Patent specialists from Tilleke & Gibbins have contributed the Myanmar chapter to the 2023 edition of Patents: Practical Cross-Border Insights into Patent Law from International Comparative Legal Guides (ICLG), published by Global Legal Group. This comprehensive guide provides readers with an in-depth look at patent laws and regulations in 23 jurisdictions around the world. Each chapter of the guide, which is in Q&A format, is organized into eight sections: Patent Enforcement Patent Amendment Licensing Patent Term Extension Patent Prosecution and Opposition Border Control Measures Antitrust Law and Inequitable Conduct Current Developments The complete Myanmar chapter is available as a PDF below. The Myanmar chapter—and the full Patents guide—are also freely available on the ICLG website.

Interest in organic farming, soil health, and regenerative agriculture has increased rapidly in recent years, and the demand for biological and organic fertilizers has accordingly undergone dramatic growth. Biological fertilizers contain specific levels of microorganisms (such as nitrogen-fixing bacteria); organic fertilizers similarly contain microorganisms and typically come from animals and plants, such as livestock manure and crop residues. Although responsible fertilizer use is still necessary to prevent unintended effects, these “living fertilizers” can boost yields and promote plant productivity without many of the adverse environmental effects and safety concerns of chemical fertilizers. This makes them highly sought after for organic farming, and prized by agricultural operators looking to promote soil health as a bedrock of sustainable agricultural practices. As the global trade for organic and biological fertilizers has scaled up, producers and agribusiness companies have expanded organic and biological fertilizer offerings to new markets. Not only do different countries have their own regulations for fertilizers in general, but they also often have specific requirements and rules for biological and organic fertilizers. This guide provides fertilizer producers and traders with an overview of the legal landscape for these fertilizers in three major Southeast Asian markets so that businesses can make their fertilizers available and foster sustainable agricultural practices in the region. The full Biological and Organic Fertilizers in Indonesia, Thailand, and Vietnam guide can be downloaded through the button below.

On September 5, 2022, the Ministry of Health of Vietnam issued Circular No. 07/2022/TT-BYT on drugs requiring bioequivalence (BE) studies and requirements for dossiers reporting BE data when registering drugs in Vietnam (Circular 07). Circular 07 will take effect on November 1, 2022, replacing Circular No. 08/2010/TT-BYT guiding the reporting of bioavailability/bioequivalence data when registering drugs. Circular 07 includes provisions on (i) generic drugs containing active pharmaceutical ingredients (APIs) or having dosage forms that require BE reporting when registering the drugs in Vietnam and (ii) dossiers for BE reporting of generic drugs. The most outstanding point under Circular 07 is that the list of APIs requiring the submission of BE reports in their drug registration dossier includes 26 APIs instead of 12 APIs as specified in the previous circular. In addition, generic drugs having the following dosage forms must have a BE report in the drug registration dossier: Drugs in immediate-release dosage form, with systemic effects, containing APIs included in the list of 26 APIs and not falling in the cases of BE reporting exemption, Drugs in modified-release dosage form, with systemic effects, that do not fall in the cases of BE reporting exemption. Roadmap for Application From November 1, 2022, the registrants of the following drugs must submit a report on BE study data along with the drug registration dossier: Generic enteric-coated drugs, in immediate-release or modified-release form, containing single APIs or fixed-dose API combinations in which the APIs are included in the list of 26 APIs mentioned above. Other generic drugs in modified-release form, except for enteric-coated drugs with APIs excluded from the list of 26 APIs. From November 1, 2025 (36 months after the effective date of Circular 07), the registrant must submit a BE data dossier along with the drug registration dossier for all generic enteric-coated drugs in modified-release form. From November 1, 2026 (48 months

Thailand’s recent removal of cannabis from the list of narcotics represents a significant development for the country, and it has some human resources teams wondering whether they should prepare certain measures in order to prevent detrimental incidents from happening in their organizations. For example, some employees could still be under the influence of cannabis because they used it before coming to work. In the past, this was rarely a consideration as cannabis was clearly banned. Using cannabis or possessing cannabis inside the employer’s premises subjected employees to criminal liability including imprisonment and fines. However, now that the government has removed cannabis from the narcotics list under the Narcotics Act, such incidents are more likely to occur. This likelihood has led to concern among many employers about how they can prevent or handle these incidents. An employer does have the right to prohibit any employee from bringing cannabis inside its premises, as it is the property of the employer. The employer has the management right to do this, particularly as an employee’s use of cannabis may very well disturb other employees. But if the employer would like to set penalties for breaching the prohibition, the picture is more complicated. Employers’ Work Rules Under the Labour Protection Act (LPA), an employer who has at least 10 employees must have Thai-language work rules. These work rules must include the following items: Specification of working days, regular working hours, and rest periods; Holidays and rules for taking holidays; Rules concerning overtime work and work on holidays; Arrangements for payment of wages (i.e., schedule and location); Overtime pay, holiday pay, and holiday overtime pay; Leave and rules for taking leave; Discipline and disciplinary actions; Submission of grievances; and Termination of employment, severance pay and special severance pay. To issue or amend work rules (e.g., to introduce cannabis-related rules), employers must: Announce the implementation of work rules within 15 days of

