As technology is advancing, the legal framework poses more and more challenges in the life science sector, specifically in biology. There are many conflicts in relation to the protection that Intellectual Property can give over biological inventions. In the context of the first part of the 20^th EIPIN Congress, Nari Lee, Professor of Intellectual Property Law at the Hanken School of Economics in Finland focused on the moral issues of gene editing and its implications regarding IP law in this changing reality.

An important turning point in the world of medicine was the Angeline Jolie Effect. When Angelina Jolie announced that she was found to possess the BRCA1 gene, predisposing her to breast cancer, she underwent double mastectomy, tripling referrals for BRCA1 and BRCA2 testing. Furthermore, in the Myriad Genetics case the US Supreme Court ruled that isolated genes are not capable of being patented under 35 U.S.C. §101 as they are still found in their natural form. With isolated genes not being patentable in the US, the situation differs considerably from the EU scenario, which according to Article 53 of the European Patent Convention (EPC) allows isolated genes to be patented.

Morality clause in the EU
A limitation of patentability is contained in Article 53(a) EPC, which prohibits the patentability of inventions that are contrary to ‘ordre public’ or morality. Moreover, Rule 28 states that patents will not be granted in respect of biotechnological inventions which concern processes for modifying the germ line genetic identity of humans. This is known as the morality clause in the EU. In contrast, there is no equivalent morality provision in the US. An example to see how different countries deal with morality is the Harvard Oncomouse, a transgenic mouse highly susceptible to cancer. A patent was granted in the US; the European Patent Office (EPO) also did, balancing the benefits for medicinal advancement with the suffering of a small number of mice  under Article 53(a). In Canada, the patent was rejected under section 40 of the Patent Act, on the basis of public considerations and morality, stating that higher life forms, including transgenic mice, are not patentable. As seen from the EU decision, there is a propensity to apply a utilitarian approach for the assessment of conflicting interests. The priorities people have, whether they are advancements in science or commercial interests along with the distinction between animal rights activists and humanitarians, all lead to different values placed on animal and human lives.

Editing of human genes
The recent discovery of CRISPR/CAS9, an enzyme which allows the precise modification of genes, has created much controversy. This enzyme can be used to remove a mutated gene, as well as to introduce a normal version of a gene. After several patent wars, CRISPR/CAS9 is protected by different patentees in different areas. In China, Dr He sliced out an HIV gene from human embryos, making the first human edited babies, causing an international outcry regarding morality around the subject, with Dr He facing criminal charges by the Chinese authorities.

A major debate regards whether Article 53 and Rule 28 EPC are sufficient to control the moral and ethical considerations regarding CRISPR/CAS9. If not adequately controlled, could this eventually lead to designer babies? It is clear that patent law is not sufficient to protect the moral concerns regarding gene editing and instead, raises additional concerns such as, are we playing God? Up to now, there is no clear rule definition of what is moral. While we know from previous EPO case law that morality relates to something about good and wrong, an issue that would create public outcry, CRISPR/CAS9 marks the beginning of an era which will certainly have unknown effects, so should certain provisions be set which deal with the morality of the matter while it is still time?

Finally, patent law may not be the correct way to cover CRISPR/CAS9 or any moral and ethical concerns which arise from CRISPR. Just like patents are granted on guns but their use is left to other legislations (such as gun laws), perhaps Article 53(a) is not sufficient to deal with the morality of such matter, and should be left to be dealt with in another, new legislation. At the end of the day, maybe morality should come from scientists themselves, as Nari Lee suggested in her presentation.