A foreign Pharmaceutical company (“Foreign Company”) owned a Malaysian Patent covering a pharmaceutical product of alendronic acid or a pharmaceutically acceptable salt (alendronate) to inhibit bone resorption in humans. Whereas, a Malaysian company (“Malaysian company”) was granted approval by the National Pharmaceutical Control Bureau to market "Alendronate" 70 mg tablets.
The Foreign Company claimed that the acts of the Malaysian Company in import, manufacture, offer for sale, sale and stocking for the purpose of sale or offer for sale of "Alendronate" 70 mg tablets have infringed its registered patent. The Malaysian Company counterclaimed for a declaration that the mentioned patent is invalid on certain grounds.
The case was brought to the High Court and the patent was held invalid for lack of inventive steps. An important point to note is that all the dependent claims of the patent were automatically held invalid as a result of the independent claim also having been held invalid, and no amendment was allowed. This decision of the court followed the precedent of the unfortunate Federal Court decision in SKB Shutters Manufacturing case of 2014.
- It is important to understand the requirements for patentability and carefully draft your claims to minimise the risk of invalidation.
- Hire a lawyer with local expertise to assist you with patent prosecution, contract drafting and legal implications. It is also very important to be aware in advance of decisions of local courts such as precedents, the court’s orientation and positioning where possible.
- Do not forget to analyse your options and collect information on local practice well in advance to integrate them in your business plan and strategy.
- Conduct regular IP due diligence exercises to assess the strength of your patent portfolio, and maintain an edge over competitors who operate in the same space.