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Latha Jishnu: Setting aside Bayer's 'spurious' claims
Two weeks ago Justice S Ravindra Bhat of the Delhi High Court dismissed with costs the writ petition filed by the German pharmaceuticals giant Bayer Corporation against the Union of India, the Drug Controller General of India (DCGI) and Cipla. The importance of Justice Bhat’s judgment cannot be overestimated. It is a clear — and sharp — judgment that puts paid to attempts by foreign companies to modify India’s regulations to suit their commercial interest.
The judge characterised the litigation as “a speculative foray; an attempt to ‘tweak’ public policies through court mandated regimes” and, in a first of its kind, awarded costs of Rs 6.75 lakh. The amount, far from being punitive, is to be shared by the government and the third respondent Cipla, one of India’s top drug companies. However, the point that the judgment makes is strong: Companies with deep pockets may “achieve short term goals of keeping out competitors through interim orders” but the court will impose ‘realistic costs’.
Patent offices to employ 1,600 personnel- Jobs-News By Industry-News-The Economic Times
India's patent offices, which has embarked on a modernisation programme, will employ 1,600 personnels in the next three-four years, a s
enior government official said on Wednesday.
As the country is emerging as a global hub for industries such as IT, pharmaceuticals, biotechnology, entertainment and research and development, its patent office will digitalise all trademark and patent records by March 31, 2009, Department of Industrial Policy and Promotion (DIPP) Joint Secretary N N Prasad said at a seminar here.
The Hindu Business Line : SC appoints new technical member for Glivec case
All decks seem to have been finally cleared for the review of the rejection of Novartis’ patent on its cancer drug Glivec. The Supreme Court has appointed Dr P.C. Chakraborty, of the Patent Office in Kolkata, as technical member on the Intellectual Property Appellate Board (IPAB) for the review of this case.
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The reason for Novartis’ concern was that the earlier technical member appointed to the IPAB, Mr S. Chandrasekaran, was the former Patent Controller under whom Novartis’ patent on Glivec had been rejected in the first place, in January 2006.
The new technical member Dr Chakraborty is Deputy Controller of Patents and Designs at the Kolkata Patent Office, and his name was selected from a list of 20 patent attorneys and 22 patent controllers that the Centre submitted to the apex court, a legal source handling the case told Business Line.
Ranbaxy loses Lipitor patent case in Denmark
Pfizer has won a patent challenge in Denmark by India’s largest drug-maker Ranbaxy Laboratories on atorvastatin, the active ingredient of the world’s largest selling cholesterol drug, Lipitor, which has global sales of over $13 billion.
A Pfizer statement said that the Eastern Division of the High Court in Copenhagen (Denmark) upheld the basic and salt patents on Lipitor. The basic patent on Lipitor expires in November 2011 in Denmark and the salt patent in July 2010. The decision, which is subject to an appeal, prevents launch of Ranbaxy’s generic version before November 2011.
“Our settlements cover more than 90-95 per cent of the Lipitor market and the existing litigations are insignificant,” commented a Ranbaxy spokesperson.
Peace on patents to boost Ranbaxy
Ranbaxy expects the settlement with Astrazeneca on Nexium, the world's second largest selling drug with annual global sales of around $5.5 billion, to fetch $1.5 billion in exclusive sale of its generic version and supply of raw materials. The out of court settlement with Pfizer on Lipitor is expected to generate even more revenues in the coming years.
By doing out of court settlements, Ranbaxy has opened multiple revenue streams from these products. Apart from generic clones, it can supply authorized generics as well as bulk drugs to some of these innovator companies.
Settlement of patent litigations, said the source, has brought certainty to the company's cash flows, besides saving it millions of dollars in legal fees. Ranbaxy still has 14 patent challenges going on at the moment. However, the source said, it may not settle all of these out of court.
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Ranbaxy expects the settlement with Astrazeneca on Nexium, the world's second largest selling drug with annual global sales of around $5.5 billion, to fetch $1.5 billion in exclusive sale of its generic version and supply of raw materials. The out of court settlement with Pfizer on Lipitor is expected to generate even more revenues in the coming years.
By doing out of court settlements, Ranbaxy has opened multiple revenue streams from these products. Apart from generic clones, it can supply authorized generics as well as bulk drugs to some of these innovator companies.
Settlement of patent litigations, said the source, has brought certainty to the company's cash flows, besides saving it millions of dollars in legal fees. Ranbaxy still has 14 patent challenges going on at the moment. However, the source said, it may not settle all of these out of court.
Patent office launches interactive Web services
Making a call at a Government office to get answers related to patents or trademarks may have been a disappointment. But now, the Indian Patent Office has launched a Web-based interactive service that would respond to your queries.
The chat services that were started from Monday by the intellectual property office of India would be available everyday from 3 p.m. to 4 p.m.
The officials from the patent office would be at your service to solve any of your problems in their respective capacity.
And in case they are unable to, they would guide you to the right link.
“This is mainly to provide public patent or trademark-related guidance, which we were finding difficult to answer over the phone,” said Government officials.
The helpdesk would try to address as many issues as it can in an hour’s time and in case it is not able to answer some of them, it would save those queries and send their response through e-mail.
