Question Q238 National Group: Title: Contributors: Reporter within Working Committee: Egyptian National Group Second medical use or indication claims Eman MOHEY, Gamal ABOU ALI Ahmed ABOU ALI Date: May 11, 2014 Questions I. Current law and practice 1) Does your country permit patents covering any aspect of new uses of known pharmaceutical compounds (hereafter referred to as second medical use claims)? If yes, please answer Questions 2) to 7) inclusive before proceeding to the questions in Parts I and II. If no, please proceed directly to the questions in Parts II and III. No. Egypt does not permit patents covering any aspect of new uses of known pharmaceutical compounds. According to Article 1 of the Egyptian Intellectual Property Law No. 82 of 2002 ( IP Law ), a patent shall be granted to any industrially applicable invention, which meets the requirements of novelty and inventive step, whether it is connected with new industrial products, new industrial processes, or a new application of known industrial processes. Second medical use lacks the inventive step requirement. In addition to the limitation imposed by this definition, the Egyptian Patent Office ( EPO ) considers second medical use as a discovery that is not patentable under Article 2 of the IP Law. 2) If the answer to Question 1) is yes, please answer the following sub questions. a) What is the basis for patent protection? b) What types of second medical use are patentable? See, for example, paragraphs 14) - 17) above/wgls. c) Are any types of second medical use impermissible subject matter? See, for example, paragraphs 14) - 17) above/wgls. d) What forms of second medical use claims are permissible? See, for example, paragraphs 26) - 33) above/wgls. e) What forms of second medical use claims are not permissible? See, for example, paragraphs 26) - 33) above/wgls. f) Has any guidance been provided by courts or the national patent office in relation to the meaning, scope and/or effect of 'treatment', 'treating' or 'use to treat' integers in second medical use claims? See, for example, paragraphs 34) - 39) above WGLs.
3) If your country permits second medical use claims: a) Who may be liable for infringement of such claims? For example: i) the party marketing the drug with label instructions which describe the patented use; ii) the physician prescribing the drug for such use; iii) the pharmacist dispensing a drug for such purpose; iv) the patient using the drug for such purpose? b) Are any parties exempt from infringement or liability for infringement of such claims. If so, what classes of party? c) Are such claims enforceable on the basis of direct or indirect infringement? Please provide details. 4) If a drug is approved for more than one indication, one or more of which (but not all) falls within the claims of a patent, is it an infringement if a party makes, supplies or uses a generic version of the drug for any use? 5) If the answer to Question 4) is yes, please answer the following sub questions in that context. a) Is each of the acts of making, supplying and using a form of infringement? If not, please specify which (or any other) acts which constitute infringement. b) Is it necessary for a finding of infringement that the party making, supplying or using the generic version of the drug does so in connection with the infringing use? c) If yes to b), is it necessary that the party knows that their actions are in connection with the infringing use? d) If yes to c), what standard of knowledge is required? See, for example, paragraphs 38) and 47) above. 6) How do the courts determine infringement of a second medical use claim? What are the legal tests and evidentiary requirements? 7) What relief is available for infringement of a second medical use claim: a) at a preliminary / interim / interlocutory level? b) by way of final relief? 8) In respect of Question 7)a), can a preliminary / interim / interlocutory injunction be granted solely upon the statements provided in the product packaging or based on the writing of a prescription? If not, what is the basis for relief? 9) In respect of Question 7)b), what level of proof is required to obtain a final injunction? II. Policy considerations and proposals for improvements to your current law 10) If your country permits second medical use claims, please answer the following sub questions. a) What are the policy reasons behind permitting such claims? 2
b) Are such claims as are currently permissible in your country considered to strike the right balance between the interests of relevant stakeholders? c) Is it considered that such claims better serve the interests of some stakeholders and/or are detrimental to other stakeholders? d) If there is any empirical or anecdotal data available, please address the following. i) What is the prevalence of second medical use claims in your country? ii) What is the profile of patentees for second medical use claims in your country? 11) If your country does not permit second medical use claims, please answer the following sub questions. a) What are the policy reasons behind not permitting such claims? Considering a second medical use claims as non patentable is due to the legal characterization of the claims. Second medical use claims do not involve any inventive step in order to make them different from original patented compounds. In addition, such claims lack novelty which makes Patents Office characterize them as discoveries rather than inventions. b) Would such claims serve the interests of relevant stakeholders? Refusal to grant patents to second medical use claims does not mean that such claims cannot be utilized commercially. The Egyptian General Administration of Pharmaceutical Affairs ( GAPA ) may approve registration of a medicine even if it is based on a second medical use; provided that, the producing company submits all relevant studies supporting such new indication. The above scheme allows other pharmaceutical companies to compete with the inventor/discoverer of the second medical use. Although the above scheme is intended to favor consumers by lowering the price of medicines, it does decrease the incentive of the inventor to enter the local market. This may be offset by the fact that the local market is big with the population nearing 90 million which incentivizes pharmaceutical companies to enter the local market even if the margin of profit is less than desired. c) Would such claims be considered to better serve the interests of some stakeholders and/or be detrimental to other stakeholders? These claims, if allowed, would better serve the interest of the inventor pharmaceutical company and to the consumer if the incentive rationale is followed but it might adversely affect competitors and consumers, with respect to pricing; although the Government can resort to mandatory pricing/licensing to mitigate this effect. 12) To what extent does your country's law in relation to second medical use claims affect the pharmaceutical industry (originator and generic) in your country? Egypt does not have a significant pharmaceutical industry which is based on local inventions, but it has a large market which is based on generic products and a market focusing on local production of foreign invented products. Thus, most medicines are 3
