Tag: Pharmaceutical

France vs SAS Arrow Génériques, September 2023, Court of Administrative Appeal, Case No 22LY00087

SAS Arrow Génériques is in the business of distributing generic medicinal products mainly to the pharmacy market, but also to the hospital market in France. It is 82.22% owned by its Danish parent company, Arrow Groupe ApS, which is itself a wholly-owned subsidiary of the Maltese company Arrow International Limited. In 2010 and 2011, SAS Arrow Génériques paid royalties to its Danish parent, Arrow Group ApS, and to a related party in the UK, Breath Ltd. According to the French tax authorities, the royalties constituted a benefit in kind granted to Arrow Group ApS and Breath Ltd, since SAS Arrow Génériques had not demonstrated the reality and nature of the services rendered and had therefore failed to justify the existence and value of the consideration that it would have received from the payment of these royalties, which constitutes an indirect transfer of profits to related companies. On appeal, the Administrative Court decided in favour of SAS Arrow Génériques. The tax authorities appealed the decision to the Court of Administrative Appeal. Judgement of the Court The Court of Appeal dismissed the appeal of the tax authorities and upheld the decision of the first instance court in favour of SAS Arrow Génériques. Excerpt 5. It is common ground that SAS Arrow Génériques is not dealing at arm’s length with Arrow group ApS, a Danish company that held 82.22% of its shares during the period under review, and the UK company Breath Ltd, which is also 100% owned by Arrow group ApS. The proposed rectifications of 26 December 2013 and 19 December 2014 addressed to SAS Arrow Génériques for the years 2010 and 2011 show that during the period under review it paid royalties of 5% of net sales to Arrow group ApS for the sub-licensing of intellectual property rights relating to the technical files used to file marketing authorisations in France, which were themselves licensed to Arrow group ApS by its parent company, Arrow International Limited, a company incorporated under Maltese law. SAS Arrow Génériques also paid royalties, on similar terms, to the UK company Breath Ltd. In order to challenge the full amount of the royalties paid by SAS Arrow Génériques to Arrow Group ApS and Breath Ltd, the tax authorities took the view that the royalties in question constituted a benefit in kind granted to Arrow Group ApS and Breath Ltd, since the audited company had not demonstrated the reality and nature of the services rendered and had therefore failed to justify the existence and value of the consideration that it would have received from the payment of these royalties, which constitutes an indirect transfer of profits to related companies. However, it is clear from the investigation, as the Court held, that the royalties in question were in return for Arrow Group ApS and Breath Ltd making available to the applicant the technical files necessary for the submission of marketing authorisation applications for its business. Contrary to what the Minister maintains on appeal, the investigation did not show that SAS Arrow Génériques had the material and human resources necessary to produce these technical files itself, which required the assistance of various professionals and the performance of clinical tests, or that it used subcontractors to do so. The fact noted by the authorities that certain molecules for which the technical files essential to the company’s business had been compiled were not held in any capacity whatsoever by Arrow International Limited, Arrow group ApS or Breath Ltd, and in particular that certain molecules were not included in their list of intangible assets, is not sufficient in itself to call into question the existence of these technical files and the services rendered by Arrow group ApS or Breath Ltd, given that this entry may fall into another category of expenditure or may be the result of an error in the entry in the accounts of these molecules and the related technical files. In addition, SAS Arrow Génériques argues, without being contradicted, that the rights attached to certain files were not acquired but leased or subleased from third parties by Arrow International Limited before being licensed and then sub-licensed. Finally, if the Minister maintains that the added value created by SAS Arrow Génériques is based on the development of its commercial network and that the royalties paid deprive it of the return on investment to which it would be entitled as a result of the activity it undertakes, such an argument does not call into question the existence of services rendered by Arrow Group ApS or Breath Ltd in return for the royalties at issue but, where applicable, only the excessive nature of the royalties paid, which therefore do not constitute an advantage in kind granted by a company established in France to a company established outside France. In addition, the Minister did not produce any evidence in his defence comparing the prices charged by the said affiliated companies with those charged by similar companies operating normally in order to establish whether the amount of the royalties paid was excessive. It follows that the Minister for the Economy, Finance and Recovery is not entitled to argue that, in the judgment under appeal, the Administrative Court of Lyon wrongly held that the payment of the royalties at issue by SAS Arrow Génériques could not be regarded as an advantage in kind granted by a company established in France to a company established outside France and that the full amount of the royalties could not therefore be reintegrated into its taxable profits on the basis of the provisions of Article 57 of the General Tax Code. 6. It follows from the foregoing that the Minister for the Economy, Finance and Recovery is not entitled to maintain that it was wrongly that, by Articles 1 to 7 of the contested judgment the Lyon Administrative Court reduced the taxable income of SAS Arrow Génériques for corporation tax purposes by an amount of 4,865,767 euros in respect of the 2010 financial year and consequently discharged SAS Arrow Génériques in ...

Czech Republic vs. Eli Lilly ÄŒR, s.r.o., August 2023, Supreme Administrative Court, No. 6 Afs 125/2022 – 65

Eli Lilly ÄŒR imports pharmaceutical products purchased from Eli Lilly Export S.A. (Swiss sales and marketing hub) into the Czech Republic and Slovakia and distributes them to local distributors. The arrangement between the Czech company and the Swiss company is based on a Service Contract in which Eli Lilly ÄŒR is named as the service provider to Eli Lilly Export S.A. (the principal). Eli Lilly ÄŒR was selling the products at a lower price than the price it purchased them for from Eli Lilly Export S.A. According to the company this was due to local price controls of pharmaceuticals. However, Eli Lilly ÄŒR was also paid for providing marketing services by the Swiss HQ, which ensured that Eli Lilly ÄŒR was profitable, despite selling the products at a loss. Eli Lilly ÄŒR reported the marketing services as a provision of services with the place of supply outside of the Czech Republic; therefore, the income from such supply was exempt from VAT in the Czech Republic. In 2016 a tax assessment was issued for FY 2011 in which VAT was added to the marketing services-income. An appeal was filed with the Administrative Court by Eli Lilly, but the Court dismissed the appeal and decided in favour of the tax authorities. An appeal was then filed with the Supreme Administrative Court. Judgement of the Court The appeal of Eli Lilly was again dismissed and the decision of the administrative court – and the assessment of additional VAT upheld. “The complainant’s objections were not capable of overturning the conclusion that the supply of marketing services and the supply of the distribution (sale) of medicines were provided to different entities and that, in the eyes of the average customer, they were not one indivisible supply.” Click here for English Translation Click here for other translation Czech vs Eli Lilly Cr August 2023 6 Afs 125-2022 - 59 ...

Israel vs Medtronic Ventor Technologies Ltd, June 2023, District Court, Case No 31671-09-18

In 2008 and 2009 the Medtronic group acquired the entire share capital of the Israeli company, Ventor Technologies Ltd, for a sum of $325 million. Subsequent to the acquisition various inter-company agreements were entered into between Ventor Technologies Ltd and Medtronics, but no transfer of intangible assets was recognised by the Group for tax purposes. The tax authorities found that all the intangibles previously owned by Ventor had been transferred to Medtronic and issued an assessment of additional taxable profits. An appeal was filed by Medtronic Ventor Technologies Ltd. Judgement of the District Court The court dismissed the appeal and upheld the assessment issued by the tax authorities. Click here for English translation Israel-vs-medtronic-ventor-ORG ...

Czech Republic vs. Eli Lilly ÄŒR, s.r.o., December 2022, Supreme Administrative Court, No. 7 Afs 279/2021 – 65

