The Supreme Court has not confirmed his decision on a drug with the active ingredients from red clover and soy for the treatment of menopausal syndromes and prostate cancer the lack of novelty, but rather problematizes the purpose limitation of a product patent: In the ongoing process will be particularly noted, ob ein Rotklee-Extrakt, the 8 % Contains isoflavones (as the undisputed composition of the defendant's product), according to the given by the defendant intended purpose as isoflavone phytoestrogen extract of clover for the treatment of premenstrual syndrome, von Symptomen, associated with post-menopausal, is used, and whether the product of the defendant to the patent, the applicant inherent purpose in terms of the specific aspect of the patented teaching (limited to the use for the treatment of premenstrual syndrome and symptoms, associated with post-menopausal) achieved in a practically significant extent.
OGH 17Ob35/09k vom 09.02.2010 – Isoflavone
The Supreme Court has appellate court as … Case of the plaintiff N ***** Limited, *****, represented by Gassauer-Fleissner Rechtsanwälte GmbH in Vienna, with the assistance of Dr. Daniel Algae, Patentanwalt in Wien, gegen den beklagte Partei A ***** GmbH, *****, represented by Dr. Andreas Manak, Lawyer in Vienna, composed of DI Peter Itze, Patentanwalt in Wien, by omission (Dispute 250.000 EUR), Elimination (Dispute 50.000 EUR), Accounting (Dispute 50.000 EUR) and publication of the judgment (Dispute 10.000 EUR), about the extraordinary appeal of the defendant against the judgment of the Higher Regional Court of Vienna as an appeal court from the 24. September 2009, GZ 5 R 35/09t-83, with the result of calling the defendant to the partial judgment of the Commercial Court of Vienna from 13. January 2009, GZ 19 Cg 178/05f-64, was confirmed, in closed session to
Decision
collected:
Saying
The revision is given episode.
The decisions of the courts, the klagsabweisenden terms of their legal force sayings remain unaffected, be repealed by the way and referred the case back in the pending remaining amount of the court of first instance for a fresh decision after further proceedings.
The costs of the appeal form further legal costs.
Text
Grounds:
The applicant is the proprietor of the European patent EP 0 656 786 B1 (Priority 19. 5. 1993) with the following requirements:
1. The use of an isoflavone phyto-estrogen extract of soy-or clover for the manufacture of a medicament for administration in unit dosage form for the treatment of premenstrual syndrome, von Symptomen, associated with post-menopausal, or prostate cancer.
2. Use as in claim 1 claimed, wherein the medicament further comprises at least one food grade excipient.
3. Use as in claim 1 or 2 claimed, wherein the isoflavone phytoestrogen is extracted from soy.
4. Use as in claim 3 claimed, wherein the isoflavone phytoestrogen extracted from Sojahypokotylen.
5. Use as in claim 1 or 2 claimed, wherein the isoflavone phytoestrogen extracted from clover.
6. Use as in any one of claims 1 to 4 claimed, the isoflavone phytoestrogen extract one or several members of the group genistein, Comprises daidzein or glycosides thereof or metabolites or derivatives thereof.
7. Use as in claim 1 or 2 claimed, wherein the isoflavone phytoestrogen genistein-and / or biochanin A: Daidzein and / or formononetin comprises, in a ratio of about 1:2 to 2:1 are available.
8. Use as in any one of claims 1 to 7 claimed, wherein the isoflavone phytoestrogens in an amount of about 20 mg bis 200 mg per dosage unit are available, the amount, if appropriate, 50 mg bis 150 is mg.
9. Use as claimed in any one of the preceding claims, wherein administration of the medicament takes place at least daily over a period of at least one month.
10. Use as claimed in any one of the preceding claims, wobei das Extrakt Coumestane, Including lignans and flavones.
11. Use as claimed in any one of the preceding claims, wherein the dosage unit form is a tablet or capsule,.
After the undisputed between the parties prior art (see Pat S 2) There are three main classes of phytoestrogens. Type 1 is the isoflavone phytoestrogen, by the predominant presence of isoflavones for smaller amounts of lignans, Coumestanen and flavones is characterized (Ersturteil S 8).
