C. Pharmaceutical Patent Law in Tha

C. Pharmaceutical Patent Law in Thailand
1. Background of Pharmaceutical Patent Protection in Thailand
Requests from domestic industries and the national policy in promoting industrial development and international trade were the early forces that drove Thailand to turn towards patent protection. As a civil law country, Thailand must enact an Act in order to legitimately recognize patent rights. The Thai government had first proposed a draft patent act for consideration by the legislature in 1965, but it was refused because of the fear that patent law would result in trade monopoly and an increased burden on consumers. The lack of readiness in terms of manpower and facilities to accommodate the patent system was another concern of the legislature.
Patent protection in Thailand was eventually recognized through the enactment of the Patent Act B.E. 2522 (A.D. 1979) (1979 Act), which came into effect on September 12, 1979. It was clearly specified under this 1979 Act that pharmaceutical products were not patentable. Only pharmaceutical processes were eligible for patent protection, which corresponded to the level of pharmaceutical development of the country at that time.
During the 1980s-1990s, the U.S. government pressured Thailand to amend the patent protection granted under the 1979 Act by tying trade retaliation measures to the protection of intellectual property rights. For instance, it cut Thailand’s Generalized System of Preferences for certain goods in January 1989 for the reason that Thailand did not provide sufficient intellectual property protection to U.S. nationals, especially on the protection of computer programs and pharmaceutical products. It also threatened to use Section 301 of the Omnibus Trade and Competitiveness Act of 1988 as a trade retaliation measure.
As a result, Thailand amended the 1979 Act in 1992 on various important issues, including making pharmaceutical products patentable. The amendment also set up mechanisms to monitor the price and availability of drugs in the market, in order to prevent pharmaceutical patent holders from abusing their rights. However, such mechanisms were later revoked by the second amendment to the 1979 Act in 1999.
2. Current Pharmaceutical Patent Protection
On the international level, Thailand is not a party to any international treaty or convention regarding patent protection, except for the TRIPS Agreement. The 1979 Act, which was amended twice respectively in 1992 and 1999, is the domestic law governing pharmaceutical patent protection in Thailand. Currently, the Patent Act recognizes protection of inventions, which include pharmaceutical products and processes. An invention is patentable if: (1) it is a new invention; (2) it involved in higher inventive step; and (3) it is capable of industrial application. The inventor might also choose to apply for a petty patent if criteria (1) and (3) are met. However, the law does not allow the application for both a patent and a petty patent for the same invention.
In order to obtain patent protection under the law, applicants have to file applications with the relevant authority in accordance with the formalities specified in the Patent Act. Generally, the patent lasts for a term of twenty years from the filing date of the patent application within the country.
As in the TRIPS Agreement, the Patent Act has also specified some flexibility for patent protection. The Patent Act recognizes compulsory licensing as a remedy to the abuse of a monopoly right. There are also two exceptions to the exclusive rights that directly concern the pharmaceutical industry. First, professional pharmacists or medical practitioners may compound drugs to fill a doctor’s prescription as well as use pharmaceutical products without the consent of, or remuneration paid to, the patent holder. This exception is aimed at protecting the public against a monopoly by the patent holders and preventing the medical practitioners from infringing pharmaceutical patent in treating patients.
The second exception is similar to the Bolar exception under the TRIPS Agreement. The Patent Act allows applicants to file for drug registration if they intend to produce, distribute or import patented pharmaceutical products after the expiration of the existing patent term. Such exception allows pharmaceutical companies to file a drug application during the patented term and enable them to release the products immediately after the expiration of the patent term. The provision is meant to promote competition among pharmaceutical companies and lessen time for generic drugs to be available to the market, which will enhance public benefit

Hasil (Bahasa Indonesia) 1:

