CANADIAN GOVERNMENT

January 5 DE 1994

THE CONTEXT

• The Canadian Patent Act does not explicity excludes lifeforms from patentability

• Priot to 1982, canadian Patent Office practice was, as was the practice in many patent office in the world, to refuse patents for lifeforms
• With the arrival of commercial biotecnology, filing of applications compelled patent offices to face the issue of patenting lifeforms
  • Currently the Office grants patents for single-cell organism, but not for higher lifeforms(plants and animals.) The Officegrants patents for processes for producing higher lifeforms
  • The Office receiving patent applicatons for higher lifeforms, includingplantas ad animals…e.g. applications for genetically engineered plants resistant to disease and genetically altered mice for pharmaceutical research.

FUNDAMENTAL CRITERIA FOR A PATENT

A patentable invention is:

• any new and useful art, process, machine, manufacture or composition of matter; or
• Any new and useful improvement in any art, process, machine, manufacture or composition of matter.

A patentable invention must also be:

• unobvious; and described with sufficiently complete and accurate details to enable a person skilled in the technology to make or use the invention.
• a biological invention a deposit of biological material in a recognized depositary could be used to complemment the description of an invention.

THE PATENT PROCESS

• First to fille. The first applicant to file a patent application is entitled to the patent.
• Upon request, the application will be examined against specific criteria and either allowed or rejected.
• If the application is rejected by the examiner, the applicant may request a review by the Commisionaer who will either reverse or uphold the examiner's decision.
• The aplplicant may appeal the dcision of the Commisioner to the Courts.
• There is no inherent commont law right to obtain a patent.

THE ROLE OF THE COMMISIONEROF PATENTS

• The Commisioner of patents is responsible for granting or rejecting patent applications under the Patent Act.
• A decision by the Commisioner to grant or reject a patent is based soley on the law (Patent Act ands Rules.)

PATENT PROTECTION

• A patents provide the right to exclude others form making, using or selling the invention within Canada.
• The right exists for 20 years from the date the application is field in Canada
• Terms and conditions of a patent are set by statue

CURRENT OFFICE PRACTICE

• Curent practice is to grant patents for microorganism (single-cell organism such as yeast and moulds), but not for higher lifeforms. The basis for this practice is found in the 1982 decision of the Commisioner in the Abitibi case.
• The Abitibi decision set down clear criteria for the patentability of microorganism in Canada:

• The Commisioner stated in the case, that all new lifeforms which are produced "en masse" as chemical compounds such that any measurable quantity will posses uniform propierties and characteristics, are patentable.

CANADIAN JURISPRUDENCE ON HIGHER LIFEFORMS

• The pionner Hi-Bred Application: The inventio was related to a new plant variety produced by it was no patentable invention under Patent act.
• Commisioner's Decision (1986): The Commisioner rejected the application stating that croos-breding are not patentable inventions under the Patent Act.
• Supreme Court of Canada (1987): No ruling was made on whether or not a higher lifeform such as a plant is proper subject matter for a patent in Canada. The decision, instead, focused on the insufficiency of the description in the application. It was judged inadequate and the patent was not granted.

• PLANT BREEDER'S RIGHTS ACT

• Pioneer Hi-Bred would have been to obtain protection under the Plant Breeder's Rights Act had it been in force in 1986. This Act gives exclusive rights to new varieties of some plant species.
  

CROSS-BREEDING VS GENETIC ENGINEERING

• Canadian jurisprudence has only rules on traditional cross-brreding which involved minimal human invention and does not result in patentable inventions

• Croos-breeding: involves crossing between two parents with different characteristics. Plants with the combined desirable traits of the parents are selected.

• There arevthose who argue that similar products obtained by cross-breeding can be obtained by genetic engineering which involves a high degree of human invention.

• Genetic Ingineering: technology by which DNA sequences are altered to make modified versions of genes, which are inserted into cells or organism. For example, a transgenic animal is produced by permanently altering its genes through the introduction of a foreign gene into the chromosomes of one of its ancestors.

Genetic ingineering produces a degree of control and reproducibility which is not possible with traditional plant and animal breeding techniques.