Authorship Franco G. Teves, Ph.D. Dipl. Phil. Acad. Microbiol. Director of Research MSU-IIT

Who is an author? Generally considered to be someone who has made substantive intellectual contributions to a published study (ICMJE) Generally considered to be someone who has made substantive intellectual contributions to a published study (ICMJE) Falls under ethical considerations in the conduct and reporting of research Falls under ethical considerations in the conduct and reporting of research Must be distinguished from other contributors Must be distinguished from other contributors

Considerations from the International Committee of Medical Journal Editors (ICMJE) CRITERIA FOR AUTHORSHIP CREDIT CRITERIA FOR AUTHORSHIP CREDIT 1. Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2. Drafting the article or revising it critically for important intellectual content; and 3. Final approval of the version to be published AUTHORS MUST MEET ALL THESE THREE CRITERIA

Large Multi-Center Group (Multiple Authorship) The group must identify individuals who accept direct responsibility for the manuscript and who qualify as authors. The group must identify individuals who accept direct responsibility for the manuscript and who qualify as authors. Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship. Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship. All other contributors are mentioned in the Acknowledgments portion. All other contributors are mentioned in the Acknowledgments portion.

Multiple Authorship Corresponding author should clearly indicate the identity of all authors, and in which order. Corresponding author should clearly indicate the identity of all authors, and in which order. Guarantors are authors who take responsibility for the integrity of the work as a whole, from inception to published article, and publish that information. Guarantors are authors who take responsibility for the integrity of the work as a whole, from inception to published article, and publish that information. Senior or First Author is the one who has contributed the most to the work, followed by others in descending order as to who has contributed the most. Senior or First Author is the one who has contributed the most to the work, followed by others in descending order as to who has contributed the most. The last author is usually the head of the lab or research group. The last author is usually the head of the lab or research group.

Prior Arrangement Decisions about contributors/authors should be jointly made by the group Decisions about contributors/authors should be jointly made by the group Corresponding author/guarantor should be prepared to explain the presence and order of authors Corresponding author/guarantor should be prepared to explain the presence and order of authors

Acknowledgments All contributors who do not qualify for authorship should be included, example: All contributors who do not qualify for authorship should be included, example: 1. Person who provided purely technical help; 2. Person who provided writing assistance; 3. Department Chair who provided only general support.

Other Declarations Disclosure of the identity of persons who have helped in the study design, data collection, data analysis, or manuscript preparation. Disclosure of the identity of persons who have helped in the study design, data collection, data analysis, or manuscript preparation. Disclosure of financial and material support. Disclosure of financial and material support. Disclosure of other conflicts of interest. Disclosure of other conflicts of interest. Readers may infer endorsement of the data and conclusion from the people in the Acknowledgments, therefore they should give written permission to be acknowledged. Readers may infer endorsement of the data and conclusion from the people in the Acknowledgments, therefore they should give written permission to be acknowledged.

Overview of the IP System: Recap

What is intellectual property? (WIPO) Creations of the human mind Creations of the human mind Relates to items of information or knowledge, which can be incorporated in tangible objects at the same time in an unlimited number of copies at different locations anywhere in the world Relates to items of information or knowledge, which can be incorporated in tangible objects at the same time in an unlimited number of copies at different locations anywhere in the world Intellectual property rights protect the interests of the creators by giving them property rights over their creation Intellectual property rights protect the interests of the creators by giving them property rights over their creation

increase the company’s market value enhance access to finance open access to new markets avoid unnecessary litigation WHY Protect IP?

General Coverage of IP Protection (Convention Establishing the World Intellectual Property Organization, 1967) Literary, artistic, and scientific works Literary, artistic, and scientific works Performances of performing artists, phonograms, and broadcasts Performances of performing artists, phonograms, and broadcasts Inventions in all fields of human endeavor Inventions in all fields of human endeavor Scientific discoveries Scientific discoveries Industrial designs Industrial designs Trademarks, service marks, and commercial names and designations Trademarks, service marks, and commercial names and designations Protection against unfair competition Protection against unfair competition All other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields. All other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.

