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In Singapore, Regulation 23(2) of the Health Products (Therapeutic Products) Regulations 106 (S 329/2016) (“TPR”) states that an applicant for the registration of a therapeutic product must, in its declaration, furnish to the Health Sciences Authority (“HSA”) certain information, including whether a patent under the Patents Act (Cap 221, 2005 Rev Ed) is in force with respect to the therapeutic product.  In a recent decision,  Millennium Pharmaceuticals, Inc. v. Zyfas Medical Co. [2020] SGHC 28, the Singapore High Court suggests that it is best for those seeking to register generic versions of pharmaceutical products to disclose all potentially relevant patents relating to those products, even if some or all of those patents do not cover the product as such. 

Millennium Pharmaceuticals, Inc. (Millennium) v. Zyfas Medical Co. (Zyfas)

Millennium is the owner of Singapore patents SG 151322 and 182998 and Singapore Application No. SG 10201600029P (collectively, the “Patents”).  The Patents are process patents relating to the manufacture of “bortezomib”, a cancer drug for the treatment of multiple myeloma and mantle cell lymphoma.  Millennium did not have any product patents covering bortezomib per se in Singapore.

On February 1, 2018, Zyfas applied to the HSA to register a therapeutic product for a generic version of bortezomib (sold under the name “Myborte”).  The registration was subsequently allowed.  At the time of submitting the declaration to HSA, Zyfas did not list the Patents.  Zyfas later admitted that they were of the view that only product patents had to be declared under the patent linkage provisions of Regulation 23(2) of the TPR. 

Sometime in July 2019, Millennium discovered that Zyfas had obtained a registration for Myborte.  On July 11, 2019, Millennium requested a copy of Zyfas’ declaration to the HSA.  On July 24, 2019, Zyfas replied stating that there was no infringement of the Patents and thus no need to declare the existence of the Patents in the HSA declaration.  Millennium disagreed and sought a declaration from the Singapore High Court that Zyfas had made a misleading statement under Regulation 24 of the TPR.  Specifically, under Regulation 24, the HSA has the discretion to cancel the registration of a therapeutic product if (among other things) it is satisfied that a court has determined that the declaration made under Regulation 23(2) contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application.

Millennium’s request that the Court declare that Zyfas made a misleading statement was granted.  Zyfas appealed. 

On appeal, Zyfas conceded that the requirement under Regulation 23(2)(a) to disclose “whether a patent under the Patents Act is in force in respect of a therapeutic product” included the disclosure of existing process patents in respect of the therapeutic product.  This concession appears to have been made in light of the decision of the Court of Appeal in Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal [2019] SGCA 31 (“Drug House case”).

Zyfas further accepted that the existence of the process patents was “a matter that [was] material to the defendant’s application” under Regulation 24(1)(a)(ii) of the TPR.

Therefore, the only issue for the Court to consider was whether Zyfas had omitted to disclose the existence of the process patents. The answer turned on the following question of interpretation, namely, whether an operative omission under Regulation 24(1)(a)(ii) of the TPR requires that the defendant knowingly or intentionally omits to state the existence of relevant patents.

Based on a normal reading of Regulation 24, the Court considered that there was nothing requiring mental elements of knowledge or intention. This interpretation was reinforced by the neighboring provision of Regulation 25 of the TPR (which deals with offenses for making false patent declarations) which uses positive phrases like “person knows or has reason to believe is false” and “intentional suppression”.  Incidentally, contravention of Regulation 25 imposes criminal liability.

The Court dismissed Zyfas’ appeal and granted Millennium the declaration it sought.

Lessons learned, and what is likely to happen next?

This decision highlights the fatal nature of making false or misleading declarations or omitting to disclose all matter material to an application.  But this raises the question – what types of patents should be deemed “material” and declared? The threshold test for materiality is clarified somewhat in the Drug House case which stated (in relation to the requisite patent linkage declaration):

“the applicant for registration has to declare the patents and then state, among several possibilities, that the patents are invalid and will not be infringed by doing of the act for which the registration of its product is sought. It is then for HSA to decide whether to invoke reg 23 (5) of the TPR to require the Respondent to serve the requisite notice on the Appellant.”

Based on the recent Millennium case, it appears that a conservative approach to declaring patents should be adopted, including declaring process, use (second-medical treatment), and formulation patents, which relate to the product to be registered.  Nonetheless, the ultimate take home message is that proper patent due diligence must be performed to identify all potentially relevant patents in order for these patents to be properly declared to the HSA.

In connection with this case, it appears that the next step for Millennium is to apply to the HSA, court order in hand, to have Zyfas’ registration for Myborte cancelled.

This post was written by Lisa Mueller and Dr. Mathew Lucas and Dr. Kian Hoe Khoo of Davies, Collison & Cave.

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