Eli Lilly ÄŒR imports pharmaceutical products purchased from Eli Lilly Export S.A. (Swiss sales and marketing hub) into the Czech Republic and Slovakia and distributes them to local distributors. The arrangement between the local company and Eli Lilly Export S.A. is based on a Service Contract in which Eli Lilly ÄŒR is named as the service provider to Eli Lilly Export S.A. (the principal). Eli Lilly ÄŒR was selling the products at a lower price than the price it purchased them for from Eli Lilly Export S.A. According to the company this was due to local price controls of pharmaceuticals. At the same time, Eli Lilly ÄŒR was also paid for providing marketing services by the Swiss HQ, which ensured that Eli Lilly ÄŒR was profitable, despite selling the products at a loss. Eli Lilly ÄŒR reported the marketing services as a provision of services with the place of supply outside of the Czech Republic; therefore, the income from such supply was exempt from VAT in the Czech Republic. In 2016 a tax assessment was issued for FY 2011 in which VAT was added to the marketing services-income and later similar assessments were issued for the following years. An appeal was filed with the District Court by Eli Lilly which was dismissed by the Court. An appeal was then filed with the Supreme Administrative Court. Judgement of the Court The Supreme Administrative Court ruled in favor of Eli Lilly – annulled the judgement of the District Court and set aside the assessment of the tax authorities. “The Supreme Administrative Court found no reason to depart from the conclusions of the judgment in Case No 3 Afs 54/2020, even on the basis of the defendant’s additional arguments. Indeed, the applicant can be fully accepted that it is at odds with the reasoning of the Supreme Administrative Court and puts forward arguments on issues which are rather irrelevant to the assessment of the case. First of all, the defendant does not dispute in any relevant way that the disputed supplies were provided to two different entities (the distribution of medicines to the complainant’s customers and the provision of marketing services to Eli Lilly Export), and that the ‘average customer’ cannot perceive those supplies as a single supply. This conclusion does not in any way undermine the defendant’s reiteration of the complainant’s assertion at the income tax audit that, for the purposes of assessing the correctness of the transfer pricing set between the complainant and Eli Lilly Export in terms of section 23(7) of the Income Tax Act, the marketing service should be regarded as an integral part of the distribution of the medicines and cannot be viewed in isolation when assessing profitability. In terms of transfer pricing, the economic interdependence of the two activities was assessed, which was essential only to determine whether the profitability of each activity should be compared separately with entities carrying out only the relevant activity. However, the aggregate assessment of these activities in terms of Section 23(7) of the Income Tax Act, which involves offsetting profits and losses from different types of business activities and comparing profitability with entities performing a similar role (i.e. performing both marketing and distribution), does not necessarily mean that there is a single transaction for VAT purposes. This issue is assessed separately in accordance with the aspects of the VAT Act and the VAT Directive respectively. [32] Nor can the defendant’s other arguments, which it repeats in support of the conclusion that the provision of marketing services constitutes a supply incidental to the domestic sale of medicines, be accepted. It does not follow from the judgment in Case 3 Afs 54/202073 that the concept of ‘third party consideration’ cannot exist. The Supreme Administrative Court has not denied that the total value of the consideration received from the final customer for the purposes of determining the tax base may, in general, also include payments from third parties (see, for example, paragraphs 62 et seq. of the judgment referred to above). However, in the context of the present case, in the case of the distribution of pharmaceuticals, the Court held that the consideration for marketing services could not be regarded as part of the value of the consideration, since those services were not provided to ‘customers’ who were merely recipients of marketing information. The consideration for those services was not then spent on behalf of or for the benefit of the customers. As regards the defendant’s reference to the judgment of the CJEU in Firma Z, the conclusions expressed there concern a different factual situation and legal issue. The substantive issue was the offsetting of a reduction in the taxable amount of one supply against the taxable amount of another supply, which is excluded under the common VAT system. However, as noted above, in the present case the complainant does not supply any other supply to its customers at the same time as the pharmaceuticals. Therefore, if the conclusion of the tax administration were accepted, it would have received a higher amount of VAT than the amount paid for the supply which was the only supply received by the customer from the complainant (the pharmaceuticals). The complainant’s final, potential or immediate customers cannot be the recipients of a marketing service at all (see above). [33] Nor can the defendant’s view that the method of pricing the marketing services shows an ‘unquestionable link’ between the marketing services and the sale of medicines be accepted. In that connection, the defendant points out that the pricing of marketing services is not based solely on the costs of marketing, but also on the costs of distributing the goods (medicines). It therefore concludes that it is a payment by a third party (Eli Lilly Export) on top of the price of the medicines which the complainant sells at regulated prices. This argument of the defendant cannot stand. As a general rule, it is a matter for the parties to negotiate the price or the method of calculating it. Furthermore, ...

Luxembourg vs “TR Swap SARL”, November 2022, Administrative Tribunal, Case No 43535

The owner of a buy sell distributor in the pharmaceutical sector had entered into a total return swap with the company and on that basis the company had deducted a commission corresponding to 85% of net profits from its taxable income. The tax authorities disallowed the deduction claiming the swap-arrangement was not at arm’s length. The commission-payments received by the owner was instead considered a non-deductible hidden distribution of profits (dividend) and a withholding tax of 15% was applied. An appeal was filed with the Administrative Tribunal. Judgement of the Administrative Tribunal The Tribunal found the appeal of “TR Swap SARL” unfounded and decided in favor of the tax authorities. Excerpt “However, the court is obliged to note that the commissions paid to Mr … on the basis of the … and corresponding to 85% of the net profits of the company … amount to … euros, … euros, … euros and … euros during the disputed tax years 2014 to 2017, i.e. a total of … euros, as shown in the management decision of 7 June 2019, these amounts not being contested by the claimant. However, the amounts made available to the companies …, respectively … by Mr … correspond, on the one hand, to a maximum annual amount of … euros, in respect of the administrative operating costs of the company … as well as, on the other hand, as it appears from the documents entitled “Margin Calculation Sheet” from April 2013 to March 2018 issued by the plaintiff, to an amount of …, within the framework of the line of credit, an amount that does not bear interest and that should be subject, according to the terms agreed between the parties concerned, to reimbursement so as to constitute only a loan. Thus, Mr …, by paying annually a maximum amount of … euros, i.e. a total maximum of … euros during the disputed years from 2014 to 2017, received, by way of commission and after the repayment of the credit line granted, a total amount of … euros, elements which allow the court to hold that the tax authorities have provided sufficient elements to hold that Mr … … was granted an advantage that exceeds a priori the market conditions between third parties, so as to cast doubt on the transactions currently at issue and reversing the burden of proof. It should then be noted that in order to establish the economically justified nature of the distribution of the net profits of the company … between Mr … and itself, the plaintiff only relied on a document describing “the method used to determine the transfer price, as well as all the data selected to calculate the transfer price over the period 2014-2018″, which however only contains interest rates provided without any other explanation and whose author is not known, so that it is devoid of any evidential value. Furthermore, in the face of the state party’s challenges, the plaintiff failed to submit to the court any element that would make it possible to establish the existence and reality of the risks allegedly weighing on Mr. … and justifying the payment of commissions to the latter according to the terms and conditions set out in the …. The Director [of the Tax Administration] was therefore right to hold that the tax office could legitimately consider that the disputed amounts paid to Mr … in the context of the … concluded with the plaintiff during the tax years 2014 to 2017 did not comply with the usual market conditions between third parties and that it thus concluded that there was a hidden distribution of profits. It follows from all of the above considerations and in the absence of any other pleas that the appeal under review must be dismissed as unfounded.” Click here for English translation Click here for other translation Luxembourg 221122 Case no 43535 ...

Israel vs Medingo Ltd, May 2022, District Court, Case No 53528-01-16

In April 2010 Roche pharmaceutical group acquired the entire share capital of the Israeli company, Medingo Ltd, for USD 160 million. About six months after the acquisition, Medingo was entered into 3 inter-group service agreements: a R&D services agreement, pursuant to which Medingo was to provide R&D services in exchange for cost + 5%. All developments under the agreement would be owned by Roche. a services agreement according to which Medingo was to provided marketing, administration, consultation and support services in exchange for cost + 5%. a manufacturing agreement, under which Medingo was to provide manufacturing and packaging services in exchange for cost + 5. A license agreement was also entered, according to which Roche could now manufacture, use, sell, exploit, continue development and sublicense to related parties the Medingo IP in exchange for 2% of the relevant net revenues. Finally, in 2013, Medingo’s operation in Israel was terminated and its IP sold to Roche for approximately USD 45 million. The tax authorities viewed the transactions as steps in a single arrangement, which – from the outset – had the purpose of transferring all the activities of Medingo to Roche. On that basis an assessment was issued according to which the intangibles had been transferred to Roche in 2010. Based on the acquisition price for the shares, the value was determined to approximately USD 160 millions. An appeal was filed by Medingo claiming that there had been no transfer in 2010. Judgement of the District Court The court decided in favor of Medingo and set aside the 2010 tax assessment – but without passing an opinion in relation to the value of the sale of the intellectual property in 2013. Excerpts “96. The guidelines indicate that in a transaction between related parties, two different issues must be examined using the arm’s length principle: transaction characterization and transaction pricing. The characterization of the transaction must first be examined and it must be examined whether it would also have been made between unrelated parties. If the examination reveals that even unrelated parties would have entered into a transaction in the same situation, then it must be further examined whether the price paid for the assets complies with market conditions. It should be noted that in accordance with the guidelines, the characterization of the transaction should not be interfered with in violation of the agreements, except in exceptional circumstances, in which the agreements are fundamentally unfounded, or in no way allow a price to be determined according to the arm’s length principle. “Tax A tax administration should not disregard part or all of the restructuring or substitute other transactions for it unless the exceptional circumstances described in paragraph 1.142 are met”. out circumstances in which the transaction between the parties as accurately delineated can be disregarded for transfer pricing purposes. Because non-recognition can be contentious and a source of double taxation, every effort should be made to determine the actual nature of the transaction and apply arm’s length pricing to the accurately delineated transaction, and to ensure that non-recognition is not used simply because determining an arm’s length price is difficult. e same transaction can be seen between independent parties in comparable circumstances… non-recognition would not apply… the transaction as accurately delineated may be disregarded, and if appropriate, replaced by an alternative transaction, where the arrangements made in relation to the transaction, viewed in their totality, differ from those which would have been adopted by independent enterprises behaving in a commercially rational manner in comparable circumstances, thereby preventing determination of a price that would be acceptable to both of the parties taking into account their respective perspective and the options realistically available to each of them at the time of entering into the transaction “. 97. Further to this, sections 1.146 – 1.148 of the Guideline, 2022, provide two examples of cases in which the characterization of the transaction must be ignored. The second example deals with a case closer to our case, where a one-time payment is paid for R&D services and their products provided – for 20 years. 98. After examining the characterization of the transaction in our case, I found no defect in it. This is a completely different case from those mentioned in the guidelines, and it has been proven to me that transactions with a similar characterization can be conducted and are also conducted between unrelated parties. Thus, throughout the proceedings, the appellant presented various examples of similar license agreements and R&D agreements signed between unrelated parties: In Phase A, the appellant presented various transactions for comparison (P / 2 (to which the respondent did not even refer), p. 332 of the minutes (and within the appeal Of EY Germany and of Gonen in which additional transactions were presented for comparison, including transactions of similar companies in the relevant market.” “104. I also believe that it makes sense to enter into such agreements, especially in the situation of the appellant at that time. Appellant faced considerable obstacles, and her chances of success were not guaranteed, to say the least….” “105. The inter-group agreements secured the appellant’s future in the near term, and gave her more chances to survive. As the appellant’s experts clarified, small companies find it difficult to survive alone in the medical device market (see for example Section 1 of the Michlin Opinion (hence, a licensing and commercialization agreement is common practice in the field and common with contractors with experience and resources); See also paragraph 41 regarding Broadcom).” “110. In conclusion, as long as the appellant and Roche acted in accordance with the inter-group agreements, which are acceptable in industry and in the circumstances of the case there is logic in concluding them, I did not find any invalidity in the characterization of the agreements (see paragraphs 85 and 87 in the Broadcom case).” “….As stated, I believe that even if there was an intention to transfer the activity, there was no final decision until the date of the announcement. Second, and this is the ...

