Dosage regimes G2-08

Artist Bjørn Bjørnholt Patentability of 2nd medical uses, dosage regime/ABBOTT RESPIRATORY -Enlarged Board of Appeal decision G2/08 Jan Mondrup Pedersen M.Sc. Chemistry and Physics, Ph.D. Synthetic Organic Chemistry Patent Attorney T +45 33 63 93 43June 2010 E jmp@pv.eu

2Content- Legal basis for 1st and 2nd medical use claims- Case law and EPO practice- The invention of G2/08- The decision G2/08- Impact of G2/08

3Legal basis Article 53 (EPC 2000), Exceptions to patentability European patents shall not be granted in respect of: - (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; - (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof; - (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

4 Legal basis Article 54 (EPC 2000), Novelty - (1) An invention shall be considered to be new if it does not form part of the state of the art. - (2, 3) The state of the art shall be held to comprise[…]1st medical - (4) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art.2nd medical - (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.

5Legal basis Amendments compared to EPC 1973 Article 52 (EPC 1973), Patentable inventions - [1-3] - (4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Art 52(4) (EPC 1973) was incorporated into Art 53 (EPC 2000) and the legal fiction of lack of industrial applicability was removed.

6 Legal basis Amendments compared to EPC 1973 Article 54 (EPC 1973), Novelty - [1-4]1st medical - (5)The provisions of paragraphs 1 to 4 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52, paragraph 4, provided that its use for any method referred to in that paragraph is not comprised in the state of the art. Art 54(5) (EPC 1973) was “moved” to Art 54(4) (EPC 2000) without significant amendments. Art 54(5) (EPC 2000) was an addition to explicitly specify that any specific novel medical use of a known substance already used as a medicament is not excluded from patentability either.

7Case law and EPO practice EPC 1973 only referred to 1st medical indications as not being excluded from patentability (Article 54(5)) This left a gap in the EPC as to whether 2nd (and further) novel medical uses were patentable, which was to be filled in by case law.

8Case law and EPO practice G5/83 of December 1984 (7 appeals referred to EBoA) introduced the “Swiss type claim” as a way around second and further medical uses not being explicitly excluded from non-patentable inventions in EPC 1973. 22. The intention of Article 52 (4) EPC, again as recognised by the [Swiss] Federal Court of Justice, is only to free from restraint non-commercial and non- industrial medical and veterinary activities. […] It should be added that the Enlarged Board does not deduce from the special provision of Article 54 (5) EPC that there was any intention to exclude second (and further) medical indications from patent protection other than by a purpose- limited product claim[…] 23. For these reasons, the Enlarged Board considers that it is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient.

9Case law and EPO practice Defining a “specified new and inventive therapeutic application”… - New indication/disease? Yes! (G5/83) …enlarged Board does not deduce […] any intention to exclude second (and further) medical indications from patent protection… - New patient sub-group? Yes! (T19/86, T893/90, T233/96) e.g. the use of attenuated Aujeszky virus on sero- negative piglets was known, but the same use for treating a sera-positive piglet population was deemed patentable. - New administration mode? Yes! (T51/93, T138/95) e.g. use of HCG for the treatment of male infertility was known using a depot pill, but equivalent treatment using subcutaneous injection was deemed patentable.

10Case law and EPO practice Defining a “specified new and inventive therapeutic application”… - New technical effect? Yes! (T290/86, T254/93) e.g. lanthanum salts where known to reduce the solubility of tooth enamel, but use for removing tooth plaque was patentable (both indications were tooth decay) - “New” mechanism? No! (T254/93, T189/95, T486/01) e.g. use of retinoid for topical treatment skin atrophy was known, and a claim for the same use further describing the mechanism of action was deemed not patentable (no increase in industrial activity).

