Question Q238 National Group: Title: Contributors: Reporter within Working Committee: Bulgarian National Group Second medical use or indication claims Valentina NESHEVA Valentina NESHEVA Date: 16 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)? 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? There is no explicit legal basis in the Bulgarian Law on Patents and Registration of Utility Models (LPRUM) providing for the legal protection of a second medical use of known compounds. Art. 6 of LPRUM say: Any inventions in any technical field are patentable, provided they are novel, have inventive step and are industrially applicable. In addition Art. 11 (13) of the Regulation on Drafting, Filing and Examination of Patent Applications (RDFEPA) indirectly provides a legal basis for the protection of second medical use, foreseeing that: When the claim relates to the use of known substances or compositions in methods for treatment or diagnostics of humans or animals, it is drafted without dividing the claim in parts. b) What types of second medical use are patentable? See, for example, paragraphs 14) - 17) above/wgls. In view of the fact that the requirements for patentable invention are novelty, inventive step and industrial applicability, the problem with any type of second medical use will 1
be if the claimed second medical use has inventive step over the prior art and in particular in relation to the first medical use. Obviously the use for treating a different disease where the known compound or composition already has first medial use (whether protected and actively applied or not) may have inventive step and may be granted legal protection. However if a mere change of the dosage regime is questionable has an inventive step is very questionable and such a claim will rather not be granted legal protection. c) Are any types of second medical use impermissible subject matter? See, for example, paragraphs 14) - 17) above/wgls. In view of the fact that the Bulgarian patent law does not explicitly provide for the protection of a second medical use, it does not also differentiate between any special types of such a second medical use. d) What forms of second medical use claims are permissible? See, for example, paragraphs 26) - 33) above/wgls. There is no particular type of claim required by the Bulgarian Patent Office but claiming Method for treatment is not allowed because such methods are deemed to lack industrial applicability. In principle the practice of the BPO is harmonized with the practice of the EPO with the distinction that the Swiss type claim will be allowed by the BPO, while this type of claim is not permissible any more before the EPO. e) What forms of second medical use claims are not permissible? See, for example, paragraphs 26) - 33) above/wgls. Claim for method of treatment of human or animal is not permissible. All other types of wording of a claim for second medical use are permissible. 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. There is no guidance provided by the Bulgarian Patent Office or the courts regarding the meaning of treatment, treating or use to treat and no distinction is made between these terms. 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; Yes ii) the physician prescribing the drug for such use; No iii) the pharmacist dispensing a drug for such purpose; Yes iv) the patient using the drug for such purpose? No The Bulgarian patent law provides for the right of the patent proprietor to use the patented invention, to forbid such a use by third parties and to dispose of the patent. The right to use includes the production, offering for sale, trade with the patented invention, including the import and use of the patented product and the implementation of the patented method. Therefore the third parties may not engage in such activities without the consent of the patent proprietor. In the above cases the party marketing a drug to be used for the patented use is clearly infringing the patent for a second medical use. The physician prescribing the drug cannot be held 2
responsible in view of the fact that he is not using the patented invention but carries out his profession for the benefit of the patient as his oath as a medical doctor obliges him. The pharmacists are infringing the patent with one specific exclusion provided by the law. The patient taking the drug to treat his medical condition or disease will not be held accountable for infringing the patent. In all cases of infringing activities it is necessary that the alleged infringer has acted intentionally. b) Are any parties exempt from infringement or liability for infringement of such claims. If so, what classes of party? Art. 20 of LPRUM provides for specific limitations of the exclusive right of the patent proprietor which are: 1. Use of the patented invention for non-commercial purposes relating to personal needs, if such use does not significantly hurt financially the patent proprietor; 2. Use of the patented invention for experimental purposes or for scientific research relating to the subject of invention; 3. One-time direct preparation of a drug in a pharmacy on grounds of a prescription by a medical doctor; c) Are such claims enforceable on the basis of direct or indirect infringement? Please provide details. The Bulgarian patent law does not distinguish between direct and indirect infringement. Claims for second medical use may be enforceable in all above mentioned cases of infringement. 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? If the patent claims protect only the use of a known chemical compound or pharmaceutical composition, the production and marketing of this compound or preparation not for the patented use but for some other use is not infringing the patent. 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? Bulgarian courts have very limited practice in patent cases and no specific tests or evidentiary requirements have been developed in this regard. 3
7) What relief is available for infringement of a second medical use claim: a) at a preliminary / interim / interlocutory level? There is no sufficient court practice to show if the court may allow preliminary injunction on grounds of a second medical use claim. Anyway if such a preliminary injunction is admitted, the court surely will require money bond to preserve the rights of the attacked party in case the patent proprietor fails to prove his claim for infringement of his patent before the court. b) by way of final relief? The patent proprietor may claim and receive any direct damages resulting from the infringing activities of the alleged infringer. Furthermore the court may order the infringer to discontinue the infringement if the patent proprietor so requests. 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? There is no sufficient court practice to answer this question. 9) In respect of Question 7)b), what level of proof is required to obtain a final injunction? The patent proprietor is obliged to prove fully his allegations with any admissible evidentiary means documents, requesting court order to provide information that is in possession of third parties or the infringer, examination by experts appointed by the court like patent experts, financial or accounting experts; questioning of witnesses. 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? The Bulgarian legislation and the practice of the Bulgarian Patent Office are harmonized with the other European countries according to the obligations of Bulgaria as member state of EC. Although the Bulgarian patent law does not provide explicitly for the legal protection of second medical use claims, considerations relating to public health and preserving rights of patent proprietors resulted in admitting such claims to legal protection in Bulgaria, in accordance with the practice of EPO. Yes. b) Are such claims as are currently permissible in your country considered to strike the right balance between the interests of relevant stakeholders? No. 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? 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 harmonisation The Groups are invited to put forward proposals for the adoption of harmonized 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, it certainly is desirable to permit such claims in order to stimulate scientific research and to improve the public health. 5
14) Is harmonization 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. 14) 17) a) Types of second medical use constituting permissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. None. b) Types of any second medical use constituting impermissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. 26) 33) None. c) Form of permissible claims. See, for example, paragraphs 26) - 33) above/wgls. d) Form of impermissible claims. See, for example, paragraphs 26) - 33) above/wgls. e) Who may be liable for infringement? The party financially benefitting from the infringement. Any use for personal needs should be excluded from infringement to preserve the right of any person to live and seek means to save his/her life or to get healthy. f) Any parties/institutions that should be exempted from infringement or liability for infringement. Patients and medical doctors if the latter do not benefit financially from the infringement. Pharmacists dispensing drugs according to a prescription by a medical doctor. 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. Producing and marketing the drug with packaging on which is indicated the patented second medical use. h) Relief available upon a finding of infringement: i) at a preliminary / interim / interlocutory level; and ii) by way of permanent relief. The current situation in Bulgaria provides the necessary balance between preserving the rights of the patent proprietor and not admitting groundless claims or using patent rights unfairly to hurt competitors. i) In each case for h)i) and h)ii), the level of proof for the granting of such relief. 6
The patent proprietor attacking an alleged infringer has to initiate a lawsuit proving his case at least at first glance and furthermore a money bond should be placed on allowing a preliminary injunction in order to preserve the rights of the alleged infringer if the patent proprietor fails to prove his allegations. 7