Delhi High Court has put on hold the government's decision to procure around 1.5 crore tablets of a medicine used to bring down drug addicts' dependancy on opiates like heroin and reduce their habit of injecting drugs which involves the risk of contracting and transmitting HIV.
Justice Sanjeev Sachdeva stayed the procurement order for Buprenorphine placed by the Ministry of Health with drug company Verve Human Care Laboratories on a plea by Rusan Pharma Ltd, which has contended that the government could not have entered into a private contract for getting the medicine when public money was involved.
Rusan submitted before the court that initially in 2014, a tender was floated for procurement of the medicine in which it was the second lowest bidder while Verve came in third.
However, the successful bidder was later debarred and the purchase order was issued to Rusan, its petition said.
In 2016, the government approached Rusan to procure the medicine at a price which was offered by the debarred successful bidder and the company had agreed to it, it said.
Rusan has claimed in its plea that it came to know later that the government had issued purchase order in favour of Verve.
Central government standing counsel Anurag Ahluwalia told the court that a fresh tender for procuring the drug would be floated soon and the purchase order under challenge was issued only as a stop-gap measure.
The court while putting on hold the procurement order asked the government and Verve to file their responses to Rusan's plea and listed the matter for further hearing on June 13.
Bayer, in its plea, had contented that once the patented
invention is permitted to be sold by way of export for regulatory approvals, the court will no longer have the jurisdiction to ensure that the exports are used for that purpose only.
Rejecting the contention, the court said the Patents Act was concerned with protection of the rights of the patentees in India only and not outside India.
"Neither our legislature, nor this Court can impose any condition on the use of the goods exported once they reach the destination country," it said.
It further said that "the laws of this country are only concerned with the sale by way of export from this country being for the purposes prescribed. As long as the sale by way of export is declared to be for purposes of section 107A and there is nothing to suggest that it is otherwise, no fetters can be imposed."
Natco has a compulsory licence for selling Sorefenat in India and the court said that grant of compulsory licence would not come in the way of the Indian company exercising its rights under section 107A.
"I thus hold that Natco as a non-patentee cannot be deprived of making, constructing and selling by way of export a patented invention for purposes specified in section 107A for the reason of having been granted the compulsory licence," the judge said.
The court had in March 2014 restrained the sale of Sofranet covered by the compulsory licence overseas.
The court had allowed Natco to export a small quantity, of less than 15 grams, for the purposes of clinical trials.
Later, in November 2014, the court had ruled that Natco could export one kilogram of the active pharmaceutical ingredient Sorafenib for the purpose of clinical trials.
Alembic wanted to export its generic version of the blood thinner to Brazil and Palestine for regulatory clearances.
