While a one-month dose of Glivec costs around Rs1.2 lakh generic drugs, manufactured by Indian companies, for the same period are priced at Rs8,000
Swiss pharma major Novartis AG today 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 judgement, 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 Rs1.2 lakh generic drugs, manufactured by Indian companies, for the same period are priced at Rs8,000.
Advocate Pratibha Singh, appearing for Indian drug firms Ranbaxy and Cipla which had opposed Novartis’ plea, said that the judgement 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 judgement, 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 Supreme 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.
Novartis' claim was opposed by Indian pharma companies, which are manufacturing generic drugs, as well as by health aid activists in the apex court.
They 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.
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.
During the arguments earlier, Novartis had tried to dispel the impression that its drug would be beyond reach of poor cancer patients due to its high cost.
“The purpose is not to make money from the poor. This is not the purpose, but am I not entitled for patent for our drug? We are fighting the case on principle,” senior advocate Gopal Subramanium, appearing for Novartis, had said.
He had submitted that there should be no cause of concern that the poor would not get treatment and had claimed that 85% of such patients are treated free under its scheme.
Constant power cuts weighed on the manufacturing sector. Moreover, the volume of incoming new work increased at the slowest pace in 16 months and export orders expanded at the slowest pace in seven months
The country’s manufacturing sector witnessed the slowest rate of expansion in 16 months in March as power outages hampered production activity and decline in new business orders, according to observations made by an HSBC survey.
The HSBC India Manufacturing Purchasing Managers’ Index (PMI)—a measure of factory production—stood at 52 in March down from 54.2 in February.
Constant power cuts weighed on the manufacturing sector. Moreover, the volume of incoming new work increased at the slowest pace in 16 months and export orders expanded at the slowest pace in seven months, HSBC said.
Though the index has remained above the 50 mark, below which it indicates contraction, for more than three years now.
The PMI reading for March showed that manufacturing operating conditions in the country has improved at slowest rate since November 2011.
“Manufacturing activity lost momentum in March, with output growth slowing notably on the back of a deceleration in new orders and power outages,” HSBC chief economist for India & ASEAN Leif Eskesen said.
India’s current account deficit hit a record 6.7% of GDP in December quarter to $32 billion on account of surge in oil and gold imports, besides weak exports, according to data released last week.
Eskesen further noted that output could get a lift in coming months as inventories are replenished. Inventories of finished goods were depleted to meet demand, partly due to the output disruptions caused by power cuts.
Meanwhile, HSBC said even as input as well as output prices increased at a moderate pace during March, the scope for further monetary policy easing remains ‘limited’.
“Encouragingly, input and output price inflation eased.
“Even so, the scope for further monetary policy easing remains limited,” Eskesen said.
Redressal of consumer complaints can entail approaching the insurance ombudsman, the consumer courts and even taking help of social media, RTI and police complaints. There are options available today to build pressure on errant service or goods providers so that they do the needful
A letter from Mohan Siroya, chairperson of the Consumer Complaints Cell, gives three examples of consumer power success using the help of the insurance ombudsman, Right to Information (RTI), social media activism and police complaints. Today, justice will be served if you are persistent in your efforts to pursue the errant service or goods provider. A consumer court may not be able to help in the absence of the postal address, but alternate means exists.
Case 1: A senior citizen was hospitalized in Seven Hills Hospital, Mumbai. New India Assurance Company refused to pay the claim of Rs12,148 submitted in August 2010. It argued about the lack of the original hospital bill/receipt, even though the insured provided documentary proof of having submitted the same. The insurer wrote a letter to the hospital asking for certain documents, including the hospital bill. It was but natural for the hospital to write the word ‘Duplicate’ on the bill as the original was already issued at the time of discharge. The insurer refused to accept this and declined to reimburse the claimed amount.
