MUMBAI: Multinational pharmaceutical company Roche which decided to drop monopoly rights on its blockbuster breast cancer drug, Herceptin in India, had lost the same patent in Europe earlier. This reaffirms the fact that it was a weak patent'' which would not have withstood the challenge in India, intellectual property lawyers point out, rubbishing the MNC's claim of the weak IP environment.
Roche reportedly decided to relinquish the secondary patent on Trastuzumab, marketed as Herceptin, because of the IP environment in India. Roche's decision paves the way for generic companies to launch the exorbitantly-priced life-saving drug, industry expert say, adding that Korean company Celltrion is already looking at launching the drug.
Sources said that the company lost the patent in Europe on the acidic variant of herceptin, Patent no 1308455, in 2010.
Roche's Herceptin is used in breast-cancer treatment and costs close to an eye-popping Rs 1 lakh for a month. If the company had pursued the patent, it would have lasted till 2019.
Domestic companies including Biocon, Reliance Life Sciences and BDR Pharma are working on a generic of Herceptin.
IP experts say that the revocation of the secondary patent in Europe has set a precedent for other countries, buttressing the fact that it could not withstand the challenge.
In India, a post-grant opposition was pending with the Kolkata for over five years, but official unresponsiveness allowed Roche to misuse this frivolous patent to implement a predatory pricing policy and block generic entry for more than six years", the Campaign for Affordable Trastuzumab, a civil society group, said in a statement earlier.
The human costs are enormous - over a million women have been diagnosed with HE2+ cancer in the six years that this patent has been in force, with less than 10% of them able to access the drug, it added.
A questionnaire sent to Roche went unanswered.
"Roche's decision to relinquish the Trastuzumab patent should not be mistaken for altruism - it is a face-saving gesture in response to the eroding legitimacy of both the patent and the pricing policy in India. It is also a tactical move to avoid compulsory licensing, which would have much more serious and far-reaching implications for its plans in the Indian market", the statement said.
The basic compound of trastuzumab was not patentable here since it was developed before India revised its patent regime to make it WTO-compatible. However, in 2007, a patent was granted to Genentech (the original developer, later acquired by Roche) for a combination of the HER2+ antibody.
In August, the Kolkata Patent Office had clarified that Roche's divisional applications on Herceptin (filed in 2005 and 2008) were dismissed because Genentech/Roche missed the stipulated deadline for filing, and failed to appear and make their case, when requested to do so by the Patent Controller.
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