COMPARATIVE ANALYSIS OF THE PROTECTIONOF NEW DOSAGE REGIME CLAIMS (France, Germany the United Kingdom, theNetherlands and Italy) Berlin, 23 January 2015 Table of Contents Situation in France . 4 Situation in Germany . 6 Situation in the United Kingdom . 7 Situation in the Netherlands . 9 Situation in Italy . 10 CMS Hasche Sigle CMS news for the CMS Website
"Patents without borders" Whereas the current position of the French Patent Office and the French
courts are not very patent-friendly for dosage regime claims of a medicinal
product, the German, UK and Dutch courts allow for the patentability of such
dosage regime claims, following the principles set out by the Enlarged Board
of Appeal of the EPO in its decision G2/08 of 19 February 2010. On the
contrary, the Italian courts have not yet issued any official position on this
With the kind collaboration of Frédérique Faivre Petit, Partner, Patent-Attorney,
European Patent Attorney, REGIMBEAU
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"Patents without borders" 2 Situation in France Will the new dosage regime claims for medicinal products, granted by the
European Patent Office, be enforceable in France?
French latest news as to the new dosage regime claims for medicinal
products: the dismissal of a preliminary injunction, based on Article L. 615-3 of
the French Intellectual Property Code (in short, "IPC"), on the ground that the
validity of a dosage regime claim is seriously challenged, in that it cannot be
considered as a patentable second medical use in virtue of Article 54(5) of
EPC, insofar as it has not been defined a new technical effect or a new benefit
related to it.
By a decision of 23 June 2014 handed down by the Judge managing the case (inGédéon v Mylan), the French Judge upholds its earlier case law according to whicha dosage regime claim cannot benefit from the exception to the rules on exclusion ofpatentability of methods of therapeutic treatment, by stressing that a dosage regimeclaim is patentable only on the condition that this dosage regime fulfils a newtechnical effect or provides a new benefit for the patient.
That was not the case in the present court case, since the subject-matter of theopposed claim was the administration of the same dosage regime, but in a singledose (1.5 mg) instead of two doses (0.75 mg) with a time difference of 12 hours (forthe same indication, emergency contraception), without explaining the technicaladvantage provided other than "the comfort of taking the dose once daily which doesnot achieve a technical effect".
Then the Judge holds that the objection of lack of novelty is serious, in that theopposed legal means aims at establishing that this is a mere dosage regime claim,excluded from patentability as being a method of therapeutic treatment which is notpatentable.
This decision is fully in line with the earlier decisions rendered on the merits by theParis first-instance court ("Tribunal de Grande instance de Paris") in Actavis Group vMerck Sharp & Dohme (3rd Chamber, 1st Section, 28 September 2010, judgment notfinal), taking into account the qualification of a method of therapeutic treatment notpatentable, and in Teva v Merck Sharp & Dohme (3rd Chamber, 1st Section,9 November 2010), holding the insufficiency of disclosure, on the ground that thetherapeutic effect should have been verified, whereas the specification does notevidence that some trials or experiments have been conducted in order to prove thetherapeutic effect related to the claimed dosage regime.
More recently, in a court case Eli Lilly v Daiichi (Division 5, Chamber 1, 12 March2014), the Paris Court of Appeal holds that some dependent claims, relating tospecific dosage regimes (in this case, for raloxifene) were invalid for lack of inventivestep insofar as those dosage regimes were determined by the doctor prescribing thismedicinal product to his patient with a broad range of spectrum (from 0.1 to 1000mg) without explaining the relevance of these dosage regimes.
Similarly, and more recently, in a court case Akzo Nobel v Teva, Ratiopharm,Merckle & Gemelogs-BRS (3rd Chamber, 1st Section, 5 December 2014, judgment CMS Hasche Sigle CMS news for the CMS Website
"Patents without borders" not final, in this case for a Progestagen-only contraceptive, 70 to 80 micrograms ofdesogestrel), the Paris first-instance court affirmed its case law, according to which adosage regime claim would not be patentable, as it would be part of a method oftherapeutic treatment, since "the medical prescription and the dosage of medicinalproducts would be an essential part of the activity of the doctor. The determination ofa dosage, as a full part of a therapeutic process is therefore excluded from protectionby patent".
Thus the current trend of French case law is to consider that dosage regime claimsare invalid for grounds of different nature, on a case-by-case basis, exclusion frompatentability as being considered a method of therapeutic treatment, for insufficiencyof disclosure or for lack of inventive step.
