As in most countries, to sell therapeutic products in Singapore it is necessary to obtain a registration of the product from the authorities. In Singapore the registration of health products is administered by the Health Sciences Authority (HSA).
In 2004, in an attempt to balance patent rights with minimizing the rising cost of healthcare and to meet the requirements of a Free Trade Agreement with the US, a new provision was introduced into the Medicines Act (Cap 176) that required applicants for a medicinal product license to provide information as to whether the medicinal product of the application is subject to a patent. This required anyone who was applying for a medicinal product license to declare:
- Whether or not a patent for the product is in force in Singapore;
- Whether the applicant
- is the patent owner;
- has obtained the owner’s consent or the owner has acquiesced the grant of the license to the applicant; or
- the applicant is not the patent owner and the patent owner has not consented or acquiesced the grant of the license to the applicant, where the applicant:
- can request for the grant of the medical product license application after the patent expires, if the license application is filed within 18 months from the end of the term of the patent; or
- will be required to serve notice on the patent owner that the patent is invalid or the licensed acts would not infringe the patent, if the license application is filed more than 18 months from the end of the term of the patent.
If the applicant has served a notice on the patent owner, the patent owner only has 45 days to institute court proceedings for a court order or declaration. The license may be granted if the patent owner does take any action; or if the patent owner applies for a court order or declaration, no court order or declaration is made within 30 months from the application for the order or declaration.
These provisions are summarized in Figure 1: Flow chart of the process for applying for a medicinal product license where the medicinal product of the application is subject to a patent.
These provisions were first put to the test in 2011 when Sanofi applied to HSA for a license to sell Rosuvastatin. The HSA requested that Sanofi notify the owner (AstraZeneca) of a Singapore patent for Rosuvastatin that to the best of Sanofi’s belief the patent is invalid or the prospective licensed acts would not infringe the patent. AstraZeneca were in a quandary as the Medicines Act did not specify the particular court order or declaration that should be applied for and without the medicinal product license Sanofi were not doing any acts that constitute infringement under the Patents Act (cap 221). AstraZeneca requested a declaration of the court that the activities in the Sanofi application would infringe their patent under the Medicines Act. Sanofi applied to strike off the action as there was no infringement. The court recognized the difficulties and concluded that:
- Where an application for the sale, supply or export of a medicinal product indicates that there is a patent for that product and the applicant is not the proprietor of the patent, upon being notified of this fact, the patent owner is not required to bring a patent infringement action against the applicant but may commence an independent and separate action under the Medicines Act.1
This paved the way for subsequent actions under the Medicines Act.
Sanofi waited more than 6 months to receive the details as to why the requested medicinal product license may infringe the AstraZeneca’s patent. All that Sanofi received was requests for information about the product as AstraZeneca did not believe it was possible to make Rosuvastatin without a multivalent cation. Sanofi was of the opinion that this was a fishing expedition to obtain information about Sanofi’s product and as such Sanofi requested the court strike out the action as it was frivolous, vexatious and otherwise an abuse of the process.
The court ordered AstraZeneca to give clear details of the alleged potential infringement within 14 days. As the Sanofi Rosuvastatin product received marketing approval within 2 months of the decision it may be assumed that no such details were filed.
Subsequently, a second case was initiated by Warner Lambert after they received a notice from Novartis who had applied for registration of pregabalin that would not infringe Warner Lambert’s Singapore patent covering the use of pregabalin for pain. Within 29 days into the 45 day limit to apply to court, Warner Lambert applied to the court for a declaration that the acts Novartis had applied to register for would infringe the Warner Lambert Singapore patent.
Novartis counter claimed that the patent was invalid and should be revoked as all 15 claims were directed to methods of medical treatment that are excluded from patentability under Singapore law.
Warner Lambert requested claim amendments be allowed to amend the claims to Swiss style claims. Novartis objected to the claim amendments on the following grounds:
the amendments constitute added matter;
the amendments would extend the protection conferred by the patent;
the court should exercise its discretion to reject the amendments as the proprietor delayed making amendments, should have known the patent was invalid and took unfair advantage of the patent;
the amendments would result in claims that were either not novel and/or not inventive
Honorable Justice George Wei found that amending the method of treatment claims to Swiss style claims did not give rise to added matter as a person skilled in the art reading that there is a requirement for therapeutically effective amount of the compound would clearly and unambiguously know that a method of manufacturing a medicament with the compound exists and is implicitly disclosed. However, taking the claims as a whole whereby all of the claims were directed to methods of treatment he found that the amendment to a method of manufacturing a medicament does not fall in the scope of the method of treatment claims granted and as such the proposed amendments would extend the protection conferred by the patent. Hence the amendments shouldn’t be allowed. Further, as the IPER mentioned that the claims were not allowed in some jurisdictions and Warner Lambert had amended claims in other applications to Swiss style claims they had enough facts to be on notice to seek legal advice. As such there was undue and unreasonable delay on the part of the patentee in taking out this amendment application so the amendment should not be allowed for this reason also. As the validity of the Swiss style claims would require expert witnesses, Honorable Justice Wei did not consider it necessary to make any decision on the validity of Swiss-style claims. 2
Warner Lambert filed an appeal. The Court of Appeal affirmed the high courts finding that amending method of treatment claims into Swiss-style claims would extend the scope of protection conferred by a Singapore patent, as the amended claims protected the manufacture of a medicament.
