New Thinking On Biotech Patents From Industry Groups

LYON, FRANCE – A new level of willingness to cooperate on major public health initiatives may indicate increased convergence in goals between large pharmaceutical companies and patient advocacy groups, particularly when addressing neglected diseases, a panel at an international life sciences conference said Monday.

“The time of polemics has finished,” said Robert Sebbag, vice president of Access to Medicines at French innovator pharmaceutical company Sanofi-Aventis.

He was speaking at a panel entitled the “Unresolved Issue of Malaria,” during the biennial BioVision conference in Lyon, France. BioVision brings together experts in the life sciences, primarily industry representatives, scientists, and academics – though some civil society representatives and governments were also present – to discuss global challenges and how the biological sciences might be applied to solve them. This year’s forum focussed on urban issues, and took place from 8 to 11 March.

The ability for public health organisations and major multinational innovative research companies to work together is critical for public health, as generic drug manufacturers will not be able to provide the new research needed for future medicines, said Sebbag.

Patents: Not Always Necessary

Sanofi-Aventis, Sebbag said, had a partnership project with the Drugs for Neglected Diseases Initiative (DNDi) to produce an anti-malarial drug, on which there would be two brand names, two packages, and two different prices. One of these was a no-profit, no-loss price (US $1 for the average treatment, and US $0.50 for children under five) for non-profits and other public sector organisations.

Sanofi-Aventis also agreed to give 3 percent of private sector sales revenue to DNDi, according to a DNDi newsletter on the issue.

“We didn’t want a patent,” on the drug. “It wasn’t useful,” he added, as some 300 million doses of the drug were needed at-cost and Sanofi-Aventis did not have the capacity to manufacture them all.

DNDi may have made the lack of a patent a key component of its partnership (IPW, Public Health, 5 March 2007). DNDi did much of the initial development work for the drug, according to its website.

Of course, this decision on patenting is not a general decision at the company, he added.

Pascal Housset of Bayer CropScience agreed with Sebbag and said the trend is for large companies to cooperate with foundations and public health non-profits.

“You should not believe” he said “that only Sanofi and Bayer are thinking this way.” Bayer has built a partnership with the Bill & Melinda Gates Foundation to share risk on a new molecule that might control the malaria disease vector, or the manner or path in which a disease is spread. It would not be possible for one company to do this kind of work on its own, said Housset, as the “market cannot command the type of resource needed.”

Industry Becoming Socially Conscious?

Amir Dossal, executive director of the UN Office for Partnerships, said he thought companies were becoming more socially conscious. Part of this is from an enlightened sense of self-interest, he said. “Without helping the poor, you won’t grow the market,” Dossal told Intellectual Property Watch. “You are, after all, creating consumers.”

Further, said James Geraghty, senior vice president of the medical biotechnology company Genzyme Corporation, “only drug companies can develop drugs.” There is a “valley of death” between initial research done by universities and publicly-funded clinical trials where you have only industry operating in drug development. But companies are not philanthropies, he added, and cannot give away shareholder money.

“The bottom line,” Housset added, is that with these public-private partnerships you can have use of the molecule at an acceptable price. And this is “thanks to non-governmental organisations ready to share risk with us at the beginning,” he added “and accept at the end that there’s a price that can go to market.”

Of course R&D risk and IP are only a part of the many issues whose resolution is needed to fight malaria. “Technical solutions… are not enough,” said Jean-Calude Berthélemy professor at the University of Paris 1 Pantheon-Sorbonne. Even if a vaccine could be developed, the populations are hard to reach, he said, pointing out that there are still many who do not have access to vaccines that have existed for decades.

“Science is the easy part,” said Housset. “The hardest part is distribution.”

Djiba Kane Diallo, coordinator of the Voices of Mali Programme, said helping populations understand how and where mosquito populations develop is necessary.

Ogobara Boumbo, director of the Malaria Research and Training Center, in Mali, emphasised the importance that public private partnerships should involve traditional healers in the process of malaria treatment.

Danger Of Divided Pharmaceutical Industry; Counterfeit drugs

Involving innovator pharmaceutical companies in developing country markets is essential, said Sebbag.

“The risk,” he added in a later interview with Intellectual Property Watch, “is to have two” industries: “big pharma” with research innovation for the global north, and generics, mainly from India and China, for the global south. “I want to prevent this,” he said. “Big pharma has to be involved in the south.”

His message to drug purchasing mechanism UNITAID and the financing institution The Global Fund is that price is important but quality must not be forgotten. If price is the only focus, he said, then such groups will always buy products from generics producers. But this will discourage big pharma from being in the market.

“This is a shame,” he said, as “for the drugs of tomorrow we need research and innovation. This… is done by big pharma” and not by generics.

Meanwhile, others have argued that fledgling pharmaceutical industries grow through generics companies and reverse engineering. Some eventually develop into innovative industries.

At the same time Sebbag emphasised that he understood the need for new models for bringing affordable drugs to smaller or poorer markets, among other reasons to combat counterfeit medicines.

Counterfeit drugs are an issue, he said, as they may contain no active ingredients or an incorrect dosage; these false drugs risk harming the patient or helping to build resistance.

But trademarks here are not the issue. “Counterfeit is not generics,” he said. “If a generic is the same formula, and good quality, there is no problem… counterfeit for me is a false drug, with bad material, bad quality: this is the most important, the problem is not the trademark.”

Differential pricing should be used to fight it, he said. “If counterfeit exists, it’s because the cost of normal drugs is very expensive and people can’t pay the normal price. When we have tiered pricing, we dry up the market” for the false drugs.