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India to issue compulsory licences on Roche, B-MS drugs World News | January 15, 2013 Kevin Grogan

Innovative drugmakers will have observed with concern plans being put in place by the Indian government to revoke patents and issue compulsory licences on another three cancer drugs - Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixempra.

Herceptin (trastuzumab) is the Swiss major's blockbuster for breast cancer), while Ixempra (ixabepilone) is a breast cancer chemotherapy and Sprycel (dasatinib) is for leukaemia. The Business Standard newspaper reported the Indian government's plan and noted that the drugs cost between$3,000-$4,500 for a month's treatment, figures which supporters of the CLs are simply not affordable for the vast majority of the country's population.

India granted its first-ever CL in March 2012, a move which allowed Natco Pharma to manufacture its version of Bayer's patent-protected liver and kidney cancer drug Nexavar (sorafenib). That move led to a 97% price reduction.

The newspaper quoted YK Sapru, chairman of the Cancer Patients Aid Association as saying that "giving a CL for a few more anti-cancer drugs is a very good move, especially for Herceptin, which was required by a large number of breast cancer patients, who were dying because the drug was not affordable". Kalyani Menon-Sen, campaign coordinator for the Campaign for Affordable Trastuzumab advocacy group based in New Delhi, said in a statement that "drug companies are holding our health hostage to their greed for profits. Roche should not be allowed to get away with such a predatory pricing policy".

However, Ranjit Shahani, president of the Organisation of Pharmaceutical Producers of India, told Business Standard that "issuing CLs is a matter of concern". He noted that there are access programmes in place by multinational pharma firms "which, very often, bring down the prices significantly".

Mr Shahani gave the example of Gleevec/Glivec (imatinib mesylate), Novartis' drug for chronic myeloid leukaemia and other cancers, which is at the centre of a high-profile case that involves the company's legal challenge against India's patent laws. He said Glivec was given free for 16,000 patients in India, covering about 95% of the patients on the drug.

He went on to say that "there has to be an interactive dialogue between the government and multinational pharma companies regarding the price difference".


India to hit Roche, BMS with compulsory licenses on 3 cancer drugs

Officials aim to usher in cheap copies of Herceptin, Sprycel, Ixempra January 13, 2013 | By Tracy Staton

India is taking another swipe at Big Pharma. Three swipes, in fact: The government has started the process of granting three more compulsory licenses, this time on cancer treatments from Roche and Bristol-Myers Squibb. That means cheap copies of the on-patent drugs could soon hit the Indian market.

The licensing moves apply to Roche's breast cancer behemoth Herceptin, and Bristol-Myers Squibb's leukemia treatment Sprycel and breast cancer therapy Ixempra. It would be the first round of new compulsory licenses since India issued its first in March, on Bayer's kidney cancer treatment Nexavar. Since then, Natco Pharma has been marketing its version at a small fraction of the branded price.

Indian officials and major drugmakers have been wrangling over patent protections and drug prices for years. Just witness Novartis' ($NVS) long fight for patent protection on its blood cancer drug Glivec; after a round of hearings at the Indian Supreme Court in December, the drugmaker can finally expect a ruling.

But the conflict intensified after a series of Indian acquisitions--culminating with Abbott Laboratories' purchase of Piramal's domestic generics business--gave Big Pharma a big chunk of the local market. The intellectual property protections India had adopted to invite foreign investment suddenly seemed less than prescient. Politicians moved into protective mode, citing worries about drug prices and access to treatment.

Coming as it did against the backdrop of the Glivec patent fight, the Nexavar compulsory license came as a shot over the bow at Big Pharma. Some drugmakers--including Roche, ironically enough--slashed prices on certain products, as if to stave off government action. And still the insults kept coming. The Indian patent office revoked IP protection on Pfizer's kidney and liver cancer drug Sutent, and pulled the patent on Roche's hepatitis C treatment Pegasys.

Meanwhile, the courts have dawdled over challenges to generic versions of still-on-patent drugs, including Cipla's unauthorized copy of Nexavar. And though a court supported Roche's patent on the cancer drug Tarceva, it also decided that Cipla's generic version didn't step on that patent. Bristol-Myers is still locked in a fight with would-be copycat Natco Pharma over Sprycel generics.

