Knowledge & News

Pharmaceutical patenting and product registration in Singapore

4 April 2018

Singapore’s government recognises that a strong intellectual property (IP) legal framework is important in attracting research-based businesses. Singapore has therefore established a robust IP regime. This has also helped to position Singapore as a leading knowledge-based economy.
 
Singapore’s IP regime has consistently been ranked as one of the best in the world by international surveys. For example, in the World Economic Forum’s Global Competitiveness Report 2017-2018, Singapore was ranked fourth in the world and top in Asia for having the best IP protection. The Global Innovation Index 2017, which ranks countries’ innovation performance, also ranked Singapore as the seventh most innovative nation in the world and first in Asia.
 
Given Singapore’s reputable IP regime, Singapore has made an active decision to develop itself as a Global IP Hub in Asia in the next decade. The goal is to build a vibrant, sustainable IP ecosystem with a host of IP activities in Singapore, thereby creating high value-add jobs across sectors that will contribute to the economy.
 
The business-friendly IP regime has attracted global pharmaceutical companies such as Procter and Gamble and Mead Johnson, among others, to select Singapore as their choice location for investments in business and research and development. These companies have cited Singapore’s strong protection of IP rights as one of the factors in their decision. In 2001, a branch of the World Intellectual Property Organization Arbitration and Mediation Centre (WIPOS AMC) was opened in Singapore to support dispute resolution in Asia. The World Intellectual Property Office (WIPO) also set up its first Asian regional office in Singapore in 2005 due to its reliable IP environment.
 
The Intellectual Property Office of Singapore (IPOS) has also come a long way since it was first established. IPOS was appointed as an International Authority to carry out search and examination of PCT applications with effect from 2015. In fact, IPOS is currently recognised as a competent International Searching Authority (ISA) and International Examining Authority (IPEA) by the US, Japan, Mexico, Cambodia, Thailand, Indonesia and Vietnam.
 
Pharmaceutical patents
 
Almost 90% of the patent applications filed in Singapore are by foreign applicants. This is quite different to other patent offices around the world where close to 60-65% of patent applications are filed by local applicants.
 
Amongst the fields of information and communications technology (ICT), chemistry, electronics and biomedical sciences (into which pharmaceuticals falls), it was found that the most number of patent applications in Singapore were filed in the biomedical sciences field from 2009-2013. Within the biomedical sciences field during this period, the highest patenting activity was related to arthritis diseases and cancer and this was contributed by major pharmaceutical companies such as Merck, Novartis and F. Hoffmann la Roche. This trend continued in 2014 and 2015, with 10.4% of the total patent applications filed in Singapore being related to pharmaceuticals.
 
The majority of the patent applicants of pharmaceutical patent applications filed in Singapore are from the United States of America, Switzerland and Germany. For example, foreign multinational pharmaceutical companies such as Roche, Pfizer, Sanofi, AstraZeneca, Novartis and Johnson & Johnson have emerged as the top companies with patent applications in Singapore. Together, they accounted for 5.5% of the Singapore patent collection between the ten-year period of 2004-2014.
 
Amongst the local patent filers, the local research institutes (Agency for Science, Technology and Research, A*STAR) and universities (National University of Singapore (NUS) and Nanyang Technological University (NTU)) are generally the ones that produce innovations in the field of pharmaceuticals, biotechnology and medical technology.
 
The field of food chemistry is also of growing interest in Singapore in recent years. Between the years 2009 and 2013, there was an average annual growth of 20.06% in the number of patent applications filed in this field locally. Companies such as Nestlé and Abbott have also focussed on Asia-specific innovations.
 
Singapore is the regional headquarters for many of the global pharmaceutical companies. This is probably why it is not surprising that over the ten year period of 2004-2013, the number of pharmaceutical related patent applications filed in Singapore was the highest at close to 10,000, and that five out of the top ten patent applicants in Singapore were pharmaceutical companies. Companies have viewed Singapore as a strategic place for patent protection due to its advantages as a global manufacturing base and a favourable place for R&D collaborations.
 
Singapore Patents Act
 
The Singapore Patents Act (SPA) was established in 1995. Prior to the establishment of the SPA, the only way one could get patent protection in Singapore was by registering the corresponding United Kingdom or European (UK) patent.
 
