Pharmaceutical IP and competition law in Singapore: overview

Be new.

Involve an inventive step.

Be capable of industrial application.

A method of treatment of the human or animal body by surgery, therapy or of diagnosis practised on the human or animal body, as it is not considered to be capable of industrial application (section 16(2), Patents Act).

An invention, the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour (section 13(2), Patents Act).

Notice of eligibility to proceed to the grant of a patent. The applicant can file a request for grant of the patent with the necessary fees within two months from the date of issue of the notice (section 30, Patents Act read with Rule 47, Patents Rules). The Registrar will then grant the patent by issuing to the patent proprietor a certificate of grant and publishing a notice of grant in the journal (section 35, Patents Act).

Notice of intention to refuse the application, based on objections disclosed in the examination report. The applicant can file a request for a review of the examination report within two months from the date of issue of the notice (section 29B, Patents Act read with Rule 46A, Patents Rules). An examination review report is then issued. If there are still unresolved objections, the Registrar will issue a notice of refusal of the application. The application is deemed refused when two months have passed from the time the notice of refusal is forwarded to the applicant. If there are no remaining objections, a notice of eligibility is issued to require the applicant to file a request for grant (with payment of the grant fees) within two months from the date of the notice.

There was an unreasonable delay by the Registrar of Patents in granting the patent.

The patent was granted on the basis of prescribed documents relating to a corresponding patent application, there was an unreasonable delay in issuing the corresponding patent, and the patent office that granted the corresponding patent has extended the term of the corresponding patent because of that delay.

The subject of the patent includes an active ingredient of a pharmaceutical product, and there has been an unreasonable curtailment of the opportunity to exploit the patent because of the need to obtain marketing approval for the first pharmaceutical product using that substance as an active ingredient, and the patent term has not been previously extended on this ground.

The invention is not patentable.

The patent was granted to a person who was not entitled to it.

The patent specification does not disclose the invention clearly and completely enough to be performed by a person skilled in the art.

The matter disclosed in the specification extends beyond that disclosed in the patent application.

An amendment or correction has been made to the patent specification or application, and the amendment should not have been allowed.

The patent was obtained fraudulently, on a misrepresentation or non-disclosure or inaccurate disclosure of prescribed material information.

The patent is one of multiple patents for the same invention which have the same priority date, filed by the same party or the successor in title to that party.

Makes, disposes of, offers to dispose of, uses or imports the invention product, or keeps it for disposal or otherwise.

Uses the invention process or offers it for use in Singapore when they know, or it is obvious to a reasonable person in the circumstances, that such use without the proprietor's consent will infringe the patent.

Disposes of, offers to dispose of, uses or imports any product obtained directly by means of the invention process, or keeps any such product for disposal or otherwise.

Is done privately and for non-commercial purposes.

Is done for experimental purposes relating to the subject-matter of the invention.

Consists of the extemporaneous preparation of a medicine for an individual in accordance with a prescription by a registered medical or dental practitioner, or consists of dealing with a medicine so prepared.

Is done in relation to the subject-matter of the patent to support an application for marketing approval for a pharmaceutical product, provided anything used to support the application is not made, used or sold in Singapore, or exported outside Singapore.

Consists of the import, disposal or offer to dispose of a patented pharmaceutical product for use by or on a specific patient in Singapore, if certain conditions are met.

An injunction (including an interim injunction).

A court order for the infringer to deliver up or destroy infringing products.

Damages or an account of profits (a court will not award both for the same infringing act (section 67(2), Patents Act)).

A declaration that the patent is valid and was infringed by the infringing party.

WIPO Paris Convention for the Protection of Industrial Property 1883 (Paris Convention).

Patent Cooperation Treaty 1970.

WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994.

US-Singapore Free Trade Agreement (USSFTA).

A sign (as defined in section 2(1), Trade Marks Act).

Capable of being represented graphically.

Distinctive (capable of distinguishing goods or services dealt with or provided in the course of trade).

Do not satisfy the legal criteria (see above).

Are contrary to public policy or morality.

The mark has not been put to genuine use in the course of trade in Singapore within five years after completion of the registration, by the proprietor or with their consent, in relation to the goods or services for which it is registered, and there are no proper reasons for non-use.

Such use has been suspended for an uninterrupted period of five years, and there are no proper reasons for non-use.

It has become the common name in the trade for the product or service for which it is registered, because of the proprietor's acts or inactivity.

Due to use of the mark by the proprietor or with their consent in relation to the goods or services for which it is registered, it is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods or services.

The mark was registered in breach of the grounds for refusal of registration in section 7 of the Trade Marks Act (section 23(1), Trade Marks Act).

There is an earlier trade mark and sections 8(1), 8(2), 8(3), 8(4) or 8(7) apply (unless the proprietor of that earlier trade mark or right consents to the registration) (section 23(3), Trade Marks Act).

Identical, for identical goods or services.

Identical, for similar goods or services.

Similar, for identical or similar goods or services, and there is a likelihood of confusion among the public.

An injunction (including an interim injunction).

Damages.

Account of profits.

Statutory damages, where a counterfeit trade mark is used.

Paris Convention.

Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks 1957.

WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS).

WIPO Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989 (Madrid Protocol).

