As indicated in the response to question 24, the draft Law on Patents and Utility Models, excludes from Patentability under Article 3(a) inventions the prevention of the commercial exploitation of which is necessary to protect public order or morality. The draft Law does not elaborate on the scope of public order or morality. As the proposed legislation is still in a draft form and hence has not yet been implemented, it is not possible at this stage to explain how the provision is or will be implemented in practice.

As indicated in the response to question 24, the draft Law on Patents and Utility Models, excludes from patentability under Article 3(e) diagnostic, therapeutic and surgical methods for the treatment of humans and animals but not products for use in any of those methods.

As indicated in the response to question 24, the draft Law on Patents and Utility Models, excludes from patentability under Article 3(d), plants and animals other than those micro-organisms and essentially biological processes.

As indicated under the responses to questions 23 and 24, by virtue of Article 2(c) and Article 3(d) of the draft Law on Patents and Utility Models, micro-organisms, non-essentially biological processes and microbiological process are patentable. Plant varieties are to be protected by a separate law which is available in a draft form. The draft law on the protection of plant varieties is based on the UPOV model law.

Article 11 of the draft Law on Patents and Utility Models provides that the patent holder shall have the following rights: a) Where the subject matter of a patent is a product: The patent holder has the exclusive right to prevent third parties not having the holder's consent from the acts of making, using, offering for sale, selling, or importing for these purposes that product. b) Where the subject matter of a patent is a process: The patent holder has the exclusive right to prevent third parties not having the holder's consent from the acts of using the process, and from the acts of: using, offering for sale, selling, or importing for those purposes the product obtained directly by that process.

By virtue of Article 2(c) of the draft Law on Patents and Utility Models pharmaceutical and agricultural chemical products are patentable.

As indicated in the response to question 29, Article 11 of the draft Law on Patents and Utility Models provides that where the subject matter of a patent is a process, the patent holder has the exclusive right to prevent third parties not having the holder's consent from the acts of using the process, and from the acts of using, offering for sale, selling, or importing for those purposes the products obtained directly by that process.

There are no additional conditions.

Article 13 of the draft Law on Patents and Utility Models provides for limited exceptions to the exclusive rights conferred by a patent whereby the use of a patent does not require the authorization of the patent holder. These are: a) The use of the patent for personal purposes, which are non-commercial and nonindustrial, or for research purposes. b) Where a third party in Bahrain has in good faith made arrangements to exploit in Bahrain the invention the subject of the patent before an application of a patent is filed and without the consent of the patent holder, that third party shall have the right to use the invention for the purposes of its own undertaking and provided that such right shall not be transferable independently of that undertaking. c) Use of the invention on a land vehicle, vessel or aircraft temporarily or accidentally present in Bahrain. d) The use by a third party of the patent during its protection period for manufacturing a pharmaceutical chemical product for the purpose of obtaining governmental approval for the marketing of the product provided that the marketing does not start prior to the expiry of the protection period.

