Indian government rejects Abbott's patent application for second-line ARV

India's patent office "has rejected American drug maker Abbott Laboratories' patent application for an HIV combination drug, allowing low-cost local drug makers to make and sell their generic versions in India and other countries where the medicine is not patented," Economic Times reports (1/4). The drug under consideration was Abbott's "Kaletra, which combines two antivirals, [lopinavir/ritonavir, and] is one of the preferred second-line treatments to fight drug-resistant HIV, according to the World Health Organization, which recommends governments include it on their list of essential medicines," Bloomberg/Businessweek writes (Narayan, 1/4).

Abbott's patent claim "was opposed by three Indian companies, including the country's largest generic drug maker Cipla Ltd, Hyderabad-based Matrix Laboratories Ltd and Okasa Pvt. Ltd, Livemint.com adds. "The application was first opposed in 2007 by the U.S. non-profit healthcare group, Initiative for Medicines, Access and Knowledge (I-MAK), soon after it was filed in India," according to the news service (Unnikrishnan, 1/3).

"Steps involved in making Kaletra 'do not constitute an invention,' the agency's Mumbai office said in documents dated Dec. 30," Bloomberg/Businessweek adds. The news source also reports that "Abbott is reviewing the patent decision and determining its next steps, spokesman Scott Stoffel said ... Newer versions of the drug don't require refrigeration and needn't be taken with food, making them better suited for patients in developing countries, he said" (1/4).

"According to non-government healthcare lobbies, the Indian patent office's decision paves the way for access to the medication to HIV patients across the world. There are some 33 million people living with HIV today and of these nearly 15 million require access to HIV drugs," Livemint.com adds. "Cost-savings generated over a three-year period by introducing generic versions of these drugs in 43 low and middle-income countries would be sufficient to start 130,000 new patients on HIV treatment, I-MAK estimates," the news service writes. "India, the world's leading supplier of affordable medicines, can now supply this drug to patients across the globe who are desperately waiting for treatment," I-MAK said in a statement [.pdf] on Monday, according to Livemint.com (1/3).

In related news, the Financial Times reports that India's commerce and health ministries "are considering whether the government should designate the pharmaceuticals industry a 'sensitive sector', which would require foreign companies seeking more than 49 percent in any Indian drugmaker to first obtain government approval" following growing concerns over the growing number of "foreign takeovers of Indian pharmaceuticals companies."

According to the news service the country's "drug industry, which specialises in low-cost, high-quality production of generic drugs, has attracted the attention of big global pharmaceuticals companies and led to a spate of high-profile deals. … But the takeovers have raised concerns about whether the change in ownership will lead to higher prices, putting drugs out of reach for India's poor."

The article examines the recent purchases of stakes in Indian pharmaceutical companies and includes comments by Jyoti Mirdha, a politician in India, "who has been pushing for tougher regulation of acquisitions in the sector," according to the Financial Times (Shivakumar/Kazmin, 1/3).