DETAILED CASE ANALYSIS OF ROCHE V.

CIPLA

Brief history of the case:

The case is the first Patent Litigation in India post India’s 2005 Product Patent Regime which
included public interest and pricing issues in addition to India’s Section 3d that prevents ever
greening. The case was followed by Pharma Giants worldwide. And finally Cipla has won the
landmark Roche V. Cipla Patent.

Parties to the suit:

The landmark case took place between Roche {which is a Swiss multinational health-care
company, which has its operations all throughout the world} and Cipla {which is an Indian
Multinational Pharmaceutical and Biotechnology Company}.

Brief Facts:

Roche’s patent claim was on the “Erlotinib Hydrochloride”- without being limited to any of its
polymorph, however Roche was commercializing a particular polymorph of the claimed drug
molecule(i.e. polymorph B), which was being marketed as “Tarceva”. Cipla manufactured and
marketed the drug which was based on the “polymorph B of Erlotinib Hydrochloride” at one
third the cost of Roche.

Ruling of the Delhi High Court:

Roche’s plea for interim injunction against Cipla was dismissed by the learned single judge of
the Delhi High Court on the ground that the public interest involves and the life-saving nature of
the drug question.

Roche’s appeal to Division Bench:

Roche appealed to the Division bench of Delhi High Court against the order passed the learned
single judge. But it was also dismissed in the year 2009, in the back of heavily public interest-
centric of the patent Act, 1970, as amended from time to time, and a detailed discussion of the
relative affordability of the drug to the common man. The division bench further felt that Cipla
had done enough to demonstrate a potentially credible challenge to the validity of Roche’s
PATENT .IN’774.

Roche Appealed to Supreme Court:

Supreme Court dismissed the special leave petition filed by Roche, challenging the order passed
by the division bench of the Delhi High Court. However, the court ordered that the ongoing trial
at the Delhi High Court be expedited. After the matter was heard by the Supreme Court, the case
was again sent back to the Single judge bench. In the year 2012, the matter was referred to Single
judge.

Roche’s version of the story:

Roche’s patent was granted in February 2007 by the Indian Patent Office, which covered its
patent right over the “Erlotinib Hydrochloride” molecule which has demonstrated breakthrough
capabilities as an “EPIDERMAL GROWTH FACTOR RECEPTOR(EGFR)” inhibitor which
spiked survival benefit in cancer including “NON SMALL CELL LUNG CANCER (NSLC)”
patients. Roche’s alleged that Cipla had infringed its impugned drug under the name “Tarceva”
by the marketing the generic version of the drug under the name “Erlocip”. Cipla’s drug was
also Erlotinib Hydrochloride and manufacture of Polymorph B by Cipla was sufficient to trigger
infringement to claim 1 of its patent IN 774.

Cipla’s version of the story:

Roche’s patent IN774 had not complied with full disclosure requirements as required under the
section 8 patent Act,1970.Roche’s patent is invalid under section 64 (1)(f) of the Patent Act 1970
for lack of inventive step and for being obvious. Not only did Roche’s patent specification fail to
disclose how it was inventive but there were compelling evidence which indicated that it was
more combination and less innovation. That Roche’s had unsuccessfully applied for “Polymorph
B” from of Erlotinib Hydrochloride (Patent IN/507/Del), acclaim which was rejected by the
Indian patent office in 2008 with the findings on ever greening, structural similarities between IN
‘774 and a lack of conclusive comparative clinical data to prove efficiency. That invention
required to be product specific, where product has commercial manifestation, since infringement
is relatable to “that product” which is patented and not to any “substance”.
While the patent sought to be enforced is for Polymorphs A+B, the product actually under
manufacture by both Roche’s and Cipla is Polymorph B which ought to be assumed to be in the
public domain and hence Cipla’s activities are non-infringement in nature.

Final Decision:

Justice Manmohan Singh has passed the judgment in favor of Cipla stating that Cipla did not
infringe Roche’s Indian patent “IN 196774”. According to the Judge, it was scientifically proven
that Cipla’s Generic Drug is the Polymorphic Form B which is not Roche’s patented Drug.

Conclusion
Roche-Cipla dispute over the lung the lung cancer drug “Erlotinib “was one of the initial dispute
filed in the country and had been keenly watched ever since. The division bench of the Delhi
High Court has referred to a plethora of judgments including that of foreign jurisdictions in order
to arrive at the aforesaid decision. It is hoped that the final outcome of the infringement suit and
the judgment would be helpful in deciding other similar pharmaceutical infringement disputes in
India.