It should, however, be stressed again that the Enlarged Board of Appeal of theEuropean Patent Office, in its decision G2/08 of 19 February 2010, has recognizedthe patentability of a claim of which the only featured claimed, which is notcomprised in the state of art, is a dosage regime ("a single dose before bedtime"), assoon as it is new and involves an inventive step.
Therefore the analysis of these decisions shows that, for obtaining, in France, anefficient protection of the dosage regime claims, such as granted by the EuropeanPatent Office, it is necessary to take certain precautions when drafting thespecification of the patents at issue, notably by sufficiently characterizing in thepatent specification the new technical effect or the new benefit related to the claimeddosage regime and, also by disclosing the trials or experiments enabling to supportthis new technical effect or this new benefit thereof.
However the difficulty certainly resides in the fact that, when filing the Europeanpatent application, these pieces of information are rarely available because thedevelopment of the medicinal product is still at its early stages and, then, the trialsand experiments are not sufficiently advanced.
Otherwise, it must be emphasized that all the commented decisions relate to aEuropean patent and, notably, the French designation of this European patent.
The situation is different in France for French patent applications, comprising dosageregime claims, which are filed with the French Patent Office ("INPI"). Indeed the current position of the French Patent Office is to issue notifications beforerejection for any dosage regime claims.
Therefore the only way for obtaining a protection for the dosage regime of amedicinal product is to file a European patent application, designating France, andhave it granted in view of the favourable case law of the Enlarged Board of Appeal ofthe EPO; the French designation of this European patent will then take effect inFrance and might be enforceable … if fortunately, in case of patent litigation, thetrend of the French courts, related to the validity of such dosage regime claims,becomes more patent-friendly and concerned of the interests of the patent holders.
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"Patents without borders" 3 Situation in Germany German Case Law, on new dosage regime claims, applies the principles set
out by the enlarged board of appeal of the European Patent Office.
By Gerd Schoenen, Rechtsanwalt, Partner, CMS Hasche Sigle
In the matter G 2/08 of 19 February 2010, the Enlarged Board of Appeal of the EPOdecided that pharmaceuticals that are already in use for the treatment of a certaindisease, may be patented again for the same disease even if the only feature thatwas formerly not included in the state of technology is a dosage regime.
In its decision, the EPO considered the patentability of a dosage regime in terms of asecond further medical indication pursuant to Article 53(c), Article 54(5) of theEuropean Patent Convention ("EPC"), to be generally permissible.
Initially, the Federal Patent Court ("Bundespatentgericht") did not follow therequirements of the EPO and denied patentability of a pharmaceutical on the basisof a dosage regime on the grounds of lack of inventive activity (BPatG 14 W (pat)13/09). The Federal Court of Justice ("Bundesgerichtshof") repealed this decision,however.
The Federal Court of Justice instead expressly confirmed the line of jurisprudenceestablished on a European level by the EPO (Federal Court of Justice X ZR 40/12 —Fettsäuren; BGH X ZB 5/13 and BGH X ZB 6/13 — Kollagenase I und II). In thisrespect, the decision of the Federal Court of Justice is based on the relevant parallelstandards in terms of the European EPC — Article 54(5), i.e. provisions Section 3(4)of the Patent Act.
By extending the principles of patentability of pharmaceuticals to cases in which theregime not only concerns the dosage as such but also other modalities ofapplication, that is, for example, the method of administration, the consistency of thesubstance, the group of patients or other parameters, the decision of the FederalCourt of Justice, to some extent, goes beyond the European requirements (BGH XZB 6/13).
In such cases, it is a condition that the objective purpose of the therapy-relatedinstructions in question are to influence the effects of the substance, or thepharmaceutical itself — it is not intended that therapy-related instructions alone canbe patented.
Therefore, by these decisions, the case law of the highest court in Germanycontinues to implement the European requirements. It is to be expected that theFederal Patent Court, too, will adjust its decisions to that effect in the future.
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"Patents without borders" 4 Situation in the United Kingdom The UK intellectual property office and the UK courts allow for the patentability
of new dosage forms of Pharmaceuticals.
By Tom Scourfield, Partner, CMS Cameron McKenna
And Dr Andrew Payne, Trainee Solicitor
The position regarding the patentability of dosage forms of pharmaceuticals in theUK is set out in detail in guidelines published by the UK Intellectual Property Office(IPO)1. The relevant statutory provision is section 4A Patents Act 1977: "4A Methods of treatment or diagnosis(1) A patent shall not be granted for the invention of —(a) a method of treatment of the human or animal body by surgery or therapy….
