3.3 Penerapan Doktrin Experimental Use dalam Hukum Paten di Beberapa
3.3.3 Jerman
A. Pengaturan dalam German Patents Act
Pengaturan mengenai experimental use berdasarkan Article 27 (b) CPC 1989, diatur dalam S 11 No. 2 of the Patentgesetz, yang menyatakan bahwa, “The rights conferred by a patent shall not extend to...acts cone for experimental purposes relating to the subject-matter of the patented invention.”294
B. Kasus-kasus yang Berkaitan dengan Doktrin Experimental Use
Keabsahan secara hukum dari uji klinis pada zat aktif interferon gamma dengan tujuan untuk indikasi lebih lanjut yang mungkin dianggap oleh Mahkamah Agung Jerman di Clinical Trials I. 295
Dalam kaitannya dengan arti dari “experiment” dan “subject-matter of the patented invention”, Mahkamah Agung Jerman menyatakan bahwa “An experiment in the sense relevant here is any (planned) procedure for obtaining any information, irrespective of the purpose which the information gained is intended to serve…”
Istilah ‘subject-matter of the patented invention’ dapat dipahami dalam hal tindakan eksperimental yang berkaitan dengan itu, berarti invensi adalah ajaran teknis yang diklaim, yang juga termasuk penggunaan substansi dari langkah inventif.296
Dari Mahkamah Agung menyatakan:
“…the wording of the Act when examined naturally rather indicates that
§ 11 No. 2 of the Patents Act in principle exempts all experimental acts as long as they serve to gain information and thus to carry out scientific
294 Joshua D. Sarnoff dan Henrik Holzapfel, A Cross-Atlantic Dialog on Experimental Use and Research Tools, De Paul University, August, 2007, hal. 27. Versi Bahasa Jerman dapat dilihat di http://www.gesetze-im-internet.de/patg/index.html Tersedia di http://works.bepress.com/joshua_sarnoff/1 diakses pada tanggal 1 Januari 2012 pada pukul 17.48
295 [1997] RPC 623 Lihat Patrick Van Eecke, dkk, Monitoring and Analysis of Technology, hal. 142
296 [1997] RPC 623., hal. 638
research into the subject-matter of the invention including its use. There are the included, for example, utilization acts for the experimental purposes undertaken with the subject-matter of the invention in order to discover the effects of a substance or possible new uses hitherto unknown. Since the provision makes no limit, either qualitative or quantitative, on the experimental acts, it cannot matter whether the experiments area used only to check the statements made in the patent or else to obtain further research result, and whether they are employed for wider purposes, such as commercial interests.”297
Dalam kasus Monsanto, Mahkamah Agung menyatakan:
“The wording of § 11 No. 2 of the Patents Act and the reasons given for the law are accordingly in favor of the assumption that clinical trials are exempted even when – as in this suit - the patented substance is used with the aim of finding whether and, where appropriate, with that administration form ad dosage interferon-gamma is able to cure or alleviate human diseases, in principle irrespective of whether, beyond the character of pure research, economic interests are also in the background, which can anyway be ruled out only rarely. The
“Touchdown” judgment [Monsanto]… should also be understood in this sense….
It is before appropriate to exempt clinical trials and investigations with active substances on humans as experimental acts according to § 11 No.
2 of the Patents Act as long as these experiments are directly aimed at obtaining information.”298
Dalam uji klinis II299, Mahkamah Agung Jerman kembali mengunjungi masalah doktrin experimental use dalam konteks uji klinis dengan specimen yang berisi rekombinan, Erythropoietin manusia dilakukan untuk mengkonfirmasi hasil tes hewan dan untuk menyediakan data yang diperlukan untuk persetujuan dari peraturan. Mengenai aktivitas komersial dan objek penelitian, Mahkamah Agung Jerman mencatat bahwa:
“According to this, the commercial orientation does not from the outset turn the experimental activity into an impermissible patent infringement.
Something else will then have to determine when it is no longer a matter
297 Ibid., hal. 639
298 [1997] RPC 623, hal. 642-643 Lihat Patrick Van Eecke, dkk, Monitoring and Analysis of Technology
299 Ibid., hal. 423
of further elucidation of the conditions, effects, applicability, and reducibility of the object of the invention, but of clarification of commercial facts such as the needs of the market, acceptance of prices, and possibilities of distribution. However, such a case is not given here.”300
Mahkamah Agung Jerman kemudian menyatakan:
“Therefore the wording of section 11 No. 2 of the Patent Act, the basis of the law, as well as the meaning and purpose of section 11 No. 2 of the Patent Act speaks for the fact that clinical research in which the digestibility and effective of a pharmaceutical contained in a protected active agent are tested in human beings is exempted even in the event that these tests were undertaken with the purpose of obtaining data necessary for the obtainment of legal pharmaceutical authorization. This does not in any way mean that research activities of any and every sort are exempted. Should the research have no relation whatsoever to technological theory or should the experiments be undertaken in such proportions as to no longer allow for justification on research grounds, then the activities are not considered to be permissible research activities within the meaning of section 11 No. 2 of the Patent Act. The same would be considered to be case if experiments are carried out with the purpose of persistently disturbing or hindering the inventor’s distribution of his product. In such cases the research does not serve the purpose of technological progress, rather it serves as a means for the accomplishment of the competitive purposes.”301
Mahkamah Agung telah menerima tahap I dan tahap II uji ke dalam pengecualian experimental use. Jadi, di Jerman, pengadilan telah mengambil pandangan liberal tentang pengecualian experimental use dan telah diterapkan untuk uji klinis dengan tujuan indikasi baru dan meninjau kembali peraturan. Hal ini dapat dikatakan suatu penafsiran yang lebih luas dari experimental use di Inggris dan tetap harus dilihat, apakah pada kasus yang tepat, pengadilan Inggris akan mengadopsi pendekatan liberal yang sama mneskipun ini tidak mungkin timbul dalam situasi yang sama seperti sekarang, bahwa Inggris dan Jerman telah menerapkan peninjauan kembali terhadap regulasi experimental use tersebut. 302
300 Ibid., hal. 433-434
301 [1998] RPC 436 Lihat Patrick Van Eecke, dkk, Monitoring and Analysis of Technology.
302 COOK analyses the German and UK case law and summarizes the positions together and not necessarily as conflicting: Lihat Cook, pp. 17-37
Namun, pendekatan yang diambil oleh Pengadilan Inggris dan Jerman ditandai dengan memperhatikan asal-usul mereka dalam ketentuan Konvensi Komunitas Paten dan untuk mengecualikan keputusan pengecualian experimental use yang sebelumnya sebagai bahan pertimbangan.303