TPG2022 Chapter II Annex II example 1

1. Company A is the parent company of an MNE group in the pharmaceutical sector. Company A owns a patent for a new pharmaceutical formulation. Company A designed the clinical trials and performed the research and development functions during the early stages of the development of the product, leading to the granting of the patent. 2. Company A enters into a contract with Company S, a subsidiary of Company A, according to which Company A licenses the patent rights relating to the potential pharmaceutical product to Company S. In accordance with the contract, Company S conducts the subsequent development of the product and performs important enhancement functions. Company S obtains the authorisation from the relevant regulatory body. The development of the product is successful and it is sold in various markets around the world. 3. The accurate delineation of the transaction indicates that the contributions made by both Company A and Company S are unique and valuable to the development of the pharmaceutical product. 4. Under these circumstances, the transactional profit split method is likely to be the most appropriate method for determining the compensation for the patent rights licensed by Company A to Company S ...

TPG2022 Chapter VI paragraph 6.123

In conducting a comparability analysis, it may be important to consider the stage of development of particular intangibles. It is often the case that an intangible is transferred in a controlled transaction at a point in time before it has been fully demonstrated that the intangible will support commercially viable products. A common example arises in the pharmaceutical industry, where chemical compounds may be patented, and the patents (or rights to use the patents) transferred in controlled transactions, well in advance of the time when further research, development and testing demonstrates that the compound constitutes a safe and effective treatment for a particular medical condition ...

Panama vs “Pharma Distributor S.A.”, July 2021, Administrative Tax Court, Case No TAT-RF-066

An adjustment for FY 2013 and 2014 had been issued to a pharmaceutical company in Panama “Pharma Distributor S.A” that resulted in an income adjustment of 19.5 million dollars, which in turn resulted in additional taxes of 2.4 million dollars. The resale price method had been used by Pharma Distributor S.A. to determine the market value of an asset acquired from a related entity that was sold to an independent entity. This method was rejected by the tax authorities based on the fact that the analysis presented by the taxpayer did not meet the requirements for application of the method. The tax authorities instead applied a TNMM. The tax authorities also rejected tax deductions for expenses purportedly paid for administrative services due to the absence of supporting documentation. Provisions of article 762-G “Administrative services received” in the Tax Code in Panama contemplates tax deductibility for such expenses exclusively when services have actually been rendered to the benefit of the recipient. Decision of the Court The Court held in favor of the tax authorities. The Court ratified the position of the tax authorities regarding the non-deductibility of the expense paid for administrative services. In addition, the Court’s resolution indicates inconsistencies and imprecision in the delineation of the transaction within the comparability analysis, selection and application of the Resale Price Method, concluding that the level of comparability presented in the supporting documentation would be inadequate for application of the method. It was also indicated that Pharma S.A assumed operating expenses in excess of those of simple distributors. Hence Pharma Distributor S.A. should be characterized as a fully-fledged distributor and be compensated for the additional functions performed and risks assumed. Due to these methodological inconsistencies, the Court agreed that the TNMM – as suggested by the tax authorities – was the more appropriate method in the case at hand. Click here for English translation Click here for other translation Panama vs Pharma 2021 ...

Poland vs A S.A., June 2021, Provincial Administrative Court, Case No I SA/Gl 1649/20

The business activity of A S.A. was wholesale of pharmaceutical products to external pharmacies, hospitals, wholesalers (including: to affiliated wholesalers). The tax authority had noted that the company’s name had been changed in FY 2013, and a loss in the amount of PLN […] had been reported in the company’s tax return. An audit revealed that the Company had transferred significant assets (real estate) to a related entity on non-arm’s length terms. The same real estate was then going forward made available to the company on a fee basis under lease and tenancy agreements. The tax authority issued an assessment where a “restructuring fee” in the amount of PLN […] was added to the taxable income, reflecting the amount which would have been achieved if the transaction had been agreed between independent parties. According to the company the tax authority was not entitled at all to examine the compliance of the terms of these transactions with the terms that would have been agreed between hypothetical independent entities, as the transactions in question were in fact concluded precisely between independent entities. (SKA companies were not CIT taxpayers in 2012, so they did not meet the definition of a “domestic entity” referred to in the aforementioned provision, and therefore a transaction between “related entities” cannot be said to have taken place). Moreover, the institution of “re-characterisation” of a controlled transaction into a proper transaction (according to the authority),could only be applied to transactions taking place after 1 January 2019, pursuant to Article 11e, Section 4 of the A.l.t.p. introduced (from that date). Judgement of the Court The Court decided predominantly in favor of A S.A. and remanded the case back to the tax authorities. Excerpts “The applicant in the course of the case referred to the judgment of the WSA in Warsaw of 18 December 2017, III SA/Wa 3661/16 (approved by the NSA in its judgment of 26 November 2020, II FSK 1919/18). The individual interpretation analysed there by the Court assessed a transaction (from 2012) concluded between a limited liability company and a general partnership. According to the WSA in Warsaw, the provisions of Article 11(4) in conjunction with Article 11(1) of the A.l.t.d.o.p. in the wording in force until 31 December 2014 may only be applied to transactions concluded between related parties – ‘domestic entities’ within the meaning of Article 11 of the A.l.t.d.o.p., and the tax authorities may only assess the income of related parties. The wording of Art. 11 of the A.l.t.p. indicates that it is intended to allow the tax authorities to estimate the income of related parties, if these parties, in transactions concluded between themselves, establish or impose terms and conditions that differ from those that would be established between independent parties, leading to an understatement of income. However, there are no grounds for this provision to be applied to transactions concluded by unrelated entities (a limited liability company and a general partnership) solely for the reason that tax on revenue from participation in a partnership is paid by its partners who are also members of the applicant’s management board. Indeed, it was only the provisions introduced by the Act of 29 August 2014 amending the Corporate Income Tax Act, the Personal Income Tax Act and certain other acts, which entered into force on 1 January 2015, that defined an “affiliated entity” as a natural person, a legal person or an organisational unit without legal personality that meets the conditions set out in the Act. If a contrary position were to be adopted Contrary to the authority’s assertions, these rulings do not concern a different factual situation. Although the audited interpretation concerned the necessity to prepare documentation pursuant to Art. 9a of the A.l.t.c., the applicant also directly inquired about classifying the applicant as an entity related to the general partnership. The courts of both instances were firmly in favour of the absence of such a link (dependence) between a capital company and a partnership, in terms of entering into mutual transactions, within the meaning of Article 11 of the A.l.t.p. in the wording in force until 31 December 2014. Thus, as shown above, the application of Article 11 of the A.l.t.d.o.p. in the present case was un-authorised, which makes it timely to consider the application in the analysed factual state of the general principles arising from Article 14 of the A.l.t.d.o.p. and Chapter 3 of this Act (tax deductible costs), which the authorities, for obvious reasons, have not undertaken so far.” “When reconsidering the case, the authority, taking into account the comments presented above, will issue an appropriate decision, containing in the justification of the decision all the elements referred to in Article 210 § 1 of the Polish Civil Code, including those arising from the cited resolution of the Supreme Administrative Court.” Click here for English Translation Click here for other translation I-SA-Gl-1649-20-Wyrok-WSA-w-Gliwicach ...