C. farmasi paten hukum di Thailand1. latar belakang farmasi perlindungan paten di ThailandPermintaan dari industri dalam negeri dan kebijakan nasional dalam mempromosikan pengembangan industri dan perdagangan internasional adalah kekuatan awal yang melaju Thailand untuk mengubah terhadap perlindungan paten. Sebagai negara hukum perdata, Thailand harus memberlakukan undang-undang untuk sah mengakui hak paten. Pemerintah Thailand telah mengusulkan undang-undang Paten rancangan pertama untuk dipertimbangkan oleh badan legislatif pada tahun 1965, tapi itu menolak karena takut bahwa hukum paten akan mengakibatkan monopoli perdagangan dan peningkatan beban konsumen. Kurangnya kesiapan tenaga kerja dan Fasilitas untuk mengakomodasi sistem paten adalah kekhawatiran lain legislatif. Perlindungan paten di Thailand akhirnya diakui melalui pemberlakuan undang-undang Paten B.E. 2522 (m 1979) (1979 Act), yang mulai diberlakukan pada tanggal 12 September 1979. Itu jelas ditentukan berdasarkan Arbitration Act 1979 produk farmasi yang tidak dipatenkan. Hanya proses farmasi yang memenuhi syarat untuk perlindungan paten, yang berpadanan dengan tingkat farmasi perkembangan negara pada waktu itu. During the 1980s-1990s, the U.S. government pressured Thailand to amend the patent protection granted under the 1979 Act by tying trade retaliation measures to the protection of intellectual property rights. For instance, it cut Thailand’s Generalized System of Preferences for certain goods in January 1989 for the reason that Thailand did not provide sufficient intellectual property protection to U.S. nationals, especially on the protection of computer programs and pharmaceutical products. It also threatened to use Section 301 of the Omnibus Trade and Competitiveness Act of 1988 as a trade retaliation measure. As a result, Thailand amended the 1979 Act in 1992 on various important issues, including making pharmaceutical products patentable. The amendment also set up mechanisms to monitor the price and availability of drugs in the market, in order to prevent pharmaceutical patent holders from abusing their rights. However, such mechanisms were later revoked by the second amendment to the 1979 Act in 1999. 2. Current Pharmaceutical Patent ProtectionOn the international level, Thailand is not a party to any international treaty or convention regarding patent protection, except for the TRIPS Agreement. The 1979 Act, which was amended twice respectively in 1992 and 1999, is the domestic law governing pharmaceutical patent protection in Thailand. Currently, the Patent Act recognizes protection of inventions, which include pharmaceutical products and processes. An invention is patentable if: (1) it is a new invention; (2) it involved in higher inventive step; and (3) it is capable of industrial application. The inventor might also choose to apply for a petty patent if criteria (1) and (3) are met. However, the law does not allow the application for both a patent and a petty patent for the same invention. In order to obtain patent protection under the law, applicants have to file applications with the relevant authority in accordance with the formalities specified in the Patent Act. Generally, the patent lasts for a term of twenty years from the filing date of the patent application within the country.
As in the TRIPS Agreement, the Patent Act has also specified some flexibility for patent protection. The Patent Act recognizes compulsory licensing as a remedy to the abuse of a monopoly right. There are also two exceptions to the exclusive rights that directly concern the pharmaceutical industry. First, professional pharmacists or medical practitioners may compound drugs to fill a doctor’s prescription as well as use pharmaceutical products without the consent of, or remuneration paid to, the patent holder. This exception is aimed at protecting the public against a monopoly by the patent holders and preventing the medical practitioners from infringing pharmaceutical patent in treating patients.
The second exception is similar to the Bolar exception under the TRIPS Agreement. The Patent Act allows applicants to file for drug registration if they intend to produce, distribute or import patented pharmaceutical products after the expiration of the existing patent term. Such exception allows pharmaceutical companies to file a drug application during the patented term and enable them to release the products immediately after the expiration of the patent term. The provision is meant to promote competition among pharmaceutical companies and lessen time for generic drugs to be available to the market, which will enhance public benefit

Hasil (Bahasa Indonesia) 2:

