Macleods Pharmaceuticals Limited And Boehringer Ingelheim Pharma GmbH & Co. KG D & Another

Case No. 25 of 2022 1 COMPETITION COMMISSION OF INDIA Case No. 25 of 2022 In re: Macleods Pharmaceuticals Limited Atlanta Arcade, Church Road Near Leela Hotel, Andheri - Kurla Road Andheri (East), Mumbai – 400059 Informant And Boehringer Ingelheim Pharma GmbH & Co. KG D 55216, Ingelheim am Rhein Germany Boehringer Ingelheim India Private Limited 202, 2F, Godrej 2, Pirojsha Nagar, Eastern Express Highway, Vikhroli East, Mumbai City, Maharashtra – 400079 Opposite Party No. 1 Opposite Party No. 2 CORAM: Ms. Ravneet Kaur Chairperson Ms. Sangeeta Verma Member Mr. Bhagwant Singh Bishnoi Member Case No. 25 of 2022 2 Order under Section 26(2) of the Competition Act, 2002 1. The present Information has been filed by Macleods Pharmaceuticals Limited “Informant”) under Section 19(1)(a) of the Competition Act, 2002 (“Act”) alleging contravention of Section 4(1) read with 4(2)(c) of the Act by Boehringer Ingelheim Pharma GmbH & Co. KG (“OP-1”) and Boehringer Ingelheim India Private Limited (“OP-2”), (hereinafter, collectively referred to as the “Opposite Parties”). 2. The Informant is stated to be a pharmaceutical company incorporated under the erstwhile Companies Act, 1956, and is engaged in development and manufacturing of Active Pharmaceutical Ingredients (APIs) and finished dosage pharmaceutical formulations. 3. OP-1 is a company incorporated under the laws of Germany and is stated to be among the world’s largest pharmaceutical companies. OP-2 is a company incorporated under Companies Act, 1956 and is a subsidiary of OP-1. OP-2 has the permission of the Drugs Controller General of India (“DGCI”) to import and market, Linagliptin Tablet and FDC of Linagliptin + Metformin Hydrochloride tablets which is the formulation of ‘Linagliptin’. 4. OP-1 holds two patents bearing nos. IN 227719 under the title “Xanthine Compounds” which was valid for a period of 20 years with effect from 21.02.2002 till 21.02.2022 (“First Patent”) and IN 243301 under the title “8-3 Aminopiperidin-I-yl-xanthine compounds” which is valid till 18.08.2023 (“Second Patent”). Both patents were granted to the Opposite Parties on the basis of two international applications dated 21.02.2002 and 18.08.2003. The compound ‘Linagliptin’ which is used in drugs for treatment of Type 2 diabetes has been claimed in both the patents. 5. It has been stated by the Informant that First Patent was claimed with Markush Structure, which allows patents of novel structure that can have many possible substituents. As per the Informant, Markush claim allows a patent drafter to condense a multitude of alternate dependent claims into one single claim. Case No. 25 of 2022 3 6. As per the Informant, both the patents, one of which have now expired, cover ‘Linagliptin’ compound and that the Opposite Parties are using their Second Patent to prohibit their competitors, including the Informant from using ‘Linagliptin’ in their drugs, which by their own admission was covered in its now expired patent, First Patent. 7. It has been alleged that the Opposite Parties, by filing multiple patents are artificially extending the period of protection beyond 20 years which is causing appreciable adverse effect on competition in the market, resulting in higher prices of drugs and denial of market access as no other competitor can enter the market. 8. With respect to the compound ‘Linagliptin’, it has been submitted that it is used for patients having Type 2 diabetes with renal problems. It is further submitted that one of the treatments used to cure Type 2 diabetes involve inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4). DPP-4 Inhibitors block the action of DPP-4, and hence regulate production of insulin in human body. One of such DPP-4 inhibitors, as per the Informant is ‘Linagliptin’. Unlike other DPP-4 inhibitors, ‘Linagliptin’ can be used without dose adjustment in patients with renal or hepatic impairment. Thus, doctors prescribe ‘Linagliptin’ in special cases where the patients have some kidney related complications. 9. It has been alleged that the descriptions of First Patent and Second Patent are not merely substantially similar, but are in fact identical in several parts. As per the Informant, the sections in First Patent and in Second Patent relating to field of the invention, background of the invention, including reference to relevant prior art, description of the invention are identical. The Informant has thus alleged that once First Patent expired, the Informant was free to use and commercially exploit ‘Linagliptin’. However, the Opposite Parties filed multiple frivolous suits for alleged infringement of Linagliptin (Second Patent), denying market access to the Informant. 