Patent protection in Singapore has always extended to inventions which are either products or processes. The patentability criteria in Singapore is that the invention must be novel, involve an inventive step and be capable of industrial application. Inventions which relate to a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body are not considered to be capable of industrial application, and therefore not patentable.
 
Although the SPA generally requires all inventions to be new, the SPA recognises the novelty of a known substance or composition for a first use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body. While there is no specific provision in the SPA to provide basis for ‘second medical use’ claims, the Singapore patent system allows such claims as long as the claims are in the “Swiss style” format of second medical use claims, i.e. Use of compound X in the manufacture of a medicament for the treatment of disease Y. It remains to be seen how such claims can be enforced in Singapore as there has been no case decided on this issue to date. The closest the Singapore courts came to discussing “Swiss style” claims was in a Court of Appeal decision – Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd [2017]SGCA 45, discussed in more detail below.
 
Patent term extension (PTE)
 
There is a provision for extending the term of patent protection beyond the 20-year period upon request by the patentee. For example, a delay in obtaining marketing approval (from the Health Sciences Authority (HSA)) could be used as one of the reasons for requesting PTE. Such a provision would be beneficial to pharmaceutical companies who often lost time due to delays in obtaining marketing approval.
 
Other reasons on which PTE may be requested are: (i) an unreasonable delay by the Registrar in granting the patent or; (ii) an unreasonable delay in the issuance of a foreign patent on which the Singapore patent relied upon for obtaining grant, provided the foreign patent office has also extended the patent term on the basis of the unreasonable delay.
 
Product registration
 
In Singapore, all therapeutic products are subject to product registration and marketing approval prior to their sale and supply as stipulated by the Health Products Act. The safety, quality and efficacy of therapeutic products are assessed by the Health Sciences Authority (“HSA”) before marketing approval is granted.
 
There are broadly two types of applications – a new drug application (NDA) and a generic drug application (GDA). A generic drug is a therapeutic product that contains one or more chemical entities, and is essentially the same as a registered product with respect to its qualitative and quantitative composition of active ingredients, pharmaceutical dosage form and clinical indication.
 
 
Following submission of an application, the application is screened to ensure correctness and completeness of the application. The application is then evaluated. At this stage, a query letter may be issued to the applicant if clarification or further information is required. A regulatory decision is then made following the conclusion of the benefit-risk assessment conducted by the HSA based on the data submitted.
 
 
Upon an approval regulatory decision, the product will be added to the Register of Therapeutic Products. The registrant is responsible for ensuring the product’s quality, efficacy and safety throughout its life cycle.
 
Patent linkage
 
At the time of applying for product registration, the applicant is required to make a declaration on whether the product in question is subject to a patent. In some cases, the applicant may be required to serve a notice to the patent proprietor to inform the patent proprietor that the applicant of the product registration believes that the patent is invalid or will not be infringed by the doing of the act for which product registration is sought. This is referred to as patent linkage, which is also covered by the Health Products Act (HPA).
 
Such patent linkage helps a pharmaceutical patent holder in policing potential infringement even before the generic drug is launched in Singapore. The HPA includes provisions that allow the patent proprietor to block the applicant of the product registration by claiming that the patent has been infringed and may bring an action in court. Just by simply starting such an action, the patent proprietor will be awarded a stay on approval of any product licence for up to 30 months (or until the patent expires/is revoked). The first case when a patent holder, a pharmaceutical company, sought to amend its patent specification in its action against another pharmaceutical company, in response to the latter’s declaration pursuant to section 12A of the Medicines Act, was in 2012 (Novartis AG and another v Ranbaxy (Malaysia) Sdn Bhd [2012] SGHC 253). In this case, the patent holder successfully amended its patent. While this may give the impression that requiring such patent linkage is pro-patentee, in a later case, AstraZeneca AB v Sanofi-Aventis Singapore Pte Ltd [2013] SGHCR 7, the Court found that the patent holder should be required to give proper particulars of its claim and that the 30-month stay is not to be used to oppress and harass competitors.
 
Pharmaceutical litigation in Singapore
 
A large number of patent infringement suits have been filed in Singapore following from a product registration application made by a generic pharmaceutical company under the Health Products Act (formerly under the Medicines Act). As explained above, the patent holder of the original pharmaceutical product can file an infringement suit against the generic company, which automatically activates a thirty-month stay in regulatory approval for the generic company’s product. The only options to overcome the automatic stay in proceedings are to seek invalidation of the patent or to come to a settlement by negotiation or mediation. 
 
