NV Organon, a subsidiary of US-based Merck & Co — one of the largest pharma companies in the world — has failed to secure a patent in India for its invention on a female contraceptive kit. The kit, which comprises a vaginal ring, is used in cyclical dosage and has a reminder system.
Organon has a similar product under trade name NuvaRing (etonogestrel/ethinyl estradiol vaginal ring), which received initial US approval in 2001 and has been marketed worldwide.
The Chennai patent office rejected the company’s application that had 36 claims originally, citing lack of inventive steps. It said that many aspects of the invention were not patentable under various sections of the Patent Act.
B Ahilan, assistant controller of patents & designs, Chennai, refused to proceed with the application, pointing out that the claims related to a reminder system for a dosage regimen do not constitute an invention under Section 2(1)(j) of the Patents Act.
Organon submitted that the invention was a female contraceptive kit which comprised at least two dosage forms, each form to be used in one of two sequential cycles and to be started on a numerical date. This will have a reminder system for a dosage regimen.
“They are describing direction to the user, that is an individual, so the users have to decide and remember the numerical date individually and follow strictly, while the product will not send reminder automatically,” the assistant controller said.
The order said that though the invention was not claiming a mathematical formula or equation, the dosage forms of the kit were directed to be used by way of a mathematical method. Therefore, the invention attracts section 3(k) of the Patents Act, which was not patentable, it said.
“It strikes in my mind that the directions for such type use of any product may be described in the form of guide or catalogue of that particular product which forms the subject of copyright,” the assistant controller said. According to the company, the dosage portion includes a vaginal ring and patch.
The patent office further observed that the kit didn’t have any detailed technical feature. It was clear that the dosage form was a vaginal ring and patch comprising estrogen compounds. The individual components thatb make the kit are known, namely vaginal ring, patch, estrogen compounds and progestogen compounds and are known in prior art.
Referring to the entire disclosure with reference to the claims, the patent office further said it could not find drawing and detailed explanation to show that how the kit would be.
The patent office also raised objections saying the subject matter disguises methods of treatment of human beings and hence the claims do not meet the requirement of Section 3(i) of The Patents Act 1970.