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26 September 2018Americas

AIPPI 2018: Sanofi and I-MAK go head-to-head on access to medicine

‘Evergreening’, ‘delinking’ and a UN report on access to medicines were all up for debate yesterday, during a panel session at the 2018 AIPPI World Congress in Cancún, Mexico.

Roberto Ribeiro, global head for emerging markets, JPAC and consumer healthcare patents at Sanofi, and Tahir Amin, co-founder and director of non-profit group the Initiative for Medicines, Access & Knowledge (I-MAK), went head-to-head on some issues during the panel, called “Access to medicines—what’s fair?”.

Evergreening of patent rights is a “deliberate strategy” that distorts the patent system, claimed Amin, who said that, to resolve this, litigation must be undertaken.

Approximately 60% of secondary patents challenged before the European Patent Office (EPO) are invalidated, with a further 15% having the patent claims narrowed, said Amin.

“The cost to society is immense as we wait for the litigation—it takes [on average] 3.6 years at the EPO for a post-grant opposition to end,” he added.

However, Ribeiro explained that if there are further patents, it means there are further developments for improvements to the benefit of the patient.

“Every time you see a patent, there is a scientific value added in that medication,” he said.

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

The report added that more than half of the top 12 drugs in America have more than 100 prospective patents per drug.

However, Christopher Ruggerio, senior legal officer, non-governmental organisations and industry relations section at the World Intellectual Property Organization (WIPO), explained that it’s not just the “usual suspects” that benefit from IP rights.

Lyrica (pregabalin), which was named as a top 12 drug, was developed at Northwestern University. The university now receives patent royalties from the drug and has used this money to invest in laboratories and education.

In 2016, the UN issued its “ High Level Report on Access to Medicines”, concluding that the world must “take bold new approaches to both health technology innovation and ensuring access”.

While Amin believes that the report “captures some of the heated debates” over what role IP plays in access to medicines, Ribeiro stated that it lacked a more holistic view in terms of the real causes of lack of access.

Ribeiro added that the lack of access is not only linked to patents, but also problems related to distribution and taxes, among other factors.

But this report is only advisory and although it has come up as a potential agenda item at WIPO, there has been no consensus to place it on the agenda. As such, WIPO “can’t do anything else but take note of it”, said Ruggerio.

The report also brought up the issue of ‘delinking’, where the costs of research and development are separated from the end price of a drug.

“Pharma companies are doing less research but are using government grants to bring products to market. Who is really paying for the research?” questioned Amin.

He added: “We hear that pharmaceutical companies are doing all of this research, but a lot of the money is coming from taxpayers, at least in the wealthier countries.”

In opposition, Ribeiro explained that the link between the development cost and the price of a drug is just part of the story, with pricing also being linked to countries’ criteria for setting medication fees.

“Frankly, I would be happier if we had a concrete proposal from the UN in terms of price structure, to have the chance to criticise and to give and amend ideas. I don’t feel prepared to propose a brand new structure,” he added.

Catherine Mateu, partner at Armengaud Guerlain in France, moderated the panel; all panellists were speaking in a personal capacity.

The 2018 AIPPI World Congress finishes today, September 26.

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