Information sheet ECTS Syllabus
Course syllabus N414R0_4B - Registrácia liečiv a patentová ochrana (FCFT - WS 2019/2020)
Slovak University of Technology in Bratislava
Course unit code:
|Course unit title:|
Registrácia liečiv a patentová ochrana
|Mode of delivery, planned learning activities and teaching methods:|
|Recommended semester/trimester:||-- item not defined --|
|Level of study:|
|Prerequisites for registration:||none|
oral exam with written part
Learning outcomes of the course unit:
The subject provides concise insight into drug registration process according to european and slovak legislation. The student will be trained to work with registered drug databases and European Pharmacopoeia. He will be informed coarsely about intelectual protection law in EU, the role of WIPO, using patent databases for searching of original patent documents. He will be trained to understand patent claims, examples and description. He will distinct between different patent types related to a commercial drug, starting from protection of a Markush structure, drug target and biological assay, through protection of drug formulation and administration to process patent, logo and trademark protection. Apart from using patent databases, an additional information on alternative patend resources will be provided (using chemical databases and internet search engines for retrieving patent contents).
1. Drug registration. (lectures: 6, seminars: 0)
a) Current legislation for a drug registration, involved institutions: slovak legislation resulting from "Zákon o
liekoch a zdravotníckych pomôckach"; EP ans ES regulation No. 726/2004 and its contents; FDA, ŠÚKL, EMA: mutual competences and interactions.
b) Process of a brand name drug registration: role of FDA in international BND registration;
IND, NDA review; NDA review workflow and methods used in the review process; drug master
file, its contents and application.
c) Process of a generic drug registration: ANDA review and its contents; solid phase polymorphism vs drug quality; methods of making and characterization of SP polymorphs;
case studies from preclinical and clinical testing.
2. Patent law and IP protection (lectures: 18, seminars: 0)
a) Intelectuaql property protection: IP and right to protect it in favor of its owner;
types of protection of an industrial invention; generic patent, supplementary protection certificate, utility model. Patent offices in SR and worldwide, international patent law.
b) patent databases: Espacenet, USPO, Google patents
c) Key parts of a generic patent, their content and relative importance: header, descripption, claims, examples. Analysis of given patent claims. Markush structure and its analysis.
d) Patent law and commercial competition. Patent infringement. Circumvencing of a patent protection, how to do it legally? Related case studies.
|Recommended or required reading:|
|Language of instruction:|
slovak or english
Assessed students in total: 0
|Name of lecturer(s):|
doc. Ing. Dušan Berkeš, CSc. (person responsible for course)
13. 5. 2020
doc. Ing. Dušan Berkeš, CSc. and programme supervisor
Last modification made by Samuel Hraško on 05/13/2020.