1. USP Life Sciences Role of Intellectual Property protection in R&D Projects Izabela Klockowska R&D Portfolio Manager Gdańsk, 13 Dec 2013 1

2. Agenda 1. Company`s brief introduction 2. Evaluation criteria of R&D Projects 3. Role and importance of protection of IP 4. Invention versus discovery 5. Methods and strategies of protection of IP 6. Good and bad practices of patenting 7. Procedures of patenting 8. Practical problems 2

3. Introduction Company belonging to USP Group: US Pharmacia (factory in Wrocław) USP Zdrowie (Warsaw) -APAP, Ibuprom, Gripex, Manti, Verdin US Pharmacia International (Rockville, MD, USA) Company’s mission Investing 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 3

4. Evaluation criteria of R&D Projects 4

5. 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 Project medicine, medical device, diet supplement, cosmetics

6. 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) 6

7. 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 7

8. Strategies of IP protection Patent has 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 secret by 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 8

9. 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) 9

10. 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) 10

11. 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! 11

12. 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 12

13. 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 13

14. 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 14

15. Structure of Patent document Patent 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 15

16. 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 16

17. 17 „ 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

18. 18 Procedures of patenting

19. 19 NATIONAL REGIONAL - EUROPEAN (EPC) REGIONAL - EUROPEAN (EPC) INTERNATIONAL (PCT) 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

20. Important dates in patenting process 12 months deadline for extension of Patent protection (PL->PCT or PL-> EP) 18 months publication of the Patent Application, disclosure in a public domain 30/31 months regional/national phase of PCT 20

21. Practical problems Intellectual 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 decisiveness Business 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 21

22. Thank you for your attention! Izabela Klockowska i.klockowska@usp.pl 22