印度专利局已启动了新一轮强制许可签发程序，此次目标为罗氏（Roche）乳腺癌重磅药物赫赛汀（Herceptin）、百时美施贵宝（BMS）白血病药物Sprycel和乳腺癌药物lxempra，这意味着这些药物的廉价仿制药将很快在印度市场上市。
去年3月9日，印度专利局向本地仿制药商Natco公司签发了该国的首个强制许可，针对的是德国拜耳抗癌药“多吉美”（英文商品名Nexavar）。
英文原文：India is taking another swipe at Big Pharma. Three swipes, in fact: The government has started the process of granting three more compulsory licenses, this time on cancer treatments from Roche ($RHHBY) and Bristol-Myers Squibb ($BMY). That means cheap copies of the on-patent drugs could soon hit the Indian market.
The licensing moves apply to Roche's breast cancer behemoth Herceptin, and Bristol-Myers Squibb's leukemia treatment Sprycel and breast cancer therapy Ixempra. It would be the first round of new compulsory licenses since India issued its first in March, on Bayer's kidney cancer treatment Nexavar. Since then, Natco Pharma has been marketing its version at a small fraction of the branded price.
Indian officials and major drugmakers have been wrangling over patent protections and drug prices for years. Just witness Novartis' ($NVS) long fight for patent protection on its blood cancer drug Glivec; after a round of hearings at the Indian Supreme Court in December, the drugmaker can finally expect a ruling.
But the conflict intensified after a series of Indian acquisitions--culminating with Abbott Laboratories' ($ABT) purchase of Piramal's domestic generics business--gave Big Pharma a big chunk of the local market. The intellectual property protections India had adopted to invite foreign investment suddenly seemed less than prescient. Politicians moved into protective mode, citing worries about drug prices and access to treatment.
Coming as it did against the backdrop of the Glivec patent fight, the Nexavar compulsory license came as a shot over the bow at Big Pharma. Some drugmakers--including Roche, ironically enough--slashed prices on certain products, as if to stave off government action. And still the insults kept coming. The Indian patent office revoked IP protection on Pfizer's ($PFE) kidney and liver cancer drug Sutent, and pulled the patent on Roche's hepatitis C treatment Pegasys.
Meanwhile, the courts have dawdled over challenges to generic versions of still-on-patent drugs, including Cipla's unauthorized copy of Nexavar. And though a court supported Roche's patent on the cancer drug Tarceva, it also decided that Cipla's generic version didn't step on that patent. Bristol-Myers is still locked in a fight with would-be copycat Natco Pharma over Sprycel generics.
And now this. Patient advocates--and some domestic pharma executives--hailed the move, saying that compulsory licenses are the only way to get lifesaving cancer treatments to the Indian masses. Generic Nexavar sells at 95% off its precompulsory licensing price, the Indian Express says, and Herceptin, Sprycel and Ixempra are all more expensive than Nexavar ever was.
But Roche has taken its own steps to broaden access to Herceptin. Last March, the Swiss drugmaker inked a deal with India's Emcure Pharmaceuticals to produce Herceptin--and the lymphoma and rheumatoid arthritis treatment MabThera--for sale domestically at lower prices. The first products of that deal, which will sell under new brand names to protect pricing in the developed world, are expected to hit the Indian market this year.
Other pricey therapies may be next to get the compulsory licensing treatment, Indian experts have said. Drug executives have been eyeing Pfizer's Sutent and its HIV drug Selzentry, as well as Roche's Tarceva. In fact, Natco has already said it plans to knock off Selzentry, with plans to sell it for about one-fourth of Pfizer's price. But even worse for Big Pharma is the prospect of other developing markets singing to India's tune. China has already said it's considering compulsory licensing as a way to keep drugs affordable for its citizenry.
