[Ip-health] Fwd: TWN IP Info: Half-truths by Roche and Reuters on patent applications' invalidation

K.M. Gopakumar kumargopakm at gmail.com
Tue Aug 13 21:23:24 PDT 2013


*Title :* TWN IP Info: Half-truths by Roche and Reuters on patent
applications' invalidation
*Date :* 14 August 2013

*Contents:*

TWN Info Service on Intellectual Property Issues (Aug13/02)
14 August 2013
Third World Network
www.twn.my

*Health: Half-truths by Roche and Reuters on patent applications'
invalidation
Published in SUNS #7644 dated 12 August 2013*

New 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 monopoly.]

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 divisional
applications.

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 and 3273/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 the Act".

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 as
abandoned".

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
divisional application.

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". +





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