I-MAK: saving lives by curing the patent system

More than 85% of Americans diagnosed with chronic hepatitis C will not receive treatment this year. It’s the same story the world over—the UK is rationing these drugs and France also has problems. These are the claims of Tahir Amin, co-founder of non-profit group the Initiative for Medicines, Access & Knowledge (I-MAK).

Why are people not receiving the life-saving treatments they need? Partly because of skyrocketing drug prices and anti-competitive strategies by big pharma, claims Amin.

The non-profit foundation is determined to increase global access to affordable life-saving medication and, to do so, I-MAK plans to try to improve the patent system.

That’s why I-MAK took on Gilead in the US last year, in a move that the non-profit claims included the “first-ever” US challenges by a public interest organisation against patents covering the company’s hepatitis C medicine sofosbuvir.

“We believe that as great as the utility of the drug is, the science behind it isn’t inventive,” explains Amin.

If Gilead’s “unmerited patents” were overturned, US taxpayers would save more than $10 billion and generics would come to market 16 years earlier, said I-MAK at the time.

“We’re not trying to devalue or diminish the usefulness of the drug, but we have to be guardians of the law. We’re asking whether the commonly practiced science behind the various patents covering sofosvbuvir are ‘inventive’ and should be monopolised from a legal perspective,” says Amin.

“Patents are not supposed to be only rewarded for something that is useful, or has utility as we say in the US. There has to be an inventive aspect to it. The current patent system has lost its way and the overpatenting problem we have is because patent offices and courts are granting or validating patents just because a thing may be useful. That was not the original social contract of the patent system.”

In July this year, I-MAK suffered a blow. The US Patent Trial and Appeal Board rejected one of the non-profit’s challenges. This was the latest refusal in a line of rejections—since May, the board has dismissed 10 petitions for inter partes reviews of Gilead’s patents.

This isn’t the non-profit’s first run-in with big pharma—since its founding in 2006, I-MAK has taken on some of the biggest pharmaceutical companies in the world and emerged victorious—in some cases.

Beginnings

In 2004, Amin moved from the UK to India where he met Priti Krishtel, who would later become the other co-founder of I-MAK.

At the time, India, the biggest supplier of generic drugs to a number of developing countries, was about to implement legislation to become compliant with the TRIPS Agreement. Amin and Krishtel worked on building safeguards into the patent system for India that would curb some of the patent evergreening practices by pharmaceutical companies.

Amin notes: “Once we worked on the safeguards, the issue then became how the law is implemented. But we realised we needed a much more focused effort, so we founded I-MAK.”

He says there wasn’t an organisation that solely represented the public interest on issues such as bringing transparency to the patent system, ie, knowing which patents relate to which drugs.

Driven by Médecins Sans Frontières’ requests to I-MAK that it wasn’t getting access to certain drugs, I-MAK began landscaping—where the organisation studied the portfolios that companies developed around their products—in earnest.

This helped I-MAK to decide which patents were blocking access and needed to be challenged.

“Stacking up the evidence before making suggestions on which patents need to be challenged is much better than just saying something is wrong,” says Amin.

Initial work was in India, where I-MAK was successful in challenging a number of first-line and second-line HIV patents, some of which were owned by Gilead and some by AbbVie.

In 2015, the Indian Patent Office rejected an application covering sofosbuvir, although this has since been reversed and is currently under appeal.

The work evolved, acting as a catalyst for more challenges that I-MAK has brought globally.

Later in 2015, China’s State Intellectual Property Office (SIPO) rejected Gilead’s patent application for Sovaldi (one of its hepatitis C drugs containing sofosbuvir) following an opposition from I-MAK.

In August 2018, following an invalidation action by I-MAK against the base compound patent for Sovaldi, Gilead withdrew a majority of its claims. As a result of the cancellation of the key claims, I-MAK believes local generic competition should now be able to enter the market.

“We started to see how we could do this in other countries. It culminated in a project when new hepatitis C drugs came out where we led a multi-country approach to tackle the patents earlier,” he explains.

The non-profit has also challenged Bristol-Myers Squibb’s (BMS) drug Daklinza (daclatasvir) in India. Amin claims that while Daklinza could be paired with sofosbuvir as a great combination drug, BMS has refused to combine them, so I-MAK is trying to “open up that possibility”.

In the US, a major US foundation approached I-MAK.

Amin explains that the foundation wanted to focus on patents because it saw there was a market failure.

“Access to life-saving drugs used to be thought of as a developing world problem which could be addressed with charitable solutions. Now it’s happening in the US and Europe and people are concerned and looking for larger systemic solutions.”

Reworking the system

I-MAK’s efforts are attempting to combat one symptom of a much bigger problem: patent systems that disproportionately uphold private interests over the public good.

“The meaning of what it means to be inventive has been diluted. Now we are really incentivising the wrong behaviour and paying the price for it,” says Amin.

He cites the example of patents covering crystalline forms of a drug: “Maybe 40 years ago they were something new, but not now, they’re standard procedure.”

Rather than discovering actual new drugs, companies tweak existing drugs in their portfolio to get as much out of them as they can, adds Amin.

“When you build these patents into an estate, the idea of a 20-year patent doesn’t exist. The drug can potentially be protected for 40 or 50 years and then generic makers have to go through multiple hoops to break this down.”

The patent system is not about real scientific progress any more, it’s about defensiveness, warns Amin, adding that honest conversations need to be had across the world.

“Economies work in two directions—the private makers and the public. But, large swathes of the public are suffering. People are having to make stark choices between putting food on the table and buying medicine.”

Unfortunately, he claims, aggressive and exploitative patenting strategies are enabling drug makers to regularly increase prices in the US and extend monopoliess.

In “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices”, a report published in August, I-MAK claimed that the 12 highest-grossing drugs in the US had an average 38 years of prospective patent protection—nearly double the 20 mandated under US patent law.

Statistics from the report state that more than half of the top 12 drugs in America have more than 100 prospective patents per drug, with the average number of applications for the 12 drugs being 125; there were 71 granted patents per drug.

Since 2012, the prices on these 12 drugs have increased by an average of 68%, with only one product’s price dropping.

“This abusive practice, known as ‘evergreening’, or what drug makers market as incremental innovation and improvements, sits at the heart of the drug price crisis in the US,” said the report.

Finding the balance

Amin is confident that the power dynamics are so entrenched that this needs to be wrestled back to where there’s a balance between the makers’ interests and those of the public.

While he admits that the legislative aspect of a heavy redesign of the patent system could be a “nightmare” effort because of the lobbying interests of pharmaceutical companies and the sacrosanct nature of patents, particularly in the US, Amin claims that “we’re living a bigger nightmare now with the way people aren’t able to get drugs and even dying”.

Earlier this year, I-MAK published a paper, “Solving the drug patent problem”, outlining seven strategies aimed at tackling the patent problem.

Perhaps the most effective tactic is the redefinition of the obviousness standard. “The way the test reads in the US makes it almost a novelty test, with the law wanting essentially like for like. It’s a narrow construct and science doesn’t work like that,” claims Amin.

I-MAK also believes that expanding the role of the public and patients within the system is the way forward.

“We’ve learned from our lessons in India. The patent system should allow participation while the patent is being examined so that others can submit evidence in a form of a pre-grant opposition,” explains Amin.

I-MAK, as part of the strategy, also commits to public education, and US Congress people are beginning to listen, he claims.

“We need to have these conversations. As the price of every drug continues to rise, it’s just going to get worse,” he concludes.

As for I-MAK’s end goal, it’s simple: a world in which life-saving medicines are readily available without excessive individual or social cost.