Spain vs BIOMERIEUX ESPAÑA SA, February 2021, National Court, Case No 2021:416

BIOMERIEUX ESPAÑA SA is active in the business of clinical and biological analysis, production, distribution, training and technical assistance. Likewise, the provision of computer services and, in particular, the computer management of laboratories. Following an audit the tax authorities found that the controlled prices agreed for the acquisition of instruments and consumables between bioMérieux España and its related entities, bioMérieux SA and bioMérieux Inc, did not provided bioMérieux España with an arm’s length return on is controlled activities. A tax assessment was issued for FY 2008 on the basis af a thorough critical analysis of the benchmark study provided by the BIOMERIEUX, and detailed reasoning and analysis in regards to comparability and market developments. Judgement of the National Court The Audiencia Nacional dismissed the appeal of Biomerieux España SA and decided in favour of the tax authorities. Excerpts “As we already reasoned in our SAN (2nd) of 6 March 2019 (Rec. 353/2015 ), it is legitimate to resort to what the Guideline calls “measures of central tendency”, but whoever resorts to them has the burden of reasoning and setting out the reasons that lead to their application. In our opinion, the Inspectorate, in this case, does reason and state the reasons.” “2008 was a year of outstanding economic results for the bioMérieux Group, as well as for bioMérieux Spain in terms of sales growth, according to the report. However, this situation of increased results for the Group is not reflected in the income statement of bioMérieux Spain’s distribution business, whose profitability fell from 8% in 2007 to 4.47% in 2008. This is not consistent either with the Group’s results or with the market remuneration for performing the same functions in 2007 and 2008, a market which has not been shown to have seen its margins of free competition reduced.” “It is true that, as stated in point 1.13 of the Guidelines, the objective sought by the rule is “to arrive at a reasonable approximation of what would be an arm’s length result based on reliable information. At this point, it should also be remembered that transfer pricing is not an exact science, but requires value judgements on the part of both the tax administration and taxpayers”. Precisely for this reason, the correct thing to do is to proceed as the inspectorate did, i.e. to ask the appellant to justify the price set and to analyse the reasonableness of the price obtained. In this sense, it is reasonable to require the appellant to keep the information regarding the criteria they have used to set the transfer price and the documentation that has justified them or, at least, to be able to precisely identify the sources from which they have obtained the information. This will allow for veriï¬cation. In this sense, paragraph 3.3 of the OECD Guidelines “considers it good practice for a taxpayer that uses comparables to justify its transfer prices ( ) to provide the other interested party with the supporting information that allows it to assess the reliability of the comparables used”.” “All these reasons, assessed as a whole, lead us to conclude that the detailed analysis carried out by the Inspectorate allows us to conclude that the calculations made by the Inspectorate are closer to the purpose of the rule, that is to say, to the search for the price set at arm’s length, than those provided by the appellant.” “The applicant submits that the Spanish authorities have reached an amicable agreement with the French authorities and have ï¬xed the agreed mark-up as market rate at 6,20 %. What is sought is to apply the same margin in relation to the US company, in respect of which there is no amicable procedure. The tax authorities opposes this argument, reasoning that the transfer price agreed with France in an amicable procedure is the result of a negotiation between sovereign entities involving considerations of international public law, and therefore its results cannot be extrapolated.” “The agreement obtained is an agreement that binds the negotiating States, but cannot extend its effects to relations with another State. The fact that the Kingdom of Spain, for reasons unknown to us, has reached an agreement with the Republic of France does not mean that the transfer price ï¬xed by the Spanish administration is not correct, but simply that the States have given in on their respective claims and reached an agreement, the effects of which cannot be extrapolated.” Click here for English Translation Click here for other translation SAN_416_2021 ...

Ireland vs Perrigo, November 2020, High Court, Case No[2020] IEHC 552 (Juridical Review)

Perrigo has lost is request for overturning a €1.64 billion tax assessment in a judicial review by the Irish High Court. The contention of the Irish Revenue is that a transaction (involving the disposal of intellectual property rights) which has been treated as part of the trade of Perrigo in its corporation tax returns should properly have been treated as a capital transaction. When treated as a capital transaction an effective tax rate of 33% is applied rather than the usual 12.5% rate. The Irish Revenue’s qualification of the transfer in question as an capital transaction results in additional taxes in the amount of €1,636,047,645. The transaction involved the sale to Biogen, in 2013, of Perrigo’s remaining 50% interest in the intellectual property relating to a pharmaceutical product sold under the brand name Tysabri which is used to treat multiple sclerosis and Crohn’s disease. “Perrigo explains that from 1st January, 2000, EPIL [Elan Pharma International Ltd] began to fund the continued development of Tysabri. It sought to find a collaboration partner with the necessary technical capability knowledge and experience in the area of multiple sclerosis research and development. Biogen was chosen as the counterparty as it satisfied both of those requirements. EPIL first disposed of 50% of its interest in the IP relating to Tysabri to Biogen in 2000 and received an upfront payment of US$15 million as reimbursement of research and development expenditure incurred to that date together with milestone payments if certain triggering events in the development process occurred. At the time of this partial disposal, Tysabri had not undergone the full clinical trials process and required “hundreds of millions of dollars of additional research and development investment with absolutely no guarantee of successâ€. Perrigo maintains that all income associated with the 2000 disposal was at the time treated and returned for corporation tax purposes as part of trading income and no issue was raised by the inspector or by the Revenue. Between 2004 and 2006, Tysabri was launched on the United States market, withdrawn from the market and subsequently relaunched. EPIL continued to actively manage the IP asset (representing the remaining 50% interest in the patents and the other IP relating to Tysabri) remaining in its portfolio. This was principally done through the detailed governance arrangements in the Collaboration Agreement with Biogen. It involved (inter alia) trying to establish the efficacy of the drug for the treatment of other diseases (such as Crohn’s disease) and attempting to secure licences for its release in jurisdictions outside the United States.” “Throughout this period of collaboration, EPIL did not manufacture Tysabri. Instead it was manufactured by Biogen. In April, 2013, the remaining 50% interest in the Tysabri IP was sold to Biogen with the consideration paid in the form of an upfront payment together with future contingent payments. The upfront payment received from Biogen in 2013 was included in the trading income in the EPIL tax return filed with Revenue in September, 2014 for the 2013 period. Perrigo complains that it was not until 30th October, 2018, not long before the expiry of the applicable four-year statutory limitation period, that the Revenue issued the audit findings letter in which the contention was made, for the first time, that the disposal of IP did not constitute part of EPIL’s trade.” Perrigo contends that the Revenue is incorrect in characterising the sale of the intellectual property (“the Tysabri IPâ€) as a capital transaction and has appealed the notice of amended assessment to the Tax Appeal Commission (“the TACâ€). In the event that the present application for judicial review fails, it will be for the TAC to determine whether the disposal of the Tysabri IP was or was not a trading transaction. In the proceedings before the court, Perrigo claims that the appeal should never have to proceed before the TAC. Perrigo claims that, irrespective of the nature of the transaction, there was no legal entitlement on the part of the inspector to issue the assessment. Perrigo has instituted these judicial review proceedings challenging the legality of the notice of amended assessment on the grounds that the assessment is (a) in breach of Perrigo’s legitimate expectations; (b) so unfair as to amount to an abuse of power; and (c) that it amounts to an unjust attack on its constitutionally protected property rights. The conclusion of the Irish High Court “Perrigo has failed to establish that there is anything in the course of dealing between the parties which would make it unfair in the present case for the Revenue to exercise its statutory powers under the 1997 Act to issue an amended assessment.” “Perrigo has failed to establish a basis for either the legitimate expectation or the abuse of power/unfairness claims, it seems to me that its argument based on the Constitution must also fail.” “Perrigo has failed to establish any basis to interfere with the assessment issued in respect of the disposal of the Tysabri IP and, accordingly, its claim must be dismissed. Whether the disposal of the Tysabri IP constituted a trading or a capital transaction will now have to be resolved before the Tax Appeals Commissioner, and according to the High Court there are clearly arguments available as to why the disposal of the Tysabri IP should be regarded as a capital transaction. Ireland vs Perrigo 2020_IEHC_552 ...

Canada vs Bayer Inc. July 2020, Federal Court, T-272-19

Bayer Inc, is a Canadian subsidiary of Bayer AG Germany. Bayer is a multinational group of companies in the pharmaceutical and life sciences industry . Since 2016, the Canada Revenue Agency has been auditing Bayer Inc. 2013-2015 taxation years. Between December 2017 and August 2018, the CRA made a series of requests to Bayer Canada for copies of agreements that had been negotiated at arm’s length with respect to the activities that are being examined in the audit. On August 21, 2018, the CRA issued Query No 17 to Bayer Canada, in which it revised its previous requests as follows: Pursuant to our discussion on July 18, 2018, we would like to audit agreements made between any member of the Bayer Group with third party(s) in force during the 2013 and 2014 taxation years that perform some or all of the following activities in regards to pharmaceutical products: â€Â Â Are located in an Organization for Economic Cooperation and Development (“OECDâ€) member nation; â€Â Â Perform research and development (clinical trial level stage II, III and/or IV, inclusive); â€Â Â Perform regulatory compliance activities (notice of compliance, product labelling verification, etc.); â€Â Â Perform client and corporate product support; â€Â Â Perform quality control and assurance activities; â€Â Â Regional marketing and sales activities (e.g. detailing, medical affairs); â€Â Â Chain supply management activities (e.g. purchasing. distribution); â€Â Â Price negotiations with local regulatory bodies; â€Â Â Price negotiations with the public (e.g. provincial formularies) and private (e.g. insurance companies) funding bodies. Please provide a matrix of no less than 50 contracts that meet some or all of the criterion [sic] listed above, and make sure activities contemplated in the agreements are highlighted, so that CRA can select contracts for further review. On November 14, 2018, the Minister of National Revenue issued a Requirement to provide foreign-based information or documents pursuant to 231.6(2) of the ITA. The Requirement was significantly broader in scope than the previous requests. Bayer Inc took the position that the requested documents were irrelevant to the audit and applied for a judicial review of the requirement pursuant to s 231.6(4) of the ITA. Judgement of the Court The application for judicial review was allowed. The court concluded that Bayer was required to provide the documentation identified in Query No 17 dated August 21, 2018. But, the scope of the Requirement was limited to the agreements with the 21 named pharmaceutical and life sciences companies that operate at arm’s length from the Bayer Group. The court clarified that the sole constraint placed on the Minister of National Revenue was that a rational connection must exist between the information sought and the administration and enforcement of the ITA (Saipem at para 26) “Parliament intended to give the Minister far‑reaching powers under section 231.6 to obtain information available outside of Canada. The Minister need only show that it is relevant to the administration or enforcement of the Act. The taxpayer is protected from abusive use of the provision through the power of a judge to review the requirement. The respondent’s requirement was not an abuse of the process nor was the request unreasonable.” Canada-vs-Bayer-T-272-19_20200707_JR_E_O_OTT_20200708105854_FGL_2020_FC_750 ...

