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12.3 The plaintiffs do not have any civil right in the drug Trastuzumab and cannot prevent the defendant No.3 from using the plaintiffs' data for manufacturing and marketing purposes, therefore once a patent has lapsed, the invention, i.e., the subject matter of the said patent, falls into public domain and the same can be appropriated by another party. The plaintiffs' patent for Trastuzumab lapsed in the year 2013. Indian jurisprudence does not recognize the concept of data exclusivity, therefore, the plaintiffs cannot claim any right with respect to Trastuzumab and its data thereof. The plaintiffs do not have any right in the name Trastuzumab' and cannot prevent the defendant from using the term thereof.

Arguments addressed on behalf of Plaintiffs

20. On behalf of plaintiffs, similar submissions, as addressed in the suit, being CS(OS) No.355/2014, are made. Mr.Rajiv Nayar and Mr.Sandeep Sethi, learned senior counsel appearing on behalf of the plaintiffs, inter alia, argued that since the approvals are contrary to the provisions of the Act, Rules and Guidelines of 2012 by Government, the defendants cannot be allowed to make misrepresentations to the doctors, hospitals and patients in the absence of requisite tests, the plaintiffs have no other remedy but to file the suit. They submit that despite of expiry of patent rights in 2013, the plaintiffs are manufacturing and marketing the drug in question and they are still market leaders in the entire world and the drug is one of the best drugs for the purpose of cancer treatment although they are not claiming data exclusively for comparison purposes at the time of obtaining the approval or any right on the molecule which was the subject matter of patent after its expiry. But the defendant No.3 on the basis of said approvals is likely to destroy the business of the plaintiffs and would cheat the public at large by making misrepresentation in order to earn easy amount on the basis of spreading false information to the hospitals, doctors and patients providing the similar data and tests admittedly not conducted by them. Mr.Sandeep Sethi, learned Senior counsel, submits that the defendant No.3 is time and again stressing that they are entitled to give all references of the plaintiffs by using of similar data. It is argued that the drug of the defendant No.3 is not bio- similar. If the defendant No.3 will manufacture and market the cancer drug without claiming bio-similarity, the defendant No.3 is free to do so for which the plaintiffs have no objection.

91. Counsel appearing on behalf of the defendant No.3 submitted that the defendant No.3 has complied all the steps as mentioned in para 25 of the plaint who has also complied the Bio-similar Guidelines 2012, the Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945.

92. The details of justification have been provided for not performing pharmacodynamics (PD) study for Trasturel. The details of justification for extrapolation of safety and efficacy data from one indication of Trastuzumab to the additional indications are also given in the reply. The defendant No.3 has also given the chart by analysis of Appendix I showing fulfilment of all requirements. The comparative analysis of different jurisdiction for abbreviated pathways on bio-similar is filed along with status of data exclusively in different countries of the world.

95. Counsel for the defendant No.3 has also informed that in many countries of the world have followed the procedure of biosimilar pathways and data and/or marketing exclusivity for innovator biologics and as details available in public domain and as pathway in place as of today. It is stated that thus it is clear that biosimilar abbreviated pathways would/can be adopted in India in which there is condition available as of today pertaining to Data Exclusivity for a reference product. The details would show that no doubt in many countries in the world as per Government policy biosimilar abbreviated pathways exit and in some of the countries right of data exclusivity is granted but in many countries said exclusivity is not granted. Learned counsel appearing on behalf of both parties have informed that so far Government has not taken any conclusive decision or framed any policy as to whether data exclusivity should be given or not. The said issue is being discussed on higher level in this country and other part of the world. However, till the time any policy decision is taken, the Court has to proceed with the matter as per existed law applicable to the case.