Farmacijos pramonei yra taikomi vieni iš griežčiausių reikalavimų. Dėl šių reikalavimų labai sutrumpėja patento suteikiamos apsaugos trukmė produktui. Siekiant kompensuoti tokią sutrumpėjusią apsaugos trukmę, įvairiose valstybėse numatyta galimybė pratęsti patento, išduoto medicinos produktams, galiojimo laiką. Europos Sąjungoje patentų teisė nėra suderinta, tačiau suteikiant papildomą apsaugą medicinos produktams, yra priimtas vieningas sprendimas. Šis sprendimas – tai galimybė medicinos produktams išduoti papildomą apsaugos liudijimą. Bendrijoje nėra vienos kompetentingos institucijos, kuri išduotų tokį liudijimą. Jis yra išduodamas kiekvienoje valstybėje narėje tam tikros kompetentingos institucijos. Išduodant tokius liudijimus skirtingose valstybėse dažnai iškyla tam tikrų klausimų. Todėl darbe aptariamos papildomų apsaugos liudijimų medicinos produktams išdavimo problemos. Tyrimo tikslas – identifikuoti ir išanalizuoti papildomų apsaugos liudijimų medicinos produktams išdavimo probleminius aspektus. Analizuojant teismų praktiką bei specialiąją literatūrą apžvelgiami įvairūs probleminiai aspektai susiję su PAL išdavimu. Išvadose apibendrinama, jog PAL išdavimo medicinos produktams pagrindiniai probleminiai aspektai yra: a) susiję su Reglamente Nr. 469/2009 įtvirtintos sąvokos „produktas“ aiškinimu, b) susiję su minėtame Reglamente įtvirtintomis sąlygomis reikalingomis gauti PAL medicinos produktams, c) dėl „neigiamo“ galiojimo PAL išdavimo galimybės ir PAL galiojimo... [toliau žr. visą tekstą] / The pharmaceutical industry is subject to one of the most stringent requirements. Because of these requirements the duration of a product patent protection is much shorter. In order to compensate such reduced duration of protection different countries provide for a possibility to extend the period of a patent issued to medicinal products. The EU patent law is not consistent; however a unanimous decision has been adopted as to granting of extra protection to medicinal products. This solution is to issue a supplementary protection certificate with respect to medicinal products. There is no single competent authority in the Community, which is responsible for the issuance of such certificate. The relevant competent authority of each Member State issues a certificate. Often many questions arise in the course of issuance of such certificates in different countries. The paper discusses the problems concerning the issuance of supplementary protection certificates for medicinal products. The aim of the research is to identify and analyze problematic aspects of the issuance of supplementary protection certificates for medicinal products. The analysis of case law and special literature deals with various problematic aspects related to the issuance of SPC. The conclusions summarize the principle problematic aspects of the issuance of SPC for medicinal products, which are related with the following: a) Interpretation of the term "product" provided for in Regulation No. 469/2009; b)... [to full text]

Resume - Supplementary Protection Certificates for Medicinal Products Nowadays, the pharmaceutical industry plays an important role in the world's economy and the pharmaceutical research has a decisive impact on the continuing improvement in public health. The system of patent law is of cardinal significance to the industry because it confers monopolies, for a limited period of time, on using innovations and provides a crucial incentive for basic research activities. Innovative companies require the guaranteed period of market exclusivity afforded by patents in order to sustain drug prices, recoup research and development expenditures and finance the development of new products. Although the availability of a patent protection for chemical and pharmaceutical products has, from a historical perspective, only been reaffirmed in the near past, it has been widely accepted as a global standard mainly through the provisions of the WTO's TRIPS agreement. On the other hand, despite the existence of various international treaties harmonising patent laws, patents have to date in their effects remained strictly limited to individual jurisdictions. Closely bound to the patent system itself are the means of the so-called off-patent protection - supplementary protection certificates and the others, for example market...