Further, the Court of Appeal observed:
amendment to an obviously invalid patent were artificial and should be rejected, as the amendment could not rectify a patent which was invalid at the time of grant and had no protection to begin with.3
Novartis’s application for registration of several different doses of pregabalin was finalized in November 2017. Interestingly, this was Several months after the Warner Lambert patent would have expired i.e., 16 July 2017 should the amendments have been allowed. Consequently, Warner Lambert was able to delay the registration of the Novartis products until after the expiry date of the patent.
In the middle of these cases, in November 2016 the provisions under the Medicines Act were partially transferred to the Health Products Act under Health Products (Therapeutic Products) Regulations 2016. Leaving the existing provisions to relate to excluded medicinal products4 also administered by the HSA.
The new provisions under Health Products (Therapeutic Products) Regulations 20165 vary only slightly from those of the Medicines Act but add additional burdens to applicants and the IPOS. Now even where the applicant declares that they have the patent owners consent to use the patent (essentially a licensee), the HSA has the right to require that the applicant informs the patentee by registered mail.
Further, a minor difference in the form adds an additional burden on the patentee as the form under the Medicines Act allowed applicants to choose between “the patent being invalid” or “the patent will not be infringed by the act sought to be registered”. In contrast the new form only allows the statement “the patent is invalid or will not be infringed by the act sought to be registered” to be made. The new form makes it imperative that a patent owner takes action to ensure that it cannot later be shown that a statement was issued that a patent was invalid and the patent owner took no action arguably agreeing that the patent is invalid. The new form will require the patent owner to take action in all situations, costing time and money to both and delaying registration of the product. Further, the new regulations indicate that a patent owner who receives a statement that the patent is invalid or will not be infringed by the act sought to be registered can request the Registrar of Patents declare that the patent is valid or will be infringed by doing the act for which registration is sought. However such a request is not available and not currently provided for under the Patent Act. The closest provisions in the Patents Act relate to the filing of counterstatements with the Registrar of Patents. These changes essentially give the Registrar of Patents additional responsibilities under the Health Product Act. This, combined with the imperative requirement for a patent owner to take action may result in the IPOS having to make many such declarations.
Other changes include a significant increase in the penalties for making false patent declarations when applying for a therapeutic product license, to a fine not exceeding S$20,000 or to imprisonment for a term not exceeding 12 months or both.
The actions under the new regulations have mostly focused on companies that have successfully made a therapeutic product application and had its product registered and the patent owner taking action to request cancellation of the registration on the bases the doing of an act authorized by the registration infringes a patent under the Patents Act6.
In both cases DHA and Zyfas Medical company had each registered therapeutic product containing bortezomib declaring that there was no patent in force in respect of the therapeutic product. Millennium pharmaceuticals Inc. had several patents directed to methods of manufacturing the therapeutic product and they applied to cancel each registration.
In the initial case, DHA applied to strike off the action as registration would not infringe a patent under the Patents Act. The High Court agreed that there were no grounds for action and it was struck off. The Court of Appeal disagreed and found that where an act authorised by a marketing approval would infringe a patent it would fall within this regulation6 irrespective of whether the act has taken place or not7.
In the second case, the High court found that Zyfas Medical company failure to declare the existence of Millennium’s process patents and held to be a relevant omission. The Court granted the declaration of the same sought by Millennium. The Court of Appeal affirmed the high court’s finding and further found that process patents should also be included in the declaration when filing a therapeutic product application as:
- The plain text of the regulation suggested that process patents were included since ‘patent under the Patents Act’ includes process
- There is no reason why product patents should be accorded more protection than process patents since a therapeutic product could infringe one or the other.8
There have now been two patent infringement actions taken under the Medicines Act and two under the Health Products Act (Chapter 122D), Health Products (Therapeutic Products) Regulations 2016. With the greater onus on generic registrants to conduct patent searches and analysis before filing a therapeutic product application in a system that favours patent owners, we may expect to see more such actions in the future. We will have to wait and see how the Health product provisions continue to affect patents and Health product registration in the future.
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1 AstraZeneca AB (SE) v Sanofi-Aventis Singapore Pte Ltd  SGHC 16
2 Warner-Lambert Co LLC v Novartis (Singapore) Pte Ltd  4 SLR 252
3 Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd  SGCA 45
4 Pursuant to section 77 of the Medicines Act (Chapter 176), Products not listed in the Health Products Act (Chapter 122D), First schedule are administered under the Medicines Act (Chapter 176).
5 The Health Products Act (Chapter 122D) Regulations 23-25 Health Products (Therapeutic Products) Regulations 2016
6 Pursuant to Regulation 24 The Health Products Act (Chapter 122D), Health Products (Therapeutic Products) Regulations 2016
7 Millennium Pharmaceuticals Inc. V Drug Houses of Australia Pte Ltd.  SGCA 31
8 Court of Appeal Zyfas Medical Co. V Millennium Pharmaceuticals Inc,  SGCA 84