[Ip-health] Madras High Court sets aside patent on valganciclovir

[aidslaw@lawyerscollective.org]

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Madras High Court sets aside patent on valganciclovir



3 December 2008, Mumbai



Greetings from Lawyers Collective HIV/AIDS Unit!



In a landmark judgment, a bench of the Madras High Court comprising Chief J=
ustice A. K. Ganguly and Justice Ibrahim Kalifulla yesterday set aside the =
patent granted to F. Hoffman-La Roche AG (Roche) for valganciclovir (Patent=
 No. 207232) for failure of the Indian patent office to comply with the pat=
ent law and remanded the matter back to the Patent Controller.  The judgmen=
t setting aside the patent was delivered in a petition filed by two Indian =
patients=92 groups=97Indian Network for People Living with HIV/AIDS (INP+) =
and Tamilnadu Networking People with HIV/AIDS (TNNP+)=97who challenged the =
Indian Patent Office=92s decision to grant a patent without hearing the pre=
-grant opposition filed by them.



As you know, Indian patients=92 groups have been filing pre-grant oppositio=
ns against patent applications relating to crucial HIV and cancer drugs.  A=
ware that a patent holder can set high, monopolistic prices once a patent i=
s granted to a drug, patients=92 groups are filing pre-grant oppositions to=
 ensure that patents are granted only if the applications comply with India=
=92s strict patentability criteria.  One such opposition filed by INP+ and =
TNNP+ was against Roche=92s patent application for valganciclovir.



At the centre of the dispute is the drug called valganciclovir, which is a =
prodrug of an already known drug ganciclovir.  This drug is crucial for tre=
atment of cytomegalovirus (CMV) retinitis, an opportunistic infection that =
affects persons living with HIV, and to prevent CMV infection in patients w=
ho have received organ transplants.  At Roche=92s maximum retail price of o=
ver Rs. 1000 (approx USD 20; 1 USD =3D approx Rs. 50) per tablet, a patient=
 who has to take a treatment course of approximately four months for CMV re=
tinitis would have to pay about Rs. 250,000 (approx USD 5000).  This puts t=
he treatment out of reach for those who need them.



In July 2006, INP+ and TNNP+ filed a pre-grant opposition before the Patent=
 Office at Chennai objecting to the grant of a patent to Roche for valganci=
clovir and requested the Patent Office for a hearing.  Under the Indian law=
, if an Opponent requests a hearing, the Patent Office is required to hear =
the Opponent.  The Patent Office sent the pre-grant opposition to Roche and=
 received a reply from Roche.  Satisfied that the objections raised by INP+=
 and TNNP+ had been met by Roche, the Patent Office went ahead and granted =
a patent without hearing INP+ and TNNP+.  The grant of the patent was publi=
shed in June 2007.  After correspondence with the Patent Office failed to y=
ield any result, INP+ and TNNP+ filed a petition in the Madras High Court i=
n October 2008.  They alleged that failure to grant them a hearing amounted=
 to violation of the mandatory requirements of the patent and also a violat=
ion of the principles of natural justice.  The Assistant Controller, who ha=
d granted the patent, filed a reply justifying the grant.  Roche objected t=
o the petition on the ground that INP+ and TNNP+ could take recourse to mec=
hanisms such as post-grant opposition or revocation available under the pat=
ent law to challenge the grant of the patent.



The final hearings in the case took place in the third and fourth weeks of =
November 2008.



Advocate Anand Grover, Director of Lawyers Collective HIV/AIDS Unit, appear=
ed on behalf of INP+ and TNNP+.  He argued that the failure of the Indian p=
atent office to hear the opponents amounted to a failure to comply with the=
 mandatory provisions of the patent law and also violated the principles of=
 natural justice.  Reading from the affidavit filed by the Assistant Contro=
ller and other documents, he showed how the Patent Office had considered th=
e reply filed by Roche to the opposition before deciding to grant a patent.=
  He informed the court that no order had been passed disposing off the pre=
-grant opposition.  He then referred the judges to the provisions of the pa=
tent law to show that even if an order was passed rejecting a pre-grant opp=
osition, no appeal could be filed against such an order.  He pointed out th=
at were INP+ and TNNP+ to file a post-grant opposition or a revocation proc=
eeding, it would amount to an admission of the grant of the patent.  These =
proceedings, he argued, were separate causes of action and did not afford a=
 remedy to INP+ and TNNP+ in this situation.  He also pointed out that as t=
he action of the Patent Office was illegal, the patent granted was void and=
 without any legal effect.  He therefore asked that the patent be set aside=
 and the matter be sent back the Patent Office for a hearing.



Senior Advocate A. L. Somayaji, senior counsel appearing for Roche, argued =
that it was open to INP+ and TNNP+ to file a post-grant opposition or revoc=
ation proceeding.  He said that a pre-grant opposition was in the nature of=
 an administrative procedure and does not give rise to a dispute between th=
e parties.  He further argued that there was no need for the Controller to =
pass an order in a pre-grant opposition proceeding.  Referring to an allege=
d delay in challenging the grant of the patent, he said that Roche would be=
 prejudiced if the patent granted were set aside by the High Court and it w=
ould impact the infringement suit filed by Roche against Cipla before the B=
ombay High Court.



Advocate R. Vaigai, counsel appearing on behalf of INP+ and TNNP+, rebutted=
 these arguments.  She said that a pre-grant opposition proceeding was a qu=
asi-judicial proceeding (like a judicial proceeding) and it was a dispute b=
etween two parties.  She said that when the grant of the patent itself was =
illegal from the outset, it was a continuing cause of action and there was =
no question of delay in approaching the court to set it aside.  She pointed=
 out that if the patent was not set aside and the opposition filed by INP+ =
and TNNP+ was merely sent back to the Patent Office for a hearing, the proc=
eeding would be akin to a post-grant opposition. She further brought to the=
 notice of the court that Roche could continue to import valganciclovir int=
o India and sell it even if the patent were set aside.



In its decision delivered on 2 December 2008, the High Court set aside the =
grant of the patent and remanded the matter back to the Patent Office.  The=
 Court held that since the Petitioners represented public interest, there i=
s no question of waiver of the principles of natural justice.  Observing a =
bias in the affidavit filed by the Assistant Patent Controller, the High Co=
urt has directed that the opposition be heard by another patent official be=
fore 31 January 2009.  The High Court also declined Roche=92s counsel=92s p=
lea to stay the operative part of the order setting aside the patent until =
a certified copy of the order was issued to them to enable them to file an =
appeal.



This decision is likely to have an impact on the infringement suit filed by=
 Roche against Cipla in the Bombay High Court.  Roche has alleged that Cipl=
a=92s generic version of valganciclovir infringes its patent.  The infringe=
ment suit will come up for hearing before the Bombay High Court on 10 Decem=
ber 2008.



We will make the copy of the judgment available on our website (www.lawyers=
collective.org) as soon as possible.



In solidarity,

Lawyers Collective HIV/AIDS Unit
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