Abstract

A patent can be defined as an exclusive right that is granted to the patent owner, which allows him to prevent others from making, selling, importing or using the invention, without license or authorization for a period of 20 years. This right is given in return for the disclosure of technical information about the patent. This disclosure of information is said to be one of the most important benefits given to the society by patents, since it enables further research and development (R&D) in the field for which it is granted. In the pharmaceutical industry, patents play a significant role in the R&D process as they encourage inventors to develop new medicines. Pharmaceutical patents are different from other kinds of patents since they need more time to be developed and granted protection. Thus, if not protected properly, numerous forms of patent infringement can occur, such as, counterfeit, illegal copying etc. This is one of the reasons why pharmaceutical companies are constantly trying to further expand patent protection. However reasonable this may seem from the perspective of the companies and inventors, the legislators should also bear in mind the need of the society as a whole. Pharmaceutical patents have been in the centre of attention in the international forum for a long time, most notably in relation to the proliferation of patent protection and its impact on human rights and public health. One of the main concerns is access to essential medicines in developing countries, or the lack thereof. The largest barrier to access to essential medicines is their price, which is inflated by patents. The TRIPS Agreement provides flexibilities in patent protection to developing countries, which are very valuable in pursuing access to medicines for all, and the least developed countries had the ten year period of delayed implementation. The Doha Declaration on TRIPS and Public Health and consequent decisions tried to improve the position of the developing countries, but the States are still unwilling to support the amendment of the TRIPS, notwithstanding these documents. Until a balance is reached between the interests of pharmaceutical companies and the need of developing countries for essential medicine, the conflict between the human right to health and access to essential medicines and pharmaceutical patents will continue to exist.

Highlights

  • Farmaceutskoj industriji neophodna je jaka patentna zaštita, pošto su troškovi za research and development (R&D) u proizvodnji lekova visoki, te jedino na ovaj način mogu da se podstaknu pronalazači da razvijaju nove lekove od kojih čitavo društvo ima koristi.[24]

  • A patent can be defined as an exclusive right that is granted to the patent owner, which allows him to prevent others from making, selling, importing or using the invention, without licence or authorization for a period of 20 years. This right is given in return for the disclosure of technical information about the patent. This disclosure of information is said to be one of the most important benefits given to the society by patents, since it enables further research and development (R&D) in the field for which it is granted

  • Patents play a significant role in the R&D process as they encourage inventors to develop new medicines

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Summary

OPŠTE KARAKTERISTIKE I USLOVI PATENTIBILNOSTI

S obzirom na predmet patentne zaštite, patenti se mogu podeliti u tri grupe: proizvodni patenti (patenti koji štite sam proizvod), patenti za. Ovaj element je veoma važan za generičku industriju lekova, pošto otkrivanje neophodnih informacija o patentiranim lekovima omogućava generičkoj industriji da reprodukuje određeni farmaceutski proizvod pod prinudnom licencom ili nakon što patentna zaštita istekne, i na taj način ponudi konkurentan i pristupačniji lek, s istim dejstvima. Profesor Hestermajer (Hestermeyer) tvrdi da je ovaj uslov jedan od osnovnih principa patentnog prava, jer patenti mogu da ispune svoju društvenu svrhu samo ako zemlje članice obezbede da otkrivanje informacija o patentu zaista daje mogućnost njihovog reprodukovanja, odnosno ukoliko ne odobravaju patentnu zaštitu pronalasku kada te informacije nisu dovoljno jasne i potpuno otkrivene.[9]. Sporazumu u skladu sa svojim nacionalnim prioritetima.[10] Način na koji se ovi kriterijumi definišu je relevantan za ostvarivanje prava na zdravlje i pristup lekovima „s obzirom na suštinske posledice koje patenti mogu imati na konkurenciju i, samim tim, na cene lekova”[11]

Novost
Inventivni nivo
Industrijska primenljivost
POSEBNE KARAKTERISTIKE FARMACEUTSKIH PATENATA
Zaštita ekskluzivnosti podataka
Dodatna zaštita patentiranih farmaceutskih proizvoda
Prinudne licence
40 Competition
SUMMARY
Full Text
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