1 Current Issues of Supplementary Protection Certificates for Medicinal Products in the Case Law of the European Court of Justice Abstract Supplementary protection certificates (SPCs) are a sui generis industrial property right. Under the conditions, which are explained in more detail in this thesis, they can be obtained for the active ingridients of certain products. The type of products eligible for SPC protection are, inter alia, medicinal products which are characterized by their social importance and therefore by the need to ensure their safety, efficacy and quality. Given that the process of providing these guarantees is both costly and time consuming and that the commercialization of the product is conditional on such guarantees, the period for which medicinal products can benefit from patent protection is therefore shortened. The aim of the SPCs is to compensate for this shortening by an additional period of protection in order to incentivise research that has a positive effect on human health and quality of life. This work analyzes the evolution of the case law of the Court of Justice with regard to an interpretative shift or clarification, in particular as regards the substantive conditions for obtaining a certificate and provisions pertaining to the term of the SPC as laid down in the SPC...

<p>Detta arbete handlar om med vilka material som det ballistiska skyddet mot finkalibriga projektiler kan förbättras på befintliga svenska ytstridsfartyg. Eftersom det befintliga fartygets konstruktion i sig innehar en viss skyddsförmåga (grundskydd) behöver denna inledningsvis beskrivas för att definiera utgångspunkt.</p><p>Att förbättra skyddsförmågan genom att komplettera den redan befintliga konstruktionen med tilläggsskydd innebär att fartyg får helt förändrade förutsättningar att klara av nya hot och uppgifter och därmed också få en förbättrad livslängd.</p><p>Genom att studera för- och nackdelar hos olika tekniska lösningar framkommer vilka som är realistiska.</p><p>Fartyg kommer sannolikt att utrustas med olika material eftersom ytor- och utrymmen kommer att behöva prioriteras. Olika materialval kommer också att styras av kompromisser mellan ballistiskt skydd och lastbärande konstruktioner.</p> / <p>This paper investigates which technical solutions can improve ballistic protection against small arm projectiles onboard Swedish naval surface warships.</p><p>Since the construction of the ship itself has a basic protection against projectiles, this will be described first.</p><p>By improving the protection capability with extra protection (supplementary protection), the ship can successfully handle several new threats that come with new tasks while also improving its length of life.</p><p>A study of advantages and disadvantages of different technical solutions will show which solutions are realistic ones.</p><p>The ship will probably be equipped with different kind of materials because of the need of prioritized areas and surfaces onboard. Different materials will be a compromise between the ballistic protection ability and construction strength.</p> / ChpT 08-10

Detta arbete handlar om med vilka material som det ballistiska skyddet mot finkalibriga projektiler kan förbättras på befintliga svenska ytstridsfartyg. Eftersom det befintliga fartygets konstruktion i sig innehar en viss skyddsförmåga (grundskydd) behöver denna inledningsvis beskrivas för att definiera utgångspunkt. Att förbättra skyddsförmågan genom att komplettera den redan befintliga konstruktionen med tilläggsskydd innebär att fartyg får helt förändrade förutsättningar att klara av nya hot och uppgifter och därmed också få en förbättrad livslängd. Genom att studera för- och nackdelar hos olika tekniska lösningar framkommer vilka som är realistiska. Fartyg kommer sannolikt att utrustas med olika material eftersom ytor- och utrymmen kommer att behöva prioriteras. Olika materialval kommer också att styras av kompromisser mellan ballistiskt skydd och lastbärande konstruktioner. / This paper investigates which technical solutions can improve ballistic protection against small arm projectiles onboard Swedish naval surface warships. Since the construction of the ship itself has a basic protection against projectiles, this will be described first. By improving the protection capability with extra protection (supplementary protection), the ship can successfully handle several new threats that come with new tasks while also improving its length of life. A study of advantages and disadvantages of different technical solutions will show which solutions are realistic ones. The ship will probably be equipped with different kind of materials because of the need of prioritized areas and surfaces onboard. Different materials will be a compromise between the ballistic protection ability and construction strength. / ChpT 08-10