Delhi High Court allows Dr Reddy’s to manufacture and export Semaglutide to non-patent markets
Novo Nordisk had sued Dr Reddy's for infringing its intellectual property rights by manufacturing Semaglutide, for which it has the patent.
Justice Manmeet Pritam Singh Arora found that Dr. Reddy's (defendant) raised a credible challenge to the validity of the suit patent by Novo Nordisk on grounds of prior claiming and obviousness.
Dr. Reddy's was permitted to continue manufacturing the drug in India for export to non-patented territories, subject to maintaining accounts.
"Since the Plaintiff (Novo Nordisk) is not manufacturing in India and only importing to India, this Court accepts the undertaking by the Defendants and permits them to manufacture the impugned drug in India and export it to countries where the Plaintiff does not have a Patent registration."
The order further stated,
"The Plaintiff has failed to make out a prima facie case for the grant of an interim injunction. On the basis of the discussion above, this Court is of the view that any damages suffered by the Plaintiff can be adequately compensated, if deemed appropriate, after the trial has been concluded in accordance with law."
The Court dismissed the application for a ban on manufacturing Semaglutide for export because it believed that the defence had presented a strong case that the patent was likely invalid. The core reasons for this potential invalidity were:
1. Prior claiming (double patenting)
The Court found that the specific Semaglutide compound was essentially already claimed in Novo Nordisk's earlier, expired 'Genus Patent'.
The Semaglutide compound differs from a compound in the earlier patent (Example 61) only by substituting Alanine ('Ala') with a different amino acid, aminoisobutyric acid ('Aib').
The earlier Genus Patent explicitly listed this specific substitution ('Aib' at the 8th position), making it part of the original claim.
Novo Nordisk's repeated filings (Form 27) with the Indian Patent Office, linking the commercial drug Semaglutide to both the old and new patents, served as an admission that the product was covered by the earlier patent.
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.
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'.
Scientific literature already taught that substituting 'Ala' with 'Aib' was a known strategy to make GLP-1 drugs more stable and last longer.
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]."
