Source: https://www.expertguides.com/articles/process-patents-and-the-partial-outsourcing-of-individual-procedural-steps-into-patent-free-foreign-countries-opportunity-or-risk-a-view-from-practice/arugzjxn
Timestamp: 2019-04-19 22:28:47+00:00

Document:
In the case of cross-border situations, the question arises as to whether a patent-infringing act of use can be assumed if, in the case of a process patent, only a part of the procedural steps are carried out in the domestic patent-protected country, and other procedural steps are transferred to a patent-free foreign country. The precise answer to this question is of great practical importance, especially in the face of progressing global and economic division of labour. From the patent proprietor's point of view, it is important that their protective rights provide the best possible protection and on the part of the person wishing to make use of the patent protected object, it is essential that they can do so without infringing any third-party intellectual property rights. While in the literature diverse opinions are expressed, the jurisprudence to date is clear. Accordingly, the need for legal counselling with regard to this question is correspondingly significant. Only recently, in the field of a prenatal diagnostic procedure consisting of several procedural steps, we have obtained a judgment before the District Court Düsseldorf,2 which fortunately provides more clarity.
Process patents do not provide protection for a specific product, but rather for a specific technical instruction.6 Process patents are regularly composed of several procedural steps. In principle, a process patent grants the proprietor the sole right to use or offer the patented process (section 9 sentence 2 no. 2 and 3 German Patent Law). When evaluating partial procedures carried out abroad, the alternative to usage are of particular relevance.
Usage within the meaning of Patent Law has occurred if all procedural steps are applied domestically, that is to say they are carried out or used as intended.7 The manifest arrangement of a device in order to apply the patented method does not constitute usage in this sense.8 If individual process steps are carried out by a third party in a patent-free foreign country, the central question is whether the partial steps carried out abroad can be attributed to the persons acting domestically and what the requirements are for these to be attributed to them. The prerequisite for their being no presumption of domestic patent infringement, in the case of partial outsourcing of individual procedural steps abroad, would therefore be that the procedural steps carried out in a patent-free foreign country cannot be attributed to the parties who are carrying out the other procedural steps that are also part of the patented procedure.9 In that case, the implementation of the patented procedure as a whole would be regarded as usage in a patent-free foreign country.
The Regional Court Düsseldorf has recently decided, with regard to a prenatal diagnostic method, that what is relevant is whether the procedural step in question is an essential element of the invention.17 The case being decided by the Regional Court Düsseldorf concerned a non-invasive prenatal test to determine the risk of foetal chromosomal disorders, which is achieved by analysing cell-free DNA from the mother's blood. In this way, serious diseases, such as trisomy 21, can be detected at an early stage. The patented process essentially involves 4 process steps; namely providing a maternal blood sample (i), separating the sample into a cellular and non-cellular fraction (ii), detecting the presence of a nucleic acid of foetal origin in the non-cellular fraction using the method of any one of claims 1 to 17 (iii) and providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid (iv).
In principle, the infringement of a procedural patent can only be assumed if all procedural steps are single-handedly applied.24 If some steps of a procedural patent are transferred to a patent-free foreign country, of relevance for the question of attribution on the basis of relevant case law, is where the process steps that are essential to the invention take place, respectively, where merely an insignificant primary product or intermediate product is produced.25 With regard to this issue and the relevant practical implications, as a consequence, fortunately more clarity and thus legal certainty has been achieved in the field of process patents.
District Court Düsseldorf, judgement dated 20.12.2016, 4c O 62/16 – not legally valid.
Benkard/Scharen, Patent Law (PatG), § 9 note 8 et seq., 11. Ed. 2015.
Kraßer/Ann, Patent Law, § 33 note 43, 7. Ed. 2016.
Higher Regional Court Düsseldorf Judgement dated 10.12.2009, 2 U 51/08, BeckRS 2010, 12415 – Prepaid-Telefonkarte.
Benkard/Scharen, PatG, § 14 note 47, 11. Ed. 2015; cf. concerning the breaking down of process patents, Mes Patent Law, § 1 note 195 et seq., 4. Ed. 2015.
BGH GRUR 1990, 997, 999 – Ethofusemat; Kühnen, Patentverletzung, A.V.7. note 270, 9. Ed. 2016.
BGH GRUR 2005, 845, 847 – Abgasreinigungsvorrichtung.
Busse/Keukenschrijver, PatG, § 9 note138, 8. Ed. 2016; Kraßer/Ann, Patent Law, § 33 note 139, 7. Ed. 2016, whereby the conditions that should be fulfilled for an attribution are not mentioned.
Hölder, Jubilee publication for 10 years of studies “International Studies in Intellectual Property Law”, 2009, p. 181, 192.
Haupt, GRUR 2007, 187, 190 ff.; Kühnen, patent infringement, A.V. note. 271, 9. Ed. 2016; Regional Court Munich, GRUR-RR 2015, 93, 99 - FLT3 Gene test using the terminology “essential“.
Haupt, GRUR 2007, 187, 191.
Benkard/Scharen, PatG, § 9 note 10, 11, Ed. 2015.
Regional Court Düsseldorf, judgement of 20.12.2016, 4c O 62/16 – not legally valid.
Regional Court Düsseldorf, judgement dated 20.12.2016, 4c O 62/16 – not legally valid; Kühnen, patent infringement, A.V. note. 271, 9. Ed. 2016.
Regional Court Düsseldorf, judgement dated 20.12.2016, 4c O 62/16 – not legally valid.
Ibidem. In the field of prenatal diagnostic procedures, the Federal Supreme Court has also recently confirmed that investigation results obtained in a patent-free foreign country on the basis of a patented process do not constitute direct procedural products within the meaning of section 9 sentence 2 no. 3 of the German Patent Law; cf. the judgment on 27.09.2016 - X ZR 124/15, BeckRS 2016, 111826 - FLT3 (Gene Test). According to this, third parties are prohibited from offering, placing on the market or making use of a product directly produced through a patented process. In the relevant case, samples were collected in Germany, nucleic acids extracted and sent to the Czech Republic to carry out the disputed procedure. The test results were then sent back to Germany.
Kühnen, patent infringement, A.V. note. 269, 9. Ed. 2016.
Terminologically comparable “key concepts” and “Focal Point Area“.

References: § 9
 § 33
 § 14
 § 1
 § 9
 § 33
 § 9