2014年11月3日讯 /生物谷BIOON/ --近日，印度第四大仿制药商——西普拉（Cipla）已请求印度政府撤销瑞士制药巨头诺华（Novartis）持有的慢性阻塞性肺病（COPD）药物Onbrez的5项专利，同时已推出售价仅Onbrez五分之一的仿制药，品牌名为Unibrez，以满足印度本土市场的需求。此举将触发印度仿制药商与跨国创新药企之间又一次冲突。
印度仿制药商和跨国创新药企之间不断扩大的矛盾可追溯到几十年前，而Cipla的举动很可能开辟新的战线，或将成为类似案例的代表，打开“潘多拉魔盒”。印度政府将被迫留意所有此类情况——即跨国药企持有药品专利但不推出或仅出售很少量的品牌药，同时政府部门将不得不就如何监察相关情况给出一个明确的立场。
诺华手握专利6年，不在印度生产且进口药量少到“可忽略不计”
Cipla已要求印度工业政策与促进部(DIPP)撤销Onbrez的5项专利，理由是诺华自2008年持有这些专利至今已6年之久，非但没有在印度本土生产该药，所进口的药量简直“可以忽略不计”，导致印度市场Onbrez严重短缺。
Cipla指控称，诺华每年进口药量仅54000个单位，这点药物甚至不能满足4500例患者，而据反馈显示，印度有1500万患者需要Onbrez，诺华的行为直接剥夺了99.9%印度患者的迫切需求。因形势所迫，Cipla已在印度推出Onbrez仿制药。Cipla表示，公司有能力生产足够数量的仿制药满足印度本土市场。
有分析师认为，Cipla的行动可能导致2家公司之间长期的法律纠纷。印度DIPP一位高级官员称，Cipla根据印度专利法第66条提交了关于撤销诺华Onbrez相关专利的诉讼，该条法律条文赋予了印度政府撤销具有重大公众利益的药品专利的权利。
关于强仿，仿制药商称正当行使权力，印度政府称专利法符合国际要求
一家跨国药企的高级行政官表示，政府不能强迫制药公司在任何一个市场出售产品。决定药物是否推广需要考虑许多因素，其中包括商业原因。印度仿制药公司利用该国薄弱的专利法，强仿品牌药，剥夺了创新药企的正当利润。
而印度仿制药商认为，它们是在法律范围内行使权力，通过生产廉价仿制药，不仅能够保持国内及世界其他地区相对较低的药品价格，还能够降低医疗成本。同时，印度政府声称，印度专利法符合国际要求，其制定旨在满足可用性（availability）、可及性（accessibility）和可负担性（affordabability）三大目标。
去年，印度最高法院驳回了诺华寻求保护新型抗癌药格列卫（Glivec）专利的请求，并允许印度本土制药商Cipla和Natco公司以远低于格列卫品牌药的价格出售仿制药。
美国贸易代表办公室（USTR）表示，印度对药品专利审批的限制以及放开专利药仿制计划，为一些创新药企带来了严峻挑战。上个月有消息传出，新德里正在研究一种新的知识产权政策，而印度政府也将成立一个智囊团，对全球知识产权问题提供建议。
多起纠纷正在印度法院上演
很多专利纠纷最终付诸于法庭，行业专家预计，诺华将采取法律手段制裁Cipla强仿Onbrez的行为。目前，有多起专利纠纷正在印度法院上演，包括：Cipla对决罗氏——强仿肺癌药物特罗凯（Tarceva）；Natco对决百时美施贵宝——强仿抗癌药Sprycel（达沙替尼），Glenmark及其他5个仿制药商对决默沙东——强仿糖尿病药物Januvia（西他列汀）。
（原标题：诺华印度再遇知识产权危机，Cipla要求撤销肺病药物Onbrez 5项专利，允许强仿）
英文原文：Cipla asks India to revoke Novartis patents on respiratory drug
MUMBAI (Reuters) - Generic drugmaker Cipla Ltd said on Thursday it has asked the Indian government to revoke five patents held by Swiss firm Novartis AG on respiratory drug Onbrez and has launched a cheaper copy to boost access in the local market.
Cipla alleged that Novartis has had patents on the medicine since 2008 but instead of producing it in India has imported a "negligible quantity" from Switzerland, leading to a shortage of supplies in the Indian market.
Big international pharma companies have been hit by wide-ranging government-imposed price cuts and legal battles over patent protection in recent years in India, a vital growth market.
Cipla, India's fourth-largest drugmaker by revenue, said because there was an urgent but unmet need for the respiratory treatment in India it has started to sell a copy of the drug in Delhi priced at a fifth of the cost of Novartis's product.
"Cipla believes that it has the potential to manufacture adequate quantities of the drug and make the same available in the country," the company said in a statement, confirming its request to the government for the patents to be revoked.
A spokeswoman for Novartis in Zurich said the company had not received any notice from regulatory or other authorities about the issue.
Cipla's action is likely to result in a prolonged legal battle between the two companies, analysts said.
A senior official at the Indian government's Department of Industrial Policy and Promotion said Cipla's filing about Novartis's patents was made under Section 66 of the Indian Patents Act.
The section grants the Indian government the power to revoke a patent in the public interest, after giving the patent holder an opportunity to explain why it should not be revoked, said the official, who declined to be named.
Onbrez, chemically called indicaterol, is used to treat breathing problems associated with chronic obstructive pulmonary disease (COPD). Cipla estimates more than 15 million Indians are afflicted with the disease.
Novartis has been particularly vocal in its criticism of India's patent laws after the country's Supreme Court last year denied the company a patent on its cancer drug Glivec, allowing Indian firms to launch cheaper copies.
The United States Trade Representative (USTR) said this year India's limits on the approval of pharmaceutical patents and its plan to open patented drugs to generic makers created "serious challenges" for some innovators.
New Delhi is working on a new intellectual property policy, and the government will also set up a think-tank to advise it on global intellectual property issues, Trade Minister Nirmala Sitharaman said last month.