Ignoring Drug Trademarks

Erika Lietzan
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Abstract

If you walk into a pharmacy with a prescription for Merck’s ZOCOR, which contains simvastatin, the pharmacist will probably give you a product containing simvastatin made by another company. The pharmacist will dispense a “generic” simvastatin product. State generic substitution laws, passed in the 1970s to help the government save money by switching patients to cheaper generic drugs, either permit or require this substitution. But drug brand names -- such as ZOCOR -- are trademarks. Like other trademarks, they distinguish goods in the market from others, and they signal the source of the goods. These state laws essentially treat the words as something else. As soon as generic drugs are available, state law instructs the pharmacist to read the brand name -- written by the doctor -- as an instruction to dispense a different company's product. This is the opposite of how trademarks are supposed to operate. This Article examines the history of substitution and drug trademarks over the last century and a half, as well as the relationship between the two, against the backdrop of an evolving drug industry, an evolving drug regulatory framework, and improvements in regulatory science. It shows that the generic drug substitution laws are an anomaly in our legal system. Substitution at the pharmacy was illegal, and it still is otherwise illegal. The substitution laws of the 1970s created an exception in pharmacy law and broke with long-standing policy in food and drug law as well as unfair competition law. This Article also shows that the substitution laws were intended to, and did, undermine proprietary (trademark) rights. This was done to achieve savings for payers, after efforts to mandate generic prescribing failed. As the Article points out, much has changed since the 1970s. The regulatory framework has changed, regulatory science has evolved, drug research and development has evolved, the industries have changed, the healthcare finance system is utterly different, the relationship among parties in healthcare delivery has evolved, and so on. The Article therefore concludes by reconsidering (and criticizing) the exception for generic drug substitution, with the benefit of a clear understanding of the relationship between a brand drug and its generic equivalents and a clear understanding of the role for drug trademark after patents have expired. The exception prioritizes short-term cost savings over the dynamic pro-competitive benefits of a properly functioning trademark system. And although the laws are more than 40 years old, this point is important today, because hostility to drug trademarks and devotion to generic substitution laws inform scholarship and policy proposals today.
忽视药品商标
如果你拿着默克公司(Merck)含有辛伐他汀的ZOCOR处方走进药店,药剂师可能会给你另一家公司生产的含有辛伐他汀的产品。药剂师会开一种“通用”辛伐他汀产品。20世纪70年代通过的州仿制药替代法,通过让患者使用更便宜的仿制药来帮助政府节省资金,允许或要求这种替代。但是药品的品牌名称——比如ZOCOR——是商标。像其他商标一样,它们将市场上的商品与其他商品区分开来,并标志着商品的来源。这些州法律基本上把这些词当成了别的东西。一旦有了仿制药,州法律就会要求药剂师阅读医生写的品牌名称,作为开具不同公司产品的指示。这与商标的运作方式恰恰相反。本文考察了在过去一个半世纪中替代和药品商标的历史,以及在不断发展的药品工业、不断发展的药品监管框架和监管科学不断进步的背景下两者之间的关系。这说明仿制药替代法是我国法律体系中的一种反常现象。药店的替代药物是非法的,在其他方面仍然是非法的。20世纪70年代的代用法在药物法上创造了例外,打破了食品药品法和不正当竞争法的长期政策。本文还表明,代用法意在损害专有(商标)权利,而且确实如此。在强制通用处方的努力失败后,这样做是为了为支付者节省开支。正如文章所指出的,自20世纪70年代以来,情况发生了很大变化。监管框架发生了变化,监管科学发生了变化,药物研发发生了变化,行业发生了变化,医疗保健金融体系完全不同,医疗保健服务各方之间的关系也发生了变化,等等。因此,本文的结论是对仿制药替代的例外进行重新思考(并进行批评),这有利于我们清楚地认识品牌药与其仿制药等同物的关系,以及清楚地认识专利过期后药品商标的作用。例外优先考虑的是短期成本节约,而不是正常运作的商标制度所带来的动态的促进竞争的好处。尽管这些法律已有40多年的历史,但这一点在今天仍然很重要,因为对药品商标的敌意和对通用替代法的热爱影响着今天的学术和政策建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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