Article 13 of the draft Law on Patents and Utility Models provides for limited exceptions where the use of a patent does not require the authorisation of the patent holder. These are: The use of the patent for personal purposes, which are non-commercial and non-industrial, or for research purposes. Where a third party in Bahrain has in good faith made arrangements to exploit in Bahrain the invention the subject of the patent before an application of a patent is filed and without the consent of the patent holder, that third party shall have the right to use the invention for the purposes of its own undertaking and provided that such right shall not be transferable independently of that undertaking. Use of the invention on a land vehicle, vessel or aircraft temporarily or accidentally present in Bahrain. The use by a third party of the patent during its protection period for manufacturing a pharmaceutical chemical product for the purpose of obtaining governmental approval for the marketing of the product provided that the marketing does not start prior to the expiry of the protection period. Also Articles 24-27 of the draft Law on Patents and Utility Models provides for the possibility of obtaining a compulsory licence in respect of a patent. It is submitted that these provisions are in line with Article 31 of the TRIPS Agreement. These provisions are reproduced below: Article 24 The Minister of Commerce and Industry may issue a non-exclusive compulsory licence for the exploitation of a patent in the following cases: a) National emergency or other circumstances of extreme urgency or for public non-commercial use provided that the holder of the patent is notified as soon as possible after the licence is granted. b) Where the holder of the patent has not made sufficient use of the patent to the extent that he has failed to satisfy the needs of the domestic market, at reasonable prices for 3, years starting from the date of the grant of the patent or 4 years starting from the date of the filing of the patent application, whichever is longer. In such a situation, the Minister shall have the right to issue a compulsory licence to any person to whom the patent holder has refused to grant a licence or to whom the holder has imposed unfair commercial terms in order to grant him such a licence. c) Where a patented invention (first patent) involves an important technical advance of considerable economic significance in relation to another patented invention (second patent), and where the first patent can not be exploited without exploiting the second patent, the holder of the first patent may be granted a compulsory licence to exploit the second patent. This is provided that the holder of the second patent has refused to allow such exploitation on reasonable terms. The exploitation of the second patent authorized in this case may not be assigned without the assignment of the first patent. The holder of the second patent may also be granted a compulsory licence to exploit, at reasonable terms, the first patent in respect to which the other compulsory licence was granted . d) Where the holder of the patent exercises his rights for anti-competitive ends. Article 25 The following provisions shall apply to compulsory licences: a) Applications for compulsory licences shall-upon the payment of the prescribed fee-be considered each upon its own merits. b) The licence shall be exploited predominantly for the supply of the domestic market. c) The applicant must be capable of effectively exploiting the invention through an enterprise existing in the State of Bahrain. d) The licence shall only be granted if the applicant has made reasonable efforts to obtain a licence from the patent holder on reasonable commercial terms and conditions, and that such efforts have not been successful within a reasonable period of time. e) The applicant shall agree to limit the exploitation of the invention to the purpose, scope, conditions and period for which the licence is to be granted. f) Where the proposed exploitation relates to semi-conductor technology, authorisation shall only be granted for public non-commercial use or to remedy practices determined to be anti-competitive. g) The proposed user shall not assign the licence except with the enterprise or the part thereof relating to the exploitation of the invention and after the approval of the Minister of Commerce and Industry. h) The patent holder shall be entitled to adequate remuneration taking into account the monetary value of the licence. The need to remedy anti-competitive practices, if applicable, may be taken into account in determining the remuneration. i) The conditions provided for in items (b) and (d) of this Article shall not apply to situations where a licence is granted to remedy anti-competitive practices. j) The Minister of Commerce and Industry shall ex officio or at the request of any interested party have the authority to amend the conditions of a compulsory licence in case of change in circumstances. Article 26 Except in cases of national emergency and other circumstances of extreme urgency as referred to under Article 24(a), the competent Directorate at the Ministry of Commerce and Industry shall provide the patent holder with a copy of the licence application. The patent holder shall be provided a reasonable opportunity to respond in writing to the application. The processing of the application shall be in accordance with the procedure specified in the Implementing Regulation. The Minister of Commerce and Industry shall issue a decision accepting or rejecting the application and may grant an acceptance subject to any conditions he deems appropriate. In all cases, the Minister shall notify the holder of the patent and the applicant of his decision within 30 days of the issuance of such a decision and the competent Directorate shall enter the decision in the register of patents. The decision shall also be published in the manner specified in the Implementing Regulation. Article 27 The Minister of Commerce and Industry shall ex officio or at the request of the patent holder have the authority to terminate the licence before the end of its term in the following cases: a) The circumstances, which led to the granting of the licence, have ceased to exist and are unlikely to recur. In such case, the legitimate interests of the licensee shall be adequately protected in accordance with the terms and procedures specified in the Implementing Regulation. b) The licensee has not exploited the licence for two years from the date of its issuance. c) The licensee has not complied with any of the conditions of the licence or has failed to fulfil his obligations under this Law and the related Implementing Regulation. The decision of the Minister of Commerce and Industry in respect of the application for a compulsory licence may be challenged based on Article 36 of the draft Law which provides: "Subject to the provisions for challenges provided for under Articles 18 and 19 and without prejudice to the provisions of Article 15 of this Law, any interested party may submit a petition to the Minister of Commerce and Industry in respect of any final decision issued in accordance with this Law within 30 days of its notification to that person. A decision in respect of the petition shall be issued within 30 days of its submission and the interested party shall be notified of the decision in writing within 30 days of its date of issuance. If the interested party is not notified of a decision within 60 days of the date of submission of his petition, such petition shall be deemed rejected. Where a petition has been rejected or deemed rejected, the interested party may appeal such rejection before the High Civil Court within 60 days of its notification or lapse of the period beyond which the petition is deemed rejected as the case may be. An appeal may not be brought before the court until a petition has been filed and a decision has been issued or the period for a decision has lapsed." Individual merits in considering authorization will be for the Minister to consider when deciding upon an application. His decision will be subject to review by the court based upon Article 36 of the draft Law.