And now this. Patient advocates--and some domestic pharma executives--hailed the move, saying that compulsory licenses are the only way to get lifesaving cancer treatments to the Indian masses. Generic Nexavar sells at 95% off its precompulsory licensing price, the Indian Express says, and Herceptin, Sprycel and Ixempra are all more expensive than Nexavar ever was.

But Roche has taken its own steps to broaden access to Herceptin. Last March, the Swiss drugmaker inked a deal with India's Emcure Pharmaceuticals to produce Herceptin--and the lymphoma and rheumatoid arthritis treatment MabThera--for sale domestically at lower prices. The first products of that deal, which will sell under new brand names to protect pricing in the developed world, are expected to hit the Indian market this year.

Other pricey therapies may be next to get the compulsory licensing treatment, Indian experts have said. Drug executives have been eyeing Pfizer's Sutent and its HIV drug Selzentry, as well as Roche's Tarceva. In fact, Natco has already said it plans to knock off Selzentry, with plans to sell it for about one-fourth of Pfizer's price. But even worse for Big Pharma is the prospect of other developing markets singing to India's tune. China has already said it's considering compulsory licensing as a way to keep drugs affordable for its citizenry.


India revokes Roche's patent on Pegasys World News | November 05, 201 Lynn Taylor

India's Intellectual Property Appellate Board (IPAB) has revoked Roche's Indian patent on its hepatitis C drug Pegasys (peginterferon alfa-2b).

In 2006, Pegasys became the first drug to receive patent protection from the Indian Patent Office (IPO) since 1970, under the country's new intellectual property legislation introduced in 2005. This patent was immediately challenged by local generic drug maker Wockhardt and Sankalp Rehabilitation Trust, a civil society group based in Mumbai, using clauses in the new law that permit such challenges on the grounds that, for example, the drug was not a not a novel innovation or that it did not demonstrate inventiveness.

Wockhardt and Sankalp argued that Pegasys did not meet either of these requirements, but in 2009 the IPO rejected their challenge and upheld Roche's patent.

Sankalp subsequently appealed to IPAB, which announced its decision in favour of the group's challenge on November 2. The ruling also upheld the rights of patient groups to challenge the validity of previously-granted patents. Public interest "is a persistence presence in intellectual property law," and it is against public interest to "allow unworthy patents to be on the Register," added the Board.

The ruling suggests that generic versions of Pegasys could become available in India fairly shortly, depending on whether or not Roche decides to appeal the IPAB ruling, comments the Indian fortnightly journal Business Today.

In a statement, Sankalp said it hoped that the absence of a patent barrier would now spur generic competition "to bring down the price of this much-needed drug.

The group also called on the government to take "concrete steps" to start providing access to Pegasys, which is not currently supplied through the public healthcare system.

Treatment of chronic hepatitis C requires a six-month course of Pegasys, which costs around 436,000 rupees - although it can be purchased at a discounted price of 314,496 rupees - and is given in combination with ribavirin, which costs 47,160 rupees for a six-month course, says Sankalp.

Business Today also suggests that other alternatives for the Swiss firm could be to make the drug available in India at a much lower price than elsewhere in the world, or to link up with an Indian manufacturer and, again, sell the drug in that market at a greatly reduced price.

The decision has opened the path for other patents to be challenged, say local observers. "Concerned patients' groups will now have been clarity in challenging patents on medicines for HIV, cancer and other diseases," comments the Lawyers' Collective HIV/AIDS Unit, which represented Sankalp in this case.

According to the Unit, IPAB's ruling "rightly observed" that Roche had "used conventional methods to pegylate interferon and obtained predictable results, thereby rendering it obvious to a person skilled in the art." The Board had also correctly held that Roche had failed to satisfy the requirement of showing enhanced efficacy," said Unit director Anand Grover, adding: "we hope that the Patent Offices too follow these standards while deciding pre- and post-grant oppositions."

The changes to India's patent law introduced in 2005 followed the nation's signing, a decade previously, of the World Trade Organisation (WTO)'s Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement.

Estimates of the number of people in India infected with the hepatitis C virus are in the range of 10-12 million.

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