quality
pharmaceutical drugs. It has particularly developed a drug formulation in
which Nilotinib i.e., the subject matter of IN' 430, is the active ... novel and inventive molecule/compound/pharmaceutical
composition with the INN name Nilotinib. It is a synthetic aminopyrimidine,
an ATP-competitive inhibitor
selling and commercially offering for sale any pharmaceutical preparations
consisting of API Nilotinib or Nilotinib Monohydrochloride Monohydrate or
any other forms of Nilotinib. The Defendants ... under:
"i.We have not commercially launched any drug of
Nilotinib, which is the subject matter of the suit patent
IN 237430;
Signature
suit patent i.e. IN-
237430 for their compound 'NILOTINIB' which is valid till 4th July, 2023.
'NILOTINIB' a synthetic aminopyrimidine ... inhibitor
of BCR-ABL, the chemical name, formula and structure of 'NILOTINIB' is
as under:
4-methyl-N-[3-(4-methyl-1H-imidazol
Bristol-Myers Squibb Company & Ors vs Mr. J.D. Joshi & Anr. on 29
Bristol-Myers Squibb Company & Anr vs Mr.D. Shah & Anr. on 29 June
that the Defendant has been granted
manufacturing Licence in respect of product Nilotinib
and the copy thereof is submitted as Document 1.
The Defendant submits ... manufacturing licence on 26th August, 2019 for commercial manufacture
and sale of Nilotinib. The suit patent is due to expire on 4th July
manufacturers in India possessing capabilities to manufacture the
pharmaceutical preparation, namely, 'NILOTINIB'. As per the said Office
Memorandum, Defendant's name ... been included in the list for the
procurement of 'NILOTINIB 150 MG TAB (BRAND: TASIGNA) 200mg'.
14. The Submission of Mr. Hemant Singh
outset, it is submitted that this Defendant only has
certain samples of nilotinib and has not commercially produced
or marketed the same. The defendant
obtained any manufacturing license in respect of the drug
"NILOTINIB". Defendant No.1 shall file an affidavit detailing its categorical
stand in respect ... Digitally Signed
By:DEVANSHU JOSHI
Signing Date:23.05.2022
18:01:48
"NILOTINIB".
4. List this matter on 26th May, 2022. A senior official
