Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PATENT of MEDICINE | - | Spring Semester | 3+0 | 3 | 7 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | Third Cycle (Doctorate Degree) |
| Course Type | Elective |
| Course Coordinator | Assist.Prof. Ayşegül SEZGİN HUYSAL |
| Name of Lecturer(s) | Assist.Prof. Ayşegül SEZGİN HUYSAL |
| Assistant(s) | |
| Aim | When the historical development of patent legislation is analyzed, it is seen that pharmaceutical patents differently recognized in the legislation of various countries, including Turkey. The aim of the course is to examine the concept of "medicine", which is the main element of the pharmaceutical patent, the importance of the pharmaceutical patent, its historical development and the relationship of the pharmaceutical patent with other intellectual property rights, as regulated in international conventions and legislation of various countries including Turkey. |
| Course Content | This course contains; Definition of Pharmaceuticals,Intellectual Property Law and Pharmaceuticals. ,Pharmaceutical Patents from a Public Health and Economic Perspective,The Importance of Patentability Conditions for Pharmaceutical Patents,Conditions for Patentability (Novelty) ,Conditions of Patentability (Inventive Step) ,Protection Provided by Patent Rights,Scope of Protection Provided by Patent Rights,Scope of the Right Arising from Patent (In General), Determination of the Scope of the Right,Duration of Patent Rights and Certificate of Additional Protection ,Infringement of Patent Right (Direct and Indirect Infringement), Infringing Acts Exhaustion of Patent Right,Patent Infringement Cases: Negative Declaration Cases Regarding the Non-Existence of Patent Infringement Patent Invalidation Cases,Parallel Imports,Compulsory License. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. Interprets the differences between pharmaceuticals and similar products. | 10, 16, 9 | A |
| 1.1. Defines the concept of medicine. | 16, 9 | A |
| 1.2. Evaluates the place of medicine in Intellectual Property Law. | 10, 9 | A |
| 2. Describe the distinctive aspects of pharmaceutical patents. | 12, 16, 9 | |
| 3. Apply the legislation in the field of pharmaceutical patents to concrete practical problems. | 10, 12, 16, 9 | A |
| 3.1. Analyzes the patenting procedure, the scope of the patent right, and the limitations imposed on it. | 16, 19, 9 | A |
| 3.2. List the conditions for granting a pharmaceutical patent. | 16, 9 | A |
| 3.3. Indicates the Importance and Characteristics of the Inventive Step Criterion in terms of Drug Patents. | 19, 9 | A |
| 4. Provides solutions to problems related to the Duration of Patent Rights and Additional Protection Certificate. | 10, 9 | A |
| 4.1. Comments on the Effect of Compulsory License in Turkish Law in terms of Pharmaceutical Patents. | 16, 19, 9 | A |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 16: Question - Answer Technique, 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Definition of Pharmaceuticals | Sezgin Huysal, İlaç Patenti, s. 6 -25. |
| 2 | Intellectual Property Law and Pharmaceuticals. | Sezgin Huysal, İlaç Patenti, s. 25-40. |
| 3 | Pharmaceutical Patents from a Public Health and Economic Perspective | Sezgin Huysal, İlaç Patenti, s. 57-79. |
| 4 | The Importance of Patentability Conditions for Pharmaceutical Patents | Sezgin Huysal, İlaç Patenti, s. 70-73. |
| 5 | Conditions for Patentability (Novelty) | Sezgin Huysal, İlaç Patenti, s. 73-97. |
| 6 | Conditions of Patentability (Inventive Step) | Sezgin Huysal, İlaç Patenti, s. 97-125. |
| 7 | Protection Provided by Patent Rights | Sezgin Huysal, İlaç Patenti, s. 139-162. |
| 8 | Scope of Protection Provided by Patent Rights | Sezgin Huysal, İlaç Patenti, s. 139-150. |
| 9 | Scope of the Right Arising from Patent (In General), Determination of the Scope of the Right | Sezgin Huysal, İlaç Patenti, s. 151-158. |
| 10 | Duration of Patent Rights and Certificate of Additional Protection | Sezgin Huysal, İlaç Patenti, s. 161-169. |
| 11 | Infringement of Patent Right (Direct and Indirect Infringement), Infringing Acts Exhaustion of Patent Right | Sezgin Huysal, İlaç Patenti, s. 144-160. |
| 12 | Patent Infringement Cases: Negative Declaration Cases Regarding the Non-Existence of Patent Infringement Patent Invalidation Cases | No preliminary preparation is required. |
| 13 | Parallel Imports | Sezgin Huysal, İlaç Patenti, s. 183-200. |
| 14 | Compulsory License | Sezgin Huysal, İlaç Patenti, s. 213- 230. |
| Resources |
| No reference will be given. |
| Ayşegül Sezgin Huysal, İlaç Patenti, Vedat Kitapçılık. |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PY1) In light of the current developments in the field of health law, develop and deepen the knowledge about the main sources, legislation and jurisprudence which related to the health law. | X | |||||
