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