11Case law and EPO practice Defining a “specified new and inventive therapeutic application”… - New dosage regime? No! (T317/95, T56/97, T584/97, T4/98, T485/99) …in particular the prescribing and modification of drug dosage regimens used for administering a particular medicament […] calls first and foremost for the exercise by a medical practitioner […] Such activities are typical of the non-commercial and non-industrial medical activities which Article 52(4) EPC intends should remain free from restraint… Yes! (T51/93, T1020/03 “overruling” the above) …This Board considers the views on Article 52(4) EPC [1973] expressed in these five decisions to have no proper basis in the EPC and to be in conflict with decision G5/83… …this board understands the use of the word “specified” […] to be merely in way of contrast to the unspecified therapy allowable in a claim for a first medical use, and not as imposing any special conditions that a further medical use had to fulfil…

12Case law and EPO practice However, uncertainties remain… Current practice is based on G5/83 and Technical BoA case law under EPC 1973 What was the intention of the amendments introduced in the EPC 2000 (broader, narrower interpretation or status quo)? Some of the Technical BoA case law points in opposite directions at least with respect to dosage regimes - [T317/95, T56/97, T584/97, T4/98, T485/99] vs T1020/03 National courts decisions have applied the medical activity interpretation with respect to dosage regimes as well: - UK: Bristol-Myers Squibb vs Baker Norton and Napro [2001] RPC 1 (TAXOL) - NL: Bristol-Myers Squibb vs Yew Tree Pharmaceuticals (2000) ENPR 26 - DE: [BGH] XZR 236/01 “carvedilol II” (required specific wording to allow claim)

13 Case law and EPO practice - review of claims allowed/disallowed under the EPC prior to G2/08Use Formulation EPC G5/83 EPC G2/08 1973 +TBoA 20001st Compound X for use as a medicament2nd Use of compound X for the manufacture of a medicament for(Swiss) use in the treatment of (new) disease Y2nd(Swiss) Use of compound X for the manufacture of a medicament for use in the treatment of (known) disease Y, wherein [new use] ?2nd Compound X for use in the treatment of (new) disease Y2nd Compound X for use in the treatment of (known) disease Y, wherein [new use] ?2nd Compound X for use in the treatment of (known) disease Y, wherein [new use = new dosage regime] ?

14The invention of G2/08 Publication No. EP 0 643 965 A1, KOS Pharmaceuticals Inc. Nicotinic acid compositions for treating hyperlipidemia ABSTRACT: An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic substantially immediately prior to each periodic physiological loss of consciousness.

15The invention of G2/08 Main independent claim: 1.The use of nicotinic acid or a compound metabolized to nicotinic acid by the body selected from the group consisting of d-glucitol hexanicotinate, aluminium nicotinate, niceritrol, d, 1-alpha-tocopheryl nicotinate and nicotinyl alcohol tartrate for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidemia, characterized in that the medicament does not comprise in admixture, 5-30% hydroxypropyl methylcellulose, 2-15% of a water soluble pharmaceutical binder, 2-20% of a hydrophobic component and 30-90% nicotinic acid. Examining division (2003): Novelty cannot be derived from the medical activity represented by the dosage regimen (T317/95, T584/97). Technical Board of Appeal (T1319/04 - 2008): The outcome will depend on the exact interpretation of Articles 53(C) and 54(5) EPC 2000 (transitional provisions). Important point of law!

16The decision G2/08 Question 1 Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?

17The decision G2/08 Arguments by the EBoA The intention of the legislator (EPC 2000)? - Firstly the explanatory remarks clearly specify that the amendments represented by Art 52(4) -> 53(c) and Art 54(5) -> 54(4) are “purely editorial” and “do not change the actual legal position”. - Regarding new Art 54(5) the EBoA considers there are two interpretations of “any specific use”: - Either merely by contrast to the generic broad protection conferred by Article 54(4) EPC […] which is then in principle not confined to any particular indication… - Treating Article 53(c) EPC as the general prohibition and giving the provisions of Article 54(5) EPC the status of lex specialis and interpreting this provision narrowly…

18The decision G2/08 Arguments by the EBoA The intention of the legislator (EPC 2000)? - The broad interpretation of Article 54(5) EPC should be applied since: …reading the term “any specific use” as necessarily meaning treatment of another disease would amount to arbitrarily introducing a distinction the law does not make in Article 54(5) EPC which refers to “any specific use” in a method of therapy. …it also appears clearly from the conference proceedings […] that the actual intention of the legislator was “as regards the second or further medical use, (that) the case law evolved by the EPO Enlarged Board of Appeal should be enshrined in the Convention.” Thus, the intention of new Article 54(5) was to incorporate the prevailing case law into THE EPC 2000, i.e. to maintain status quo (and thereby “force” the contracting states (e.g. UK, NL) to comply).

