Originals versus generics
This balancing act is particularly important but difficult for developing countries, such as Malaysia.
Original pharmaceutical drugs are generally protected by patents, which are essential to ensure a return on investment (in research and development, clinical studies, clinical trials), through a fixed-term market monopoly. On average, it can take between seven and 10 years for original drugs to get from the laboratory to the market. By comparison, a granted Malaysian patent confers a non-extendable 20-year monopoly, calculated from the filing date of the patent application.
Patent owners argue that, due to delays in patent prosecution and the process of regulatory approvals, this 20-year monopoly is insufficient compensation for the substantial investment committed to bring original drugs to the market. Unlike in the US or Europe, there are no provisions in Malaysian patent law for the grant of either supplementary protection certificates (SPC) or patent term extensions (PTE) to patents.
Tipping the balance in favour of generics, a Bolar-type exemption similar to Section 271(e)(1) of the US Hatch-Waxman Act was introduced into the Malaysian Patents Act with effect from August 1, 2001:
“The rights under the patent shall not extend to acts done to make, use, offer to sell or sell a patented invention solely for uses reasonably related to the development and submission of information to the relevant authority which regulates the manufacture, use or sale of drugs.”
In September 2001, the Drug Control Authority (DCA), an executive body of the National Pharmaceutical Control Bureau (NPCB), issued a statement allowing generic drug manufacturers to submit their applications for regulatory approval up to 24 months before expiry of the patent term. This potentially allows generics to go on sale the moment original drugs lose their patent protection.
Data exclusivity, used in some countries to compensate for insufficient patent protection by preventing health authorities from accepting applications for generics during the period of exclusivity, is not yet available in Malaysia.
Malaysia’s Patents Act provides for compulsory licensing of drugs during medical emergencies. CIPLA Limited of India became the first company in the world to benefit from such a licence on September 29, 2004, when the Malaysian government issued a two-year compulsory licence to Syarikat Megah Pharma Vaccines Sdn Bhd to import CIPLA’s anti-retroviral patented drugs didanosine, zidovudine and combivir.
Although government policy and legislature seem to favour generics, all is not bleak for patent owners. In the sole case to date, the Malaysian courts ruled in favour of original drugs.
In an application for interim injunction in the infringement dispute between Aventis Pharma and local manufacturer Dabur Enterprise Aventis Pharma and local manufacturer Dabur Enterprise (Aventis Farma SA (M) Sdn Bhd & Anor v. Rohibul Sabri Bin Abas @ Megat (Dabur Enterprise) & Anor), Justice Vincent Ng decided in favour of patent owner Aventis Pharma.
Its patent covers a method of producing docetaxel trihydrate, the active ingredient in a cancer drug sold under the brand name Taxotere. The defendants manufacture and sell the generic version of the drug under the brand name Daxotel.
The plaintiffs claimed that the defendants had infringed their Malaysian patent and applied for an interim injunction to restrain them from selling Daxotel. The defendants contended that the process they employed in manufacturing the active ingredient docetaxel trihydrate was different to the plaintiffs’ method. They further contended that public interest would be better served if they were allowed to continue selling Daxotel, since it costs substantially less than Taxotere.
When delivering his decision to allow an application for preliminary injunction in view of patent infringement, Justice Ng said: “It may be true that the defendants’ drug costs less to cancer patients here, but pirated compact disks, watches and DVDs sold in Petaling Street, Kuala Lumpur are also famously dirt cheap. It does not then follow that because such pirated goods could save our consumers considerable sums of money, it is in the public interest to condone such activities.”
The manufacture and export of off-patent generic drugs has become a significant market in Malaysia. The admission of Malaysia to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation/Scheme (PIC/S) has further boosted the country’s exports of off-patent generics, especially to PIC/S member countries, with total exports in 2008 amounting to RM513 million ($150 million).
To the general public, including medical professionals, there is no great difference between original drugs and generics. The only vital distinguishing factor is cost. Can originals and generics co-exist in the market of a developing country such as Malaysia? Only time will tell.
Oon Yen Yen is business development manager and registered patent agent at Henry Goh & Co Sdn Bhd. She can be contacted at: yen@henrygoh.com
