Info Service on Health Issues (Aug13/02)
14 August 2013
Third World Network
Half-truths by Roche and Reuters on patent applications' invalidation
Published in SUNS #7644 dated 12 August 2013
Delhi, 9 Aug (K. M. Gopakumar) -- Pharmaceutical giant Roche and news
agency Reuters have revealed half-truths regarding the invalidation
of three of Roche's patent applications on the anti-breast cancer
medicine Trastuzumab, marketed under the brand name Herceptine.
In response, the Government of India issued a press release on 5 August
2013 to provide the full picture of the situation (see http://pib.nic.in/newsite/erelease.aspx?relid=97629).
[Trastuzumab is a biotechnology-based medicine used for the treatment
of HER2+ variant of breast cancer, which affects around one in four
patients diagnosed with the disease. In 1998, the US Food and Drug
Administration (FDA) granted marketing approval for Trastuzumab. Roche
markets Trastuzumab and enjoys a monopoly in the global market due
to patent protection. The original patent on Trastuzumab is to expire
in 2014. However, Roche has obtained multiple patents on various formulations
of Trastuzumab and its combinations in order to extend its patent
The Reuters report on 4 August 2013 quoted Swiss newspaper Schweiz
am Sonntag that the Kolkata branch of the Indian Patent Office has
lifted the divisional patent applications on Trastuzumab on 17 July.
The report contains a quote from the Roche spokesperson, who stated:
"I can confirm that the Assistant Controller of Patents at the
Kolkata Patent Office has revoked divisional patents of Herceptine
and that we are now considering the further course of action".
The spokesperson projected the decision of the Patent Office as a
revocation of the patent application. However, neither Roche nor Reuters
revealed the real reasons behind the decision of the Patent Office
or what were actually rejected.
The Reuters report also interpreted this development as a move against
patent protection. It stated: "The decision is the latest in
a series of rulings on intellectual property and pricing in India
that have frustrated attempts by Western drug makers to sell their
medicines in India's fast-growing drugs market".
However, the report did not reveal the real facts behind the invalidation
of the three divisional patent applications of Roche on Trastuzumab.
What was not said is that the decision of the Patent Office does not
affect the patent status of Trastuzumab in India. Roche still enjoys
the patent rights on Trastuzumab even after the invalidation of its
The Reuters report and the spokesperson of Roche omitted this important
fact and projected this story as an example of non-respect for patents
by the Government of India.
This prompted an immediate official response via the 5 August press
release issued by the Press Information Bureau (the official communication
agency of the Government of India), in which the Kolkata Patent Office
clarified the reasons for treating Roche's divisional applications
as invalidated or abandoned.
THE BACKGROUND AND FACTS
Even though there is no patent on the basic molecule in India because
it was developed at a time when the country's patent law did not allow
such patenting, Roche did obtain at least two patents on Trastuzumab
subsequently under the amended law.
As a result, there is no competition for Roche's product in the Indian
market. Roche charges between US$2,000-2,200 for a single dose of
Trastuzumab in India. A patient needs 5 to 12 doses of Trastuzumab.
In April 2012, Roche announced a new marketing arrangement with the
Indian company Emcure to market Trastuzumab at a discounted price
under a different brand name. This move by Roche was to contain the
threat of a compulsory license that allows a generic version to be
produced by another party during the patent period without the permission
of the patent holder.
In November 2012, the public interest Campaign for Affordable Trastuzumab
(Campaign) was launched. The Campaign made the following five demands
to the Government of India through a letter endorsed by around 200
civil society organisations and concerned individuals:
• Make Trastuzumab available free of cost to patients in government
hospitals, and at a reasonable and affordable cost in the open market;
• Constitute a High-Level Inter-Ministerial Task Force in the Health
Ministry involving biotechnology experts from public-funded research
organisations and civil society organisations to address the technological
issues that may be involved in the production of Trastuzumab;
• Take effective measures to ensure that no secondary patents on Trastuzumab
are granted or enforced in India;
• Issue compulsory licenses (as allowed by the Indian Patents Act,
2005) in case there are existing process or product patents that block
the development of bio-similars of Trastuzumab;
• Provide adequate resources for research and development, manufacture
and clinical trials of a bio-similar of Trastuzumab, and ensure a
fast-track process for regulatory approval.
[In December 2012, an Expert Committee appointed by the Indian Health
Ministry recommended Trastuzumab as a fit case to have an expedited
procedure to issue a compulsory license under Section 92 of the Indian
Patents Act. However, the Department of Industrial Policy and Promotion
(DIPP), the nodal department for the administration of patent law
in India, is yet to take a final decision on the recommendation of
the Health Ministry.]
In 2000, Genentech, the originator of Trastuzumab, filed a patent
application on Trastuzumab IN/PCT/2000/ 00391/KOL and a patent was
granted on 5 April 2007 (IN205534) that will expire in 2020. Roche
became the patent owner after it took over control of Genentech.
India's Health Ministry recommended an expedited procedure for granting
of compulsory license on this patent, which is believed to scare the
generic companies from producing the bio-similar version of Trastuzumab.
In the absence of an original patent on the molecule, this granted
patent has acted as a blocking patent for the local production of
Trastuzumab in India.
However, Roche then filed three divisional applications claiming improvements
on the existing patent filed in 2000. The first divisional application
1638/KOLNP/2005 was filed on 16 August 2005.
