Bioethics and Patent Law: The Relaxin Case

Biotechnology is booming. Innovation in biotech is producing new medicines, treatments and processes with the potential to save or transform the lives of millions. As new technological frontiers are crossed, our expectations continue to rise. But so too do the complexities of the associated bioethics, i.e. the ethical questions relating to the implications and applications of biological research. One aspect of this complex area concerns the way in which biotechnological inventions are protected - or excluded from protection - by intellectual property (IP) rights.

When considering bioethics in an IP context, some critical distinctions have to be kept in mind. For instance, ethical arguments for or against permitting researchers to undertake research on certain technologies (e.g. on embryonic stem-cells) should be distinguished from the rights or wrongs of permitting the outcomes of such research to be patented. But the patent system does not exist in a moral vacuum. The intersection between bioethics and IP lies rather in questions such as: Is it morally acceptable to grant exclusive patent rights over a particular technology, such as isolated DNA sequences? What issues of prior informed consent arise when genetic resources are used to develop a patented invention? What ethical concerns arise regarding the way that exclusive rights over a technology are exercised, such as patents on diagnostic tools?

The same, but differen-

In the patent laws of most countries, the same basic rules and principles govern the patenting of biotechnological inventions as other technologies: only genuine inventions - not mere discoveries - are eligible; the same conditions of novelty, inventive step, and industrial applicability apply; the applicant must fully disclose how to carry out the invention; and so forth.

But biotechnology is special, not least because it is based on living organisms. Indeed, biotechnological inventions can be self-reproducing and self-disseminating, as in the case, for example, of a genetically engineered seed (which may itself be considered an invention if it is truly novel and inventive).

Patent law has accordingly developed certain special rules for biotechnological inventions. These include public interest exceptions to patentable subject matter - some countries exclude patents on plants or animals, for instance - and some provide special disclosure requirements relating to inventions based on genetic...