Roche vs CIPLA: The Final Day…

“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).”

i) That Erlotinib is not a derivative of Gefatinib. (for a detailed analysis of the structures etc, visit Varun Chhonkar’s blog here).

ii) Even assuming it is a derivative, it crosses the section 3(d) hurdle, as it demonstrates increased “efficacy”.

Let’s take point (i) first. Section 3(d) states that any “derivative” of a known pharma substance has to demonstrate increased efficacy in order to be patentable. If Erlotinib is not a derivative of Gefatinib at all, then section 3(d) does not apply. Apparently, this point was argued in Natco’s pre-grant opposition proceeding as well and the patent office found that Erlotinib is not a “derivative”. Unfortunately, owing to the lack of a robust patent database in India, we don’t have access to any of NATCO’s arguments and the final decision by the patent office. In Bilcare, we recently saw that the court and the patent office reached diametrically opposite conclusions on the merits of a patent–will we see the same trend here?

As regards the second point on “efficacy”, I’m not entirely sure whether Singhvi argued that Erlotinib was more efficacious for the same indication (lung cancer) or that that it could be used for a different indication altogether (pancreatic cancer). See our previous post here in this regard, where we stated that if the alleged indication is an altogether new one, then, even assuming that Erlotinib is considered to be a derivative of Gefatinib, Roche crosses the section 3(d) hurdle. It is helpful to lay out the structure of section 3(d) again:

“the mere discovery of a new form of a known substance which does not result in increased efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant. Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

In essence, section 3(d) states that:

1. No “new form” of an existing substance may be patented, unless it demonstrates increased efficacy. If it does demonstrate increased effficacy, then it is treated as an altogether “new substance”.

2. The “mere new use” of a known compound cannot be patented.

If Erlotinib is found to have an additional indication (pancreatic cancer) not possessed by Gefatinib, then, as one of the anonymous commentators to our last post argues, it may be hit by the “new use” bar under point (2) above. However, this is not true, since if a new form of a known substance (or a derivative) is found to have a “new use”, then it will be considered to be a “new substance” altogether. To explain further:

If there is a new indication for Erlotinib, then under the explanation to section 3(d), such new use would easily qualify as “differing significantly in properties with regard to efficacy”. In other words, if a new use is found for Erlotinib, then Erlotinib qualifies as as “new substance” altogether under the Explanation to section 3(d)–to this extent, it cannot be construed as a “known compound”.

Date of Patent Grant?

This date has direct relevance for determining the dates of the opposition proceedings. Natco filed an opposition on 10th April 2007. If the Feb 2007 date is taken to be the date of grant, then NATCO’s opposition is a post-grant one. However, if the 6th July 2007 date is taken, then Natco’s opposition qualifies as a “pre-grant” one. Under the Indian patent regime, the scope for pre-grant opposition is wider than post grant.

1. Details of Roche patent involved in Litigation:

Granted patent: IN196774 (‘774)
Grant Date: 23 Feb 2007 or 6 July 2007 (we’re not sure)
Application Number: 537/DEL/1996
Corresponding US patent: US 5747498 (‘498)

2. Second Patent Application for Erlotinib: A later patent application for Erlotinib was filed in India (IN/PCT/2002/00507/DEL). This corresponds with US patent 6900221 (the ‘221 patent).

Jaitley argued that CIPLA’s product implicates the latter patent by Roche (US patent ‘221) and not the patent in dispute (US patent ‘498 and Indian patent ‘774)!! Now if this is true, then there can be no “infringement”, as the US patent ‘221 is still not issued in India. It is pending as Application No IN/PCT/2002/00507/DEL.

Anyway, while our courts grapple with all these niceties, patent lawyers will argue endlessly on what these sections mean–add many more hours to the bills of their hapless clients and laugh all the way to the bank!!