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IP issues

The Commonwealth Scientific and Industrial Research Organization (CSIRO) of Australia and the companies Lubrizol Enterprises and Mycogen Plant Science (U.S.) have jointly filed and been granted patents related to the Adh promoter and “regulatory elements”. Actual assignment of the patent rights varies among jurisdictions according to Inpadoc. The table shows the entity identifed by Inpadoc as owning the patents granted in Australia, Canada, Europe and the United States.  These may now be controlled by Dow.

Approximate scope of protection

The patents do not refer to the maize Adh-1 promoter as such. They cover some elements derived from the promoter regions of maize aldolase gene, maize Adh-1 and Adh-2genes. The patents are in general directed to two different aspects:

  • the ARE regions of the promoters of maize ADH genes and maize aldolase gene, and
  • the chimeric pEmu having ARE regions and an intron

1. Patents directed to the ARE enhancer regions

  • Patents directed to these regions were granted in the U.S., Canada, and Europe. The enhancer regions are part of a recombinant promoter molecule that has, from 5′ to 3′ direction, at least:
    • the ARE regions
    • a promoter expressible in plants, which is basically reduced to a TATA box, and
    • a structural gene under the control of the above mentioned elements
  • The claims of the European patent encompass the DNA sequences of the ARE regions of:
    • maize aldolase gene,
    • maize adh-1 and adh-2 genes, and
    • sequences that are at least 66% homologous to the mentioned genes
  • The Canadian patent also claims a method for the expression of a structural gene in a plant under conditions of low oxygen.

2. Patents directed to a chimeric promoter known as pEmu

  • The patents on a recombinant promoter for enhancing-expression of structural genes in monocot plant cells have been granted in the U.S., Europe and Australia. The minimum elements of the promoter in direction 5′ to 3′, claimed in all three jurisdictions, are:
    • several ARE enhancer elements
    • a TATA box
    • a transcription start site
    • an intron and
    • a structural gene;
  • In addition, the independent claims of the U.S. and the Australian patents comprise enhancer elements derived from the ocs promoter region.
  • Although the examples provided in the specification refer to the ARE regions and intron 1 derived from the maize aldolase and maize adh genes, the ARE regions and the intron of the recombinant promoter claimed in the patents in all three jurisdictions are not limited to the elements of the maize adh genes. Thus, the use of other ARE enhancer elements and introns might be protected by the claims of these patents. The prosecution histories of the patents might shed light on this aspect.

The patent information, a summary of the independent claims and the actual independent claims of each patent are presented in the following tables.

Patents on the ARE of maize ADH and maize aldolase promoters

Patent number

Title, Independent Claims and Summary of Claims

Assignee
US 5001060

  • Earliest priority – 6 February 1987
  • Filed – 15 June 1987
  • Granted – 19 March 1991
  • Expected expiry – 18 March 2008
 Title – Plant Anaerobic regulatory element

Claim 1
A recombinant DNA molecule comprising:
(a) an anaerobic regulatory element;
(b) a plant-expressible promoter located 3′ to said anaerobic regulatory element, and
(c) a plant-expressible structural gene located 3′ to said plant-expressible promoter such that said structural gene is placed under the regulatory control of said promoter and said anaerobic regulatory element wherein said structural gene is not in nature under the regulatory control of said anaerobic regulatory element.
  • A recombinant DNA molecule comprising from 5′ to 3′ direction an ARE, a plant- expressible promoter and a plant-expressible structural gene.

Lubrizol EnterprisesInc. & CSIRO
CA 1338858

  • Earliest priority – 6 February 1987
  • Filed – 5 February 1988
  • Granted – 21 January 1997
  • Expected expiry – 20 January 2014
 Title – Plant Anaerobic regulatory element

Claim 1
A recombinant DNA molecule comprising: (a) an anaerobic regulatory element; (b) a plant-expressible promoter located 3′ to said anaerobic regulatory element, and (c) a plant-expressible structural gene located 3′ to said plant-expressible promoter such that said structural gene is placed under the regulatory control of said promoter and said anaerobic regulatory element wherein said structural gene is not in nature under the regulatory control of said anaerobic regulatory element.
Claim 25
A method for selective expression of a plant-expressible structural gene under anaerobic conditions in plant tissue which comprises the steps of:
(i) constructing a recombinant DNA moleculae which comprises (a) an anaerobic regulatory element; (b) a plant-expressible promoter located 3′ to said anaerobic regulatory element, and (c) a plant-expressible structural gene located 3′ to said plant-expressible promoter such that said structural gene is placed under the regulatory control of said promoter and said anaerobic regulatory element.
(ii) transforming said plant tissue with said recombinant DNA molecule, and
(iii) placing said transformed plant cell under anaerobic conditions so that said plant-expressible structural gene is expressed.
  • A recombinant DNA molecule the same as described in the US patent US 5001060.
  • A method for the anaerobic expression of a plant-expressible structural gene. The method comprises transforming a plant tissue with a recombinant DNA molecule as described and placing the tissue under anaerobic conditions to trigger expression.