Important Milestones in IP Protection Paris Convention for the Protection of Industrial Property (1883) Paris Convention for the Protection of Industrial Property (1883) Berne Convention for the Protection of Literary and Artistic Work (1886) Berne Convention for the Protection of Literary and Artistic Work (1886) Creation of WIPO (1967) Creation of WIPO (1967) Bayh-Dole Act, USA (1980) Bayh-Dole Act, USA (1980) Treaty on Intellectual Property in Respect of Integrated Circuits (1989) which was included in the Agreement on Trade- related Aspects of Intellectual Property Rights (TRIPS), 1994 Treaty on Intellectual Property in Respect of Integrated Circuits (1989) which was included in the Agreement on Trade- related Aspects of Intellectual Property Rights (TRIPS), 1994 R.A (1998) prescribes the IP code and establishes the IPO, providing for its powers and functions, and for other purposes R.A (1998) prescribes the IP code and establishes the IPO, providing for its powers and functions, and for other purposes House Bill 3270 (still in Congress), Techno Transfer Bill House Bill 3270 (still in Congress), Techno Transfer Bill

Two Branches of IP Copyrights – artistic creations, such as poems, novels, music, paintings, and cinematographic work; excludes others from making copies of the expressions without permission Copyrights – artistic creations, such as poems, novels, music, paintings, and cinematographic work; excludes others from making copies of the expressions without permission Industrial properties: Industrial properties: 1. Patents to protect inventions 2. Industrial designs – aesthetic creations determining the appearance of industrial products 3. Trademarks to protect reputation 4. Service marks 5. Layout designs of IC 6. Commercial names and designations 7. Geographical locations 8. Protection against unfair competition

Copyrights Have a lifespan of 50 years or until the death of the author, and is transferable Have a lifespan of 50 years or until the death of the author, and is transferable

PATENT A statutory grant by the Government conferred to an inventor or his legal successor, in return for the DISCLOSURE of the invention to the public, the RIGHT for a limited period of time to exclude others from making, using, selling or importing the invention within the territory of the country that grants the patent. A statutory grant by the Government conferred to an inventor or his legal successor, in return for the DISCLOSURE of the invention to the public, the RIGHT for a limited period of time to exclude others from making, using, selling or importing the invention within the territory of the country that grants the patent.

granted for inventions technical solution to a problem in any field of human activity PATENT a patent owner has the exclusive right to make, use, sell or import the patented products or process First-to-file rule Term of Protection: 20 years from filing date

Patents: Conditions of Patentability (Section 21, R.A. 8293) Industrial applicability Industrial applicability Novelty Novelty Inventive step Inventive step Patentable subject matter (depending on country) Patentable subject matter (depending on country) Lifespan of 20 years Lifespan of 20 years

Statutory Classes of Inventions An invention may be, or may relate to: An invention may be, or may relate to: -a useful machine; -a product; - a process or improvement of the foregoing; - microorganism; - non-biological & microbiological processes (Sec. 21, IP Code, Rule 201, IRR)

Biotechnological Inventions are inventions which concern products consisting of or containing biological materials or processes by means of which biological materials are produced, processed or used. are inventions which concern products consisting of or containing biological materials or processes by means of which biological materials are produced, processed or used. Biological material - any material containing genetic information and capable of reproducing itself or being reproduced in the biological system

Patentable Inventions in the Field of Biotechnology Products Products including cellular and non-cellular organisms including cellular and non-cellular organisms Processes Processes Uses Uses

List of Patentable Biotechnological Inventions PRODUCTSPROCESSESUSES 1. Chemical a) antibiotics, natural chemicals (gums,sec. metabolites) (gums,sec. metabolites) b) peptides or proteins monoclonal antibodies monoclonal antibodies c) genes, other DNA & RNA molecules, e.g. expression control signals (promoters, molecules, e.g. expression control signals (promoters, enhancers etc.) antisense oligo- nucleotides enhancers etc.) antisense oligo- nucleotides d) ribozymes, plasmids or other vectors other vectors e) pharmaceutical compositions containing compositions containing any of the above any of the above2.Live a) microorganisms 3. Cellular a) Bacteria b) fungi(including yeasts) c) algae c) algae d) protozoa e) animal or plant cells or cell lines 4. Non-cellular a) Viruses and bacteriophages b) Viroids c) fungi 5. Apparatus 1. Processes for preparing: preparing: a) proteins b) genes, other RNA or DNA molecules DNA molecules c) microorganisms d) cell lines e) viruses f) medical products 2. Processes for producing products by fermentation 1. Use of the product in the process (to prepare another product) 2. Medical uses

Exceptions to Patentability in Biotechnology Discoveries Discoveries Methods for treatment of the Methods for treatment of the human or animal body by surgery or therapy & diagnostic methods practiced on the surgery or therapy & diagnostic methods practiced on the human & animal body human & animal body

