Second medical use or indication claims. Winnie Tham, Edmund Kok, Nicholas Ong

Transcription

1 Question Q238 National Group: Title: Contributors: Reporter within Working Committee: AIPPI SINGAPORE Second medical use or indication claims Winnie Tham, Edmund Kok, Nicholas Ong THAM, Winnie Date: 17 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. 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? Patent protection for second medical use can be found in the legislation. Section 14(7) of the Singapore Patents Act states that [in] the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art. b) What types of second medical use are patentable? See, for example, paragraphs 14) - 17) above/wgls. First medical uses of a known compound or substance are patentable pursuant to Section 14(7) of the Singapore Patents Act. 1

2 Second, or subsequent, medical uses are also patentable. This would include drugs initially developed for a particular therapeutic purpose that are found to also be useful for another therapeutic area. Similarly, drugs for which the first known use of the compound did not succeed but are discovered to be useful for another therapeutic area are also patentable. c) Are any types of second medical use impermissible subject matter? See, for example, paragraphs 14) - 17) above/wgls. Apart from the general prohibition against patents which encourage offensive, immoral or anti-social behavior, there are no types of second medical use which are impermissible subject matter. d) What forms of second medical use claims are permissible? See, for example, paragraphs 26) - 33) above/wgls. Two types of medical use claims are permissible. Firstly, purpose-limited product claims for the first medical use of a known compound or substance are acceptable. Secondly, second or subsequent medical use claims in the Swiss type format of the use of substance X for the manufacture of a medicament to treat disease Y are also acceptable. e) What forms of second medical use claims are not permissible? See, for example, paragraphs 26) - 33) above/wgls. Pursuant to Section 16(2) of the Singapore Patents Act, claims for methods of treatment are not patentable due to a lack of industrial application. Further, the Intellectual Property Office of Singapore ( IPOS ) clarified in 2010 that claims for the second medical use of a substance or compound by using a purpose-limited product claim e.g. Compound X for use in the treatment of disease Y are not acceptable. This form is a result of EPC2000 and Section 4A(4) of the UK Patents Act, which Singapore does not have an equivalent. Claims drafted in this format would not be novel if the compound or substance had been used in any medical method in the prior art. 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. IPOS has clarified that the methods of treatment and diagnosis exception to patentability should be read narrowly. Section 16(2) of the Singapore Patents Act is primarily intended to ensure that medical or veterinary practitioners are not hindered by patent rights from properly exercising their professional skills. As such, it follows that IPOS has also adopted Jacob J s reasoning in Bristol- Myers Squibb v Baker Norton Pharmaceuticals Inc, explaining that the purpose of the exception is merely to keep patent law from interfering directly with what the doctor actually does to the patient. 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 2

3 ii) iii) iv) patented use; the physician prescribing the drug for such use; the pharmacist dispensing a drug for such purpose; the patient using the drug for such purpose? There are currently no cases on the infringement of second medical use patents. Also, Singapore allows second medical use claims in Swiss-style format. Swiss-type claims are considered to be unclear because, although they define a method of manufacturing a medicament, the invention does not in fact relate to the method of production but instead relates to the intended use of the medicament. Prima facie, any party who does an infringing act would be liable unless their act falls under one of the exceptions (see 3b) below). Also, the Patents Act specifies that there may be an infringement where the invention is a process, where one disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise. On these grounds, the parties who could potentially be liable would include: 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 manufacturer b) Are any parties exempt from infringement or liability for infringement of such claims. If so, what classes of party? The legislation does not exempt any class per se. However, there are various exceptions to infringement. The pharmacist dispensing a drug for such purpose will not be liable provided his act, pursuant to Section 66(2)(c) of the Singapore Patents Act, consists of the extemporaneous preparation of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner. The patient will not be liable because of the statutory exemption for private, non-commercial use. c) Are such claims enforceable on the basis of direct or indirect infringement? Please provide details. These claims will usually be enforceable on the basis of direct infringement, though Section 66(1) of the Singapore Patents Act states that it is also an infringement to dispose, offer to dispose or import infringing goods. Additionally, a party might be guilty of indirect infringement under the common law tort of procuring an infringement. It should be noted that the tort does not cover the sale of a non-patented article to a person who, to the vendor s knowledge, intended to use it in a patented process. 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? 3