| 2 | PY2) With understanding relationships among concept, institution and method that related to disciplines of health law, come up with original solutions by using knowledge requiring proficiency on analysis, synthesis and assessment of new and complex ideas | ||||||
| 3 | PY3) Evaluate and use new information within the health law in a systematic approach | X | |||||
| 4 | PY4) Evaluate innovative aproach an already known knowledge about health law or research and implement an original subject. | X | |||||
| 5 | PY5) Solve the problems encountered in the legal theory and practice by using research methods that specific to field of law. | X | |||||
| 6 | PY6) Evaluate innovative aproach an already known knowledge about public law or carry out an independent study which needs expertise in the field of health law and its sub-disciplines. | X | |||||
| 7 | PY7) Develop different perspectives and take responsibility to solve complex issues which require expertise and encountered in the field of health law and its sub-disciplines. | X | |||||
| 8 | PY8) Develop new ideas and methods in the field of health law by using high level mental processes such as creative and critical thinking, problem solving and decision making. | X | |||||
| 9 | PY9) Defend original views when exchanging ideas in the field of health law and itssub-disciplines with professionals and communicate effectively by showing competence in the field. | ||||||
| 10 | PY10)Ability to communicate and discuss orally, in written and visually with peers by using a foreign language at least at a level of European Language Portfolio C1 General Level. | ||||||
| 11 | PY11) Demonstrate functional interaction by using strategic decision making processes in solving problems encountered in the field of law. | X | |||||
| 12 | PY12) With developing understanding of honesty, justice and ethics are required to be lawyer, teach around them. | X | |||||
| 13 | PY13)Contribute to the solution finding process regarding social, scientific, cultural and ethical problems in the field of law and support the development of these values. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 50 | |
| Rate of Final Exam to Success | 50 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 14 | 3 | 42 | |||
| Guided Problem Solving | 6 | 6 | 36 | |||
| Resolution of Homework Problems and Submission as a Report | 4 | 10 | 40 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 4 | 10 | 40 | |||
| General Exam | 4 | 10 | 40 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 198 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(198/30) | 7 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PATENT of MEDICINE | - | Spring Semester | 3+0 | 3 | 7 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | Third Cycle (Doctorate Degree) |
| Course Type | Elective |
| Course Coordinator | Assist.Prof. Ayşegül SEZGİN HUYSAL |
| Name of Lecturer(s) | Assist.Prof. Ayşegül SEZGİN HUYSAL |
| Assistant(s) | |
| Aim | When the historical development of patent legislation is analyzed, it is seen that pharmaceutical patents differently recognized in the legislation of various countries, including Turkey. The aim of the course is to examine the concept of "medicine", which is the main element of the pharmaceutical patent, the importance of the pharmaceutical patent, its historical development and the relationship of the pharmaceutical patent with other intellectual property rights, as regulated in international conventions and legislation of various countries including Turkey. |
| Course Content | This course contains; Definition of Pharmaceuticals,Intellectual Property Law and Pharmaceuticals. ,Pharmaceutical Patents from a Public Health and Economic Perspective,The Importance of Patentability Conditions for Pharmaceutical Patents,Conditions for Patentability (Novelty) ,Conditions of Patentability (Inventive Step) ,Protection Provided by Patent Rights,Scope of Protection Provided by Patent Rights,Scope of the Right Arising from Patent (In General), Determination of the Scope of the Right,Duration of Patent Rights and Certificate of Additional Protection ,Infringement of Patent Right (Direct and Indirect Infringement), Infringing Acts Exhaustion of Patent Right,Patent Infringement Cases: Negative Declaration Cases Regarding the Non-Existence of Patent Infringement Patent Invalidation Cases,Parallel Imports,Compulsory License. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. Interprets the differences between pharmaceuticals and similar products. | 10, 16, 9 | A |
| 1.1. Defines the concept of medicine. | 16, 9 | A |
| 1.2. Evaluates the place of medicine in Intellectual Property Law. | 10, 9 | A |
| 2. Describe the distinctive aspects of pharmaceutical patents. | 12, 16, 9 | |
| 3. Apply the legislation in the field of pharmaceutical patents to concrete practical problems. | 10, 12, 16, 9 | A |
