Novartis loses patent battle in India

NEW DELHI: Swiss pharma major Novartis AG has lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company’s plea.
A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the claim of the Swiss firm for getting exclusive rights for manufacturing the cancer drug on the ground that a new substance has been used in the medicine.
The judgment, which was keenly watched by pharma companies across the world, will clear hurdles coming in the way for the manufacture of generic drugs in India for cancer patients.
While a one-month dose of Glivec costs around Rs 1.2 lakh generic drugs, manufactured by Indian companies, for the same period are priced at Rs 8,000.
Advocate Pratibha Singh, appearing for Indian drug firms Ranbaxy and Cipla which had opposed Novartis’ plea, said that the judgment is a victory for Indian companies as they can now manufacture cheaper drugs so long as there is no patent over a medicine.
“Patents will now be granted only for genuine inventions and not on repetitive inventions. The Supreme Court said there was no new invention in the Novartis’ drug,” she said.
She also said there should be no fear that foreign firms would be affected with the verdict since as long as they have genuine inventions, patents will be given to them.
In its judgment, the apex court also held that ‘imatinib mesylate’ used in Glivec is a known substance and Novartis can’t claim patent over the drug for using this chemical.
Novartis had approached the apex court in 2009 against the order of Chennai-based Intellectual Property Appellate Board (IPAB), which had rejected its claim for patent.
The multinational company (MNC) had applied for patent in 2006. .

‘Will hinder medical progress’
Reacting to the verdict, Novartis said, “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options”. A spokesperson for the Swiss firm said it will continue to file for patents in India.
Domestic drug manufacturer associations, including Indian Pharmaceutical Alliance (IPA) and Indian Drug Manufacturers’ Association (IDMA), however, termed the apex court’s verdict as a landmark judgment in favor of poor patients.
“The decision of the Supreme Court will come as a relief to patients suffering from these dreadful diseases as several Indian companies, including Cipla, Ranbaxy and Natco, can continue marketing Imatinib at a fraction of the cost of the Novartis product,” IPA Secretary General D G Shah said in a statement.
Novartis had approached the apex court in 2009 against the order of Chennai-based Intellectual Property Appellate Board (IPAB), which had rejected its claim for patent. The multinational company (MNC) had applied for patent in 2006.
Earlier, the Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law.
Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products.
Upholding the verdict of the appellate board, the apex court said, “We firmly reject the appellants case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann patent”, its earlier patent.
“We are completely unable to see how Imatinib Mesylate can be said to be a new product, having come into being through an invention that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art.
Imatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent,” the bench said.
“In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal model.”

‘All inventions not barred
The bench, however, made it clear that the judgment does not mean that Section 3(d) of Patent Law bars protection for all incremental inventions of chemical and pharmaceutical substances.
“We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances.
“It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment,” it clarified.
“In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with cost,” the bench said.
Novartis’ claim was opposed by Indian pharma companies, as well as by health aid activists which had claimed that the MNC is not entitled for patent and it is indulging in “ever-greening” of patent by simply changing the composition of the ingredients of the drug.
Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire.
A patent on the new form would have given Novartis a 20-year monopoly on the drug.-PTI