Securing IP In Stem Cells

Author:Mr Noel Courage and Laurence MacPhie
Profession:Bereskin & Parr LLP

Stem cells are at the centre of research into regenerative medicine. They have the ability to continuously produce newly differentiated cells and replace damaged cells with healthy new cells.  They are also a valuable tool for drug discovery and development. The transition to successful clinical treatments using stem cells has been slow and difficult. However, there is still commercial optimism as the use of stem cells becomes more established and therapeutic applications of stem cells start to enter the market.  

Obtaining effective patent protection for inventions related to stem cells is vital.

Criteria for Patentability

Any invention must meet certain key criteria for patentability.  Firstly, it must be patent-eligible subject matter. The boundaries of what is considered patentable subject matter differ in each patent office, but in the US and Canada, stem cells and their commercial uses can be patented. An eligible invention must also be new, useful and inventive compared to previously known information (called "prior art'). For stem cells, there can be difficult issues in drafting patent claims, since they are a complex living system.  Proving to patent offices that an isolated stem cell is new and inventive compared to previously known cells, and therefore patentable, can be a challenge.

Embryonic Stem Cells

Embryonic Stem ("ES") cells are derived from the inner cell mass of a developing embryo and are characterized by their ability to differentiate into every cell type (i.e. pluripotency). While a number of human ES cell lines are now available, their creation traditionally required the destruction of a human embryo which has generated substantial controversy.

United States

In the US, ES cells are considered patentable subject matter, as are methods for isolating or producing ES cells, even if the invention requires that a human embryo be destroyed.  The recent US Supreme Court decision in Mayo v. Prometheus has rekindled the debate regarding whether certain types of inventions are patent eligible.  In the meantime, isolated stem cells continue to be patentable subject matter in the US Patent Office. 


In Canada, isolated stem cells are also patentable subject matter. Processes or methods that involve embryonic stem cells or the harm or death of an embryo are not excluded from patentability.

Adult Stem Cells and Induced Pluripotent Stem...

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