The Hindu Business Line : Patent pool for public health: Breakthrough or Quixotic initiative?

Is the effort by United Nations-supported UNITAID, an international drug purchasing facility, to create a patent pool in the interest of public health a break-through initiative or is the agency tilting at windmills?

In the past, patent pools have been tried and with a reasonable degree of success in information technology (IT), where it was necessary because of the inter-dependent nature of products. And the concept is being discussed in the context of environmen t as well, to encourage green technology, as we battle climate change.

A patent pool works on a voluntary mechanism, where the innovator supplies technical know-how, otherwise protected by a patent. Other companies gain access to this technology by paying a royalty that usually goes back into the pool. So while the UNITAID’s initiative is laudable as it addresses a major concern — making medicines accessible to people — it will have to grapple with the hydra-headed intellectual property (IP) ‘monster’ that gets awakened in the process.

Will Big Pharma bite the bait and ‘volunteer’ patents on critical medicines to the pool? Who will administer the pool and where? How much royalty will be paid? And, most important, who will regulate it, as a patent pool gone awry can work as a cartel. So will patent pools be regulated by the competition laws of different countries?

Implementable

Some drug companies are more forthcoming than others, says Ms Ellen ’t Hoen, Senior Advisor IP and Medicines, UNITAID, on the response of pharma companies to the pool. UNITAID received the mandate to create the pool in July 2008 and is meeting stake-holders to note their concerns and address them when the final ‘implementable’ plan is put in place, possibly later this year.

On a visit to India as part of this brain-storming process, Ms ‘t Hoen met domestic generic-drug makers such as Cipla, Ranbaxy, Hetero, Aurobindo, Matrix and Emcure, among others. The reason being Indian generic manufacturers would be likely licencees of the pool.

UNITAID is confident of replicating some of the success achieved by patent pools in IT and agriculture, says Ms ‘t Hoen. Besides, the pharma industry is moving to a collaborative model and hence a public health pool can have something in it for everybody, she suggests.

UNITAID is starting with anti-retrovirals (ARV) or AIDS-related medicines. And the access programme, depending on its success, will be extended to malaria and tuberculosis.

Early days yet, but there have been no commitments from drug-makers. UNITAID’s approach, however, will not be to wait for what companies are willing to give. It will, instead, be driven by medical needs of the time, “else there is the risk of getting IP that is not useful”, explains Ms ‘t Hoen.

The pool has met with layered responses from the IP fraternity. Some say Big Pharma will not be enthused to put good patents in a pool, as it is ‘antithetical’ to investing in innovative research.

It may work in the electronics or semi-conductor segment, where numerous, inexpensive, incremental innovations permit pooling to resolve overlapping of patent rights, they say. But the economics of making medicines, involving expensive innovations, does not lend itself to a pool, they observe.

Ms ‘t Hoen counters that patent pools could see large drug companies sell in markets it may not have sold otherwise. And for generic-makers like those in India, pools help gain access to different technology. Such collaborations benefit patients, she defends.

India has been at the heart of the changing IP environment that triggered the patent pool concept, says Ms ‘t Hoen. Indian drug companies have been suppliers of inexpensive medicines, particularly in the AIDS segment, to several countries.

The product patent regime, in place from 2005, made new medicines patentable and so out of reach for generic drug-makers, affecting their ability to provide affordable treatment, she observed.

Patents provide a monopolistic 20-year grip on a product, allowing a recoup of money spent on research and marketing of the product. But it also keeps competition at bay, resulting in high prices.

One-stop shop

UNITAID’s initiative starts with fixed-dose-combinations (FDC) or drugs that, for instance, combine two or three medicines. FDCs are a treatment of choice for HIV/AIDS as they reduce the risk of resistance (where the body stops reacting to a particular medicine); it is easy for the patient as he is taking a single pill as against three or more pills at one time.

This improves adherence to the regime by the patient, and he responds better to therapy. It also has advantages in logistical, inventory management, Ms ‘t Hoen points out.

But making an FDC is troublesome, as each medicine in the FDC has a different patent life. So if an FDC combines three individual drugs, the company making the FDC would usually have to get permission from the three different makers of the ingredient medicines, or be embroiled in a patent litigation over it.

In a patent pool, the basics and revenue concerns are sorted out, so it works like a one-stop-shop for the generic drugmaker to make the FDC. This saves time and money for all involved. The pool will also focus on paediatric anti-AIDS drugs, not on the radar for several drug companies.

Regulator

Idealism needs to be rooted in reality and it is imperative to outline who regulates the patent pool and how it would operate in different countries. The patent pool will be run by a separate entity, says Ms ‘t Hoen, but other details are still on the drawing board.

Illustrating the economics of UNITAID’s concern, she says, the agency spends $1 billion on medicines for HIV/AIDS/ TB and malaria. Half this amount is spent on just AIDS-related medicines and if their prices go up, it means less medicines for the same money. Recently, Indian authorities too expressed similar concerns, cautioning that it is not just about AIDS drugs, but other critical segments such as cancer and hypertension, as well.

With this being the discomforting ground reality, UNITAID will have to navigate tricky IP-laced pathways. Whether its patent pooling initiative translates into a workable model to access medicines or turns into a Quixotic pursuit remains to be seen.

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