2. Obviousness (lack of inventive step)
The Court determined that the slight modification made to create Semaglutide was obvious and did not require an inventive step.
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Since the inventors of both the earlier and later patents were the same, the Court applied a high standard, treating them as a ‘person in the know’.
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Scientific literature already taught that substituting ‘Ala’ with ‘Aib’ was a known strategy to make GLP-1 drugs more stable and last longer.
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For a ‘person in the know,’ experimenting with this established substitution on the already potent Example 61 compound was an obvious step with a reasonable expectation of success.
“Thus, this Court is satisfied that the single substitution made to the GLP-1 analogue of Example 61 compound of the Genus Patent/IN’964 to arrive at the Semaglutide compound in the Suit Patent/IN’697 were obvious to try for a ‘person skilled in the art’, or in this case, the ‘person in the know’ with a reasonable expectation of success, i.e. to obtain GLP-1(7-37) analogue with increased half-life for effective treatment of Type 2 Diabetes. 130. Therefore, this Court is of the prima facie opinion that the Suit Patent/IN’697 is vulnerable on the ground of obviousness on account of the claims and compounds disclosed in the Genus Patent/IN’964 as well as the teaching in the prior art in Deacon [1998] and Knudsen [2004].”