Czech Republic vs. Eli Lilly ÄŒR, s.r.o., December 2019, District Court of Praque, No. 6 Afs 90/2016 – 62

Eli Lilly ÄŒR imports pharmaceutical products purchased from Eli Lilly Export S.A. (Swiss sales and marketing hub) into the Czech Republic and Slovakia and distributes them to local distributors. The arrangement between the local company and Eli Lilly Export S.A. is based on a Service Contract in which Eli Lilly ÄŒR is named as the service provider to Eli Lilly Export S.A. (the principal). Eli Lilly ÄŒR was selling the products at a lower price than the price it purchased them for from Eli Lilly Export S.A. According to the company this was due to local price controls of pharmaceuticals. Eli Lilly ÄŒR was also paid for providing marketing services by the Swiss HQ, which ensured that Eli Lilly ÄŒR was profitable, despite selling the products at a loss. Eli Lilly ÄŒR reported the marketing services as a provision of services with the place of supply outside of the Czech Republic; therefore, the income from such supply was exempt from VAT in the Czech Republic. In 2016 a tax assessment was issued for FY 2011 in which VAT was added to the marketing services-income. Judgement of the Court The Court dismissed the appeal of Eli Lilly CR s.r.o. and decided in favour of the tax authorities. According to the court marketing services constituted partial supply that was part of the distribution activities and should have been considered, from the VAT perspective, a secondary activity used for the purpose of obtaining benefit from the main activity. Therefore, Eli Lilly CR s.r.o should have been paying VAT on income from the marketing services. “a customer purchasing medicinal products from the claimant is the recipient of a single indivisible supply (distribution and marketing),†“the aim of such marketing is certainly to increase the customer awareness of medicines distributed by the claimant, and, as a result to increase the marketability of these medicines†For Eli Lilly Export S.A., marketing was a secondary benefit. Eli Lilly CR s.r.o. was the owner of the products when the marketing services were provided. Eli Lilly Export S.A. was not the manufacturer of the products and did not hold the distribution license for the Czech market. Therefore, Eli Lilly Export S.A. could not be the recipient of the marketing services provided by Eli Lilly CR s.r.o. Hence, the payment received by Eli Lilly CR s.r.o. for marketing services was in fact “a payment received from a third personâ€. An appeal to the Supreme Administrative Court was filed on 14 February 2020 by Eli Lilly CR. Click here for English Translation Click here for other translation Czech vs Eli Lilly 2020 ...

Italy vs J.T.G.P. spa, September 2019, Lombardi Regional Tribunal, Case No 928/20/2019

The Italian company J.T.G.P spa, a subsidiary in a multinational pharma group ALPHA J, had recorded operating losses for fiscal years 1997 to 2013, where, at a consolidated level, the group had showed positive results. According to the Italian tax authorities, the reason why the Italian company was still in operation was due to the fact that the group had an interest in keeping an international profile, and to that end the Italian company performed marketing activities benefiting the Group. An assessment was issued where the taxable income of the Italian company was added compensation for inter-company marketing services carried out by the Italian company on behalf of the group. The company argued that the pharmaceutical market and the governmental policy on the prices of medicines in Italy was the reason for the losses. In support of this claim the company submitted broad documentary evidence during the audit. Judgement of the regional Court The Court held in favor of the taxpayer. According to the Court, the company had demonstrated that the reasons for the losses were not the result of improper transfer pricing policies, but rather local market conditions – drug prices, etc. Furthermore, the court found that no conclusive evidence had been provided by the tax authorities to support the existence of “hidden” marketing services performed by the Italian company to the benefit of the group. Excerpt “The existence of losses has been demonstrated by the taxpayer where the type of products marketed and the specificity of the Italian pharmaceutical market, which is stationary as a result of the forced reduction in the prices of reimbursable drugs and the regulation of price increases for C-range products and the difficulty of competing with larger groups, have been highlighted. In addition, the company does not operate in the field of generic products but deals exclusively with general practitioners and specialists and distributes its products through a network of pharmaceutical wholesalers who, in turn, serve pharmacies throughout the country and is subject to government policies regarding the pricing of pharmaceutical products. In any event, it should be noted that, from a statutory point of view, the company had achieved positive results in 2013 and in subsequent years in terms of net income, as shown by the financial statements for the years ended 31 December 2013, 31 December 2014, 31 December 2015 and 31 December 2016 on file, nor did the Office prove that the services had resulted in an advantage for the group, having limited itself to presumptions.“ Click here for English translation Click here for other translation Italy vs Corp Commissione tributaria 1 marzo 2019, Case n. 928 ...

Switzerland vs R&D Pharma, December 2018, Tribunal fédéral suisse, 2C_11/2018

The Swiss company X SA (hereinafter: the Company or the Appellant), is part of the multinational pharmaceutical group X, whose parent holding is X BV (hereinafter referred to as the parent company) in Netherlands, which company owns ten subsidiaries, including the Company and company X France SAS (hereinafter: the French company). According to the appendices to the accounts, the parent company did not employ any employees in 2006 or in 2007, on the basis of a full-time employment contract. In 2010 and 2011, an average of three employees worked for this company. By agreement of July 5, 2006, the French company undertook to carry out all the works and studies requested by the parent company for a fee calculated on the basis of their cost, plus a margin of 15%. The French company had to communicate to the parent company any discoveries or results relating to the work entrusted to it. It should also keep the parent company informed of the progress of the transactions, directly or through the Company. The results of all studies became the property of the parent company. By an agreement of February 19, 2008, the parent company granted the Swiss Company access to the research and development activities carried out by the French company, in exchange for paying the parent company a royalty of 2.5% of all revenues generated on the products or registered by the parent company through the French company. In 2013, the Swiss Tax Administration informed the Company of the initiation of a tax assessment for the years 2008 to 2010, as well as a tax evasion attempt procedure for the year 2011. These proceedings resulted from a communication from the Federal Tax Administration that mentioned the existence of charges not justified by commercial use during the years in question. Later the same year the Tax Administration informed the Company that the proceedings were extended to the years 2003 to 2007. In 2014 a tax assessment was issued for the tax years 2003 and 2005 to 2010. The Tax Administration estimated that the Company had paid royalties to the parent company for the use of research and development of certain molecules. However, the latter company had no substance or technical expertise to carry out this activity. In practice, the research and development of the X group was led by the Swiss Company, which subcontracted some of the tasks to the French company. The amount of royalties paid by the Swiss Company to the parent company, after deduction of the costs actually borne by the company for subcontracting, constituted unjustified expenses on a commercial basis. The Swiss company stated that the parent company assumes important financial, regulatory and operational risks, for which it should be compensated. The Supreme Court concluded that the parent company was a mere shell company, and as a result, disregarded the transaction. The court found that the parent did not hold the required substance to be entitle to any royalty payments. The parent was not involved in the group’s R&D activity and had no/very few employees. It was not even the legal owner because the patents were registered in the Swiss company’s name. The Swiss company had 60 employees and made all the strategic decisions over the R&D functions. The Federal Tribunal ruled in favor of the Swiss Tax Administration. The Court found the transactions and payments to be a hidden distribution of profit leading to tax evasion. Click here for translation Swiss vs Pharma Corp2 ...

Pharma and Tax Avoidance, Report from Oxfam

New Oxfam research shows that four pharmaceutical corporations — Abbott, Johnson & Johnson, Merck, and Pfizer — systematically allocate super profits in overseas tax havens. In eight advanced economies, pharmaceutical profits averaged 7 percent, while in seven developing countries they averaged 5 percent. In comparison, profits margins averaged 31 percent in countries with low or no corporate tax rates – Belgium, Ireland, Netherlands and Singapore. The report exposes how pharmaceutical corporations uses sophisticated tax planning to avoid taxes. cr-prescription-for-poverty-pharma-180918-en ...

TPG2017 Chapter II Annex II example 1

1. Company A is the parent company of an MNE group in the pharmaceutical sector. Company A owns a patent for a new pharmaceutical formulation. Company A designed the clinical trials and performed the research and development functions during the early stages of the development of the product, leading to the granting of the patent. 2. Company A enters into a contract with Company S, a subsidiary of Company A, according to which Company A licenses the patent rights relating to the potential pharmaceutical product to Company S. In accordance with the contract, Company S conducts the subsequent development of the product and performs important enhancement functions. Company S obtains the authorisation from the relevant regulatory body. The development of the product is successful and it is sold in various markets around the world. 3. The accurate delineation of the transaction indicates that the contributions made by both Company A and Company S are unique and valuable to the development of the pharmaceutical product. 4. Under these circumstances, the transactional profit split method is likely to be the most appropriate method for determining the compensation for the patent rights licensed by Company A to Company S ...