In the patent (S 21 f) as an example 1 described for carrying out the invention, the preparation of the product closer to red clover. After harvesting of the raw plant material that is dried and extracted in a solvent mixture of water and organic solvents, which the isoflavones are drawn from the material. The concentration of the liquid (typically by distillation) the extracted natural product then in capsules, Transferred tablets or other forms convenient for integration.
The patent relates to drugs, phytoestrogens or Pyhtoöstrogen metabolites (= Metabolite intermediates of a metabolic process) contain, for the treatment of premenstrual syndrome, Menopause syndrome or prostate cancer be used. In the priority date, although there was already a growing interest in the probable influence of a relative lack of phytoestrogens in the diet on the development of the so-called "Western diseases”, especially prostate cancer, prämenstruelles Syndrome und Menopausesymptome. In women with menopausal symptoms, a beneficial effect of fortification of food with red clover was, inter alia,, having a high content of phytoestrogens, determined and the effect attributed to the Phytoöstrogengehalt dietary supplement. By the mere food intake but a constant supply is not secured, because the usually consumed legumes relatively poor sources of phyto-oestrogens and the concentrations can be varied to a great extent. In the priority date of the option was known, use natural products from plant extracts to enrich; was known further, that these natural substances are also contained in soy and clover, and the formulation of drugs in dosage unit form. The use of an extract of producing a made-in unit dosage form drug was therefore obvious. In contrast, the use of red clover for the treatment of premenstrual syndrome and menopause symptoms in the priority date was not obvious: Until now, only for soy flour, been achieved but not for red clover advantageous results, Red clover was previously sold only as a herbal tea, repeated using the germination of seeds and the consumption of sprouts in the treatment of menopausal symptoms is recommended, and there were adverse effects of clover (particularly in the form of "clover disease”) known. In view of the negative effects of red clover (eg the clover disease in sheep and the negative effect in breast cancer when used only low doses) Although there was a further research close. However, it was not obvious, that the use of drugs, containing an isoflavone from red clover Phytoöstrogenextrakt, only the desired positive effects in the absence of negative effects would result.
The defendant sells in pharmacies with "Vita Lady Vital Capsules” designated product, Namely, a dietary supplement, whose income as described, among other relief for menstrual- to cause or menopause symptoms as a result of it contains, among other isoflavones of red clover. It contains 8 % Rotklee-Extrakt = 150 mg per capsule and is discharged in the form of capsules, the intake is recommended by a capsule daily on non limited time. The isoflavones contained therein are ononin, Sisstorin, Biochanin A und Formononetin.
The applicant seeks, to the defendant, to refrain, operatively in Austria (according to the claim 1. ihres Patents) an isoflavone phyto-estrogen extract of clover for the manufacture of a medicament for administration in unit dosage form for the treatment of premenstrual syndrome, von Symptomen, associated with post-menopausal, or use of prostate cancer, in particular, a use according to the claims 6, 7, 8, 9 and 11 des Klagspatents, and / or in accordance with these requirements, in each case immediately crafted items, Production: "Vita Lady”-Capsules, sale, kept, bring in traffic, use to, importing or stocking. She put a further disposal, an accounting- and an opinion publication desire. The patent applicant is a method patent within the meaning of § 22 Abs 2 Patent Law and refers to drugs, which for the purposes of the patent also dietary supplements are to be understood. The defendant violated the Klagspatent, especially its claims 5 to 9 and 11, by a dietary supplement, containing the isoflavones of red clover, under the name "Vita Lady” bring in traffic.
