By Stephanie Jacob
Dr Ismail Merican
It will be difficult for drug manufacturers to obtain extensions to their patents in Malaysia based on frivolous changes to the drugs because Malaysia’s drug regulators have provisions in place to prevent this from happening, said Mahsa University pro-chancellor Dr Ismail Merican to Malaysiakini.
“No, I have been assured by the Drug Control Authority (DCA) that it is difficult for them to do that. I know that is one of the most contentious issues – where you tweak here, tweak there; change this, change that, and then you receive a patent.
“Because of the clause that they (DCA) have right now, it is not possible for them to do that. The evergreening and the overhanging is not quite possible,” he said.
There is the concern that drug companies would try and obtain extensions to their patents by making minor changes to their product.
This happened in the case of a lung cancer medication called Alimta, which is manufactured by pharmaceutical company Eli Lilly. Alimta’s patent was supposed to expire in December 2015, but Eli Lilly introduced a vitamin regimen that is supposed to be given to patients before Alimta is administered, to avoid side effects. And this gained the manufacturer a patent extension until 2021.
Generic drug manufacturers had tried to challenge the extension arguing that the regimen only involves administering two common vitamins to cancer patients using Alimta. However, court rulings in the UK and the US determined that Eli Lilly’s patent is sound.
The issue of medicines under the Trans-Pacific Partnership (TPP) has been controversial due to concerns that stronger intellectual property rights measures would lead to longer patents, which would prevent cheaper generics from entering the market.
However, on the recently released TPP text, there have been no changes to the patent period for medicines, which remains to 20 years as per the World Trade Organisation standards.
Meanwhile, Malaysia will introduce a five-year data exclusivity period for biologics under TPP. Previously Malaysia had not had any protection on biologics, which is a new class of medicines being used in treatment for cancer, HIV and other serious illnesses.
Manufacturers could only request for an extension if there had been an unnecessary delay to their patent being granted originally. Ismail said this was unlikely in Malaysia because the patent issuance process was very efficient.
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