Can’t restrict patented products with applications: NPPA

The National Pharmaceutical Pricing Authority (NPPA) has asserted that it is legally required to give the retail price to the existing manufacturers on the receipt of their application for price approval. According to law, patent disputes on a drug cannot affect this process.

National Pharmaceutical Pricing Authority (NPPA) decided the several representations sent by pharma major Boehringer Ingelheim and the Organisation of Pharmaceutical Producers of India (OPPI). Both of them had applied against the retail price fixation of new drugs, the fixed-dose combinations (FDCs) comprising linagliptin and metformin tablets and sitagliptin and metformin tablets. These diabetes drugs are on the verge of becoming off-patent, according to the National Pharmaceutical Pricing Authority (NPPA) documents,

Linagliptin is a compound patented by Boehringer Ingelheim, and sitagliptin is a compound patented by Merck Sharp and Dohme. According to National Pharmaceutical Pricing Authority (NPPA), linagliptin will become off-patent in the year 2025, while the patent rights for sitagliptin are expected to expire in the next few months.

Boehringer Ingelheim informed the National Pharmaceutical Pricing Authority (NPPA) that it had received an injunction order from the High Court of Himachal Pradesh which restricted Macleods Pharmaceuticals Ltd from manufacturing and selling the product under the brand name Linmac and Linaone.

However, National Pharmaceutical Pricing Authority (NPPA)’s legal division opined that the case between Boehringer Ingelheim and Macleods Pharmaceuticals is only a civil suit between two private parties contesting their rights for the patent of a particular drug. NPPA regulates and monitors the prices of pharma drugs in the country and must ensure that affordable medications are available to the public in compliance with the Drugs (Prices Control) Order (DPCO).

According to the law, when the existing manufacturer of a pharma drug with dosages and strengths as specified in the National List of Essential Medicines (NLEM) must launch a new drug, they should apply for the price approval in a specific form under the Drugs (Prices Control) Order (DPCO). Para 15 of the Drugs (Prices Control) Order (DPCO), 2013, provides the fixation of the retail price of a new pharma drug for the existing manufacturers of the scheduled formulation. Para 15(3) mandates the union government of India to forward the application to the Standing Committee of experts, who must recommend the retail price within thirty days from the receipt of the application.

The National Pharmaceutical Pricing Authority (NPPA) also observed an Office Memorandum from the Department of Promotion of Industry and Internal Trade, Ministry of Commerce and Industry, on August 8, 2019, has clearly stated that the Indian Patents Act, 1970 does not contain any provisions to link the patent rights to marketing approval for a product. It also asserted that the Drugs (Prices Control) Order (DPCO) does not require the Drug Controller General of India (DCGI) to check whether a patent exists on a drug for which an application for marketing approval has been received. The Drug Controller General of India (DCGI) is not empowered to take that view.

The Office Memorandum further commented that the National Pharmaceutical Pricing Authority (NPPA) takes decisions for fixation of retail prices as per Drugs (Prices Control) Order (DPCO) 2013 and relevant laws. It is not technically qualified to decide on the existence and scope of any patents in the proposed formulation.

“DPCO, 2013 does not provide any express distinction between patented and non-patented drugs. Since Para 15 (3) of DPCO, 2013 is a mandatory provision, not a directory provision. Therefore the Government is obligated to give retail price to the existing manufacturer on the receipt of the application for the price approval of the new drug for the compliance of DPCO 2013,” National Pharmaceutical Pricing Authority (NPPA) claimed.

“Furthermore, patents are private rights that are to be enforced by the patent owner. If any other entity infringes on the rights, the patent owner can initiate legal proceedings against them,” it observed.