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9 Jun 2015

Case Study: Recent case of patent refusal of Novartis on anti-diabetes and Wyeth’s cancer drug in India in section 3(d) of Indian Patent Act

Patent refused to Novartis on anti-diabetes formulation

The Indian Patent Office (PO) in Delhi, has recently refused to grant a patent for an application of Novartis, the Swiss pharmaceutical company, for a modified release formulation of its diabetes drug, Vildagliptin, which it markets under the brand name of Galvus.Galvus1

Novartis has been engaged in litigation with some Indian companies on a patent for Vildagliptin in India.

The company filed an application with the PO in November 2007.

As per patent office statement reason of refusal is mentioned below –

Claims failed to meet the requirements under Section 2(1)(j) of the patent law, which says an invention means a new product or process involving an inventive step and capable of industrial application. The company also failed to meet the requirements of Section 3(d) and 3(e) of the Act, he said. So, a grant of patent was refused.
Wyeth denied patent for cancer drug

Wyeth, which was acquired by US- based pharma major Pfizer Inc, has suffered a major setback in India with the country’s patent office rejecting the company’s application for an injectable form of its renal cell cancer drug, Temsirolimus, marketed under trade name Torisel. torisel-logo_1
The patent office order came in response to a pre-grant opposition filed by Fresenius Kabi Oncology, which alleged that the ‘invention’ was publicly known in India before the priority date of Wyeth’s claim.
Fresenius also submitted that the invention was obvious and clearly did not involve any inventive step, and the applicant had failed to disclose to the controller the information required under Section 8 — relating to the status of the patent in other countries.

Dismissing the application,  assistant controller of patents and designs, Kolkata, said; “I hereby accept the representation filed by opponent under section 25(1) to read with rule 55(1) and refuse the patent application. I am further of the opinion that efficacy is related to therapeutic efficacy and is not related to stability of the compound. I am unable to find out any effort in the specification to prove the same as the applicant of the instant patent application has not shown any efficacy by way of experimentation and therefore held that the composition of instant invention is not patentable under section 3 (d) of the Patents Act.”

Section 3(d) of the Patents Act said the mere discovery of a new form of a known substance, which did not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus, unless such known process results in a new product or employs at least one new reactant, is not an invention within the meaning of the Act. Section 3(e) states a substance had by a mere admixture, resulting only in the aggregation of the properties of the components thereof, or a process for producing such a substance, is not an invention within the meaning of the Act

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