华盛顿邮报：专利从来不是奖励研发失败的
编者按：在拜登新政府还未任命美国专利商标局局长之前，各方游说力量显然在加强。华盛顿邮报近期刊登的一篇对大型制药企业借助专利制度攫取垄断利润，却将药品成本高涨的原因归结于新药研发需要面临大量失败上，这引发了作者对于专利制度与制药行业当前实际情况的讨论。这篇文章相信会引起非常广泛的讨论，但是在拜登希望未来药品降价的背景下，是否也隐含了某种政治信号，不得而知，未来会给美国的制药行业带来哪些影响，我们拭目以待。现编译本文以飨读者，因为写的太好了，原文附在文后。
专利应该激励成功。在200多年的时间里，它们已成为推动社会进步的重要工具，鼓励发明者创造和分享成功的创新，以换取在有限时间内将他人排除在市场之外的权利。
然而今天专利法并不是这样运作的。相反，我们面临着激励失败的风险。法院、国会和董事会正在推进一种简单的逻辑，这一逻辑改变了专利制度。其后果体现在制药行业，该行业利用成功药物的专利作为工具，以弥补公司因其他研究不成功而蒙受的损失。更糟糕的是，专利已经成为一种在市场上获得长期垄断的方式，这种垄断远远超出了药物本身的范围。
例如,强生公司的报告他认为，一种药物的成本不仅应反映与该药物相关的研究成本，而且还应包括“研发失败的候选药物”的费用。该公司认为，“制药公司和科学界的其他成员可以从这些失败中吸取教训，以改进研究过程”，这意味着消费者应该为这些失败付出代价。报告的方法概括了制药业如何为药品的高价格辩护。
但是，尽管科学可能从失败中吸取教训，但这与专利或它们打算做什么无关。事实上，对失败的研究进行补偿的整个概念使现代专利法的应用与专利的历史和理论发生了冲突，可以追溯到这个国家成立之初。
专利制度旨在奖励成功。一个人的尝试或失败的创造将获得不了一个发明的专利。同样，专利的奖励反映了成功的发明，而不是对其他失败尝试的补偿。
建国以来的情况就是如此。1790年，国会颁布了第一项专利法规，乔治·华盛顿签署了第一项美国专利，该专利由塞缪尔·霍普金斯(Samuel Hopkins)负责制造钾肥。从那时起-并通过多次重复专利法规-法律一直要求专利持有人披露他们的发明，以便那些“精通这项技术”的人能够在专利过期后制作和使用。专利交易的双方--社会的和发明者的--都被严格和谨慎地限制在专利权人可以证明已经创造的精确的发明上。
事实上，在1790年至1865年期间，没有一个专利法或法院案例说明或甚至表明专利授予是为了补偿专利权人开发一项失败的（即从未获得专利的）发明的费用。事实上，除了有限的例外情况外，早期专利法甚至没有建议专利应补偿开发专利的成本。成功发明专利，更不用说超出专利发明的成本了。这是为这项发明授予知识产权。
20世纪30年代和40年代，法院制定了禁止滥用专利的法律原则，广义上定义为不允许扩大专利时间或范围。目的是确保国家专利法不提供违反反垄断法的通行证。因此，当专利持有人试图将其专利权扩大到专利的范围之外时，它的行为是不适当的。
所有这一切都表明，专利制度有多么严格地依附在专利中披露的发明的具体界限，而不涉及其他研究的成本。
2006年，当“医疗现代化法案”生效时，这一切都发生了变化，为处方药提供了全面的医疗保险。随着市场的扩大和安全，制药公司开始提高现有和新药物的价格。为了证明不断飙升的价格点是合理的，企业需要一种方法来使它们的高利润率合法化。补偿失败的药物--那些没有上市的药物--符合要求。
为了在一段时间内保持较高的价格，公司不得不将更便宜的竞争对手排除在市场之外，包括通过专利制度的反竞争博弈。任何遏制这种行为的尝试，直到今天，都会遇到这样的论点，即该系统应该为那些从未上市的药品公司提供补偿。
乍一看，确保回报包括失败的代价似乎是合乎逻辑的。毕竟，如果一个人想让发明家投资于新的研究，那么回报难道不应该足够大来弥补失败的漫长而寒冷的冬天所带来的痛苦吗？
然而，尽管这一概念听起来很有吸引力，但允许专利制度补偿失败的代价，会产生一种反常的影响，尤其是当工业界利用专利制度游说扩大专利保护的时候。争论已经变成：我们需要更多地推迟竞争，这样我们就可以收取更多的费用来弥补过去的失败。但这扭曲了专利的目的：鼓励公司取得成功，并以尽可能高效的方式。如果专利奖励失败，那么一家公司失败的次数越多，当他们成功的时候，垄断的时间就越长，范围也就越广。但是为什么我们想要一种专利制度是在当他们较少成功的时候给予他们更多的奖励呢？
在一个完美的世界里，人们可能会期望购买者在这个系统上创造一个中立的制动。理论上，除非买家愿意支付，否则不能收取价格。然而，医疗保健是一个奇怪的市场。病人可能会服用这种药物，但是医生们负责选择药物，而且大部分的费用都是由保险支付的。因此，消费者没有充分的信息，也不承担全部的费用负担。此外,药品审批报销制度中的现代战略行为可以削弱竞争，否则可能会阻止制药公司提高价格，不受挑战。因此，限制价格的正常压力在处方药市场上受到了抑制。
鉴于过去十年制药业的历史性转变，激励失败尤其成问题。面对停滞不前的研究成果，该行业已转向外包创新。具体来说，制药行业的大部分创新来自学术界或小型生命科学公司。然后，大型制药公司通过FDA的批准程序将这些药物引导进入生产阶段。因此，最终，大公司--那些通过高额专利回报为失败寻求补偿的公司--并不是那些为药物开发承担最大风险的公司。相反，他们在玩弄专利制度：维持高价格，并通过专利保护将竞争对手拒之门外。
想想吉列的丙型肝炎治疗药物，Sovaldi。该公司仅在销售的第一年就收回了开发药物的成本。五年后，该公司从这种药物的销售中获得了超过580亿美元的收益，这是它从一开始就获得这种药物的5倍多，该公司承担了最初的风险并进行了创新。或者考虑默克的免疫治疗药物Keytruda。仅在2020年，这种药物的销售额就超过了140亿美元，没有下降的迹象。“福布斯”估计Keytruda的价值为2,000亿美元，与3亿美元收购的价格相差甚远。
