USP Life Sciences Role of Intellectual Property protection in R&D Projects Izabela Klockowska R&D Portfolio Manager Gdańsk, 13 Dec 2013

USP Life Sciences

Role of Intellectual Property protection in R&D Projects

Izabela KlockowskaR&D Portfolio ManagerGdańsk, 13 Dec 2013

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Agenda 1. Company`s brief introduction2. Evaluation criteria of R&D Projects3. Role and importance of protection of IP4. Invention versus discovery5. Methods and strategies of protection of IP6. Good and bad practices of patenting7. Procedures of patenting8. Practical problems

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Introduction• Company belonging to USP Group:US Pharmacia (factory in Wrocław)USP Zdrowie (Warsaw)-APAP, Ibuprom, Gripex, Manti, VerdinUS Pharmacia International (Rockville, MD, USA)

• Company’s missionInvesting in applicable R&D projects with market potential and IP protection to obtain return on investment by either launching a product on the market by USP Group or out-licensing of created IP to an entity such as Big Pharma

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Evaluation criteria of R&D Projects

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Business• Clearly defined final product of the Project• Innovation as a market power of the product: first in class (new scientific concept) the best in class (category of products based on the same

scientific concept and mechanism of action)• Market potential (market size including competition

analysis and estimated return on investment)• Duration of the Project • Budget of the Project• Registration status of the potential product – influence on

the budget and duration of the Projectmedicine, medical device, diet supplement, cosmetics

Science

• Applicability of the Project • Scientific concept of the Project: new, in accordance

with trends, crowded, old-fashion• Methodology and results of conducted studies

depending on the status of the Project proof of concept studies (in vitro, in vivo) proper animal model for specific indication (preclinical

stage) statistically significance• Scientific expertise of the researchers/Institution in

specific research area (main domain or not)

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Intellectual Property (IP)

Depending on the Project`s status:A)Patent documents:• Patent Granted and/or Patent Application submitted• Evaluation of the scope of patent claims• Evaluation of disclosure the subject matter of the invention• Territorial scope (Poland, international)B) Lack of Patent Documents• Materials for Patent Application, conducted proof of

concept studies • Patentability research of a potential invention

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Strategies of IP protection

• Patenthas guaranteed time of protection for 20 years in exchange for disclosing the information to the public. It provides the owner of the right to prevent unauthorised use of the protected technology• Trade secretby definition not disclosed to the world, confidential information kept by company to obtain economic benefit, not time and territority limited (ex. Coca Cola). The disadvantage- no protection once information is uncovered by others. • Trade mark is a recognizable sign, design or expression which identifies products or services of a particular source from those of others

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Role and importance of Patents

• Patents are means of encouraging innovation by making it public to contribute in scientific progress and promote creativity

• Exclusive rights of the Patent holder to exploit the invention in a professional or commercial manner

• The granting of a patent does not automatically grant the right to use the patented invention (country regulations, implementation of the invention involves an infringement of other patents)

• Patent is valid for 20 years in a specified territory (time and territory limitation)

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Definition of invention

• Only an invention can be patented • An invention is a new, inventive and industrially

applicable technical solution to a given technical problem

• When an invention is created, its inventor can apply for a patent to a Patent Office

• A patent is the legal document that describes the invention and grants a property right to the inventor(s) or their successor(s)

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Novelty

• Invention is not a part of the state of the art(public disclosure - publications, patent documents, public oral presentations which revealed the subject of the invention before priority date-Patent Application submission)

Publish……..and be damned!

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Inventive step

• Invention does not result from the state of the art in an obvious manner for the expert in the field

• Invention presents surprising, non-obvious effect for the expert in the field

• Invention shows substantially improved efficiency• Invention successfully solves a technical problem • Invention is not an equivalent solution, does not result from

synergic, logic effect

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Industrial application

• Industrially applicable technical solution to a given technical problem

• An invention can not be solely theoretical but must have the potential to be put into practice

• A final product related to an invention must be reproducible

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What cannot be patented

• inventions contrary to law and order• discoveries, scientific theories, mathematical formulas• aesthetic creations, plans, principles and methods, rules

of games• information, computer programs • animal species, plants, or animal/plant breeding• surgical or therapeutic methods of treating human or

animal bodies and methods of diagnosis

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Structure of Patent documentPatent composition:• Bibliographic data and

abstract• Description and drawings -

Patent embodiments what explains implementation of invention and interpretation of patent claims

• Patent claims - define the scope of patent protection

In Practice:• The wider range of protection by

Patent claims the better (group of substances, use, method preparation)

• Patent claims should have supportive technical data in a description

• Proper disclosure- invention should be described clearly and comprehensively enabling reproduction

• Useful data: reference studies, in case of composition -data showing synergic effect of components

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The most common mistakes

• Lack of patent application = Lack of any protection • Previous exposure/disclosure before the filing (ie.publications)• Badly created, narrow patent claims• Lack of international Patent protection (limited to PL)

NOTE Disclosure of the solution at fairs, conferences and other public

events without prior filing the application with the Patent Office for protection becomes the existing state of the art

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„Almost 50% of patent applications are rejected,

because the authors reveal a solution before their application for a patent and shall notify solutions already patented. This is because they have no

knowledge of the procedures for awarding patents”

Alicja Adamczak, Ph.D. President of Patent Office of the Republic of Poland

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Procedures of patenting

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NATIONAL REGIONAL -EUROPEAN (EPC)

INTERNATIONAL(PCT)

e.g. patent valid only in Poland

38 members of EPC one patent necessity of validation of EP patent indesignated countries

148 countries 2 stages: Intermediate Regional/National

(after 30/31 months)

Priority right - within 12 months from the original application

Important dates in patenting process• 12 monthsdeadline for extension of Patent protection (PL->PCT or PL-> EP)• 18 monthspublication of the Patent Application, disclosure in a public domain • 30/31 months regional/national phase of PCT

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Practical problemsIntellectual Property Protection• Lack of knowledge or of respect for the rules of IP protection • Publishing before Submitting a Patent Application and/or before its disclosure

(18 months)• Badly formulated Patent Applications within the scope of claims• Territorial restrictions to PL Scientific Institutions/Higher Education Institutions• Excessive bureaucracy – extended period of negotiations and signing of

business contracts • Lack of decisivenessBusiness• Financing of applicable projects from the stream of support for basic research

– data publishing • Lack of a real business value in applicable research• Competitiveness of public financing – scientists’ reluctance to cooperate with

business

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Thank you for your attention!

Izabela [email protected]

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