[Ip-health] Update: Indian Patent Office hears post-grant opposition on Pegasys

[Julie George]

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[ Picked text/plain from multipart/alternative ]
*INDIAN PATENT OFFICE HEARS POST-GRANT OPPOSITION ON PEGAYS*



9 September 2008. The Assistant Controller of Patents at the Chennai Patent
Office, India, yesterday heard a post-grant opposition filed by Sankalp
Rehabilitation Trust against the grant of a patent to F. Hoffmann La Roche
AG (Roche) for Pegasys, a drug used to treat Hepatitis C.



This was the first hearing on a post-grant opposition filed by a public
health group. The Indian Patent Office had granted a patent to Roche in 200=
6
for Pegasys. Patients with chronic Hepatitis C need a six-month course of
treatment of Pegasys (pegylated interferon alfa2a), which costs about Rs.
4,36,000 (available at a discounted price of Rs. 3,14,496). Pegasys is to b=
e
taken in combination with Ribavarin, which costs Rs. 47,160.



In May 2007, Sankalp Rehabilitation Trust, a Mumbai-based NGO that works
with drug users, filed a post-grant opposition against the grant. Injecting
drug users are particularly vulnerable to infection with Hepatitis C. It is
estimated that about 92% of adult Indian injecting drug users are infected
with Hepatitis C virus. Hepatitis-C is also a major co-infection that
affects persons living with HIV. In fact, a study estimates that about 92%
of PLHIV in the North-East have HIV-Hepatitis C co-infection. Because the
drugs are so highly priced, patients with chronic Hepatitis C, who require
treatment, are unable to afford it. The irony is that while PLHIV in the
North East access free first line antiretrovirals through the government
roll-out, they are dying because they cannot get themselves treated for
Hepatitis-C. As Ajitshwor, a Manipur-based INP+ member noted, "I know that =
I
will not die of AIDS...what is going to kill me is hepatitis C."



Mr. Anand Grover, counsel for Sankalp Rehabilitation Trust, argued that the
claimed invention, Pegasys=97the branched pegylated form of interferon alfa
2a=97did not satisfy the patentability criteria under Indian law. He argued
that Roche's patent for Pegasys involves combining interferon=97a naturally
occurring protein with antiviral effects that has been known for years=97wi=
th
a structure called polyethelyene glycol (PEG), an inert substance that help=
s
to prevent the interferon from being broken down by the body, thus allowing
it to remain in the bloodstream longer.  This technology of combining
interferon and other biologically active proteins with PEG had also been
known for years prior to this patent.  In fact, the technology embodied in
Roche's patent is essentially identical to that disclosed in an academic
paper that was published a year prior to the filing of Roche's patent
application. Therefore, all Roche did was apply what was already known to
interferon alfa 2a. Mr. Anand Grover said that, in light of this, the
invention was not new and, in the alternative, also was obvious to the
person skilled in the art and lacked inventive step. He further argued that
Roche had also failed to satisfy section 3(d) of the Patents Act, which
requires a showing of enhanced efficacy. He pointed out that admittedly,
pegylated interferons were known substances at the time of the application.
However, Roche did not provide data to show that the claimed invention was
significantly more efficacious than other pegylated interferons. He said
that the limited data provided by Roche to show enhanced efficacy was not
adequately proved as required by law and further was not conclusive for all
human cell lines. Raising another ground, Mr. Anand Grover argued that
pegylated interferon was merely an admixture of known substances, with no
showing of synergistic effect, and therefore failed to satisfy section 3(e)
of the Patents Act.



Responding to this, Mr. Guru Natraj, counsel appearing for Roche, first
questioned the standing of Sankalp Rehabilitation Trust to file a post-gran=
t
opposition. He claimed that under the law, only a "person interested" could
file a post-grant opposition and Sankalp Rehabilitation Trust did not
satisfy this criterion. He then argued that the burden of proving the
invalidity of the patent was on the opponent, and it was not for Roche to
prove that its patent was valid. Responding to the documents cited by Mr.
Anand Grover, Mr. Guru Natraj attempted to distinguish them and claimed tha=
t
they taught pegylation of enzymes and that as interferon was not an enzyme,
these documents could not be used to object to the novelty and inventive
step involved in the pegylation of interferons. He added that the documents=
,
in fact, taught away from using pegylated interferon of the higher molecula=
r
weights claimed by Roche. He argued that none of the documents cited by Mr.
Anand Grover disclosed all the elements of the branched pegylated interfero=
n
of a particular molecular weight that Roche was claiming. Mr. Guru
Natrajfurther argued that the patent satisfied the "technical advance"
requirement
of inventive step because Pegasys was more efficacious.



Rejoining to the arguments, Mr. Anand Grover argued that the question of
standing of Sankalp Rehabilitation Trust had not been raised earlier. In an=
y
event, he relied upon a decision of the Delhi High Court to show that a
public interest group was a "person interested" as required under law. On
the issue of burden of proof, Mr. Anand Grover relied on a judgment of the
Supreme Court to show that the burden of proving inventive step was on the
patent holder, Roche in this instance.  He pointed out that pegylation of
biologically active molecules, including various proteins, enzymes and
hormones, was known to produce certain desirable effects and that it could
not be said that pegylation of proteins such as interferon alfa 2a was
unknown. Responding to the proving of "technical advance", Mr. Anand
Groversaid that "technical advance" and obviousness are components of
the
inventive step requirement and ought not to be conflated with the
requirement of showing of efficacy under section 3(d) of the Patents Act.



The parties have been given until 25 September 2008 to file their written
submissions.



Today, the Patent Office will be hearing a post-grant opposition filed by
Wockhardt against the same patent.



After the hearings conclude, the Patent Office will decide whether Roche's
patent is valid or whether it should be amended or revoked.



Further details relating to the Pegasys opposition will be made available o=
n
our website (www.lawyerscollective.org) shortly.



In solidarity,

Lawyers Collective HIV/AIDS Unit