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TWN Info Service on Intellectual Property Issues (Sept06/04) 12 September 2006
The multinational pharmaceutical industries usually claim that patents are needed to recoup their investment in the research and development of innovative medicines. It is also on this basis that these companies are pushing developing countries to adopt higher and higher standards of IP rights in particular provisions that go beyond the TRIPS Agreement such as data exclusivity that have disastrous consequences on access to medicines. Because of the monopoly obtained through extended IP rights, these companies are able to charge higher prices. Attached is a document that shows very clearly that most of the products produced by these multinational pharmaceutical industries are me too products, i.e. having no therapeutic advantage over the existing drugs. The truly novel innovative medicines are very few. Briefly,
the document looks at While “me-too” drugs provide moderate, little or no improvement - in terms of effectiveness and safety - compared to older alternatives, however, on average, “me-too” drugs cost about 2.5 times as much per prescription as comparable older drugs. The article show evidences of similar findings in other countries as well. A recent WHO report by the Commission on Intellectual Property, Innovation and Health (CIPIH), has shown that the number of new molecular entities approved by the United States Food and Drug Administration (FDA) has not risen between the first half of the 1990s and the first half of this decade. Instead annual figures have shown a decline since the mid-1990s from a peak of 53 in 1996 to a low of 17 in 2002, although approvals recovered to 31 by 2004. The data also suggest that while the number of new molecular entities approved each year is broadly the same as in the early 1990s, the proportion regarded by the FDA as potentially significant therapeutic advances over existing drugs (which are given "priority review" status) has tended to decline. Between 1990 – 94 there were 63 new molecular entities that received priority review approvals. But the figure has dropped to 49 (between 2000 – 2004). More information on this is available at page 81 of the report that is available at http://www.who.int/intellectualproperty/documents/thereport/en/index.html in various languages. PATENTING OF ME-TOO DRUGS Besides the fact that since most new “me-too” drugs are much more expensive than equally effective older drugs, they represent a waste of health care resources, the above development also explains why the MNCs are pushing aggressively for patents to be granted on me-too drugs. If patents are not allowed for me too drugs (which are also marketed aggressively as a replacement to the older drug for which patents are expiring), then these companies will lose their market monopoly. If these drugs are not “novel” but are just new use/form/modification of existing drugs and it is obvious from the approvals above that this is the case, then patents should not be granted for these drugs. In short these drugs should be excluded from patentability altogether. “"(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;".
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