IP status – the partner's view


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IP status – the partner's view

  1. 1. IP status – the partner’s view Yael Weiss Medical Director MSD Israel
  2. 2. Rules of thumb <ul><li>Strong IP (not use patents, ability to expand and maintain IP) </li></ul><ul><li>Novelty </li></ul><ul><li>Ability to incubate and mature project in house because of “The later the better” concept: mandatory – proof of concept in vivo </li></ul><ul><li>Partnership for collaboration and further/future development (depending on type of deal) </li></ul><ul><li>Strategic fit (less relevant in case of VC’s) </li></ul>
  3. 3. Collaboration with Emerging Scientific Markets <ul><li>Objectives </li></ul><ul><li>Identify ex-U.S. markets with high potential for I.P assets , entities and technologies in pharma-related R&D: </li></ul><ul><ul><li>NCEs: novel chemistry; known MOA (is highly preferred, but not essential); proof of concept; validated in vivo </li></ul></ul><ul><ul><li>NBEs: proof of concept; validated in vivo </li></ul></ul><ul><ul><li>Platforms: HTS; assays; informatics; drug delivery; molecular profiling </li></ul></ul>Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)
  4. 4. Projects at MRL: Product Types <ul><li>New Chemical Entity (NCE) – Small molecules: </li></ul><ul><li>Novel chemistry - single enantiomer with Mol. Wt. 200-800 </li></ul><ul><li>Product patent (vs. use) & worldwide </li></ul><ul><li>Defined biochemical mechanism (potent & specific) </li></ul><ul><li>Proof-of-concept in at least one animal model (oral activity, low dose) </li></ul><ul><li>Favorable PK & few metabolites </li></ul><ul><li>First- in-class or best-in-class is ideal </li></ul><ul><li>New Biological Entity (NBE) – Therapeutic proteins: </li></ul><ul><li>Characteristics (fully human, high binding affinity, low toxicity/immunogenicity) </li></ul><ul><li>Patent (composition and use) </li></ul><ul><li>Targets (ID, Cancer, Inflammation); or, where small molecules do not work </li></ul><ul><li>Flexibility (antagonist or agonist, single chain, may be bispecific) </li></ul><ul><li>Administration (IV or SC, minimal infusion reactions) </li></ul><ul><li>Manufacture (ease of production, reasonable cost of manufacture) </li></ul>Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)
  5. 5. Collaboration with Emerging Scientific Markets <ul><li>Factors Considered Include : </li></ul><ul><li>Research centers with strongest scientific disciplines </li></ul><ul><li>Publications and patents </li></ul><ul><li>Number of scientists engaged in academia and industry </li></ul><ul><li>Level of government support & R&D incentives </li></ul><ul><li>Local on-the-ground support </li></ul><ul><li>Potential Interactions Include: </li></ul><ul><li>Acquire new lab methodologies </li></ul><ul><li>Purchase sample collections </li></ul><ul><li>Establish basic research collaborations </li></ul><ul><li>Chemistry Outsourcing </li></ul><ul><li>Optimize an early lead compound </li></ul><ul><li>License-in a specific NCE or NBE </li></ul>Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)
  6. 6. Academic Environment: Knowledge Capital Notes: * Leading magazines; Nature, Science, The Cell Source: Monitor Report , PubMed/Medline Database, “Technology Profile Report, Patent Examining Technology Center Groups, 1630-1660, Biotechnology” US Patent & Trademark Office, 2001 Publications of Life Science Research in Leading Magazines* per 100, 000 Inhabitants (1999) US Patents Granted in Biotechnology by Origin of Inventor per 100, 000 Inhabitants (1999)
