India Case Pits Patients Against Patents
照顧病人或尊重藥品專利 印度兩難
By Vikas Bajaj and Andrew Pollack

MUMBAI, India – India has become the largest provider of cheap, lifesaving medicines in poor countries worldwide.
對世界各地的窮國而言，印度已經成為便宜救命藥品的最大供應國。

But most of that medicine has been generic copies of brand-name drugs protected by patents in Europe and the United States. Now a big Swiss drug company, Novartis, may force the Indian government to recognize a patent for a cancer treatment seen as a breakthrough for people with a deadly form of leukemia.
這些藥品多為在歐美受專利保護的品牌藥的學名藥。現在瑞士的諾華大藥廠也許會迫使印度政府承認一種癌症藥的專利權，此藥被視為治療一種致命性血癌的重大突破。

The case, involving the drug Gleevec, is before the Indian Supreme Court. It represents a highstakes showdown between defenders of intellectual property rights, who say the generic knockoffs stifle innovation by drug makers, and Indian drug companies and international aid groups, who warn that a ruling in favor of Novartis could dry up the global supply of inexpensive medicines to treat AIDS, cancer and other diseases.
抗癌藥「基利克」的官司已上訴到印度最高法院，是智慧財產權捍衛者與印度藥廠和國際救援組織間高賭注的對決。前者說仿冒的學名藥扼殺了藥廠的新藥發明。後者警告道諾華勝訴會使治療愛滋病、癌症和其他疾病的便宜藥物全球供應枯竭。

“There will be nothing left to defend if we lose,” said Leena Menghaney, a manager based in New Delhi for Doctors Without Borders, which advocates for generic drugs.
力挺學名藥的「無國界醫師」組織印度執行長麗娜．曼加內說：「輸掉官司，我們可就沒啥好捍衛了。」

The Indian government denied the patent for Gleevec, as it has for many other drugs made by many Western drug makers. Novartis sued, and the case has been going on for six years. The government is under some pressure from its trading partners to relent in the dispute.
印度政府不承認基利克的專利權，一如一向不承認許多西方藥廠製造的許多其他藥品的專利。諾華提出告訴，官司已纏訟六年。印度政府受到貿易夥伴國的壓力，要求它採寬容立場。

The decision could help determine how much Western drug companies invest in India at a time when they want to increase sales in emerging markets.
此際西方藥廠正想在新興市場擴張，裁決結果對這些藥廠決定在印度投資多少金額會有影響。

Gleevec can cost $70,000 a year in the United States, though the company says it has discount programs for poor patients. Indian generic versions cost about $2,500 a year.
在美國，癌症病患使用「基利克」每年花費可達七萬美元，不過諾華表示會給窮人折扣。使用印度學名藥每年花費則約為2500美元。

The drug, sold outside the United States as Glivec and known generically as imatinib mesylate, has turned deadly chronic myelogenous leukemia into a manageable chronic disease for many. It is also used to treat a form of gastrointestinal cancer.
此藥在美國國外以專利藥品名「基利克」出售，學名為imatinib mesylate（一種甲磺酸鹽），能將讓許多病患致命的慢性骨髓性白血病變成可控制的慢性疾病，也用於治療一種胃腸道癌症。

India is the world’s third-largest drug producer by volume and exports about $10 billion worth of generic medicines every year, more than any other country, primarily selling to other developing countries that are expected to become significant new markets for big drug companies.
以量計印度是全球第三大製藥國，每年出口100億美元學名藥，居全球之冠，主要賣到其他開發中國家，而這些國家可望成為大藥廠的重要新市場。

Doctors Without Borders says that 80 percent of the generic AIDS drugs it supplies to an estimated 170,000 people are made in India.
「無國界醫師」組織表示，該組織約為17萬人提供愛滋病學名藥，有八成在印度製造。

The case in India involves a section in India’s patent law that prohibits a newer form of a known substance from receiving a patent unless it significantly improves the medicine’s effectiveness. The standard was aimed at preventing “evergreening,” in which a company makes minor changes to existing drugs and earns new patents, providing many more years of protection from generic competition.
此案涉及印度商標法部分條文，其中載明一種已知物質不得以新形式再次取得專利，除非它能使藥品療效大增。如此規定旨在防止「萬年專利」手法，也就是藥廠將藥品做些微改變後又取得專利，再獲多年專利保護以阻擋學名藥的競爭。

“The implications of the case go to all medicines,” said Brook K. Baker, a professor of law at Northeastern University in Boston. “The question is, Do you get one patent monopoly for the basic ingredient or do you keep tweaking it to get more patents?”
波士頓東北大學法律教授貝克說：「這件案子涉及所有藥品。關鍵在於，究竟一種基本成分只能得到一次壟斷專利權，還是可以不斷稍加改變而一再取得專利？」

Professor Baker said a victory for Novartis would not shut off the production of generic Gleevec or of other existing generics, but could impede the ability of Indian manufacturers to develop generic versions of future drugs.
貝克說，諾華勝訴不會使基利克學名藥或其他現有學名藥的生產停擺，但可能損及印度藥廠發展未來新藥學名藥的能力。

Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group in New York that works on patent cases to foster access to drugs, said many drugs for AIDS and other diseases have been denied patents in India because of the clause and manufacturers might benefit from a Novartis victory. Gilead Sciences, for instance, is appealing India’s rejection of a patent application for its drug Viread, which is used to treat H.I.V. infection. And Roche is fighting several court cases to uphold its patent on the anticancer drug Tarceva, which Indian drug makers argue does not meet the effectiveness standard.
紐約的「藥品普及與知識計畫」是致力於專利案件以促使藥品普及化的組織，理事艾敏說，許多愛滋病和其他病的藥因這個條文而無法在印度取得專利，諾華若勝訟，原廠商可獲利。例如，吉利德科學公司因印度政府駁回愛滋病毒感染藥「惠立妥」的專利申請正在上訴。羅氏大藥廠也在打幾個官司以捍衛抗癌藥「得舒緩」的專利權。印度藥廠指陳「得舒緩」療效未達標準。

Shamnad Basheer, a law professor who has filed a friend of the court brief suggesting ways to clarify the effectiveness standard, said both sides have valid points. Mr. Basheer, a professor at the West Bengal National University of Juridical Sciences in Kolkata, said the court should “interpret the law in a way that balances the need for innovation against public health concerns.”
加爾各答國立西孟加拉法科大學法律教授巴希爾已提出「法庭之友」（與案件無涉、向法官提供專業意見的第三者）簡報，建議一些明定藥效標準的方式。他說，雙方都言之有理。他說，法院應該「以能在鼓勵創研與滿足公衛需求之間取得平衡的方式解釋法律。」

原文參照：
http://www.nytimes.com/2012/03/07/business/global/indias-supreme-court-to-hear-long-simmering-dispute-on-drug-patents.html

2012-03-20聯合報/G9版/UNITEDDAILYNEWS 田思怡譯 原文參見紐時週報七版左