One on the market composition is in any case not new, if the composition can be analyzed by a specialist and reproduced without undue burden. In a not readily identifiable complex composition, it is sufficient for the, if the expert can develop a manageable number of plausible hypotheses about the possible nature of the composition, von denen sich eine mit den ihm zur Verfügung stehen-den Analysemöglichkeiten verifizieren lässt.
BGH X ZR URTEIL 120/11 from 23. October 2012 – Gelomyrtol
EPÜ Art. 54 Abs. 2; PatG § 3 Abs. 1
One on the market composition is in any case not new, if the composition can be analyzed by a specialist and reproduced without undue burden. In a not readily identifiable complex composition, it is sufficient for the, if the expert can develop a manageable number of plausible hypotheses about the possible nature of the composition, von denen sich eine mit den ihm zur Verfügung stehen-den Analysemöglichkeiten verifizieren lässt.
BGH, Judgment of 23. October 2012 – X ZR 120/11 – FEDERAL PATENT COURT
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Der X. Zivilsenat des Bundesgerichtshofs hat auf die mündliche Verhandlung vom 23. October 2012 by the presiding judge Prof. Dr. Meier-Beck, the Richter Keukenschrijver, Judge Mühlens and judges Dr. Und Dr Grabinski. Bacher
hereby:
The appeal against the at 26. July 2011 announced the judgment 3. Senate (nullity Senate) the Federal Patent Court is rejected at the expense of the defendant.
By rights
Facts:
The defendant is the proprietor of the 12. September 2000 under Inan-claim acquisition of a German priority of 16. September 1999 ange-reported European patent 1 212 072 (the patent). The in suit-tent is named “pharmaceutical composition, compre-send eucalyptus- and orange oil”; It includes twelve claims. The independent claims 1, 6 and 12 denominated in the process-language:
“1. A pharmaceutical composition for oral Verab-filing in the form of a hard- or soft gelatin capsule comprising Eucalyptus oil and orange oil.
6. A pharmaceutical composition for oral Verab-submission in the form of a liquid comprising Eucalyptus oil and orange oil.
12. Use of a pharmaceutical composition according to any one of claims 1 to 11 egg for the manufacture of-
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a medicinal product for the treatment of infectious diseases and Erkran-airway inflammation.”
Die Klägerin hat geltend gemacht, the subject of in suit-tents is not patentable.
The Patent Court declared the patent invalid.
Against the defendant objects with their vocation, with which they continue seeking the dismissal of the action.
Reasons:
The admissible appeal is unfounded.
I. The patent relates to a pharmaceutical Zusammenset-requisite for oral administration in the form of a hard- or soft gelatin capsule or a liquid, the eucalyptus- and oranges(peel)oil comprises in combined form and which can be preferably used for the treatment of diseases of the respiratory tract He-crane, which are caused by microorganisms.
The contested patent describes outset, that uncomplicated bronchitis representing one of the directions of doctors most commonly diagnosed diseases. The inflammatory disease of the lower respiratory-way will primarily triggered by a number of viruses, but could give rise to bacterial superinfection according to viral infections. A causal therapy of viral infection was not possible, a bacterial superinfection is treatable with antibiotics. In practice, would be estimated at more than 65% all patients prescribed diagnosed with acute bronchitis antibiotics. Under practical conditions, each-but successes often no exact diagnosis, so antibiotics without the-
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peutic necessity would be used. Uncritical use of antibiotics has led to an increase in the resistance of increasingly bac-rien, depending on the frequency of use. Accordingly, there appears a need for an alternative course of action, the therapeutically equivalent and few side effects was.
This will be achieved by a pharmaceutical composition-tion, which is intended for oral administration, in the form of a hard- or soft gelatin capsule is present and eucalyptus- and orange oil to-sums.
II. The Patent Court adopted, the subject of the Pa-tentansprüche 1 and 12 was not new to the priority date, because I heard the composition of the drug Gelomyrtol forte at this time point to the state of the art. As evidenced by the red list 1993 (NiK 6) was already before the priority-tätstag commercially the drug Gelomyrtol forte. As the active ingredient of this drug have included as well as the today still sold under the same name preparation Myrtol. The ingredients of the drug are, what the Be-lamented not imagine denied, seit 1978 remained unchanged. There were a mixed distillate from eucalyptus oil, Orangenöl, Myrtenol und Sofa ronenöl. Thus the product Gelomyrtol forte public was too-accessible.