而Keytruda的专利之船将公司的定价方案与竞争隔离开来。然而，真正的创新者--也就是承担研究风险的公司--并不是获得最大回报的公司。更确切地说，专利奖励的大部分流向了走了最后一英里的公司。
这些例子表明，现代制药市场是如何允许大公司获得超额回报的，而创新者则是如何得到奖励不足的。如果社会真的想要一个对失败进行补偿的专利制度，那么这些钱就会流向那些对研究进行投资并冒失败风险的人--发明家。这一切在这里都没有发生。相反，通过将如此少的利润传递给那些成功的研究人员，这个系统会冲淡研究的动机。我们不仅仅是在激励失败，我们还把这些钱送到了创新链中最不具创造性的部分。
简而言之，激励失败和这句话听起来一样适得其反。为什么我们想要一个专利制度，让效率较低的人--一路上失败更多的人--得到更大的回报？除非我们认识到这个问题，否则国家可能会发现自己悄悄地陷入了一种自古以来就破坏专利制度轮廓的做法，阻碍了我们在关键领域创新的能力。
Our patent system is broken. And it couldbe stifling innovation.
Patents were never supposed to rewardfailure
Patents are supposed to incentivizesuccess. Across more than 200 years, they have emerged as an important tool foradvancing society by encouraging inventors to create and share successfulinnovations, in exchange for the right to exclude others from the market for alimited period of time.
And yet that’s not how patent law workstoday. Rather, we are at risk of incentivizing failure. The courts, Congressand boardrooms are advancing a simple logic that turns the patent system on itshead. The consequences are on display in the pharmaceutical industry, whichuses patents on successful drugs as vehicles to compensate for the lossescompanies incur when other research doesn’t pan out. Even worse, patents havebecome a way to gain an extended monopoly in the marketplace, one that reachesfar beyond anything related to the drug itself.
For example, a Johnson & Johnson reportargues that the cost of a drug should not only reflect research costs relatedto that drug, but also should include expenses from “drug candidates that failin development.” The company contends that “pharmaceutical companies and therest of the scientific community can learn from these failures to improve theresearch process,” suggesting that consumers should pay for these failures. Thereport’s approach epitomizes how the pharmaceutical industry justifies highprices for medication.
But while science may learn from failures,that has nothing to do with patents or what they’re intended to do. In fact,the entire notion of compensating for failed research puts the modernapplication of patent law on a collision course with the history and theory ofpatents, reaching back to this nation’s inception.
The patent system is designed to rewardsuccess. One does not receive a patent for an invention one tried and failed tocreate. Similarly, a patent’s reward reflects the successful invention, ratherthan compensation for other attempts gone bad.
