US case highlights problems for human gene patents on both sides of the Atlantic, says expert

Patent law expert Adrian Murray of Pinsent Masons, the law firm behind Out-Law.com, said that though the difficulties faced in the US and EU are different, they are significant in both cases.

In the US Supreme Court case pharmaceutical firm Myriad Genetics will have to win the argument about whether patents covering DNA sequences are excluded from patentability by the bar on protecting 'products or laws of nature' , while companies seeking protection in the EU continue to face challenges proving that the gene isolating process is inventive enough to deserve patent protection.

The US Supreme Court is considering its verdict in a case brought by the Association for Molecular Pathology. Previously the US Court of Appeals for the Federal Circuit held that isolated genes can be patented, but the decision was appealed to the Supreme Court by the Association for Molecular Pathology in a bid to render invalid patents held by Myriad for two genes linked to breast and ovarian cancer, known as BRCA1 and BRCA2.

US law states that material related to laws of nature cannot be patented. However, US case law has established that "anything under the sun that is made by man" can be patented. That was the view taken by the Supreme Court in a case in 1980 and since then it has been used as a legal test in US courts for determining whether a particular subject matter is patentable.

Murray said that in the EU the right to patent material isolated from nature is enshrined in law. The Biotech Directive says that “biological material which is isolated from its natural environment or produced by means of a technical process” may be patentable “even if it previously occurred in nature".

In Europe companies face a different problem: they must show patent authorities that the subject matter for which protection is sought satisfies the demand that anything that is patented is inventive and is not just a trivial or obvious development of existing knowledge.

"The application of the law on inventive step has been applied by the European Patent Office in an increasingly stringent manner over the last 20 years," Murray said. "This is principally because the techniques used to identify, isolate and reproduce sequences of interest from DNA have become increasingly mechanised during that time, making it considerably more difficult for patent applicants to establish that isolation of the sequences they are looking to protect required the expense of inventive effort, rather than simple routine experimentation."

"Typically, in order to persuade the European Patent Office (EPO) to grant a patent covering an isolated gene sequence it is necessary to establish that the sequence exhibits surprising and unexpected effects and also that those effects are unique to the sequence in question," he said. "Indeed, the number of applications granted by the EPO in the biotech space, at 27%, is considerably lower than the overall figure of 47%."

Murray said that even if Myriad loses the US Supreme Court case it may still be able to gain patent protection for processes or tests which use the gene and or compositions including that sequence, rather than the DNA sequence itself.

"Owing to the rigorous way in which the EPO examine these types of applications, it is not uncommon for EU applicants to introduce similar types of limitations into their applications," he said. "This means that the same amendments, albeit made for different reasons, may be required to secure patent protection on both sides of the Atlantic."