Policy and Legislation

Generic company wins right to produce antibiotic

A South African generic manufacturer recently won its case against pharmaceutical giant SmithKline Beecham allowing it to produce a generic of SKB’€™s penicillin-based antibiotic.

South African generic medicine producer, Triomed, has emerged victorious in a legal battle with pharmaceutical giant SmithKline Beecham over the right to produce a generic version of a special penicillin-based antibiotic.

SmithKline Beecham, producers of the drug Augmentin, accused Triomed of trademark infringement, following the launch of its generic counterpart AugMaxcil. It objected to Triomed’€™s name for the tablet and the fact that Triomed retained the shape of the original tablet.

The SmithKline Beecham patent on Augmentin expired in 1996.

In a recent judgment, the Pretoria High Court found that Smithkline Beecham (SKB) had no right to claim patent rights over the shape and name of the tablet. It did find, however, that Triomed had infringed copyright in reproducing parts of the package insert and granted an interdict to SKB in this matter.

In his judgment, Judge Smit said that the trademark, which depicts an elliptical, bi-convex tablet with a band, was too vague for the purposes of a valid trademark registration. He added that SmithKline Beecham appeared to be trying to obtain a monopoly over the shape as well as
any similar shape and that this would limit the development of the pharmaceutical industry and would stifle competition.

Judge Smit said the shape of the tablet could not be claimed as a trademark of the

Triomed general manager Gary Holloway said the case was a victory against “the monopolistic bullying tactics of the big drug companies to protect their high profits”. It was also a victory for the rights of consumers to access cheaper generic alternatives. The cost of the generic, AugMaxcil is approximately a quarter of the price of the original, Augmentin.

“By attempting to register different trademarks, including the shape of the tablet, Smithkline Beecham was trying to control access to the drug beyond its patent life,” said Holloway.

However, the attorney for SKB, Brian Wimpey, said the matter had nothing to do with the quest for affordable healthcare.

He said the issue was one of trademark infringement and validity. “SmithKline Beecham has no objection to the launch of a generic substitute to its successful Augmentin product ‘€“ it objected to Triomed launching a product identical in shape, colour and size to its own and utilising a similar name,” said Wimpey.

He added that SKB had appealed the judgment.

The decision in favour of Triomed, the third largest generic company in South Africa, comes in the context of several other challenges to the patent rights of big pharmaceutical companies.

In recent months, the Treatment Action Campaign (TAC) has imported two consignments of the Thai-produced drug, Biozole, the generic version of Fluconazole to which Pfizer holds the patent in South Africa. The TAC has complied with all the requirements laid down by the Medicines Control Council to gain a Section 21 exemption to allow for the use of Biozole as an approved generic.

Fluconazole is an effective antidote to cryptococcal meningitis and thrush ‘€“ two opportunistic infections that often affect people with HIV/AIDS. If these infections are treated, people with HIV/AIDS are able to lead healthy, active lives.

Dr Steve Andrews of the Brooklyn Medical Centre in Cape Town, the private medical practice which will import the generic in contravention of Pfizer’€™s patent, says he is doing it because he is tired of watching patients die because they don’€™t have access to affordable drugs.

“Dying of starvation and dehydration because you can’t swallow [because of thrush] in the presence of drugs that can stop that is approaching the level of crimes against humanity,” says Andrews.

More than three years ago, an attempt by the previous Minister of Health, Dr Nkosazana Zuma, to pass legislation to ensure access to affordable medicines drew sharp reaction from the Pharmaceutical Manufacturers’€™ Association (PMA). It instituted legal proceedings against Section 15c of the Medicines and Related Substances Control Act No 90 of 1997 because, it said, the new law did not respect patent rights.

Yesterday, the PMA announced it would resume its litigation to block the manufacture and importation of generic drugs as provided for in Section 15c of the Medicines and Related Substances Control Act. The case is due to be heard in the Pretoria High Court in March.

Developing countries such as Brazil, India and Thailand each have strong generic production capacity ‘€“ some are private companies and others are state-owned. In Brazil, the production of affordable generic anti-AIDS drugs has had a significant impact in improving the quality of life of people with HIV/AIDS. ‘€“ Health-e News Service

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