Second medical use patents

Transcription

1 Second medical use patents The European Swiss perspective AIPPI Helsinki 2013, Pharma Workshop II Andri Hess

2 Part 1 Second medical use claims the protection they confer 2

3 Second (or further) medical use What do we mean with "second (or further) medical use"? Use of known pharmaceutical composition for treatment of a new indication Use of known pharmaceutical composition for treatment of a known indication in a new patient group Use of known pharmaceutical composition for treatment of a known indication in a new dosage form Use of known pharmaceutical composition for treatment of a known indication with a new dosage regime 3

4 Europe pre EPC 2000 Claim categories for pharmaceutical inventions: Pharmaceutical substance product claim 1st medical use purpose-limited product claim (Art. 54(5) EPC 1973; Art. 54(4) EPC 2000) 2nd (or further) medical use under EPC 1973 (and national laws): Not: purpose-limited product claim (lack of novelty) Not: use for treatment (Art. 52(4) EPC 1973; G 583) Different solutions found in different jurisdictions, e.g. Swiss-type use claim (legal advice of the Swiss patent office of 30 May 1984, later on adopted by the EPO) and German-type use claim 4

5 EPC 2000 EPC 2000 allows purpose-limited product claim also for 2nd (and further) medical uses, as for 1st medical use (Art. 54(5) EPC 2000) Purpose-limited product claim replaces Swiss-type claim format (G 208) Nevertheless: coexistence of Swiss-type claims and purpose-limited product claims for many years to come 5

6 Prominent remarks regarding the scope of protection (13) Explanatory notes to the Swiss proposal for Art. 54(5) EPC 2000; Special edition No. 4 OJ EPO 2007; Case Law of the Boards of Appeal, I.C. 5, 2.1 Introduction: "It [the new Art. 54(5)] unambiguously permits purpose-related product protection for each further new medical use of a substance or composition already known as a medicine. This protection is equivalent, as far as the further uses are concerned, to that offered by the Swiss type claim. In contrast to Article 54(5) EPC 1973 (now Article 54(4) EPC 2000) which provides broad (generic) protection for the first use in a medical method, new Article 54(5) EPC is expressly limited to a specific use in such a method. This limitation is intended to match as closely as possible the scope of protection to the scope provided by a Swiss type claim." 6

7 Prominent remarks regarding the scope of protection (23) At the EPO: T 25005: Change of claim category from Swiss-type claim to purpose-limited product claim may violate the prohibition to extend protection (Art. 123(3) EPC) G 208: "In respect of second and further medical indications the EPC now allows use-related product claims directed to the substance itself whereas under EPC 1973 decision G 5/83 allowed claims directed to the use of a substance for the manufacture of the drug for a therapeutic indication ("Swiss-type claims"). It appears that the rights conferred on the patentee by the claim category under Article 54(5) EPC are likely broader, and could, in particular, lead to possible restrictions on the freedom of medical practitioners to prescribe or administer generics." No double patenting if two patents for same second medical use are obtained, once in the form of a Swiss-type claim and once in the form of a purpose-limited product claim 7

8 Prominent remarks regarding the scope of protection (33) Swiss Federal Supreme Court, BGE 137 III 170: "It is to be expected that the new claim category according to Article 54(5) EPC2000, that of purpose-limited product claim, will result in broader protection for the patentee than was previously the case " now: what is correct? 8

9 Analysis (13) Swiss-type claim German-type claim EPC 2000 Type Use claim Use claim Purpose-limited product claim Format Use of compound X for the manufacture of a pharmaceutical composition for the new therapeutic application Y. Use of compound X for the new therapeutic application Y. Compound X for use in the new therapeutic application Y. 9

10 Analysis (23) Direct Infringement Swiss-type claim German-type claim EPC 2000 Use of X for the therapeutic application Y (by physician) No (no use for manufacture) Yes (conflicting judgments), regardless whether this is labeled or off-label use Yes, regardless whether this is labeled or offlabel use Manufacture of drug containing X and instruction to use drug for Y ("sinnfällige Herrichtung" "manifest customization") Yes Yes (not self-evident; "trick" to construe industrial applicability of medical use claim) Yes Supply and marketing of customized medicament Only if Swiss-type claim is considered claim for manufacturing process and customized medicament is considered directly obtained product Yes (not self-evident) Yes 10

11 Analysis (33) Swiss-type claim German-type claim EPC 2000 Off-label use contributory infringement No, because there is no direct infringement by physician who prescribes drug for patented off-label use (?) Yes, general principles apply Yes, general principles apply 11

12 Part 2 Skinny labeling labeling carve-outs, off-label use and contributory infringement 12

13 The problem (13) The regulator's dilemma: General rule: product information of generic must contain same information as that of the original drug, including indications, dosages and method of administration If indication or dosage is still patented, general rule could prevent market entry of generics for non-patented dosages or indications Provisions such as Article 11 of Directive EC 13

14 The problem (23) Article 11 of Directive EC "The summary of the product characteristics shall contain, in the order indicated below, the following information: 4. clinical particulars: 4.1. therapeutic indications, 4.2. posology and method of administration for adults and, where necessary for children, For authorizations under Article 10 [generics], those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included." 14

15 The problem (33) The tension between patent law and public health law: Typically, prescription does not mention the indication or dosage etc. Dispensing pharmacy or physician incentivized or required to substitute original drug by generic, irrespective of label Reimbursement by health insurance irrespective of label health care law stimulates infringing off-label use The patent law question: Does skinny-labeling protect against a finding of contributory infringement? 15

16 Requirements of contributory infringement Agreement relating to Community Patents 1989, Article 26 "A Community patent shall also confer on its proprietor the right to prevent all third parties not having his consent from supplying or offering to supply within the territories of the Contracting States a person, other than a party entitled to exploit the patented invention, with means, relating to an essential element of that invention, for putting it into effect therein, when the third party knows, or it is obvious in the circumstances, that these means are suitable and intended for putting that invention into effect." Swiss Federal Supreme Court, BGE 129 III 588 " the offeror or supplyer only becomes liable under private law if he knows or must know that the means offered or supplied by him are suitable and are intended by the addressee of the offer or the supply to be used for practicing the patented invention " 16

17 Analysis Issue under patent law: Does generic company know, or is it obvious in the circumstances, that skinny-labeled generic is suitable and intended for being used for patented 2nd (or further) medical use? But: Even if this is answered in the affirmative, sale of skinny-labeled generic unlikely to be stopped (?) Available remedies unlikely to effectively stop off-label use (?) Problem is not primarily one of patent law but of public health law (substitution irrespective of label and reimbursement of patent-infringing offlabel use) Can patent law do the job on its own or should we discuss remedying the law that causes the tension? 17

18 Thank you for your attention. Andri Hess T Homburger AG Prime Tower Hardstrasse 201 CH-8005 Zurich P.O. Box 314 CH-8037 Zurich