Italy vs Recordati Industria Chimica e Farmaceutica S.p.A, September 2017, Supreme Court, Case No 20805

Recordati Industria Chimica e Farmaceutica S.p.A had been issued an assessment by the tax authorities for FY 2003 on various issues related to transfer pricing. Recordati Industria Chimica e Farmaceutica S.p.A. disagreed with the assessment and brought the case to court. The Regional Tax Commission of Lombardy (Ctr) issued a decision where it partially annulled the assessment. This decision was challenged both by the tax authorities and Recordati Industria Chimica e Farmaceutica S.p.A. Judgement of the Supreme Court Before the Supreme Court there were 29 issues to be resolved. The Supreme Court predominantly ruled in favour of the tax authorities. The court confirms that transfer pricing adjustments are applicable even in the absence of proof by the administration of a concrete tax advantage by the taxpayer. The shift of taxable income following transactions between companies belonging to the same group and subject to different national regulations, does not require the administration to prove the elusive function, but only the existence of “transactions” between companies linked at an apparently lower than normal price. The court also states that it cannot be excluded that overall business strategy can induce companies to carry out uneconomic operations in view of and in function of other benefits “(…) the essential aspect of transfer pricing does not concern the justification of the lower price from an economic point of view, but whether the discounts can be considered justified from a fiscal point of view, that is, whether they respond to the principle of free competition, in accordance with the teachings of the Supreme Court.” Click here for English translation Click here for other translation Sentenza del 06_09_2017 n. 20805 - Corte di Cassazione - Sezione_Collegio 5 ...

US vs. Medtronic Inc. June 2016, US Tax Court

The IRS argued that Medtronic Inc failed to accurately account for the value of trade secrets and other intangibles owned by Medtronic Inc and used by Medtronic’s Puerto Rico manufacturing subsidiary in 2005 and 2006 when determening the royalty payments from the subsidiary. In 2016 the United States Tax Court found in favor of Medtronic, sustaining the use of the CUT method to analyze royalty payments. The Court also found that adjustments to the CUT were required. These included additional adjustments not initially applied by Medtronic Inc for know-how, profit potential and scope of product. The decision from the United States Tax Court has been appealed by the IRS in 2017. US-Memo-2016-112-Medtronic-v.-Commissioner ...

Canada vs McKesson Canada Corporation, September 2014, Tax Court, Case No 2014 TCC 266

Following the Tax Courts decision in 2013 (2013 TCC 404), Judge Boyle J. in an order from September 2014 recused himself from completing the McKesson Canada proceeding in the Tax Court. This extended to the consideration and disposition of the costs submissions of the parties, as well as to confidential information order of Justice Hogan in this case and its proper final implementation by the Tax Court and its Registry. Postscript An appeal was filed by McKesson with the Federal Court, but the appeal was later withdrawn and a settlement agreed with the tax authorities. In May 2015 McKesson filed a 10-K with the following information regarding the settlement “…Income tax expense included net discrete tax benefits of $33 million in 2015, net discrete tax expenses of $94 million in 2014 and net discrete tax benefits of $29 million in 2013. Discrete tax expense for 2014 primarily related to a $122 million charge regarding an unfavorable decision from the Tax Court of Canada with respect to transfer pricing issues. We have received reassessments from the Canada Revenue Agency (“CRAâ€) related to a transfer pricing matter impacting years 2003 through 2010, and have filed Notices of Appeal to the Tax Court of Canada for all of these years. On December 13, 2013, the Tax Court of Canada dismissed our appeal of the 2003 reassessment and we have filed a Notice of Appeal to the Federal Court of Appeal regarding this tax year. After the close of 2015, we reached an agreement in principle with the CRA to settle the transfer pricing matter for years 2003 through 2010. Since the agreement in principle did not occur within 2015, we have not reflected this potential settlement in our 2015 financial statements. We will record the final settlement amount in a subsequent quarter and do not expect it to have a material impact to income tax expense.” Further information on the settlement was found in McKesson’s 10-Q filing from July 2015 “…We received reassessments from the Canada Revenue Agency (“CRAâ€) related to a transfer pricing matter impacting years 2003 through 2010, and filed Notices of Appeal to the Tax Court of Canada for all of these years. On December 13, 2013, the Tax Court of Canada dismissed our appeal of the 2003 reassessment and we filed a Notice of Appeal to the Federal Court of Appeal. During the first quarter of 2016, we reached an agreement to settle the transfer pricing matter for years 2003 through 2010 and recorded a discrete income tax benefit of $12 million for a previously unrecognized tax benefit.” 2014tcc266 ...

Czech Republic vs. ARROW International CR, a. s., June 2014, Supreme Administrative Court , Case No 7 Afs 94/2012 – 74

The applicant, ARROW International CR, a.s., seeks a judgment of the Supreme Administrative Court annulling the judgment of the Regional Court, and referring the case back to that court for further proceedings. The question of whether the applicant carried out business transactions in the tax year 2005/2006 with a related party (Arrow International, Inc., hereinafter referred to as ‘Arrow US’) in a manner which did not comply with the principles of normal business relations and whether, as a result, the applicant’s basis for calculating the corporate income tax rebate was unjustifiably increased and the special condition for applying the tax rebate under Article 35a(2)(d) of Act No 586/1992 Coll. was breached is decisive for the assessment of the merits of the present case, on income taxes, as in force until 31 December 2006 (‘the Income Tax Act’). Pursuant to Section 35(6) of the same Act, such an act has the effect that the entitlement to the discount ceases and the taxpayer is obliged to file additional returns for all tax periods in which the discount was claimed. The applicant was therefore also under that obligation in respect of the tax year 2002, for which it was additionally assessed by the decisions of the administrative authorities in the amount of CZK 7 505 031 (‘the tax’). According to the contents of the administrative file, the Financial Directorate concluded that the part of the applicant’s activities which consisted in the distribution of medical devices from the Arrow group to customers in the Czech Republic, whereby the goods distributed by the applicant were purchased from Arrow US, did not comply with the principles of normal business relations. On this distribution, the applicant achieved a gross profit margin of 171,45 % in the tax year 2005/2006, whereas other distributors of similar goods found by the tax authority achieved average gross profit margins ranging from 28,40 % to 80,60 %. In each case, the tax authorities found that the goods which the applicant had purchased for redistribution in the Czech Republic from Arrow US at a certain price had previously been sold by the applicant itself – as goods manufactured by it – to Arrow US at a higher price than the price at which it then bought them from Arrow US. Furthermore, the tax authorities found that the applicant’s gross profit margin in 2005/2006, the last period of the investment incentive, had increased significantly compared to the previous and subsequent tax periods, roughly three to four times. The Financial Directorate found that the distribution of Arrow medical devices in the Czech Republic was an activity separable from the applicant’s other activities (production of medical devices for the Arrow group or central purchasing of medical devices for the Arrow group from other manufacturers in the Czech Republic) from an economic point of view. The conclusion that the distribution of Arrow medical devices in the Czech Republic is separable from the applicant’s other activities was also reached by the Financial Directorate taking into account the fact that this activity is significantly less important for the applicant from an economic point of view than the other activities (the two types of distribution activities together accounted for only 6 % of the applicant’s total turnover, while the rest of the turnover was accounted for by the production of medical devices for the Arrow group). Thus, the Directorate of Finance treated the distribution of medical devices of the Arrow group in the Czech Republic as a separate activity for the applicant and as such assessed it separately in terms of the prices negotiated between the applicant and Arrow US in the context of that activity, which differed from the prices (and the gross profit margins based thereon) of other distributors of medical devices in the Czech Republic according to the criterion of the gross profit margins achieved therein. Thus, in considering whether the applicant had breached the special conditions for the application of the tax rebate pursuant to Article 35a(2)(d) of the Income Tax Act, the Financial Directorate considered only the prices (and the markups based thereon) achieved in the context of that one of the applicant’s activities, since it considered that it should be regarded as an economically relatively separate activity, not sufficiently linked to the applicant’s other activities and, on the contrary, separable from them in those respects. It therefore did not accept that the applicant’s activities should be considered as a whole (the sum of all their activities taken together) in the sense that, for the purposes of examining whether there has been a breach of the conditions of that provision, it is possible for significant profits from one activity to be offset by smaller profits from other activities, so that the overall profitability of the applicant’s business remains within the limits of what is normal for other comparable operators. The Regional Court agreed with those conclusions of the tax authorities and therefore dismissed the action brought by ARROW International CR, a.s. as unfounded. An appeal was then filed with the Supreme Administrative Court Judgement of the Court The Court dismissed the appeal and decided in favour of the tax authorities. “In the present case, the tax authority bore its burden of proof to establish that the complainant’s business operations involved transactions with the persons referred to in section 23(7) of the Income Tax Act which, by their specific objectively identifiable features, appeared outwardly, on the basis of rational consideration, not to correspond to the economic principles of normal business relations. First of all, it established that the three types of activity of the applicant, which could be regarded as relatively independent of each other in terms of the conditions of their technical implementation (independent in the sense that, in principle, each of them could be carried out independently in such a way that – in the abstract – it could make economic sense in itself, and that none of them necessarily required, in itself, either for production or commercial reasons, legal or otherwise, to operate ...

Indonesia vs Roche Indonesia, February 2014, Tax Court, Put.53966/2014

In the case of Roche Indonesia the tax authorities had disallowed deductions for royalties paid by the local company to F. Hoffmann-La Roche & Co. Deductions for marketing and and promotions costs paid by the local company had also been disallowed. Judgement of the Tax Court The court decided predominantly in favour of the tax authorities. Roche Indonesia had been unable to prove the value, existence and ultimate owner of intangible assets for which the royalty was paid. In regards to the disallowed deductions of cost related to marketing and and promotions, half of the costs were allowed and the other half disallowed. Click here for translation putusan_put.50616_pp_m.xii_b_15_2014_20210530 ...

