Discussions on a number of intellectual property issues in October showed that deep divisions remain on how to counter biopiracy and on whether so-called non-violation complaints should be allowed under the TRIPS Agreement.
The Council for Trade-related Aspects of International Property Rights (TRIPS) again heard arguments for and against amending the TRIPS Agreement so that it would require patent applicants to disclose the origin of genetic material and any associated traditional knowledge involved in their inventions. The topic has been discussed in the council for years, but there is no sign of the two camps moving closer.
A large group of developing countries continues to push for a mandatory disclosure requirement, which they see as necessary to prevent biopiracy, or the granting of patents on erroneous grounds of novelty. India, for instance, had to spend millions of dollars on legal fights to get the European and US patent offices to revoke patents on anti-fungal neem tree derivates and wound-healing turmeric. Both plants have been known for similar (and other) uses in India for centuries.
At the October TRIPS Council meeting, several other countries, including Japan and the US, maintained their position that a disclosure requirement would be ineffective in preventing biopiracy or inappropriate patenting.
In July 2008, more than 100 countries - including the ACP and African Groups, as well Brazil, China, India, Indonesia, the EU, Switzerland and others - co-sponsored a draft ‘modalities’ decision on three TRIPS-related issues. The proposal requested the start of formal negotiations, as part of the Doha Round, on a mandatory disclosure requirement and stronger protection for geographical indications (GIs, or product names associated with a particular location or tradition). It also called for an intensification of ongoing negotiations for a register for GIs denoting wines and spirits.
Many of the sponsors argued in favour of this proposal in October, while Argentina, Australia, Japan, the US and others said that linking the three issues would complicate the discussions.
WTO Members agreed to seek a decision at the upcoming ministerial conference on whether ‘non-violation complaints’ - i.e. disputes alleging the nullification of benefits that could reasonably be expected rather the a breach of any specific provision - should be allowed under the TRIPS Agreement.
A moratorium on such complaints - extended by trade ministers several times in the past - is currently in place, and most countries would like to see it prolonged again in December. However, the US told the TRIPS Council that in could not agree to another extension. The conflict was subsequently resolved, and ministers prolonged the moratorium.
Generic Drug Seizures
India complained that two more unlawful seizure of legitimate generic drugs in transit through European airports had taken place this year, one in Frankfurt and the other in Paris. The first shipment - about three million tablets of Amoxillin - was destined for Vanuatu, and the second - 1.74 million doses of the blood thinner Clopidogrel - was heading for Venezuela.
India told the council that, by permitting such seizures, the EU’s Customs Regulation 1383/2003 violated GATT Article V on the freedom of transit, as well as the TRIPS Agreement and the Doha Declaration on TRIPS and Public Health.
India also expressed concern about a deliberate effort by developed countries to amalgamate the issue of sub-standard drugs (a regulatory concern) with intellectual property protection as part of an ‘orchestrated campaign’ to impose TRIPS-plus enforcement norms on other Members.
In response, the EU stressed the importance of preventing exports of dangerous fake medicines, and said that the ‘detention’ - rather than ‘seizure’ - of medicines (even in transit) at the border was ‘legitimate and necessary’ to allow right holders to verify products. It also suggested that attention to the issue was maintained artificially for political reasons.
WTO Dispute Looms
In related news, the WTO ambassadors of India and Brazil confirmed in October that their governments intended to file formal WTO complaints on the detention of generic medicines in transit through the EU, but did not say when the requests would be submitted.
The two countries have contemplated a WTO challenge ever since a shipment of the generic anti-hypertension drug Losartan, en route from India to Brazil, was detained by Dutch customs officials in December 2008 (Bridges Year 13 No.1 pages 12 and 13).
Deadline Extended for TRIPS Public Health Amendment
In a rare show of consensus, Members agreed to extend until end-2011 the deadline for accepting an amendment to the TRIPS Agreement that would allow countries lacking the capacity to produce generic drugs to import them under compulsory licence from abroad. The decision is of minor importance, however, as a provisional waiver will cover the arrangement until two-thirds of the membership have approved the permanent amendment. At the time of writing, fifty-two of the WTO’s 153 member countries had done so.
Representatives of the African and LDC Groups argued that the system was inefficient. Since the adoption of the waiver in August 2003, the procedure has been used only once, by Rwanda, which has imported a generic HIV/AIDS drug from Canada. The chair of the TRIPS Council will hold consultations on whether the system is too cumbersome.
Add a comment
Enter your details and a comment below, then click Submit Comment. We’ll review and publish the best comments.