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In Australian BRCA Patent Challenge, Plaintiffs Not Satisfied With Myriad's IP Gift

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Originally published Nov. 1.

By Turna Ray

Even though Myriad Genetics
has offered to surrender one of its key BRCA patents in Australia, the company may still be unsuccessful in squelching a challenge to the patent-eligibility of isolated genes following a request by opponents to broaden the scope of an ongoing gene-patenting suit.

Plaintiffs challenging Myriad's 686,004 BRCA1 patent in the Australian federal court have recently applied to amend the lawusuit to include additional BRCA patents held by the diagnostics firm.

Following a March ruling by a US federal district court that several of Myriad's BRCA patents covering its flagship BRACAnalysis test were not patentable, a cancer patient group challenged Myriad's 686,004 patent, which covers certain BRCA1 mutations, in the Australian federal court. The defendants in the Australian case also include '004 patent holders Centre de Recherce de Chul in Canada and the Cancer Institute in Japan, as well as exclusive license holder Genetic Technologies.

Plaintiffs bringing the Australian challenge against Myriad have structured their arguments similarly to plaintiffs in the US court case and are arguing that isolated gene sequences cannot be patented since they are products of nature and are not markedly different from genes sequences in the body (PGx Reporter 06/16/10).

In August, Myriad sent a letter to the plaintiffs — Cancer Voices Australia, the law firm Maurice Blackburn, and breast cancer patient Yvonne D'Arcy — offering the '004 patent as a "gift … to the people of Australia." Legal experts have interpreted the move as an attempt on Myriad's part to ensure that legal determinations about the patent eligibility of isolated DNA by foreign courts do not erode its standing in the US, where Myriad is challenging the district court's decision about its patents in the US Court of Appeals of the Federal Circuit.

However, a lawyer working with the plaintiffs in the Australian patent challenge told PGx Reporter this week that the plaintiffs have applied to expand their lawsuit to include two additional patents on BRCA genes held by Myriad. The two patents are Australian Patent No. 691,331, covering a "method for diagnosing a predisposition for breast and ovarian cancer," and Patent No. 691,958 for a "17q-linked breast and ovarian cancer susceptibility gene."

The plaintiffs have filed an application to extend the patent challenge "because leave of the court is required to amend the pleadings and join new defendants," Luigi Palombi, director of the Genetic Sequence Right project at the Australian National University and a gene patenting scholar, told PGx Reporter this week. Patents '331 and '958 list Myriad, the US Department of Health and Human Services, and the University of Utah as co-owners.

Even though these additional patents involve a US government entity as a co-owner,Palombi noted that the plaintiffs decided to move to amend their complaint before the US Department of Justice made its position on gene patenting known.

This week, the DoJ submitted an amicus brief in Association for Molecular Pathology et al. vs. the United States Patent and Trademark Office et al. in the federal appeals court. In the brief, the DoJ agreed with the district court's decision that isolated genes occurring in the body are not patent eligible. However, the government body disagreed with federal district court Judge Robert Sweet's decision that composition claims on cDNAs, which researchers must generate in a laboratory as a tool for biotechnological and diagnostic applications, are also not patentable (see related story).

"The Australian plaintiffs had, prior to the US government's position becoming known, broadened the patent challenge to include the other two BRCA patents co-owned by Myriad and the US government," said Palombi, who is working with plaintiffs to craft the challenge against Myriad's BRCA patents in Australia..

The Australian federal court is slated to hear the motion on Nov. 24. Myriad and its law firm Jones Day have not yet responded to the plaintiff's motion to broaden the scope of their litigation. The defendants can either consent or oppose the application.

After the Australian federal court hears the motions later this month, it may decide to grant the plaintiffs' application to amend the complaint or end the case by accepting Myriad's surrender of the '004 patent.

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