India's Ranbaxy hits rough weather?

Posted AtIndiadaily.com

First, it was the setback in its patent challenge litigation against world's biggest pharmaceutical company Pfizer for the cholesterol lowering medicine Lipitor (chemical name atorvastatin) in the UK. Then came another blow. Ranbaxy Laboratories Ltd (BSE:500359), India's biggest drugmaker reported a loss after tax of Rs.10.77 crore for the quarter ended September 2005 as against a net profit of Rs.141.3 crore in the corresponding period last year. Aiming to grab a share from the pie of the world's best-selling drug for four straight years, Lipitor--which helped the American pharmaceutical giant pocket a global sales of almost $11 billion in 2004--Ranbaxy had challenged the patent in UK.

In a mixed verdict, Justice Pumfrey of the UK High Court ruled that one of Pfizer's patents was invalid but that Ranbaxy's atorvastatin product infringed another patent. In the high stake game of patent litigation, particularly for a drug like Lipitor, the judgement comes as a setback to Ranbaxy's hopes of launching a generic version of Lipitor in the UK market, which is estimated to contribute just about 7 per cent of Pfizer's global Lipitor sales. Under the present circumstances it will not be able to do so until 2011, when the patent expires. Pfizers Lipitor, which accounted for about 21 per cent of its annual sales, has been a target of many generic companies. The US drugmaker had earlier tried to ward off copies in the US by filing several patent infringement lawsuits against websites selling generic atorvastatin. The ruling by the UK High Court was interpreted as victories by both sides but it was clear that Ranbaxy was on the disadvantaged side. Pfizer chairman and CEO Hank McKinnell said after the court ruling that it was an important victory, not only for Pfizer, but for all innovators pursuing high-risk medical discoveries that benefit current and future generations. But he said Pfizer would appeal against the other ruling. Busting both patents would have allowed the Indian company to sell a cheaper copy of the largest-selling drug in the pharmaceutical industrys history. Undeterred by the judgement, Ranbaxy said it would appeal against Justice Pumfrey's ruling that its proposed product infringed on one of the patents of the Pfizer brand. And more importantly the company said the verdict was not in any way going to affect its future growth plans. Ranbaxy's President (Pharmaceuticals) Malvinder Singh said the company was confident of winning its appeal on the basic patent and expected a favourable verdict from the higher court. Assuring its investors, Ranbaxy said the rulings of the UK High Court was not going to affect its future plans. "It is not going to have an effect on our future plans for growth, both organically as well as inorganically," Ranbaxy CEO Brian Tempest said. Technically, Ranbaxy's case was brought against Warner Lambert, the original holder of the patents, which was acquired by Pfizer in 00. Earlier, Ranbaxy had won a patent challenge on the same claim in Austria, where Pfizer sells it under the name Sortis. As per the judgement by the UK High Court, Warner Lambert/Pfizers European patent 409 281 was found to be invalid in the UK. Ranbaxys proposed product was found to infringe Warner Lambert/Pfizers European patent 247 633 in the UK. What assumes significance is that the Ranbaxy and Pfizer are locked in a similar litigation in the world's biggest pharmaceutical market, US. Ranbaxy had brought a suit against two Lipitor patents in the United States, where $6.6 billion, or about 61 per cent, of the drugs sales are generated. A ruling is anticipated by the end of the year. Industry analysts are of the opinion that the US case is more important because of the economic implications. They, however, warn attempt should not be made to extrapolate the US ruling from the UK court judgement because of the different legal standards. In case of a similar ruling in the US, where Pfizer wins on the active ingredient but loses on the second patent, then it would be bad news for Pfizer. This is because of the fact that the second patent expires 15 months later so a loss would deprive Pfizer of over a years worth of Lipitor revenue. After the Liptor case in UK, came more bad news for Ranbaxy. It reported a loss after tax of Rs.10.77 cr loss after tax in the third quarter ended September 30, 2005, as against a net profit of Rs. 141.3 crore in the corresponding period last year. The company cited continuing price deflation in the US market, increased R&D spending and litigation bills as reasons for the loss. Commenting on the results, RLL CEO Brian Tempest said," It has not been a good quarter for us. Weakness in the US market due to price deflation has not only affected our sales but also our net profit. He said the price deflation in the worlds largest pharmaceutical market, US, which started in the beginning of the year, continued in the third quarter and was expected to continue through the year. This is going to carry on through the year and will continue in the next year as well," he said. Tempest said another main reason for the poor showing of profitability in the third quarter was the increased spending on R&D, which increased by 79 per cent as against the same quarter last year. "The company's litigation bills also impacted profitability as well. We have a budget of about 30 million dollars as litigation cost for the year," Tempest said, adding that in the next year the budget was expected to remain more or less the same. The company's total income also decreased to Rs.870.23 crore in the third quarter ended September 30, 2005 as against Rs.896.57 crore in the corresponding period last year. For Ranbaxy and its subsidiaries, the consolidated profit after tax (after minority interest) in the third quarter was down by 90.8 per cent at Rs.18.4 crore as against Rs.200.1 crore in the same period last year. The company's consolidated sales stood at Rs.13,03.9 crore as against Rs.1,343.9 crore last year. Tempest, however, said Ranbaxy was looking forward to the next year with few first-to-file products being lined up for launches, two of them are expected in the first half of the year. "We believe we have already got the exclusive rights period for these products," he said. Clearly, Ranbaxy needs some products to give it a fillip to overcome the rough weather it has encountered.

November 02, 2005