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Showing contexts for: bayer in Merck Sharp And Dohme Corp. & Anr. vs Sms Pharmaceuticals Limited on 20 July, 2021Matching Fragments
22. Ms. Meenakshi Arora, learned Senior Counsel for the defendant-applicant refutes the submission of Mr. Anand. She emphasises the fact that Section 107A of the Patents Act allows, as a matter of right, sale of the patented product for research and development purposes and clearly holds that such sale/usage would not amount to infringement of the patent. She submits that the exports being sought to be effected by her client are not to companies of dubious lineage, but to well-established entities engaged in research and development, located in Spain and Switzerland. She submits that, in para 112 of its decision in Bayer Corporation2, this Court has provided sufficient safeguards to cater to any possibility of misuse of the permission granted under Section 107A. She has also relied on paras 117, 120 and 121 of the report in Bayer Corporation2. She has further emphasised the fact that the quantities of Sitagliptin Hydrochloride exported by her client in the past are much less than the quantities permitted to be exported by the Drug Control Authorities, clearly indicating that the exports were not for commercial exploitation. She submits that exports, in any lesser quantities, would be commercially impractical, given the cost of shipment. She further submits that there is no requirement, either in Section 107A or in the judgment of this Court in Bayer Corporation2, that exports for research and development purposes should only be to sister concerns. Nevertheless, she reiterates her submission that Chemo, Verben and the defendant had entered into a joint venture undertaking for the purpose for research and development. She undertakes, on behalf of her client, to report, to the Court as well as the plaintiff, the quantities exported by her client, should permission be granted by this Court, as prayed. Non-grant of such permission, she submits, on the other hand, would result in making it impossible to have the generic version of Sitagliptin in place and available for use by the public even after the expiry of the suit patent in July, 2022. Additionally, it would also result in severing the contractual relationship between the defendant, Chemo and Verben.
The judgment in Bayer Corporation2
26. The judgment of the Division Bench of this Court in Bayer Corporation2 arose out of WP (C) 1971/2014 (Bayer Corporation v. U.O.I.) and CS(COMM) 1592/2016 (Bayer Intellectual Property GMBH v. Alembic Pharmaceutical Ltd.), both of which were initially decided by a learned Single Judge of this Court on 8th March, 2017. The judgment of the Division Bench of this Court, and its impact on the present dispute, can properly be appreciated only if, in the first instance, the decision of the learned Single Judge is briefly noticed.
28. As already noticed, the learned Single Judge adjudicated WP (C) 1971/2014 and CS (COMM) 1592/2016 by a common judgment. WP (C) 1971/2014 sought directions to the Customs authorities, to restrain exports, by M/s Natco Pharma Ltd. (NATCO) of "SORAFENAT". For the said purpose, Bayer asserted its patent IN 215758 (IN'758), which claimed a drug named "SORAFENIB". Bayer initially filed CS (OS) 1090/2011 for restraining NATCO from making, marketing or selling any drug involving "SORAFENIB" or "SORAFENIB TOSYLATE". Alleging that NATCO's "SORAFENIB" product infringed IN'758, directions, as noticed hereinabove before, were sought, to the customs authorities, to restrain such exports. NATCO applied, in the writ petition, for permission to export, to China, 1 kg of the API SORAFENIB for development/clinical study and trials. Bayer contested the application.
29. Bayer contended, before the learned Single Judge, that Section 107A did not permit export of patented products, even if they were APIs. NATCO contended, per contra, that, so long as the patented product was being exported for research and development, Section 107A was not infracted. As was contended by Mr. Anand before me, Bayer contended before the learned Single Judge that, were the prayer of NATCO to be granted, there was every possibility of the suit patent of Bayer being infringed abroad, beyond the reach of the jurisdiction of this Court. It was emphasised that this Court would have no control over the use of the exported goods. NATCO expressed its willingness not to export any patented product for commercial purposes or for any purpose not covered by Section 107A.