The debate over patents in India continues. India has been struggling to bring its intellectual property laws up to a standard that will invite multinational companies to do business there. But public opinion is strongly in favor of domestic companies, putting Big Pharma in a tough spot. Drugmakers want to sell their branded drugs at a branded drug price–which might be lower in India than in, say, the U.S. But thanks to a strong local drugs business, Indians have enjoyed cheap meds for years.

The latest skirmish involves 81 drug patents granted over the first four years of India’s new patent laws, 76 of which went to foreign pharma companies. One-third of them were divided among some of the top names in Big Pharma: Novartis, Eli Lilly and Pfizer.

The domestic industry now is questioning the validity of those patents, saying that they were issued in violation of two sections of the new law. These sections would deny patent protection to modified forms of long-ago-patented drugs and to new drugs that aren’t a big leap forward. An industry lobby demanded a review of these patents, and now the drugs in question–and some other related data–have been made public by a government agency.

The disputed patents include one granted to Eli Lilly for a combination of the antipsychotic drug Zyprexa (olanzipine) and the antidepressant Prozac (fluoxetine). Another, given to Novartis, covers a combo of blood pressure meds Norvasc (amlodipine) and Diovan (valsartan), with hydrochlorothiazide, a diuretic.

The industry lobby is fighting hard against these patents, calling for that controversial section of Indian patent law known as 3(d) to be strictly enforced. But others, including the U.S.-India Business Council, are calling for 3(d) to be abolished. It’s a hot-button issue on both sides, and the debate isn’t close to being resolved.

Source: FiercePharma

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FDA approved Novartis’ Tekturna HCT® tablets as initial therapy for hypertensive patients likely to need multiple blood pressure medications. The drug is a single-pill combination of the direct renin inhibitor, aliskiren (Tekturna/Rasilez), and the diuretic hydrochlorothiazide (HCT).

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Tekturna HCT was first approved in the U.S. in January 2008 as a second-line treatment for high blood pressure, and in the EU in January 2009. Novartis says that it is also developing other single-pill aliskiren combinations including a combination with Diovan (valsartan) and one with amlodipine.

The single-agent direct renin inhibitor, Tekturna, was first approved in March 2007 and is now available in over 70 countries. Most recently in July 2009 it entered Japan.

Source: GEN News

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The FDA released the third quarterly installment of a list of drugs that it is currently reviewing over potential safety issues. The agency specified that if a product appears on the list, “it means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk.”

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According to the information available on the agency’s site, among other compounds, the FDA is reviewing the safety of Roche’s weight-loss drug Xenical (orlistat) over concerns about the risk of rectal bleeding in patients receiving the drug. Novartis’ fungal treatment Lamisil (terbinafine) is being reviewed for potential links to psychiatric events and the drugmaker’s hypertension drug Diovan (valsartan) is being examined over concerns about haemolytic anaemia. Furthermore, the agency is investigating the risk of birth defects in babies born of women administered antidepressants and is also examining Bristol-Myers Squibb’s schizophrenia compound Abilify (aripiprazole) over potential concerns about liver toxicity.

The agency, which has already announced safety reviews for many of the products that appear on the list, posted the data to its website as part of its ongoing examination of potential adverse drug reactions.

Source: FirstWord

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