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The Egyptian Patent Office Approach to the Examination of Pharmaceutical Patents Dr. Mona Mohamad Yahia Acting President, Egyptian Patent Office Objectives Highlight the importance of TRIPS Flexibilities regarding patent examination

  1. The Egyptian Patent Office Approach to the Examination of Pharmaceutical Patents Dr. Mona Mohamad Yahia Acting President, Egyptian Patent Office

  2. Objectives • Highlight the importance of TRIPS Flexibilities regarding patent examination • Describe the examination of pharmaceutical patents in Egypt: Law and Practice • Discuss how adopting the appropriate examination standards could support a well- functioning patent system in the pharmaceutical field

  3. TRIPS Flexibilities and Patent Examination Patentability Option to Exclude Disclosure Levels Criteria Subject Matter • Universal Criteria • To protect public • Enablement order • Methods for • National Standards • Best Mode treatment • Plants and animals

  4. Balance Patent Holder Society Private Rights Public Rights

  5. Examination of Pharmaceutical Patent Applications in Egypt Law and Practice

  6. Disclosure level • Enablement Clear and complete to enable a person skilled in the art to carry out the invention • Best Mode The best mode known by the inventor to carry out the invention Art. 13 of the EG IP Law 82/2002

  7. Non-Patentable Subject Matter Art. 2 of the EG IP Law 82/2002 - Contrary to public order or morality - Prejudicial to the environment, or life and health of human, animal or plant - Discoveries, scientific theories, mathematical methods, programs and schemes - Diagnostic, therapeutic and surgical methods for humans and animals - Plants and animals - Essentially biological processes - Organs, tissues, living cells, natural biological substances, nucleic acid and genome

  8. Novelty • Absolute • Implicit / explicit disclosure Art. 1&3 of the EG IP Law 82/2002

  9. Inventive Step • Significant degree of progress • Prior art includes common knowledge • Person skilled in the art Art. 1 of the EG IP Law 82/2002

  10. EGPO Pharmaceutical Patent Examination Section Continuous Training Background and Databases (Search Skills, Subst. Education (Advanced / Field Examination, Public (Pharmacy and Law) Specific) Perspective) Self-learning and Quality Team Guidelines Group work

  11. The Choice of the Appropriate Patentability Standards What to Consider?

  12. Pharmaceutical Patent Quality Pharmaceutical Patents • Should - Foster innovation and R&D - Achieve patent system intended socioeconomic goals • Should NOT - Impede medicine availability and affordability - Stifle competition - Deter local generic manufacturing

  13. Lax Examination Does Not Lead to High Quality Patents Evergreening High numbers of Low Patentability low quality Standards patents Patent Proliferation

  14. Sofosbuvir

  15. Efficient Utilization of TRIPS Patent Flexibilities Post- grant Granted Pre-grant flexibilities Pharmaceutical flexibilities Patent (more complex, costly and lengthy)

  16. Questions

  17. Thank You Thank You

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