[Ip-health] Delhi High Court Rules in Favour of Treatment Access

[Kajal Bhardwaj]

--
[ Picked text/plain from multipart/alternative ]
DELHI HIGH COURT RULES IN FAVOUR OF TREATMENT ACCESS

  Right to life, public interest, access to drugs and irreparable injury to=
 patients are important considerations in determining whether or not grant =
injunctions in patent infringement suits.

  =93Therefore, this Court is of the opinion that as between the two compet=
ing public interests, that is, the public interest in granting an injunctio=
n to affirm a patent during the pendency of an infringement action, as oppo=
sed to the public interest in access for the people to a life saving drug, =
the balance has to be tilted in favour of the latter.=94 =96 Delhi High Cou=
rt

  In January this year Roche (under license from patent holder Pfizer) appl=
ied to the Delhi High Court seeking a permanent injunction, restraining Cip=
la from manufacturing, offering for sale, selling and exporting the lung ca=
ncer drug Erlotinib. Pfizer was granted a patent by the Delhi patent office=
 in 2007. Cipla has filed a counter-claim for revocation challenging the va=
lidity of the patent.

  In its order dated 19 March 2008, the Delhi High Court did not grant the =
injunction to prevent the generic manufacture/sale of erlotinib. One of the=
 key factors considered in the decision =96 the high price of Roche=92s erl=
otinib as compared to the more affordable generic version.

  This court decision is a must read for the following reasons:

  1. In determining whether to grant an injunction, the court should apply =
all factors. Courts should follow a rule of caution, and not always presume=
 that patents are valid.

  Laying down the principles to be followed by a court in granting an injun=
ction in a patent infringement suit, the Court held that it had to apply al=
l factors including examine the merits of the arguments of both parties, ba=
lance of convenience and irreparable hardship. The Court seems to have part=
icularly distinguished the case of life saving drugs while discussing anoth=
er recent case where an injunction was granted. The Court also found that I=
ndian courts have consistently held that in cases of recently granted paten=
ts where validity is not proven, injunctions should not be granted in infri=
ngement cases and where the defendant alleges invalidity then it should be =
refused. The Court held that particularly given that India's patent law inc=
orporates several levels of scrutiny, courts should examine a claim for inj=
unction with some circumspection.

  While examining the merits of Roche=92s and Cipla=92s arguments, the Cour=
t also made the following observations and rulings:

  =A7         Non-patented goods are not inferior where they have received =
a license for sale in India.
  =A7         Grant of patents in other jurisdictions is no indication of v=
alidity; India has to apply its own patentability standards.
  =A7         Patentability criteria of non-obviousness should not be confu=
sed with novelty

  Concluding that while Roche had an arguable case, Cipla=92s challenge als=
o had some merit, the Court then examined the balance of convenience, which=
 it held included the impact on patients.  (Note: the Court did not conclud=
e one way or the other regarding the validity of the erlotinib patent).

  2. Balance of Convenience in favour of access to drugs; price difference =
in the case of life saving or life improving drugs is a critical factor; Ar=
ticle 21 (Right to life under the Indian Constitution) not to be stifled by=
 stopping supply of low cost generic.

  The Court observed that in the case of pharmaceutical products, courts ha=
ve to tread with care; more so on the case of life saving drugs. In such ca=
ses balancing the convenience would have to factor in =93imponderables=94 s=
uch as the likelihood of injury to unknown parties.

  Holding that an injunction would stifle Article 21 of the Indian Constitu=
tion which guarantees the right to life, the Court held that, =93price diff=
erential in the case of a life saving drug -- or even a life improving drug=
 in the case of a life threatening situation, is an important and critical =
factor which cannot be ignored by the court.=94

  3. Refusal of injunction would not cause irreparable hardship to Roche th=
at cannot be compensated; damage to patients lives, however, would be irrep=
arable.

  The Court held that the damage to Roche was assessable in monetary terms =
but the injury to the public would lead to the shortening of lives =96 dama=
ge that could not be restituted in monetary terms; damage that could not on=
ly not be compensated =96 it was irreparable.

  In its judgment, the Court referred to a plethora of precedents including=
 Indian, UK and US cases (e-bay, KSR International and Cordis Corporation).=
 There are many other interesting observations and rulings made by Justice =
Ravindra Bhat in this Delhi High Court judgment. To read the decision see h=
ttp://courtnic.nic.in/dhcorder/dhcqrydisp_j.asp?pn=3D1031&yr=3D2008

  Citation:
  F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Limited
  I.A 642/2008 IN CS (OS) 89/2008
  Delhi High Court
  Order dated 19 March 2008

  Kajal Bhardwaj & Leena Menghaney


---------------------------------
Be a better friend, newshound, and know-it-all with Yahoo! Mobile.  Try it =
now.