Urgensi Pengaturan Mekanisme Pregrant Opposition Sebagai Upaya Pencegahan Terhadap Raktik Patent Evergreening Di Indonesia

Wijaya, Steven Aristides and Ranitya Ganindha, S.H., M.H., and Afrizal Mukti Wibowo, S.H., M.H. (2025) Urgensi Pengaturan Mekanisme Pregrant Opposition Sebagai Upaya Pencegahan Terhadap Raktik Patent Evergreening Di Indonesia. Sarjana thesis, Universitas Brawijaya.

Abstract

Dalam skripsi ini, penulis membahas mengenai urgensi pengaturan mekanisme pre-grant opposition sebagai upaya pencegahan terhadap praktik patent evergreening di Indonesia. Penelitian ini dilatarbelakangi oleh beberapa kasus terkait praktik patent evergreening di Indonesia, seperti kasus obat Sofosbuvir dan kasus obat Bedaquiline. Praktik patent evergreening sangat berbahaya dan dapat merugikan masyarakat, yang mana pencegahannya dapat dilakukan melalui mekanisme patent opposition. Indonesia sudah memiliki pengaturan mekanisme patent opposition, seperti mekanisme post-grant opposition yang diatur pada pasal 67 dan pasal 70-72 Undang-Undang Nomor 65 Tahun 2024 tentang Perubahan Ketiga atas UU Paten, serta mekanisme third party observation & protest yang diatur pada pasal 49 Undang-Undang Paten. Namun, kedua mekanisme ini masih mempunyai beberapa kelemahan dan tidak maksimal dalam mencegah praktik patent evergreening. Berdasarkan hal tersebut, skripsi ini mengangkat rumusan masalah, yakni: (1) Bagaimana urgensi pengaturan mekanisme pre-grant opposition sebagai upaya pencegahan praktik patent evergreening di Indonesia; dan (2) Bagaimana pengaturan yang tepat mengenai mekanisme pre-grant opposition sebagai upaya pencegahan praktik patent evergreening dalam Undang-Undang Nomor 13 Tahun 2016 Tentang Paten. Penelitian skripsi ini menggunakan metode yuridis normatif dengan pendekatan perundang-undangan (statute approach) dan pendekatan komparatif (comparative approach). Bahan hukum primer, sekunder, dan tersier yang diperoleh penulis akan dianalisis dengan menggunakan metode interpretasi gramatikal, interpretasi sistematis, dan interpretasi komparatif. Dari hasil penelitian tersebut, penulis memperoleh jawaban bahwa terdapat urgensi yang sangat signifikan untuk mengatur mekanisme pre-grant opposition sebagaimana hal ini didorong adanya praktik patent evergreening yang dilakukan dengan mengelabui Pasal 22 Undang-Undang Paten. Praktik ini bertentangan dengan tujuan sistem paten yang seharusnya menyeimbangkan perlindungan hak inventor dengan manfaat publik. Mekanisme third party observation and protest memiliki keterbatasan dan tidak maksimal dalam mencegah pemberian paten yang tidak layak sejak awal. Ketiadaan mekanisme pre-grant opposition memperparah masalah ini, seperti yang terlihat dalam kasus obat Sofosbuvir dan Bedaquiline. Adanya mekanisme pre-grant opposition akan memberikan pencegahan terhadap dampak buruk yang terjadi setelah pemberian paten. Tanpa pembaruan ini, praktik patent evergreening dapat terus berlanjut dan membahayakan masyarakat. Pengaturan yang tepat mengenai mekanisme pre-grant opposition dapat dilakukan dengan mengatur suatu mekanisme yang dapat diajukan oleh setiap orang secara tertulis kepada kantor paten (DJKI) terhadap paten apa pun setelah pengumuman permohonan paten dan sebelum pemberian paten. Pengaturan mekanisme ini juga harus mencakup prosedur persidangan dan dasar-dasar untuk mengajukannya.

English Abstract

In this thesis, the author discusses the urgency of regulating the pre-grant opposition mechanism as an effort to prevent patent evergreening practices in Indonesia. This research is motivated by several cases related to patent evergreening practices in Indonesia, such as the Sofosbuvir drug case and the Bedaquiline drug case. Patent evergreening practices are very dangerous and can harm the society, which can be prevented through the patent opposition mechanism. Indonesia already has patent opposition mechanism regulations, such as post-grant opposition mechanism regulated in Article 67 and Article 70-72 of Law Number 65 of 2024 concerning the Third Amendment to the Patent Law, as well as third party observation & protest mechanism regulated in Article 49 of the Patent Law. However, these two mechanisms still have several weaknesses and cannot maximally prevent patent evergreening practices. Without pre-grant opposition mechanism regulations in Indonesia, patent evergreening practices can continue to develop. Based on this, this thesis raises the following problem formulations: (1) How urgent is the regulation of pre-grant opposition mechanism as an effort to prevent patent evergreening practices in Indonesia; and (2) What is the appropriate regulation regarding pre-grant opposition mechanism as an effort to prevent patent evergreening practices in Law Number 13 of 2016 concerning Patents. This thesis research uses normative legal method with statute approach and comparative approach. The primary, secondary, and tertiary legal materials obtained by the author will be analyzed using grammatical interpretation, systematic interpretation, and comparative interpretation methods. From the results of the study, the author obtained the answer that there is a very significant urgency to regulate the pre-grant opposition mechanism as this is driven by the practice of patent evergreening which is carried out by deceiving Article 22 of the Patent Law. This practice is contrary to the purpose of the patent system which should balance the protection of inventor rights with public benefits. The third party observation and protest mechanism has limitations and is not optimal in preventing the granting of ineligible patents from the early stage. The absence of a pre-grant opposition mechanism exacerbates this problem, as seen in the cases of the drugs Sofosbuvir and Bedaquiline. The existence of a pre-grant opposition mechanism will provide prevention against the adverse impacts that occur after the granting of a patent. Without this reform, the practice of patent evergreening can continue and endanger the public. Proper regulation of the pregrant opposition mechanism can be done by regulating a mechanism that can be submitted by anyone in writing to the patent office (DJKI) against any patent after the announcement of the patent application and before the granting of the patent. The regulation of this mechanism must also include trial procedures and the grounds for filing it.

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