  7. 7. Academic Environment: Knowledge Capital <ul><li>86% of the projects are in the academia </li></ul><ul><li>14% of the projects are in the Hospitals </li></ul><ul><li>Yissum of the Hebrew University & Yeda of the Weizmann Institute hold almost 60% of all the available projects. </li></ul>Total of 210 projects . Source: Technology Transfer Companies web sites and company web sites Applied Research Projects in the Academia & Hospitals Available for the Industry (2003) <ul><li>In the Biotechnology industry in Israel, especially in the therapeutics and bioinformatics segments, almost 50% of all the companies and projects are based on knowledge created in the academia and transferred to the industry. The rest of the industry is mostly based on independent ideas of local and newly immigrating scientists </li></ul><ul><li>Alternative sources of knowledge can be found mainly in the medium/big companies, where some knowledge is created in-house or in-licensed from foreign companies </li></ul><ul><li>Companies created by spin-offs are very few </li></ul>
  8. 8. Government Support: Many Different Initiatives <ul><li>“ Nofar” Pre-Seed Grant for applied Bio-Research in Academia </li></ul><ul><li>Grant (without Royalties) </li></ul><ul><li>90% up to $ 100 K over 1 year </li></ul><ul><li>“ Incubator” Pre-Seed Grant & Infrastructure for Start-ups </li></ul><ul><li>Grant with Royalties reimburse </li></ul><ul><li>85% up to $ 300 K over 2 year </li></ul><ul><li>“ Tenufa” Pre-Seed Grant for Entrepreneurs </li></ul><ul><li>Grant (without Royalties) </li></ul><ul><li>85% up to $ 50 K </li></ul>Academia Industry <ul><li>“ Magneton” Technology Transfer from Academia to Industry </li></ul><ul><li>Grant (without Royalties) </li></ul><ul><li>66% up to $ 0.5 M over 2 Years </li></ul><ul><li>“ Magnet” Consortium for Developing Platform Technologies </li></ul><ul><li>Grant (without Royalties) </li></ul><ul><li>66% over 3 years </li></ul><ul><li>“ Haznek” Seed Fund for Start-ups </li></ul><ul><li>Convertible Bonds ………………….. with option to investor </li></ul><ul><li>50% up to $ 1 M over 2 Years </li></ul><ul><li>“ Bio-Incubator” Seed Grant & Infrastructure for Biotech Start-ups </li></ul><ul><li>Convertible Bonds </li></ul><ul><li>75% up to $ 1.35 M over 3 year </li></ul><ul><li>“ Bi-National” & “International” Funds for industrial collaboration </li></ul><ul><li>Grant with Royalties reimburse </li></ul><ul><li>50% up to ~ $ 0.9 M (BIRD-F) </li></ul><ul><li>Support for R&D based Companies </li></ul><ul><li>Grant with Royalties reimburse </li></ul><ul><li>20-50% </li></ul><ul><li>Support for Long Term R&D Big-Companies (with manufacturing) </li></ul><ul><li>Grant (without Royalties) </li></ul><ul><li>50% up to $ 15 M </li></ul><ul><li>Incentive for Approved Factory (in regular & preferred location) </li></ul><ul><li>Grants with Royalties reimburse </li></ul><ul><li>Tax exemptions </li></ul>Pre-Seed Seed Mature <ul><li>“ Privatized-Incubator” Grant & Infrastructure for Start-ups </li></ul><ul><li>Convertible Bonds </li></ul><ul><li>85% up to $ 500 K over 2 Years </li></ul>Source: Ministry of Industry & Trade (www.moit.gov.il)
  9. 9. How are we perceived? <ul><li>Upside Downside </li></ul><ul><li>(well recognized) (areas for improvement) </li></ul><ul><li>General Entrepreneurial Culture difference </li></ul><ul><li>Innovative Distance </li></ul><ul><li>Basic research High quality Mostly very early stage </li></ul><ul><li>Governmental funding IP (?) </li></ul><ul><li>Clinical trials Very high quality Costs increasing </li></ul><ul><li>Marketing Receptive to innovation Small and limited market </li></ul><ul><li>IP and data protection issues </li></ul>
