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  • Pfizer’s patent on cancer drug revoked

Pfizer’s patent on cancer drug revoked

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DNA
05 Oct 2012
Stage set for entry of generics; drug costs a whopping `4,357 per 25 mg capsule now

This will cheer up cancer patients a tad.

In yet another blow to Big Pharma, the Delhi Patent Office has revoked a patent granted in 2007 to US drugmaker Pfizer for sunitinib (brand name Sutent), a drug used to treat a type of kidney cancer, which had global sales of $1.19 billion in 2011.

The ground for the revocation was a lack of inventive step, the Patent Office said.

The drug costs roughly `1.96 lakh for a 45–day treatment, or `4,357 per 25 mg capsule. With a patent in place, no other brand could enter the market, thereby giving Pfizer a monopoly and the drug beyond the reach of most patients.

The revocation follows a post–grant opposition by Mumbai–based generic drug maker Cipla against Pfizer’s patent on the drug. Pre–grant opposition invites greater scrutiny before the grant of a patent, while post–grant is an option to challenge the grant of a patent.

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However, Cipla officials did not comment on the ruling. An email seeking details such as the size of the market and whether the company was ready with a generic version of the drug remained unanswered at the time of going to press.

On it part, Pfizer India plans to appeal the decision before the Intellectual Property Appellate Board. "We believe the decision undermines intellectual property rights in India and we will defend our basic Sutent patent," Jazz Tobaccowalla, MD, Pfizer India, said in a statement. Humanitarian organisations have hailed the development.

"Both pre–grant and post–grant opposition to a patent are key in developing countries as they work to open up generic competition. They are mechanism to challenge a patent," Leena Menghaney, access campaign India coordinator at Medecins Sans Frontieres, pointed out.

This is the second major patent revocation in India. In May 2010, the Chennai Patent Office had revoked Swiss firm Roche’s patent on HIV drug valganciclovir (brand name Valcyte) following post–grant applications by patient groups. Valcyte was then priced at `1,023 per tablet, while the generic competitors were priced at `245 per tablet.

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Big Pharma sure has had it tough in India this year. In March, German firm Bayer received a jolt in the form of a compulsory licence (CL) being granted by the Patent Office to Indian firm Natco. The CL meant Natco could manufacture and sell a generic copy of Bayer’s patented cancer drug Nexavar, which cost patients `2.8 lakh for a month’s treatment.

Like several pharma multinationals, Pfizer has a patient assistance programme with NGO partners for providing Sutent at subsidised rates. However, according to an expert from healthcare firm, such programmes are merely to ward off criticism vis–a–vis their highly priced products. "They use assistance programmes as an excuse to defend their patents. Availability of generics and competition is far greater than access programmes to bring the drug within easy reach of people. Competition automatically brings down prices."

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