Key Hepatitis C Patent Rejected In India, Clearing Way For Generic Treatment Costing A Thousand Times Less Than US Price
from the rather-exorbitant dept
As Techdirt explained back in 2009, India has a long and complicated relationship with patents, but more recently, it has established itself as the leading “pharmacy of the developing world,” thanks to its generic drug manufacturers which are able to supply key medicines at affordable prices. A recent patent decision, reported here by Intellectual Property Watch, continues that tradition:
Today’s rejection by the Patent Office Controller of India of a patent application by Gilead company for a key drug against hepatitis C is being hailed by advocates as a path to dramatically lower costs of treatment for the disease. Hepatitis C has made news for the emergence of exorbitantly priced medicines over the past year.
A press release on the news from Médecins Sans Frontières explains just how exorbitant:
The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.
That gives an idea of the kind of profit margin involved — rather excessive even allowing for generous research and development costs. But as well as being good news for those who will soon be able to afford this drug, the judgment is also significant for its underlying reasoning, as Intellectual Property Watch notes:
A look at the decision shows that a provision in India’s law continues to stop patent applications if they fail to show sufficient novelty and inventive step — and are subject to opposition.
That’s important because it confirms that India is still taking a very strict approach to granting pharma patents, which must meet stringent conditions of novelty and inventiveness. Millions of people in the developing world who stand to benefit from India’s low-cost generics will be grateful, while some in the West may be less happy.