タイが最近麻薬のリストから大麻を削除したことは、同国にとって重要な変化であり、人事チームの中には、会社内で有害な事件が起きないようにするために、何らかの対策をすべきではないかと考えている場合もあるだろう。 例えば、出勤前に大麻を使用したため、勤務中に大麻の影響を受けている労働者がいたらどうだろう。以前は大麻が明確に禁止されており、使用者の敷地内で大麻を使用したり所持したりすると、労働者は懲役や罰金などの刑事責任を問われたため、このような問題はほとんど考慮されていなかった。しかし、政府が麻薬法に基づいて麻薬のリストから大麻を削除した今、そのようなことがより起こりやすくなっており、多くの使用者の間で、どうすればこのようなことを防止し、対処できるかという懸念が生じている。 会社の敷地は使用者の支配下にあるから、使用者には労働者が社内に大麻を持ち込むことを禁止する権限がある。特に、労働者が大麻を使用することは他の労働者を著しく妨害する可能性があるため、雇用主はこれを管理する権限を有する。しかし、労働者が禁止に違反した場合の罰則を設けたい場合は、そこまで単純にはいかない。   就業規則  労働者保護法（Labor Protection Act）では、10人以上の労働者を雇用する場合、タイ語の就業規則を定めなければならない。就業規則には、次の項目が含まれている必要がある。 労働日、所定労働時間及び休憩時間の指定。 休日・休日の取得の規則。 時間外労働及び休日労働に関する規則。 賃金の支払いの手配（支払日と支払場所）。 時間外賃金、休日賃金及び休日時間外賃金。 休暇及び休暇の取得の規則。 懲戒処分。 苦情の申出。 雇用の終了、解雇補償金及び特別解雇補償金。   就業規則（例えば、大麻関連のルールを導入するために）を作成又は変更する場合、使用者は次のことを行う必要がある。（なお以前は、労働者保護局長又はその指名する者に就業規則又は就業規則の変更書の写しを送付することが義務付けられていたが、2017年の労働者保護法改正でこれは撤廃された。） 就業規則を作成又は変更した日から15日以内に就業規則の実施を公表すること。 就業規則及びその変更を常時社内に保管すること。及び 就業規則・その修正を職場において公開していること。使用者は、就業規則又はその修正を電子的に公開することもできる。   しかし、労働者の雇用条件に影響を与えるような就業規則の変更には、より多くの意見を聞くことが必要である。労働関係法（Labor Relations Act）の下では、使用者は雇用条件を一方的に変更することはできない。 「雇用条件」という用語は、タイ法の下での広い概念であり、賃金、福利厚生、労働日数、労働時間等など雇用の条件であることが明確なものから、労働者の苦情の提出に関する規則、雇用の終了、懲戒処分、就業規則の改正、その他契約又は慣行により義務とされる職場の条件などの事項までを広く含む概念である。例えば、変動制のボーナスの基準は雇用条件とみなされ得るため、雇用者が書面においてそれを変更する権利を明示的に留保していない場合、これらの基準を使用者が一方的に変更することができない可能性がある。同様に、労働者に支給されるシャトルサービスなどの福利厚生も、雇用条件になりうる。 労働条件に影響を与える就業規則の変更をしようとする場合には、労働関係法に従い、労働者に対し要求を記載した通知書を交付して交渉するか、労働者の同意を得なければならない。ただし、就業規則に、使用者が将来就業規則を変更する権利を留保する旨の条項がある場合は、雇用条件に影響を与えない範囲での就業規則の変更をすることができる。例えば、就業規則に部署ごとの労働者数が記載されている場合などは、雇用条件の利益に影響を与えない範囲で変更することができる。 以上から、大麻に関する規則については、前述のとおり、使用者が社内で労働者が大麻を使用することを禁止することは可能だが、大麻を社内に持ち込んだ労働者を解雇するという規則を設けたい場合又はその他の罰則を科すとしたい場合には、雇用条件に影響があると考えられるため、使用者が一方的に行うことはできない。したがって、このような就業規則の改正を考える使用者は、労働関係法の手続きに従って、労働者に要求を記載した通知書を交付するか、労働者に同意を求めることによって、手続きを進めなければならない。   備考：本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。Cannabis and Human Resources Considerations in Thailand

