Here's a belated but surely much awaited update on the ongoing Roche-Natco hearings in the Delhi High Court. SpicyIP's friend GenericIPGuy has already updated that the hearing is next scheduled for 16 July 2010. The SpicyIP team here offers news of what actually transpired at the previous hearing on 2 June, where Natco commenced its arguments. We hope there's enough spice in the news to make up for the delay in posting this detailed transcription of what took place. Our previous posts on this are here.
Natco's arguments hinged on the following basic issues (which are substantiated below) -- that Roche does not manufacture the product in question; that the patent is invalid; that Natco does not infringe; that the Division Bench order of the Delhi HC (in the Roche-Cipla case) is binding in this case; and that there is material suppression of facts.
First, Senior Counsel Arvind Nigam, appearing for Natco, argued that Roche's product (the anti-cancer drug Tarceva) did not conform to the patent specification they were claiming infringement of. By extension, Natco suggested that Roche's patent was effectively a "paper patent", and not capable of being worked. From what I gather, Mr Nigam appeared to argue that the patent had to be manufactured in order to be worked in India. (We've discussed this issue many times on the blog here)
The second line of argument was that since neither Tarceva (Roche's product), nor Erleva (Natco's product) could be associated with the patent in question, there could be no infringement.
Expectedly, Natco then drew attention to the Roche-Cipla case, where Roche had been denied an interim injunction by the Division Bench of the Delhi High Court (mentioned above). In view of the DB order, it would be inconsistent to suggest that the same patent could be considered invalid against one party (Cipla), and not invalid against others. Natco also reiterated the "public interest" argument that had come up in the DB order, as also that the same order had noted that a credible challenge had been raised against Roche's patent.
Surely enough, and with an evident reference to Roche's previous arguments, Justice VK Shali, who is hearing the case, pointed out that the Supreme Court order in the Roche-Cipla case had reiterated the general principle that interim orders were not binding,
Natco then proceeded to tackle Roche's reference to the pre-grant opposition and the compulsory licensing application that followed. Readers will recall Roche's contentions, among others, that Natco was estopped, and that res judicata came into play. Natco responded, not surprisingly, that the pre-grant was neither final nor binding, and that Indian patent law allowed anyone to question the validity of a patent at any stage. It also argued that the fact that Natco's not filing a post-grant opposition was inconsequential.
Natco then went into the meatier aspects of the patent and the product, arguing variously as follows --
- That Roche had suppressed material facts, in not disclosing the composition or form of their product. Roche was aware that their product was in fact the "Polymorph B" form of the compound claimed in the suit patent. Explaining what a polymorph was (one compound with differing crystal structures), Natco claimed that Roche had failed to bring to the attention of the court that each Polymorph of a compound could exhibit different physical properties- which could be drastically different from the main compound.
- That the US equivalent of the Indian patent US 5747498 was for "a mixture... a formula". And to highlight that the patent in question was not the same as Tarceva, Natco's senior counsel referred to the Polymorph B application in the United States and India.
- That the Indian patent specification made no mention that the patent cured Non-Small Cell Lung Cancer. This was contrary to the Polymorph B application (and the patent as granted in the US) which made specific reference to the same.
- That the Division Bench had specifically asked Roche to disclose X-ray diffraction data. On its part, Natco submitted affidavits on such data to show that both their Erleva and Roche's Tarceva were the Polymorph B form of the patent in question, thus confirming that Roche did not manufacture the patent, and that there could be no infringement.