Biopharmaceuticals and agrobioproducts: a North – South conflict?

1. Biopharmaceuticals and agrobioproducts: a North – South conflict? November 16-17, 2006, Warsaw

2. The lecture: • new • inventive • commercial

3. IPR in BIOTECHNOLOGYmeans: • CONNECTION of science, technology and industry; • Globalisation; • Innovations, property and profit; • Highly skilled researchers and workers in industry; • Productivity, growth and structural changes; • Information and communication policy.

4. SECTORS in ECONOMY • Agriculture = green biotech • Industry = white biotech • Health = red biotech • violet = legislation (IPR) • In summary: Contribution of biotechnology to the entireBIOeconomy

5. VAC • value added chain • = • science & technology • + • law & IPR • + • society & perception

6. Aims of genetic engineering: identification of specific property as a gene; transfer and/or modification of a gene; regeneration of a modified organism. commercialisation[legislation, biosafety, public perception]

7. Bioproducts in national and global economy: 1. Biomedicine • Biopharmaceuticals, • Molecular markers, • Targeted therapies, • Diagnosis. 2. Food & feed • Functional food • Nutraceutics 3. Plants for industry • biomaterials • bioenergy • bioreactors

8. Biotechnology is green: • Essential for sustainable future of our society: • Renewable resources (“green” bio-resources: biomass, bioenergy, biomaterials) • Clean production[recycling is possible] • The transition from ChemistryBio-based chemistryone of the essential leads for the transition to renewablebio-resources

9. opportunities • Genomics and modern (Bio)Technology offers excellent tools for major improvements and innovations for the transition of our strong petro-based chemistry to bio-based chemistry • The use of bio-waste (“biomass”) offers a way of turning environmental burden into environmental advantage

10. A report by the USDA national statistics service states that the U.S. has increased the acreage of soybean, corn, and cotton this year. Biotech soybean was the most popular choice amongst farmers, accounting for 89% of the total of all soybeans grown in the U.S. The statistics released include:* 66.6 million acres of biotech soy were planted in ’06, up from 62.76 million in 2005.* 12.6 million acres of biotech cotton were planted, accounting for 83% of all cotton grown.* 48.4 million acres of biotech corn were planted, accounting for 61% of all corn planted, and 6 million acres more than in 2005. Additional information is available at: http://usda.mannlib.cornell.edu/usda/nass/Acre//2000s/2006/Acre-06-30-2006 .pdf

11. These can be converted to any desired product(s)

12. Shopping List • Fruit pie • Biscuits • Bread rolls • Chicken soup (tinned) (for vegetarians: vegetable soup) • Chocolate bar • Cornflakes • Crisps • Margarine • Mayonnaise • Pasta • Ready meal Asian food • Readily prepared schnitzel coated with breadcrumbs (for vegetarians: corn burger) • Spaghetti sauce (instant) • Sandwich spread • Vanilla ice cream

13. biopharmaceuticals& biomarket trends • Market: 2005 - 602 bln USD (+7,7% from 2004) • 2010 - 842 bln USD Participation in the market: North America + EU + Japan = 82,3% Generics: USA 40% Germany 60% Poland 90% New biopharmaceuticals: nervous system + cardiovascular + metabolism therapy  HORMONES The leader in biotechnology: AMGEN (12,5 bln USD 2005)

14. Fig. 5. 2003 sales value and 2010 sales forecast of individual biopharmaceuticals on global market of recombinant proteins [37] • (EPO - erythropoietin; IFN - interferons; INS - insulin; CSF – colony stimulating factors; BF – blood coagulation factors; HT – hormone therapeutics; F/PI – fusion proteins/protein inhibitors; ENZ - enzymes; IL - interleukins; PA – tissue plasminogen activators; GF – growth factors) • Acc. P. Borowicz, M. Jarecka • Biotechnologia 2005

15. Bioeconomy - how to describe it? • The question: What are the basic indicators of biotech contribution to productivity and overall economy? • The answer: Patents; but: internationally comparable indicators are not available

