Biotech Values

[genisi]

On MYGN/BRCA patent war

Surrendering a Gene Patent: An International Twist in Myriad Debate

Posted by Dan Vorhaus and John Conley on September 29, 2010

http://www.genomicslawreport.com/index.php/2010/09/29/surrendering-a-gene-patent-an-international-twist-in-myriad-debate/

Several months ago we reported that a group of Australian plaintiffs had initiated litigation challenging the validity of Myriad’s Australian BRCA patents. Much like its U.S. counterpart, the Australian lawsuit represents a frontal attack on the patentability of genes.

Here in the U.S., the gene patent litigation shows no signs of reaching a swift resolution. Over the summer, Myriad appealed March’s widely-discussed district court ruling invalidating several of its key BRCA patents and claims, and the current appeal is unlikely to be the last, regardless of the outcome. In Australia, however, Myriad appears to be taking a different tack: offering to surrender its BRCA patent.

An Offer to Surrender. The development was first reported by the Australian news program Four Corners, which earlier this month ran a program (transcript) on the gene patenting debate and its impact on the availability of genetic testing in Australia. The program concluded with the following:

Three weeks ago, lawyers acting on behalf of Myriad offered to surrender ownership of its Australian breast cancer patent. In a letter obtained by Four Corners, the company stated:

‘Myriad wishes to gift Australian Patent No 686004 [the ‘004 Patent] to the people of Australia.’

Myriad’s critics argue it’s a cynical ploy to kill of [sic] any legal challenge in Australia which could bolster the New York court decision.

Significantly the company pointed out:

‘Myriad’s offer does not constitute an admission that the [‘004 Patent] is invalid.’

In the twists and turns of the genes war, the battle is far from over.

While the GLR has been unable to locate a complete copy of the letter, Myriad has filed with the Australian Official Journal of Patents an “offer to surrender” the ‘004 Patent, which claims “in vivo mutations and polymorphisms in the 17q-linked breast and ovarian susceptibility gene” (pdf).

The main claims in the ‘004 Patent (.pdf) largely track those of Myriads’ BRCA-1 patents that are at the core of the U.S. litigation. The primary difference is that the Australian patent’s claims are not directed at the normal BRCA-1 gene, but at a set of “bad” mutant or polymorphic versions of that gene. Despite this difference, the Australian claims still appear to be valuable for purposes of BRCA diagnostic testing.

Will Myriad’s Surrender be Accepted? Pursuant to Chapter 12, Section 137 of the Australian Patent Act, the Commissioner of Patents may accept an offer to surrender a patent from a patentee (i) “after hearing from all interested persons who…wish to be heard” regarding the proposed matter and, (ii) “where relevant proceedings in relation to a patent are pending,” only with “either the leave of the court or the consent of the parties to the proceedings.”

As in the U.S., the Australian litigation is being positioned by the plaintiffs as an opportunity to argue that genes, including the BRCA genes, are “not an invention capable of patent protection.” With the plaintiffs taking the position in the press that patenting genes is “morally wrong,” it seems reasonably likely that the plaintiffs might object to Myriad’s patent surrender, at least to the extent it moots some or all of their claims.

What about the Rest of Myriad’s Portfolio? Given that Myriad’s notice of surrender refers solely to the ‘004 Patent, the Australian litigation may go forward irrespective of whether Myriad’s surrender is successful. The company is also listed as either the sole patentee or a co-patentee on several related patents, including patents for a “method for diagnosing a predisposition for breast and ovarian cancer” (pdf) or for a “17q-linked breast and ovarian cancer susceptibility gene” (pdf).

These patents bear substantial similarities to those at issue in the U.S. litigation, and it is unclear – and seemingly doubtful – whether the surrender of the ‘004 Patent would materially impair Myriad’s (or its licensee’s) ability to control the market for BRCA testing in Australia.

What Happened to GTL? As we discussed in our earlier post, in 2002 Myriad granted an exclusive license to perform diagnostic testing in Australia and New Zealand of the BRCA-1 and BRCA-2 genes to Genetic Technologies Limited (“GTL”). (We note that GTL is not identified as a licensee of the ‘004 Patent or of the other breast cancer-related patents identified in the IP Australia database, although GTL has publicly discussed its exclusive license.)

According to reports, when GTL first licensed the BRCA intellectual property from Myriad, the company announced that it would refrain from enforcing its rights as a “gift to the people of Australia and New Zealand.” GTL briefly changed that policy in 2008, announcing a “commercial decision to enforce the rights granted to it under an exclusive license from Myriad.” GTL sent warning letters to government testing letters around Australia, only to quickly back off in response to substantial public outcry.

But as Myriad attempts to gift at least one of its BRCA patents back to the people of Australia and New Zealand, what are GTL’s rights and what, if anything, does it think of Myriad’s decision?

In a very brief op-ed earlier this year in The Australian, GTL’s CEO, Paul MacLeman, clarified that, contrary to popular belief:

In fact, [GTL] would materially benefit from any scaling back of genetic patent rights in this area, as we are the only entity paying for the right to use it even though the test is quite widely used.”

In light of this, it is possible that GTL and Myriad have taken steps to terminate the BRCA license. Or it may be that the license never applied to the ‘004 Patent at all.

Both scenarios are pure speculation, and neither explain Myriad’s apparent decision to pull back on only a portion of its Australian patent portfolio. For the moment, we do not know nearly enough about the rationale behind Myriad’s decision to attempt to surrender the ‘004 Patent while retaining its other patents.

What Does this Mean for Myriad in the U.S.? The simple answer is very little, particularly for the moment. As we wrote when the Australian litigation was first announced, the status of Myriad’s or any other party’s Australian patents is unlikely to have any direct bearing on the validity of Myriad’s U.S. patents. There has been some speculation, including by Four Corners, that Myriad’s patent surrender is a defensive gesture meant to “kill of [sic] any legal challenge in Australia which could bolster the [U.S. district court ruling].” However, given the differences in Australian and U.S. patent law, as well as the likelihood that the Australian litigation will proceed despite Myriad’s attempted surrender of the ‘004 Patent, this seems an unlikely – and at any rate, likely unsuccessful – strategy for Myriad to pursue.

Still, the Myriad gene patent litigation is about more than any specific set of patents or claims. It is an attempt, particularly by the plaintiffs in both the U.S. and Australia, to put the patentability of genetic information and associations on trial in the court of public opinion as well as in the courtroom. So perhaps Myriad’s decision is nothing more than a somewhat puzzling attempt at public relations maneuvering.

As we wrote in June when the Australian litigation was first announced:

…the new Australian case will be, at a minimum, a chance for that country to engage in a public debate over the wisdom and legality of patenting genes—which is exactly what is happening in the United States as a result of the ACLU litigation.

As the debate over the patentability of genes continues to rage on, its effects will be felt in the form of high-profile government investigations (e.g., the SACGHS gene patent and licensing report and the Australian Senate’s similar investigation), more closely observed and contested patent proceedings and myriad other ways beyond the courtroom, in the United States, Australia and around the world.