4 To date, there are no Singapore cases or legislation on point. In essence, one would have to look at the indications on the packaging for the drug in question when determining whether the manufacture or sale of the drug would infringe on the second medical use claim. There is infringement if the packaging includes an indication that is claimed in the second medical use claim. If the patented indication is not present in the packaging, then there could be arguments that there may not be an infringement. In the UK case of Actavis v Merck, Jacob LJ expressed obiter support for the view that a skinny labelled drug is not being sold for the patented use and as such does not infringe the patent. This has not been tested in the Singapore courts but is likely to have some persuasive value. 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? To date, there is no Singapore case that deals with the infringement of a second medical use claim. As such, it is uncertain whether the usual rules on patent infringement apply. To determine whether there has been an infringement generally, the courts first assess the scope of the monopoly claimed in the patent. Subsequently, the courts determine whether the alleged infringement falls within the words of one of the claims. If it does, the patent has been infringed. As patent infringement is a statutory tort, the civil standard of proof would apply the claimant would have to show, on balance of probabilities, that the defendant infringed his patent. Where appropriate, the claimant would also have to establish the validity of the patent. 7) What relief is available for infringement of a second medical use claim: a) at a preliminary / interim / interlocutory level? The claimant may restrain the defendant by interlocutory injunction if the claimant can establish that he has an arguable case on the facts and that if the injunction is refused, he will not be adequately compensated by an award of damages at the full trial. The court will then determine, on the balance of convenience, whether an interlocutory injunction should be granted. 4

5 b) by way of final relief? The following remedies are available for patent infringement: (i) (ii) (iii) (iv) Account of profits; Damages; Permanent injunction; and Order for delivery. 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? It appears likely for a Singapore court to grant an interlocutory injunction solely upon the statements provided in the product packaging since there is likely to be an infringement if the packaging includes an indication that is claimed in the second medical use claim. However, one would probably need further evidence and facts (e.g. what transpired and led to the writing of the prescription) for obtaining an interlocutory injunction based on the writing of a prescription. In any event, it should be highlighted that, because an interlocutory injunction is an equitable relief, a Singapore court will also take into consideration a whole range of other factors in granting the injunction including whether there is an arguable case on the facts adequate compensation by an award of damages. 9) In respect of Question 7)b), what level of proof is required to obtain a final injunction? Likewise, a final injunction is an equitable relief and a Singapore court will take into consideration a whole range of other factors in granting the injunction.the court will usually grant a final injunction unless the circumstances negative the probability of infringement in the future. 5

6 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 Singapore Patents Act provisions on second medical use claims are largely based on those of the United Kingdom Patents Act However, Singapore has not adopted Section 4A(4) of the United Kingdom Patents Act 1977, which concerns purpose-limited product claims. There are various policy reasons why Singapore might allow second medical uses to be patented. One reason might be to incentivize research into better treatments for various diseases. For instance, a drug that does not succeed in respect of its first known use might turn out to be very effective at treating another disease. Similarly, substances originally not known to have therapeutic effects might turn out to have the same. Without the protection of the patent system, there is little incentive for pharmaceutical companies to conduct such research. Another reason might be to achieve a level of consistency with the international community. Many of the developed countries, such as the UK, US and Australia, provide patent protection in one form or another for second medical uses. Given that a substantial portion of Singapore s patent laws are derived from the United Kingdom Patents Act, it is not surprising that Singapore has permitted claims for second medical uses. b) Are such claims as are currently permissible in your country considered to strike the right balance between the interests of relevant stakeholders? Whether patents for second medical uses strike an appropriate balance between the relevant stakeholders depends on the scope of the monopoly afforded to the proprietors. It could be possible that a Singapore court may take the position that skinny labelling is not a defence to a claim for indirect infringement. Unfortunately, there is a paucity of Singapore case law on how second medical use claims are to be constructed. Singapore permits the patenting of Swiss-type claims and first time medical uses of known substances. Prima facie, this approach strikes a desirable balance as it is important to incentivize further research into pre-existing drugs and/or substances. c) Is it considered that such claims better serve the interests of some stakeholders and/or are detrimental to other stakeholders? Currently, the law has been interpreted in a manner that is favourable to patentees. It remains to be seen whether such an approach would have a corresponding detrimental effect on other stakeholders, such as patients and medical professionals. d) If there is any empirical or anecdotal data available, please address the following. There are no empirical or anecdotal data that is readily available to us. i) What is the prevalence of second medical use claims in your country? 6

