The Supreme Court will hear oral arguments next month in Association for Molecular Pathology v. Myriad Genetics, Inc. and will consider whether to permit isolated human genes patents. Much has been written about the Myriad case, but little attention has been paid to the potential international consequences of the decision. Dissimilarities in patent rights in the biotechnology field could create competitive disadvantages for some countries, and complicate business strategies of companies. A brief overview of international laws on gene patents seems to be in order.
TRIPS
The most significant international agreement on patents is the Agreement on Trade-Related Aspects of Intellectual Property Rights, more commonly known as “TRIPS.” Article 27(1) of TRIPS states that “patents shall be available for any inventions… in all fields of technology, provided that they are new, [non-obvious, and useful.]” The “all fields of technology” provision casts a wide net, meaning that no field of research is per se un-patentable. The real question under TRIPS is: what constitutes an invention? Unfortunately, TRIPS provides few clues as to the meaning of this key term, instead leaving it to Member States to develop their own definitions.
Gene Patents in the US
In the U.S., isolated genes and cDNA are currently considered to be patentable.
Gene Patents in the EU
In the European Union, while the simple discovery of a gene sequence is not patentable under Article 52(2) of the European Patent Convention, an isolated gene sequence is patent-eligible as long as it meets the standard patentability requirements. Article 5(2) of the 1998 EU Biotechnology Directive states: “An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.”
Gene Patents in Japan
Japan has similar patent eligibility laws to those of the EU. As illustrated in Chapter 2, Section 1.1.2.1.1 of Japan’s Implementing Guidelines for Inventions in Specific Fields, an isolated gene is patent eligible, as long is it meets the typical patentability criteria and the gene’s function is sufficiently described.
Gene Patents in India
Indian patent law has a slightly more restrictive view of when to permit gene patents. Section 3(c) of the Patents Act (as amended in 2002) states that “the mere discovery of a scientific principle or the formulation of or discovery of any living or non-living substance in nature” is not an “invention” under the act. India appears to require more than mere isolation of a gene sequence identical to that existing in nature. Indeed, Chapter 5.8.11 of the 2008 Indian Draft Patent Manual explains that “when a genetically modified Gene Sequence… is novel, involves an inventive step and has industrial application” it qualifies as an invention.
Conclusions
Though this survey is brief, and there are exceptions to gene patents in various countries (such as for morally objectionable purposes and diagnostic tests), it should be clear that many countries having significant biotechnology industries already permit patents on genes, under substantially similar rationales. If the Supreme Court reverses the Federal Circuit in the Myriad case and finds genes not patent-eligible, for example because they are products of nature, inventors and users of biotechnology should watch to see if laws in the EU and elsewhere change to maintain homogeneity.