In a carefully and a well-researched judgment, Justice S. Ravindra Bhat of the Delhi High Court refused to grant an injunction (temporary) on Cipla from selling in India, a generic versions (Eroclip) of a patented anti-cancer drug (Erlotinib or Tarceva) belonging to Roche.
However, Cipla was disallowed to export to other countries (temporarily). Due to the inability of the plaintiff (Roche) to prove its contention, the judgement of the case was based on the grounds of “public interest” To force a judgement favouring the injunction on Cipla the plaintiff (Roche) had to contend on the following grounds, i) That it had a prima facie case ii) That the “balance of convenience” was in its favour iii) That it would suffer “irreparable injury”, if CIPLA was not injunctedA prima facie case is a case where there are sufficient evidences to support (but not necessarily force) an outcome, provided the evidences are not challenged. There the prima facie evidence is the patent that Roche acquired in Indian in 2007 for Erlotinib (Tarceva). The irony is that the prima facie evidence is the main point of contention.
The defendants (Cipla) argued that Erlotinib is not a new drug but at the best a pre-1995 variant of an older drug, thus cannot be patented according to Section 3(d) unless and otherwise proved to have an increase in efficacy.The plaintiffs did not contribute considerable arguments about the increase in efficacy, thus this contention was ruled out due to the lack of merit. “Balance of convenience” deals with the question, “Who (plaintiff or the defendant) will be subject to higher inconvenience when not ruled in his/her favour?” The court held that the “balance of convenience” was not in favour of Cipla, because Roche can always claim back compensation for damages if it manages to overcome the challenge on its patent. On the same grounds the contention for “irreparable injury” was dismissed.
The courts having found no real merit in the Plaintiff’s contention, passed judgement on the case on the ground of “public interest”.The reasons for the same as put forward by the court are as follows: a) Since the patent is not yet proved to be credible it did not want to deprive the patients of a drug that is 1/3rd cheaper that Roche’s drug, as it is a very critical drug. b) Roche imported its drug, thus the court expressed concern over sustainability and long term dependence on an MNC which did not produce in India. c) Cipla’s drug is cheaper and thus makes the drug available for a cheaper cost to a wider customer base.
The judgment was a fair balance between protecting the rights of the patentees and making resources available for a cheaper cost to the masses.The judgement was well argued, thus further judgements are going to be similar unless Roche proves, 1) The low cost of Cipla does not necessarily mean that the drugs can reach more people, or 2) Cheaper costs of Cipla is not without its disadvantages to the poople 3) Roche’s drug has a higher efficacy than that of the older drug and that it is not an attempt at ever greening.