19The decision G2/08 Arguments by the EBoA …Article 54(5) EPC, however, refers to "any specific use”. On the basis of that wording in conjunction with the declared intention of the legislator to maintain the status quo of protection evolved in the case law of the boards of appeal under decision G 5/83, the Enlarged Board holds that said use cannot be ex officio limited to a new indication stricto sensu… Answer to Question 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.

20The decision G2/08 Question 2 If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?

21The decision G2/08 Arguments by the EBoA …Having regard to its findings with respect to the first question and considering in particular that, since Article 54(5) EPC may be used in cases of the treatment of the same illness, the "specific use" in the sense of that provision may reside in something else than the treatment of a different illness, the Enlarged Board of Appeal holds that there is no reason to give to a feature consisting in a new dosage regime of a known medicament a different treatment than the one given to any other specific use acknowledged in the case law…

22The decision G2/08 Arguments by the EBoA …The Enlarged Board of Appeal does not ignore the concerns with respect to undue prolongations of patent rights potentially resulting from patent protection or claims purporting to derive their novelty and inventive step only from a not hitherto so defined dosage regime […] Therefore, it is important to stress that, […] the whole body of jurisprudence relating to the assessment of novelty and inventive step generally also applies. In particular, the claimed definition of the dosage regime must therefore not only be verbally different from what was described in the state of the art but also reflect a different technical teaching… …It appears that the rights conferred on the patentee by the claim category under Article 54(5) EPC are likely broader [than Swiss type claims], and could, in particular, lead to possible restrictions on the freedom of medical practitioners to prescribe or administer generics…If deemed necessary, the freedom of medical practitioners may be protected by other means on the national level…

23The decision G2/08 Answer to Question 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.

24The decision G2/08 Question 3 Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?

25The decision G2/08 Arguments by the EBoA Regarding the Swiss type claim introduced by G5/83: …Article 54(5) EPC now permits purpose-related product protection for any further specific use of a known medicament in a method of therapy. Therefore, as mentioned in the preparatory document (MR/24/00, point 139) the loophole existing in the provisions of the EPC 1973 was closed. In other words "cessante ratione legis, cessat et ipsa lex" , when the reason of the law ceases, the law itself ceases… …Swiss-type claims could be (and have been) considered objectionable as regards the question as to whether they fulfill the patentability requirements, due to the absence of any functional relationship of the features (belonging to therapy) conferring novelty and inventiveness, if any, and the claimed manufacturing process. Therefore, 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 G 5/83…

26The decision G2/08 Answer to Question 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 G 5/83. A time-limit of three months after publication of the present decision in the Official Journal of the European Patent Office is set in order that future applicants comply with this new situation. (not yet published in the OJ)

27 Impact of G2/08 - Review of claims allowed/disallowed under the EPC 2000Use Formulation EPC G5/83 EPC G2/08 1973 +TBoA 20001st Compound X for use as a medicament2nd Use of compound X for the manufacture of a medicament for(Swiss) use in the treatment of (new) disease Y2nd Use of compound X for the manufacture of a medicament for(Swiss) use in the treatment of (known) disease Y, wherein [new use] ?2nd Compound X for use in the treatment of (new) disease Y2nd Compound X for use in the treatment of (known) disease Y, wherein [new use] ? ? Compound X for use in the treatment of (known) disease Y,2nd wherein [new use = new dosage regime] “New uses” are naturally still required to be novel and inventive

28Impact of G2/08 Status Quo is maintained with respect to second medical claims in Europe after G2/08: - 2nd medical uses are not restricted to the use in treatment of new diseases - Compounds for use in novel and inventive 2nd and further medical treatments where the only novelty lies in e.g. mode of administration, patient sub-groups, new technical effects and dosage regimes were, and are still, patentable. Importantly however, Swiss type claims will no longer be allowed for applications having a filing date/priority date after publication of G2/08 in the OJ + 3 months.

29Impact of G2/08 Some advice to clients: All in all this decision is good news for patent applicants, however: - They should discontinue the use of Swiss type claims in future European applications. - As no national court has compared the scope of the two types of 2nd medical use claims, applicants may introduce/maintain the Swiss wording and the Art 54(5) wording in the claims of presently pending applications as a precaution – when possible.

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Dosage regimes G2-08

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Dosage regimes G2-08 — Presentation Transcript