No. According to the PTO s internal examination guidelines, second medical use claims are not patentable.

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1 Question Q238 National Group: Title: Contributors: Reporter within Working Committee: Argentina Second medical use or indication claims Gastón RICHELET, Ricardo D. RICHELET Gastón RICHELET Date: May 19, 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)? No. According to the PTO s internal examination guidelines, second medical use claims are not patentable. Said guidelines indicate that second medical use claims are equivalent to methods of therapeutic treatment and that they lack industrial applicability. Furthermore, it is therein established that second medial use claims cannot be patented even if drafted as Swiss-type claims. It is important to clarify that while our Patent Law does not consider methods of therapeutic treatment as inventions, there is no prohibition or patenting exception in said Law regarding use, second use or second medical use claims. Additionally, there is no provision in our Patent Law which makes or considers second medical use claims as equivalent to methods of therapeutic treatment. The prohibition regarding the patenting of second medical use claims has been established by a Joint Resolution issued by the PTO and the Ministries of Health and Industry which contents clashes with our Patent Law, its Regulations and the Treaties signed by our country. The contents of said Joint Resolution where then incorporated into the PTO s internal examination guidelines. According to our legal system and Constitution, Treaties, Laws and Regulations in that specific order have a superior hierarchical legal status compared to Resolutions issued by the PTO or the Ministries. Therefore, the contents of the Joint Resolution above mentioned are unconstitutional. 1

2 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? 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. 2

3 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? 3

4 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? 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? The issue of the patenting of second medical use claims has been and still is a political issue in our country since the local generic pharmaceutical industry has traditionally being opposed to the grant of this type of claims. However, there is nothing in the Patent Law preventing its protection. There is no sound legal policy reason behind this de facto prohibition. b) Would such claims serve the interests of relevant stakeholders? Such claims would definitively serve the interests of some relevant stakeholders, particularly the interests of the companies and entities which do R&D and investigate in this area. c) Would such claims be considered to better serve the interests of some stakeholders and/or be detrimental to other stakeholders? Such claims would better serve the interests of the originator companies, organizations and research institutes and centers which nowadays are prevented from seeking protection for second medical use claims in Argentina. Some of said 4

5 entities are Argentinean and they are faced with a situation where they can seek protection abroad but not locally. The allowance of said claims would obviously be detrimental to those companies which are not focused in innovating. 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? There is a clear difference in our country between originator and generic pharmaceutical companies. The allowance of patenting of certain claims is one of the main reasons that has made said division so clear. The local pharmaceutical industry has been historically against the patent system in general and second medical use claims in particular. III. Proposals for 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? It is desirable to permit second medical use claims, as does our current Patent Law. 14) Is harmonisation of laws relating to second medical use claims desirable? Harmonisation of laws relating to second medical use claims is desirable. 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. All of those mentioned in paragraphs 14) -17). b) Types of any second medical use constituting impermissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. A priori none. c) Form of permissible claims. See, for example, paragraphs 26) - 33) above/wgls. In principle all use claims described in the chart of paragraph 31). d) Form of impermissible claims. See, for example, paragraphs 26) - 33) above/wgls. Those drafted as methods of treatment. e) Who may be liable for infringement? In principle all subjects or entities as in any other case whether directly or as a contributor. 5

6 f) Any parties/institutions that should be exempted from infringement or liability for infringement. We understand that doctors, hospitals and pharmacists should be excluded under certain conditions. 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. All acts should constitute patent infringement but only if the alleged infringer knows, or under the circumstances it is obvious, that the ultimate users will put the invention into effect or use it under the protected use. There should be no patent infringement where the person has no reason to believe that the product will be used by recipients contrary to the given indications or when reasonable steps have been taken to ensure that the product will only be used in a non-infringing manner. For example, when labelling does not include any infringing use. h) Relief available upon a finding of infringement: i) at a preliminary / interim / interlocutory level; and All available for other types of patents with the same level of proof. ii) by way of permanent relief. All available for other types of patents with the same level of proof. i) In each case for h)i) and h)ii), the level of proof for the granting of such relief. 6

7 Summary According to the PTO s internal examination guidelines, second medical use claims are not patentable in our country. However, said prohibition is included in the PTO s guidelines and not in our Patent Law. According to our legal system and Constitution, Treaties, Laws and Regulations have a superior hierarchical legal status compared to Resolutions issued by the PTO. Therefore, the contents of the PTO s guidelines that clash with our Patent Law, such as those dealing with the prohibition of second medical use claims, are unconstitutional. It is the position of the Argentinean Group that second medial use claims should be protectable and that harmonization in this area is desirable. As to the standards suggested, the Group believes that they should be as broad as possible. Résumé Selon les lignes directrices pour examens internes du PTO, les revendications de deuxième usage médical ne sont pas brevetables dans notre pays. Toutefois, cette interdiction est incluse dans les lignes directrices du PTO et pas dans notre Loi sur les Brevets. Selon notre système juridique et Constitution, les Traités, Lois et Règlements ont un statut juridique hiérarchique supérieur par rapport aux Résolutions émises par le PTO. Par conséquent, le contenu des lignes directrices du PTO qui s'opposent à notre Loi sur les Brevets, telles que celles portant sur l'interdiction de revendications de deuxième usage médical, est inconstitutionnel. C'est la position du Groupe Argentin que les revendications de deuxième emploi médical devraient être protégeables et qu une harmonisation dans ce domaine est souhaitable. Quant aux normes proposées, le Groupe estime qu'elles devraient être aussi larges que possible. Zusammenfassung Nach den internen Überprüfungsrichtlinien der PTO (Patent and Trademark Office) sind in unserem Lande die Ansprüche auf eine zweite medizinische Anwendung nicht patentierbar. Dieses Verbot ist jedoch in den Richtlinien der PTO enthalten und nicht in unserer Patentgesetzgebung. Nach unserer Rechtsordnung und der Staatsverfassung genießen Abkommen, Gesetze und Regelungen einen höheren rechtlichen Rang, als die von der PTO erlassenen Beschlüsse. Darum sind die Inhalte der PTO-Richtlinien, die mit unserem Patentgesetz kollidieren wie etwa jene auf das Verbot von Ansprüchen auf eine zweite medizinische Anwendung bezogenen verfassungswidrig. Der Standpunkt der argentinischen Gruppe ist, dass Ansprüche auf eine zweite medizinische Anwendung Gegenstand des Rechtsschutzes sein sollten und eine Harmonisierung auf diesem Gebiet wünschenswert sei. Hinsichtlich der vorgeschlagenen Standards ist die Gruppe der Ansicht, sie sollten so umfassend wie möglich sein. 7