A recent lawsuit involving patents on human genes related to cancer brought against the United States patent office, a biotechnology company and a foundation has attracted international attention to the issue of gene patenting, and on 27 August a group of influential associations voiced their opposition to such patents.

The American Civil Liberties Union (ACLU) with the Public Patent Foundation in May filed a lawsuit against the patenting of two human genes associated with breast and ovarian cancer. They claim the patents are unconstitutional and invalid as they are impeding research that could uncover cures and are limiting women’s choices concerning their medical options, according to the ACLU website.

The lawsuit, filed on behalf of four scientific organisations, individual researchers, health groups, genetic counsellors and individual women, targets the US Patent and Trademark Office (USPTO), biotechnology company Myriad Genetics, and the University of Utah Research Foundation, which now holds the patents on the two genes.

A set of patents were granted to Myriad Genetics by the USPTO on the genes known as BRCA1 and BRCA2.

It is generally accepted that certain mutations on the BRCA1 and BRCA2 genes would induce higher risk for developing hereditary breast and ovarian cancer. Invalidating the patents would enable research, testing and clinical practice involving those two genes, ACLU argues.

On 27 August, the American Medical Association, the American Society of Human Genetics, the American College of Obstetricians and Gynecologists, the American College of Embryology, and the Medical Society of the State of New York filed an amici curiae brief in support of the ACLU’s action. In the brief, they seek to provide the court “with insight into the adverse effects on medical care and innovation that gene patents cause.”

The ACLU action is a much broader case than simply challenging some patents – it is about gene patents in general, according to Shobita Parthasarathy, co-director, science, technology and public policy programme at the University of Michigan. What is remarkable, she told Intellectual Property Watch, is that they have been able to get the support of a number of organisations and have mobilised a lot of people around the issue to support their challenge.

According to the ACLU, about 20 percent of all human genes are patented in the United States.

The ACLU argument that it is unconstitutional to extend patent law to human genes might not hold in court, said Richard Gold, professor at McGill University and chair of the Innovation Partnership, an international expert group on biotechnology, innovation and IP. That’s because the US Congress did not make the decision but the USPTO did, based on language by the courts.

“Courts have upheld gene patents in several suits,” he said, and it is unlikely that this case will turn out differently and swing the tide against patents on human genes.

On 13 July, the USPTO, the University of Utah and Myriad Genetics filed motions seeking to dismiss the legal action on gene patentability, arguing that the complaint should be dismissed for lack of subject matter jurisdiction. “The patent system has worked exactly as it was designed to do,” Myriad said in the motion. (USPTO motion available here; Myriad-Utah motion available here.)

Different Path in Europe for the Myriad Patents

In 2001, Myriad Genetics was awarded several patents in Europe concerning genes BRCA1 and BRCA2 for their mutations and testing on those mutations. But Dominique Stoppa-Lyonnet, head of the genetics department at Curie Institute in France and professor of medical genetics at the University Paris-Descartes, discovered by developing her own method that the patented test was missing 10 percent of mutations, according to the Curie Institute.

In order to automate the process to carry out a large number of tests, Myriad “neglected” those mutations, Stoppa-Lyonnet said.

Along with several other institutions, the institute appealed the patents, also later appealed by several European genetic companies, and supported by the European Parliament. The patents were totally or partially cancelled by the European Patent Office in 2004 and 2005 but Myriad appealed those decisions. In November 2008, the University of Utah Research Foundation patent was partially upheld for the method of “diagnosing a predisposition for breast and ovarian cancer caused by certain mutations of the human BRCA1 gene isolated from the genome,” according to the EPO’s Technical Board of Appeal decision.

The complainants consider the EPO’s decision a turnaround since the EPO had previously considered that mutations patented by Myriad Genetics were not patentable under to the European Patent Convention, according to the institute.

However, according to EPO spokesperson Rainer Osterwalder, the November 2008 decision by the EPO Technical Board of Appeal was not based on previous decisions and the outcome could not be anticipated and therefore is not a turnaround.

For Alain Gallochat, consultant and representative of the EPO, the opposition against the Myriad patents was not meant to challenge gene patentability but rather to challenge the patent itself. “The November decision does not constitute a reversion on the part of the EPO,” he said.

Since the EPO’s decision in November 2008 upholding the patent, there has been no attempt from Myriad Genetics and the University of Utah Research Foundation to enforce their rights in Europe, according to Stoppa-Lyonnet.

In France, 15 laboratories are using genetic testing on BRCA1/2, she said, and in Europe, a number of academic laboratories are using those tests too. They are not strictly the same as Myriad’s but have the same purpose, she said, adding that in Europe, no monopoly would be possible on those tests, only royalties could be requested.

A main difference between the EU and the US, according to Parthasarathy, is that the US does not have an opposition process but has a re-examination process, which is very narrow. The EU is more open to third party challenge in general, she said.

It is unlikely that the US legal decision on the Myriad patents and the USPTO gene patenting will influence the EPO future decision, said Osterwalder, as the EPO is solely tied to the European Patent Convention.

In the field of biotechnology, the EPO grants fewer patents than in other fields, he said. The EPO approach on gene patenting is very restrictive, he added.

US Advisory Committee: No Obvious Repercussion on Gene Patenting

In the United States, a largely private-sector and academic advisory group called the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) issued a draft report of its work on the effects of patents covering genetic tests and related licensing practices, and a range of policy options. This draft report was available for consideration and comment by the public, from 9 March to 15 May.

The work began in 2004, after the advisory committee identified the effect of gene patents and licensing practices on patient and clinical access to genetic tests as a high-priority, according to the committee.

The report concluded that based on its review of the literature, case studies, and review of international policies regarding gene patents, there was little evidence that showed either positive or negative effects on gene patents on patient access to diagnostic tests, nor did it reveal consistent overpricing of patented tests. It also said that “the role of patents in spurring innovation and investment in biomedical research is widely recognised and supported.”