Thursday, 12 December 2013

Day 4 of the Global Congress on IP for the Public Interest

The Global Congress is well underway today (posts from previous days here, here, here, here, here, and here), and has split into five tracks: User Rights; Openness; Enforcement; Traditional Knowledge (TK); and Access to Medicines (A2M).

The A2M track began with a review of developments in patent laws and policies of developing countries. Julie Hill, a representative from Doctors Without Borders (MSF), debunked several myths and arguments made by pharmaceutical companies regarding access to medicines and the patent system. She cited the lack of a patent examination system in SA as the reason that over 2400 pharmaceutical patents were granted in SA in 2008 (compare with Brazil, which granted only one-tenth as many in the five year period 2003-2008). Furthermore, as Ms. Hill stated, the oft-cited figure of 1 Billion USD as the amount required to bring a drug to market is misleading or flatly contradicted by pharma’s own statements, and in any case R&D accounts for less than 16% of spending by pharma companies. [This Leo notes that most initial-stage R&D is no longer done by Big Pharma, but rather is done by small start-ups, which are then bought by Big Pharma when they find a good candidate drug.]

A topic not mentioned in the MSF presentation, although it is frequently mentioned by A2M advocates, is one of Evergreening (i.e., extending the effective patent term of drugs by filing new patent applications toward minor changes to formulations or drug identity). Nothing makes Evergreening more difficult than a strict enforcement of patentability requirements (particularly the requirement of non-obviousness). Thus, the lack of an examination system would seem to make Evergreening incredibly simple and a highly likely phenomenon. Do readers know of Evergreening examples in SA, particularly examples that would likely not have occurred had there been an examination process in place? Surely some of those 2400 SA patents from 2008 were for drugs that were previously protected by other patents…

An afternoon session led by Prof. Hafiz Aziz ur Rehman of the International Islamic University, Islamabad, Pakistan, discussed the patent status of various new drugs that are considered essential to diseases of the developing world (HIV, Tuberculosis, Hepatitis-C, cancer, etc.). Encouragingly, the A2M movement is using existing channels for challenging patent validity where such channels exist. The various patents were described as “very good” or “weaker”, with such characterizations being based on the uniqueness of the drug chemical structures (and therefore, presumably, the likelihood of finding invalidating prior art). This Leo wonders, is the A2M movement conducting pro-active invalidity searches of the prior art? Or does the movement rely on other players such as would-be generic manufacturers to do such work? A thorough prior art search can run tens-of-thousands of dollars, but compared with other activities that might be quite a bargain (particularly because a successful search can completely invalidate a patent years ahead of the expiry date). [An interesting website/concept on this is MSF's Patent Opposition Database]
Hard at work making new drugs
Alfred Bader, A Chemist's Laboratory, 1827

Another speaker in the same session, Jamie Love (Director, Knowledge Ecology International), criticized (and presented data showing) that only a few hundred patients are used, on average, in the trials to assess efficacy of various cancer drugs, and that the treatment regimens for the resulting drugs usually costs over $100,000 per year (while the drugs are on-patent).

And finally, from Jamie Love, a terrible statistic. In SA, the percentage of breast cancer diagnoses that are made at the early stage (i.e., the more treatable stage where the cancer is isolated rather than metastasized) is 30% for White women and only 5% for Black women.

There is a notable difficultly that is inherent in the arguments made here. The A2M movement wants readily available drugs for a wider variety of diseases, and drugs that have been tested on a large number of patients during trials so they are shown to be safe and effective, and drugs that are provided at low cost. More drugs, more testing, less cost. Can you have all of these things together? Is it reasonable to expect that all diseases will be treated at low cost by a single industry that, at the end of the day, is in business to make money?

Knowing that this is a terribly hot-button issue, this Leo will still ask: what do readers think?

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