Second medical use claims - current developments and challenges in Europe Ahmedabad, January 15, 2019 Dr. Markus Engelhard German and European Patent Attorney München engelhard@boehmert.de
Pharma Patents - Lifecycle Market authorization for product X Assay / Screening process Compound class 5 years SPC or Specific compound / drug 5 years SPC candidate or Composition / 3 years formulation New salts / new delivery / new matrices 2010 New indications New patient group New dosage regimen New combinations of drugs 5 10 15 20 25 30 0 35 40 2
1. Second medical use claims Use of compound X (for the manufacture of a medicament) for the treatment of disease y (G005/83, G006/83, EPC 2000) Compound X for use in a method of treatment of disease y 3
1. Second Medical Use Claims A fair balance must be struck between: 1. The (heavily) investing innovators versus access to affordable medicines for the public 2. Incentives for innovators‘ R&D activities versus prevention of patent protection being misused as „evergreening“ instrument 4
1. Second Medical Use Claims Patentability New therapeutic applications can be based on (EPO practice): 1. A new indication 2. A new patient group to be treated 3. A different mode of drug administration 4. A different technical effect 5. A different dosage regimen 5
1. Second Medical Use Claims Patentability Claim 1 of EP 0903148: „Use of ribavirin for the manufacture of a pharmaceutical composition for treating a patient having chronic hepatitis C infection to eradicate detectable HCV-RNA by a method comprising administering an effective amount of ribavirin in association with an effective amount of interferon alpha for a time period of 40 - 50 weeks, wherein the patient is one having failed to respond to a previous course of interferon alpha therapy, characterised in that the patient has a viral load of greater than 2 million copies per ml of serum as measured by HCV-RNA quantitative PCR of a HCV genotype 1 infection.“ 6
1. Second Medical Use Claims Patentability Selection of new patient group can confer novelty if: New patient group does not overlap with prior art patients (T893/90, T233/96, T531/04) New patient group is distinguished from known patients by physiological or pathological status (T19/86, T893/90, T1399/04, T734/12 ) New patient group has not been selected arbitrarily (T34/14) 7
1. Second Medical Use Claims Patentability T734/12 "1. Use of an unconjugated antibody which is rituximab in the manufacture of a medicament for treating rheumatoid arthritis by intravenous administration of two doses of antibody of 1000 mg to a human who experiences an inadequate response to a TNFα-inhibitor , wherein the first dose is administered on day 1 of treatment and the second dose on day 15." 8
1. Second Medical Use Claims Patentability T734/12 continued Patentee: „The disclosure of document (10) was not detrimental to the novelty of the subject-matter of claims 1 and 2 of all claim requests since it disclosed neither a RA patient sub-group experiencing an inadequate response to a TNFα-inhibitor nor the successful treatment of this particular patient group.“ „… the RA patient group of claims 1 and 2 of the main request is distinguishable from the patient group of document (10) by its physiological and pathological status and consequently, according to the established case law of the Boards of Appeal (cf. Decisions T 1399/04, T 19/86 and T 893/90, above) represents a new therapeutic application.” 9
1. Second Medical Use Claims Patentability T734/12 continued Novelty by Selection Doctrine or by Inherency doctrine? G 2/88 (OJ 1990, 93, Corr. 469) emphasized that “the question to • be decided is was what has been “made available” to the public: the questions is not what might have been “inherent” in what was made available” to the public. Furthermore, when considering how far the teaching in a written description also made the inevitable result of carrying out such teaching available to the public, in each case „a line must be drawn between what is in fact made available, and what remains hidden or otherwise has not been made available“. � Relevant question before the EPO : What has been explicitly disclosed in the prior art? 10
1. Second Medical Use Claims Patentability T 1319/04 “Use of nicotinic acid … for the manufacture of a sustained release medicament for use in the treatment of hyperlipidaemia by oral administration once per day prior to sleep …” Prior art: Treatment of hyperlipidaemia using nicotinic acid using a regime of 3 administrations per day 11
1. Second Medical Use Claims Patentability T 1319/04 cont’d G02/08 1. “Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness. 2. Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art. 3. Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss- type claim, as instituted by decision G5/83. 12
2. German Practice regarding Infringement/Enforcement of Second Medical Use Claims 13
Scope of the Claims of a European Patent According to the Decision of the Enlarged Board of Appeal of the EPO G 2/88: Art. 69 (1) EPC and the according protocol have to be applied before the EPO and before the national courts of the member states when determining the scope of the patent. However, the rights arising from a patent are determined according to the national law of the member states (Art. 64 (1) EPC). 14
2. Infringement/Enforcement of Second Medical Use Claims Claim 1 of EP 0903148: „Use of ribavirin for the manufacture of a pharmaceutical composition for treating a patient having chronic hepatitis C infection to eradicate detectable HCV-RNA by a method comprising administering an effective amount of ribavirin in association with an effective amount of interferon alpha for a time period of 40 - 50 weeks, wherein the patient is one having failed to respond to a previous course of interferon alpha therapy, characterised in that the patient has a viral load of greater than 2 million copies per ml of serum as measured by HCV-RNA quantitative PCR of a HCV genotype 1 infection.“
2. Infringement/Enforcement of Second Medical Use Claims Ribavirin, LG Düsseldorf, 2004 Alleged infringement activities: The defendant 1, whose business manager is the defendant 2, produces by order of M. GmbH, Berlin, Ribavirin-capsules with the name “Ribavirin M” with a concentration of 200 mg Ribavirin per capsule. Package leaflet: treatment of HCV as ribavirin monotherapy or as combination therapy with interferon a; no mention of specific patient group The plaintiff argues that patent in suit is infringed through the marketed Ribavirin-capsules directly, alternatively indirectly.
2. Infringement/Enforcement of Second Medical Use Claims Ribavirin, LG Düsseldorf, 2004 Direct patent infringement only in case of an “evident preparation” for the patented subject matter. There must be at least directions to a “purposive realization” of the claimed specific use of Ribavirin to a considerable extent. No indirect infringement of the Swiss type claim because defendant does not offer the drug for an act of manufacturing 17
2. Infringement/Enforcement of Second Medical Use Claims Ribavirin, LG Düsseldorf, 2004 Principle of “evident preparation” or “manifested • arrangement” (“ sinnfällige Herrichtung ”) Looks for some material manifestation in the • manufactured product itself, the packaging, the label, the product leaflet, the SmPC � which can be attributed to the new patented use of the drug 18
2. Infringement/Enforcement of Second Medical Use Claims Ribavirin, LG Düsseldorf, 2004 Principle of “evident preparation” in various Federal Court of Justice (BGH) landmark decisions: − 1977, “phenyl sulfonyl urea” − 1982, “sitosteryl glycosides” − 1983, “Hydropyridine” − 1990, “slitted covering film” 19
2. Infringement/Enforcement of Second Medical Use Claims OLG Düsseldorf: mere advertising of the drug for the patented use in flyers, marketing materials, advertisements etc. likely not to constitute direct patent infringement as it does not form part of a “evident preparation” − OLG Düsseldorf, 248/4 - Ubichinon Qn − OLG Düsseldorf 2454/11 – Cistus Incanus − LG Düsseldorf, 4a O145/12 Chronic Hepatitis C 20
2. Infringement/Enforcement of Second Medical Use Claims Ribavirin, LG Düsseldorf, 2004 Carving out is possible - “Skinny labelling” No protection for innovator from cross-label use of drug BUT: District Court of Hamburg recently awarded 5 injunctions for indirect infringement 21
3. Indirect Infringement of Second Medical Use Claims 22
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