raised by the EPO. “It is possible in a number of countries,” Kelly said, adding that WARF has had several stem-cell patents issued in the UK and Sweden.

One option is for WARF to pursue the patent in various countries within the EU or even outside of the EU, as not all countries in the union subscribe to the “morality issues” raised by the EPO. “It is possible in a number of countries,” Kelly said, adding that WARF has had several stem-cell patents issued in the UK and Sweden.

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