EU – CHINA Patent Training Program Case Studies EP “Custodiol II” DE “lubricant for trombone slide” Prof. Dr. Christian Osterrieth, attorney at law, Düsseldorf Mr. Gisbert Steinacker, former presiding judge of the patent senate of the court of appeal, Düsseldorf Overseas Exchange Center of Beijing University, March 2010

Case Study EP „Custodiol II“ Case Study for European Patent EP 0 054 635 – protective solution for heart and kidney, and manufacturing process – Custodiol II Priviledged and Confidential

Case Study EP „Custodiol II“ Following facts are given:   Claimant was owner of the EP 0 054 635 (patent in suit) - which is expired by now - with the effect for i.a. The Federal Republic of Germany. The patent in suit concerns a protective solution for heart and kidney and the manufacturing process. Claim 1 of the patent in suit says: Priviledged and Confidential

Case Study EP „Custodiol II“ "Protective solution for preventing ischaemia damage to the heart and kidneys and also other organs in operations and in organ transplant work, characterised in that it contains the following additives per litre:   potassium or sodium hydrogen a-ketoglutarate 4 ± 3 millimols sodium chloride 15± 8 millimols potassium chloride 10 ± 8 millimols magnesium chloride 10± 2millimols trytophane 2± 1 millimol histidine 150±100 millimols histidine hydrochloride 16 ± 11 millimols mannitol 50± 50 millimols fructose 50± 50 millimols ribose 50± 50 millimols inosine 50± 50 millimols the osmolarity of the solution amounting to approximately 300 to 350 mosm, and the pH of the solution being between 6.8 and 7.4." Priviledged and Confidential

Case Study EP „Custodiol II“ In the dispensary of the defendant's urban hospital M. an organprotective solution was produced and used during the duration of the patent, which matches with claim 1 of the patent in suit except for the following deviations: The additive for magnesium chloride amounts 4 mmol/l; the histidine hydrochloride is replaced by hydrochloric acid 25 %. The preparation, that was distributed at that time by the plaintiff and which the plaintiff considered to be matching with the patent, contained 4 mmol/l magnesium chloride. Priviledged and Confidential

Case Study EP „Custodiol II“ It can be assumed that it is indisputable for parties that hydrochloric acid 25 % (equal in quantity to histidine hydrochloride) for an expert is a different additive but with the obvious same effect. Due to this, the scope of protection of the patent is not exited according to the corresponding opinions of the parties. Though, it is litigious whether claim 1 of the patent in suit is used regarding feature magnesium chloride 10± 2millimols. Priviledged and Confidential

Case Study EP „Custodiol II“ The plaintiff considers the defendant's manufacturing of the preparation as an infringement of the patent in suit which creates on obligation for the defendant to pay damages. The plaintiff states that at the priority date it was known by experts that magnesium chloride concentrations of 10 mmol/l as well as of 4 mmol/l have comparable effects in the field of cardioplegia and organprotection, even though the lower concentration was considered to be less effective regarding a calcium-antagonistic effect. Priviledged and Confidential

Case Study EP „Custodiol II“ According to the plaintiff, it would not be justified to limit the cope of protection of the patent in suit to its wording concerning the tonnage band, because the only new component of the patent in suit was the α-ketoglutarate, while the patent specification did not contain explanations concerning the tonnage bands and the expert knew, that there was a more or less large scope available for the concentrations. Priviledged and Confidential

Case Study EP „Custodiol II“ The defendant claims that the content of 4 mmol/l amounts only half of the lower limit of claim 1 of the patent in suit. Due to this, the patent in suit was not infringed.   Priviledged and Confidential

Case Study EP „Custodiol II“ Following questions had to be answered by the court: of what significance are the numerical area specifications on claim 1? can a literal infringement of claim 1 be assumed even though the content of magnesium chloride is beyond the given value? should then an infringement by equivalence be assumed? Priviledged and Confidential

Case Study DE „lubricant for trombone slide“ for German Patent DE 40 12 915 - lubricant for trombone slide - Priviledged and Confidential

Case Study DE „lubricant for trombone slide“ Following facts are given: Plaintiff is owner of the German Patent DE 40 12 915 (patent in suit) concerning a lubricant for a slide of a trombone or similar musical instruments. Claim 1 of said patent says: "A lubricant for a slide of a trombone or similar musical instruments characterized in that it consists of the two components silicone fluid aqueous soap solution that are applied to the respective slide in the indicated order." Priviledged and Confidential

Case Study DE „lubricant for trombone slide“ The defendant distributes lubricants for trombones or similar musical instruments in the Federal Republic of Germany. The matter it is a silicon oil emulsion that consists of water to more than 90 %. Furthermore, the lubricant contains about 3,1 % polydimethylsiloxan (= silicon oil) and paraffin oil. It is litigious whether the product contains further components and if so, what these components are. Priviledged and Confidential

Case Study DE „lubricant for trombone slide“ The plaintiff claims that the attacked emulsion infringes the patent in suit literally. The plaintiff furthermore states, that claim 1 is a "product-by-process" claim. Due to this, the way of manufacturing was irrelevant. The only deciding factor would be that the attacked product contained the components given in claim 1. Apart from that, the compositions in claim 1 were not final, so that it is possible for the emulsion to contain further components. Claim 1 was at least infringed by equivalence. Priviledged and Confidential

Case Study DE „lubricant for trombone slide“ The defendant claims that the attacked lubricant did not contain further components, namely a solubilizer, a stabilizer (glycerin), a remedy enforcing the sliding effect (paraffin oil) and a special emulsifier, claim 1 was not a "product-by-process" claim. It would be necessary for the components given in the claim to be captured in the given order. the patent was not infringed by equivalence Priviledged and Confidential

Case Study DE „lubricant for trombone slide“ The court had to answer the following questions: Must the lubricants due to the patent only contain the components given by claim 1 (silicon oil and aqueous soap solution)? Of which significance is the demand of the patent that said two components should be captured in the given order? Does the attacked emulsion infringe all claims literally? Priviledged and Confidential

Case Study DE „lubricant for trombone slide“ or, in the case the last question would have to be denied: Does the attacked emulsion infringe the patent by equivalence? Priviledged and Confidential

Priviledged and Confidential Thank You! Priviledged and Confidential

Christian.Osterieth@rokh-ip.com Gisbert.Steinacker@rokh-ip.com Steinstraße 20 Tel. +49 (0)211 550 22 0 40212 Düsseldorf Fax +49 (0)211 550 22 550 Christian.Osterieth@rokh-ip.com Gisbert.Steinacker@rokh-ip.com www.rokh-ip.com