印度專利法規惹惱藥業巨頭

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.

在印度藥品市場，一場衝突在所難免。外國製藥商，面對西方國家市場的龜速增長，正對印度市場垂涎三尺。諮詢公司普華永道（PwC）估計，印度國民收入的增長和慢性疾病發生率的居高不下可能將藥品年銷售額從2010年的120億美元推高到2020年的740億美元。但想從高增長率中掘金得先獲得保護知識產權的專利。印度有着生機勃勃的非專利藥業，其仿製藥的市場佔有率高達90%。印度的藥物專利法7年前剛剛頒發。印度政府熱衷於支持非專利藥業，以保持藥品的低價。

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.

現在，考驗印度專利法的時候來了。瑞士巨頭諾華製藥質疑印度拒絕授予Glivec專利的決定，Glivec是該公司突破性的抗癌藥。9月11日印度高等法院將開庭審理此案。德國藥企拜爾正面臨另一個問題：今年3月印度專利監察員命令其向當地藥企許可一種藥品。拜耳申訴的第一次聽審於9月3日舉行。這起官司將會決定印度12億人口多久能以多少價格得到新藥。

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.

印度的藥業有一段獨特的歷史。30多年以來，印度不承認藥品專利。國內企業精於廉價生產仿製藥品。在1995年加入世貿組織（WTO）後，印度不得不修改其專利政策。但自2005年起實施的新系統包括了對病人和非專利藥企的特殊保護。

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，該法規定，對現有藥品進行的小改動不算專利。對現有藥品進行小改動的做法在業內叫作"常青"。爲了將專利延伸到其他國家，藥企經常對藥品的配方進行更改；這個做法在印度不受保護。印度"強制許可"包括的範圍也很廣。WTO協議允許各國在一些情況下強迫企業向非專利藥企許可專利藥品。印度的法規賦予政府很大的權力進行"強制許可"。

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.

現在這兩項規定都受到抨擊。2006年印度拒絕向諾華公司授予Glivec的專利，稱其是對現有物質伊馬替尼（imatinib）的不可申請專利的修正。諾華公司堅持認爲這是胡說八道。諾華公司只是將其做成鹽的形式甲磺酸伊馬替尼（imatinib mesylate）以發揮藥效：使人體吸收藥物容易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.

諾華熱帶疾病研究所主席Paul Herrling說這起官司將檢驗什麼藥品在印度可以申請專利。"我們被控告常青，"他說。"Glivec是抗癌治療的重要突破之一，將那個概念用在Glivec上真是荒唐。" 非營利機構醫生無國界的Michelle Childs反駁到，諸如諾華這樣的藥企不應贏得藥品微小改進的專利。這將使非專利藥退出市場，擡高藥價。

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.

拜爾的官司同樣引發關注。2008年，拜爾贏得腎癌藥Nexavar的印度專利。但今年3月，印度專利監察員簽發了該國的第一張強制許可。該監察員寫到拜爾沒有讓Nexavar處於"在合理的可承擔價位"（一個月的用量拜爾開價高達5000美元），且拜爾對該藥的產量不足，並且，從貿易保護這點看，進口該藥進一步使拜爾處於不利地位。監察員命令印度公司Natco以拜爾公司要價的1/13銷售Nexavar。拜爾將得到6%的使用費。與此同時，拜爾正在和另一個競爭對手Cipla打官司，該公司已經銷售非專利的Nexavar好幾年了。

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.

隨着這些官司越拖越久，印度政府正在考慮其他獲得更低廉藥品的方法。該國政府計劃向公立醫院提供免費非專利藥，這將大幅提升廉價仿製藥的銷售。政府還可能制定專利藥品的價格控制。但是，非專利藥企並非沒有監管壓力。部長們計劃擴大價格控釋的範圍，以包括大量的非專利藥。

Cost versus innovation

要價格低廉還是要科學創新

"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.

印度藥企聯盟的D.G. Shah解釋到："我們意識到行業會受到打擊。"該聯盟代表了大型非專利藥企的利益。"我們正在尋求一種解決方案，以在不威脅藥業長期增長的情況下解決政府對病人能否買到及是否買得起藥品的擔憂。"如果他們能找到這種解決方案，那真是不錯。