10. It has been alleged that Opposite Parties, in declaration to Form 27 of Patents Act, 1970 have admitted that First Patent covers ‘Linagliptin’ and under Second Patent, it is Case No. 25 of 2022 4 commercially sold. It has been stated that Opposite Parties have filed a suit for permanent injunction being CS (COMM) No. 240 of 2019, before the Hon’ble Delhi High Court against Vee Excel Drugs and Pharmaceuticals Ltd. alleging infringement of First Patent and Second Patent, admitting that ‘Linagliptin’ was covered in both the patents. It has been stated that a similar case has been filed in Canada against Sandoz Canada Inc.. 11. In addition to above, Opposite Parties also sent cease and desist notice dated 01.11.2021 to the Informant stating that both patents, First Patent and Second Patent cover ‘Linagliptin’, and that the Informant should cease and desist from launching, making, using, selling, offering to sell ‘Linagliptin’ in any form whatsoever. 12. It has been alleged that the dispute started when after expiry of First Patent on 21.02.2022, the Informant and other competitors of the Opposite Parties, started using ‘Linagliptin’ which by operation of law became public and began manufacturing ‘Linagliptin’ based drugs. The Informant also started manufacturing ‘Linagliptin’ 5 mg tablets under the brand names “Linamac” and “Linaone”. However, the Opposite Parties restricted its competitors from using the knowledge of its First Patent on the ground that it also infringes Second Patent. This has been alleged to be clear abuse of process. 13. Thereafter, the Opposite Parties filed a commercial suit bearing no. COMS No. 03 of 2022 against the Informant before the Hon’ble Himachal Pradesh High Court seeking permanent injunction restraining the Informant from using the compound ‘Linagliptin’. As per the Informant, the Opposite Parties did not emphasise before the said court that ‘Linagliptin’ was covered in First Patent but has rather claimed that First Patent covered ‘Xanthine compounds’ for Markush formula being the genus patent while Second Patent is the species patent. 14. In addition to above, it has been alleged that Opposite Parties also sent communication to third parties, like doctors, asking them not to deal with competitors of Opposite Parties including the Informant selling ‘Linagliptin’. One such WhatsApp communication dated 25.02.2022 has been referred to by the Informant in the Information. Case No. 25 of 2022 5 15. It has been alleged that the Second Patent granted to the Opposite Parties was secured on the basis of an active suppression and misrepresentation of facts before the Controller of Patents, who consequently granted protection to the Opposite Parties for the same invention and subject matter covered and claimed in the earlier patent i.e. First Patent which is not permissible under the law. Therefore, the Informant filed a Revocation Petition before the Hon’ble Delhi High Court in terms of section 64 (1) of the Patents Act, 1970 seeking revocation of patent Second Patent on the grounds, inter alia, that the First Patent covered the same compound, viz., ‘Linagliptin’. The said Revocation Petition is pending adjudication before the Hon’ble Delhi High Court. 16. In relation to delineation of the relevant market, it has been stated that in the instant case, the pharmaceutical drugs in question are based on ‘Linagliptin’, which is specifically used for treatment of patients with Type 2 diabetes having renal (kidney related) complications. From the perspective of doctors, there are no substitutes for ‘Linagliptin’. Further, the drugs in question are imported or manufactured for the purpose of sale in India. Hence, the relevant geographic market would be India. Accordingly, relevant market proposed by the Informant is “market for biological drugs based on Linagliptin for treatment of Type 2 diabetes in India”. According to the Informant, Opposite Parties hold a dominant position in the delineated relevant market, as the Opposite Parties are the sole manufacturer and seller of ‘Linagliptin’ in India and have a 100% market share. 17. With respect to abuse of dominant position by the Opposite Parties, the Informant has stated that Opposite Parties by obtaining a Second Patent for the same molecule which was covered in the First Patent, which now stands expired, has attempted to evergreen its patent. By doing so, the Opposite Parties are keeping the competitors away for another 1.5 years, denying market access, limiting production of goods in the market, limiting technical and scientific development relating to drugs based on ‘Linagliptin’ causing prejudice to end consumers (patients).