F.Hoffmann La Roche Limited additionally called Roche Holding AG is a Swiss
multinational healthcare organisation that generally operates beneath neath
divisions: pharmaceutical and diagnostics. In February 2007, Roche and Pfizer as
joint candidates claimed that they maintain a patent of the drug Erlotinib
Hydrochloride (Polymorphs A and B) wherein Roche become commercialising a
specific polymorph of the claimed drug which is being advertised as "TARCEVA",
this drug becomes a patented for the treatment of cancer. In 2006, TARCEVA
already began advertising in Indian markets however in 2007 The Controller
General of Patents, New Delhi granted patent in admiration of Erlotinib.
Cipla Limited is an Indian multinational pharmaceutical business enterprise, it
develops drug treatments to deal with respiratory, cardiovascular diseases,
arthritis, diabetes, and different clinical conditions. In 2008, Cipla released
a familiar model of Erlotinib and commenced production and advertising of the
product at one third of the fee of Roche.
After understanding this the plaintiff (i.e. Roche) filed against Cipla for
infringement along with application for seeking ad-interim injunction. Roche
lost the case because the Honourable court felt that preventing Cipla's
production may affect the public interest in the company so the case turned in
favour of Cipla's.
After seven long years of extensive litigation between Roche and Cipla, the case
turned into the Division Bench wherein the case went in favour of Roche.
- Whether Roche's compound patent i.e IN 774 legitimate or not?
- Whether Cipla infringed Roche's patent for the compound Erlotinib?
When Roche learned about the Cipla released on Erlotinib, which prices Rs. 1600
is consistent with the pill in comparison to Roche's which prices Rs. 4,800
consistent with a pill. Roche sued Cipla for infringement, however, Cipla claims
that it didn't infringe, as they offered the drug that is from polymorphic B.
Single judge ruling:
The single judge dismissed Roche's plea for an interim injunction against Cipla
on the grounds of public interest i.e, the lower price which Cipla generic
version is cheap compared to Roche. Court noted that the right to access to
life-saving drugs and the need for secure long term supplies, is serious in
The claim the Cipla to preserve the patent invalid on the ground of obviousness,
"Erlotinib" were a known compound and the requirement under section3(d) of the
patents act changed into unfulfilled as the increased efficiency criteria was
also not met forth was outrightly denied by the single judge bench and they held
that Roche contention was not obvious for a skilled person in the same art to
have replaced methyl or ethynyl, the ruling went in favour of Cipla.
When both Roche and Cipla appealed to the Divisional Bench, Roche misplaced
earlier than the Divisional Bench, the Divisional Bench upheld the important
findings of the trial decision and it imposed expenses on Roche for suppression
of material "patent" information. It changed into additionally discovered out
that Roche hasn't mounted a prima facie case of infringement, for the reason
that Cipla's prevalent manufacturing didn't appear to implicate the patent in
The Supreme court dismissed the special leave petition by Roche, challenging the
order which was passed by the division bench of the High Court. The order also
clarified that nothing in the division bench order would bind the trial court
judge, who is expected to decide the case in the final judgement.
- The single judge dismissed the claim on Roche and held that Cipla was
not infringing Roche's patent and refused to grant an injunction to them.
- Both Cipla and Roche challenged the single court judgement; the division
bench refused to revoke Roche's patent as sought through the Cipla.
- The bench criticised Roche for now no longer having enough X-ray
diffraction facts for Tarceva and Erlocip that could have proven whether or
not or now no longer the crystalline shape of Cipla's Erlocip pills
correspond to Roche's patented invention.
In March 2016, The final judgement went in favour of Roche, however, granted a
permanent injunction on manufacture by Cipla. Cipla was made liable to render
accounts concerning manufacturing and sale of Erlocip and decreed costs in
favour of Roche of Rs. 5,00,000.
The division judgement stated that there is no infringement changed into an
aggregate of polymorphs A and B, while the Tarceva drug consisted of only
polymorph B. The factor right here to be noted is that Roche applied for a
patent of polymorph B however it was denied by the Indian Patent Office because
it no longer fulfils the standards of section 3(d) and takes a test of
patentability. In September 2012, Cipla Limited received a landmark patent case
for Roche limited.