Can you patent a disease?

The outbreak of a novel coronavirus in the Middle East is not only raising worldwide health concerns but triggering questions about the ability of organizations to patent the genetic sequences of diseases for profit.

The World Health Organization reports that there have been 53 lab-confirmed cases of infection with a new coronavirus called the Middle East Respiratory Syndrome (MERS-CoV). Thirty-one of the people infected with the disease have died.

• WHO team, including Canadian, investigates how MERS spreads
• B.C. health officials on lookout for deadly new virus

Saudi Arabia has seen the most cases, but the infection has also been found in countries such as Tunisia, Jordan and Qatar, as well as in Germany and Italy.

'You can’t patent a disease condition per se, such as cancer or influenza. But if you’re talking about patenting a lifeform like a bacteria or virus, if altered by man, the answer there is yes.' — Canadian patent lawyer David Schwartz

The virus was identified in September 2012, three months after the Erasmus Medical Center in Rotterdam, Netherlands, acquired a sample of it. The centre has taken out a patent on the virus’s genetic sequence.

While Saudi officials and the WHO have said the patent will impede the process of containing MERS-CoV and developing treatments, Erasmus has defended the move.

Albert Osterhaus, a virologist at Erasmus, told Bloomberg News that patenting the virus was a "normal thing to do."

Indeed, the patenting of genetically modified or isolated viruses is nothing new, says David Schwartz, a patent lawyer and partner at the Canadian intellectual property firm Smart & Biggar.  

"You can’t patent a disease condition per se, such as cancer or influenza," says Schwartz. "But if you’re talking about patenting a lifeform like a bacteria or virus, if altered by man, the answer there is yes."

Intellectual property concerns

A patent is a form of intellectual property that allows the patent holder to control the use of a product or method of doing something. That control includes the ability to charge royalties for its use.

Schwartz says that obtaining a patent on a simple mechanical invention, such as a Christmas tree stand, in a single country might cost about $10,000. But getting a patent on a more complex technology - such as one involving chemical synthesis - that also covers multiple countries can run $200,000 or more.  

While patent law differs somewhat from country to country, in the area of microorganisms most nations agree on general principles, says Schwartz.

You can’t patent something that is naturally occurring, he says, but if an organism is modified in some way, it is patentable.

One of the most famous cases of biological patenting is the so-called "Harvard mouse," a type of laboratory mouse genetically modified by scientists at Harvard University to carry an "oncogene," which makes the animal susceptible to cancer. It was patented in the United States, though not in Canada.

"Ninety-nine point nine per cent of the mouse is God’s creation, but in its totality, as you would claim it as the subject for a patent, it’s a non-naturally occurring, man-made thing," says Schwartz.

In the case of a gene, modifying its information or removing it from its chromosome typically would be enough to warrant a patent, says Schwartz, because the snippet of chromosome would not appear in nature by itself.

This is a key point in the case of the novel coronavirus. To pinpoint it, Erasmus likely used what is called "deep sequencing," says Earl Brown, executive director of the Emerging Pathogens Research Centre at the University of Ottawa.

In this process, the infected sample would be run against databases of known genes and viruses to determine its genetic composition. Brown says the researchers would then typically remove the sequence from its chromosome and copy it in order to conduct further tests.

The rationale for patenting a genetic sequence such as the novel coronavirus is to be able to develop products, such as diagnostic tests or a vaccine, that could be marketed and sold, says Bernard Dickens, professor emeritus of Health Law and Policy at the University of Toronto.

"Profit is what underlies the whole patent system," he says.

The patenting boom

But as the science of biotechnology advances, people are taking a second look at some of the original patent decisions that helped set precedent.

The boom in biological patenting began with the identification of the gene for breast cancer, says Dickens.

In 1994, the University of Utah, National Institute of Environmental Health Sciences (NIEHS) and Myriad Genetics filed a U.S. patent on BRCA1, a gene that indicates a woman’s susceptibility to breast and ovarian cancer. The patent was granted in 1997. (In 1995, the same consortium filed a patent on the BRCA2 gene, which was granted in 2000.)

BRCA1 was recently in the news after Hollywood actor Angelina Jolie announced that she had undergone a double mastectomy after learning that she had a "faulty" BRCA1 gene that greatly increased her risk of breast cancer.

The problem with the breast cancer patent, Dickens says, is that Myriad Genetics was charging exorbitant rates for the use of its diagnostic tests.

"They were prohibiting hospitals, including in Canada, from undertaking the test using their technique. They were imposing charges that were really at a prohibitive level," says Dickens.

The dispute over the BRCA1 and BRCA2 patents has sparked a legal challenge that is currently before the Supreme Court in the U.S. 

• Question over human gene ownership before U.S. Supreme Court

Depending on the court's decision, the case could either strengthen or undermine what can and can't be patented.

An incentive to invest

Meanwhile, at the World Health Organization’s annual conference in Geneva in May, WHO Director General Margaret Chan stressed that countries need to share information on the novel coronavirus.

"Making deals between scientists because they want to take [intellectual property], because they want to be the world's first to publish in scientific journals, these are issues we need to address," she said.

Albert Osterhaus, the virologist at Erasmus, has said that his organization is sharing this coronavirus "with everyone who wants to do public health research."

The aim of patenting, says Dickens, is to encourage organizations to pour investment into solving a specific problem.

"The balance, and it still hasn’t been satisfactorily resolved in every case, is giving investigators an incentive to invest in research to produce products, which they can then license and receive results on," says Dickens.

Some universities patent particular inventions for the purpose of preventing commercial exploitation, Dickens says. They get the patent and then publish it widely, so it’s available to all researchers.

"That’s part of the mission of universities, of course: to make investments for the public good," says Dickens. "So it doesn’t follow that [a patent] is necessarily going to be exploited for profit."

Schwartz says that while some may see biological patents like a hindrance to gaining a handle on potentially lethal organisms such as a coronavirus, they are ultimately intended as an incentive for researchers to find solutions.  

"Perhaps there are also other ways of advancing industry and science, but this is the globally accepted system," he says.