As reported in our recent article[i], Singapore’s Court of Appeal held that a generic applicant must declare the existence of all patents, including patents that only cover processes for making the drug when attempting to comply with Singapore’s patent linkage regulations[ii]. However, the appeal did not provide any guidance on whether a simple omission of the process patents from the patent linkage declaration is sufficient to enable a marketing authorisation to a generic company to be revoked. This question has now been answered in the first instance by Millennium Pharmaceuticals, Inc v Zyfas Medical Co  SGHC 28.
Zyfas applied for and was granted a marketing authorisation by the Health Sciences Authority (HSA; Singapore Regulatory Agency) for a bortezomib product, sold under the name “Myborte”. During the application process, Zyfas did not declare the existence of any patent belonging to Millenium that related to the process of manufacturing bortezomib or compositions thereof. This lack of disclosure prevented Millennium from being able to delay or block the marketing authorisation using the procedure discussed in our recent article[i]. When Millenium asked whether such information had been provided to the HSA, Zyfas asserted that there was no infringement of the process patents and that they did not need to be declared.
Millennium sought a declaration that in failing to declare the existence of their process patents, Zyfas had submitted a “statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application”. Under Section 24 of the Health Products (Therapeutic Products) Regulations 2016 (TPR), obtaining such a declaration would allow Millenium to apply for cancellation of Zyfas’ marketing authorisation. During trial, Zyfas conceded that:
- the process patents should have been declared (given the ex tempore Court of Appeal judgement[ii]); and
- the existence of process patents was a matter material to Zyfas’ application.
During the proceedings, the declaration was amended to one relating to omission only. As such, the only contentious point was whether Zyfas had omitted to declare the existence of the process patents. More specifically, the question was whether such an omission requires that the defendant knowingly or intentionally omits to declare the existence of the patents.
In deciding on this point, the Judicial Commissioner compared the wording of Sections 24 and 25 of the TPR. The wording of Section 24 simply requires that the declaration “omits matter that is material to the application”. In contrast, Section 25 (which relates to criminal liability for a false declaration), includes the phrases “knows”, “has reason to believe”, and “intentional suppression of any material fact”. Due to the clear difference in wording between these sections, Section 24 relates to an administrative process and therefore does not require proof of an intentional or knowing act of omission. Therefore, the failure to declare the existence of Millennium’s process patents was held to be a relevant omission and the Court granted the declaration sought by Millennium. This decision is now under appeal to Singapore Court of Appeal.
This decision highlights the burden placed on generics companies who wish to obtain marketing authorisation in Singapore, and is further evidence that the regulatory landscape and courts in Singapore are generally favourable to innovator companies. If the decision is upheld by the Court of Appeal and Zyfas’ marketing authorisation is revoked, it may take quite some time for Zyfas to obtain a new marketing authorisation. This is because Millenium will almost certainly make use of Singapore’s patent linkage provisions to block Zyfas’ easy re-entry to the market. While such a block can last for up to 30 months, it may be possible to reduce this if Zyfas can provide sufficient proof that their processes do not infringe those covered by Millenium’s patents.
[i] Singapore's Patent Linkage Scheme and its effects on Marketing Approval for Generic Drugs
[ii] Millennium Pharmaceuticals, Inc. v Drug Houses of Australia Pte Ltd  SGCA 31