Strict examination criteria needed for drug patents

  • Nation
  • Sunday, 26 Aug 2018

Patent problem: The Health Ministry is paying high prices for many crucial drugs while generic versions can be obtained at lower prices.

THE PHARMACEUTICAL company for an important HIV/AIDS drug that combines Lopinavir and Ritonavir did not file for patents on the two base compounds in Malaysia.

However, between 1999 and 2006, several secondary patents were filed on the compounds and granted by the Malaysian intellectual property office.

The patents for Lopinavir and Ritonavir base compounds expired worldwide between 2014 and 2017 respectively. But unfortunately, the last secondary patent is due to expire in Malaysia in 2027.

“All of these increase the patent life of the drug by about another 10 to 12 years even though the base compounds are no longer under a monopoly in Malaysia and anywhere in the world,” says Third World Network legal advisor S. Sangeeta, pointing out the irony of drug patent issues.

As a result, Malaysia still does not have the cheaper generic version of the drugs, she says.

The Malaysian Competition Commission review of the pharmaceutical sector revealed that the Health Ministry is paying high prices for this HIV/AIDS drugs – the patented drug costs US$1,489 (RM6,112) per patient per year under a Health Ministry procurement contract, while a generic version from India can be obtained at US$268 (RM1,100).

That would be about 82% savings for the Government if it had been able to gain access to the generic drug, says Sangeeta.

“When granting drug patents to pharmaceutical companies, the Malaysian patent office has to ensure that the invention is new, involves an inventive step and is capable of industrial application.

“But if countries loosely define the criteria, they can expect many patents being registered that extend the monopoly period and this delays generic versions from entering the market,” she says, adding that prices drop significantly, up to 90%, when there is robust generic competition.

Among the strategies used by pharmaceutical companies to prevent the entry of generic competition is a practice commonly known as ‘patent evergreening’ where multiple secondary patents are claimed over a pharmaceutical compound, patents over different forms such as crystals, liquids, tablets or heat-stable forms, uses, combinations, formulations and even dosages, she says.

It is important, that the ministry responsible for intellectual property and the patent office apply rigorous patentability standards on pharmaceutical patent applications, with the aim of avoiding secondary patents and patent evergreening, she says.

Sangeeta says that over the years, data from the US Food and Drug Administration shows that the number of new chemical entities for medicines has dropped since 1994, but the number of patents registered have increased, the US being usually the first country for patent filing.

This growth in pharmaceutical patents is a problem in developed and developing countries.

She also says that an Inquiry by the European Commission in 2009 revealed that in relation to 219 drugs, out of the 40,000 patents applications granted and pending, 87% were secondary patents.

“That means a large proportion of the patents granted are trivial patents,” she says.

The same inquiry found an estimated loss of around three billion Euros due to delays in the entry of generic products caused by misuse of the patent system, she says.

In South Africa, a study found 92 secondary patents were granted for 24 cancer medicines, with 74 likely to block competition from generic versions, she says.

She says there are lessons to be learned from other countries.

India, for instance, has a patent law which generally does not recognise patenting of new forms or uses of a known substance while Argentina has set up strict guidelines for the examination and grant of pharmaceutical patents.

Sangeeta believes there is a need for more sensitisation of the effect of the Malaysian patent office’s work on prices of medicines and access to medicines in Malaysia.

“If the Government does not ensure application of strict criteria for the examination of pharmaceutical patent applications, the prices of many life-saving treatments are going to remain high, and consequently, inaccessible to many patients.

“The bar has to be much higher, because now, many frivolous patents are being granted,” she says.

In 2016, the Report of the United Nation Secretary General’s High Level Panel on Access to Medicines recommended that World Trade Organisation Members adopt and apply rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants to curtail the evergreening of patents, and to award patents only when genuine innovation has occurred.

Sangeeta believes another measure that Malaysia can take to ensure only real inventions are patented is to introduce administrative pre- and post- grant oppositions system to patents.

She says that is because the court system is too time consuming and expensive.

“The opposition system will help patent examiners to conduct more rigorous examination of patent applications and have better examination practices. We are proposing the instituting of this opposition systems and that it be an administrative procedure and not a court case,” says Sangeeta.

Before a patent is granted, anyone who has an interest to file an opposition, such as generic drug companies or patient groups, could file an opposition before the patent office, showing why the patent should not be granted, she says.

A similar administrative procedure would apply after the granting of the patent in the form of a post-grant opposition system, she adds.

“Internationally, this has been found to be an important tool to ensure that patents are not wrongly granted,” she says, noting that this had a huge impact on facilitating access to affordable medicines in many developing countries.

“This would be especially beneficial and life-saving for patients suffering from cancer, HIV/AIDs, Hepatitis C, and rare diseases who pay very high prices for treatments,” she says.

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Health , Business , drugs , patent


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