navigating the patent maze

Cancer Research UK has announced the grant of European Patent No: EP 868 467 B1 and moreover, that public laboratories will be able to use the claimed invention without charge. Interestingly, the press release from Cancer Research neglects to state that Duke University is a co-owner of the patent. A related patent was granted in the year 2000 in the United States (US 6045997), although the claims of the two patents differ.

The BRCA1 and BRCA2 genes have been implicated in breast cancer development. Patents on the genes BRCA1 and BRCA2 and diagnosis based on mutations of these genes have prompted substantial public criticism of the granting of patents for human genes. Myriad Genetics, Inc. in Salt Lake City, UT holds many patents in the U.S. and Europe and markets a test for diagnosis of and predisposition to breast cancer. At least one of the European patents is still being opposed (a procedure whereby one challenges the patentability of the claims).

The latest Cancer Research patent claims specific nucleic acid sequences of the exons of a splice variant of BRCA2 and alleles. The full-length cDNA molecule is only claimed as the result of a detailed procedure for cloning. Full-length protein sequences and fragments are also covered. The key claim however, appears to be Claim 16, which claims a method of diagnosing a susceptibility or predisposition to breast, ovarian and prostate cancers by direct sequence analysis of nucleic acid or polypeptide or by PCR to screen for normal or mutant BRCA2 genes in patient samples.

In the U.S. patent, the claims are directed to the exon sequences or portions of those sequences that are at least 20 bases long and peptide sequences or fragments. There are no diagnosis claims, however. Presumably, there are still pending patent applications in the U.S. with claims to diagnosis.

It remains to be seen whether the European patent will be opposed. Oppositions can be filed up to 9 months after the grant date. It also remains to be determined what is the relationship of the patents of Myriad Genetics and Cancer Research and whether this new patent will affect the ability of Myriad to market their test.

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