Contrary to what the defendant it was to those skilled possible, determine the composition of the biological active loading constituents of Gelomyrtol forte by analysis. Skilled is a pharmacist or chemist, the have specialized after his studies in the field of pharmaceutical biology and dispose over long years of experience in the field of development of herbal medicines for the treatment of diseases of the respiratory system and is part of a team, the anyway also in the analysis of
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essential oils experienced pharmacist or chemist belonged same technical direction. Such a skilled person would, when he was faced with the task, to examine the composition of Myrtol closer, undergo drug-sen a gas chromatography, before coming back to grab other analytical methods. A skilled artisan should known, that the main ingredients of Myrtol cineole, Limonene and α-pinene are. was the basis of the chromatogram for him by the pattern of the side- and Spurenkom-components as well as the quantity of the three main components seen from the outset, that it did not constitute an enriched individual substances essential oil, but a blend of essential oils. A skilled artisan should further known, that in particular the eucalyptus oil and orange oil are, which would usually drawn for preparing Ätherischölgemischen into consideration. The reason for this is the exceptionally high concentration of substances in cineol Euka-lyptusöl and limonene in orange oil. It adds, that eucalyptus oil would traditionally used in the treatment of respiratory diseases, and that the availability of both oils, which would be produced in large quantities, is straightforward and low cost causing. Against this background, the identification of the main components of Myr-tol performing essential oils have to be made by the skilled artisan unzumutba-ren effort. Thus, faced with eucalyptus oil and orange oil to two oils very different material composition and this in particular with regard to the side- and Spurenkom-nents applies, have the skilled person to identify the essential oils, from which Myrtol consists essentially, therefore already obtained sufficient evidence to actually ahead composition based on a comparison with the gas chromatograms merchantable Eukalyp-tusöle and orange oils. Using the usual coupling of gas chromatography and mass spectroscopy, he can secure the Won-nene Result.
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The subject matter of claim 6 is not based in any case an inventive step, because it constitutes a usual straight on the Indikationsge-field of respiratory diseases measure, applying active substances in the form of liquids.
III. This keeps the review on appeal was.
1. The product Gelomyrtol forte, that was to the undisputed findings of the Patent Court in time of priority for years on the market, contained, as well as the defendant does not deny, Since its approval by the former Federal Institute for Drugs a Ge mixture of 66% eucalyptus oil, 32% oranges(peel)Beer, 1% myrtle and 1% lemon oil. The resulting from this composition chemi-rule ingredients were - without mentioning their origin - multiple ver-published was: In the Red List 1993 (NiK 6) are the ingredients as dLimonen, Cineole and α-pinene indicated. In the publication of Meister et al, Efficacy and Tolerability of Myrtol Standardized in Long-term Treatment of Chronic Bronchitis, Drug Research / Drug Rese-arch 1999, 351 (NiK 4) is running, that Gelomyrtol forte was a phy-totherapeutischer extract and consists essentially of three monoterpenes, namely α-pinene, dLimonen and 1,8-cineol, wherein the drug-medium 15% a-Pinen, 35% dLimonen and 47% 1,8-Cineol per capsule ent-hold.
2. This was the subject of the claim 1 the in suit-tents not new in priority date.
For the novelty of a substance or composition, it is important, if the substance or the constituents of the composition are commonly available, or at least the expert is able, to obtain the object of the patent with the help of his expert knowledge and skill in the hand. CNN's Dhinsatehan, whether to already ge-
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nügt, that a subject of the invention is available on the market, as here was the case with the product Gelomyrtol forte. Because the-denfalls it suffices, If such an object by an expert analy-Siert and without undue burden can be reproduced (Bus-se / Keukenschrijver, 6. Ed, § 3 RN. 127). In a not readily identifiable complex composition, it is sufficient for the, if the expert can develop a manageable number of plausible hypotheses about the possible nature of the composition, from a standing available to him analytics de-nen ve easily supporting leaves. A unique in every respect Result, rules out all other conceivable composition with security, is not to he-necessary. It is enough, that are made for the expert no reasonable two-fel on the results of its analysis. By then REQUIRED-chen degree of certainty the expert was able to determine the presence of eucalyptus oil and orange oil in Gelomyrtol forte.
