Category: Malyasia

Filing a Divisional Application in Malaysia – Part 9

August 10, 2020

This is the ninth 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 eight posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, and Pakistan 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, and Divisional Practice – Pakistan.

Time Periods for Filing a Divisional in Malaysia

Pursuant to the Malaysia Patents Act of 1983 (Patents Act), a divisional application can be filed (1) in response to an objection under Section 26 of the Patents Act, for a lack of unity of invention; or (2) in response to any objection raised in an Examiner’s first examination report. Additionally, the Patents Act also permits the filing of one or more voluntary divisional applications at the Applicant’s discretion.  Finally, one or more divisional applications can be filed off of an original (e.g., parent application) and nested divisional applications are also permitted.

While a divisional application can be filed at any time after an original (e.g., parent) application is filed but prior to issuance, according to Regulation 19A of the Malaysian Patents Regulations of 1986 (Regulations), a divisional application must be filed no later than 3 months from the mailing date of an Examiner’s first examination report.  Therefore, it is recommended that an Applicant file any divisional applications at the same time when filing amendment and/or response to the first examination report.  In situations where the Examiner’s first report indicates that the claims are allowable and the application is proceeding to grant (e.g., usually, within 1 month from mailing of the clear examination report), Applicant can file one or more divisional applications while the application remains pending.

Requirements for filing a divisional application

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

(a) Patents Form 17 for appointment of patent agent;

(b) Patents Form 1 (application form);

(c) full description, claims, abstract and, if applicable, drawings;

(d) Patents Form 5 (request for substantive examination) or Patents Form 5A (request for modified substantive examination); and

(e) the appropriate filing fees.

A request for substantive or modified substantive examination must be filed when filing a divisional application.

The subject matter of a divisional application cannot go beyond the disclosure in the initial application as filed.  If additional subject matter is added in one or more divisional application, the Applicant will be requested to remove the additional subject matter.  Failure to do so will result in the divisional application being refused.

The date a divisional application is filed will become the filing date of a divisional application; however, the divisional application will be accorded the benefit of any right of priority to its original (e.g., parent) application for any subject matter contained therein. 

The examination of a divisional application is carried out in the same manner as for any other application. 

Double Patenting

The claims of one or more divisional applications cannot be identical to those of any prior parent application, otherwise the claims in the divisional application will be rejected for double patenting.

This post was written by Lisa Mueller and Ng Kim Poh of Christopher & Lee Ong

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.