Lawyers suggest patent system could be used as ethics tool

Ethical concerns over issues like the use of embryonic stem cells in research could be addressed in the patent system, a new paper has argued.

The paper, The Moral Tollbooth, by Canadian lawyers Richard Gold and Timothy Caulfield and published in the June 29 issue of The Lancet, said that the patent system itself could be used to circumvent social and ethical dilemmas such as the patenting of genes that predispose to breast cancer.

"Many believe that those who commercialise biotechnology patents have an ethical obligation to share the benefits associated with their invention with patient groups," and there are other concerns about the speed of scientific progress, experimentation on animals, unnecessary use of gene technology and other issues, the paper said.

Gold and Caulfield described the patent system as a "practical way to regulate compliance with ethical and social values", and suggest expanding the European notion of withholding patents for breaches of ethical standards by specifying activities, rather than inventions, that defy those standards.

"If an activity would render the commercial sale of an invention ethically unacceptable, for instance, our process would permit countries [...] to withhold or revoke patents on that activity," the paper said.

Under the proposed model, ethicists, rather than patent examiners, would make the relevant ethical decision.

The pair gave the example of research into Canavan syndrome at the Miami Children's Hospital, which relied on donations of blood, urine, skin and brain tissue from sufferers. But "the hospital adopted a restrictive licensing policy that some say inappropriately restricted access to a diagnostic gene test, hurting the very community that had donated the material," said the authors.

"If our proposal had been in place, the patients with Canavan disease would have been able to challenge the patents granted to the Miami Children's Hospital [...] for the Canavan-linked gene."

The paper said that such a proposal would ultimately strengthen patents' economic effects by increasing public confidence in the system: "After all, public opinion is vitally important to the future of biotechnology."

Karen Sinclair, a principal at Melbourne-based patent attorney Watermark, said the paper presented an interesting concept.

But she said that the European ethics-based component of its patent office was barely exercised, and with the global trend towards streamlining the patent process, an extra hurdle might sway companies to work outside the system.

"If a company decided that this process would delay the commercialisation process, they might choose to avoid the system altogether," she said. "Not all innovations go through the patent system."

The patent process was already in backlog, Sinclair said, with European and US patent offices receiving more applications than they could examine each year.

The lengthy timeline of a biotechnology discovery also played a part in the ethical process, Sinclair pointed out. "Ethics are very much frozen in time," she said. "Some of the things that people had difficulty dealing with 10 years ago, they now don't."