Exceptions to Patentability in Biotechnology Exceptions to Patentability in Biotechnology Plant varieties or animal breeds or essentially biological processes for the production Plant varieties or animal breeds or essentially biological processes for the production of plants and animals of plants and animals Contrary to public order or Contrary to public order or morality morality (Sec. 22, IP Code) (Sec. 22, IP Code)

Requirements of Patentability 1. Novelty an invention shall not be considered new if it forms part of a prior art. (Sec. 23, IP Code) (Sec. 23, IP Code)

Prior Art- everything made available to the public by means of: PRIOR ART

Requirements of Patentability 2. Inventive Step 2. Inventive Step an invention involves inventive step if, an invention involves inventive step if, having regard to a prior, it is not obvious having regard to a prior, it is not obvious to a person skilled in the art at the time to a person skilled in the art at the time of the filing date or priority date of the of the filing date or priority date of the application. application. (Sec. 26, IP Code) (Sec. 26, IP Code)

Requirements of Patentability 3. Industrial Applicability 3. Industrial Applicability an invention that can be produced an invention that can be produced and used in any industry shall be and used in any industry shall be industrially applicable. industrially applicable. (Sec. 27, IP Code) (Sec. 27, IP Code)

Special Patentability Requirements for Biotech Inventions Priority Priority Sufficiency of Disclosure Sufficiency of Disclosure Deposition of microorganism (Budapest Treaty)(Rules 408 & 409, IP Code) Deposition of microorganism (Budapest Treaty)(Rules 408 & 409, IP Code) The claims: the requirement of clarity & support by the description The claims: the requirement of clarity & support by the description

Requirements for Filing a Patent Application Completely filled-out request form for a patent grant Completely filled-out request form for a patent grant Specification and claim(s) Specification and claim(s) Drawing necessary for understanding the invention Drawing necessary for understanding the invention Abstract of the invention Abstract of the invention Filing fee Filing fee

Utility Models For certain inventions in the mechanical field For certain inventions in the mechanical field Less complex inventions, have shorter commercial life Less complex inventions, have shorter commercial life Novel, but may lack an inventive step Novel, but may lack an inventive step Shorter maximum term of protection (between 7 to 10 years) Shorter maximum term of protection (between 7 to 10 years) Lower fees for obtaining and maintaining the rights Lower fees for obtaining and maintaining the rights

Industrial Designs Novel ornamental or aesthetic aspect of a useful article (shape, pattern, color) Novel ornamental or aesthetic aspect of a useful article (shape, pattern, color) Design must have visual appeal and performs its intended function efficiently (main difference with copyright) Design must have visual appeal and performs its intended function efficiently (main difference with copyright) Must be reproducible by industrial means Must be reproducible by industrial means Maximum term of years Maximum term of years

Layout Designs of Integrated Circuits Something new that do not fall under industrial design, copyright, and patent Something new that do not fall under industrial design, copyright, and patent

Trademarks Sign, or combination of signs, which distinguishes the goods or services of one enterprise from those of another (words, letters, numerals, pictures, shapes, colors) Sign, or combination of signs, which distinguishes the goods or services of one enterprise from those of another (words, letters, numerals, pictures, shapes, colors) In other countries include 3D forms (Coca-Cola bottle, Toblerone), sounds, smell In other countries include 3D forms (Coca-Cola bottle, Toblerone), sounds, smell If applied for services, become a service mark If applied for services, become a service mark

Trade Names Name or designation that identifies an enterprise Name or designation that identifies an enterprise May be registered or not, depending on the country, but protection is still given May be registered or not, depending on the country, but protection is still given

Geographical Indications Signs used on goods that have a specific geographical origin and possess qualities or reputation that are due to that place of origin Signs used on goods that have a specific geographical origin and possess qualities or reputation that are due to that place of origin

Protection Against Unfair Competition Competitor creating confusion Competitor creating confusion False allegations False allegations

Who should own the patent/copyright in a university setting? The university owns the patent/copyright normally The university owns the patent/copyright normally All contributors share the royalties, including the funding agencies All contributors share the royalties, including the funding agencies Thesis outputs with potential commercial value must be decided before hand with regards to patent ownership Thesis outputs with potential commercial value must be decided before hand with regards to patent ownership

IP Policies Should Pave the Way for Technology Transfer Steps in technology commercialization: Steps in technology commercialization: 1. Technology generation 2. Invention report 3. Assessment 4. Patent filing 5. Valuation 6. Marketing 7. Licensing 8. Commercial development

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