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15. Similarly, paragraph 37 of the plaint in the Cadila suit, which sums up the aforesaid submissions of the plaintiffs, is set out below:-

"37. In view of the above, (i) the RCGM approvals for preclinical trials for the Defendant's Drug; (ii) the approval of the Defendant's CTR by Defendant No. 2 on March 10, 2014; (ill) the clinical trials purportedly conducted by Defendant No.1 pursuant to the Defendant's CTR; (iv) the SEC Recommendation; (v) the Package Insert Recommendation; (vi) the Manufacturing Authorisation; (vii) the manufacturing and marketing authorisation received from the State FDA; and (viii) the NOC for Additional Indications are in violation of the Drugs Act, the Drugs Rules and the Biosimilar Guidelines. Defendant No. 1 has failed to establish bio similarity between the Defendant's Drug and the Plaintiffs' Trastuzumab on the basis of the clinical trials purportedly conducted pursuant to the Defendant's CTR. Consequently, the launch and marketing of the Defendant's Drug for all three indications i.e. HER2+ metastatic breast cancer, HER2+ early breast cancer and HER2+ metastatic gastric cancer) is in violation of the Drugs Act, the Drugs Rules and the Biosimilar Guidelines and deserves to be restrained by this Hon'ble Court."

"(a) a decree of declaration that the Defendant's drug, a purported biosimilar version of the Plaintiffs' bevacizumab, has not been tested as a bio-similar product under applicable laws;

(b) a decree of declaration that Defendant No. 3's CTR Registration Number CTR/2015/05/005757 dated 08 May 2015, which was last modified on 04 August 2015, is invalid and is not in accordance with applicable laws;

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(viii)an injunction restraining Defendants No. 1 from representing the Defendant's Drug as a biosimilar version of the Plaintiffs' Trastuzumab or of HERCEPTIN®, HERCLONTM or BICELTIS® or from claiming similarity and/or comparability with 'Trastuzumab' or with HERCEPTIN®, HERCLONTM or BICELTIS® until biosimilarity between the Defendant's Drug and the Plaintiffs' Trastuzumab is established pursuant to appropriate tests under the Drugs Act, the Drugs Rules and Biosimilar Guidelines;"

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132. It is a matter of fact that the defendant No.2 is claiming that the approvals have been granted as per Act and approval and all the requisite clinical trials have been conducted. It is also stressed by the defendant No.2 that after approvals they are entitled to refer its drug as biosimilar to the drug of the plaintiffs and they can declare to all hospitals, doctors and the entire world that their product is biosimilar and can compare both drugs. In view of such circumstances, the party has a right to know that under what circumstances the approvals were granted to the defendant No.2 of their bio-similar product or not. The plaintiffs are the aggrieved party. One fails to understand that once the approval is granted why now the data used by defendant No.2 before defendant No.1 cannot be examined by the plaintiffs. Though record has been submitted by the defendant No.1, this Court is not an expert for comparing characterisation of two Roche India Pvt Ltd & Ors v. Drugs Controller General of India and Ors, [2016 SCC OnLine Del 2358] drugs of the parties. Further the aggrieved party is entitled to know the nature of the clinical trials conducted by the party who intends to use the biosimilar drug of the innovator.