Malaysia's drug regulators have provisions in place to prevent drug manufacturers from obtaining patent extensions for making frivilous changes to the drug, said Mahsa University pro-chancellor Dr Ismail Merican.

“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, when asked at the sidelines of a roundtable dicussion on TPPA in Kuala Lumpur today.

Ismail had been a speaker on the pharmaceutical aspects of the controversial agreement at the discussion organised by the Asian Strategy and Leadership Institute (Asli).

He was asked whether the drug patent case of the lung cancer medication Alimta can also happen in Malaysia if the country signs the TPPA.

Article 18.37.2 of the agreement reads: “[...] each party confirms that patents are available for inventions claimed in at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product,” although exclusions can be made including in the interest of health.

According to Reuters , Alimta's patent was supposed to expire in December 2015.

However, its manufacturer Eli Lilly also introduced a vitamin regimen that is supposed to be given to patients before Alimta is administered, to avoid side-effects. This was given an additional patent that lasts until 2021.

When the generic drug manufacturer Allergan made a bid to sell a generic version of Alimta after the 2015 patent expires, Eli Lilly sucessfully challenged it in court.

The Court of Appeal in London ruled that the generic version of Alimta would indirectly infringe the 2021 patent, according to Reuters .

A similar decision had also been reached in US courts, according to The Wall Street Journal .