Thailand’s Office of the Personal Data Protection Committee (PDPC) has opened a public hearing period on its draft notification regarding cross-border transfer of personal data. The public hearing is open through October 24. The notification, once issued, will supplement the principle of cross-border transfer of personal data outside of Thailand set out in the Personal Data Protection Act (PDPA). The notification sets out the following key matters: Definitions “Transfer of personal data” means any sending or transferring of personal data by a transferor of personal data, either by way of a physical transfer or a remote transfer through a computer system or an internet network to the recipient of the personal data. It does not include sending personal data through an intermediary by transiting between computer systems or internet networks, or any storing or retaining of personal data, either permanently or temporarily, by a cloud computing service provider, whereby the personal data transferor and the personal data recipient (1) are not making the order, (2) are not involved with any data selection or the content of the personal data sent and received through the computer systems or internet networks, or (3) have the purpose of entering into an agreement or any juristic act. “Binding corporate rules” means the agreed terms or policy on personal data protection made between the personal data transferor and the personal data recipient to establish appropriate measures for safeguarding personal data within a group of corporations or companies. “Standard contractual clauses” means the contractual terms made between the personal data transferor and the personal data recipient to establish appropriate measures for safeguarding personal data. “Code of conduct” means a code that sets out the obligations of a personal data transferor and a personal data recipient outside of Thailand. “Certification” means an undertaking in relation to safeguarding personal data, in order to establish

On October 3, 2022, Thailand’s Ministry of Labour issued an announcement canceling the prohibition on lockouts and strikes, which had been in place since the onset of the COVID-19 pandemic. While this cancellation does not apply to ongoing labor disputes already being considered under the interim arrangements, it will apply to all other labor disputes from October 5, 2022, when it was published in the Government Gazette. Lockouts and strikes are basic rights of employers and employees under the Labour Relations Act B.E. 2518 (1975). However, these rights can be suspended—as they have been since May 8, 2020, when the Ministry of Labour announced that all labor disputes that could not be resolved through negotiation must be presented to the Labour Relations Committee in lieu of organizing strikes or lockouts. The announcement referred to the necessity of such special administration during the COVID-19 situation in order to prevent possible negative impacts on both employers and employees. On September 30, 2022, Thailand ended its COVID-19 emergency decree and dissolved the country’s Centre for COVID-19 Situation Administration. In light of this, the Ministry of Labour decided to end the requirement that unresolved labor disputes be sent to the Labour Relations Committee. The ministry’s cancellation of the prohibition will once again allow employers and employees to organize lockouts and strikes under the Labour Relations Act, starting October 5, 2022. For more details on this development, or for assistance with employment-related questions or disputes in Thailand, please contact Tilleke & Gibbins at [email protected] or +66 2056 5555.

On September 5, 2022, Vietnam’s Ministry of Health (MOH) issued Circular No. 08/2022/TT-BYT on the registration of drugs and drug materials (Circular 08). Circular 08 will come into effect on October 20, 2022, and replace Circular No. 32/2018/TT-BYT and its amendments, which are the current regulations on drug registration. Below are some noteworthy contents of Circular 08: The requirements on providing a Certificate of Pharmaceutical Product (CPP) are less stringent under the new regulations. For example, a CPP is now only required to include content as stipulated in the WHO’s CPP template. No additional contents—such as specification of finished products, APIs, herbal ingredients, and names and addresses of the API/herbal ingredient’s manufactures as under the current regulations—are required. Another new point is that, for the registration dossiers of new chemical drugs, vaccines, and imported biologicals (except probiotics), applicants are required to submit only one CPP issued by the manufacturing country if the CPP issuing authority is the EMA or any SRA (Stringent Regulatory Authority); no additional CPP/legal document is required as currently. There will be a new option for providing legal documents of the manufacturer of APIs, excipients, capsule shells, semi-finished herbal medicine products, and herbal ingredients to prove compliance with GMP requirements. In particular, in addition to a GMP certificate, manufacturing license stating the manufacturer meets GMP, CPP for API with content satisfying GMP, Certification of Suitability (CEP), or self-evaluation form, it is acceptable if the company submits a Good Agricultural and Collection Practices/GACP certificate (for herbal ingredients) or other legal documents granted by the authorities containing at least the following contents: name and address of the manufacturer, certification that the manufacturer meets GMP requirements, and name of the drug substance/excipient/capsule/semi-finished medicinal material/medicinal ingredient. For vaccines, serums containing antibodies, and derivatives of human blood and plasma, Circular 08 introduces a more lenient