In a decision on 13 June, the highest court of the USA, the US Supreme Court, said the final word in the highly publicized “gene patent” case involving Myriad Genetics. The decision is available here. See our previous reports on this case here, here and here.
In brief, a group of plaintiffs wanted the courts to invalidate Myriad’s patents on the breast cancer susceptibility genes BRCA1 and BRCA2. The matter has been going through the various federal court instances since 2010, and is now finally settled.
The US Supreme Court, in their unanimous decision yesterday, held that claims to naturally occurring DNA are not allowable as a matter of principle. In other words, it is not a patentable invention to isolate such DNA, regardless of the effort involved or the practical benefits of these efforts. However, DNA that is further modified such that it is no longer identical to the DNA occurring in nature, is not barred from patentability.
The decision was somewhat expected, judging from the public discussion about the case during the last six months, and especially from the oral hearing in the Supreme Court on 15 April this year. This, however, does not mean that it will not have a great impact.
It is still too early to know the full consequences of the decision. It is, however, clear that the established legal landscape of 25 years or so, making DNA patents possible, has been radically altered, and that many thousands of granted patents on genes are now essentially worthless. In other words, any business depending on the exclusivity for a naturally occurring sequence will be adversely effected by the decision.
Apart from casting doubt on many settled expectations, the court decision also opens the door to future questions concerning the validity of patents to other naturally occurring molecules. What, for example, is the situation concerning naturally occurring proteins, such as hormones and enzymes? Many biopharmaceutical products in this category have been brought to the market based on patents for the products, patents motivated by their isolation and industrial application.
Another aspect of the case is that international harmonization of patent law, in particular between the US and the European Union, has suffered a setback. In the EU, the directive on legal protection of biotech inventions (98/44/EC) expressly permits, in Article 5(2), the kind of patents now prohibited in the US.
Niklas Mattsson, Partner and European Patent Attorney