Dose of bitter pills, few booster injections for pharma sector in 2013

Dec 29 2013, 15:55 IST
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SummaryDomestic firms coming under increased scrutiny of global regulators, resulting in Ranbaxy paying a record USD 500 million fine, and drugs becoming cheaper in India thanks to a new pricing policy marked a roller-coaster year 2013 for the pharma industry.

decisions were made. The Supreme Court rejected plea of Swiss pharma giant Novartis, for a patent on cancer drug Glivec paving way for Indian generic firms to offer cheaper alternatives.

Ending a seven-year legal battle, the apex court dismissed the company's plea and held that there was no new invention and no new substance used in the drug.

The development raised questions over India's patent regime from multi nationals but the government stood firm and said Indian laws were WTO compliant and no country could allow "ever-greening" of patents.

In another blow to foreign pharma companies, the Intellectual Property Appellate Board (IPAB) ordered the revocation of the patent given to GSK Pharma's popular breast cancer drug, Tykerb.

In view of the developments, Swiss pharma major Roche Holding AG said it won't pursue the secondary patent for its breast cancer drug 'Herceptin' in India.

On the other hand, the government rejected a compulsory licensing application by BDR Pharmaceuticals to manufacture the generic version of patented anti-cancer drug 'Dasatinib', a decision that is seen as evidence that IP rules prevail in India.

Commenting on the developments, Novartis India Vice Chairman and Managing Director Ranjit Shahani told PTI: "As far as the innovator Pharma Companies were concerned they continue to face challenges on implementation of patents and threat of more compulsory licenses."

While most of the domestic industry welcomed India's stand on the patents, in an interview to PTI, Biocon Chairman and Managing Director Kiran Mazumdar-Shaw said that India needs to show the world that it respects intellectual property rights if it wants global pharmaceutical firms to invest in India.

It was not always the foreign multinationals who were at the receiving end, Indian major Sun Pharma along with Israel's Teva had to pay a sum of USD 2.15 billion to Pfizer and Takeda as part of patent infringement settlement for acid reflux medicine Protonix in the US.

As part of the agreement, Teva will have to pay Pfizer and Takeda USD 1.6 billion while Sun was to pay USD 550 million.

The year saw government continuing efforts to fix prices of essential drugs under the new drug pricing policy and continuation of collection of data on essential medicines from the pharma firms.

NPPA asked pharma associations to submit data so that prices of 348 drugs listed under National List of Essential Medicines (NLEM) could be fixed in time. The process of deciding the ceiling prices of medicines is already underway.

The industry, however, said

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