WEEKLY SELECTION-VENEZUELA: Patent Battle Over Sex Pill

By Estrella Gutiérrez Reprint | | Print |

Estrella Gutierrez

CARACAS, Apr 10 1999 (IPS) - A legal battle between local and transnational drug companies over the anti-impotency pill “Viagra” has moved into Venezuela’s Supreme Court of Justice.

Venezuelan companies are ready to reproduce the drug that, in the past year, has revolutionised the global pharmaceutical market. The cite a 1995 law which declares that, as a rule, products in the sexual dysfunction area of the health sector cannot be patented.

However the Autonomous Service of Intellectual Property (SAPI), the highest authority on the issue, has granted patent rights to Viagra to the transnational concern “Pfizer”, the manufacturers of the drug.

The fight over Viagra was highlighted by the newspaper “El Nacional” as part of a wider struggle between national and foreign companies, which also affects the Andean Community, the trade bloc to which this country belongs.

The First Court of Administrative Disputes accepted a lawsuit from a local laboratory last month for nullification of the patent granted by SAPI to Pfizer, whose stock went up 60 percent in 1998 when it introduced Viagra on the US market.

Local laboratories have used a traditional two-pronged strategy of promoting market protection from foreign competition while seeking to keep the sector free of patents.

Six Venezuelan-owned laboratories brought legal actions for the right to manufacture male anti-impotency products with the same active ingredient as Viagra, called pirazolopirimidon.

They also requested permission from health authorities to sell their “copies” on the domestic market, under brand names like “Sildenafil” and “Viasek” — much less evocative than the combination of the words “vigor” and “Niagara” (Falls), with which Pfizer baptised its pill.

The local “copies” will cost 50 to 70 percent less than Viagra which sells at around 10 dollars a pill.

Pfizer, which has not confronted obstacles to obtaining a patent in other countries, warned that it will exhaust every legal remedy to prevent Venezuela from becoming the starting point for the “cloning” of Viagra, which would erode its control.

The director of the Chamber of Venezuelan Laboratories, Milagro Ladera, elaborated that in fact, the laboratories did not face any impediments in manufacturing the drug, other than obtaining the permission of local health authorities, a very slow process due to red tape.

Ladera argued that Venezuelan law is very clear in exempting medicines from the patent regime, based on the public interest and as a way of containing the rising costs of medicine — in practice, a total failure.

But in reality, drug patents are being granted in the Register of Industrial Property of SAPI, pointed out Francisco Allende, director of the chamber of transnational laboratory affiliates.

“The Register accepted at least 230 pharmaceutical patents and there are many others being applied for,” since 1994, when the Andean Community established a common regimen for industrial property, he indicated.

The director of SAPI, Francisco Astudillo, based his decision in favor of Pfizer on that regimen, which has compulsory application in member countries, according to the Andean Tribunal. The other Andean members are Bolivia, Colombia, Ecuador and Peru.

The official argued that in accord with regional Andean legislation, it has the right to patent any pharmaceutical product that originates from new research and whose uses were not previously known, as is the case of Viagra.

“We are not innovating (the law), just once more applying the general principles of patents and Andean standards,” he affirmed.

Astudillo warned that if any laboratory other than Pfizer obtained permission from the health authorities and commercialised the anti-impotence product, with the same pharmaceutical chemical ingredient as Viagra, the Irish company will sue.

He also raised the possibility that if the Supreme Court sided with national laboratories on the Viagra issue, “it would be disowning every industrial property right applied for the last eight years,” as well as the enforcement within the country of Andean rules.

The episode with Viagra is not unprecedented. At the beginning of 1998, a system entered into force in the Andean Community to facilitate the commercialisation of medicine within the bloc, which operates as a free trade zone and a customs union.

This system, known as decision 418, limits the bloc countries to a 30-day period to grant or deny permission for the sale of drugs of Andean origin, and assumes silence to be a positive response.

The rule was appealed in February 1988 before the Supreme Court by the same national laboratories, who consider it unconstitutional and argue that any international standard must be approved by the local Congress according to the constitution.

But the Andean Tribunal insists that any rule of the bloc is enforceable once it is published in the Andean Gazette, and the Venezuelan Supreme Court has always given precedent to Andean legislation over other sources, although it has not yet ruled on that issue.

The attorney Allan Brewer, an advocate of the laboratories’ claims, insisted that Viagra is not entitled to a patent under national law and the constitution. He added that the fact that the authorities have repeatedly violated these laws before is not an argument in favor of them continuing to do so.

Astudillo stressed that pharmaceuticals is the only sector that opposes Andean standards and that the situation will only be resolved when the Supreme Court confirms that the treaty which gave life to the Andean Community, and was ratified by the local Congress in 1983, is Venezuelan law.

The plaintiff laboratories did not rely only on the supremacy of local laws in their arguments against the patenting of Viagra, but also on points relating to the natural science of medicine.

They argue that it should not be treated as an invention, but rather the discovery of a new application of a principle that was already patented for other uses and was public knowledge.

They are presenting documents that pirazolopirimidon was already used as an active ingredient in a drug previously patented as a capillary dilator for the treatment of hypertension, but which did not prove very effective.

Pfizer discovered the “secondary use” of the compound Sildernafil, which increases blood flow to the penis, when patients participating in clinical trials of the product refused to give back their remaining pills, explain the plaintiffs.

But beyond the coincidence and good luck of the discovery, the patent has been registered in the United States and Europe, on the basis of which, even if it happened as they say, there was a new investigation and an unknown use. (FIN-IPS-eg-if-he-ks-99)