Organized by WIPO in Cooperation with GCC Patent Office Saudi Arabia, Riyadh 15-16 October, 2012

1. Sub-regional Workshop on the Protection of Invention in Pharmaceutical Sector, Patent, Undisclosed Information and Health Policies Organized by WIPO in Cooperation with GCC Patent Office Saudi Arabia, Riyadh 15-16 October, 2012

2. Pharmacist Batool Jaffer SuleimanBSc Pharmaceutical science, MSc Clinical Pharmacology Director, Rational Use of Medicines / WTO & FTA Focal Point MoH, Sultanate of Oman Patent, Data Protection & Registration of Pharmaceutical products in Oman

3. General Information • Oman has a very good government sponsored programs designed to increase access to medicines • Spending on medicines globally is expected to exceed $ 1 trillion in 2013 reaching nearly 1.2 trillion by 2016. • Innovation brings new therapies but also increased spending levels to governments and private payers • Patent expiries will reduce brand spending by $ 127 Billion through 2016 The Global Use of Medicines: Outlook Through 2016 Report by IMS Institute for Healthcare Information

4. Key 2011-2016 Numbers The Global Use of Medicines: Outlook Through 2016 Report by the IMS Institute for Health Information

5. What MoHs are looking for • General availability, affordability and access to medicines • Factors to be considered: 1- Local laws and by-laws for the registration & pricing of pharmaceutical products Ministerial Decision No. 86/2000 2-WTO Agreements (TRIPS) Oman’s WTO accession in Nov.2000.

6. Continued 3- Free Trade Agreements (FTA) Royal Decree No. 109/2006 for the approval of Oman-US FTA on 15 October, 2006 4- Royal Decree No. 67/2008 led to the publication and implementation of the Patent Law on May, 2008.

7. Registration of pharmaceuticals • No documents related to patent protection • No articles related to Data Protection • Scientific reports involve drug indication, method of manufacture, indication, side effects (no data of clinical trials & bioavailability studies –in most of the cases-) • No article related to Bolar provision

8. Pricing of Pharmaceuticals • CIF plus 55% profit margin for the local agent (wholesaler) including a profit margin of 22% for the retailer • Different systems for pricing Innovated Patented products and Generic products • No obligation on the ph. companies to provide information on price reduction for off-patent medications • CIF price provided in the local currency of the exporting country

9. Laws and Regulations of IPR The areas of IP covered by the TRIPS Agreement that are related to medicines include: • Patents • Trademarks • Undisclosed information, including trade secrets and test data. 

10. Patent Protection in TRIPS & FTA TRIPS • Patents shall be available for any inventions, whether products or processes (Article 27.1) • Members may exclude plants from patentability (Article 27.3b) • Patent protection for 20 years from the filing date (Article 33) Note: The effective period of patent protection is less than 20 years FTA • New uses and new methods for treatment of particular medical condition (Article 15.8,1b) • Patent for plants (Article 15.8,2) • Bolar provision do not allow commercial export to other markets who allow it (article 15.8, 5)

11. Patent Protection in TRIPS & FTA TRIPS • Does not contain an obligation to introduce such system FTA • Patent extension compensation for not more than 5 years for delay in granting the patent if granted more than 4 years after the filing date, or 2 years from the request for examination or regulatory delay in marketing approval (unreasonable delay for more than 24 months)

12. Patent Protection in TRIPS & FTA TRIPS • No linkage or notification. The patent system and the drug regulatory system are separate and independent mechanisms FTA • Linkage of marketing approval and patent (Article 15.9,4a) • Notification of the patentee when a generic manufacturer applies for marketing approval (Article 15.9, 4b) Health authorities became enforcers of medicine patents

13. Market exclusivity Data exclusivity/ Market exclusivity: • Adoption of specific periods of protection during which health authorities cannot relay on that data to review or grant marketing approval to a second applicant. • It is calculated from the date of granting marketing approval and is independent on patent protection

14. Market exclusivity TRIPS • protection against unfair commercial use of undisclosed test or other data whose submission is required by governments as a condition of approving the marketing of pharmaceutical FTA • Five years for information concerning safety or efficacy for a new chemical entity (Article 15.9, 1a) • Three years for new clinical information (other than bioequivalence) for existing CE • The periods of 5 and 3 years of protection is also applicable when reliance of the approval is based on another country

15. Royal Decree No. 67/2008 Article 71 ( Enforcement Measures) • Cancellation of Marketing Approval • MoH to pay adequately for damages (unauthorized disclosure ) • The competitor to pay adequately for damages (marketing of the product) • The competitor to cease marketing of the product

16. Recommendations for the Patent office • Be sure that the invention is new, involves inventive step and is industrially applicable. • Be sure that patent for new use or new methods of use really involve inventive steps. • Avoid unreasonable delay in the issuance of a patent. • Carefully evaluate requests for patent extension

17. Recommendations for MoH • Use Bolar exception effectively • Avoid unreasonable delay in marketing approval. • Valid certificate of patent registration for the brand drug issued by the concerned local authority or from the GCC patent office • Undertaken letter from generic manufacturer indicating the subject drug is off patent. • Application for marketing approval of NCE to be submitted to MoH within three years for first marketing else where. • Identify specific mechanisms to ensure transfer of the technology to the country.

18. Recommendations • Monitor and control drug pricing (reduced prices post patent expiry). • Consider Compulsory License if the invention is not available in sufficient quantities or quality or at predetermined reasonable prices in the country, either through local manufacture or through importation. • An automatic waiver of data protection in case of compulsory license. Termination of data exclusivity following a grant of a voluntary license by the originator • Setting up the bases and standards to assure drug security. • Permission for a drug needed for serious disease or it is considered as life saving drug.

19. Recommendations • Three years data protection for the new use is not for the product itself, MoH could register any generic drug provided that the new indication is not claimed for this generic. • Careful evaluation for requests submitted by the originators to obtain approvals for new indications. New therapeutic indication with unpublished (undisclosed) data and considerable efforts is to be considered. • Since the 5 yrs data protection is calculated from the date of marketing approval (Registration Certificate), MoH should prioritize registration of unregistered pharmaceuticals imported to meet the requirement of any health institution

20. Recommendations • In case of public health emergency, governments should have the right to waive off any obstacle related to data protection. • Amendment of Article 28 (Ministerial Decision No. 86/2000) to be read as: The TCR may cancel registration of any product if the product is found to be harmful, discontinued in the country of origin, any change introduced without prior approval, unavailability without valid reason & not complying with the conditions of registration and data protection should be ceased

21. Recommendations • The provision of data protection should not be applied for the exportation of pharmaceuticals made by a local manufacturer. • A Bolar provision allowing application for marketing approval even during the period of data exclusivity.

22. Thank you