Breaking News: Roche Sues Cipla Again

The details of the Roche patent covering this drug are as below:

i) Indian patent number is 207232 (Chennai), granted on 1st June 2007. An official journal published this patent on 29th June 2007.

ii) Corresponding EPO Patent (0694547) is similar to the Indian patent and claims:

“The compound 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-3-hydroxy-1-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R)- or (S)-diastereomers, or in the form of mixtures of the two diastereomers.”

iii) Corresponding US patent (6083953) claims: “The compound 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-3-hydroxy-1-propanyl-L-val inate hydrochloride in crystalline form”. However, unlike the Indian or EPO patents, this patent is in the name of Syntex USA Inc (at least on the USPTO database).

Note that the US patent contains limitations in terms of “hydrochloride” and “crystaline form”. Contrast this with the Indian and the EPO patent claims (which are more or less identical) which do not contain this limitation.

Post grant oppositions against this patent were filed by Ranbaxy, Cipla and one patient group (Delhi Network of Positive People (DNP+), an organization representing the needs of people living with HIV/AIDS (PLHAs). The main claim in these opposition petitions are that the current patent is obvious over a previously known compound and that it violates section 3(d).

Roche is expected to file its reply to these post grant oppositions soon. Thereafter the parties would be heard and an order on this can be expected in the next 3-4 months or so.

Likely Result

Given the above pending post grant oppn proceedings, the easiest way for the Bombay High Court to deal with this issue is to:

i) stay the suit proceedings till such time as the post grant proceedings are completed
ii) injunct Cipla in the interim to maintain status quo.

As we mentioned in our last post, if the post grant goes against Roche and the patent is invalidated, then the suit before the court becomes infructuous. However, if the patent is upheld, the Bombay High court can lift the stay and hear the injunction application afresh.

Therefore, a stay of the suit (along with an order injuncting Cipla in the interim ) and a direction to the patent office to dispose of the post grant proceedings speedily seems the most sensible way forward for the Bombay High Court..

Having said this, it is important to bear in mind that Bombay High Courts have been more restrained in their grant of injunctions in IP cases than the Delhi courts–so one is not sure as to whcih way the court is likely to go on this issue.

As for the trademark issue, from my limited understanding of the facts, Cipla is likely to win. While Roche’s drug is called “Valcyte”, Cipla’s drug is “Valcept”. The term “Val” derives from the chemical name of the active ingredient, “Valgancyclovir”. Since “Val” is not a proprietary term but one that is derived from a chemical name, the courts may hold that Cipla’s “Valcept” does not infringe. The court is also likely to give due consideration to the fact that:

i) There is a significant price difference between the products
ii) These are not over the counter drugs (brought directly by the average consumer) but prescription drugs dealt with by more erudite and informed doctors.

A Delhi High Court ruling last year involving Astra Zeneca (whose drug was called “Meronem”) and Orchid Pharma (drug called “Meromer” ) is instructive. The chemical name of the molecule in queston was “Meropenem”. The court held:

“Admittedly, ‘Mero’, which is common to both the competing marks, is taken by both the appellants/plaintiffs and the respondent/ defendant from the drug ‘Meropenem’, taking the prefix ‘Mero” which is used as a prefix in both the competing marks. Both the appellants/plaintiffs and the respondent/defendant are marketing the same molecule ‘Meropenem’.

Neither the appellants/plaintiffs nor the respondent/defendant can raise any claim for exclusive user of the aforesaid word ‘Meropenem’. Along with the aforesaid generic/common prefix, ‘Mero’, the appellants/plaintiffs have used the syllables ‘nem’, whereas, the respondent/defendant has used the syllable ‘mer’.”

and later…

“Meropenem’ is the molecule which is used for treatment of bacterial infections. In that view of
the matter, the abbreviation ‘Mero’ became a generic term, is publici Jurisdiction and it is distinctive in nature. Consequently, the appellants/plaintiffs cannot claim exclusive right to the use of ‘Mero’ as constituent of any trademark. The possibility of deception or confusion is also reduced practically to nil in view of the fact that the medicine is sold only on prescription by dealers. The common feature in both the competing marks i.e. ‘Mero’ is only descriptive and publici Jurisdiction and, thereforee, the customers would tend to ignore the common feature and would pay more attention to the uncommon feature.”