Category: Signapore

Filing a Divisional Application in Singapore – Part 10

September 16, 2020

This is the tenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first nine posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan and Malaysia can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand,  Divisional Practice – Pakistan, and Divisional Practice – Malaysia.

Time Periods for Filing a Divisional in Singapore

In Singapore, a divisional application can be filed at any time while an application is pending (i.e., before the conditions for grant are met) or before the application has been refused, withdrawn or abandoned.  The divisional application may be filed of the Applicant’s own volition or to address a lack of unity objection under Section 25(5)(d) of the Patents Act.

Requirements for filing a divisional application

When filing a divisional in Singapore, the following must be submitted:

  1. A Request for Grant of a Patent;
  2. A Statement of Inventorship;
  3.  Full description of the invention, claims, abstract and, if applicable, drawings; and
  4. The official fee of SGD $160 (about $120 USD).

The Statement of Inventorship must provide the full details for each inventor (including full name, address, country of permanent residence and nationality) as well as information on how the Applicant derived its rights to the invention from each of the inventors (such as via assignment or employment).

The divisional application will be treated as having, as its date of filing, the date of filing of the earlier application.

A divisional application must not contain any additional matter extending beyond that disclosed in the original application.  Added matter is a ground for revocation under Singapore law.

Double Patenting in Singapore

Double patenting is a ground for revocation in Singapore. The test for double patenting is whether the granted divisional claims are directed to “the same invention” as those of the parent patent. Careful drafting of the divisional claims is therefore required to ensure that they are not identical in scope with any of the parent claims.  For example, claims that use different terminology but are otherwise identical in substance, or dependent claims where the combination of limitations or additional features results in claims having identical scope in the divisional and the parent, should be avoided.

Examination

For a divisional application filed on or after January 1, 2020, a request for substantive examination must be filed within 36 months from the filing or lodgement date of the divisional application. It is no longer possible to rely on the allowed or granted claims of a corresponding application under supplementary examination due to closure of the supplementary examination route for applications having a filing or lodgement date on or after January 1, 2020.

This post was written by Lisa Mueller and Kian Hoe Khoo of Davies Collison Cave Asia Pte. Ltd.

Patent Linkage in Singapore – It’s Better to be Safe than Sorry

March 16, 2020

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.

USTR 2018 Special 301 Report: Pharmaceutical and Medical Device Innovation and Market Access

May 11, 2018

Last month, the Office of the United States Trade Representative (USTR) released its 2018 Special 301 Report (the Report), identifying trading partners that do not adequately or effectively protect and enforce intellectual property (IP) rights or otherwise deny market access to U.S. innovators and creators that rely on protection of their IP rights.  The Report calls on U.S. trading partners to address IP-related challenges with a special focus on the countries identified on the Watch List and Priority Watch List.

Countries identified on the Watch List are:

  • Barbados
  • Bolivia
  • Brazil
  • Costa Rica
  • Dominican Republic
  • Ecuador
  • Egypt
  • Greece
  • Guatemala
  • Jamaica
  • Lebanon
  • Mexico
  • Pakistan
  • Peru
  • Romania
  • Saudi Arabia
  • Switzerland
  • Tajikistan
  • Thailand
  • Turkey
  • Turkmenistan
  • United Arab Emirates
  • Uzbekistan
  • Vietnam

Countries identified on the Priority Watch List are:

  • Algeria
  • Argentina
  • Canada
  • Chile
  • China
  • Colombia
  • India
  • Indonesia
  • Kuwait
  • Russia
  • Ukraine
  • Venezuela

With respect to pharmaceutical and medical device innovation and market access, the Report details the efforts of the USTR over the last year to engage with trading partners to ensure that U.S. IP owners have a full and fair opportunity to use and profit from their IP, including by the promotion of transparent and fair pricing and reimbursement systems.  In addition to ensuring that trading partners have robust IP systems, the USTR has sought to reduce market access barriers to pharmaceutical products and medical devices, including measures that discriminated against U.S. companies, were not adequately transparent or did not offer sufficient opportunity for meaningful stakeholder engagement.  Additionally, the USTR pressed trading partners to appropriately recognize the value of innovative medicines and medical devices so that these partners can fairly contribute their share to the research and development of new treatments and cures.  USTR activities with respect to specific countries are described in more detail below:

  • Canada and Mexico: Sought strong IP provisions during the renegotiation and modernization of the North American Free Trade Agreement (NAFTA) including seeking provisions that ensure the national-level government processes for the listing and reimbursement of pharmaceutical products and medical devices are transparent, provide procedural fairness, are nondiscriminatory and provide full market access for U.S. products.
  • South Korea: Sought to obtain, through negotiations, improvement and better implementation by South Korea of the U.S.-Korea Tree Trade Agreement (KORUS FTA).  Specifically, the USTR sought to obtain Korea’s commitment to better implement its KORUS FTA commitments to provide fair and non-discriminatory treatment of pharmaceutical products, including imported products, under certain medical pricing and reimbursement programs.
  • Japan: Engaged with Japan in the context of the U.S.-Japan Economic Dialogue to ensure transparency and fairness and address other concerns with respect to pharmaceutical and medical devices pricing and reimbursement policies.
  • China: Pressed China on a range of issues that impact and affect the pharmaceutical sector.  These included: providing for effective protection against unfair commercial use, unauthorized disclosure of test and other data generated to obtain marketing approval for pharmaceutical products, as well as expediting the implementation of an effective mechanism for the early resolution of potential patent disputes.
  • India: Engaged with India to secure meaningful IP reforms on a number of longstanding issues. These issues included:  criteria for patentability and compulsory licensing as well as protection against unfair commercial use, as well as unauthorized disclosure of test or other data generated to obtain marketing approval for pharmaceutical products.
  • Indonesia: Engaged Indonesia to resolve a number of concerns regarding revisions to Indonesia’s patent law. These revisions included:  criteria for patentability, local manufacturing and use requirements and the grounds and procedures for issuing compulsory licenses.
  • Argentina: Engaged Argentina with respect to concerns regarding the scope of patentable subject matter and effective protection against unfair commercial use, as well as unauthorized disclosure of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.
  • Saudi Arabia: Engaged Saudi Arabia regarding its protection and enforcement of patents and effective protection against commercial use as well as the unauthorized disclosure of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products.
  • United Arab Emirates: Sought confirmation that the United Arab Emirates will continue to protect pharmaceuticals through local procedures and the Gulf Cooperation Council (GCC) patent system.

The Report also highlights concerns regarding IP protection and enforcement and market access barriers affecting U.S. entities that rely on IP protection, including those in the pharmaceutical and medical device industries.  Examples of such barriers by trading partners include:

  • Unfair issuance, threat of issuance, or the encouragement of others to issue compulsory licenses. Trading partners being monitored with respect to such activities include Chile, Colombia, El Salvador, India and Malaysia.
  • Employment of measures that are discriminatory, nontransparent, or otherwise trade-restrictive that have the potential to hinder market access in the pharmaceutical and medical device sectors and which might potentially result in higher product costs. Examples include unreasonable regulatory approval delays and non-transparent reimbursement policies (such as pricing and reimbursement systems which are non-market-based or that do not otherwise appropriately recognize the value of innovative medicines and medical devices).  Trading partners being monitored with respect to such activities include Algeria, Australia, Canada, Japan, Korea, Turkey and New Zealand.

In our next few posts, we will examine in detail the USTR’s findings with the countries on the Priority Watch List.

This post was written by Lisa Mueller.