| Abstrakt: |
Pharmaceutical inventions may be defined as inventions that have effect on humans for medical purposes, whether they prevent or heal diseases or for other purposes. The patent as a subjective right can belong to a person or a legal authority, to a territory and for a certain time, and the holder of the patent rights have an exclusive right to the protected invention, to use and exploit the material and moral values for the duration of the patent protection. The Intellectual property Law recognizes the granting of patents for inventions of drugs, in terms of Article 27(1) of the TRIPS. When the patent for an invention of a drug is granted, its holder is authorized to undertake certain exclusive entitlements and to claim such exclusivity relating to third parties (Article 28 of the TRIPS). A patent is a recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. These legal rights confer an exclusive right to the inventor or his assignee to fully utilize his invention for a given period of time. It is very well settled that IPRs play a vital role in the modern economy. IPR is a strong tool established to protect investments in time, money and effort invested by the drug inventor since it grants the inventor an exclusive right to use his invention/creation for a certain period of time. Thus IPRs, in this way aid the economic development of a country by promoting healthy competition and by encouraging industrial development and economic growth. The protection of inventions with patents in the pharmaceutical industry has a specific role in the development of society and represents one of the drivers in economic development. The investments in research and development of a novel chemical or biologic medicine are encouraged and awarded by granting a patent, which is associated with building a reliable and efficient system regarding innovation and research incentives. Biological products are complex molecules, produced by living cells, that are naturally produced in the human body, or monoclonal antibodies, but also blood products, immunological medicinal products, sera and vaccines, allergens, and advanced technology products such as gene and cell therapy products. Copies of these products, known as biosimilars are not identical, so specific regulatory issues are required for licencing and for placing them in the market. The licensing of biosimilars is usually based on a very robust registration process, to demonstrate efficacy and safety profile and to ensure that the biosimilar is highly similar to the original biological product. Biosimilars can be placed in the market only after IPRs and other exclusivities of the original biological product are no longer valid. It is very important for biosimilar developers to fully understand the patent terms and their longevity, to avoid any patent disputes and patent litigation. [ABSTRACT FROM AUTHOR] |
