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Supreme Court rejects AstraZeneca plea against manufacturing of low-cost versions of its diabetes drug

Dapagliflozin is marketed in India by Sun Pharma and Abbott Healthcare through licensing agreements with the British firm.

Supreme Court rejects AstraZeneca plea against manufacturing of low-cost versions of its diabetes drug
“Post along with the contempt plea,” the CJI said. (File Photo)

The Supreme Court on Tuesday rejected British pharma major AstraZeneca’s plea seeking to prevent Indian generic drugmakers from manufacturing and selling low-cost versions of its diabetes medicine, Dapagliflozin (DAPA). It asked the Delhi High Court to proceed with the matter and decide on the appeal expeditiously.

The division bench of the HC had on July 20 last year dismissed nine appeals by AstraZeneca against two separate single-judge orders that refused to restrain nine pharma companies — Intas Pharmaceuticals, Alkem Labs, Zydus Healthcare, Eris Lifesciences, USV Pvt Ltd, Torrent Pharmaceuticals, MSN Labs, Micro Labs and Ajanta Pharma – from manufacturing and selling generics of DAPA, paving the way for the sale of the diabetes drug at competitive prices in the Indian market.

AstraZeneca, which owns two patents for the novel compound, Dapagliflozin, had alleged infringement by 13 companies. Dapagliflozin is marketed in India by Sun Pharma and Abbott Healthcare through licensing agreements with the British firm.

Another HC single judge had on November 2, 2020, denied any interim relief to AstraZeneca on the grounds that its patent for DAPA had no technical advancement and hence lacked an inventive step. Even the coordinate bench of another single judge had denied any breather.

AstraZeneca told the SC that the HC’s findings on principles of law by two different benches “were diametrically contrary to each other on as many as seven out of nine grounds” and despite a clear contradiction, the division bench refused to interfere with either decision. “Upholding both the decisions is fundamentally flawed as it leaves the law in a confused state, with both right-owners and the generic companies unclear on which of the two decisions to follow,” it said, adding that “the impugned judgment has created a paradox, thereby leaving the law unclear, ambiguous and in a confused state”.

Terming it a blockbuster drug, which has attained phenomenal success worldwide in the treatment of Type 2 diabetes, AstraZeneca in its appeal stated that DAPA was “purely manmade and not found in nature”. The drug is protected by two patents — one for the skeletal structure granted in 50 countries and the other covering Dapagliflozin alone granted in over 70 countries — it said, adding that the first expired on October 2, 2020, and the other one is due to expire on May 15, 2023.

The division bench had also imposed a fine of `45 lakh on AstraZeneca for “trying their chances” before different benches, which the British pharma firm termed “completely wrong and incorrect”.

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