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Directs BDR to Seek Before Dabrafenib Launch in Novartis Suit
The has issued an in a patent infringement suit, ordering to obtain the court's before taking any steps toward of the cancer drug Dabrafenib. Justice A.J. Bhambhani passed the order on , while hearing an application filed by Swiss pharmaceutical giant .
Apprehension Born from an RTI Response
The dispute stems from Novartis's fear that BDR was preparing to commercially launch Dabrafenib, a drug used to treat metastatic melanoma, in violation of its patent rights. The concern was triggered by an RTI response dated , from the , which revealed that manufacturing licenses for Dabrafenib, its active pharmaceutical ingredient (API), and its formulations had been sought – and granted – to certain entities, including and .
Defendants' Assurances and Limitations
, appearing for BDR, sought to allay Novartis's apprehension by submitting that the defendants held only a limited license to manufacture Dabrafenib for the purposes of "
," and that the license explicitly stated:
"Not for clinical trial unless or otherwise permitted by the licensing authority."
He further argued that
, which permits the use of a patented invention for tests and experiments necessary for regulatory approval, fully protected the defendants at this stage.
In compliance with an earlier court order, BDR filed an affidavit on , reiterating that their license was strictly limited to examination, testing, and analysis, and did not extend to clinical trials without specific permission.
Novartis Counters: No Clinical Trials Needed for APIs
, representing Novartis, contested BDR's position, arguing that for an active pharmaceutical ingredient, no clinical trials are required. He claimed that the defendants' affidavit was "inaccurate and misleading" to the extent that it suggested were necessary. According to Sibal, this made Novartis's apprehension in the action entirely justified.
Sai Deepak maintained his stance, asserting that BDR was
"nowhere close to obtaining a license for manufacturing, distributing or marketing DABRAFENIB as an API or as tablets,"
and that
on the formulation were still required.
Court's Directive: Before Commercial Launch
Taking note of BDR's own submission that they were not yet at the commercial stage, Justice Bhambhani directed the defendants to move an appropriate application before the court seeking before taking any steps towards of Dabrafenib, whether as an API or as tablets, for export or the domestic market. The court clarified that once such an application is filed, it would consider whether further orders are necessary in relation to the relief sought by Novartis.
The court further ordered that BDR's application under , which seeks , shall be considered before any other applications are taken up.
Key Observations
"Before taking any steps towards
of 'DABRAFENIB' as an API or as tablets for export and/or for the domestic market, the defendants shall move an appropriate application before this court seeking
for that purpose."
"The objections taken by the defendants in their application filed under
shall be considered before any other applications are taken-up in the present proceedings."
What Lies Ahead
The case has been listed before the on , for completion of pleadings, admission/denial of documents, and marking of exhibits. The court's ensures that Novartis's patent rights remain protected while the legal battle unfolds, requiring BDR to seek judicial clearance before any move toward commercialization of the drug.