The total number of cases involving pharmaceutical companies which have proceeded to the Singapore courts is small. The few that have proceeded to court have primarily been to determine the validity of the patent following an infringement allegation. To date, the Singapore courts have not indicated a tendency to be either pro-patentee or pro-generics. Two particularly significant decisions relating to the pharmaceutical field are discussed below.
 
AstraZeneca AB v Sanofi-Aventis Singapore Pte Ltd [2013] SGHCR 7
 
Sanofi-Aventis had applied for a product licence with the HSA. As part of the application process, Sanofi-Aventis was required to inform AstraZeneca, as the patent holder, that it had applied for a product licence and that to the best of its knowledge, the patent had not been infringed or was invalid. 
 
AstraZeneca alleged that Sanofi-Aventis infringed its patent and therefore a 30-month stay in the application process was set in place. AstraZeneca also demanded that Sanofi-Aventis provide details of its product so that AstraZeneca could determine whether or not its patent was indeed infringed by Sanofi-Aventis. Sanofi-Aventis proceeded to provide details, on the High Court’s request. In return, Sanofi-Aventis requested that AstraZeneca provide further and better particulars of how its product infringed the patent. While the Court disagreed with some of Sanofi-Aventis’ requests, the Court partially allowed Sanofi-Aventis’ request for particulars of infringement. The Court also recognised that the 30-month stay period on the application process, while intended to encourage settlement of patent infringement claims before the allegedly infringing product entered the market, could be misused to delay the manufacture, importation and sale of pharmaceutical products by competitors of the patent holder and could therefore have the effect of hindering public access to the competitor’s products. Hence, the Court concluded that where a claim had serious consequences to the public and to a competitor’s legitimate business, as a matter of good practice, the patent holder should be required to give proper particulars of its claim so as to save considerable amount of time, energy and expense from being wasted.
 
Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd [2017] SGCA 45
 
The Singapore Court of Appeal (COA) dismissed Warner-Lambert’s appeal and upheld the decision of the High Court judge who had denied Warner-Lambert leave to amend its patent relating to a method of treating pain by administering pregabalin. The High Court judge had previously found that there was an undue delay by Warner-Lambert in seeking the amendments, and further, that the amendments (to recast method of treatment claims into Swiss-style second medical use claims), if made, would extend the scope of the protection of the patent. While the COA was not required to comment on the validity of Swiss-style second medical use claims (“Swiss-style claims”), the COA made some observations. These observations, though in obiter, are the first ever to be made in the Singapore courts in relation to Swiss-style claims.
 
The COA commented that s.14(7) of the SPA appeared to support the patentability of second and subsequent medical uses of known substances because by “its ordinary meaning, [it] does protect any use, first or subsequent, which is not part of the state of the art”. By virtue of this interpretation, the COA endorsed the position that the patenting of second and subsequent uses of a known substance was enabled, and a purpose-limited product claim in the form of “Compound X for use in the treatment of disease Y” may suffice to obtain protection, thereby removing the necessity of Swiss-style claims. The COA further added that while it did not disagree with the validity of Swiss-style claims as currently allowed by IPOS, it believed that if the COA’s interpretation of s.14(7) was given, Swiss-style claims would not be needed.
 
It therefore remains to be seen whether the law in Singapore will be amended to recognise a similar purpose-limited product claim as in the UK in view of the comments of Singapore’s highest court.
 
Conclusion
 
The pharmaceutical industry remains a key industry for Singapore, with companies setting up not just manufacturing facilities, but research centers too. This is evidenced by the number of clinical trials conducted in Singapore, which has been steadily rising, as well as the number of patent publications in Singapore in the fields of pharmaceuticals, biotechnology and medical technology which has risen from 4.8% in 2005 to 19.9% in 2015. Therefore, it is important for Singapore to maintain its robust regulatory and IP ecosystem so as to support the pharmaceutical industry.     

Authors

Mark Dewey

Mark Dewey Trainee Patent Attorney Singapore

Upasana Patel

Upasana Patel Partner Singapore Registered (SG) and Chartered (UK) Patent Attorney

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POSTED 28 November 2018

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