The defendant objected, ihr Produkt Vita Lady” was no drug, but a dietary supplement without therapeutic healing effect, already so therefore there is no patent infringement (Pleading of 23. 10. 2006, Band I/ON 33). The defendants do not use the special extract of the applicant for their product, but a combination product. The Klagspatent was not legally valid: The effect of red clover and soy for the treatment of menopausal syndromes and prostate cancer was known. The patent of the applicant, a Swiss-Claim-Claim, is the circumvention of the prohibition on patentability of therapeutic treatments within the meaning of § 2 Abs 2 Patent Act void.
The first instance was with the contested part of the judgment for injunctive relief with the exception of the final decision reserved desire with respect to the claim 7 the Klagspatents and (legally rejected) Desire with respect to the use of the isoflavone phyto-estrogen extract of clover for the treatment of prostate cancer sequence, also the place on the imaging part of desire relating Disposal- and accounting claim as well as the publication of the judgment desire (with a slight, legal force adult partial dismissal). The claims relate to a drug for the treatment of health problems. The change of wording in the claim filing process means no limitation of the scope. The proof of the invalidity of the patent was the defendant failed; the use of red clover extract in connection with the indication "Treatment of Premenstrual Syndromes, menopausal symptoms and prostate cancer” was not due to the prior art in the priority date have been obvious. A dietary supplement could infringe the patent. The scope of "food additive” and "drug” joined not mutually exclusive; the definition of medicinal in European patent law be inconsistent with the Austrian Medicines Act.
The appeal court upheld that judgment and expressed, that the value of the decision object 30.000 EUR on climb and the regular appeal was not admissible. The lower court had affirmed the novelty of the invention, the applicant rightly: In view of the negative effects of red clover Although further research were displayed, but it was not obvious to those skilled in the art, that the use of drugs, containing an isoflavone phytoestrogen extract of red clover, while avoiding the negative effects the desired positive effects would result. The use of protected material by the defendant fell within the scope of the patent in suit. On the mentioned in the appeal hearing – judgment given only after conclusion of the negotiation of First Instance – Decision of the European Patent Office dated 8. 7. 2009 can not be taken care. There could be no question of, that any occurrence of side effects in humans through the consumption of red clover extract is excluded. also claim 6 the Klagspatents was injured: This demand only, that the isoflavone phytoestrogen extract one or more representatives from the group of genistein, embrace daidzein or glycosides or metabolites or derivatives thereof. From the HPLC analysis of the "Vita Lady”-Capsules (Supplement to opinion of the patent attorney DI Beer ./G) go forth, that the product in the defendant contained isoflavone phytoestrogen extract representatives from the group of genistein, daidzein embrace. also claim 8 was injured, because the intervention product 150 mg red clover extract per capsule containing.
Legal Analysis
The revision is admissible, because the appeals court has not dealt with the objection of lack of therapeutic healing effects of the intervention product; the appeal is also authorized for the purposes of its application for annulment.
1. It should first be, that the Court of Appeal the objection, the patent of the applicant's lack of novelty void, has negated with true justification; it is to refer (§ 510 Abs 3 Code of Civil Procedure).
2.1. The defendant draws from the fact, that the applicant had restricted the registration process their application for protection via several intermediate steps to the now registered use claim for preparation of a medicament, the conclusion, that the protection of claim 1 not on food supplements – as the product of the defendant – could extend; the applicant was aware of "dispensed by the restriction on a drug to the general supplement originally claimed” (Klagebeantwortung S 5 f = AS 59 f). That argument can not be accepted.
2.2. Not Art 69 Abs 1 The extent of protection conferred by a European patent or a European patent application by the content of the claims is determined. The specification and drawings are, however, be used to interpret the claims.
2.3. It follows, that it is important for the determination of the content of the patent claim, as explained by the description and drawings wording of the granted patent must be interpreted. Whether to grant files for a narrower scope talk, is not decisive. Because the grant files provide no guarantee, reproduce all the action, which has actually led to the grant of the patent as amended, and the consideration of its contents managed in many cases, new problems of interpretation. A suggestion, which provided for such consideration, has therefore to a November 2000 held Diplomatic Conference to revise the EPC also found no majority (Scharen in Benkard, EPÜ Art 69 Rz 27 mwN).