17. Track to receive the biotechnological invention

18. Track to receive the biotechnological invention discovery

19. Track to receive the biotechnological invention discovery aim

20. Track to receive the biotechnological invention discovery aim inven- tion patent

21. Track to receive the biotechnological invention discovery aim inven- tion techno- logy

22. Track to receive the biotechnological invention discovery aim inven- tion techno- logy optima- lization

23. Track to receive the biotechnological invention discovery aim inven- tion techno- logy optima- lization preclinical tests (animals) In case of medicament

24. Track to receive the biotechnological invention discovery aim inven- tion techno- logy optima- lization preclinical tests (animals) clinical tests I, II, III In case of medicament

25. Track to receive the biotechnological invention discovery aim inven- tion techno- logy optima- lization preclinical tests (animals) clinical tests I, II, III Regis- tration In case of medicament

26. Track to receive the biotechnological invention – inculding costs discovery aim inven- tion techno- logy optima- lization preclinical tests (animals) clinical tests I, II, III Regis- tration 5% 25% 70% In case of medicament

27. Discovery and Development of a Successful Medicine YEARS PHASES 15 INTRODUCTION/ REGISTRATION 14 IV POST-MARKETING SURVEILLANCE 13 1 12 III 11 2 10 2 - 5 CLINICAL TEST (HUMANS) II 9 DEVELOPMENT 8 I 5 - 10 7 6 PRECLINICAL TEST (ANIMALS) 10 - 20 5 4 3 2 3,000 - 10,000 SYNTHESIS, 1 BASIC EXAMINATION & RESEARCH 0 SCREENING QUANTITY OF SUBSTANCES Scientific Risk of Research Activities Source: Based on PhRMA analysis, updated for data per Tufts Center for the Study of Drug Development (CSDD) database

28. Patent protection strategy Pharmaceutical form (for example oral), after 20 years - II medical indication compound A method of preparation pharmaceutical composition I medical indication 2. Method of preparation for example after 10 years next preparation methods Pharmaceutical form (for example iniection), for example after 15 years - compositions - pharmaceutical products - forms

29. Pharmaceutical industry NEW [BIO] PHARMACEUTICALS GENERICS Patents SPC Waiting for patent expiration EXCLUSIVITY COMPETITION New pharmaceuticals and generics

30. Suplementary Protection Certificate (SPC) • for pharmaceuticals and plant protection products • these regulations allow the owners of patents involving innovative drugs and plant protection products to extend the patent protection for even up to five years.

31. Bolar Amendment in CE • The Bolar Amendment permits generic firms to make use of originating firms’ otherwise protected clinical data before the relevant patent have expired. • In contrast, regulatory regimes and enabling legislations in many other developed nations are complex and tend to inhibit the rapid marketing of generic drugs.

32. PHARMACEUTICALS originals generics Submit undisclosed (safety and efficacy data) Submit bioequivalent studies Consequence: unfair commercial use • Generic drug registration is used/relied on data of original drug before the relevant patent has expired.

33. Aspects: • the balance between [costs – losses – profits]; • transfer of knowledge [North to South???, one-way direction] • fostering innovation; • preservation of national heritage and biodiversity; • regional specificity; • local needs for highly qualified staff; • functioning of current licensing practice; • cost of licensing vsprice of patenting; • availability of licensing; • blocking [false] patents.

34. INNOVATION -specific parameters vs. value of innovation • Priority, • Affordability, • Quality, • Sustainability, • Uncertainty, • Monopoly rights, • Stimulation of research, • Avoiding duplication.