(…)(4) In the case of an invention consisting of a substance or composition for a specificuse in any such method, the fact that the substance or composition forms part of thestate of the art shall not prevent the invention from being taken to be new if thatspecific use does not form part of the state of the art." The effect of section 4A(4), which stems directly from Article 54(5) of EuropeanPatent Convention revised in 2000, is that a claim to a known substance orcomposition for a specific medical use is novel if the substance or composition hasnot previously been used for that specific purpose.
Prior to 2008, although "Swiss-type" claims2 for second medical uses were generallygranted by the IPO and allowed by the English courts, the practice of the IPO was totreat those claims which defined the new use in terms of the mode of administrationor the quantity, frequency or timing of dosage only, as being not patentable, on thegrounds that they were merely methods of treatment that lacked novelty over theprior use of the substance to treat the same disease. 3,4 However, in the Court of Appeal decision in Actavis v Merck5 in 2008, Jacob LJ heldthat a claim for the use of finasteride (a known drug previously used for treatingprostate conditions) for the preparation of a medicine for treating alopecia, with adosage much lower than that previously used for treating prostate conditions, was 1 Examination Guidelines for Patent Applications relating to Medical Inventions in the Intellectual PropertyOffice, May 2013 (http://www.ipo.gov.uk/medicalguidelines.pdf). See in particular paragraphs92-93, 114-115, 124-137 and 173-175.
2 "Swiss-type claims", so called due to first being allowed by the Swiss patent office, are claims for the useof compounds for the manufacture of medicaments for specified second medical uses, where the samecompounds have previously been used in medicine for different purposes.
3 Bristol-Myers Squibb v Baker Norton Pharmaceuticals  RPC 1.
4 Merck's Patents [Alendronate]  FSR 498.
5 Actavis UK Limited v Merck & Co Inc  EWCA Civ 444.
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"Patents without borders" not invalid for lack of novelty, applying the previous EPO decision in Eisai6 in which itwas determined that such Swiss-type claims were valid.
Since the Actavis v Merck decision, the position in the UK regarding the patentabilityof new dosing forms and methods of a known substance has been clarified: the UKadopts an approach consistent with the EPO Enlarged Board of Appeal in AbbottRespiratory7. Second medical use claims which are distinguished from the prior artsolely by the dosage regime used, or the mode of administration, are consideredpatentable if the claimed use is both novel and inventive, with the proviso that if theclaim is directed at the activity of the physician rather than the drug manufacturer, itmay be objectionable under Section 4A(1)(a) Patents Act 1977, which precludes thepatentability of methods of treatment of the human body by therapy.
6 G5/83 Eisai  OJ EPO 64.
7 G 02/08 ABBOTT RESPIRATORY/Dosage regime OJ EPO 2010, 456.
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"Patents without borders" 5 Situation in the Netherlands The Dutch District Court of The Hague allows for the protection of new dosage
regime claims; it is likely to be confirmed by the court of appeal in The Hague.
By Willem Hoorneman, Partner, CMS Derks Star Busmann N.V
After EPC 2000 had entered into force, including its new article 54(5), comprising apurpose-related product protection for any further specific use of a knownmedicament in a method of therapy, no justified reason existed for the so-calledSwiss-type claim. So it came without surprise when the Enlarged Board of Appeal ofthe European Office decided in its decision G 2/08, dated 19 February 2010, that theuse of Swiss-type claims was no longer allowed. Instead the Enlarged Boarddecided that dosage regimes of known medical products could be patented if theclaimed use should be considered new and inventive. So the Swiss-type form forsecond medical use claims was replaced by the so called "purposed-limited productclaims", e.g. the format "compound X for the use in the treatment of disease Y",meaning that new dosage regimes on existing medicines could be patented.
Dutch courts tend to follow the leading case law of the European Patent Office(EPO). This means that under Dutch law, new dosage regimes are relevant technicalfeatures which should be taken into account when assessing novelty and inventivestep.
This was confirmed in a recent decision of the District Court of The Hague, regardingthe "finasteride"8 1 mg products9. Until now this decision has not been confirmed bya higher court, e.g. the Court of Appeal in The Hague. Nonetheless, considering thatDutch courts tend to follow the case law of the EPO, it is likely that also these highercourts will consider new dosage regimes as relevant technical features for theassessment of novelty and inventiveness.