  10. 10. Projects at MRL: Therapeutic Areas <ul><li>Top Priority includes: </li></ul><ul><li>Obesity </li></ul><ul><li>Alzheimer’s disease </li></ul><ul><li>Cancer </li></ul><ul><li>Biologics </li></ul><ul><li>High Interest: </li></ul><ul><li>Neurological Disorders: anxiety, cognition, depression, schizophrenia, Parkinson's diseases </li></ul><ul><li>Metabolic Diseases: type II diabetes </li></ul><ul><li>Infectious Diseases : anti-bacterial, anti-fungal, anti-viral & vaccines </li></ul><ul><li>Cardiovascular Diseases : atherosclerosis, hypertension, atrial arrhythmia </li></ul><ul><li>Respiratory Diseases : asthma, chronic bronchitis & COPD </li></ul><ul><li>Immunological and Inflammatory Diseases : autoimmune diseases, chronic pain, osteoarthritis & rheumatoid arthritis </li></ul><ul><li>Ophthalmology </li></ul><ul><li>Osteoporosis </li></ul><ul><li>Opportunistic: </li></ul><ul><li>Gastroenterology </li></ul><ul><li>Also: </li></ul><ul><li>Imaging techniques to follow response to therapy, animal models of disease, platform technologies </li></ul>Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel), phone conversation with GW
  11. 11. Backups
  12. 12. Merck Research Laboratories: Facts & Figures <ul><li>Merck Research Laboratories (MRL) is the R&D division of Merck operating at multi-locations world wide, with nearly 10,000 employees. </li></ul><ul><li>Merck had a research budget of $3.2 Billon in 2003. </li></ul><ul><li>The accomplishments include: </li></ul><ul><ul><li>Over 1000 scientific papers published each year </li></ul></ul><ul><ul><li>About 250 new patent applications filed each year </li></ul></ul><ul><ul><li>16 new drug applications (NDA) approved in past 7 years </li></ul></ul><ul><li>Actively pursue of external relationships to complement internal research </li></ul>Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)
  13. 13. Merck Research Laboratories: Strategy <ul><li>Select major medical targets </li></ul><ul><li>Select the right target by understanding the mechanism to improve existing therapies Focus on the new chemical entity (NCE) </li></ul><ul><li>Shorten length of R&D at the research & pre-clinical development </li></ul><ul><li>Discriminate between projects as they progress through development, with a rapid proof-of-concept tested clinically </li></ul><ul><li>Establish the best scientific program in the area by either internal research, external collaborations, or both </li></ul><ul><li>Partner & collaborate with top R&D organizations, to support future growth, by a wide range of relationships: from licensing through joint ventures </li></ul>Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)
  14. 14. Projects at MRL: Technology Areas <ul><li>Research Technology Platforms </li></ul><ul><li>Lead discovery technology: HTS, robotics, assays, imaging, chemistry, structural biology </li></ul><ul><li>Lead optimization technology: ADME, Pharmacokinetics </li></ul><ul><li>Drug Delivery Systems: </li></ul><ul><li>Oral drug delivery for enhanced bioavailability </li></ul><ul><li>Inhalation delivery </li></ul><ul><li>Formulation technology - controlled release/ fast dissolve </li></ul><ul><li>Vaccine adjuvant delivery </li></ul><ul><li>Molecular Profiling Platforms </li></ul><ul><li>Informatics and Databases </li></ul><ul><li>Gene Monitoring </li></ul><ul><li>Modifying Genes </li></ul><ul><li>Model Organisms </li></ul><ul><li>Protein Analysis </li></ul><ul><li>Samples and Pharmacogenomics </li></ul>Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)
  15. 15. The deterioration in Israel’s IP regime 1998 - 2005 <ul><li>1998 – Amendment to the patent law to allow experiments on patent protected products. </li></ul><ul><li>2000 – Israel does not adopt data exclusivity despite its commitment under TRIPs </li></ul><ul><li>2004 – Government proposes a marketing exclusivity bill which falls far short of international standards. </li></ul><ul><li>2005 – The Government proposes to amend the patent law and considerably shorten the patent extension period. </li></ul>