Second medical use or indication claims. Mr. Antonio Ray ORTIGUERA Angara Abello Concepcion Regala & Cruz Law Offices Philippines

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1 Question Q238 National Group: Title: Contributors: Reporter within Working Committee: PHILIPPINES Second medical use or indication claims Mr. Alex Ferdinand FIDER Mr. Antonio Ray ORTIGUERA Angara Abello Concepcion Regala & Cruz Law Offices Philippines Mr. Alex Ferdinand FIDER Date: 13 May 2014 Questions I. Current law and practice Groups are invited to answer the following questions under their national laws. If those national and regional laws apply to a set of questions, please answer the questions separately for each set of laws. Please number your answers with the same numbers used for the corresponding questions. 1) Does your country permit patents covering any aspect of new uses of known pharmaceutical compounds (hereafter referred to as second medical use claims)? Yes. Please note that patents covering new aspect of new uses of pharmaceutical compounds is an exception to the general rule that the mere discovery of any new property or new use for a known substance, or the mere use of a known process unless such known process results in a new product that employs at least one new reactant. The said rule has been clarified and modified under the Philippine Bureau of Patent Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances where second medical use claims are expressly recognized. Please see discussion in Questions 2a) and 2b) below. 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. 2) If the answer to Question 1) is yes, please answer the following sub-questions. a) What is the basis for patent protection? Republic Act No. 8293, as amended, otherwise known as the Intellectual Property Code of the Philippines (IP Code) is the basis for patent protection, in general, in the Philippines. 1

2 With respect to the patentability of second medical use, the Joint Department of Health- Department of Trade and Industry-Intellectual Property Office-Bureau of Food and Drugs Administrative Order No which is the Implementing Rules and Regulations of Republic Act 9502, otherwise known as the Universally Accessible, Cheaper and Quality Medicines Act of 2008, and the Philippine Bureau of Patent Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances are the relevant rules to consider. b) What types of second medical use are patentable? See, for example, paragraphs 14) - 17) above. Under the Philippine Bureau of Patent Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances, the concept of second medical use can only be applied to claims relating to the subsequent use of known substances or compositions for the preparation of a medicament intended for therapy, surgery or diagnosis. c) Are any types of second medical use impermissible subject matter? See, for example, paragraphs 14) - 17) above. Yes. They are the second medical uses that are outside the scope and coverage of the concept of second medical use as discussed in paragraph b above. d) What forms of second medical use claims are permissible? See, for example, paragraphs 26) - 33) above Under the Philippine Bureau of Patent Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances Swiss-type claims are acceptable as follows: i. Use of a substance X in the manufacture of a medicament for the treatment of disease Y. ii. Use of a substance X in the preparation of a medicament for the treatment of disease Y. iii. Use of a substance X in the preparation of a pharmaceutical composition for the treatment of disease Y. e) What forms of second medical use claims are not permissible? See, for example, paragraphs 26) - 33) above. Under the Philippine Bureau of Patent Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances the following claims are not allowable: i. Method of treating disease Y by administering (a therapeutically effective amount of) a substance or composition X. ii. Use of a substance or composition X for the treatment of disease Y. iii. Use of a substance or composition X as an antibacterial (cardiovascular, bronchiolytic, etc.) agent. iv. Use of a substance or composition X as a medicament for the treatment of disease Y. v. Use of substance or composition X for the method of treatment of disease Y. The aforecited claims are not allowed for being considered as methods of treatment. 2

3 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. The only clear guidance concerning second medical claim use is the Philippine Bureau of Patent Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances which provides the methodology to be observed by patent examiners of the Intellectual Property Office of the Philippines in the examination of applications for patents on drugs and medicines. 3) If your country permits second medical use claims: a) Who may be liable for infringement of such claims? Under Section 71 of the IP Code, a party commits patent infringement by making, using, offering for sale, selling or importing the patented product. Thus - For example: i) the party marketing the drug with label instructions which describe the patented use; Yes, as it may be considered offering for sale. ii) the physician prescribing the drug for such use; No. iii) the pharmacist dispensing a drug for such purpose; Yes, if selling. iv) the patient using the drug for such purpose? No. Section 72.2 of the IP Code includes as a limitation to patent rights where the act is done privately and on a non-commercial scale or for a non-commercial purpose. b) Are any parties exempt from infringement or liability for infringement of such claims. If so, what classes of party? Under Section 72 of the IP Code, with regard to drugs and medicines, the right to import and sell patented drugs and medicines shall be available to any government agency or any private third party after the drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner. Also, exempt from infringement are: i. acts that include testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product. 3

