If a pharmaceutical drug enjoys patent protection in Malaysia under the Patents Act 1983, can the Drug Control Authority (DCA) of the Ministry of Health grant marketing approval for another generic drug allegedly falling within the claims of the patent and applied for by a rival company? And if marketing approval is given, can the rival company market the generic drug without infringing the patent or without consent of the patentee? Pharmaceutical drug marketing companies often face this dilemma.
This issue recently came up before the High Court in Kuala Lumpur in the case of Ranbaxy (M) Sdn Bhd and E.I. Du Pont De Nemours and Company (Suit No.: D5(IP)-22-16-2009). In the dispute between the two pharmaceutical giants, Ranbaxy argued that since it has obtained DCA approval for its COVANCE drug, it should be allowed to market the drug, notwithstanding the drug may have infringed Du Pont’s MY-110414-A patent still subsisting in Malaysia. The High Court, in its decision on 18th February 2011, held that obtaining DCA approval does not exempt the product from the exclusive rights granted to a patentee. Therefore Ranbaxy’s drug, on the facts of this case, was held to infringe Du Pont’s patent.
Is there a conflict of laws?
The Patents Act and the legislation to obtain DCA approval before putting pharmaceutical drugs in the market (The Control of Drugs and Cosmetics Regulations 1984) are two separate laws of Parliament, dealing with different but related issues. The fact that a firm obtains DCA approval for a drug does not mean that it is exempted from the provisions of the Patents Act (or any other Acts for that matter), and vice-versa. Obtaining a patent for a drug would mean the patentee has exclusive rights to the drug, but that does not tantamount to permission to manufacture, import or market the product if other legal requirements are necessary to be met.
Pharmaceutical giants battle it out in India
A similar case in India in December 2010 involved Bayer Corporation and Bayer Polychem (India) Ltd, of one part and the Drug Controller General of India (DCGI). The Supreme Court of India, under corresponding legal provisions in India, held that it was incorrect to say that the DCGI did not have authority to grant marketing approval to generic versions of patented drugs. The issue of injunction sought by Bayer against CIPLA was to be decided in a suit for infringement under the Patents Act.
In Malaysia, can a patentee sue a purchaser (for example, a hospital) of a generic drug for which DCA approval has been obtained? What should a purchaser of a generic drug do under such circumstances? Such a purchaser of a generic drug has two options. Firstly, he can refuse to buy the generic drugs unless and until the supplier of the generic drugs obtains a Declaration of Non-Infringement of Patent from the High Court. Secondly, he can take the risk but obtain full indemnity from the supplier in the event he is sued for patent infringement and is held to have infringed the patent. It must be remembered that the patentee has the liberty to sue anyone or all those involved in importing, manufacturing, offering to sell, selling, stocking for sale and even the purchaser and user of infringing products.
Notice: This article is intended only to address matters of concern or interest to readers and should not be treated as legal advice on the issues discussed. For specific queries on IP matters, please contact us for further assistance.