USP Life Sciences Role of Intellectual Property protection in R&D Projects Izabela Klockowska R&D Portfolio M

1. USP LifeSciencesRole of IntellectualPropertyprotection in R&D ProjectsIzabela KlockowskaR&D Portfolio ManagerGdańsk, 13 Dec 2013

2. Agenda 1. Company`sbriefintroduction 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 badpractices of patenting 7. Procedures of patenting 8. Practicalproblems

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 eitherlaunching a product on the market by USP Group or out-licensing of created IP to an entity such as Big Pharma

4. Evaluation criteria of R&D Projects

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 studiesdepending on the status of the Project proof of conceptstudies (in vitro, in vivo) properanimal model for specificindication (preclinicalstage) statisticallysignificance Scientific expertise of the researchers/Institution in specificresearcharea (maindomainor not)

7. IntellectualProperty (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

8. Strategies of IP protection Patent hasguaranteed 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, confidentialinformationkept by company to obtaineconomic benefit, not time and territoritylimited (ex. Coca Cola). The disadvantage- no protection once informationis 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

9. Role and importance of Patents Patents are means of encouraging innovationby makingitpublicto contribute in scientific progress and promote creativity Exclusiverights of the Patent holder to exploit the inventionin a professional or commercial manner The granting of a patent does not automatically grant the right to use the patented invention(country regulations, implementationof the invention involves an infringement of other patents) Patent isvalid for 20 years in a specifiedterritory (time and territorylimitation)

10. Definition of invention Onlyaninventioncan be patented An invention is a new, inventive and industrially applicable technical solution to a given technical problem When an invention is created, its inventorcan 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)

11. Novelty Inventionis not a part of the state of the art (public disclosure - publications, patent documents, public oralpresentationswhichrevealed the subject of the inventionbeforeprioritydate-Patent Application submission) Publish……..and be damned!

12. Inventive step Inventiondoes not result from the state of the art in anobviousmanner for the expert in the field Inventionpresentssurprising, non-obviouseffect for the expert in the field Inventionshowssubstantiallyimprovedefficiency Inventionsuccessfullysolves a technical problem Inventionis not anequivalentsolution, does not result from synergic, logiceffect

13. Industrialapplication Industriallyapplicable technical solution to a given technical problem An invention cannot be solely theoretical but must have the potential to be put into practice A finalproductrelated to aninvention must be reproducible

14. Whatcannot 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/plantbreeding surgical or therapeutic methods of treating human or animal bodies and methods of diagnosis

15. Structure of Patent document Patent composition: • Bibliographicdata and abstract • Description and drawings - Patent embodimentswhatexplainsimplementation of inventionandinterpretation of patent claims • Patent claims - define the scope of patent protection In Practice: • The widerrange of protection by Patent claims the better (group of substances, use, methodpreparation) • Patent claimsshouldhavesupportivetechnical data in a description • Properdisclosure- inventionshould be describedclearlyand comprehensivelyenablingreproduction • Useful data: referencestudies, in case of composition -data showingsynergiceffect of components

16. The most commonmistakes Lack of patent application = Lack of anyprotection Previousexposure/disclosurebefore the filing (ie.publications) Badlycreated, narrow patent claims Lack of international Patent protection (limited to PL) NOTE Disclosure of the solution at fairs, conferences and other publicevents without prior filing the application with the Patent Office for protection becomes the existing state of the art

17. „Almost 50% of patent applications are rejected, becausethe 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. Procedures of patenting

19. NATIONAL REGIONAL - EUROPEAN (EPC) INTERNATIONAL (PCT) e.g. patent validonlyin Poland 38 members of EPC one patent necessity of validation of EP patent indesignatedcountries 148 countries 2 stages: Intermediate Regional/National (after 30/31 months) Priority right - within 12 months from the original application

20. Importantdates in patentingprocess 12 months deadlinefor extensionof Patent protection (PL->PCT or PL-> EP) 18 months publicationof the Patent Application, disclosure in a public domain 30/31 months regional/nationalphase of PCT

21. Practicalproblems 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

22. Thankyou for yourattention!Izabela Klockowskai.klockowska@usp.pl