[Ip-health] Economic Times: Delhi HC upholds Roche's patent claims on Tarceva against Cipla

Thiru Balasubramaniam thiru at keionline.org
Mon Nov 30 02:59:01 PST 2015


http://economictimes.indiatimes.com/articleshow/49948468.cms

Delhi HC upholds Roche's patent claims on Tarceva against Cipla

By ET Bureau | 28 Nov, 2015, 12.44AM IST
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MUMBAI: A division bench of the Delhi High Court sided with Roche against
Indian firm Cipla, upholding the Swiss drug maker's patent claims on key
lung cancer drug erlotinib hydrochloride, branded Tarceva. The ruling is
the second in a month to have upheld patent rights of an overseas drug
company and sets a key precedent with regard to intellectual property,
experts said.

The court, however, rejected Roche's plea for an injunction on Cipla's
product, considering the patent expires in March 2016. Roche, which was
granted a patent for Tarceva in 2007, sued Cipla in 2008 after the Indian
company launched cheaper version Erlocip. Cipla said it hadn't infringed
the innovator's patent as it sold a polymorphic form of the drug.

Legal experts noted that Cipla may appeal against the decision of the
division bench to the Supreme Court but this could not be confirmed from
the company. In its latest order, the court directed Cipla to pay Rs 5 lakh
while adding that it will be liable to render accounts concerning the
manufacture and sale of Erlocip "to record evidence pertaining to the
profits made by Cipla concerning the offending product."

In a statement to ET, Roche said it welcomed the decision of the court,
which has upheld the patent covering erlotinib hydrochloride (Tarceva) and
found Cipla to have infringed it.

The latest decision sets aside a 2009 verdict by a single judge in the same
court that had rejected Roche's arguments and allowed the Indian drug firm
to continue selling its product.

Roche and Cipla then cross appealed against that decision and last year, on
directions from court, the two had agreed to discuss a settlement via a
mediation exercise. However, an amicable settlement remained elusive and
the case moved back to court. In a 106-page order, Justices Pradeep
Nandarajog and Mukta Gupta outlined contentions of the two sides. The court
was clear about nature of infringement.

"This (the patent claim) is a sufficiently broad claim that is clearly not
limited to any polymorphic version of erlotinib hydrochloride, but to
erlotinib hydrochloride itself," it said. "This compound may exist in
several polymorphic forms, but any and all such forms will be subsumed
within this patent. Therefore as Cipla's Erlocip is admittedly one
particular polymorphic form of the Erlotinib Hydrochloride compound
(Polymorph B), it will clearly infringe IN'774 patent."


Roche had said its patent covered all polymorphs and derivatives of
erlotinib while Cipla contended its product (polymorph B) didn't infringe
Roche's intellectual property. Cipla had also demanded Roche's patent be
revoked under Section 3(d) of the Indian Patent Act that essentially bars
incremental innovations unless significant efficacy is proven.

Bringing clarity to Section 3(d), the judges wrote: "We understand Section
3(d) as a positive provision that in fact recognizes incremental innovation
while cautioning that the incremental steps may sometimes be so little that
the resultant product is no different from the original. The inherent
assumption in this is that infringement of the resultant product would
therefore be an infringement of the original i.e. the known substance and
by no stretch of imagination can Section 3(d) be interpret ..



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