The Ministry of Health of Vietnam recently issued Circular No. 10/2021/TT-BYT dated June 30, 2021, stipulating the list of substances prohibited from use in the production and trading of health supplements (“Circular 10”). Circular 10 will come into effect on September 1, 2021. Accordingly, substances found on the following lists will be prohibited from use in health supplements: The list of drugs and drug materials prohibited from importation and production found in Annex V of Decree No. 54/2017/ND-CP of the Government dated May 8, 2017, guiding the implementation of Law on Pharmacy (Decree 54). Lists promulgated with Decree No. 73/2018/ND-CP of the Government dated May 15, 2018, stipulating the list of narcotic substances and precursors, including: List I: Narcotic substances banned from use in healthcare and daily life, the use of which for analysis, testing, scientific research, and criminal investigation is subject to permission by competent authorities. List II: Narcotic substances restricted from analysis, testing, scientific research, criminal investigation, or healthcare as regulated by competent authorities. List III: Narcotic substances permitted in analysis, testing, scientific research, criminal investigation, healthcare, and veterinary medicine as regulated by competent authorities. List IVA: Essential precursors involved in forming the structure of narcotic substances. The list of narcotic active ingredients found in Annex I of Circular No. 20/2017/TT-BYT of the Ministry of Health, detailing articles of the Law on Pharmacy and Decree 54 related to drugs and drug materials under special control. The list of toxic drugs and toxic drug materials under Circular No. 06/2017/TT-BYT of the Ministry of Health dated May 3, 2017. Lists under Circular No. 42/2017/TT-BYT of the Ministry of Health dated November 13, 2017, stipulating the lists of toxic herbal materials, including: Annex I: List of toxic herbal materials of plant origin. Annex II: List of toxic herbal materials of animal origin. Annex III: List of toxic herbal materials of mineral origin. A list of 80 additional chemical substances included as an Annex to Circular 10, including 1-3-dimethylamulamine, sildenafil, betamethasone, etc.

In April 2021, the Vietnamese government made public a draft decree to amend Decree No. 43/2017/ND-CP of the Government dated April 14, 2017, on goods labeling (“Decree 43”), which is the primary legislation in Vietnam on the labeling requirements for domestically circulating goods and imported goods. Some noteworthy differences between the draft and the current Decree 43 include the following: 1. Original labels for imported products For imported goods, the draft adds a requirement on compulsory information for original labels, which is not mentioned in Decree 43. In particular, the original product label for goods being imported to circulate on the Vietnam market must contain the following compulsory information in a foreign language or in Vietnamese before customs clearance: Product name; Name and address of the entities responsible for the products; Product origin or place where the final production stage to complete the product was conducted. (If this information is not presented on the original product label, it must be included in the import documents accompanying the product.) 2. Vietnamese labels for imported products Under the draft, if it is impossible to determine the product origin under rules/guidance on determining product origin in Vietnam, it is acceptable to instead indicate on the product label the place(s) where the final production stage to complete the product was conducted. 3. Nutritional information for food Instead of being optional information as mentioned in Decree 43, “nutritional value” is compulsory information on labels for some food products under the draft. The Ministry of Health will have a roadmap for carrying out nutritional labeling and will provide appropriate guidance to manufacturers and importers, as well as issue regulations on types of food that are partially or entirely exempt from declaration of nutritional value. The draft has not yet been finalized and is subject to further revision; no expected date of issuance has been announced.

Developing and launching a new drug on a commercial scale requires an enormous amount of time and investment in research and development (R&D), including pre-clinical testing and clinical trials. When considering the aggregate amount of drug development costs, it is important to recognize that this includes not only the investment in developing new drugs that get approved by a government food and drug regulator and are successfully brought to market, but also the R&D expenditures on a large number of potential pharmaceutical compounds and products that never actually make it to market. In particular, considerable investment is required in order to conduct and produce clinical trial data—to prove safety, efficacy and effectiveness of a new drug—that would warrant marketing approval by the regulatory authority. Such data is proprietary in nature and highly valuable for a research-based pharmaceutical company that develops an original drug. On the other hand, patent law typically confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to obtaining marketing approval for a generic product before the patent for the original drug expires (commonly known as a “Bolar provision”). Since a generic drug maker may submit an application for marketing approval of a generic product before the relevant patent expires, the extent to which the drug originator’s data submitted to the regulatory authority is protected—or in other words, the extent to which the generic company may rely on the drug originator’s previously filed data, which underpins the safety and efficacy of the drug, to support the generic marketing approval application—becomes a critical issue. Availability of data exclusivity thus provides a form of market exclusivity outside that provided by patent rights. While some countries offer exclusivity or protection of the drug originator’s data submitted to the regulatory authority for marketing approval and prevent generic drug manufacturers from relying on such data in their own applications, many countries still do not have practical data exclusivity protections. In this guide, we discuss the availability of data exclusivity protections and limitations in Southeast Asian countries, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand, and Vietnam. The full guide can be downloaded below.

