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Patentability of Biotechnology Inventions

What Is Not Patentable:

A Microorganism found in nature.
A species of microorganism.
An unknown product or work of nature.
A natural phenomenon.
Gene therapy in and of itself, in vitro or in vivo.

What May Be Patentable:

1) A therapeutic composition for treatment of a specific disease; making and using the composition.

2) A monoclonal antibody (e.g. a hybridoma cell line), the antibody secreted by the cell line, and the immunoassay kit incorporating the antibody.

3) A nucleic acid sequence not found in nature. DNA claims must include a novel gene sequence or a novel purpose for the gene sequence.

4) A protein not found in nature. The protein must pass the applicable test.

5) A short sequence of amino acid for a particular purpose, (e.g. binding).

 

6) A multi-cellular organism (e.g. previously patented: oyster, mouse). (How the organism is made must be described with particularity)

7) A novel microorganism (e.g. bacterium, fungus, alga) not found in nature.

8) A novel use for an existing microorganism.

9) A novel plant not found in nature. (The plant must be described with particularity).

10) A novel seed not found in nature. (Use and purpose of the seed must be described with particularity).

What May be Claimed:

A product.
A method for making the product
A method for using the product

Importance of an Enabling Disclosure:

The detailed disclosure of the invention claimed, in the patent application as filed, must enable one of the ordinary skill in the art to make and use the claimed invention.


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