An ongoing lawsuit in the US has attracted a lot of attention worldwide. The American Civil Liberties Union has, together with other parties, sued the US Patent and Trademark Office, Myriad Genetics and others. On Monday 29 March 2010, a judge in a federal District Court in New York ruled that the “Myriad patents” in the USA are invalid, and that patents on isolated genes are not lawful. The verdict is likely to be appealed to the Court of Appeals for the Federal Circuit.
The controversy centers on patents on breast cancer genes BRCA1 and BRCA2. In 2009, when a decision was reached about the BRCA1 patents in Europe, Niklas Mattsson had the following to say about the European situation. The article has been previously published in Swedish in the magazines Pharma Industry and Onkologi i Sverige.
Patents on genes, especially human genes, have been a focus of fierce debate over the past ten years or so. The debate has been profoundly influenced by the controversy surrounding the “Myriad patents”, a number of patents covering the BRCA1 and BRCA2 genes, and the use of the genes in the diagnosis of cancer. The patents were initially held by Myriad Genetics Inc and a number of research institutes and US government agencies. Through two decisions in November 2008 the European Patent Office (EPO) decided the proper scope of the patents for the BRCA1 gene in Europe. See also our previous blog post.
Different views on gene patents
According to established jurisprudence in Europe, patents on isolated genes and their use are permissible, as long as the general requirements on novelty and inventive step are fulfilled. Detractors of the patenting of gene inventions often refer to the Myriad case, claiming that it illustrates the undesirable consequences of the current situation. These detractors argue that the system should be changed so that gene inventions can no longer be patented, or at least so that the possibilities are strictly limited. Proponents, on the other hand, have argued that the current patent system works well. According to the proponents, the problems arising in the Myriad controversy have more to do with business ethics and licensing policies than with a perceived but non-existent problem in the patent system.
Myriad and the BRCA patents
Myriad was established in 1991 as a spin-off from the University of Utah. The founder, Mark Skolnick, was a researcher at the university, and member of an international consortium that sought to find genetic links to breast cancer. Through extensive research, scientists from Myriad, the University of Utah and other institutions succeeded in identifying and sequencing the two genes BRCA1 (in 1994) and BRCA2 (in 1995). In addition, they identified links between certain mutations in the genes and an increased risk of breast and ovarian cancer.
Based on this genetic information, Myriad was able to develop diagnostic tests and start commercializing them. Naturally, the company had an interest in protecting its investment with the aid of patents.
Consequently, Myriad and its partners filed a number of patent applications in the USA, following these up with applications in other countries. In Europe, they made use of the EPC, filing the applications with the EPO. The scope of protection in the patent applications was directed to the genes as such, as well as the use of different gene variants to determine the risk of breast and ovarian cancer. In 2001 after what, in the circumstances, may be regarded as a more or less normal prosecution time, the EPO granted the patents with some amendments.
Broad BRCA1 patents granted in Europe
Through three different BRCA1 patents, Myriad was awarded exclusive rights to the isolated BRCA1 gene (European patent, EP, 705 902 B1), to use of the gene in cancer diagnosis in general (EP 699 754 B1), and to some 30 different mutations in the gene that are associated with an increased risk of cancer (EP 705 903 B1). Regarding BRCA2, there is one patent (EP 785 216 B1) covering detection of one specific BRCA2 mutation in a particular population, and a pending application (EP 1 260 520 A1). The present article is concerned only with the BRCA1 patents.
Having obtained these patents, Myriad contacted healthcare providers throughout Europe and offered licenses for the patents. Many people felt, however, that the prices that Myriad asked for using the technology were excessive: fees of up to 3,000 USD per sample were reported. Also, the licensing terms did not allow licensees to perform tests themselves, but mandated sending samples to Myriad for analysis. Myriad, on the other hand, has pointed out that its analysis is very accurate, and that the company provides a level of confidence that cannot be equaled in a general hospital or clinical laboratory that does not specialize in the analysis.
