Posts Tagged: "Drug"

India’s booming $26 billion generic drug industry and public health sector rejoiced over the Indian Supreme Court’s recent decision to reject a patent filed by the Swiss pharmaceutical giant, Novartis for their landmark leukemia drug, Gleevec. Novartis received a patent for an earlier variation of Gleevec in 40 countries including Russia, China, and Taiwan. However, India’s troubled IP regime applies an ambiguous standard to patentability, the so-called “enhanced efficacy” for new forms of known substances. India only applies their “efficacy” requirement to the chemical and pharmaceutical drug industry as a protectionist measure. India codified the efficacy requirement in section 3(d) of their patent code and this may contravene with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) as set forth by the World Trade Organization (WTO).

Critics argue that pharmaceutical patents are a barrier to wide-reaching access to medicines, especially for vulnerable populations in the developing world. They cast their argument in the phrase, “Patents Kill” and advocate against intellectual property (IP) protection for medical innovation and the trade agreements that incorporate them… Not surprisingly, barriers to access are more prevalent in less developed nations and access to medicine is a function of the level of economic development. Not surprisingly, higher-income nations benefit from greater access to medicines.

Once again, a plethora of interesting events has occurred since the last time we stopped by. What was the biggest headline? That decision may be up for grabs, but certainly, the $500 million penalty paid by Ranbaxy Laboratories is high on the list. In other news, yet another Johnson & Johnson manufacturing scandal has erupted, this time in South Korea, where the authorities plan to bring criminal charges against its Janssen unit and ban production of five products – notably, a type of Children’s Tylenol. A non-profit group put Bayer on notice that a lawsuit will be filed charging the drugmaker with making “unsubstantiated and illegal claims” about the ability of its One-A-Day vitamin to prevent various disease, such as breast cancer, bolster physical energy and improve immunity, among other things.

Senator Ron Wyden (D- OR) is a man with an idea for lowering health care costs. Unfortunately, it’s an idea which proved disastrous the last time it was forced on the National Institutes of Health. But that hasn’t dissuaded the Senator from trotting it out again. He seems sincere in his concern with the ever escalating costs of medicine. Unfortunately, his proposed solution empowering the government bureaucracy to second guess industry drug pricing decisions simply because they worked with NIH would make things worse. We could see fewer new drugs at any price.