Limitations and implications of granted patents

Geographical limits

  • It is worth emphasizing that the geographical scope of protection for the patented chimeric genes and other features of the inventions is confined to the United States and its territories. Monsanto may enforce its rights over these inventions only in the United States. Users in all other countries are free to employ in any way the products claimed in the patents. The only restriction would come when such users seek to import products, i.e. plants containing chimeric constructs claimed in the patents, into the United States. In this case, users without permission from Monsanto would be in breach of the rights of the patent holder.

Any antibiotic resistance and certain promoters as part of the constructs

  • A basic chimeric gene, which is the subject matter of the claims of patents US 5034322 and US 6174724, corresponds to a chimeric gene similar to those routinely and widely used in plant transformation technologies all over the world. The comprising elements of the chimeric gene of the inventions are the essential components in a chimeric construct designed for the selection of transformed plants based on their acquisition of antibiotic resistance capacity. Thus, essentially, in the United Statesthe use of any antibiotic resistance gene for transformation of plants is covered by the present Monsanto patents.
  • The claims, however broad, do have certain limitations. The antibiotic resistance gene must be used in conjunction with a promoter derived from the opine synthesis genes of A. tumefaciens or from a rbcS gene (‘532 patent) or a promoter naturally expressed in plants (‘724 patent) ( i.e. promoter from a plant gene or a promoter from a non-plant gene that is normally expressed in a plant cell environment). These limitations potentially leave the window open for the use of promoters from genes of organisms such as bacteria (except maybe Agrobacterium/Rhizobium), fungi, animals and viruses which are not normally expressed in the plant cells. The inventors themselves ruled out during the examination process promoters of these sorts as part of the scope of their inventions.

How such broad claims could be granted so recently?

  • Readers may wonder how patents with such broad claims directed to an enabling technology known and used for selection of transformed plants for at least more than a decade could have been granted at all. In this case, the answer is related to the earliest priority date claimed by the applicants for their inventions. The first filing related to the inventions was January 1983, a time when the development of vectors for transformation and methods to select the transformed cells was taking its first steps. Thus, although the applications for these particular patent documents were filed in 1995 and 1999 (see Bibliography table), the only published information that counts for assessing the novelty and non-obviousness of the inventions is that published before the earliest priority date claimed: that is, the relevant prior art to the inventions published prior to January 17, 1983. The myriad research and developments in this area published after January 17, 1983 may not be used by the patent office examiners in assessing patentability of the inventions.