The government of Venezula has invalidated two patents registered in the country by Bayer for its antibiotic Avelox, local reports have confirmed.
Late last week, the country’s Trade Ministry stated that the government had commenced the process of annulling the patents after being informed by two locally-owned generic drugmakers which have been producing Avelox (moxifloxacin) that the multinational had begun legal proceedings against them.
According to Trade Minister Eduardo Saman, “procedural problems” in the granting of the two patents been discovered.
This week Arlen Pinate, director general of the national patent office (SAPI), confirmed that Bayer’s two patents had been invalidated. The reason for annulling the first patent was that it had been granted in 1992, when the 1956 Industrial Property Law, which excluded pharmaceutical patents, was still in operation, she said. The second patent had been registered in 1996, when the legislation had been amended to permit drug patents, but is now deemed to be invalid because of “prior publication;” ie, the first patent meant that the drug was already in use in the country so it failed the Venezuelan patent law’s requirement that the invention should be “novel.”
However, in her announcement of the annulments, Ms Pinate also accused Bayer of putting public health at risk, leading commentators to note that this move is in fact the latest development in President Hugo Chavez’s policy of preventing overseas-owned patents being enforced in the country. Announcing the policy back in June, Mr Saman – who was formerly head of SAPI – did not specify which patents would be invalidated, but said that “patents have become a barrier to production, and we cannot allow barriers to the access of medicine or transnational medicine companies to impose their rights on the Venezuelan people.”
Venezuela is currently Latin America’s third largest market for pharmaceutical imports, with an estimated current value of $1.2 billion out of a total market worth $3.5 billion last year. A recent report from Research and Markets forecasts that the national drugs market will grow by an average 28.2% a year to 2013, when it will be worth $12.1 billion, although in US dollar terms its value that year will be $2.7 billion, having experienced a negative compound annual growth rate of 5.1% during the period.
Despite Mr Saman’s subsequent announcement in August that imports of finished medicines will be restricted in order to support local production, Research and Markets forecasts that the market will remain heavily reliant on pharmaceutical imports, buoyed by its overseas trade in oil.
