SC dismisses Bayers SLP Conversation on patent linkage with Prof Shamnad Basheer

The Supreme Court has dismissed German drug maker, Bayer’s plea against the Delhi High Court’s dismissal of their attempt to block Mumbai based Cipla from marketing a copy of Bayer’s patented anti-cancer drug Nexavar..The Supreme Court has dismissed German drug maker, Bayer’s plea against the Delhi High Court’s dismissal of their attempt to block Mumbai based Cipla from marketing a copy of Bayer’s patented anti-cancer drug Nexavar..A Supreme Court Division Bench comprising of Justices Aftab Alam and R.M. Lodha rejected the special leave petition filed by Bayer..Bayer was represented by Senior Advocate S.C. Agarwala along with Advocates Sanjay Kumar, Arpita Sawhney and Adarsh..Cipla was represented by Senior Advocates Abhishek Manu Singhvi and Maninder Singh along with Advocates Pratiba M. Singh, Saya Choudhary, Kapil Wadhwa and Abhinav Mukerji..Union of India and Others were represented by Advocates Asha G. Nair and D.S. Mahra along with Advocates Anand Grover, Ravinder S. Garia, Pratibha S, Jayant K. Mehta and Sukant Vikram..The Economic Times reports that early this year, the Delhi High Court had quashed an appeal by Bayer to stop Drug Controller General of India (DCGI) from giving marketing approval for its patented medicine Nexavar to Cipla..Bar & Bench first reported in 2009 about Delhi High Court dismissing Bayer’s plea to restrain the DCGI from granting a licence to Cipla for the manufacture, sale and distribution of the drug ‘soranib’. Pratibha S, who represented Cancer Patients Association of India, a party to the Bayer-Cipla case told Economic Times that the court said this matter should be decided in its patent infringement suit which is pending with the Delhi High Court..World over, drug manufacturers have been demanding of such a provision, to better protect their patented medicines but, this has been opposed by the generic drug makers and health activists, as it could result in delaying the launching of low price medicines and could lead to an increase in healthcare costs, for the public..Bar & Bench spoke with Prof. Shamnad Basheer (pictured) of NUJS, Kolkata, on patent linkage and his views on the Supreme Court decision..B&B: Your thoughts on the Supreme Court dismissing Bayer’s appeal..Shamnad Basheer (SB): It’s a surprise that this issue even made it to the Supreme Court, when the point of law seemed as crystal clear as Swarovski’s elegant offerings. Indian law simply does not permit patent linkage i.e. the Drug Controller General of India (DCGI) does not have the legal or institutional competence to assess whether or not an application for drug approval implicates an existing patent. The DCGI’s job is simply to approve only those drugs that are safe and efficacious..However, the DCGI needs to foster more transparency and ensure that its website list out all drug applications, so that patentees can monitor and sue in a court of law, where they apprehend that a drug (corresponding to a filed application), will, if introduced in the market, violate their patent rights..B&B: Can you elucidate patent linkage? .SB: Patent linkage is a concept that essentially entails a drug controller denying regulatory approval to a drug on the ground that the said application implicates an existing patent..The drug regulatory process is very different from a patent process. A patent is filed very early on in the R&D process, when the relevant inventor scientist identifies a promising new drug lead. If the new molecule is inventive and meets all other patentability criteria, it merits a patent. The drug molecule is then tested through a series of lab experiments and clinical trials and huge piles of data are generated relating to the “safety” and efficacy of the said molecule. This data is then submitted to the drug controller who assesses whether or not the drug is “safe” and “effective” for human consumption. It is only then that the drug is approved for being sold in the market..Given this background, it is amply clear that the institutional and other competence required of a patent office that checks the patent worthiness of a new molecule is very different from that of the drug controller’s office that assesses whether or not the said drug molecule is safe and effective for human consumption..As it is, our courts have only been coming to grips recently with complicated patent concepts…. imagine if this complex adjudicatory task were handed over to the DCGI!.The right route for Bayer would have been to simply file a patent infringement suit against Cipla for infringing or threatening to infringe their patent. In fact, this is what Bayer did in the end and the suit is now pending before Justice Ravindra Bhat of the Delhi High Court..And the pendency of this trial is one of the reasons why the Supremes refused to interfere in the matter. Holding instead that the said trial must be expedited.. Normal 0 false false false EN-IN ZH-TW X-NONE MicrosoftInternetExplorer4 Bayer was represented by Senior Advocate S.C. Agarwala along with Advocates Sanjay Kumar, Arpita Sawhney and Adarsh. Cipla was represented by Senior Advocates Abhishek Manu Singhvi and Maninder Singh along with Advocates Pratiba M. Singh, Saya Choudhary, Kapil Wadhwa and Abhinav Mukerji. Union of India and Others were represented by Advocates Asha G. Nair and D.S. Mahra along with Advocates Anand Grover, Ravinder S. Garia, Pratibha S, Jayant K. Mehta and Sukant Vikram.