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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.
Ranbaxy buyout awaits CCEA nod
Japan's Daiichi Sankyo's proposal to acquire Ranbaxy will go to the Cabinet Committee on Economic Affairs (CCEA) for approval. Any foreign deal exceeding Rs 600 crore has to be approved by the CCEA under the existing policy.
Industry secretary Ajay Shanker told reporters that he does not see any problems related to the Tokyo-based Daiichi Sankyo's controlling bid on Ranbaxy Laboratories. The takeover is valued at $ 4.6 billion (Rs 19,780 crore).
The open offer by Daiichi to acquire upto 20 per cent of Ranbaxy's shares will close on September 4
Ranbaxy buy may hit generic drugs supply
Ranbaxy has been aggressive in supplying generics, like anti-AIDS drugs, to developing countries, the company has participated in pre-grant oppositions in India (where a patent application is opposed before the Patent Office takes a decision) and it has been able to make similar versions of drugs like Tamiflu, used in the case of bird-flu, even as the patent situation was not clear.
This generic orientation could get influenced under the new owner and that would affect the supply of low-cost medicines to patients in India and other developing countries, the Centad representative said.
Corporate mergers and acquisitions in the pharma segment should not be viewed with the same lens as a regular corporate deal, as it could affect access to medicines, he added.
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.
Ranbaxy begins operations in Yemen
Pharma-major Ranbaxy Laboratories Ltd on Wednesday said it has commenced its operations in Yemen, strengthening its presence in the West Asian region.
Ranbaxy has tied up with Pharma Ltd (Natco) as business partners for its Yemen operations. Ranbaxy will focus on therapy areas such as anti-infectives, gastro-intestinal, cholesterol lowering and anti-allergic categories in Yemen.
Ranbaxy, Merck in pact for anti-infective drugs
Ranbaxy Laboratories on Monday announced it has signed a collaboration agreement with US-based Merck & Co for drug discovery and clinical development of products in the anti-infective field.
Both would work to develop clinically validated anti-bacterial and anti-fungal drug candidates, with Ranbaxy slated to get an undisclosed upfront sum and more than $100 million for each drug target, depending on successful development and regulatory approval. It will also be entitled to royalties under the five-year deal.
“Ranbaxy will carry out drug discovery and clinical development through phase II ‘a’ clinical trials, with Merck conducting development and commercialisation of drug candidates thereafter,” a company statement added. According to the agreement, the collaboration would begin this year with an initial term of five years and can be extended mutually thereafter by the parties.
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Ranbaxy Laboratories on Monday announced it has signed a collaboration agreement with US-based Merck & Co for drug discovery and clinical development of products in the anti-infective field.
Both would work to develop clinically validated anti-bacterial and anti-fungal drug candidates, with Ranbaxy slated to get an undisclosed upfront sum and more than $100 million for each drug target, depending on successful development and regulatory approval. It will also be entitled to royalties under the five-year deal.
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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