3.1. The defendant alleges breach of laws of thought in affirmation of infringement of claim 1 of the applicant's patent claims. It just stand firmly, that together put their product from red clover extract; However, such a contained "natural isoflavones in small quantities” and will only result "enrichment” of isoflavones to isoflavone phytoestrogen extract, like him claim 1 protect. On the merits, the defendant repeatedly so its already at first instance invoked and obtained consent on appeal objection of lack of patent procedure, she relies on it, that their product no drug, but a dietary supplement without therapeutic healing effect was, especially since they use for their product not the special extract of the applicant, but a combination product used. The other objection of the defendant, the product of the defendant corresponds to "not describing loud suit”, but the analysis lt Beil ./28 and ./29, has the applicant replies, of said inserts is clear, that the product isoflavone phytoestrogen extracts containing from Klee and already therefore infringing the patent (AS 438/Band I). This replica does not go far short, because it is based solely on ingredients, which included the patent purpose, however unconsidered leaves.
3.2. Rights of claim 1 of the patent is the use of an isoflavone phyto-estrogen extract of clover, inter alia, for the manufacture of a medicament for administration in unit dosage form for the treatment of premenstrual syndrome, von Symptomen, associated with post-menopausal, or prostate cancer.
3.3. According to this version of the claim is a dedicated protective fabric for use in a (here:) therapeutic methods (Art 54 Abs 5 EPU iVm Art 52 Abs 4 EPÜ). Such purpose-bound protection is – exceptionally (Art 52 Abs 4 EPÜ) – for substances and mixtures (particular drug) to disposal, that already belong to the prior art, their use for (among others) therapeutic method but new (Spangenberg in Singer/Stauder, European Patentübereinkommen4 Art 54 Rz 87). Novelty substantiating the effect (medical purpose specification); composition, Structure or formulation are in the novelty test no significance (Melullis in Benkard, EPÜ Art 54 Rz 226 mwN; Reich, Substantive European patent law Rz 583).
3.4. The concept of therapeutic treatment within the meaning of Art 52 Abs 4 EPC detected at its core, the restoration of health by curing diseases and the alleviation of suffering, but also methods to maintain health through prophylactic treatments. The therapeutic character of treatment presupposes, that characterized a pathological condition or a disorder with disease value in a normal state returned or pathological condition to be prevented. The concept of treatment is not to be interpreted strictly: Also the alleviation of pain or discomfort and the restoration of physical performance, even if their reduction is not caused by disease, must be regarded as therapeutic treatment within the meaning of that provision. Although the mood disorders have natural causes (eg menstruation, pregnancy, Alter), so they overlap but with Disease- and injury symptoms and are often indistinguishable from. It is very difficult and not appropriate, to distinguish between treatments for the causes and symptoms compared to. Below the limit for medical prophylaxis are procedures, which only serve to improve the general well-being, such as the use of healthy food (Reformkost) or the physician not specifically indicated administration of vitamins (Nack/Moufang in Beier/Haertel/Schricker/Straus, European Patent Convention, Munich Gemeinschaftskommentar, Art 52 Rz 371 ff; Singer/Stauder in Singer/Stauder, European Patentübereinkommen4 Art 52 Rz 55 each mN to Rsp of the European Patent Office).
3.5.1. In cases of a dedicated fabric protection, stating the intended use of the patent claim (Art 54 Abs 5 EPU iVm Art 52 Abs 4 EPÜ) Patent protection includes only products and products, which are suitable for the intended purposes (Spangenberg ibid Rz 86). The final element of the purpose limits the scope of the patent. The holder (nur) those actions reserved, on grounds relating to production and use of substances of the same nature and purpose as a medicinal product in the claimed indication (Melullis AAO 238; cf. BGH 1987, 794 – Antivirusmittel). Whether a third party from the teachings of such patent makes use, depends first and foremost on the, if the same material is used for the same purpose (Melullis AAO RZ 238).