Mycogen Plant Science Inc.& CSIRO
EP 278658 B1

  • Earliest priority – 6 February 1987
  • Filed – 2 February 1988
  • Granted – 10 January 1996
  • Expected expiry – 1 February 2008
 Title – Use of a plant anaerobic regulatory element

Claim 1
A method for selective expression of a plant-expressible structural gene under anaerobic conditions in plant tissue, which method comprises using as an anaerobic regulatory element a recombinant DNA molecule comprising a sequence selected from:
1) 5′ -GCTGGTTTCT-3′
2) 5′ -CGTGGTTTGCTTGCC-3′,
or a sequence having about 66% or greater homology thereto
3) 5′ -CGAGCCTTTCTTCCC-3′
4) 5′ -CTGCCTCCCTGGTTTCT-3′, and
5) 5′-CTGCAGCCCCGGTTTCG-3′,
or a sequence having about 66% or greater homology thereto,
a plant-expressible promoter being located 3′ to said anaerobic regulatory element, and a plant-expressible structural gene being located 3′ to said plant-expressible promoter such that said structural gene is placed under the regulatory control of said promoter and said anaerobic regulatory element.
  • A method for the anaerobic expression of a plant-expressible structural gene using a recombinant DNA molecule as described in the Canadian patent. The ARE sequences are selected from maize aldolase gene, regions I and II of the ARE of maize adh-1 and adh-2. Also, sequences with at least 66% of homology to the mentioned ones are covered.

Lubrizol EnterprisesInc. & CSIRO
Remarks The granted Japanese patent JP 8826414 B2 assigned to Lubrizol Enterprises & CSIRO was not analyzed. The European patent has lapsed in Belgium (BE), France (FR), Gemany (DE), Netherlands (NL), Spain (ES), Sweden (SE) and UK.
An application is pending in South Africa (ZA 8800320 A).

Patents on the recombinant promoter pEMU

Patent number

Title, Summary of Claims and Independent Claims

Assignee
EP 459643 B1

  • Earliest priority – 19 May 1990
  • Filed – 9 May 1991
  • Granted – 16 August 2000
  • Expected expiry – 8 May 2011
 Title – A recombinant promoter for gene expression in monocotyledonous plants

Claim 1
A recombinant promoter molecule for enhancing expression of a plant-expressible structural gene in a monocot plant cell comprising: (a) a plurality of ARE enhancer elements (b) a truncated, plant expressible promoter providing a TATA box region necessary to initiate transcription positioned 3′ to said plurality of enhancer elements; and (c) a nucleotide sequence naturally found as an intron positioned between the transcription start site and the translation start site in a plant-expressible gene; whereby a plant-expressible structural gene placed 3′ to said recombinant promoter molecule is expressed in said monocot plant cell under regulatory control of said recombinant promoter molecule.
  • A recombinant promoter molecule comprising from 5′ to 3′ a plurality of ARE enhancer elements, a promoter providing a TATA box, and an intron. A plant-expressible gene is located 3′ to and under the control of the mentioned recombinant molecule. The gene is expressed in a monocot plant cell.

Mycogen Plant Science Inc. & CSIRO
US 5290924

  • Earliest priority – 19 May 1990
  • Filed – 21 April 1993
  • Granted – 1 March 1994
  • Expected expiry – 20 April 2013
 Title – Recombinant promoter for gene expression in monocotyledonous plants

Claim 1
A recombinant promoter molecule, useful for enhancing expression of a plant-expressible structural gene in a monocot plant cell, said promoter molecule comprising: (a) a plurality of enhancer elements selected from the group consisting of only ARE elements, only OCS elements, and combinations of ARE and OCS elements; (b) a truncated, plant expressible promoter, providing a TATA box region and a transcription start site, said promoter selected from the group consisting of Δ35S and ΔADH positioned 3′ to said plurality of enhancer elements wherein said truncated promoter excludes the presence of enhancer sequences and wherein said truncated promoter is recombined with said plurality of enhancer elements positioned 5′ to said truncated promoter; and (c) a maize Adh1 intron positioned 3′ to said transcription start site whereby a plant-expressible structural gene, placed 3′ to said recombinant promoter molecule, is expressed in said monocot plant cell under regulatory control of said recombinant promoter molecule.
  • A recombinant promoter molecule for expression in monocots similar to the one claimed in the European patent. The enhancer elements are selected from ARE, OCS, and a combination of both. There is also a plant-expressible termination signal 3′ to the gene of interest.

CSIRO
CA 2042831

  • Earliest priority – 19 May 1990
  • Filed – 17 May 1991
  • Granted – 25 July 2000
  • Expected expiry – 24 July 2017
 Title – Recombinant promoter for gene expression in monocotyledonous plants

Claim 1
A recombinant promoter molecule for enhancing expression of a plant-expressible structural gene in a monocot plant cell comprising: (a) a plurality of enhancer elements selected from the group consisting of ARE and OCS elements; (b) a truncated, plant expressible promoter providing a TATA box region necessary to initiate transcription positioned 3′ to said plurality of enhancer elements; and (c) a nucleotide sequence naturally found as an intron positioned between the transcription start site and the translation start site in a plant-expressible gene; whereby a plant-expressible structural gene placed 3′ to said recombinant promoter molecule is expressed in said monocot plant cell under regulatory control of said recombinant promoter molecule.
  • A recombinant promoter molecule for enhancing the expression of a gene of interest in monocots comprising several ARE and OCS elements, a promoter having a TATA box, an intron. A structural gene is located 3′ to the recombinant promoter.

Lubrizol EnterprisesInc. & CSIRO

Remarks

 The granted Australian patent (AU 643521 B2) has lapsed. The European patent registered in Denmark (DK), France (FR), Germany (DE), Italy (IT), and Spain (ES).
A patent was also granted in Japan (JP 3325589 B2) and an application in China (CN 1063506) was withdrawn.

Note: Patent information on this page was last updated on 13 March 2006.