In the complaint to the insurance ombudsman, there was a claim of not only the claim amount but also‘compensation’ for undue delay in not settling/refusing to settle the claim on a flimsy or false ground and deliberate “mental torture” caused to a senior citizen. The ombudsman passed an award granting not only of the claimed amount, but also a penalty of Rs2,000, directly favouring the complainant in settlement within three working days, failing which a fine of Rs500 would be payable by the company for each day of delay. Usually, the ombudsman does not levy penalty, but it did in this case on the insurance company for wrongful delay and refusal.
Case 2: A consumer had purchased two heaters, which were offered cheap on the Deal92.com website as an online transaction. The online payment was made through a credit card. When the consumer received the ordered goods they were found in broken and in non-usable condition. The consumer protested on the only ‘email’ address available demanding either the replacement of goods or refund of entire paid amount. There was no response even after reminders. The National Consumer Helpline was unable to take the complaint for redressal in absence of any postal address of Deal92.com. Mr Siroya took recourse of putting this complaint on social networking websites. That defiled their name and potential customers were cautioned. The aggrieved consumer was also advised to raise a formal dispute to deny the payment made to the online merchant and treat it as a fraudulent transaction. This was done and a temporary credit was given in his account. This was further refurbished, when a complaint was filed with the cyber cell regarding this online fraud and praying to ban the seller’s website. That made Deal92.com to act. They refunded the entire amount to the same credit card account.
Case 3: As a consumer activist, Mohan Siroya had filed a case at the MIDC police station for having received a threat on his mobile in May 2010, “threatening me to stop lodging complaints against the companies for Consumer Cause and Protection”. This particular case he was referring for the company “Fedders Lloyd” against which a complaint was sent by him to the then Union minister for civil supplies and consumer protection, Sharad Pawar. Another non-cognisable (NC) complaint was filed by him in the MIDC police station against a firm called “Modern Tech Services” for having failed to give the contracted service for second year of the contract. Mr Siroya tried to contact the firm’s office and proprietor but all the listed phones were not working/not in existence. A written notice was sent by Mr Siroya to the postal address printed in the contract/letter head. It transpired that now in that premises some other business, by some other party, was carried out. Mr Siroya filed a complaint of cheating and fraud for having failed to give the contracted service or refund of 50% of paid amount against the firm, whose address was now ‘Unknown’.
The police was requested to find out the person in whose account the cheque/ money was paid and his whereabouts. Mr Siroya made an application under RTI to know the progress. It came in mere two words “Under Investigation”. He then appealed to the First Appellate Authority (FAA) for specific “status/progress” of investigations made, besides complaint of delay in providing information. The FAA also simply ordered “As earlier informed Under Investigation”. The order reached Mr Siroya beyond 45 days of appeal date, thus another violation of the Act without giving any reasons for delay.
Mr Siroya went in for a second appeal to the SCIC (State Chief Information Commissioner), who within five months, heard his appeal. On the eve of hearing date, a police constable personally came to his home to deliver a letter that said, “In first NC, the police filed a case against one Mr Gupta under Section 504, 506 of IPC.” The second NC complaint against Modern Tech Services was of civil nature and I should go to the civil/consumer court,” Mr Siroya said.
In the hearing, the SCIC upheld delays under the Act and also for suppressing the available investigation progress/report on record. The Authority also agreed with the interpretation that in absence of a party whose whereabouts are unknown, is covered under ‘Fraud’ and thus the police is supposed to take cognisance of the same.
The SCIC further gave two specific directions—to summon the SPIO (State Public Information Officer) in person to explain “Why penalty under Section19 (8) (g) and Section 20 (1) should not be levied on him”, failing which orders will be passed under Section 20 (2)”. “Another landmark relief for me was that the concerned offices should furnish me an opportunity to inspect the information so far available on record on all such files free of charge. After two days, police started investigating about the address of the payee through the banking channels,” Mr Siroya stated.
The police machinery worked overtime, gave Mr Siroya updated information in both the cases, one through the CBI, as Fedders Lloyd Co was from Delhi. The other one they traced through the banking channel in Mumbai and made him to refund Rs1,000 in cash.