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Making a call at a Government office to get answers related to patents or trademarks may have been a disappointment. But now, the Indian Patent Office has launched a Web-based interactive service that would respond to your queries.
The chat services that were started from Monday by the intellectual property office of India would be available everyday from 3 p.m. to 4 p.m.
The officials from the patent office would be at your service to solve any of your problems in their respective capacity.
And in case they are unable to, they would guide you to the right link.
“This is mainly to provide public patent or trademark-related guidance, which we were finding difficult to answer over the phone,” said Government officials.
The helpdesk would try to address as many issues as it can in an hour’s time and in case it is not able to answer some of them, it would save those queries and send their response through e-mail.
Ranbaxy gets mixed verdict on Pfizer’s Lipitor in Australia
In a partial victory for Ranbaxy Laboratories in its patent litigation against Pfizer, an Australian court has ruled in favour of the Indian company in a case relating to Atorvastatin, the world’s largest selling cholesterol-lowering drug (marketed by Pfizer as Lipitor).
The court at the same time also ruled that a proposed Ranbaxy generic product under a different patent infringed Pfizer’s basic Lipitor patent.
The Federal court had ruled that one of Pfizer’s patents was invalid for inutility, false suggestion and misrepresentation in obtaining the grant of Australian patent.
Mr Jay Deshmukh, Ranbaxy’s Senior Vice President-Global Intellectual Property, noted, “We are pleased with this decision as it stands, as it advances the entry of Ranbaxy’s generic atorvastatin in Australia to May 18, 2012.”
The ruling, the culmination of a lawsuit filed in 2005 by Ranbaxy, preserves Lipitor’s patent coverage in Australia through May 2012. Ranbaxy can appeal the decision.
Financial Express : New DGCI system to make life easier for the pharma industry
In an effort to facilitate the fast growing Indian pharma industry to position itself globally, Drugs Controller General of India (DGCI) has initiated a centralised uniform system for various processes of the industry.
“Online real time system for various approvals will be fully operational within two to three,” the new DGCI DrSurendra Singh said, while inaugurating a seminar on ‘How quality pays’, organised by the Indian Drug manufacturing Association.
Singh said 60% of the delays faced by the industry was in getting test licence, export NOC and to get approval for conducting clinical trials and all these delays will be addressed by setting up a system e-governance by digitalising offices (both head office and regional offices) and having interactive portals.
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In an effort to facilitate the fast growing Indian pharma industry to position itself globally, Drugs Controller General of India (DGCI) has initiated a centralised uniform system for various processes of the industry.
“Online real time system for various approvals will be fully operational within two to three,” the new DGCI DrSurendra Singh said, while inaugurating a seminar on ‘How quality pays’, organised by the Indian Drug manufacturing Association.
Singh said 60% of the delays faced by the industry was in getting test licence, export NOC and to get approval for conducting clinical trials and all these delays will be addressed by setting up a system e-governance by digitalising offices (both head office and regional offices) and having interactive portals.
DGCI office is trying to fix time frame for all the procedures of not more than eight weeks, including issuing of test licenses, NOC for export and clinical trials, in cooperation with the pharma industry.
Pharmaceutical firms opt for inlicensing to push sales
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Ranbaxy Laboratories, Dr Reddy's Laboratories, Nicholas Piramal and other pharmaceutical companies are betting on inlicensing or strategic marketing tie-ups to help grow local sales after India banned copying of patented drugs.
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ndian drug makers are forging alliances with overseas companies such as CD Pharma, Gnosis SpA, Crawford Healthcare and Syrio Pharma to sell drugs for chronic and acute cases.
These companies are doing so because it fetches higher profits vis-a-vis investments and is less risky after the world's second most populous nation adopted drug patents in 2005.
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China to grow rice in Tanzania as global food shortage worsens
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China, the world's biggest grower of rice, will start planting the grain in Tanzania next year as global food shortages create investment opportunities for the Asian country, a government report said.
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Financial Express : Patent Trials
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With drugs worth $60 billion going off patents in the US pharma market by 2011, Indian firms known for their expertise in copycat making are moving away from patent offices and aggressively taking the litigation route to get exclusive marketing rights in different parts of the world. Indian majors like Dr Reddy’s Labs, Sun Pharma, Glenmark and Ranbaxy have already entered into patent litigation with US-based MNCs to get the major chunk of the revenue from the sales of blockbuster drugs (having sales over $1 billion) in the US.
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The number of Paragraph IV abbreviated new drug applications (ANDA) submitted by Indian firms in the US has increased manifold in the last few years and what makes this more attractive is the chance for getting 180-day marketing exclusivity. “As part of building a large generics business through Glenmark Generics Limited (GGL), our Paragraph IV strategy would offer significant value,” says Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Ltd.
According to the US FDA, a Paragraph IV certification begins a process in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts prior to the expiration of the patent. Paragraph III ANDAs can be submitted before the patent expiry, seeking marketing approval for the drug once the patent expires. Paragraph IV ANDA submission enables the applicant to prove that such patent is invalid or will not be infringed by the generic drug, for which approval is being sought.
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