In 2008, two further divisional applications were filed viz. 3272/KOLNP/2008
[Generally, a divisional patent application is filed to protect the
unity of an invention. According to this principle, a single unique
invention can be claimed under a patent application. Divisional patent
applications facilitate the protection of the other related inventions
which are mentioned in the parent application. Often, divisional patent
applications are used to delay the final disposal of the parent patent
application and delay the generic entry.]
According to the 5 August press release of the Government of India,
"an applicant has to file a request for examination for an application
within forty eight months from the date of priority of the application
(other than divisional applications) and within forty eight months
from the date of priority or within six months from the date of filing
in the case of divisional applications. If the requests are not filed
within time they are treated as withdrawn under section II B(4) of
Roche's first divisional patent application (1638/KOLNP/2005) was
filed on 16 August 2005. The request for examination was to be filed
on 16 February 2006. However, Roche filed the request for examination
only on 17 March 2007, which "goes beyond the prescribed period
according to Rule 24(B)(iv) of the Patents Rules".
The second divisional application, i. e. 3272/KOLNP/2008 is a divisional
application of 1638/KOLNP/2005. The request for examination was filed
on 12 February 2009.
According to the press release of the Government of India, "In
the matter of 3272/KOLNP/2008, the Controller found that the instant
application was divisional to a divisional application, which in his
opinion was not permissible".
Further, it was also found that this divisional application was filed
after the grant of patents on the first filed application (IN/PCT/2000/391/KOL).
As per the Indian patent law and procedure, the divisional application
should be filed prior to the grant of the first patent application.
Therefore, the Patent Office invalidated this divisional application.
The third divisional application, i. e. 3273/KOLNP/2008 is a divisional
application out of 1638/KOLNP/2005. The request for examination was
filed on 12 February 2009.
According to the press release, "the application no. 3273/KOLNP/2008
is not considered to be a divisional application at all within the
meaning of section 16 of the Act. The application has not been properly
filed complying with the requirements of the Act and therefore, treated
The press release also stated that in the case of the second divisional
application, "The Controller gave due opportunity of hearing
to the agent (of Roche) on 31/05/2013. After the first hearing, the
Controller fixed another date of hearing in the subject matter on
15/07/2013, which was not attended by the applicant".
Similarly, Roche's agent did not turn up for the hearing of the third
The Reuters report is conspicuously silent about the non-appearance
of Roche for the hearing.
The patent invalidation action by the Patent Office is believed to
be triggered by a letter from the Campaign for Affordable Trastuzumab
dated 24 April 2013 in which the Campaign demanded suo moto action
to designate the divisional patent applications as deemed withdrawn/invalid
on two grounds.
First, there has been a delay in the filing of a request for examination.
According to the letter, "for applications 3272/KOLNP/2008 &
3273/KOLNP/2008, the legal deadline for filing a request for examination
was February 11, 2009. However, the request for examination for both
the applications was filed on February 12, 2009, after the expiry
of the statutory six month period laid down under Section 11B. The
Patents Act 1970 has mandatory time-lines within which the request
for examination of the patent application must be filed. This time-limit
is laid down in the statute and is not extendable under any circumstances".
Secondly, the divisional applications were filed after the grant of
the patent. The letter stated, "The Kolkata Patent Office had
grounds to not accept the divisional patent applications as 3272/KOLNP/2008
& 3273/KOLNP/2008 were filed 16 months after the parent application
IN/PCT/2000/00391/KOL was granted in April 2007."
In its letter, the Campaign also stated: "Roche is using divisional
applications as a strategic tool for delaying the entry of competitors
and maintaining the price of Trastuzumab at its present unjustifiable
and unaffordable level".
In a press statement dated 6 August, the Campaign welcomed the decision
of the Kolkata Patent Office.
The Campaign stressed: "Trastuzumab has a dramatic impact on
the HER2+ variant of breast cancer, significantly reducing the risk
of recurrence and expanding the possibility of a disease-free life.
However, the drug is priced exorbitantly and, at Rs. 900,000 (around
USD17,000) for a minimum course of 12 injections, is out of reach
for the majority of Indian women. According to official statistics,
more than 25,000 Indian women (increasingly in the under-45 age group)
are diagnosed with HER2+ breast cancer every year, of whom less than
5 percent are able to access Trastuzumab".
According to the Campaign, "Roche's reaction to the decision
of the Kolkata Patent Office reveals its determination to continue
its predatory pricing policy even if it means subverting Indian law
to reap a profit that is completely disproportionate to the cost of
development and production of Trastuzumab".
The Campaign also expressed concern over news reports that suggested
that the Government's "decision will depend on generic manufacturers
already having applied for marketing permission for a bio-similar
version of Trastuzumab. This approach is one of putting the cart before
the horse - it is unlikely that generic manufacturers will reveal
their hand by applying for marketing permission without being assured
of a clear field where patent barriers will not block their entry
into the market. On the other hand, we have reason to believe that
the announcement of compulsory licensing by DIPP will open the door
for marketing applications from generic manufacturers who have Trastuzumab
bio-similars in the pipeline".
The Campaign urged the Government of India to act without delay to
allow generic manufacturers to produce bio-similars of Trastuzumab,
stressing that "The lives of thousands of Indian women are at
stake - allowing a single predatory company to control the drug that
can save them is ethically, legally and economically unjustified".