Patent landscape overview

Some of the patents in the two patent families, owned by Genetic Technologies Ltd, are directed to intron sequence analysis methods for detection of haplotypes and genomic mapping. Other members of the families are directed to similar subject matter except specifically claim the invention in relation to the human MHC (major histocompatibility complex) and, as such, will not be discussed herein.

The breadth of the claims in the patents listed below and their possible dominance over much of the current technology in molecular markers prompts a more detailed analysis of these patents. Furthermore, as mentioned above, one of the patents, US 5,612,179 (the ‘179 patent) is very contentious in the scientific research world.

The two patent families are complementary. The first family, exemplified by US 5,612,179, is directed toward detecting polymorphisms in non-coding regions of genomic DNA; the second family, exemplified by US 5,851,762 is directed to identifying polymorphisms that comprise a haplotype associated with a trait, such as a disease. As can be seen in the table below, these subject matters have been aggressively patented or pending in many countries, including Europe, Australia, Canada, Israel, Japan, and New Zealand.

Patent No. Subject Matter Comments
US 5,612,179 Methods for amplifying noncoding region DNA that encompasses an allele and detecting the allele. Issued 18 Mar 1997 with 17 year term, but subject to terminal disclaimer; expires 9 Mar 2010.

Related patents: AU 654111 B2, AU 672519 B2; IL 95467, JP 22417690; NZ 235051, SG 4700747; US 5192659; US 5789568; ZA 9006765;

Related patents pending: CA 2023888, US 09/935,998

EP 0414469 B1 Title – Intron sequence analysis method for detection of adjacent and remote locus alleles as haplotypes. Registered in AT, BE, CH, DE, DK, ES, FR, GB, GR, HK, IT, LI, LX, NL, SE
US 5,851,762 Methods for mapping and identifying haplotypes of polymorphic markers in noncoding DNA, wherein the haplotypes are associated with a trait. Issued 22 Dec 1998 with 17 year patent term; expires 22 Dec 2015.

Related patents: AU 647086 B2; IL 98793; JP 3409796; NZ 238926; ZA 9905422

Related patents pending: CA 2087042

EP 0570371 B1 Title – Genomic mapping method by direct haplotyping using intron sequence analysis. Registered in AT, BE, CH, DE, DK, FR, GB, IE, IT, LI, LX, NL, SE