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Bayer and ajanta

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Bayer and ajanta

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Bayer and ajanta

  1. 1. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com SUCHITRA BAI PATENT DEPARTMENT BAYER VS AJANTA.NEW JURISPRUDENCE IN PUBLIC INTEREST FOR INJUNCTIONS
  2. 2. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com FACTS OF THE CASE • Bayer Intellectual Property GmbH, Patent was granted for Application No. IN225529 (3275/DEL/1998). • Bayer filed a suit against Ajanta Pharma Ltd. • On grounds that the patent covered vardenafil, a drug used to treat erectile dysfunction, and that Ajanta was manufacturing and selling the drug under its brand Valif.
  3. 3. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Contd… • The Patent was filed on 12 November 1997 as priority date. • After the grant of Patent to Bayer Healthcare AG, the said Patent was assigned to Bayer’s IP holding company in 2013. • During the Periods of 2013, 2014, 2015 and 2016 Bayer has filed Form 27 [Statement regarding the working of the Patented Invention on commercial scale in India] to disclose the working of the patent, as mandated by Section 146. • In the Form 27, Bayer stated that the patented invention has not been worked commercially in India because “it is evaluating the market for the product”.
  4. 4. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com FORM 27 THE PATENTS ACT, 1970 AND THE PATENTS RULES, 2003 STATEMENT REGARDING THE WORKING OF THE PATENTED INVENTION ON COMMERCIAL SCALE IN INDIA In the matter of Patent No. ----- of ------, we, ------, the Patentees under Patent No. ----, hereby furnish the following statement regarding the working of the patented referred to above on a commercial scale in India for the year 2013, 2014, 2015 and 2016. (i) The patented invention: [ ] Worked [x] Not Worked Please find below the reasons for not working and steps being taken for working of the invention: EVALUATING THE MARKET FOR THE PRODUCT. (ii) The licences and sub-licences granted during the year. Nil (iii) State whether public requirement has been met partly/adequately/to the fullest extent at reasonable price. Not Met The facts and matters stated above are true to the best of our knowledge, information and belief. Dated this -----day of ---- 2017. --------- To The Controller of Patents The Patent office At Chennai
  5. 5. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Contd… • Bayer as globally marketing the drug through a co-promotion agreement with GlaxoSmithKline since 2001. • Following the drug’s failure to meet expectations GSK sold its marketing rights back to Bayer. • It was clear that Bayer has exclusive rights to manufacture and market the drug in Indian market.
  6. 6. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Contd… • During the period of 2016, Bayer realised that Indian companies were already manufacturing a drug that it was still “evaluating the market” . • On 11 August, Bayer obtained an ex parte injunction against Vipro Lifescience, a company which was manufacturing vardenafil. • Subsequently, Vipro submitted in court that it would cease infringement, and further agreed to give Bayer information about the foreign customers who purchased its shipments of vardenafil so as to enable Bayer to proceed against them abroad. • Based on this assurance, Bayer dropped proceedings against Vipro on 22 November. • Bayer is also proceeding against Mehta API Pvt. Ltd., Manus Aktteva Biopharma LLP, Rakshit Pharmaceuticals Ltd., Hetero Drugs Ltd., and Dr. Reddy’s in the Delhi High Court.
  7. 7. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Contd… • On 20 December an ad interim injunction was given against Ajanta. • On 4 January 2017, Ajanta filed an application under O39R4 to vary the terms of the injunction. Ajanta’s application was based on multiple factors, including jurisdiction, but primarily invoked Franz Xaver Huemer v. New Yash Industries to plead that non-working of a patent disentitles its holder to injunctive relief. Curiously, Ajanta appeared to suggest that it was not infringing since Section 48 does not explicitly cover export. • In response, Bayer pointed out that the exclusive right under Section 48 covered manufacture regardless, and cited Novartis v. Cipla to argue that although non-working could be a ground for revocation before the Controller, it’s no defence for infringement.
  8. 8. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com MEANING OF INJUNCTION • Injunction is as an equitable remedy in the form of a Court Order, whereby a party is required to do, or to refrain from doing, certain acts. • Interim injunction is a remedy that prevents the violation of rights pending the trial of the suit. • The object of the interlocutory injunction is to protect the patentee against injury by violation of his right for which he could not be adequately compensated in damages recoverable in the action if the uncertainty were resolved in his favor at the trial.
  9. 9. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com GROUNDS FOR INJUNCTION • An Injunctive relief must establish (1)they have a prima facie case with a reasonable chance to succeed on merits; (2)Denial of the injunction will result in irreparable harm; (3)the balance of convenience favours the grant of an injunction; and (4)the injunction would not oppose the public interest.
  10. 10. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com CONCLUSION • Justice RK Gauba found that the “self-interest of the patentee” had to be “balanced against the larger public interest”. • The Indian courts have time and again opined that “public interest” in pharma patent litigation as the interests of the patients who need access to the patented drug. • This order denies injunctive relief on the ground that it would lead to “not only loss of employment, but revenue to the state as well”.
  11. 11. CHENNAI C2-A, Industrial Estate, Guindy, Chennai - 600 032. Tel: +91 - 44 – 42104341/ 7341 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com THANK YOU

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