initially approved outside Egypt prior to their commercial use in Egypt. The more significant effect therefore relates to availability and pricing to consumers. III. Proposals for harmonisation 13) Is it desirable to permit second medical use claims? It is desirable to permit second medical use claims whether to the original inventor or the discoverers of the second medical use in order to open the market for a wider range of products as well as incentivize local pharmaceutical companies to allocate more resources and effort to research and development. Although pricing for the consumers is always a key issue, it can be addressed through pricing mechanisms. A shorter term of protection may be considered as a compromise between the interests of consumers, local producers and international pharmaceutical companies. 14) Is harmonisation of laws relating to second medical use claims desirable? Yes. Harmonization of laws relating to second medical use claims, and more generally to intellectual property rights in the pharmaceutical industry, is desirable as it provides more certainty and predictability for pharmaceutical companies; therefore facilitating their entry into newer markets. 15) Please provide a standard that you consider to be best in each of the following areas relating to second medical use claims. a) Types of second medical use constituting permissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. The following examples may constitute permissible grounds for patentability: Where a drug is developed for a certain purpose and after research was found to be useful for another medical purpose. Unsuccessful compounds used originally to treat specific conditions and subsequently used successfully to treat other diseases. b) Types of any second medical use constituting impermissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. Dosage and method of administration should not be patentable as this is more difficult to demonstrate. In addition, in many cases there is no agreement within the scientific community regarding the dosage and methods of administrations. It may also be the case that dosage and method of administration require less research and development cost, especially if intended to treat the same disease. c) Form of permissible claims. See, for example, paragraphs 26) - 33) above/wgls. The EBA decision G2/08 seems to be a good standard for allowing second medical use claims: Substance X for use in the treatment of condition Y. We understand that this standard requires more than merely using the same substance without any additions/amendments to treat a different condition. It is therefore possible to pass a more lenient inventive step test. 4
d) Form of impermissible claims. See, for example, paragraphs 26) - 33) above/wgls. We are of the opinion that the new dosage regime should be a form of impermissible claims. e) Who may be liable for infringement? Producers of the same compounds for different treatment may be liable for infringement. f) Any parties/institutions that should be exempted from infringement or liability for infringement. It may be difficult and impracticable to hold doctors prescribing a medicine for a second medical use liable. It may also not be desirable to require the competent authority GAPA in Egypt s case to be held liable for authorizing second medical use as this may result in a restrictive approach by GAPA which may result in refusing to allow medicines that may otherwise not be violating second medical use claims. g) Where a drug is approved for more than one indication, one or more of which (but not all) falls within the claims of a patent, the acts that should constitute patent infringement, and in particular, the standard of knowledge of the alleged infringer. Patent infringement should be invoked only where the producer of the drug markets it expressly for the second medical use (i.e. one or more the indications which falls within the claims of a patent) but not with respect to unprotected claims. Actual knowledge, in this approach, would be presumed without need for evidence by the infringed party if the claims are patented (i.e. a knew or should have known standard should be applied). h) Relief available upon a finding of infringement: i) at a preliminary / interim / interlocutory level; and ii) by way of permanent relief. A preliminary / interim / interlocutory level would be more desirable so as to avoid the prevention of the drug s use for unprotected claims. i) In each case for h)i) and h)ii), the level of proof for the granting of such relief. The standard of proof is that the infringer knew or should have known. Summary Q238 Egypt does not permit second medical use claims, on the grounds that they do not meet the requirements of novelty and inventive step. Refusal to grant patents to second medical use claims does not mean that such claims cannot be utilized commercially. 5
It is desirable to permit second medical use claims in order to open the market for a wider range of products as well as incentivize local pharmaceutical companies to allocate more resources and effort to research and development. A good standard for allowing second medical use claims is: substance X for use in the treatment of condition Y, as it requires more than merely using the same substance and may therefore pass a more lenient inventive step test. Doctors and relevant health authorities should not be held liable for second medical use infringement. Patent infringement should be invoked against producers who knew or should have known of the infringement. 6