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TWN Info Service on Health Issues (Aug13/02)
14 August 2013
Third World Network

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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