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In a latest to the efforts of Swiss drug firm Vifor International to protect the patent of its iron carbohydrate complex drug ferric carboxymaltose (FCM), the company has filed petitions against Indian drug majors Cipla Ltd and J B Chemicals and Pharmaceuticals seeking permanent injunction restraining them from infringement of the patent.
The Delhi High Court heard the submissions of Vifor on May 2, and posted the matter for hearing on May 11, 2023, for submissions on behalf of the defendants. Various patent litigations filed by Vifor related to the same patent have been transferred to the Single Bench for hearing.
Vifor International holds the patent for manufacturing of water-soluble iron carbohydrate complex, designated as ferric carboxymaltose or iron carboxymaltose, which is used for the intravenous treatment of iron deficiency and iron deficiency anaemia when oral iron preparations are ineffective or cannot be used. The company received the patent on June 25, 2008 with a priority date of October 23, 2002 and the term of the patent expires on October 20, this year.
The company, in its petition filed on April 24, said that it discovered marketing or promotional material in the third week of April, 2023 in respect of an intended launch of a generic version of the drug, by JB Chemicals under the name JBCarb and by Cipla under the name CipFCM. It also alleged that the launch of the products would result in infringement of the suit patent.
The company submitted to the Court details of over 20 lawsuits filed by them against third parties, where it received orders protecting its rights. It further submitted that the suit patent is a ‘product by process patent’, which covers both the product and the process.
The counsels appearing on behalf of the defendants (JB Chem and Cipla) submitted that the suit patent is only a ‘process patent’ and therefore, the plaintiffs (Vifor International) cannot be granted an ad interim injunction if the products are manufactured by the defendants by using a different process. It was further submitted by the counsels for the defendants that they do not manufacture the products themselves. The products are being manufactured by BDR Pharmaceuticals and the defendants only market the aforesaid products they submitted.
It may be noted that the war for the market of FCM in India has seen one of the unique litigations in the industry where an individual approached the Competition Commission of India (CCI) alleging that the company is maintaining control over the entire supply chain and market by entering into exclusive licensing agreement with Emcure Pharmaceuticals for the injectable FCM under the trade name Encicarb and another exclusive licensing agreement with Lupin for importation and distribution of the FCM injections named Ferinject, manufactured in Switzerland, thus restricting the production and supply of the product to charge higher prices from the consumers.
The individual also alleged that Vifor has refused to deal with another Indian manufacturer - West Bengal Chemical Industries Ltd (WBCIL), allegedly eliminating the possibility of production of relevant product at lower price, thus, resulting in harm to consumers. The company also charges unfair and discriminatory prices and Emcure has supplied FCM injectables to various public procurers at a price which is almost half the price at which it is being sold to the consumers in the open retail market, alleged the informant.
The CCI, in an order on October 25, 2022, concluded that it does not prima facie find any contravention on the part of Vifor under various sections of the Competition Act, 2002.
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