| 3.1. Analyzes the patenting procedure, the scope of the patent right, and the limitations imposed on it. | 16, 19, 9 | A |
| 3.2. List the conditions for granting a pharmaceutical patent. | 16, 9 | A |
| 3.3. Indicates the Importance and Characteristics of the Inventive Step Criterion in terms of Drug Patents. | 19, 9 | A |
| 4. Provides solutions to problems related to the Duration of Patent Rights and Additional Protection Certificate. | 10, 9 | A |
| 4.1. Comments on the Effect of Compulsory License in Turkish Law in terms of Pharmaceutical Patents. | 16, 19, 9 | A |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 16: Question - Answer Technique, 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Definition of Pharmaceuticals | Sezgin Huysal, İlaç Patenti, s. 6 -25. |
| 2 | Intellectual Property Law and Pharmaceuticals. | Sezgin Huysal, İlaç Patenti, s. 25-40. |
| 3 | Pharmaceutical Patents from a Public Health and Economic Perspective | Sezgin Huysal, İlaç Patenti, s. 57-79. |
| 4 | The Importance of Patentability Conditions for Pharmaceutical Patents | Sezgin Huysal, İlaç Patenti, s. 70-73. |
| 5 | Conditions for Patentability (Novelty) | Sezgin Huysal, İlaç Patenti, s. 73-97. |
| 6 | Conditions of Patentability (Inventive Step) | Sezgin Huysal, İlaç Patenti, s. 97-125. |
| 7 | Protection Provided by Patent Rights | Sezgin Huysal, İlaç Patenti, s. 139-162. |
| 8 | Scope of Protection Provided by Patent Rights | Sezgin Huysal, İlaç Patenti, s. 139-150. |
| 9 | Scope of the Right Arising from Patent (In General), Determination of the Scope of the Right | Sezgin Huysal, İlaç Patenti, s. 151-158. |
| 10 | Duration of Patent Rights and Certificate of Additional Protection | Sezgin Huysal, İlaç Patenti, s. 161-169. |
| 11 | Infringement of Patent Right (Direct and Indirect Infringement), Infringing Acts Exhaustion of Patent Right | Sezgin Huysal, İlaç Patenti, s. 144-160. |
| 12 | Patent Infringement Cases: Negative Declaration Cases Regarding the Non-Existence of Patent Infringement Patent Invalidation Cases | No preliminary preparation is required. |
| 13 | Parallel Imports | Sezgin Huysal, İlaç Patenti, s. 183-200. |
| 14 | Compulsory License | Sezgin Huysal, İlaç Patenti, s. 213- 230. |
| Resources |
| No reference will be given. |
| Ayşegül Sezgin Huysal, İlaç Patenti, Vedat Kitapçılık. |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PY1) In light of the current developments in the field of health law, develop and deepen the knowledge about the main sources, legislation and jurisprudence which related to the health law. | X | |||||
| 2 | PY2) With understanding relationships among concept, institution and method that related to disciplines of health law, come up with original solutions by using knowledge requiring proficiency on analysis, synthesis and assessment of new and complex ideas | ||||||
| 3 | PY3) Evaluate and use new information within the health law in a systematic approach | X | |||||
| 4 | PY4) Evaluate innovative aproach an already known knowledge about health law or research and implement an original subject. | X | |||||
| 5 | PY5) Solve the problems encountered in the legal theory and practice by using research methods that specific to field of law. | X | |||||
| 6 | PY6) Evaluate innovative aproach an already known knowledge about public law or carry out an independent study which needs expertise in the field of health law and its sub-disciplines. | X | |||||
| 7 | PY7) Develop different perspectives and take responsibility to solve complex issues which require expertise and encountered in the field of health law and its sub-disciplines. | X | |||||
| 8 | PY8) Develop new ideas and methods in the field of health law by using high level mental processes such as creative and critical thinking, problem solving and decision making. | X | |||||
| 9 | PY9) Defend original views when exchanging ideas in the field of health law and itssub-disciplines with professionals and communicate effectively by showing competence in the field. | ||||||
| 10 | PY10)Ability to communicate and discuss orally, in written and visually with peers by using a foreign language at least at a level of European Language Portfolio C1 General Level. | ||||||
| 11 | PY11) Demonstrate functional interaction by using strategic decision making processes in solving problems encountered in the field of law. | X | |||||
| 12 | PY12) With developing understanding of honesty, justice and ethics are required to be lawyer, teach around them. | X | |||||
| 13 | PY13)Contribute to the solution finding process regarding social, scientific, cultural and ethical problems in the field of law and support the development of these values. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 50 | |
| Rate of Final Exam to Success | 50 | |
| Total | 100 | |