A CLASH over India's drug market was inevitable. Foreign drugmakers, facing paltry growth in the West, are eyeing India hungrily. Rising incomes and rates of chronic Disease may push sales from $12 billion in 2010 to $74 billion in 2020, according to PwC, a consultancy. But tapping this growth means having patents that protect intellectual property. India is home to a thriving generics industry, whose copycat drugs make up about 90% of the market. India's drug-patent laws are just seven years old. Its government is keen to encourage generics and keep prices down.
在印度药品市场，一场冲突在所难免。外国制药商，面对西方国家市场的龟速增长，正对印度市场垂涎三尺。咨询公司普华永道（PwC）估计，印度国民收入的增长和慢性疾病发生率的居高不下可能将药品年销售额从2010年的120亿美元推高到2020年的740亿美元。但想从高增长率中掘金得先获得保护知识产权的专利。印度有着生机勃勃的非专利药业，其仿制药的市场占有率高达90%。印度的药物专利法7年前刚刚颁发。印度政府热衷于支持非专利药业，以保持药品的低价。Now India's patent rules are being put to the test. Novartis, a Swiss giant, is challenging India for denying a patent for Glivec, its blockbuster cancer drug. The fight is due to reach India's Supreme Court on September 11th. Bayer, a German drugmaker, has a different problem: in March India's patent controller ordered it to license a drug to a local manufacturer. Its appeal had its first hearing on September 3rd. The cases will help decide how quickly India's 1.2 billion people get new drugs, and at what price.
现在，考验印度专利法的时候来了。瑞士巨头诺华制药质疑印度拒绝授予Glivec专利的决定，Glivec是该公司突破性的抗癌药。9月11日印度高等法院将开庭审理此案。德国药企拜尔正面临另一个问题：今年3月印度专利监察员命令其向当地药企许可一种药品。拜耳申诉的第一次听审于9月3日举行。这起官司将会决定印度12亿人口多久能以多少价格得到新药。India's drug industry has a unique history. For more than 30 years, the country did not recognise pharmaceutical patents. Domestic firms became masters at copying medicine and making it cheaply. After joining the World Trade Organisation (WTO) in 1995, India had to change its patent policy. But its new system, in place since 2005, includes special protections for both patients and generic manufacturers.
印度的药业有一段独特的历史。30多年以来，印度不承认药品专利。国内企业精于廉价生产仿制药品。在1995年加入世贸组织（WTO）后，印度不得不修改其专利政策。但自2005年起实施的新系统包括了对病人和非专利药企的特殊保护。
For example, the law bars patents of minor changes to existing drugs, a practice known as "evergreening". Drug reformulations are often used to extend patents elsewhere; they get no protection in India. The country also has broad criteria for "compulsory licensing". A WTO agreement allows countries, in some instances, to force a firm to license a patented drug to a generic company. India's rules give officials broad powers to do this.
例如，该法规定，对现有药品进行的小改动不算专利。对现有药品进行小改动的做法在业内叫作"常青"。为了将专利延伸到其他国家，药企经常对药品的配方进行更改；这个做法在印度不受保护。印度"强制许可"包括的范围也很广。WTO协议允许各国在一些情况下强迫企业向非专利药企许可专利药品。印度的法规赋予政府很大的权力进行"强制许可"。Now both provisions are under attack. In 2006 India denied Novartis a patent for Glivec, calling it an unpatentable modification of an existing substance, imatinib. Novartis insists this is nonsense. Only by making it in salt form, imatinib mesylate, did Novartis have a proper drug: the body absorbed the medicine 30% more easily.
现在这两项规定都受到抨击。2006年印度拒绝向诺华公司授予Glivec的专利，称其是对现有物质伊马替尼（imatinib）的不可申请专利的修正。诺华公司坚持认为这是胡说八道。诺华公司只是将其做成盐的形式甲磺酸伊马替尼（imatinib mesylate）以发挥药效：使人体吸收药物容易30%。Paul Herrling, the chair of Novartis's Institute for Tropical Diseases, says the case is a test of what is patentable in India. "We are being accused of evergreening," he says. "Having that concept applied to Glivec, which was one of the major breakthroughs in cancer therapies, is completely ridiculous." Michelle Childs of Médecins Sans Frontières, a non-profit, retorts that drug firms such as Novartis should not win patents for minor improvements. This would keep generics off the market, driving up prices.
诺华热带疾病研究所主席Paul Herrling说这起官司将检验什么药品在印度可以申请专利。"我们被控告常青，"他说。"Glivec是抗癌治疗的重要突破之一，将那个概念用在Glivec上真是荒唐。" 非营利机构医生无国界的Michelle Childs反驳到，诸如诺华这样的药企不应赢得药品微小改进的专利。这将使非专利药退出市场，抬高药价。Bayer's case is equally heated. In 2008 it won an Indian patent for Nexavar, a kidney-cancer drug. But in March India's patent controller issued the country's first compulsory licence. He wrote that Bayer had not made Nexavar "reasonably affordable" (Bayer offered it for a whopping $5,000 a month), that the company failed to provide enough of the drug and, in a protectionist nod, reckoned that importing Nexavar further hurt Bayer's case. The controller ordered an Indian company, Natco, to sell Nexavar for one-thirtieth of Bayer's price. Bayer will receive a 6% royalty. Meanwhile Bayer is fending off another competitor, Cipla, which has sold generic Nexavar in India for years.
拜尔的官司同样引发关注。2008年，拜尔赢得肾癌药Nexavar的印度专利。但今年3月，印度专利监察员签发了该国的第一张强制许可。该监察员写到拜尔没有让Nexavar处于"在合理的可承担价位"（一个月的用量拜尔开价高达5000美元），且拜尔对该药的产量不足，并且，从贸易保护这点看，进口该药进一步使拜尔处于不利地位。监察员命令印度公司Natco以拜尔公司要价的1/13销售Nexavar。拜尔将得到6%的使用费。与此同时，拜尔正在和另一个竞争对手Cipla打官司，该公司已经销售非专利的Nexavar好几年了。As these cases drag on, India's government is considering other ways to get cheaper medicine. It plans to offer free generics in public hospitals, which would drive up sales of very cheap copies. It may also set price controls for patented drugs. However, generic companies are not immune to regulatory pressure. Ministers plan to expand price controls for a broader swathe of generics.
随着这些官司越拖越久，印度政府正在考虑其他获得更低廉药品的方法。该国政府计划向公立医院提供免费非专利药，这将大幅提升廉价仿制药的销售。政府还可能制定专利药品的价格控制。但是，非专利药企并非没有监管压力。部长们计划扩大价格控释的范围，以包括大量的非专利药。Cost versus innovation
要价格低廉还是要科学创新"We realise the industry will take a hit," explains D.G. Shah of the Indian Pharmaceutical Alliance, which represents big generic companies. "We're trying to find a solution so that the government's concerns on access and affordability are addressed without threatening the long-term growth of the pharmaceutical industry." Nice work, if they can get it.
印度药企联盟的D.G. Shah解释到："我们意识到行业会受到打击。"该联盟代表了大型非专利药企的利益。"我们正在寻求一种解决方案，以在不威胁药业长期增长的情况下解决政府对病人能否买到及是否买得起药品的担忧。"如果他们能找到这种解决方案，那真是不错。