Tarceva, an anti cancer molecule that created patent history in India (for inter-alia ushering in “public interest” into Indian patent jurisprudence) continues to make legal waves. And big ones at that.We’ve now learnt that Roche sued Matrix Labs for patent infringement before the Madras High Court and procured an ex parte restraining order! (an ex parte restraining order is one where an injunction is granted without even hearing the other party).
The only details we have at present are that the order was procured from the Madras High Court on Friday (17th September). And that the suit itself was triggered by references in Matrix’s revocation petition before the IPAB (challenging the validity of Roche’s Tarceva patent) to its intention to manufacture the product.
Ex-parte restraining orders to prevent alleged IP infringement used to be the forte of the Delhi High Court till a bunch of sensible samaritans such as Justice Bhat and Justice Muralidhar came along and swung the pendulum the other way. It appears that this IP ex parte culture is slowly migrating and finding a more hospitable habitat down South.
As we’ve been repeatedly blogging on this forum, ex parte orders are a terrible idea when it comes to patent infringement cases. Such cases often involve complicated issues of claim construction and validity…and orders cannot be passed without hearing the defendant in question. Particularly so in this case, where three High Court judges (Justice Bhat at the first instance and Judges Muralidhar and AP Shah at the appellate level) had reservations about the validity of the patent. In fact, the matter has now moved to the trial stage at the Delhi High Court, where a judge is hearing arguments and evidence on the validity of the patent. And will soon decide on whether or not Roche’s case is strong enough to merit a permanent injunction.
Further, a revocation petition filed by Matrix is being assessed by the IPAB on this very same issue. I’m not entirely sure if Matrix is selling the drug in India or whether it intends to sell in India. In the light of their para IV filing against the Tarceva patent in the US, it would appear reasonable to assume that they have the US market in mind (at least for now). And that they intend to manufacture small quantities of the drug in India for testing purposes (“bio-equivalence” and the like), as would enable them to procure regulatory clearance from the FDA. If this assumption holds true, their activity falls within the legitimate corners of the rather wide “Bolar” exemption that the Indian patents act carves out. For those interested, an article on the experimental use exception by Prashant Reddy and me deals with the Indian “Bolar exception” and its wide latitude.
This being so, how could a judge have granted a restraining order without even hearing Matrix?
Perhaps, much like the Delhi High Court in its earlier avatar, the Madras High Court is mistakenly equating patent cases with copyright and trademark infringement suits (to which they have been accustomed for the last several decades) , without realising that such cases are several times more complicated and are not immediately susceptible to a robust prima facie evaluation.
In fact, I would go to the extent of arguing (as I do in this paper here with Prakruthi Gowda) that it is far better to dispense with the interim injunction phase altogether in complicated patent disputes and move directly to the trial stage, where issues of validity and infringement are assessed once and for all, after looking into expert evidence etc. This approach finds support in a Supreme Court ruling by Justice Katju last year and more recently by Justice Bhat. For those interested in this theme, I plan to elaborate on this point in a future post.
Prima facie for patent cases, it may appear that grant of ex-parte injunction is a bad idea- may be true from pharma perspective. However if it were a non-pharma patent, it is not a bad idea after all. And if one does conduct a survey, non-pharma patents hardly get overturned by the Patent Office even after stiff oppositions, be it pre or post grant. Therefore one rule may not work for all.
However in the Matrix case I do agree that the Court should have exercised some degree of caution. Any idea who the judge was and who represented Roche?
“Audi alteram partem” is a principle of fundamental justice. But ex-parte injunctions are passed quite often.
An anon commentator (whom I am very grateful to for passing on this information writes:
“It was Justice Rajeswaran who gave the order. The Advocate General Mr. P. S. Raman appeared for Anand & Anand on behalf Roche.
The crux of roche’s argument, from what i understood, was that Matrix had stated in its revocation petition that it was ready to enter the market with drugs infringing Roche’s Tarceva patent. The suit number is CS. No. 801 of 2010.”
a) From what I understand, the Mumbai High Court- in the earlier Valcyte case (Roche v. Cipla)- advised that there will not be an injunction until the IPO had decided the opposition – particularly since the 2 parties had already approached the IPO for the post grant matter.
The Mum HC wanted the technical body to advise on validity, before moving further.
In the present case too, it seems that the patent been challenged by the generic company, for revocation.
a) Do you/ any one know if Roche responded to the IPAB revocation?
b) Was this fact (of revocation petition filing) advised to the Chennai Court… if yes, there is a fair chance that the Court would have advised in a manner, similar to Mumbai high court.
c) Also, in your multiple (and excellent) posts on Erlotinib- Delhi High Court, the injunciton was not granted. Is there any reason why the Chennai High Court- on possibility of marketing in India granted an injunction while the Del HC, even after actual commercial marketing by Cipla, did not give the injunction…
(this is a rhetorical question – the Del HC judgment is an excellent read on why no injunction was granted… my question is here what made Madras High Court move in the opposite direction).
d) Finally, do you have a copy of the order? Tried searching it on Judis / Indiakanoon- not much there.
NOT Anonymouse/ NOT bad mouthing Anon commentor.
Such ex parte orders do not seem to be compatible with the requirements and form involved in patent litigation. Many people unfamiliar with the specifics of patent law tend to equate it with copyright and trademark law, but it is very different, and should be treated as such.