European Journal of Human Genetics

TABLE 3

FROM:

Analysing DNA patents in relation with diagnostic genetic testing

Birgit Verbeure, Gert Matthijs and Geertrui Van Overwalle

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Table 3. Classification template for the subject matter covered by the claims with application to the BRCA1 and BRCA2 patents (A): Different categories of claims covering product, method or use claims. (B): classification of European patents related to the BRCA1 and BRCA2 gene

A   B
   BRCA1 BRCA2
   EP0699754 [1] 11.08.1995 a EP0705902 [1] 11.08.1995 a   EP0705903 [1] 11.08.1995 a   EP0820526 [2] 12.02.1997 a EP0821733 [3] 19.04.1996 a EP0785216 [1] 17.12.1996 a   EP0858467 [4] 25.11.1996 a
I Product           
 Locus-related sequences          
 1 Markers          
 Nucleic acid          
 2 cDNA  1, 2   1  1, 2   3, 4
 3 Individual exons          
 4 Individual exons with flanking intron          1, 2
 5 Genomic sequence          
 6 Complementary seq.  5         
 7 Fragment          1, 5
 8 Primers/probes  6, 7, 8 1 3, 311b    6   
 Variation/mutation          
 9 % Identical/variation  3         
10 Nonspecific mutation          
11 Specific mutation  4   1, 2, 30   15 3, 4, 5   
 Peptide          
12 Wild type  15–16, 18, 21    2    11 (full), 12 and 13 (fragment)
13 Mutated  17, 18, 21, 22   13    610    
14Antibody  19, 20         
 Diagnostic kit comprising:          
15 Nucleic acid  25, 26         
16 Peptide          
17 Antibody          
 Composition/preparation          
18 Nucleic acid          
19 Peptide    9–11, 12, 32    11, 12   
 Purpose-limited product          
20 Nucleic acid  27       16  10
21 Peptide  29        14
 Recombinant technology          
22 Vector  9, 10, 11 2 4, 5 2b    7   6
23 Host  12 3 6 3b    8   7
24 Peptide          
25 Antibody          15
26 Organism producing Ab          
27 Transgenic organism  34         
            
II Method           
 Determination of a variation          
 1 Mutation not specified        15   
 2 Mutation specified          
 Diagnostic method (NA)          
 3 Linkage analysis          
 4 Mutation scanning 1, 2, 3–8, 14, 15, 17, 18, 21–23      3, 4, 5, 6c     16 d
 5 Mutation analysis9, 16, 19, 20, 24    16, 17, 18–29, 33    11    
 6 Quantitative 25, 26, 27–28          
 7Diagnostic method peptide 5, 10–13, 25–27, 29    19    12    16
 8Diagnostic method antibody          
 9Recombinant expression  13, 14   7, 8     9, 10   8, 9
10Screening for therapeutics  31, 32, 33         
            
III Use           
 medical use: treatment          
1 As such          
2 Disease oriented        17 (NA) 18 (pept)  
3 Method oriented  28 (NA), 30 (pept)    7 (NA) 8 (pept)    
 Medical use: diagnostic          
4 As such          
5 Disease oriented         1  
6 Method oriented          
 Use in recombinant technology          
7 Of nucleic acid          
8 Of peptide  23, 24   14, 15    13, 14   

 Independent claims are in bold. Claims in the patents as originally granted but revoked or amended during opposition procedures at the EPO are in italic and separated from the current enforceable set of claims by a dotted line. [1] The patent has been jointly filed by Myriad Genetics, the University of Utah Research Foundation and the United States of America. Recently, Myriad Genetics transferred its rights on the invention in Europe over to the University of Utah Research Foundation; [2] The patent was originally filed by Oncormed that has been taken over by Gene Logic; [3] The patent proprietor is the Regents of the University of California; [4] the patent was originally filed by Cancer Research Campaign Technology Limited and Duke University, the former merged with the Imperial Cancer Research Fund and formed Cancer Research UK.

a Date of filing the patent application.

b Claim refers to one specific mutation only (185delAG).

c Claim disclaims diagnostic methods determining mutations known in prior art.

d Claim covers mutation scanning in part of the BRCA2 gene only.

 (NA): method or use based on the nucleic acid, (pept): method or use based on the peptide.

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