So to incentivize pharma companies to keep innovating and burning money, regulators across the country offer them a special kind of protection. If they create something magical that could alter the course of human history— say a drug to battle AIDS, cancer, or even the dreaded coronavirus — they’ll be granted a patent. For 20 years. And during that period, they’ll have exclusive rights to manufacture and sell the drug. No other company can create the same drug with the same formulation. (View Highlight)
Once the 20 years are up, other companies can step in. These copycats create their own versions of the drug and sell them in the market. They’re called generics. The competition heats up and it drives drug prices downwards. It becomes more affordable. (View Highlight)
And they come up with an idea. They decide to make a few minor tweaks to the formulation. They might replace compound X with compound Y. The difference might be trivial but they’ll claim this as a breakthrough. They’ll say the drug is 25% more effective now. That it can save more lives. (View Highlight)
They go back to the patent office. And they’ll do this maybe a year before the current patent on the drug is due to expire. They’ll file another patent and ask for an extension. They tell the patent officers that the innovation must be protected because they put their blood, sweat, and tears into it. (View Highlight)
The pharma company hopes they can continue to milk the drug for all it’s worth. And keep the patent for a good 39 years (19+20). (View Highlight)
This, folks, is called the evergreening of patents — when a pharma company uses a small tweak to keep its patent monopoly. And this delays the entry of generic drugs that can drive the price down. (View Highlight)
In fact, one researcher looked at all the drugs in the market between 2005 and 2015 and found something shocking. Out of all the patents being issued, a whopping 78% were for extensions. Or rather, for evergreening. (View Highlight)
Now here’s the thing you must know about India. We’re pretty wise to the antics of the pharma industry. And in 2005, the government tweaked the Patent Act of 1970. It inserted a Section 3(d) to prevent evergreening. And it said, “mere discovery of anew form of a known substance which does not result in the enhancement of the known efficacyof that substance or themere discovery of any new propertyor new use for a known substance or of themere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant”, cannot be given patent protection. (View Highlight)
Just look at what happened with Swiss pharma giant Novartis in 2013. Novartis tried to get a patent for a new version of its cancer drug Gleevec/Glivec and said that with the tweaks they made, the drug could be more easily absorbed into the bloodstream. It could more easily save lives. But the Indian Patent Office denied the request. And when Novartis went to the courts, India’s Supreme Court put its foot down too. It cited Section 3(d) and said, “Sorry, here’s a 112-page order just to say NO!” (View Highlight)
So, India and the UK are hashing out an FTA and it has been in the works for a while now. It’s expected to facilitate trade between the two countries. Remove tariffs and stuff. But it seems there’s something in the draft about India’s patent laws too. A leaked excerpt (first appearing on bilaterals.org) revealed that the UK wants India to relax its strict evergreening laws. It wants leeway for British pharma companies. And apparently, it says that both India and the UK “shall not require a patent applicant to prove enhanced efficacy “— in complete contrast to the pathbreaking Section 3(d). It’ll allow pharma companies to evergreen their patents. It’ll keep drug prices sky-high and help pharma giants to mint more money. And worse? It’ll hamper the entry of generics. And don’t forget, India is the generic king of the world — 20% of the global supply comes from us. It’s India-made generic drugs that are lifesavers in low and middle-income countries. And if we dilute our patent laws, it can hinder the production of generics. And this could have unintended consequences across the globe. (View Highlight)
