Landmark Verdict- Novartis Plea for Patent Rejected by Supreme Court

Novartis plea for the patent of drug used to treat Cancer has been rejected by Supreme Court. Novartis is a Swiss pharma company present in India since 1947.

What was the issue with Novartis of which it was claiming Justice?

Novartis was seeking Patent for the beta crystalline salt form of Imatinib Mesylate, a modified  form of Imatinib Mesylate, a drug used to treat chronic Myeloid Leukaemia(CML), a type of blood cancer.

The company’s price for its version of the drug, sold under the brand name of Glivec, is Rs 1,20,000 per month per person, but the generic version available in the market costs around Rs 8000- Rs 12000 Per Month. Hence, Novartis had applied for patent of the drug, to make the price more competitive and to stay in the business.

What are the series of events that led to the case in the Supreme Court?

In 1997- Novartis filed a patent application in India for its drug Glivec.

In 2005- India introduced the Indian Patent Act to prevent the evergreening or patenting  of new forms of already known molecules.

In Jan 2005- The patent controller in chennai denied Novartis the sought Patent.

In May 2006- Novartis challenged the Indian govt and four other Companies in Madras Court.

In Aug 2007- The Madras court ruled against Novartis’s Case.

In June 2009- The intellectual Appellate Board rejected a fresh appeal.

In Aug 2009- Novartis approached Supreme Court of India

In April 2013- Supreme Court Denied the Patent

Which section of Indian Patent Act was causing Problem to Novartis?

Novartis sought to overturn Section 3 (d) of Patent Act, 1970, an amendment introduced by parliament in 2005, that disallows patenting of new forms of already known molecules, unless the patent applicant shows significant enhancement in efficacy of its product.

What is the verdict of Supreme Court?

The court said that the Patents (Amendment) Act, 2005 established that the ” mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not an invention for the purpose of Patenting.

The bench dismissed the argument that the new form of drug is more soluble than the earlier saying that it does not pertain to increased efficacy of new form of drug.

The court held that patents can be granted only for medicines that are truly new and innovative. For new forms and new uses of existing medicines, applicants of patent must prove increased efficiency.

Who is going to be benefited?

The landmark verdict of Supreme Court has recognized the right of patients to access of affordable medicines.

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