Canada vs McKesson Canada Corporation, December 2013, Tax Court of Canada, Case No. 2013 TCC 404

McKesson is a multinational group engaged in the wholesale distribution of pharmaceuticals. Its Canadian subsidiary, McKesson Canada, entered into a factoring agreement in 2002 with its ultimate parent, McKesson International Holdings III Sarl in Luxembourg. Under the terms of the agreement, McKesson International Holdings III Sarl agreed to purchase the receivables for approximately C$460 million and committed to purchase all eligible receivables as they arise for the next five years. The receivables were priced at a discount of 2.206% to face value. The funds to purchase the accounts receivable were borrowed in Canadian dollars from an indirect parent company of McKesson International Holdings III Sarl in Ireland and guaranteed by another indirect parent company in Luxembourg. At the time the factoring agreement was entered into, McKesson Canada had sales of $3 billion and profits of $40 million, credit facilities with major financial institutions in the hundreds of millions of dollars, a large credit department that collected receivables within 30 days (on average) and a bad debt experience of only 0.043%. There was no indication of any imminent or future change in the composition, nature or quality of McKesson Canada’s accounts receivable or customers. Following an audit, the tax authorities applied a discount rate of 1.013%, resulting in a transfer pricing adjustment for the year in question of USD 26.6 million. In addition, a notice of additional withholding tax was issued on the resulting “hidden” distribution of profits to McKesson International Holdings III Sarl. McKesson Canada was not satisfied with the assessment and filed an appeal with the Tax Court. Judgement of the Tax Court The Tax Court dismissed McKesson Canada’s appeal and ruled in favour of the tax authorities. The Court found that an “other method” than that set out in the OECD Guidelines was the most appropriate method to use, resulting in a highly technical economic analysis of the appropriate pricing of risk. The Court noted that the OECD Guidelines were not only written by persons who are not legislators, but are in fact the tax collecting authorities of the world. The statutory provisions of the Act govern and do not prescribe the tests or approaches set out in the Guidelines. According to the Court, the transaction at issue was a tax avoidance scheme rather than a structured finance product. Canada_Tax_Court_McKesson ...

Canada vs. GlaxoSmithKline. October 2012, Supreme Court

The Canadian Supreme Court ruled in the case of GlaxoSmithKline Inc. regarding the intercompany prices established in purchases of ranitidine, the active ingredient used in the anti-ulcer drug Zantac, from a related party during years 1990 through 1993. The Supreme Court partially reversed an earlier determination by the Tax Court, upholding a determination by the Federal Court of Appeals in its conclusion that if other transactions are relevant in determining whether transfer prices are reasonable, these transactions should be taken into account. However, the Supreme Court did not determine whether the transfer pricing method used by GlaxoSmithKline Inc. was reasonable, and instead remitted the matter back to the Tax Court. Canada_Glaxo_Supreme-Court ...

Spain vs. Roche, January 2012, Supreme Court, Case No. 1626/2008

Prior to a business restructuring in 1999, the Spanish subsidiary, Roche Vitaminas S.A., was a full-fledged distributor, involved in manufacturing, importing, and selling the pharmaceutical products in the Spanish and Portuguese markets. In 1999 the Spanish subsidiary and the Swiss parent, Roche Vitamins Europe Ltd., entered into a manufacturing agreement and a distribution agreement. Under the manufacturing agreement, the Spanish subsidiary manufactured products  according to directions and using formulas, know-how, patents, and trademarks from the Swiss parent. These manufacturing activities were remunerated at cost plus 3.3 percent. Under the distribution (agency) agreement, the Spanish subsidiary would “represent, protect and promote†the products. These activities were remunerated at 2 percent of sales. The Spanish subsidiary was now characterized as a contract manufacturer and commission agent and the taxable profits in Spain were much lower than before the business restructuring. The Spanish tax authorities argued that the activities constituted a PE in Spain according to article 5 of DTT between Spain and Switzerland. Therefore, part of the profits should be allocated to the Spanish subsidiary in accordance with article 7 of the DTT. Supreme Court Judgement The Supreme Court held that the restructured Spanish entity created a PE of Roche Vitamins Europe Ltd. in Switzerland. The profits attributed to the PE included not only the manufacturing profits but also profits from the distribution activity performed on behalf of Roche Vitamins Europe Ltd. in Switzerland. Excerpts “The administration is therefore correct in stating that the applicant company operated in Spain by means of a permanent establishment…” “In short, what is laid down in these two paragraphs 1 and 2 of Article 7 of the Spanish-Swiss Convention (in summary form) is that: (a) If a taxpayer acts in a State, of which he is not a resident, through a permanent establishment, then the profits of that taxpayer may be taxed in that State, but only to the extent that such profits are attributable to the said re-establishment. (b) This means that only the profit that the non-resident would have made in that State if he had had a full presence (as a resident), through a separate and distinct company, will be taxable in that State; but, of course, only in respect of the activity carried out by that establishment. The Audiencia Nacional, contrary to this reading of Article 7, establishes that if a non-resident company has a permanent establishment, then it must be taxed in the State in which that establishment is located for all the activities carried out in the territory of that State, even if they are not carried out through the permanent establishment. Contrary to this, and by application of the only possible interpretation of Article 7(1) and (2) (already explained and in accordance with the criteria of the OECD Tax Committee, as we shall see below), a permanent establishment should only be taxed in the State in which it is located on the profit derived from the activity carried out through the permanent establishment.” “…the sales figure must include all sales made by the permanent establishment. We consider that it is established in the file, contrary to the appellant’s submissions, that those sales must include those made to Portuguese customers, since they were made as a result of the promotional and marketing activities of Roche Vitaminas SA and are therefore attributable to it. It is also common ground that the expenses referred to by the appellant have been taken into account, as is stated in the official document dated 12 July 2002. For the rest, we refer to what was established in the settlement agreement dated 23 April 2003, as well as to the full arguments contained in the judgment under appeal.” Click here for english translation Click here for other translation Spain-vs-Roche-Januar-2014-Supreme-Court-case-nr.-1626-2008 ...

Turkey vs Pharmaceutical Industry and Trade Corporation, December 2011, Danıştay Üçüncü Dairesi, E. 2009/2352, K. 2011/7637, UYAP, 20.12.2011.

A Turkeys Pharma Company carried out drug production, import and sales operations, and had purchased different active ingredients from foreign group companies. Following an audit the tax office found that the prices paid by the Pharma Company for six ingredients had been above the market price resulting in a hidden distribution of profits. A price study was performed for similar active ingredients suggesting price deviations ranging from 167 – 975 % Table 2: Price deviation from market price Theophylline 167.26%ibuprofen 478.34%Fluoxetine 975.15%Hyoscine-N-Butilbrüm 150.13%Povidone Iodine 176.83%metamizolesodi 260.05% An assessment was issued where the cost of the ingredients – and thus taxable income of the Pharma company – was adjusted based on the price paid for similar active ingredients between unrelated parties. The Pharma Company disagreed with the assessment and brought the case before the tax court. The Tax Court issued a decision in favor of the Pharma company. In a study from the Turkish Pharmaceutical Association it was stated that active ingredients could have different prices due to reasons such as using original methods, impurities, crystal structure and polymorphism, mesh size, batch size, certificate differences etc. Based on this study the Tax Court found, that although it had been determined that the Pharma Company had purchased active ingredients at higher prices compared to other companies, there was no clear information about the characteristics of the active substance, production factors, or other factors that will cause price differentiation. This decision was appealed by the tax authorities. The Court of Appeal approved of the decision issued by the tax court and dismissed the appeal. Click here for translation Turkey 2009-2352-k-2011-7637-t-20-12-2011 ...

India vs. Fulford (India) Limited, July 2011, Income Tax Appellate Tribunal

Fulford India Ltd. imported active pharmaceutical ingredients (APIs) from related group companies and sold them in India. The TNM method was used for determening transfer prices. The tax administration found the CUP method to be the most appropriate. Fulford India argued that the CUP method requires stringent comparability and any differences which could materially affect the price in the open market should be taken into consideration. In the pharmaceutical world, APIs whith similar properties may still be different in relation to quality, efficiancy, impurities etc. Therefore, the two products cannot be compared. In court, it was further explained that Fulford also performed secondary manufacturing functions, converting the APIs into formulations. Hence, Fulford could be descriped as a value added distributor. The Court concluded that the selection of the best method should be based on functional analysis and the characterisation of the transactions and the entities. The fact that Fulford had secondary manufacturing activities had not previously been explained to the tax authorities. Accordingly, the case was returned to tax administration for a revised assessment. Fulford_(I)_Ltd,_Mumbai_vs_Assessee ...

