Pharma Cos against patent linkage – Government considering easing the linkage requirement

The pharmaceutical industry in India for long time has been opposing all efforts of Bayer Corporation to connect patent status of a drug to regulatory approvals. Their efforts to oppose have gotten more stronger.

In 2009, honorary High Court of Delhi in Cipla V. Bayer had smeared the efforts of Bayer to connect patent status of a drug with regulatory approvals. The High Court had ruled that grant of a patent on a drug and regulatory approvals for producing generic version of the same are two separate issues. Further, the court concluded that the drug approval authorities are under no obligation to look into the patent status of the drug and consequently deny regulatory approvals to generic manufacturers who want to manufacture the drug. The court also opined that regulatory approvals are only to ensure safety of the proposed generic version of a drug. However, later Bayer challenged the decision of the High Court in the Supreme Court. The hearing of the matter in the Supreme Court is scheduled to commence shortly.

Now, in a recent statement the pharmaceutical industry has appealed to the government to completely lay to rest the patent linkage issue. The industry has appealed to the government to remove the clause on ‘Patent status’ in Form-44 of D&C rules. 

Recently, reports have emerged that the Indian drug makers met health minister Ghulam Nabi Azad in Mumbai to strengthen their appeal. “The minister saw some sense in our recommendation and agreed to it. Why should the drug regulator have any linkage with the patent status of a drug?” said Daraa B. Patel, secretary general of the Indian Drug Manufacturers’ Association. This clearly shows that the proposal has been considered by the government, and the health ministry may move soon to remove a question on the patent status of a drug from the form that medicine companies. This is a big blow to Bayer’s efforts of connecting drug approval with patent status of a drug

Inohelp Consulting Solutions Pvt. Ltd.

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