Myriad Gene Patent Litigation Goes Down Under
On Tuesday, June 9, 2010, several plaintiffs, including a breast cancer patient and a cancer advocacy group, sued in a Sydney, Australia federal court to invalidate Myriad Genetics’ patents on the breast cancer susceptibility genes BRCA-1 and 2. According to published reports and comments by Australian patent law experts, the suit substantially tracks the much-publicized one filed in New York by the American Civil Liberties Union. In particular, this suit is also a frontal attack on the Myriad patents, seeking a judgment that genes in isolation from the body are products of nature and thus not patentable inventions.
The factual background in Australia seems a bit different. Myriad has granted an exclusive license to perform BRCA gene tests to a Melbourne company called Genetic Technologies Limited, which is a co-defendant in the case. But GTL has been reported to have “gifted” its patent rights to health care institutions, and not to charge royalties. Nonetheless, the plaintiffs’ lawyers have expressed concern about the possibility of GTL exploiting their monopoly as in the U.S., where the tests cost over $3,000. They note that on two earlier occasions GTL sent letters to hospitals telling them to stop testing. A number of Australian sources have also worried aloud about the implications of the patents for medical research.
In a technical sense, the case will have no direct effects outside of Australia. The general principle of international patent law is “non-extraterritoriality”—a jaw-breaker that means simply that a patent is enforceable only within the boundaries of the country that issues it. So even if the Australian courts ultimately invalidate the Myriad patents, that will not affect their status anywhere else. Plaintiffs who want to challenge the patents will have to do so country-by-country.
But as is so often the case with legal issues (fortunately for lawyers, and unfortunately for their clients), the situation is more complicated on a practical level. First, there is a partial exception to the country-by-country rule: the European Patent Office in Munich. There is still no such thing as a true “European patent” (the European Union has been working on it for years), but the EPO will examine applications under a single standard for patentability (established by a treaty called the European Patent Convention) and issue what it calls a “bundle” on national patents. That is, you can designate the countries in which you want your patent to be effective—say the U.K., France, and Germany—and the EPO can issue you a bundle containing a British, a French, and a German patent. Although you have to go to the individual countries to sue infringers, some challenges to the patent can be brought in the EPO. The Myriad patents have a long and complex history in the EPO, with the net result that they have a narrower scope than in the U.S.
A second point is that the Australian court system is well-regarded throughout the world, so a decision against the patents there could influence courts facing the same issue elsewhere—even though it wouldn’t bind them. Even the U.S. Supreme Court, which has long paid little or no attention to foreign precedent, has been citing foreign legal authorities more frequently in recent years.
The final point relates to the potential business strategy of competitors of companies like Myriad. Assume that a U.S. company wants to include genes patented by others (Myriad or someone else) in a broad-based diagnostic testing program. One approach would be to seek a license from the patent-holder. But there is an alternative: do the testing in a country that doesn’t recognize the patent. U.S. patent law (like that of almost every country) forbids making, using, or selling the patented invention within the U.S. There are some circumstances in which U.S. law can reach foreign activities (such as when the infringer sells parts of the invention from the U.S. to be assembled abroad), but under the present state of the law it would probably not be infringement to test patented genes abroad and send the results back to the U.S. The more countries that invalidate the patent, the more places there are to execute this strategy.
So 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. But in the long term it could serve to undercut the practical value of gene patents everywhere.
So you could spit in a cup, mail to Australia, and get the test results?
Will this all be a non-issue when people have their DNA sequenced? How hard would it be to setup a server in the Cayman Islands that allows people to upload their DNA sequence and give them an answer?
Hard to believe the legal system would be useful for enforcing the patent laws because it would be so easy for consumers to get around it.
Kevin: without commenting too specifically, there are difficulties associated with trying to conduct activities off-shore in an effort to avoid existing patents. First and foremost may be the difficulty of finding a jurisdiction with (a) sufficient biotechnology infrastructure to conduct this sort of testing and (b) a patent system that is either hostile or indifferent to the patents one is seeking to avoid. That may become easier, as you suggest, as some services transition to pure bioinformatics operations, but I do not know if it will ever be a trivial task.
One additional note. A guest post on the Patent Docs blog indicates the Australian Senate is preparing a report on the impacts of gene patents. It appears to be somewhat similar in nature to the SACGHS gene patent report released earlier in the year in this country. This is a good reminder that in Australia, as here, the most expedient (if not, perhaps, the most likely) route to changing the biotechnology patent landscape is unlikely to be through the judicial system.
Regardless, my concern is that someday, someone who has patented a gene and/or its therapy uses it to gain custody of a child due to unlicensed reproduction of their intellectual property because said gene was not the “naturally occurring” one the parent was born with, not that this would happen in the US.
That was very informative and well written. Mentioned below is an article on gene patent debate:
“The amicus brief submitted by the Department of Justice (DOJ) in the Breast Cancer Gene patent appeal before the Federal Circuit has drawn great attention during the last week. A US District Court had earlier rejected isolated gene sequence claims in Myriad’s patent stating that they do not satisfy the patentable subject matter requirement because they are products of nature. Aggrieved by the decision of the District Court, Myriad appealed to the Federal Circuit. The Department of Justice has filed an amicus brief before the Federal Circuit stating that the District Court’s opinion was right with respect to genomic DNA sequences. As the DOJ’s opinion is very persuasive, it has once again brought the gene patent debate to life.
The DOJ has clearly pointed out in its brief that cDNA sequences, vectors, recombinant plasmids and chimeric proteins are patentable but the genomic DNA sequence, which exists in human body is not patentable. As per DOJ, merely isolating the exact sequence as it exists in the body does not merit patent protection as it amounts to product of nature. The DOJ has in its brief logically pointed out that isolation of such a sequence and identifying the fact that it encodes a protein that causes breast cancer, which is a natural relationship, is not sufficient to make the sequence patentable.”……read more at http://www.patentpill.com/2010/11/gene-patent-debate-is-alive-again.html