In 2015, the United Nations Secretary-General Ban Ki-moon convened a High-Level Panel on Access to Medicines. Its charge was to recommend solutions to the fallaciously described “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” Unfortunately, their starting point was misguided, and – not surprisingly – the resulting report is dangerous nonsense. Continue reading
Apothecurry welcomes back guest columnist Dr Kristina Lybecker. Her latest column is an elegantly simple “where the rubber hits the road” exposition of the recent rejection of patents on US biopharma company Gilead’s Hepatitis C drug Sovaldi in India. Coincidentally, Gilead’s European patent on Sovaldi was challenged yesterday by charity Medicins du Monde marking yet another interesting turn of events in this breakthrough drug’s eventful life. Read on as Dr Lybecker explains how the Indian Patent Office’s decision rather than aiding clarity in the understanding of India’s patent rules has only muddied the waters. Continue reading
The banning of diabetes drug pioglitazone (now looking set to be revoked) has put Merck’s patented drug sitagliptin or Januvia back into the limelight in India. Critics of the ban have highlighted the added expense of moving patients from pio to sitagliptin, a possible alternative. This is a good time to take another look at a patent infringement lawsuit currently pending between Merck and Mumbai’s Glenmark which launched a generic of sitagliptin in India some months ago. Continue reading
Recent Indian patent rulings, as well as those to come, are changing the intellectual property rights (IPR) landscape for emerging economies. They are watched with keen interest by other developing nations to measure the response of innovative pharmaceutical firms and the global community. Whether or not they are precedent-setting remains to be seen. Continue reading
The uncertainty surrounding the grounds on which compulsory licenses on patented drugs may be granted and lengthy legal proceedings endanger the vitality of the Indian intellectual property (IP) environment. An even greater threat, perhaps the greatest, is the uncertainty surrounding biologic drugs. Continue reading
The Indian government made several critical patent decisions over the past year. Their impact on the Indian intellectual property (IP) landscape is still evolving, with important implications for IP rights, the global pharmaceutical industry, Indian consumers, and emerging economies.
The stakes are high and reflecting on the ways in which these decisions will shape the future of industry and innovation is essential. In this column, I consider the implications of these decisions for innovative pharmaceutical manufacturers and their strategies. Continue reading
On November 2, the Indian Intellectual Property Appellate Board (IPAB) revoked Hoffmann-La Roche’s patent on the hepatitis C drug Pegasys. In particular, the IPAB found that Roche failed to demonstrate Pegasys is more efficacious than an earlier version of the drug. Read the ruling here. The ruling brings three critical issues to the fore. Continue reading
A recent article in Health Affairs considers how secondary patenting can extend market exclusivity and delay generic competition. Amin and Kesselheim examine two key anti-HIV drugs Norvir and Kaletra.
Through the analysis of 108 patents, they find generic competition could be delayed for an additional twelve years beyond the expiration of the patents on the drugs’ base compounds. Continue reading
Frustration with the status quo of the patent system and its inability to address the growing needs of developing countries has inspired the development of a new innovation paradigm, a global research and development (R&D) convention. Such an effort will certainly generate controversy and be met with skepticism. Here’s why. Continue reading
Given the intense public debate over access to and pricing of patented medicines, academics, policymakers, lawyers, and others have begun to think creatively about what it is that actually incentivises innovation and encourages drug development.
While doing so, it is important to identify the points in the R&D process where the failures occur. There are many : scientific and technical limitations; insufficient funding for research, particularly on neglected diseases; insufficient funding to take potentially promising research forward to the clinical development stage; and distribution problems that prevent existing treatments from reaching patients. Continue reading