Second Reading Speech on Patents (Amendment) Bill 2004 by Associate Prof Ho Peng Kee
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- Mr Speaker, Sir, I beg to move, "That the Bill be now read a Second time."
- This Bill amends the Patents Act to strengthen our patent regime. The changes will encourage innovation and research activities in Singapore. In particular, they will support the growth of the pharmaceutical and biomedical industries. As Minister for Law had earlier said, many of the amendments are a result of consultations with patent professionals stretching over 2 years. Several of the amendments are also an outcome of the USSFTA.
- Now, let me highlight the key amendments in the Bill.
- Clause 9 (new Section 36A) provides for an extension of the patent term to compensate for delays. These delays may occur either in the process of obtaining a patent grant or, in the case of a pharmaceutical product, in the process of obtaining marketing approval. Getting a patent grant can be a lengthy process. Patent offices have to conduct rigorous examinations on the invention, to determine if it is patentable. A delay in the grant of a patent, can affect a company's ability to enforce its rights in any event of infringement. Applicants should not be prejudiced for delays arising from the patent office's processes. For this reason, should there by any undue delay on the part of the patent offices, we will compensate the patent owner by extending the term of protection correspondingly.
- Section 36A(1)(c) further recognises that a patent term for a pharmaceutical product can be curtailed if there were unreasonable delays in the granting of marketing approval by the relevant authority. While the pharmaceutical product may have been granted a patent, the owner can only market the product in Singapore after the Health Sciences Authority has granted approval for the sale of the product in Singapore.
- Mr Speaker, Sir, the drug discovery process is a high-risk and costly venture for pharmaceutical companies. I am told that, in the US for example, it takes US$400 million to bring a drug to market. Pharmaceutical companies depend very heavily on patent protection, to recoup the investment and R&D costs involved in developing new drugs. Unreasonable curtailment of the protection period will have significant impact on the company's business viability, as it will have a shorter period of market exclusivity.
- Just as we should not prejudice an applicant for undue delays in the granting of a patent, we should likewise not prejudice applicants if there were unreasonable delays in the marketing approval process caused by HSA. We want to assure the pharmaceutical industry that the patent period available to them in Singapore would not be unfairly shortened. Already, countries such as Australia, Japan and US provide for patent term extensions arising from delays in marketing approvals.
- Let me stress that these amendments do not imply that IPOS or HSA have been tardy in their processes. Rather, countries with advanced patent systems have chosen to set out the expected standards in the laws. We too, want to reflect the standards in our law, and thereby reassure patent owners that in the event of an unreasonable delay, they will not be disadvantaged in Singapore.
- We have proposed two other refinements to the patent system in Clause 20 of the Bill, to take into account the unique nature of the pharmaceutical industry.
- The first is set out in the new Section 66(2A). Under this new Section, a patent owner will have a right to bring an action to stop a parallel importer from importing the patent owner's patented pharmaceutical product, if the product has not previously been sold or distributed in Singapore. However, once the owner brings in the patented product, the right to bring action ceases, and he will be subject to the same competitive pressures from parallel imports. This is a delicate balance we have sought to preserve between the interests of the patent owner and the interests of users of pharmaceutical products. Essentially, the patent owner has a "first mover advantage" in the Singapore market, but once he is in, will have to compete with the parallel importers.
- In drafting this amendment, Mr Speaker, Sir, we have given special consideration to ensure that no Singaporean would be denied adequate medical care as a result of this new right. Under new Section 66(2)(i), a patented pharmaceutical product which is needed for the treatment of a specific patient in Singapore, may with HSA's approval, be imported specifically for use by that patient, even if the patent owner has not brought the pharmaceutical product into Singapore.
- The second refinement is the introduction of what is commonly known as a "Bolar" provision.
- The new Section 66(2)(h) allows a generic drug producer to carry out activities covered by a patent without the consent of the patent owner, provided the activities are carried out to support an application to HSA for marketing approval for a pharmaceutical product. This will facilitate the manufacture, sale and distribution of generic versions of patented drugs immediately after the patents for those drugs have expired, something that will benefit the consumers.
- The "Bolar" provision is not a new concept. In balancing the interests of right holders and the needs of users, the "Bolar" provision serves as a useful counterbalance to the Patent Term Extension. It originated from the US, and has been incorporated into the patent legislation in countries such as Canada and Australia. With the introduction of this provision into our patent legislation, Singapore consumers too, will be able to gain access to generic versions of a drug, as soon as the patent expires.
- Next, let me turn to Clause 13, which seeks to amend the conditions of a grant and use, of compulsory licences under Section 55 of the Patents Act. Currently we have in place several grounds which a party can rely on, to apply to the Courts for a compulsory licence. To give patent owners greater control over their rights, we have narrowed the grounds for granting a compulsory licence to one specific situation, which is to remedy an anti-competitive practice.
- In addition, we are proposing to restrict Government's use of patented inventions, without prior consent, to situations involving national emergency, extreme urgency or public non-commercial use. Clause 14 amends Section 56 to give effect to this, with consequential amendments being made to Clauses 11, 12, 15 to 19.
- Clause 22 amends Section 74 to allow an exclusive licensee to bring an infringement action in his own name without involving the patent owner. This is similar to what Minister for Law had earlier explained under the Trade Marks Bill.
- Mr Speaker, Sir, we are also amending our search and examination and patent grant processes to make it more efficient and cost-effective.
- A key feature of this modified procedure is a two-track system. It reflects the growing diversity and needs of businesses in Singapore and our commitment to ensure a nimble patents system to meet these needs. We recognise that some companies are anxious to obtain their patents quickly, while others prefer more time to think through their business strategies before they commit funds to obtain patent protection. The two track system will introduce a default "fast track", which allows the patent applicant an accelerated application process so that he can obtain his patent as quickly as possible. Alternatively, the patent applicant can choose the second "slow track", where he will have more time to work out his marketing plans and decide on his patent strategy. Overall, this new system will provide greater flexibility and lead to potential cost savings for the applicants.
- This and other amendments that modify the procedural requirements and improve the quality of our patents have been worked out over the past two years in consultation with patent professionals, and will lead to a more business-friendly regime.
- Sir, to conclude, these amendments will provide a system of protection comparable to those in the most advanced countries in the area of IP. Overall, the amendments have been designed to give patent owners greater certainty and incentive to innovate. Consumers will also benefit, as new products are introduced in the market.
Sir, I beg to move. |
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