C. Hukum Paten Farmasi di Thailand
1. Latar Belakang Farmasi Perlindungan Paten di Thailand
Permintaan dari industri dalam negeri dan kebijakan nasional dalam mempromosikan pengembangan industri dan perdagangan internasional adalah kekuatan awal yang mendorong Thailand untuk mengubah arah perlindungan paten. Sebagai negara hukum perdata, Thailand harus memberlakukan Undang-Undang untuk secara sah mengakui hak paten. Pemerintah Thailand telah pertama kali diusulkan tindakan paten rancangan untuk dipertimbangkan oleh legislatif tahun 1965, namun ditolak karena takut bahwa hukum paten akan mengakibatkan monopoli perdagangan dan beban meningkat pada konsumen. Kurangnya kesiapan dalam hal tenaga dan fasilitas untuk mengakomodasi sistem paten adalah kekhawatiran lain dari legislatif.
Perlindungan paten di Thailand akhirnya diakui melalui pemberlakuan UU Paten BE 2522 (AD 1979) (1979 Act), yang datang ke efek pada tanggal 12 September 1979. Hal itu jelas ditentukan di bawah 1979 Undang-undang ini bahwa produk farmasi yang tidak dipatenkan. Hanya proses farmasi yang memenuhi syarat untuk perlindungan paten, yang berhubungan dengan tingkat perkembangan farmasi dari negara pada waktu itu.
Selama tahun 1980-tahun 1990-an, pemerintah AS menekan Thailand untuk mengubah perlindungan paten diberikan di bawah 1979 Act dengan mengikat tindakan pembalasan perdagangan untuk perlindungan hak kekayaan intelektual. Misalnya, memotong Generalized Sistem Thailand dari Preferensi untuk barang-barang tertentu pada bulan Januari 1989 dengan alasan bahwa Thailand tidak memberikan perlindungan kekayaan intelektual yang cukup untuk warga negara AS, terutama pada perlindungan program komputer dan produk farmasi. Hal ini juga mengancam akan menggunakan Pasal 301 Perdagangan Omnibus dan Daya Saing Act of 1988 sebagai ukuran pembalasan perdagangan.
Akibatnya, Thailand diubah tahun 1979 Undang-Undang tahun 1992 tentang berbagai masalah penting, termasuk membuat produk farmasi dipatenkan. Amandemen ini juga mengatur mekanisme untuk memantau harga dan ketersediaan obat di pasar, untuk mencegah pemegang paten farmasi menyalahgunakan hak-hak mereka. Namun, mekanisme seperti itu kemudian dicabut oleh amandemen kedua tahun 1979 Undang-Undang tahun 1999.
2. Saat Paten Perlindungan Farmasi
Di tingkat internasional, Thailand bukan merupakan pihak untuk perlindungan paten perjanjian atau konvensi mengenai internasional, kecuali untuk perjanjian TRIPS. 1979 Act, yang telah diubah dua kali masing-masing pada tahun 1992 dan 1999, adalah hukum domestik yang mengatur perlindungan paten farmasi di Thailand. Saat ini, UU Paten mengakui perlindungan penemuan, yang meliputi produk farmasi dan proses. Sebuah invensi dapat dipatenkan jika: (1) itu adalah penemuan baru; (2) itu terlibat dalam langkah inventif yang lebih tinggi; dan (3) yang mampu aplikasi industri. Penemu juga dapat memilih untuk mengajukan permohonan paten kecil jika kriteria (1) dan (3) terpenuhi. Namun, hukum tidak memungkinkan aplikasi untuk kedua paten dan paten kecil untuk penemuan yang sama.
Dalam rangka untuk mendapatkan perlindungan paten di bawah hukum, pelamar harus mengajukan aplikasi dengan otoritas yang relevan sesuai dengan formalitas yang ditentukan dalam Paten Bertindak. Umumnya, paten berlangsung untuk jangka waktu dua puluh tahun dari tanggal pengajuan aplikasi paten dalam negeri.
Seperti dalam perjanjian TRIPS, UU Paten juga telah ditetapkan beberapa fleksibilitas untuk perlindungan paten. Paten Act mengakui lisensi wajib sebagai obat untuk penyalahgunaan hak monopoli. Ada juga dua pengecualian untuk hak eksklusif yang langsung menyangkut industri farmasi. Pertama, apoteker profesional atau praktisi medis mungkin senyawa obat untuk mengisi resep dokter serta produk farmasi digunakan tanpa persetujuan dari, atau remunerasi yang dibayarkan kepada, pemegang paten. Pengecualian ini bertujuan untuk melindungi masyarakat terhadap monopoli oleh pemegang paten dan mencegah praktisi medis dari melanggar paten farmasi dalam mengobati pasien.
Pengecualian kedua adalah mirip dengan pengecualian Bolar bawah perjanjian TRIPS. Paten Act memungkinkan pelamar untuk mengajukan registrasi obat jika mereka berniat untuk memproduksi, mendistribusikan atau produk farmasi impor dipatenkan setelah berakhirnya masa paten yang ada. Pengecualian tersebut memungkinkan perusahaan farmasi untuk mengajukan aplikasi obat selama jangka dipatenkan dan memungkinkan mereka untuk melepaskan produk segera setelah berakhirnya masa paten. Ketentuan ini dimaksudkan untuk mempromosikan kompetisi di antara perusahaan farmasi dan mengurangi waktu untuk obat generik akan tersedia untuk pasar, yang akan meningkatkan kepentingan publik