This will be for the Minister to consider on a case-by-case basis as stipulated under Article 25(a). His decision is subject to review by the court. By virtue of Articles 24 and 25 of the draft Law on Patents and Utility Models, the draft Law provides that except where a compulsory licence is granted to remedy an anti-competitive practice or in cases of national emergency or other circumstances of extreme urgency or for public noncommercial use, the proposed user must have made reasonable efforts to obtain a licence from the patent holder on reasonable commercial terms and conditions, and that such efforts have not been successful within a reasonable period of time. The draft Law does not define "reasonable time", as is the case with the TRIPS Agreement. It was not considered appropriate to provide such a definition and instead it was decided to leave this matter to be determined on a case by case basis depending on the relevant circumstances peculiar to the application.

The draft Law does not provide for additional protection for patented invention after the lapse of 20 years which is counted from the filing date (Article 14 of the draft Law on Patents and Utility Models).

This is accounted for by providing the following in the draft Law: Article 42 Without prejudice to the provisions of any agreement or treaty to which the State of Bahrain is party, patents granted in accordance with existing Laws and Regulations prior to the date of entry into force of this Law shall enjoy protection, and be considered as though they are registered under this Law. The elapsed period of protection shall be deducted from the term of protection provided for under this Law and its Regulations. Article 43 The provisions of this Law shall apply to any application filed prior to the entry into force of this Law and which has not been granted a patent. The applicant may amend his application in accordance with the provisions of this Law. Article 46 Ministers shall, each within its own capacity, implement this Law upon its publication in the Official Gazette.

Article 12 of the draft Law on Patents and utility Models provides the following: "With due regards to the defendant's right to protect his industrial and commercial secrets, the civil court may, in a claim relating to the exploitation of a patented industrial process used without the consent of its owner, order the defendant to prove that the process used to obtain an identical product is different from the patented process. This is provided that the plaintiff has been unable to identify the process actually used despite reasonable efforts and provided the court believes it is likely that the identical product was made using the protected process."

The proposed draft Law on Layout Design of Integrated Circuits will provide protection to Topographies of Integrated Circuits. The draft Law incorporates the provisions of Articles 35 to 38 of the TRIPS Agreement.

Article 6 of the draft Law on Layout Designs of Integrated Circuits provides: "The owner of the layout-design shall have the exclusive right to exploit it for commercial purposes. Third parties may not reproduce, whether by incorporation in an integrated circuit or otherwise, the protected layout-design in its entirety or any new part thereof; nor import, sell or otherwise distribute for commercial purposes a layout-design or an integrated circuit in which a layout-design is incorporated, without the authorization of the right holder. Notwithstanding, where any of the acts referred to in Paragraph (a) are performed by a person who had no knowledge nor reasonable ground to know, when performing such act, that the integrated circuit or article contains a protected layout-design, he may after being notified ,by the right holder with registered mail with recorded delivery , that the integrated circuit or article contains a protected layout-design, dispose of the stock of articles in his possession or that he has ordered but shall in either cases be liable to pay a fair compensation to the right holder."

Please refer to the response to question 40 above.

Article 8 of the draft law on the Protection of Layout Design of Integrated Circuits provides that the term of protection is 10 years counted from the date of filing an application for registration in the State of Bahrain or from the date of its first commercial exploitation in the State of Bahrain or abroad, whichever expires earlier, but in all cases the term of protection shall expire 15 years after the creation of the layout design.

A defined period for protection is prescribed only with respect to undisclosed tests or data the origination of which involves a considerable effort, and which have been submitted to the competent authorities for the purpose of obtaining approval for marketing of pharmaceutical or of agricultural chemical products which utilise new chemical entities. Article 2 of the draft Law on the Protection of Trade Secrets provides that the competent authorities which receive such tests or data shall protect them against disclosure as from the date they are received until they are no longer secret, and shall prohibit their unfair commercial use by preventing any third party not having the consent of the person who submitted them from relying on such data or tests in the marketing of similar drugs or products for 5 years following the date of marketing approval of the drugs or products in Bahrain.

Article 1 of the draft Law on the Protection of Trade Secrets provides that Trade Secrets include: a) information considered secret if it, as a body or in its precise components, is unknown or not available among or readily accessible to persons who normally deal with such kind of information. b) information that has commercial value because it is secret. c) information that has been subject to reasonable steps under the circumstances by the person lawful in control of the information to keep it secret.