Sweden vs Ferring AB, June 2011, Swedish Court, Case no 2627-09

In connection with a restructuring, Ferring Sweden (a Scandinavian pharmaceutical) had transferred intangible assets to a group company in Switzerland. Among the assets transferred was an exclusive worldwide license to manufacture and sell a drug and a number of ongoing R&D projects. The question in the case was whether the price agreed between the Group companies was consistent with the arm’s length principle. The Ferring’s position was that the price was consistent with the arm’s length principle, while the Swedish Tax Agency believed that an arm’s-length price was significantly higher. In support of its pricing, the company had submitted a valuation made by the audit company A, where the value of Ferring after the transfer (the residual company) was compared with the value of the company if it had continued to operate as a full-fledged company (the original company). These values ​​were determined through a present value calculation of the future cash flows in each unit. The difference in value was considered to correspond to the value of the intangible assets transferred. The Swedish Tax Agency had made its own assessment of a market-based remuneration for the license only to manufacture and sell the drug. In this valuation, the present value of the future cash flows was calculated according to what the sale of the drug could be expected to generate, ie the income that the Swedish company would lose after the transfer of the license. The value obtained exceeded the price that the Group companies had agreed on for all intangible assets. The Swedish Tax Agency had also made a calculation regarding the ongoing R&D projects. In this calculation, the present value of the estimated costs of R&D projects was compared with the present value of the future revenues that these projects could be expected to lead to. In support of the assessment, the Swedish Tax Agency also relied on a valuation made by the audit firm B, which was made on behalf of the Swedish Tax Agency. Like the audit firm A, the accounting firm B calculated the value of the transferred assets by comparing the value of the parent company with the value of the residual company. However, Audit Company B came to a significantly higher value in its valuation than Audit Company A did. The Court of Appeal considered that clearly overwhelming reasons indicated that the audit firm B’s valuation provided a reasonable arm’s length value. This conclusion was reinforced by the Swedish Tax Agency’s evaluation of the license to manufacture and sell the drug, by the Swedish Tax Agency’s calculation of R&D projects, and by an evaluation of the outcome of the respective auditing companies’ values ​​by using multiples. The Court of Appeal also took into account the size of the amounts that the Swedish company invested in R&D in the years prior to the transfer. The Court found that in the absence of proportionality and in the absence of explanations, the relationship between the value of intangible assets and the sums invested in developing them may give an indication that the price is not market-based. The Court of Appeal also held that the information contained in the case was insufficient to explain the seemingly unreasonable relationship between what had been invested in R&D up until the transfer and the price that was then determined at the transfer of assets, which included the R&D projects. All in all, the District Court considered that the Swedish Tax Agency had sufficiently proved that the market price of the assets transferred between the Group companies exceeded the agreed price, at least with the increase decided by the Swedish Tax Agency. According to the court, the Swedish Tax Agency had therefore had grounds for taxing Ferring in the manner that had taken place. Click here for translation 2627-09 ...

Australia vs. Roche July 2008, Administrative Appeals Tribunal NT 2005/7 & 56-65

The Applicant is an Australian subsidiary of the Roche Group, the parent company of which is a resident of Switzerland. Roche is a major pharmaceutical corporation with integrated operations in many countries. It carries on research and development, manufacturing, marketing, selling and distribution of pharmaceuticals, vitamins, chemicals, diagnostic and other products. During the 1993 to 2003 income years (the relevant income years) the Applicant carried on business in Australia marketing, selling and distributing Roche products through three divisions: the Prescription Division (dealing in prescribed drugs), the Consumer Health Division (dealing in over the counter pharmaceuticals) and Diagnostic Products (dealing in diagnostic equipment and supplies). Australia-vs-ROCHE-PRODUCTS-PTY-LTD-July-2008-Administrative-Appeals-Tribunal ...

Korea vs Pharma Corp, September 2007, Supreme Court, Case No 2007ë‘13913

A Korean pharma corporation produced and sold finished pharmaceuticals. Active ingredients were imported from foreign related parties in the United States and Ireland. The Korean pharma corporation produced and sold the original finished products by importing the five original patented raw materials that had expired from the patent period in each business period from December 1, 2001 to November 30. The tax authorities calculated the normal price of the original raw materials by a comparable third party pricing method. As for the specific methodology, the median price of imported generic raw materials for other domestic pharmaceutical companies was calculated by multiplying the ratio between the original product and the medical insurance price of the drug (generic finished product) produced by the domestic generic raw material by other domestic pharmaceutical companies. After calculating the normal price of the raw materials, the difference between the original price of the original raw materials and the difference between the original price and the normal price of the raw materials was included in the income. The tax authorities filed a law suit against the company for the disposition of a corporate tax levy, which had the following points:there are significant differences between generic drugs (or their raw materials) and original drugs (or their raw materials) in terms of customer loyalty,was not a market price reflecting the difference in quality but a government regulation price, which is an indicator of finished products, andwas not correlated with the import price of raw materials, so it was pointed out that it was inappropriate as an index to adjust for significant difference. Judgement of the Supreme Court “Generic raw materials in this case have the same composition and molecular structure as the original raw materials of the case and their efficacy, ie biological efficacy, do not seem to be much different, so the rest of the generic raw materials It would be possible to derive reasonable normal prices through such adjustments to the import prices of generic raw materials in this case. The medical insurance drug price does not include the consideration of the market value of the drug and its raw materials in the decision process, and furthermore, it is not considered whether the raw material of the drug is original or generic. And the upper limit is also determined by the number of items listed on the same ingredient formulation and the upper limit of the listed ingredients. Therefore, the price of the original finished product in the case of the health insurance drug price and the price of the generic drug It is hard to say that the adjustment method that utilizes the difference between drug prices can not be a way to rationally eliminate differences in consumer loyalty etc. that have a significant impact on the import price of generic raw materials in this case.” The Supreme Court concluded that if the original drug (or raw material) and generic drug (or raw material) are different in terms of customer loyalty, sales method and cost structure, and if the difference can be reasonably adjusted, it was possible to derive a reasonable normal price. The problem was whether rational adjustments could be applied to take into account the difference in price between the original drug and the generic drugThe Supreme Court held that such an adjustment could not be made, at that the assessment issued by the tax authorities was illegal. Click here for English translation Korean TP case 2007ë‘13913 ...

US vs Eli Lilly & Co, October 1998, United States Court of Appeals

In this case a pharmaceutical company in the US, Eli Lilly & Co, transferred valuable pharmaceutical patents and manufacturing know-how to its subsidiary in Puerto Rico. The IRS argued that the transaction should be disregarded (substance over form) and claimed that all of the income from the transferred intangibles should be allocated to the U.S. parent. The Judgment from the Tax Court: “Respondent’s argument, that petitioner, having originally developed the patents and know-how, is forever required to report the income from those intangibles, is without merit. Respondent ignores the fact that petitioner, as developer and owner of the intangible property, was free to and did transfer the property to the Puerto Ricanaffiliate in 1966.†The Court of Appeals altered the judgement from the Tax Court. According to the Court of Appeals, the parent company had received an arm’s length consideration for the transfer of intangibles in the form of stock in the subsidiary. Hence, the Court disallowed the allocation of the intangibles’ income to the U.S. parent. US vs Eli Lilly ...

Philippines vs CYANAMID PHILIPPINES, INC, August 1995, Tax Court, CTA CASE No. 4724

Cyanamid Philippines, INC was engaged in the marketing of various products in the areas of pharmaceutical, animal health and nutrition, and crop protection chemicals as well as medical devices. The tax authorities issued an assessment for deficiency income tax, arising from (a) overstatement of cost of goods due to transfer pricing of products, namely; aurofac and minocycline, which petitioner purchased from its parent company, American Cyanamid; and (b) unnecessary and unreasonable payment of royalties to the latter company for the supply of technical know-how. Judgement of the Tax Court The Court decided in favour of Cyanamid Philippines. According to the court, the tax authorities had acted in an arbitrary, unreasonable, and capricious manner. There were no apparent attempt to verify the comparability of the pharmaceutical products being compared under a comparable uncontrolled price (CUP) method analysis. “It can be gleaned readily from the facts that the physical property and circumstances in the processing and sale of petitioner’s products are not “identical” or “so nearly identical that any difference can either have no effect on price, or such difference can be reflected by a reasonable number of adjustments to the price” of Pfizer’s products.”  “We so hold, therefore, that respondent never had any valid justification to declare the cost of goods of petitioner’s products, aurofac and minocycline, as having been overstated in price when bought from its parent company, American Cyanamid. “ On the issue of Royalties the Court stated “The obligation to pay royalties is founded on a licensing agreement duly sanctioned by proper government agencies. Without the license to use know-how, petitioner cannot engage in the processing and selling of its products. Petitioner continues to exist as a legitimate domestic corporation solely by virtue of its licensing agreement and any attempt to deny it the use of know-how would simply result in the natural cessation of its business. The elements of necessity and reasonableness are easily appreciated in the use of know-how in petitioner’s business. “ “In sum, we uphold the validity and the legality of the payment of royalties for know-how made by petitioner to its parent company, American Cyanamid.”  The decision was later affirmed by the Court of Appeals in 1999. Philippines vs CYANAMID PHILIPPINES 4724_D_1995AUG28_ASS ...

France vs. PHARMATIQUE INDUSTRIE, July 1994, CAA, No 92PA01392

The Pharmatique Industrie case shows the high comparability standard required by the courts of France. The tax authorities used five similar license agreements in the same pharmaceutical sector, as comparables in a transfer pricing dispute regarding payments of royalties for the use of knowhow and trademarks. Judgement of the Court The court ruled in favour of the tax authorities. Excerpt “.., is not confirmed by a reading of the contracts attached to the file not only the granting of trademarks for the specialities in question, but also, as in the grants put forward by way of comparison by the administration, of manufacturing processes or know-how, the service must be regarded as providing proof of the exaggerated nature and therefore non-deductible nature of the said royalties in the above-mentioned proportion; that in any case, and without it being necessary to examine whether the royalties are deductible in principle, it follows that the company PHARMATIQUE INDUSTRIE is not entitled to maintain that it is wrongly that, by the judgement in question, which is sufficiently reasoned, the Administrative Court of Paris rejected the request of the company Laboratoires Schoum for discharge of the supplements to corporation tax…” Click here for English translation Click here for other translation Société Pharmatique Industrie, July 1994, CCA, No 92PA01392 ...