3. The skilled person was known to the findings of the Patentge-Richts, that few essential oils α-pinene, include limonene and 1,8-cineole as main components. In particular, the skilled man knew from his general knowledge, that eucalyptus oil as the main ingredient 1,8- Cineol and as a minor component mainly containing α-pinene and that orange oil to 90% consisting of limonene (vgl. Römpp, Encyclopedia natural materials, 1997, S. 213, 214 and 255 – NiK 5). Out-of-the was known to the expert after the other findings of the Patentge-Richts, that eucalyptus oil is traditionally used to treat respiratory diseases consistently use. Eucalyptus oil and orange oil ka-men also therefore as components of Gelomyrtol forte into consideration, because they are produced in large quantities and are relatively kostengüns-tig. The expert had on these grounds rise to the hypothesis, that Gelomyrtol forte eucalyptus- and contains orange oil.
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On the other hand, that – as the defendant has the run in the hearing-lung – for the preparation of the product Gelomyrtol forte of a matrix obtained in a different manner the ingredients limonene, Cineole and α-pinene could have been inflicted, speaks, that it is Ge lomyrtol forte according to the statements in the citation NiK 4 (S. 352 No.. 1 3. Abs.) a vegetable drug (a phytotherapeuti-rule extract) handelt, the to 97, but not to 100 % consists of three Monoter-Penen. The defendant is the applicant's arguments, Any resultant located, that Gelomyrtol forte is a distillation of plant parts and not a mixture of chemically pure individual compounds, not entgegenge-occur. Although only through 14. AMG amendment, the definition of § 4 Abs. 29 AMG has been inserted into the law, are to the vegetable-Arz Medicinal Products drug, containing as active ingredient exclusively one or more herbal substances or one or more herbal PREPARATIO gene or one or more such herbal substances in combination with one or more such herbal preparations. Nor is beyond dispute, if so pure chemical substances of vegetable origin are excluded. However, it corresponds to the administrative practice and the case law, not classified pure chemical substances pflanzli-chen origin as herbal medicines (S. to Kü gel / Müller / Hofmann / Krüger, AMG, § 4 RN. 203). In addition, have the outward pointing to a plant extract and the fact, that the Inhaltsstof-fe not 100 % sum up, also point to a herbal preparation.
To acceptance, Gelomyrtol forte encompasses eucalyptus- and Oran genöl, to verify, it was sufficient, prepare a mixture of these oils in a ratio, that the chemical components of 1,8-cineol, α-pinene and limonene (essentially) einstellten so, as in the cited documents NiK 4 and Nik 6 is indicated. Customised the skilled man of this mixture to a gas chromatogram, what the patent-
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Court has undisputedly considered usual method of investigation and compared this with a gas chromatogram of the drug Ge lomyrtol forte, could he draw from this with the requisite degree of certainty the conclusion, that eucalyptus- and orange oil are Bestandtei-le this product. The occurring further peaks confirmed, moreover, the adoption, that Gelomyrtol forte does not constitute a combination of chemical pure substances.
The defendant can not be accepted in, die Chromato-gramme, which it receives by letter 14. September 2012 submits, annexed May 15a and 15b, showed, that differences in the two mixtures tested, namely the active ingredient of Gelomyrtol forte one hand and a distillate from myrtle and lemon oil on the other hand, were not clearly determine. The applicant has rightly pointed at the hearing on differences in each pattern of peak arrangements. In particular, in the retention times 13.507 and 14.177 (strong Gelomyrtol) as well as 13.517 and 14.202 (myrten- Lime oil mixture) covered the differences in the eye. The applicants has also not objected-rin.
4. The correct explanations of the judgment under claim 6 are not attacked by the Appeals. In this reference is made.
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IV. The decision on costs follows from § 121 Abs. 2 PATG verb in dung-mit § 97 Abs. 1 ZPO.
Meier-Beck Keukenschrijver Mühlens
Grabinski Bacher
lower court:
FEDERAL PATENT COURT, Decision of 26.07.2011 – 3 Ni 7/10 (EU) –