Universitat Internacional de Catalunya
Strategies for the Protection of Intellectual Property
Other languages of instruction: Catalan, English
Teaching staff
Questions will be resolved before or after class. Any questions from online students will be answered by videoconference.
Professors:
Montserrat Jané
Mónica López
Bernabé Zea
Introduction
This course is aimed at showing the key aspects of the intellectual capital protection strategy at (bio)companies. The course presents what the intellectual capital of a company is, and the different formulas to protect it. Throughout the course, the legal mechanisms are explained, as well as how to use them to create a solid strategy for the protection of intellectual property. Competitive surveillance and its strategies are also exposed. Finally, intellectual property transfer issues are covered.
Pre-course requirements
The Entrepreneurship and Innovation subject.
Objectives
- To know what the intellectual capital of a company is and what it involves.
- To understand the mechanisms to protect intellectual property.
- To know how to create optimal strategies for the protection of intellectual property.
- To understand competitive surveillance strategies.
- To understand the basic concepts of technology transfer.
Competences/Learning outcomes of the degree programme
CB5: That students have developed those learning skills necessary to undertake further studies with a high degree of autonomy.
CG11: Recognizing basic concepts from different fields related to biomedical sciences.
CE19: Recognizing the principles of biomedical sciences related to health and learn to work in any field of Biomedical Sciences (biomedical company, bioinformatics laboratories, research laboratories, clinical analysis company, etc.
Learning outcomes of the subject
At the end of the course, the student will:
- Understand the operation of intellectual property in the biomedical company and the professional opportunities of the environment.
- Understand intellectual property protection strategies, understand the different protection mechanisms, and know in which cases each instrument should be used.
- Have seen cases of conflict related to intellectual property disputes.
- Understand competitive surveillance strategies.
- Be familiar with technology transfer processes.
Syllabus
Introduction to intellectual-industrial property (BZ). Function and justification of the patent system. Operation of the patent system in the biomedical sector. Protection modalities: copyright, trademarks, geographical indications, designs and patents. The industrial secret as an alternative to patents. Complementary protection certificates.
Main concepts related to patents (BZ). What is a patent. Example. What can be patented. Examples of inventions. The negative right conferred by patents. Introduction to patent infringement. Patent Unit. What to keep as a trade secret. How to determine inventors and patent holders. Rights that correspond to them.
Patentability requirements (BZ). Industrial applicability. Exceptions to patentability. What is the state of the art. The requirements of novelty and inventive step. How to use the problem-solution approach to determine the inventive step.
Utility models (BZ). Particularities of utility models. Exceptions to protection through utility models.
Protection in different territories (BZ). Strategy according to the nature of the applicant: universities, public research centers, small companies dedicated to research, large companies with research centers and generic companies. Right of priority. The concept of patent families. Procedures for processing protection abroad: national, European patent and international application (PCT). Validation of European patents: changes due to the London Agreement. Costs associated with patent protection: drafting of the application, processing fees (application, search report, concession), response to official actions, translation, maintenance fees. Processing fees. Summary of the US procedure. Preparation to pass an IP due diligence (audit that will be carried out by third parties at the time they are interested in purchasing or participating in the holder's IP assets).
Patent Infringement (BZ). Rights granted and acts prohibited. Scope of protection of claims (independent and dependent). Rule of the simultaneity of all elements. Element-by-element analysis. Doctrine of equivalents. Direct infringement and indirect infringement (by contribution or by induction). Judicial actions. Reversal of the burden of proof. Fact-checking proceedings. Precautionary measures. Consequences of the infraction. Nullity of patents.
Patent searches (MJ). What is the information for? Free and commercial databases. Search tools. Types of searches. Practical cases. Thematic searches, by chemical structure, by patent number, by holder/applicant. Location of the registration status of patent documents. Identification of patent families and location of complete patent documents and their processing files. Obtaining automatic translations. Calculation of expiration dates of US patents. Orange Book. Searches for complementary protection certificates and pediatric extensions.
Patent Drafting (MJ). Preparation of the parts of the patent document. Evaluation of the starting information and experimental support. Define the scope of patent protection. unit of invention Approach to the state of the art and choice of the technical problem to be solved. Description of the invention to comply with the sufficiency of the description requirement. Aspects of the invention protectable. Particular realizations and examples. Category of claims. Drafting of independent and dependent claims. Form of claims. Clarity of claims. Number of claims. Drafting taking into account the peculiarities of different patent offices. Practical exercise of drafting a patent application.
European patent with unitary effect (EP-UE) and the Unified Patent Court (UPC) (MJ). The current system versus the future European patent with unitary effects (EP-UE). What the unit effect means in practice. How to obtain a patent with unitary effect. The new regime of translations. Temporary provisions and compensation regime. Costs of a EP-UE compared to the classic European patent. The agreement on the Unified Patent Court. Member States and entry into force. Structure and composition of the UPC. The judges of the UPC. Types of actions before the UPC. UPC costs. Patent strategy before the new system.
Matter subject to protection in Europe and the US in the biomedicine (ML) sector. Legal framework in both territories. Examples. Protection of inventions based on nucleic acid, peptide and protein sequences. Sequence listing. Definitions. Protection of inventions based on biological matter (microorganisms, cell lines, viruses, etc.). Introduction to the Budapest Treaty. protection of inventions based on biomarkers. Practical aspects to consider when drafting biomedical patents.
Complementary Protection Certificates (BZ). Basic knowledge about CCPs. Manufacturing waiver.
Data exclusivity. Bolar Arrangement (BZ). Protection that confers data exclusivity. Bolar arrangement and experimental exception.
Specific biomedical (ML) searches. Specific approaches in this sector. Sequence searches using various free access databases.
Teaching and learning activities
In person
Lectures: 50-minute presentation of a theoretical topic by the lecturer.
Case methods (CM): Approach to a real or imaginary situation. Students work on the questions formulated in small groups or in active interaction with the lecturer and the answers are discussed. The lecturer intervenes actively and, if necessary, contributes new knowledge.
The practical cases will include at least one case of conflict between companies over intellectual property issues and another case of optimal strategy for the protection of intellectual property.
A practical exercise will be carried out in groups of two or three students to analyse a patent and give a presentation on it. Additionally, a practical exercise will be carried out in groups of two or three students to prepare a freedom-to-operate report.
Online education (OE): Online material that the student can consult from the computer, at any time, and that will contribute to independent learning for the concepts on the course.
Evaluation systems and criteria
In person
1) Assessment:
40% final exam
20% Exercise 1
20% Exercise 2
20% Exercise 3
Exam: 20 test questions and 1 topic to be developed.
Scoring: 0.3 points for each of the first 20 (incorrect answers drop 0.2, except for the first two errors), and 4 points for the last question.
You must get at least a 5 in each of the parts to pass the course.
2) Retakes: the notes of the approved parts will be saved.
Bibliography and resources
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Patents for Chemicals, Pharmaceuticals, and Biotehcnology 6º Ed., 2016; Philip W. Grubb / Peter R. Thomsen / Gordon Wright / Thomas Hoxie
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Estudios sobre propiedad industrial e intelectual, por Bernabé Zea Checa, Grupo Español de la AIPPI.
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XXXII Jornada de Estudio sobre Propiedad Industrial e Intelectual, Bernabé Zea, Grupo Español AIPPI
Evaluation period
- E2 26/06/2023 A09 16:00h