3.5.2. To answer the question, whether that is pursued and achieved in the mentioned patent or other purpose, is a practically reasonable scale to invest, leaves no room for sophistical perspectives. That means – also – suitable for said purpose in the patent in suit, does not necessarily mean, that it to such use (in dosage, formulation, Kitting and packaging,) is also directed. To use the in the "assigned claim” placed under protection doctrine has to be added rather, that of the invention inherent purpose achieved in terms of the concrete aspect of the patented teaching in a practically significant extent (realized) shall (BGH 1987, 794 – Antivirusmittel).
3.6. Whether in the present case those conditions a patent law procedure (Use of the same substance, achieves the same purpose to a significant extent) the contested product the defendant "Vita Lady Vital Capsules” hold true, can not be answered definitively on the basis of previous findings. The contested decision must be annulled and the case back for a fresh decision after further proceedings in the sense indicated in the first instance.
4.1. In the ongoing process will be particularly noted, ob ein Rotklee-Extrakt, the 8 % Contains isoflavones (as the undisputed composition of the defendant's product), according to the given by the defendant intended purpose as isoflavone phytoestrogen extract of clover for the treatment of premenstrual syndrome, von Symptomen, associated with post-menopausal, is used, and whether the product of the defendant to the patent, the applicant inherent purpose in terms of the specific aspect of the patented teaching (limited to the use for the treatment of premenstrual syndrome and symptoms, associated with post-menopausal) achieved in a practically significant extent.
4.2. The aforementioned evidence themes is factual relevant for the alleged patent law engaging facts, is obliged to provide proof of the general principles to the applicant. Under certain – detail below displayed – but conditions will also obtain these factual relevant facts by using experience-circuits within the meaning of prima facie evidence in question.
4.3. The prima facie have jurisdiction and teachings for the purpose of developing, not to allow the law enforcement fail to difficulties of proof (RIS-Justiz RS0040281 [T4]). The prima facie evidence is based on typical Geschehnisabläufen, whose realization is probable. It serves as proof to that relief, who demonstrate entitlement facts, allows a shift of proof issue and the burden of proof and can be invalidated by the enemy by the evidence of a serious consideration to withdrawing atypical Geschehnisablaufs (RIS-Justiz RS0040266 [T8]). The prima facie evidence in cases perceived as appropriate, where concrete evidence from the evidence requirement reasonably can not be expected (2 Whether 167 / 07h mwN = RIS Justice RS0123919). Typically this is the case, when it comes to circumstances, which are solely the realm of the enemy and therefore known only to him and only through him are provable (RIS-Justiz RS0040266 [T12]; RS0040281 [T6]).
4.4. In these proceedings findings missing to, how the defendant has shown the efficacy and indication of their engagement product in advertising to consumers and / or doctors or pharmacies. In case of conformity of advertising moderate view of the engagement with the product patent purposes moderately protected – for which the applicant would be obliged to provide proof – can this situation within the meaning of prima facie evidence in human experience suggests, that the intervention product has a patent proper purpose direction and achieves the effect of the patent in a practically significant extent. Of course, would be in this case the defendant, the quashing of the prima facie evidence, open, for example by demonstrating the serious possibility, that their product is ineffective. In this case, the applicant would then be provided conclusive proof of the alleged patent law intervention.
4.5. Succeed in continuing method of proof to the limits set 4.1. topics shown, will be further determine, whether the isoflavone phyto-estrogen in the product of the defendant genistein and / or biochanin A: Daidzein and / or formononetin comprises, in a ratio of about 1:2 to 2:1 are available (this as a prerequisite of infringement of claim 6) and whether the isoflavone phytoestrogens in the product of the defendant in an amount of about 20 mg bis 200 mg per dosage unit are available, the amount, if appropriate, 50 mg bis 150 is mg (this as a prerequisite of infringement of claim 8).
5. The cost of title based on § 52 Abs 1 second sentence ZPO.
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