4 ii. iii. acts consisting of making or using exclusively for experimental use of the invention for scientific purposes or educational purposes and such other activities directly related to such scientific or educational experimental use. acts consisting of the preparation for individual cases, in a pharmacy or by a medical professional, of a medicine in accordance with a medical prescription or acts concerning the medicine so prepared. c) Are such claims enforceable on the basis of direct or indirect infringement? Please provide details. Both direct and indirect infringement can be used as a basis to enforce such claims. Direct infringement may be committed by a party making, using, offering for sale, selling or importing the patented drug. A party may also be liable for indirect infringement by actively inducing the infringement or provides the infringer with a component of a patented product or of a product produced because of a patented process knowing it to be especially adopted for infringing the patented invention and not suitable for substantially non-infringing use. The liability of the indirect infringer is jointly and severally with the direct infringer. (see Section 76.6 of the IP Code). 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? Yes, so long as the drug is still patented. 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. Yes. 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? Yes. c) If yes to b), is it necessary that the party knows that their actions are in connection with the infringing use? No. d) If yes to c), what standard of knowledge is required? See, for example, paragraphs 38) and 47) above. NA. 6) How do the courts determine infringement of a second medical use claim? What are the legal tests and evidentiary requirements? Court will apply the test of literal infringement and doctrine of equivalence. 4

5 7) What relief is available for infringement of a second medical use claim: a) at a preliminary / interim / interlocutory level? Preliminary injunction and seizure of the drugs. b) by way of final relief? Permanent injunction, damages and destruction of the drugs. 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? No. Courts will usually require an expert to testify that the drug is infringing. 9) In respect of Question 7)b), what level of proof is required to obtain a final injunction? The quantum of evidence required in a civil case for injunction is preponderance of evidence. II. Policy considerations and proposals for improvements to your current system 10) If your country permits second medical use claims, please answer the following subquestions. a) What are the policy reasons behind permitting such claims? The general policy rational is public health considerations and the development of domestic and creative activity, i.e., the research and development conducted to determine the second medical use. b) Are such claims as are currently permissible in your country considered to strike the right balance between the interests of relevant stakeholders? Yes c) Is it considered that such claims better serve the interests of some stakeholders and/or are detrimental to other stakeholders? It better serves the stakeholders who spend resources on research and development in the second medical use. Giving second medical use of known substances or compositions patent protection is permitted on the condition that it will be able to satisfy the eligibility standard requirement on mere discoveries, i.e. inherency. Any application for patent protection must also pass the three (3) criteria of patentability of novelty, inventive step and industrial applicability; where the novelty is derived from the claimed new use. Please note that claims or processes that are or have become part of public domain, whether explicit or inherent, will no longer be allowed patent protection. 5

6 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? No data available. ii) What is the profile of patentees for second medical use claims in your country? No data available. 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? b) Would such claims serve the interests of relevant stakeholders? c) Would such claims be considered to better serve the interests of some stakeholders and/or be detrimental to other stakeholders? 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? III. Proposals for substantive harmonisation The Groups are invited to put forward proposals for the adoption of harmonised laws in relation to second medical use claims. More specifically, the Groups are invited to answer the following questions without regard to their existing national laws. 13) Is it desirable to permit second medical use claims? Yes, provided they must also pass the three (3) criteria of patentability of novelty, inventive step and industrial applicability; and, provided further, that such second medical use claim is not intended to bring back to patent space the knowledge or process already part of the public domain. 14) Is harmonisation of laws relating to second medical use claims desirable? Yes. 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. Where the drug is initially developed for a particular purpose and later found to be useful for the preparation of another medicament intended for therapy, surgery or diagnosis. b) Types of any second medical use constituting impermissible subject matter. See, for example, paragraphs 14) - 17) above. Any second medical use that does not pass the three (3) criteria of patentability of novelty, inventive step and industrial applicability. 6

7 c) Form of permissible claims. See, for example, paragraphs 26) - 33) above. Swiss-type claims since they are construed as an activity of formulating the medicament s active substance which constitutes the process for obtaining the medicament and pass the requirement of industrial applicability. It also considers that the intended purpose of the manufacture of the agent is the use of a known compound in the treatment of the human or animal body by surgery or therapy or in a diagnostic method. d) Form of impermissible claims. See, for example, paragraphs 26) - 33) above. Methods of treatment claims. e) Who may be liable for infringement. Those who make, offer for sale, sell or import. f) Any parties/institutions that should be exempted from infringement or liability for infringement. Personal users and use relating to scientific research, testing, etc. 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. No knowledge should be required. h) Relief available upon a finding of infringement: i) at a preliminary / interim / interlocutory level; and Preliminary injunction and seizure. ii) by way of permanent relief. Permanent injunction, damages and destruction. i) In each case for h)i) and h)ii), the level of proof for the granting of such relief. Preponderance of evidence. The Groups are invited to comment on any additional issues concerning any aspect of second medical use claims that they deem relevant. 7

8 Summary In the Philippines, the general rule is that patents covering any aspect of new uses of known pharmaceutical compounds are not permitted. Giving second medical use of known substances is permitted only on the condition that it will be able to pass the three (3) criteria of patentability of novelty, inventive step and industrial applicability, wherein the new use pertains to the issue of novelty. This requirement is expressly found in the Philippine Bureau of Patent Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances. Presumably, the policy rational for second medical use patents is to encourage creative activities. By allowing patent protection, a return on the resources spent for research and development is assured. In a developing country like the Philippines, allowing second medical use patents may have both positive and negative effects. Pharmaceutical companies benefit in the short term, but the long term benefit is to the public. 8