Diving into the patent pool

When it comes to treating HIV in low and middle income countries (LMICs), there are two crises—the first garners much attention, but the second hasn’t yet become high profile.

The first crisis is that many people with HIV in LMICs who need anti-retroviral drugs (ARVs) aren’t yet receiving them.  Despite the increased availability of ARVs in LMICs, WHO estimated in 2007 that only 27-34% of people in need of ARVs worldwide were receiving treatment.

But there’s a second crisis.  While prices of older ARVs have fallen dramatically in LMICs, due to competition from generic drug manufacturers, the cost of new first-line treatments, and of second- and third-line treatments (for those who fail first- and second-line therapy), remains prohibitively expensive.  As Dr. Selina Lo, Medical Coordinator of MSF’s  Campaign for Access to Essential Medicines, said in 2008:

Today we pay at best between US$613 and $1,033 for the newer WHO-recommended regimen for first-line AIDS treatment. This is a seven to twelve-fold increase compared to older first-line treatments which are now available for $87 for one patient’s yearly treatment.

One possible solution to the second crisis is to create patent pools, which were the focus of a meeting last week at Berkeley Law School.

What’s a patent pool?  MSF defines it as follows:

A patent pool is a mechanism whereby a number of patents held by different entities, such as companies, universities or research institutes, are made available to others for production or further development – for example of paediatric formulations or fixed-dose formulations. The patent holders receive royalties that are paid by those who use the patents. The pool manages the licences, the negotiations with patent holders and the receipt and payment of royalties.

While patents have expired on several of the older first-line ARVs, making them available cheaply from generic drug manufacturers, patents are present on most new and second- and third-line ARVs.  The TRIPS agreement, the most comprehensive multilateral agreement on intellectual property (IP), meant that these newer medicines became patentable for a minimum of 20 years.

At the Berkeley meeting, MSF’s Emi MacLean said that a patent pool would be “a response to the need to overcome patent barriers.”

In the post-TRIPS era, she said, generic competition isn’t bringing down prices for newer ARVs or for second-  or third-line treatments. “The current system threatens treatment access,” she said.

If drug companies were to place patents on newer ARVs into a patent pool, she explained, then other producers (especially generic manufacturers) would be able to make cheaper versions of these medicines under pre-determined licensing conditions.

“What molecules should be in the pool?” asked MacLean.  The pool must contain newer drugs, she said, “so they become available quickly in low income countries.”  The pool should include, she said, fixed-dose combinations, pediatric ARVs, and new classes of HIV drugs such as integrase inhibitors and entry inhibitors.

MSF has written to all the ART-manufacturing drug companies, she said, to ask them to put their patents into the pool.  “All said they’re interested.  Gilead has publicly voiced support.”  She noted that there aren’t yet any patents that have been placed into a pool.

Ellen ‘t Hoen, Senior IP Advisor At UNITAID, is leading UNITAID’s effort to launch an HIV patent pool. The vision of this patent pool, she said, is to “improve access to appropriate, affordable antiretrovirals in developing countries.” The pool aims to provide access to IP relating to fixed-dose combinations and new pediatric formulations.

MSF and Knowledge Ecology International proposed the idea of a patent pool to UNITAID in 2006, she said, which was followed in 2007 by a feasibility study, based on which UNITAID moved ahead with the idea in 2008.

‘t Hoen explained that 92% of patients who are on antiretrovirals in LMICs are on generic ARVs (mostly the triple combination D4T/3TC/nevirapine).  “The pre-TRIPS patent laws allowed this to happen,” she said, but in 2005, medicines became patentable under TRIPS. The patents on newer ARVs extend for a very long time.  The patent on  darunavir, for example, extends to 2023, said ‘t Hoen.

“Generic competition won’t kick in until these dates have passed,” she said.  “That won’t work for getting prices down.”

What are the next steps in making an HIV patent pool happen?

‘t Hoen said that, together with the WHO, UNITAID will figure out the highest priority essential ARVs, identify the relevant patents, and ask the patent owners to put their patent into the pool.  There will then need to be negotiations with the patent owners, and a licensing mechanism will need to be established.

And what are the challenges in getting the pool off the ground?

“Patent holders have strong rights,” she said, “so it depends on their willingness to participate.”

‘t Hoen acknowledged that the idea of a patent pool is “a radical proposal” but was confident that it was also “a doable proposal.”

“It could have a lot of winners.”