Patent Pool-ViiV Collaboration On Paediatric HIV Sparks Reactions, Hope

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The Medicines Patent Pool has announced a ground-breaking collaboration with a private sector joint venture that it said will facilitate greater availability of critical medicines for children with HIV worldwide. The announcement spawned a wave of positive reactions across the public health community, with many hoping for more in the future.

The deal allows the royalty-free licensing of a key HIV medicine, abacavir, in 118 countries where 98.7 per cent of children with HIV live, as well as future commitments for licensing of pipeline drugs.

According to the World Health Organization, there are 3.4 million children with HIV worldwide, but only 562,000 have access to medicines. This collaboration will allow abacavir to be made and sold under a patent licence in 118 countries, accounting for 98.7 per cent of the world’s children living with HIV.

The Medicines Patent Pool (MPP), a Geneva-based non-profit organisation founded in 2010 by the WHO-based UNITAID, works to lower prices on HIV medicines and encourage development of new ones.

ViiV Healthcare is a joint venture of UK firm GlaxoSmithKline (GSK), US firm Pfizer, and Japanese firm Shionogi. The office is housed at GSK in the United Kingdom.

The 13 February memorandum of understanding (MOU), licence, MPP press release, and an MPP expert advisory committee report are all available here.

The MOU goes further than previous deals struck by the Pool, which came under some criticism for possibly not being ambitious enough in getting commitments from partner companies.

In particular, a previous deal with Gilead only allowed manufacturing by licence in India, and the new one allows it anywhere in the world, as long as it is destined for the licensed countries.

Another significant aspect of the agreement is that it is expected to include future drugs developed by the industry venture.

The MPP has a priority list of antiretrovirals (ARVs) to fight HIV and AIDS, based on the most needed and those that are patented (and therefore not readily available at affordable prices).

ViiV has a number of desirable ARVs in the pipeline, and has committed allow the MPP to licence them for paediatric use for the same geographic territory, once the drugs receive approval.

The two sides also agreed to collaborate on use of “catalytic interventions” such as technology transfer, access to regulatory data, or partnerships as needed to bring about the development of needed paediatric ARV formulations.

Other elements of the MOU include: agreement to support generic product development; looking for ways to expand the availability of novel ARV formulations outside the defined licence territory; and allowing MPP to carry out research on clinical unmet product and formulation need. Also, MPP will identify generic manufacturing partners with R&D, manufacturing or other capabilities to produce and supply products based on ViiV’s patents and catalytic interventions at accessible prices.

The detailed licence agreement between parties provides terms for MPP to sub-licence the patented technology of ViiV to third parties in order to promote access in low and middle-income countries.

A sticking point in the past was that companies were reluctant to agree to share their innovations for low-cost competitors in larger developing countries. But in the case of paediatric HIV, the vast majority of cases occur outside of those countries. As a result, the majority of cases can be addressed while countries such Brazil, China, Russia, and Ukraine are not covered by the ViiV memorandum. But this could be of concern for future deals involving adult treatments. Developed country industry is reluctant to give up its control of those larger developing markets for profit reasons.

The new agreement does protects countries rights of using compulsory licensing to obtain affordable versions of patented medical products, and waives data exclusivity and prevents data exclusivity in sub-licences as well.

In a press release, ViiV said the voluntary licence agreement fits with its 2010 announcement that it would make its pipeline available through “royalty-free voluntary licensing and not-for-profit initiatives in all least developed countries, all low income countries and all of sub-Saharan Africa.” ViiV already has 13 voluntary licence agreements with generics companies.

ViiV CEO Dominique Limet said in the statement that the group has “committed to playing our part to address the gaps in care and treatment of paediatric HIV.” The group also has a Paediatric Seed Fund which aims to “improve paediatric HIV research, care and treatment in resource-limited settings.”

Positive Reactions, with Hope for More

There was an outpouring of support for the agreement from the public health community.

The civil society delegations to the UNITAID Board said in a statement that “pediatric HIV medicines have been one of the most neglected areas in global HIV treatment access and abacavir is an important drug in pediatric HIV treatment. This license is timely as UNITAID finances the development of a pediatric 4-in-1 formulation that will contain abacavir.”

