Singapore Improves Pharmaceutical Patent Bill

In June 2004, Singapore amended its Patent Bill in hopes of strengthening the country’s pharmaceutical patent system. The changes should improve the pharmaceutical sector by encouraging greater innovation and research in Singapore pharmaceutical industry. Specifically, the amended Bill focuses on improving three key areas in Singapore patent regulations, (1) the patent term, (2) parallel importation of products, and (3) improving the patent application process. These changes will not only give patent owners more security and incentive to bring new products into Singapore, but will also benefit consumers and patients as new products become available in the market.

First, the amendment provides for flexibility in the patent term. In Singapore, after receiving a patent, the patent term begins even though the product has not been approved yet. Frequently, there are delays during the process of obtaining the market approval for a pharmaceutical in Singapore. In this case, a company could lose many weeks or months of the patent term since they are not yet able to market the product. Under the new amendment, the patent term will start once the product is approved.

Second, Singapore is trying to preserve the balance between the interests of patent owners and users of pharmaceuticals by altering the parallel importation rules for pharmaceutical products. Under this new section of the Bill, a patent owner has special rights concerning parallel (generic or similar) products. Specifically, a patent owner is able to stop a parallel importer from importing a product that is a generic equivalent or similar to the patented product, if the product has not been previously sold or distributed in Singapore. But, once the patent owner imports the product into Singapore, this right will be voided the patent owner may be subject to competition from parallel importers.

There is one exception to the above regulation. If a patented pharmaceutical product is needed for the treatment of a specific patient in Singapore, the product may be parallel imported with the HSA’s approval, regardless of whether the patent owner has brought the product into Singapore. This will ensure that Singaporeans receive adequate medical treatment and will not be denied treatment due to the lack of certain pharmaceutical products in the country.

Finally, Singapore is improving its patent approval system through the creation of a two-track system. This system will better cater to a company’s needs, rather than the current one-track system, providing little flexibility. Track one is a fast track, which enables a patent applicant to expedite the application process and obtain a patent as soon as possible. The second process is the slow track, allowing a patent applicant to spend more time working on a marketing plan and patent strategy before entering the patent term. This new system should make the patent approval process more efficient and cost-effective by better catering to each applicant needs.