In addition to the controversies surrounding Myriad’s demands, some commentators held that the situation illustrated a more general problem; namely, the negative consequences of granting this type of patent in the first place. Interestingly, very few other gene patents have attracted the same amount of attention, despite the fact that thousands of such patents have been granted in Europe, both before and after Myriad’s patent applications (see for example Caulfield et al, Nature Biotechnology 24(9):1091-1094 (2006)).
Opposition against the patents
Embodied in the EPC is a possibility to question the decision of the EPO to grant a patent through the filing of a notice of opposition within nine months from grant. The opposition is examined in a form similar to a lawsuit, and the EPO determines whether the patent owner or the opponent is right. The possible outcomes are that the patent is revoked in its entirety, limited in some way, or upheld in unchanged form.
In the light of the conflicts surrounding Myriad’s licensing policy and the general debate on gene patents, it is hardly surprising that the EPO received an uncommonly large number of oppositions against the BRCA1 patents granted in 2001. Also unusual was the fact that most of the opponents were not direct competitors of the patent owner, but organizations and institutes that were eager to question the existing system.
Oppositions were filed by, among others, Greenpeace, the Minister for Public Health in the Netherlands, and the Social Democratic party in Switzerland. Oppositions were also filed by the French research institutes (including Institut Curie) that had once been involved in the breast cancer consortium together with Skolnick and the University of Utah.
EPO decisions limit the patents
The opposition procedure concerning the first patent – that covering the BRCA1 gene as such – was concluded in 2007, following an appeal procedure (Board of Appeal decision T1213/05). After the dust had settled, it became clear that Myriad had lost patent protection for the gene as such in Europe. It is important to note, however, that the outcome was not the result of a decision that genes cannot be patented, but a consequence of Myriad’s failure to satisfy the traditional criteria for obtaining a patent. The patent applications originally filed described a DNA sequence that contained errors. After the filing of these applications, the correct DNA sequence was published before Myriad had filed a patent application disclosing this sequence. Thus, the correct DNA sequence was already known before a patent application containing this sequence was filed: it was, therefore, not novel. No novelty, no patent.
The final decision with regard to the oppositions against the two other patents on BRCA1-related inventions was reached in November 2008, also after appeals against the first instance decisions (Board of Appeal decisions T80/05 and T666/05). The written decisions were issued by the EPO on 7 March 2009. From the file histories it is clear that the broad protection sought by Myriad from the outset – and initially granted by the EPO to some extent – has been severely limited. What remains is patent coverage of one single specific cancer mutation, and of the detection of frame shift mutations in the gene.
The decisions state the exact reasons why the patent claims had to be limited, and in these two cases, too, this is due to failures to meet the “classic” existing rules, rather than any sign of a change in jurisprudence concerning gene inventions in general.
It remains to be seen what future commercial effect these patents will have on the testing of BRCA1-related cancer risk. Whoever supplies tests for BRCA1 mutations for the purpose of diagnosis should study the patents as now finally decided, to ensure that there is freedom to operate.
A working system of checks and balances
The general debate on the patent system and gene inventions continues in Europe, despite the fact that the Myriad case is, to all intents and purposes, closed. At present, there is a discussion concerning whether the best way forward would be to introduce a limitation of the scope of protection, such that a patent owner should not be able to block all uses of a gene, even though it had never before been identified and isolated, but only obtain an exclusive right to the actual use described in the patent application. Some European countries have introduced such legislation, but it is too early to tell what the consequences will be.
To summarize, the European chapter in the Myriad Genetics patent saga is practically concluded. Despite widespread concern that European patent offices are over-generous in granting patents on gene inventions, it appears that the existing system and the conventional patentability criteria – including the possibility of opposition – have worked well in this case. The application of the criteria during EPO’s processing of the applications led to limitations on the patent protection that Myriad applied for, and what is left could be said to correspond to a reasonable compensation for the contribution to the art that Myriad and their collaborators provided.
Niklas Mattsson, European Patent Attorney, Awapatent
