By P. Kandiah & Kimberly Liam
What happens when a patent for a particular drug expires or is about to expire? Patented drugs lose their patent exclusivity as they go off patent and pharmaceutical companies that own these patents start to worry as the generic pharmaceutical companies begin to sell their drugs in the market. Generic drug makers will most likely begin to manufacture these drugs on a smaller scale in order to apply for regulatory approval prior to manufacturing them on a larger scale for commercial purposes.
Most of us will know that the manufacture, use, sale or import of a patented product without permission is an act of patent infringement, in places where a patent for the product subsists. So how can generic drug makers go about taking steps to manufacture the generic drugs to obtain regulatory approval and so forth well before the expiration of the patents of the drug of interest?
In the U.S. and Europe, the Bolar provision (also known as the Roche-Bolar provision) allows other parties to conduct studies, research and tests for drug regulatory approval and other related acts such as manufacturing the drug. This provision or exemption originated in the U.S. by virtue of the Roche Products vs. Bolar Pharmaceuticals judgment.
Under this exemption, generic drug makers have the advantage of producing or making serious preparations to produce the generic drugs well before the patent expiration of the drug of interest, without the risk of being accused of patent infringement. Most countries adopt this provision, which is part of the TRIPS agreement, allowing researchers and scientists to utilize information from a patented invention to further understand the invention for the purpose of manufacturing the generics and perhaps developing or manufacturing new and innovative drugs.
What is the situation in Malaysia?
In Malaysia, Section 37 1(A) of the Patent Act 1983 states that “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.” This translates to allowing the manufacture, use or sale of a drug which has been patented without first obtaining the owner’s permission for the purposes of researching, developing and submitting information to relevant regulatory authorities.
In many countries, the Bolar exemption applies to not only pharmaceutical drugs but also to various fields such as medical devices, cosmetics, food products and more. However, Malaysia’s Bolar exemption, as indicated in the Patent Act, is limited to drugs. Therefore, the Malaysian interpretation of the Bolar exemption is considered narrow and restrictive compared to most countries. In addition, there is no specific mention as to when one can begin the permitted act before expiry date of a patent.
Without this exemption, generic drug makers will only be allowed to conduct research and develop the equivalent of the patented product after the patent has expired, and the sale of the generic product will only happen years after the expiration of the patent. This indirectly extends the monopoly of pharmaceutical companies or the patent owner of the said patented product for several more years after the patent expires.
The generic market now has a formidable presence in the pharmaceutical market compared to a few years back where the market was dominated by blockbuster drugs. This is due to more consumers being aware of generic drugs and opting for generic drugs which are much cheaper than innovator drugs due to the lack of breakthrough research, advertising or marketing expenditure. With the adoption of the Bolar exemption, foreign generic manufacturing companies have the incentive to relocate to Malaysia.
This freedom is limited and exists for the benefit of the public. Either way, the Bolar provision provides many more advantages especially for a country where R&D is the driving force in the nation’s development and also for the consumers who are able to have access to top-selling prescription drugs at a very much lower price.