8 "Finasteride" in a dosage of 5 mg can be used to treat the enlargement of the prostate, "Finasteride" in adosage of 1 mg can be used to treat male pattern baldness 9 IEPT 2014.04.23, Rb Den Haag, MSD v Mylan CMS Hasche Sigle CMS news for the CMS Website
"Patents without borders" 6 Situation in Italy New dosage of drugs under Italian jurisdiction, patentability and
By Paola Nunziata, Counsel, CMS Adonnino Ascoli & Cavasola Scamoni
The issue of patentability of pharmaceutical products on the sole ground of adifferent dosage regime has been thoroughly addressed at a European level.
However, in Italy, case law on the matter is lacking, with the consequence that thereisn't any official position yet.
Having specified the above, it is worth pointing out that both the legal framework andauthors do offer a few insights on the topic at hand which should be taken intoaccount.
In particular, pursuant to Article 46 of Legislative Decree No. 30/2005 (the "Code of
Industrial Property"), concerning the "novelty" requirement for patentability, patents
can be granted with respect to "a substance or a combination of substances already
included in prior art, provided that this is for the purpose of a new use". Through said
rule, Italian law allows the so called "Swiss-type claims", i.e. the patentability of
known substances or combination of substances with respect to a medical use
different from the use or uses covered by the preceding patents.
In light of the above, a few Italian authors suggest expanding the aforementionedrule so to include the patentability of drugs even when the inventive characterconcerns only the dosage regime and not also the treatment of different diseases.
Another issue worth considering is the one regulated by Article 71 of the Code ofIndustrial Property concerning dependent patents. According to said Article "acompulsory license may be granted if the invention protected by a patent cannot beused without jeopardizing the rights of a patent granted based on a prior application.
In such event, a license can be granted to the holder of the later patent in such ameasure as to allow the same to exploit the invention, as long as the latterrepresents, compared with the object of the prior patent, a material technicalprogress having a substantial economic value. A license so obtained may not beassigned otherwise than together with the patent for the dependent invention. Theholder of the main patent, in turn, has the right to be granted with a compulsorylicense on the patent of the depending invention, at reasonable conditions". As a fewauthors pointed out, dosage patents should fall within the scope of such rule, with allthe consequent limitations (for example, with respect to the payment of royalties);this is because such patents are achieved also thanks to the research anddevelopment of the originator company which patented the drug first: failing to do sowould essentially grant companies patenting the sole dosage regime a sort of "R&Dfree riding". Indeed, the latter concerned patent, though granting a full exclusivity onthe new product, derives not only from the research carried out by the patentingcompany with respect to the new dosage regime, but also from the R&D investmentsby the company who patented the pharmaceutical product first.
Lastly, pursuant to Article 68, paragraph (1), letter c (regulating the so called"Galenic exception"), the exclusive right granted by a patent does not extend "to the CMS Hasche Sigle CMS news for the CMS Website
"Patents without borders" extemporaneous preparation of drugs made in pharmacies, on a unit by unit basisand for prescription medications so prepared, as long as industrially made activeprinciples are not used". The rationale behind the Galenic exception is balancing outthe patent owner's right to exclusivity with the patient's right to health, aconstitutionally guaranteed principle. In a recent decision (please refer to judgementNo. 39187/2013), the Italian Supreme Court clearly outlined the limitations to theGalenic exception and ruled that the dosage regime plays a significant role in thisperspective. More precisely, according to the Court, in addition to the requirementsprovided for by the aforementioned Article 68 and to the fact that the Galenicexception is applicable only when specific therapeutic reasons occur, in order toassess whether or not the chemist's conduct falls within the exception at issue, thedifferent dosage of the drug extemporary prepared by the chemist must beconsidered as well: indeed, if the drug made by the chemist has the same dosage ofthe patented drug, the Galenic exception does not apply, on the contrary acounterfeiting case occurs.
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PRESENTAZIONE DEL "RAPPORTO SVIMEZ SULLE ENTRATE TRIBUTARIE DELLA REGIONE CALABRIA" Incontro di studio (12 febbraio 2014) Roma, settembre 2014 Quaderno SVIMEZ n. 42 Associazione per lo sviluppo dell'industria nel Mezzogiorno Il 12 febbraio 2014, a Roma, presso la Sala delle Lauree dell'Università degli Studi Roma Tre, si è tenuta, su iniziativa della SVIMEZ, la presentazione del "Rapporto sulle entrate tributarie della Regione Calabria", Numero Speciale dei "Quaderni SVIMEZ" pubblicato nel febbraio 2014.
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