7 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? The Singapore Government has taken steps to develop Singapore as a hub for biological and pharmaceutical research. As such, it is likely that the permissibility of second medical use claims would reinforce Singapore s attractiveness to originators as a viable location for research facilities. The impact of second medical use claims on generic manufacturers is unclear, given that there are no cases on the construction of second medical use claims. Additionally, the US-Singapore FTA introduced patent linkage as one of the requirements for applying for marketing approval. As such, patent linkage may help the drug patent owner in policing potential infringement even before generic drugs are launched. 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? Yes. 14) Is harmonisation of laws relating to second medical use claims desirable? Yes. It makes it easier for Applicants if the laws on second use medical claims were consistent so that they do not have to look at the situation according to each country to determine whether or not patenting is available. 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. 7

8 First medical uses for known substances and second medical uses are also patentable. This would include drugs initially developed for a particular therapeutic purpose that are found to also be useful for another therapeutic area. Similarly, drugs for which the first known use of the compound did not succeed but are discovered to be useful for another therapeutic area should also be permissible. As mentioned earlier, research into this areas could yield important medical solutions and as such warrant the incentivization provided by the patent system. It is less clear whether new dosage regimes deserve the protection of the patent system. Allowing new dosage regimes to be patented might make it too easy for an originator to obtain a valid patent over a drug which patent is about to expire, effectively extending its monopoly by another twenty years. This would have detrimental effects on various stakeholders such as patients and medical professionals, as the price of the drug would remain costly. However, this problem may be ameliorated by proper application of an inventive step requirement. b) Types of any second medical use constituting impermissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. In light of the potential benefits yielded by research into pre-existing substances, only second medical uses that might encourage immoral or offensive behavior should be unpatentable. c) Form of permissible claims. See, for example, paragraphs 26) - 33) above/wgls. Swiss-type medical claims should be permissible. It is less clear whether purpose-limited product claims should be permissible. In G 02/08, the Enlarged Board of Appeal accepted that the rights conferred by a purpose limited product claim could be broader than that conferred by a Swiss-type claim. In particular, purpose-limited product claims could lead to possible restrictions on the freedom of medical practitioners to prescribe or administer generics. In order to protect the freedom of medical practitioners, it may be necessary to disallow purpose-limited product claims. Alternatively, the implementation of a class specific exemption from infringement for medical practitioners may also be viable. d) Form of impermissible claims. See, for example, paragraphs 26) - 33) above/wgls. Claims for methods of treatment should not be permissible. Allowing methods of treatment to be patented would result in a significant interference with the work of medical professionals. e) Who may be liable for infringement? All parties who do not fall under the exemptions (below) should be liable for infringement. This should include: (i) the party marketing the drug with label instructions which describe the patented use; 8

9 (ii) the manufacturer. f) Any parties/institutions that should be exempted from infringement or liability for infringement. The following parties should be exempted from infringement: (i) (ii) (iii) (iv) medical professionals who perform the infringing act in the course of their duties; the prescribing physician; the pharmacist preparing the drug for such a purpose provided the act is extemporaneous; patients, provided their infringing act is private and non-commercial. 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. Any act that falls within the claims of the patent should prima facie constitute direct patent infringement. Where a generic manufacturer has adopted skinny labelling, this should not be regarded as direct patent infringement though liability for indirect patent infringement might be appropriate. The alleged infringer s knowledge or intention becomes relevant when considering his liability for indirect infringement. An appropriate standard would be where the alleged infringer is liable if he knew or it was obvious in the circumstances that the end user would infringe the patent. Constructive liability is appropriate for two reasons. Firstly, there are significant difficulties associated with proving actual knowledge and intention. Secondly, in light of the benefits of second medical uses, it is necessary to provide proprietors with robust patent protection. h) Relief available upon a finding of infringement: i) at a preliminary / interim / interlocutory level; and Interlocutory injunctions should be available. ii) by way of permanent relief. The following remedies should be available: (i) (ii) (iii) (iv) Account of profits; Damages; Permanent injunction; and Order for delivery i) In each case for h)i) and h)ii), the level of proof for the granting of such relief. For interlocutory injunctions, the claimant should have to show that if the injunction is refused, he will not be adequately compensated by an award of damages at the full trial. 9

10 In order to obtain permanent relief, the claimant should have to prove on a balance of probabilities that the defendant has infringed his patent. SUMMARY Singapore allows the patenting of second medical uses provided they are claimed in certain forms. However, the extent of the monopoly accorded to such claims is uncertain as there is no case law that deals with the infringement of a second medical use claim. The Singapore Group recognizes the benefits that arise from a robust protection of second medical use patents. Further, harmonization is desirable and global standards should be derived from a thorough study of the relevant policy objectives underlying the patentability of second medical uses. 10