Question Q238 National Group: Title: Contributors: Reporter within Working Committee: AUSTRIA Second medical use or indication claims Marc KESCHMANN Marc KESCHMANN Date: May 12, 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? Para. 3 Sec 3 of the Austrian Patent Act b) What types of second medical use are patentable? See, for example, paragraphs 14) - 17) above/wgls. All types mentioned in paragraphs 14) - 17) of the WGLs c) Are any types of second medical use impermissible subject matter? See, for example, paragraphs 14) - 17) above/wgls. No. d) What forms of second medical use claims are permissible? See, for example, paragraphs 26) - 33) above/wgls. 1
Swiss-type claim format 'purpose-limited' product claim format ('Substance X for use in the treatment of condition Y) e) What forms of second medical use claims are not permissible? See, for example, paragraphs 26) - 33) above/wgls. Use claim ('Use of compound X for treatment of disease Y') however, undecided. Method of treatment 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. Yes - The Supreme Court (OGH) in the Isoflavon -case (17Ob35/09k, GRUR Int 2010,1080) elucidated that second medical use claims (in this case a Swiss type claim) are only infringed if it has been shown that the intended purpose of the invention, i.e. the medical treatment, is indeed achieved to a substantial extent. 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; There is no case law in Austria. iii) the pharmacist dispensing a drug for such purpose; Yes (in case of a 'purpose-limited' product claim format). iv) the patient using the drug for such purpose? No this falls under the exemption of private use. b) Are any parties exempt from infringement or liability for infringement of such claims. If so, what classes of party? Only privately acting parties are exempt from infringement or liability for infringement. Medical doctors are not considered acting privately when exercising their profession. Otherwise, no class of party is generally exempt from infringement or liability for infringement. However, the Bolar exemption applies. c) Are such claims enforceable on the basis of direct or indirect infringement? Please provide details. 2
The claims may be enforceable both, on the basis of direct and indirect infringement. Direct infringement would be the case, if a generics company produces, offers or sells a drug for the patented indication (e.g. by including the indication in the product information leaflet). Indirect infringement would have to be affirmed in a case as described below under question 4. 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? In case the patented indication is mentioned in the product information leaflet (onlabel use), the act of making and supplying constitutes a direct infringement. In case the patented indication is not specifically mentioned in the product information leaflet (off-label use), indirect infringement could be affirmed provided that the supplier knows or it is obvious in the circumstances, that the drug will be prescribed and/or used by the patient for the patented indication. 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. The acts of making, offering, supplying and using as well as the acts of importing and holding for the aforementioned purposes constitute direct infringement. Only the acts of offering and supplying constitute indirect 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. Positive knowledge of the infringement or the infringement is obvious from the circumstances. 6) How do the courts determine infringement of a second medical use claim? What are the legal tests and evidentiary requirements? According to the Austrian group s knowledge, in all pertinent court cases the Court determined infringement of a second medical use claim on basis of information found 3
in the product information leaflet - such as Isoflavon - decision (17Ob35/09k, GRUR Int 2010,1080) 7) What relief is available for infringement of a second medical use claim: a) at a preliminary / interim / interlocutory level? Interim injunction b) by way of final relief? Injunction, damages, delivery up/destruction, publication of judgment, order to provide information about origin and delivery, account of profits 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, there are no interim injunction restrictions that are specific to second medical use claims. 9) In respect of Question 7)b), what level of proof is required to obtain a final injunction? see question 5d) 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? Adequate protection of pharmaceutical research and development 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? No. d) If there is any empirical or anecdotal data available, please address the following. N/A 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 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? 14) Is harmonisation of laws relating to second medical use claims desirable? 5
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 types mentioned in paragraphs 14) - 17) of the WGLs b) Types of any second medical use constituting impermissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. None c) Form of permissible claims. See, for example, paragraphs 26) - 33) above/wgls. 'purpose-limited' product claim d) Form of impermissible claims. See, for example, paragraphs 26) - 33) above/wgls. Claims referring to a method of treatment e) Who may be liable for infringement? Any entity not acting privately, such as a patient. f) Any parties/institutions that should be exempted from infringement or liability for infringement. No 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. When mentioned the patented indication in the product information leaflet, at least the acts of making, offering and supplying should constitute a direct infringement. In case the patented indication is not specifically mentioned in the product information leaflet (off-label use), indirect infringement should be affirmed in case the supplier knows or it is obvious in the circumstances, that the drug is prescribed and/or used for the patented indication. h) Relief available upon a finding of infringement: i) at a preliminary / interim / interlocutory level; and Interim injunction ii) by way of permanent relief. Injunction, damages, delivery up/destruction, publication of judgment, order to provide information about origin and delivery, account of profits i) In each case for h)i) and h)ii), the level of proof for the granting of such relief. 6
Zusammenfassung: Die österreichische Landesgruppe ist der Auffassung, dass Patentansprüche betreffend eine zweite medizinische Indikation hauptsächlich in der Form des zweckgerichteten Stoffanspruchs zur Verfügung stehen sollte. Hinsichtlich der Haftung für Verletzungshandlungen sollte es keine speziellen Ausnahmen geben (mit Ausnahme der Bolar Regel). Lediglich im privaten Bereich sollte die Verwendung der patentierten Indikation keine Patentverletzung darstellen, wie dies auch bei jedem anderen Erfindungsgegenstand der Fall ist. Das Herstellen, Anbieten, in Verkehr bringen und Gebrauchen sowie das Importieren und Besitzen für die genannte Zwecke sollten eine unmittelbare Verletzung darstellen. Im Zusammenhang mit der off-label Verwendung sollte eine wirksame Durchsetzung der Patentrechte im Wege der mittelbaren Verletzung gewährleistet sein. Summary The Austrian Group is of the opinion that second medical use claims should mainly be available in the 'purpose-limited' product claim format ('Substance X for use in the treatment of condition Y). There should not be any special exemption from liability for infringement of such claims (except of the Bolar exemption). Only privately acting parties should be exempt from infringement or liability for infringement as is the case with any other patented subject matter. The acts of making, offering, supplying and using as well as the acts of importing and holding for the aforementioned purposes should constitute direct infringement. Indirect infringement should be available in particular in connection with off-label use in order to secure efficient patent enforcement. Résumée Le Groupe Autrichien est d'avis que les revendications relatives à une deuxième indication médicale devraient être principalement sous la forme de revendication dans le format "substance X pour utilisation dans le traitement de la maladie Y. Responsabilité à l'égard des actes de contrefaçon il devrait y avoir aucune exception spéciaux (à l'exception de la règle Bolar). Seulement dans le secteur privé, l'utilisation de l'indication brevetée ne doit pas constituer une contrefaçon, comme c'est le cas avec tout autre objet invention. La production, l offre, la mise sur le marché et l'utilisation ainsi que l'importation et la possession aux fins ci-dessus devrait constituer une contrefaçon direct. Dans le cadre de l'utilisation offlabel d'une application effective des droits de brevet doit être garantie par voie de contrefaçon indirecte. 7