After the hearing on the 31st, the judge is likely to reserve judgment–so we may see an order only by the first or second week of February. MoneyControl’s Vikas Dandekar carries an interesting update on this case here.
Those of you following the case closely will know that section 3(d) is a major bone of contention in this case as well. CIPLA argues that the Tarceva (Erlotinib) patent does not demonstrate how it is more efficacious than an earlier known compound (Gefatinib). So with the Gleevec case and the Tarceva case reaching the courts, we will finally have some clue on how section 3(d), India’s unique patent section is to be interpreted.
What does “efficacy” mean? Does it mean “therapeutic efficacy” or will it be wider to encompass any other kind of advantage or surprising result (eg. heat stability etc) Also, what is the level of proof required for demonstrating efficacy? Will the fact that this provision was blindly lifted from a European Drug Regulatory Directive cause the courts/patent office to interpret it in a drug regulatory sense i.e. the patent office would insist on “clinical trial” to demonstrate that the drug is more efficacious. As one can appreciate, such proof will run completely antithetical to the very rationale of patents–i.e. to incentivise early disclosure. Clinical trial data etc is generated many years after a molecule is discovered. Also, the patent application itself my run the risk of falling foul of the novelty test–since trials etc were conducted and the substance is known to the public (unless of course, we construe this as “secret use” or “experimental use” and therefore “novel”). Whilst interpreting section 3(d), one has also to bear in mind that it is a double edged sword. In an attempt to keep out the bad MNC’s, a hike in the standards could also impact the applications filed by our home grown Indian companies. Under such a heightened standard, will Ranbaxy’s CIPRO O-D (once a day) gain protection?
Back to the Tarceva litigation. The case law on the grant of temporary injunctions in patent matters is very interesting. There are more than 10 cases that seem to suggest that the moment a defendant counterclaims invalidity, the court cannot grant a temporary injunction. Particularly, when the patent is a recently granted one. Illustratively, see Manicka Thevar v Star Plough Works AIR 1965 Madras 327. See also the Bilcare case which has been extensively discussed on this blog.
Interestingly, even in the Novartis EMR case (Norvatis AG and Anr. v. Mehar Pharma and Anr. 2005 PTC 160, para 28), since the defendants challenged the validity of the recent EMR grant to Novartis, the court held in favour of the Defendants and did not grant an injunction. The Court held that the balance of convenience lay in the defendants favour, as the drug was a life saving one and the plaintiffs did not manufacture the drug in India, but imported it.
Reading the cases, the non grant of a temporary injunction seems an almost automatic rule. Which essentially means that in India, one can never get a temporary injunction in a patent matter!! (since in almost all such matters, the defendants would always counterclaim invalidity). However, they’re some 3 odd cases (eg. Telemecanique vs Schneider) where such injunctions have been granted. I’m not sure which way the judge will go. But here are some thoughts/predictions:
1. Most of the cases where the injunction was denied (on account of an invalidity attack) were cases where either the “opposition” mechanism was exhausted or where none was filed. In the Tarceva case, the post grant window is still open. And the judge may well insist upon CIPLA filing such opposition–till the time the opposition is decided, the judge may injunct CIPLA.
2. CIPLA’s statements in the press that it will outrightly infringe may weigh against CIPLA here.
3. I haven’t studied the “validity” issue in detail, but my sense is that unless Roche submits some really concrete evidence demonstrating how Erlotinib is increasingly efficacious over Gefatinib, they will lose on section 3(d).
We have to wait and watch to see how this patent litigation that will set the tone for future pharma cases in India turns out…. We’re interested in hearing what our readers have to say in the way of crystal ball gazing–which way do you think the courts will go? We can perhaps replicate a jury like situation and get some votes here!!