Singapore Treaty on the Law of Trade Marks 2006.

Agreements between undertakings, decisions by associations of undertakings or concerted practices which have as their object or effect the prevention, restriction or distortion of competition within Singapore (Section 34 Prohibition).

Undertakings from engaging in conduct which amounts to an abuse of a dominant position in any market in Singapore (Section 47 Prohibition).

Mergers that have resulted, or may be expected to result, in a substantial lessening of competition within any market in Singapore for any goods or services (Section 54 Prohibition).

Impose a fine up to 10% of the undertaking's annual turnover in Singapore for each year of infringement, up to a maximum of three years.

Issue directions to modify or cease behaviour, and/or require other necessary activity to end the infringement.

GSK Trading Services Limited's acquisition of distribution and marketing rights in Singapore from UCB Singapore Pte Ltd (2009).

Novartis AG's acquisition of shares in Alcon Inc (2010).

Fresenius Medical Care Beteiligungsgesellschaft mbH and Fresenius Medical Care AG & Co. KGaA's acquisition of Asia Renal Care, Limited (2010).

Proposed Acquisition by Johnson and Johnson of Synthes, Inc (2012).

Asia Renal Care (SEA) Pte Ltd's acquisition of shares in Orthe Group (2012).

Parkway would have become the only commercial supplier of radiopharmaceuticals in Singapore.

In relation to providing radiology and imaging services, the merged entity would have had a very substantial market share, the merger companies were each other's closest competitors, entry barriers are moderate to high and the bargaining power of customers is weak.

A substantial lessening of competition would have been likely due to vertical integration of the merger parties' operations. The merged entity would have been able to restrict competition in the market for radiology and imaging services by controlling supply, prices and/or a range of radiopharmaceuticals available to its downstream competitors.

Grantbacks. The licensee agrees to assign to the licensor all rights to any improvements it may make to the licensed technology. This may have pro-competitive effects, for example, if it increases the licensor's incentive to license or promote dissemination of the improvements. However, anti-competitive concerns may arise if it significantly reduces the licensee's incentive to conduct R&D.

Technology pools. At least two parties create a pool of technology which they cross-license as a package to each other and third parties. This is generally pro-competitive if the technologies in the pool are essential and complementary to each other. However, if the pool is largely made up of technologies that are solely or mainly substitutable with each other, the pooling may be an anti-competitive agreement in breach of the Section 34 Prohibition. In assessing if anti-competitive effects arise, the CCCS will also consider the risk of foreclosing alternative technologies that are not in the pool.

Refusal to supply a licence. An IP right owner can generally decide who to license its technology to. However, in certain circumstances a refusal to license by a dominant licensor may give rise to anti-competitive effects in breach of the Section 47 Prohibition, for instance if it refuses to license access to technology that is an essential facility. A facility is seen as essential if there are no potential substitutes (through duplication or otherwise) and it is indispensable to the exercise of the activity in question.

Tying. If a dominant licensor, as a condition of granting a licence, requires licensees to buy additional products unrelated to the technology being licensed, this may result in anti-competitive effects in breach of the Section 47 Prohibition. It is open to the dominant licensor to objectively justify its conduct by showing, for example, that buying the additional products is necessary for the satisfactory exploitation of the licensed technology.

R&D. Licensing agreements which, directly or indirectly, restrict the ability or incentive of any of the parties to carry out independent R&D, including R&D with third parties, may have anti-competitive effects. However, in its proposed amendments to the IP Guidelines, the CCCS noted that it would consider whether the restriction is indispensable to prevent the disclosure of licensed know-how to third parties. To be covered by the exception, the restrictions imposed to protect the licensor's know-how against disclosure must be necessary and proportionate to ensure such protection. For instance, where the agreement designates particular employees of the licensee to be trained in and responsible for the use of the licensed know-how, it may be sufficient to oblige the licensee not to allow those employees to be involved in R&D with third parties.

The product has not previously been sold or distributed in Singapore by or with the consent of the patent proprietor or any person licensed by them.

The import will result in the product being distributed in breach of a contract between the patent proprietor and a person licensed by the patent proprietor to distribute the product outside Singapore, and the importer has actual or constructive knowledge of the breach.

For patents, registration allows a person who acquires rights under the registered transaction to be entitled against a person claiming rights under an earlier transaction, provided that at the time of the later transaction, the earlier transaction was not registered, and the person claiming under the later transaction did not know of the earlier transaction (section 43, Patents Act).

For trade marks, a similar rule applies to certain transactions (for example, an assignment of a registered trade mark) but not to a grant of a licence (sections 39(3) and 39(5), Trade Marks Act).

For patents, a patent proprietor or licensee will not be awarded damages or an account of profits in a patent infringement action occurring before a registrable transaction is registered, unless the transaction is registered within six months of its occurrence (or the court or IPOS Registrar is satisfied that it was not practicable to register the transaction in this period and it was registered as soon as practicable thereafter) (section 75, Patents Act).

For trade marks, there is a similar restriction on claiming damages, an account of profits or statutory damages for infringement occurring before registration of certain transactions (for example, an assignment), but this does not apply to a grant of a licence (sections 39(4) and 39(5), Trade Marks Act).