“We are encouraged by the license conditions that set the bar higher than earlier licenses with multinational companies,” the delegations said. They called on “companies that still stay on the sidelines to now urgently join the Pool.”

Health Action International congratulated the two sides on “the great improvement of pro-public health licensing conditions” under this agreement. But it also mentioned that the licence does not cover all developing countries, and that it is limited to development of treatments for children.

“Ultimately, these restrictions will prevent some of the most needy beneficiaries from accessing lifesaving HIV therapies,” HAI Global’s Tim Reed said in the statement. HAI called on ViiV to make abacavir and pipeline products available to both adults and children in all developing countries, and urged other companies to follow suit. It took a shot at Johnson & Johnson, as the company walked away from talks with the MPP in 2011, and at Abbott, which to date has refused to talk with MPP at all.

“More licenses to the pool are needed, and needed fast,” said Tessel Mellema of HAI Europe.

Washington, DC-based Public Citizen congratulated the parties, and said that where other companies refuse to negotiate, compulsory licences will be sought “to overcome pharmaceutical monopolies.”

Public Citizen’s Peter Maybarduk, in the statement, also encouraged GSK, Pfizer and Shionogi to “take the important next step” of licensing adult formulations of pipeline drugs to the MPP “while maintaining the pro-competitive terms of the pediatric license, and including all low- and middle-income countries. And Public Citizen urged AbbVie, formerly part of Abbott Labs, to enter licence negotiations for their patents on lopinavir and ritonavir, which are other important HIV medications.

Knowledge Ecology International said that GSK, Pfizer and Shionogi “deserve credit and goodwill for entering into a license” with the Pool. KEI President James Love said in an analysis that the deal expands markets for generics and provides more certainty for generic producers.

“By offering the license, ViiV has created new momentum for open licensing of HIV/AIDS related patents, and that is a good thing,” Love wrote.

The Drugs for Neglected Disease initiative (DNDi) called the agreement an “important precedent for facilitating development of paediatric ARV formulations.”

“DNDi hopes that this agreement will bring other relevant patent holders to the table in order to expedite the development of appropriate ARV combinations and formulations for children with HIV/AIDS anywhere in the world,” it said. The group is currently working with generics producer Cipla and other partners to develop “an improved first-line therapy for infants and toddlers with HIV/AIDS, with support from UNITAID, the French Development Agency (AFD), and Médicins Sans Frontières (MSF), it said.

MSF itself praised the licence as showing “welcome improvements” over the previous MPP licence, but said it is “disappointing that ViiV is not including all developing countries in the agreement, given the fragile and fragmented nature of the paediatric HIV medicines market.”

While it’s encouraging to see ViiV taking steps towards greater collaboration on access to paediatric formulations, the real breakthrough we’re looking for is an agreement to make the company’s promising new drug dolutegravir available to both adults and children in all developing countries, Aziz ur Rehman, intellectual property advisor for the MSF Access Campaign, said in the statement. “Efforts to increase transparency in voluntary licence negotiations, including making the licence and its terms publicly available, are appreciated.”

Prof. Brook Baker of Northeastern University Law School in Boston gave a positive analysis of the deal, but put it in a more sobering perspective.

“At its best, this and future MPP pediatric licenses will cover merely 10% of all people living with HIV because it is limited to children only,” he said. “For the other 90% of people affected, namely adults – the parents and caretakers of children, the critical question will be the conditions and territorial scope of a future DTG license.”

“It is fervently hoped that ViiV and its owners (and other IP rightholder companies) can be convinced by the MPP, developing country governments, global health initiatives, multilateral organizations, and people living with HIV and AIDS and their supporters that there should be licensed access in all low- and middle-income countries,” Baker said. “Absent broad coverage, which would acknowledge that adult lives are equally important as children’s, the ViiV-MPP agreements will be judged harshly against the gold standard of universal access to affordable medicines.”

In its statement, ViiV said the company’s aim is “to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV.”

The next gains remain to be seen.

William New may be reached at wnew@ip-watch.ch.

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