ANALISIS YURIDIS REVERSE PAYMENT SETTLEMENT AGREEMENT PADA SEKTOR INDUSTRI FARMASI DITINJAU DARI PERSPEKTIF HUKUM PERSAINGAN USAHA DI INDONESIA - Bintang Pratama Latumahina (Brawijaya Law Student Journal, 2023)
Bintang Pratama Latumahina, Sukarmi, Moch. Zairul Alam Fakultas Hukum Universitas Brawijaya Jl. MT. Haryono No. 169 Malang e-mail: bintangpratama@student.ub.ac.id Abstrak Reverse Payment Settlement Agreement (RPSA) merupakan perjanjian penyelesaian sengketa, di mana pelaku usaha pencetus obat yang masih memegang paten proses pembuatan obat yang zat aktifnya telah menjadi public domain membayar pelaku usaha obat generik untuk tidak memasuki pasar hingga waktu yang disepakati. RPSA di Uni Eropa telah diklasifikasikan sebagai perjanjian yang bersifat naked restraint. RPSA sendiri berpotensi untuk terjadi di Indonesia, akan tetapi hukum persaingan usaha di Indonesia masih belum mengatur terkait batasan penggunaan hak eksklusif tanpa melalui perjanjian lisensi serta penilaian pesaing potensial. Penelitian ini mengangkat beberapa rumusan masalah: (1) Bagaimana analisis potensi pelanggaran yang timbul dari reverse payment settlement agreement ditinjau dari Undang-Undang Nomor 5 Tahun 1999 Tentang Larangan Praktek Monopoli dan Persaingan Usaha Tidak Sehat? (2) Bagaimana pengaturan yang ideal untuk menangani kasus reverse payment settlement agreement di Indonesia?. Penelitian ini merupakan penelitian hukum normatif dengan menggunakan pendekatan kasus, pendekatan perundang-undangan, dan pendekatan komparatif. Hasil penelitian menunjukkan bahwa RPSA yang berpotensi terjadi di Indonesia berpotensi melanggar Pasal 11, 15 ayat (1) dan (3) huruf b, dan 25 ayat (1) huruf a dan c UU 5/1999. Kemudian, didapati bahwa pemaknaan perjanjian yang berkaitan dengan HKI tidak dapat dimaknai lagi sebatas perjanjian lisensi, sehingga penulis merumuskan pengaturan terkait batasan penggunaan hak eksklusif oleh pelaku usaha, khususnya paten serta diperlukannya pengaturan pesaing potensial agar UU 5/1999 dapat diaplikasikan secara ideal pada RPSA yang berpotensi terjadi di Indonesia. Kata Kunci: Reverse Payment Settlement Agreement (RPSA), hak eksklusif, pesaing potensial Abstract Reverse Payment Settlement Agreement (RPSA) aims to settle disputes, where drug inventors holding patents in the process of production of drugs whose active substances have become public domain pay the generic drug manufacturers to ensure that they do not enter the market until the time that has been agreed upon. RPSA in European Union has been classified as a naked restraint agreement and is likely to happen in Indonesia. However, the law concerning business competition does not regulate the limitation in the use of exclusive rights without making any licensing agreement and the assessment of potential competitors. This research investigates the following research problems: (1) the analysis of the potential of the violations arising from reverse payment settlement agreements seen from the perspective of unfair business competition, and (2) ideal regulation that deals with the case of reverse payment settlement agreements in Indonesia. This research employed a normative method and case, statutory, and comparative approaches. The research result reveals that the RPSA is likely to happen in Indonesia, potentially violating Articles 11, 15 Paragraph (1) and (3) letter b, and 25 Paragraph (1) letter a and c of Law 5/1999. Moreover, the agreement regarding Intellectual Property Rights can no longer be defined as a license agreement. Thus, this research formulates the regulation regarding the limitation of the use of exclusive rights by business actors, especially patents. Regulation regarding potential competitors is also needed to ensure that Law 5/1999 can be applied appropriately in RPSA that potentially happens in Indonesia. Keywords: Reverse Payment Settlement Agreement (RPSA), exclusive rights, potential competitor