PERLINDUNGAN HUKUM TERHADAP PRODUK NANOTEKNOLOGI MELALUI HUKUM PATEN

<p>Karakteristik produk nano tidak hanya berukuran kecil, dan hanya masyarakat<br />yang dekat dan peduli dengan nano serta ilmuwan dan produsen, yang memahami<br />sifat khas produk nano dan bagaimana menjaganya sehingga memenuhi syarat<br />patentable invention. Secara khusus penelitian ini dilakukan dengan tujuan untuk:<br />(1) menciptakan cara dan bentuk pematenan produk nanoteknologi dan (2)<br />membuat evaluasi dan rekomendasi kepada decision maker tentang bentuk<br />pematenan dan upaya pemberdayaan masyarakat nano serta peningkatan<br />technological capabilities. Penelitian ini termasuk dalam penelitian deskriptif<br />kualitatif dengan pendekatan sosiologis, atau dalam penelitian hukum biasa disebut<br />normatif terapan / normatif empiris. Penelitian lebih difokuskan pada implementasi<br />legal awareness utamanya guna membentuk masyarakat yang berdaya guna secara<br />progresif dalam upaya perlindungan hukum produk Nano. Berdasarkan hasil<br />penelitian diketahui bahwa hingga saat ini Direktorat Jenderal Hak Kekayaan<br />Intelektual Republik Indonesia belum menerapkan kebijakan khusus mengenai<br />cara dan bentuk pematenan produk nanoteknologi. Ditjen HKI hanya menerapkan<br />kebijakan pendaftaran paten secara prodeo/gratis bagi invensi yang didaftarkan<br />oleh universitas/perguruan tinggi dan usaha kecil dan menengah (Januari –<br />September 2012). Permohonan paten atas produk nano pun tidak berbeda dengan<br />produk teknologi lainnya. Cara dan bentuk pematenan produk nano yang tepat<br />yakni dengan standar nano yang jelas dalam bentuk regulasi dan penegakan hukum<br />yang kuat, didukung oleh ketersediaan SDM. Terdapat hambatan pada sumber<br />daya manusia di Ditjen HKI dan BPOM (ketidaksiapan tenaga profesional / ahli<br />Nano), ketidakseimbangan produsen dan konsumen, status legal dan ilegal nano<br />dari luar negeri (perlu sertifikasi), dan dukungan pemerintah. Selain itu dalam<br />bidang perlindungan hukum, perlu dijelaskan secara konseptual, apa batasan /<br />definisi partikel, cara mengatasi karakterisitik Nano, syarat dan aturan produk<br />nano yang legal, di samping maraknya bisnis yang mendaku menggunakan<br />teknologi nano baik impor dan nano dari Indonesia sendiri. Pemberdayaan<br />masyarakat nano belum diimbangi oleh kebijakan pemerintah dan uluran tangan<br />pelbagai pihak yang mendukung, seperti halnya dalam rangka ketersediaan sumber<br />daya ahli di pelbagai institusi dan upaya perlindungan hukumnya. MNI ingin<br />melangkah tidak hanya sebatas tempat komunikasi, akan tetapi lebih ditingkatkan<br />ranah kegiatannya khususnya dalam pengembangan nanoteknologi dan<br />perlindungannya.</p>

What Can Be Patented

This chapter considers the kinds of inventions that are patentable. Specifically, it explains the requirements of the European Patent Convention (EPC) and European national laws, and US law. There are three simple requirements for a patentable invention, as set out in TRIPs, the EPC, and in the laws of EPC member states. These are that (a) the invention must be new; (b) it must involve an inventive step; and (c) it must be capable of industrial application. The same three basic requirements are also present in the US system,. The remainder of the chapter discusses the law on special categories of invention: chemical compounds, manufacturing processes, and uses; pharmaceuticals and new pharmaceutical uses; microbiological inventions; and computer-related and business method inventions.

No Patents on Seeds Files an Opposition against Monsanto's Patent EP 2 134 870 B1 Covering the Selection of Soybean Plants and Seeds

On 25th November, 2014, the coalition “No Patents on Seeds” filed an opposition against the European patent EP 2 134 870 B1, held by the U.S. Company Monsanto Technology. The patent, granted on 26th February, 2014, by the European Patent Office, covers “utility of SNP [single nucleotide polimorfism] markers associated with major soybean plant maturity and growth habit genomic regions” and includes “methods for screening plants and seeds from the genus Glycine withmarkers associated with genomic regions that are related to the plant maturity and growth habit of Glycine plants”.“No Patents on Seeds” claims that the patent should be completely revoked, as it falls within the exclusion of essentially biological processes for the production of plants from patentability under art. 53(b) of the European Patent Convention (EPC2000) and is not a patentable invention according to art. 52(2)(a) EPC. This case note gives an overview of the opposition and discusses its implications.

How to Successfully Patent Therapeutic Antibodies

Therapeutic antibodies have become an established class of drugs for the treatment of a variety of diseases, especially cancer and autoimmune/inflammatory disorders, and a sufficient patent protection is a prerequisite for their successful commercialization. As monoclonal antibodies and their therapeutic potential have been well known for decades, the mere production of yet another therapeutic antibody is in many jurisdictions not considered a patentable invention. In contrast, antibodies with novel structural features and/or improved properties may be patentable. When drafting the claims, care should be taken to obtain a broad patent scope that protects both the antibody of interest and related antibodies having the same functional features, thereby preventing competitors from marketing a functionally equivalent antibody. Furthermore, the application should contain experimental evidence showing the improved properties of the claimed antibody. After the filing of a priority patent application, patent protection should be initiated at least in countries that are of particular commercial importance. Subsequent inventions relating to novel uses, formulations, dosage regimens, and combinations with other treatment modalities should be protected by further patent applications to extend patent term.

Science Inside Law: The Making of a New Patent Class in the International Patent Classification

ArgumentRecent studies of patents have argued that the very materiality and techniques of legal media, such as the written patent document, are vital for the legal construction of a patentable invention. Developing the centrality placed on patent documents further, it becomes important to understand how these documents are ordered and mobilized. Patent classification answers the necessity of making the virtual nature of textual claims practicable by linking written inscription to bureaucracy. Here, the epistemological organization of documents overlaps with the grid of patent administration. How are scientific inventions represented in such a process? If we examine the process of creating a new patent category within the International Patent Classification (IPC), it becomes clear that disagreements about the substance of the novel inventive subject matter have been resolved by computer simulations of patent documents in draft classifications. The practical needs of patent examiners were the most important concerns in the making of a new category. Such a lack of epistemological mediation between the scientific and legal identities of an invention depicts a legal understanding that science is already inside patent law. From an internal legal perspective, the self-referential introduction of the new patent category may make practical sense; however it becomes problematic from a technological and scientific standpoint as the remit of the patent classification also affects other social contexts and practices.