74458 - Socioeconomics and Pharmaceutical Patent Law

Learning outcomes

The course deals with the socio-economic issues underlying the choices in the field of public pharmaceutical assistance as well as the national and international regulations on the protection of industrial property in the pharmaceutical field.

Course contents

SOCIO-ECONOMICS AND PHARMACEUTICAL PATENTS

Socio-Pharmaceutical Economics:

Notion of “pharmaceutical socio-economics” (The examples are recalled during the course) - Origins of the Welfare State - the Beveridge Report - Containment of public pharmaceutical expenditure on generic / equivalent medicines - The FDA Orange-Book (outline).

Patenting (general part):

Intellectual property - Intangible assets - Distinction between patent (industrial property) and copyright (copyright) - Other forms of intellectual property protection (outline) - Social function of the patent - Historical evolution of the patent system: the regionalization phase - Fundamental principles of the Paris Convention (1883) - Alternative to the patent - Commercial trademark (notes) - Italian legislation on patents: Industrial Property Code - Legislative Decree 10.2.2005, n. 30 and its Implementation Regulation D.M. 13.1.2010 N. 33 - Concept and structure of the patent - Patentability requirements of the invention - Exclusions and limits of patentability - Concept of unity of the invention - The patent application - Italian patent application - Assignment and licenses (negotiable and mandatory ) - Know-how of the invention - European Patent Convention (EPC - Munich Convention and subsequent amendments EPC 2000) - Submission of the patent application at the European Patent Office (EPO) - Examination of the application - Search Report - Method assessment of the patentability requirements - The problem solution approach - Claims - Issue of the European Patent - Opposition to the granting and revocation of the patent (the examples are recalled during the course of the course) - Problem of costs - European Patent with unitary effect upon entry in force, positive and negative aspects - Jurisdiction of the European Patent and the European Patent with Unitary effect - Patent Cooperation Treaty (facilit multiple filing: PCT system) - International Patent Classification (IPC) - Cooperative Patent Classification (CPC new patent classification system) - Patent law of the People's Republic of China (outline).

Patenting (special part):


The pharmaceutical and biotechnological patent:

Role of pharmaceutical innovation - Removal of the prohibition of patenting of medicines in Italy (socio-economic reasons) - Pharmaceutical patent: basic and selection, product, product and procedure together, synthetic intermediate, 2nd and further therapeutic uses, for different administration and / or dosage regimens - Protection conferred to the basic chemical patent - The essence of the invention - The case of Terfenadine and its metabolite MT - The case of Cimetidine - The Pfizer / Lilly / Sildenafil case Citrate and second therapeutic indication - The EBA decision G 2/08 - A case of pre-disclosure of the invention (EP 509752 / Merck & Co) - Overcoming the technical prejudice (the case of Alendronate) - Exhaustion of the so-called swiss claim form - Infringement and falsification of medicines - Cluster of patents - Examples of evergreening (Normix case) - WTO / Doha Declaration on Trips and Public Health Agreement - EC Regulation no. 816/2006 relating to the Trips Agreement on the granting of compulsory licenses for medicines to be exported to countries with public health problems - Trips-Plus multilateral agreements - Supplementary Protection Certificate of medicines in the Italian (CCP) and Community (SPC) legislation - Calculation of the CCP - Commercial value of the CCP equal to zero or negative in relation to the PIP (Pediatric Investigation Plan) - Data Exclusivity (data protection for AIC) - Market exclusivity (medicines for orphan diseases) - The galenic exception in 'Italian and European legal system - Concept of contributory infringement - Genetic engineering inventions - Limit between discovery and invention - Budapest Treaty on the international recognition of the deposit of microorganisms - Diamond case v. Chakrabarty - UPOV Convention and Community rights for plant varieties (hints) - Convention on biological diversity (hints) - Directive on the use of GMOs (hints) - Limits of the biotechnological patent - The Harvard onco-mouse case and its European / international jurisprudence in relation to the non-patentability of new animal varieties - Cross technical feasibility - Directive 98/44 / EEC on the legal protection of biotechnological inventions (in detail and in relation to the EPC Reg.) - The right of animals to be protected from unnecessary suffering - Privilege of the farmer (notes) - Law 78/2006 transposing Directive 98/44 / EEC - The problem of informed consent - Patentability of primate embryonic stem cells (The Warf / Technion / Brüstle cases) - The Patent attorney - Attribution of rights on inventions in universities - Academic spin-offs - Knowledge Transfer Office - EPO First to file System / USPTO First Invent to file System (Leahy-Smith America Invents Act Implementation) - USPTO Period of Grace - The problem of scientific publication delays caused by patenting - The figure of the patent expert in the pharmaceutical company.

Readings/Bibliography

A. Vanzetti - Industrial Property Code - Giuffré Editore -
L.C. Ubertazzi - Brief Commentary on Intellectual Property and Competition Laws - Ed. Cedam -

Teaching methods

1. lectures + PC classroom exercises 

Assessment methods

The final exam consists of an oral test that can begin with a presentation in pptx that illustrates in a new and in-depth way, a detail related to a certain theme chosen by the student among those indicated in the program.
The exam aims to evaluate the achievement of the following didactic objectives:
- knowledge of the fundamental aspects relating to the European and international legislation on industrial property;
- knowledge of the patentability dynamics of medicines, supported by national and European jurisprudence in particular;
- ability to search in databases of patents and patent applications;
- learning the concepts that allow you to design, within the pharmaceutical company, medium and long-term strategies relating to the management of the so-called The company's "patent portfolio";
- ability to evaluate problems relating to the introduction on the market of generic / equivalent medicines at the time of the expiry of the reference patent.
In particular, the following are assessed: the interest shown in the subject, the ability to link the various topics as well as the socio-economic aspects connected to them and the ability to recognize and apply practical solutions to the hypotheses formulated during the exam questions.

Office hours

See the website of Patrizia Rampinelli