35. IPR actors: [1] • Private sector • Public sector • Finance and banking • Busines&economy • Science & research & development • Research at academia & industry • Industry at agriculture, pharmacy, food and feed, etc. • Management • Legislation • Non-governmental organisation

36. IPR actors [2] • Scientists • Managers • Business people • Greens • Lay people

37. Patents: new inventive commercial Art. 10 Art. 24 p.w.p (Poland) Art. 52.1 EPC in biotech: a) product of biology, b) containing biologics, c) biological method. INVENTION

38. Generics • Essential similarity • Biosimilar (but not identical)  the same chemical formula (?)  the same bioavailability (?)  the same bioeffect (?) • simplified registration procedure • low cost

39. Research-based Industry Generics manufacturer Employment 560,000 (incl. 88,000 R&D) in 2002 - 114,800 within German Market 85,000 (mostly CEE) Trade balance €28,000 million in 2001 (up from €5,200 million in 1985) ? (negative) Research - 35 NCE (New Chemical Entites) global launched in 2000 (5 global annual „blockbusters”) - 36 NCE (New Chemical Entites) global launched in 2001 no discovery or advanced Development costs €895 millions and growing less than €1 million Development time 10-13 years 2-3 years Development risk significant: one in 5-10,000 zero risk, pick most successful Different Levels of Added Value

40. Protein structure 1. Amino acid sequence 2. Linear 3. Three dimensional 4. Interactions Interferon Beta MW 19'000D

41. Denaturation and Breakdown

42. Oligonucleotides complementary to L-rRNA

43. To differentiate Biosimilars and Generics • Manufacturing Process; • Molecular Properties; • Safety; • Efficacy

44. Safety Considerations For Biotech Medicines, each product has a unique safety profile dependent on its: • Mechanism of action • Unique manufacturing process • Composition (by-products and impurities)

45. Aspects of novelty [1]: • Research • Commercialization • Simplicity covered by “omics and logics” • Monopoly vs public goods • Biodiversity vs monoculture of agriculture

46. Aspects of novelty [2]; solutions: • Patent pool [collaborative mechanism]; • Clearing-house mechanism; • Fostering collaboration. • The necessary factors to be included: technical, business, financial, legal, public perception, anti-trust concerns.

47. Patent pool[collaborative mechanism] • The term patent pool is commonly used to refer to a joint patent licensing program that consists of a number of companies who have decided to offer a joint license for their patents that are essential to the practice of a defined specification. • An Essential Patent is a patent that contains one or more claims that are unavoidably and necessarily infringed by the implementation of a specification for which it is essential. • Competition authorities have indicated that the pro-competitive benefits of patent pools-of allowing a broader group of companies to have access to Essential Patents efficiently through a joint licensing program-may be diluted by including patents that are not Essential Patents.www.oecd.org

48. Clearing-house mechanism • Expertise in managing information and technology varies enormously from country to country. For this reason, the Convention on Biological Diversity [in 1992] has established a "Clearing-House Mechanism" to ensure that all governments have access to the information and technologies they need for their work on biodiversity.Thenetwork of national focal points for the mechanism is being established to address matters relating to technical and scientific cooperation. The Parties have recently emphasized the need to strengthen the role of these focal points. Building a network of non-governmental organizations and other institutions working on biodiversity could contribute to this goal. Establishing National, Regional, Subregional and Thematic Clearing-House Focal Points for specific topics could also help.The clearing-house is based on the philosophy that broad participation and easy access must be a top priority. Its database can therefore be tapped through both traditional and electronic means of communication. Special efforts are made to ensure the participation of indigenous communities, whose unique knowledge and expertise are so important.The Clearing-House is coordinated by the Executive Secretary and overseen and guided by an Informal Advisory Committee (IAC) set up by the Parties to the Convention.www.oecd.org

49. Foster collaboration • Series of laws use patent ownership to foster collaboration between parties in the research and development enterprise. Patents protect the inventor’s investments in generating the knowledge that is the basis for innovation and serve as an incentive to the commercialization of new ideas. As R&D has become more expensive, ownership of title to inventions has been used as a means to encourage collaborative work amongdifferent players in the research enterprise. [Wendy H. Schacht]

50. Problemsexample: patent trolls • Patent Act: ... The right to exclude others ... from making, using, offering for sale, or selling the invention ... • Patent trolls: patent holders who do not practice the invention but instead use patents primarily for obtaining license fees.