Introduction Currently, under Vietnam’s Law on Intellectual Property of 2005, as amended in 2009 and 2019 (“IP Law”), secret prior art cannot be used in evaluating patent applications. However, an approach to evaluate secret prior art has been included, for the first time, in the draft amendment of the IP Law. Below is our discussion of this interesting topic. Recognition in Other Jurisdictions Secret prior art is the name given to prior art that, at the time of filing of a new patent application, was not discoverable by the new applicant or not publicly available. It exists as a filed but unpublished application, unavailable to the public until publication. Until that point, only the applicants and the patent examiners of the unpublished application know of its existence. Even though it is not discoverable or available to the public, secret prior art can still be used as a bar for novelty in many jurisdictions. Secret prior art is not limited to situations in which the first applicant and the new applicant are different people; secret prior art applies regardless. There is, however, a domestic limitation: Applications filed and not yet published in a foreign country are not considered to be secret prior art. When the applicants are different people, the new applicant has no way of discovering the secret prior art that exists as a filed and unpublished application of the first applicant. Regardless of the completeness of the patent search, the previously filed and unpublished application cannot be discovered. At the time of filing, the new applicant’s invention would seem novel. Later, it would be discovered that the application was actually filed after another application for the same invention, barring patentability. This creates confusion and unfairness among multiple applicants. One applicant can also file two separate applications at different times, in which the later filed application claims subject matters disclosed in the earlier filed application. Thus, the earlier filed application—regardless of its availability to the public—can be used as secret prior art for barring novelty. This is called “self-collision.” Some jurisdictions allow for excluding this secret prior art because it arose from the same applicant. This is called the anti-self-collision exception. This is favorable to applicants, because otherwise their own disclosures may result in a bar to novelty in their own subsequent patent applications. The anti-self-collision exception is not a perfect solution to the problems secret prior art creates for an applicant filing two patent applications. Normally, the subject matter disclosed in the first application could not be subsequently claimed by another party, because the first application would be considered during novelty assessment. However, with this exception, that subject matter would not be considered, which could result in an unfair patent term extension for the applicant in jurisdictions employing the anti-self-collision exception. One method for solving this situation is requiring a terminal disclaimer filed with the new application, effectively limiting its term to that of the first application. In Vietnam Currently, although there is no “self-collision” based on secret prior art, the Intellectual Property Office of Vietnam (IP Office) has another method for disqualification of the later-filed application without using secret prior art. The IP Office targets the later-filed application using Article 91 of the IP Law—the priority principle. The below summary of a case study may clarify this practice by the IP Office. An applicant files two Vietnam applications—a prior application A1 (claiming priority to an unpublished application P1) and a new application A2 (claiming priority to an unpublished application P2). The inventions disclosed in A1 and A2 are considered as being similar in nature. The timeline of the related application is illustrated here for reference.   Under the current IP regulations, without any secret prior art concepts, A1 is not prior art against A2 if P2 is recognized as A2’s priority. However, at practical examination, this priority right is refused, creating a situation in which A1 may become a barrier for novelty of A2. See the below language from the IP Law: “Article 91. Priority principle: An applicant for registration of an invention, industrial design or mark may claim priority on the basis of the first application for registration of protection of the subject matter.” In the view of the IP Office, upon publication of A1, it becomes publicly known that P1 is the earliest application disclosing the A1/A2 inventions. Thus, P2 is invalid as priority for A2 because it was not the first application to disclose the subject matter. Because A2’s priority date is invalid, the basis for its novelty assessment is now its filing date. Any published applications can be used as prior art that were available to the public before the claimed date. Since A1 was published before A2 was filed, A1 is used as prior art against A2, resulting in A2 being considered not novel. This priority rule approach brings the same effect to the later-filed application as would the secret prior art approach. A New Approach Recently, an approach to add secret prior art to the next amended version of the IP Law has been drafted. The suggested amendment and supplement to Article 60.1 of the IP Law reads as follows: “An invention in the invention registration application with a subsequent filing date or priority date is considered having lost its novelty if it is disclosed in another invention registration application with earlier filing date or priority date but published on or after the filing date or priority date of such invention registration application.” With this amendment, the IP Office would be able to directly determine novelty over a secret prior art instead of using the current methods of applying the first-to-file rule and objecting directly to the priority claim from an earlier-filed application that results in a direct/indirect pathway for barring patentability. This proposed amendment, however, is not clear on several details. The language “another invention registration application” does not specify domestic application; thus, it is a grey area whether the secret prior art is only a Vietnam application or if