And that has been the case since thenation’s founding. In 1790, Congress enacted the first patent statute andGeorge Washington signed the first U.S. patent, which went to Samuel Hopkinsfor an invention related to making potash. Since that time — and throughvarious iterations of the patent statute — the law has consistently requiredpatent holders to disclose their invention so that those “skilled in the art”can make and use it after the patent has expired. Both sides of the patent deal— society’s and the inventor’s — are strictly and carefully limited to theprecise invention that the patentholder can prove to have created.
In fact, there was not a single patent lawor court case between 1790 to 1865 stating or even indicating that a patentgrant was intended to compensate the patentee for the costs of developing afailed (that is, never-patented) invention. Indeed, with limited exceptions,early patent law does not even suggest that a patent should compensate for thecosts of developing the successful invention being patented, let alone costsbeyond the patented invention. It was about granting intellectual property forthat invention.
During the 1930s and 1940s, the courtsdeveloped a doctrine of law prohibiting patent misuse, which is broadly definedas an impermissible attempt to expand the time or scope of a patent. The goalwas to ensure that the nation’s patent laws did not provide a pass forviolating antitrust law. And so, when a patent holder tries to extend itspatent power outside the bounds of the patent, it acts improperly.
All of this shows how closely the patentsystem has clung to the specific boundaries of the invention disclosed in thepatent, while not concerning itself with costs of other research.
This all changed in 2006, when the MedicareModernization Act went into effect, providing full Medicare coverage forprescription drugs. With a vastly expanded and secure marketplace,pharmaceutical companies began raising prices on existing and new medications.To justify soaring price points, companies needed a way to legitimize theirhigh profit margins. Compensating for the failed drugs — the ones that didn’tmake it to market — fit the bill.
To maintain those high prices across time,companies had to keep cheaper competitors out of the market, including throughanticompetitive gaming of the patent system. Any attempt to rein in such behavior,to this day, is met with the argument that the system should compensate thecompanies for drugs that never made it to market.
Ensuring that rewards cover the costs offailure might appear logical at first glance. After all, if one wants inventorsto invest in new research, shouldn’t the payoff be large enough to compensatefor the pain of slogging through the long, cold winters of failure?
As appealing as the concept may sound,however, allowing the patent system to compensate for the cost of failures hasa perverse effect, particularly when industry uses it to lobby for expansion ofpatent protection. The argument has become: We to need to hold off competitionmore, so that we can charge more to compensate for past failures. But thatdistorts the purpose of a patent: encouraging companies to succeed — and in themost efficient manner possible. If patents reward failure, then the more acompany fails, the longer and broader of a monopoly they’ll need when they dosucceed. But why would we want a patent system that rewards companies more whenthey are less successful?
In a perfect world, one might expectpurchasers to create a natural brake on the system. In theory, one cannotcharge a price unless buyers are willing to pay. Health care is a strangemarket, however. Patients may consume the medication, but doctors are in chargeof choosing it, and insurance pays for much of it. As a result, consumers donot have full information and do not bear the full burden of the costs. Inaddition, modern strategic behaviors in the drug approval and reimbursementsystem can diminish the competition that might otherwise prevent drug companiesfrom raising prices unchallenged. Thus, the normal pressures that would limitprices are dampened in the market for prescription medicine.
Incentivizing failure is particularlyproblematic in light of a historic shift in the pharmaceutical industry overthe past decade. Faced with stagnating research results, the industry hasshifted to outsourcing innovation. Specifically, the majority of innovation inthe pharmaceutical industry comes from academia or from small life-sciencecompanies. Large pharmaceutical companies then shepherd the drugs through theFDA approval process and into production. And so, at the end of the day, thebig companies — the ones arguing for compensation for failure through hefty patentreturns — are not the ones taking the greatest risks for drug development.Rather, they are gaming the patent system: maintaining high prices and keepingcompetitors out with patent protections.
Consider Gilead’s hepatitis C cure,Sovaldi. The company more than recouped what it paid for the drug in the firstyear of sales alone. And after five years, the company reaped in excess of $58billion dollars from sales of the drug, more than five times what it paid toacquire the drug from the start-up that took the initial risk and engaged inthe innovation. Or consider Merck’s immunotherapy drug, Keytruda. In 2020alone, the drug’s sales topped $14 billion, with no signs of flagging. Forbesestimates that the value of Keytruda is $200 billion — a far cry from the $300million the company paid to acquire it.
And Keytruda’s boatload of patentsinsulates the company’s pricing scheme from competition. Yet the true innovator— that is, the company that took the research risk — isn’t the one reaping thelion’s share of the reward. Rather, the bulk of the patent reward is going tothe company that walked the last mile.
Examples such as these show how modernpharmaceutical markets allow large companies to be over-rewarded whileinnovators are under-rewarded. If society actually wanted a patent system thatcompensates for failure, the dollars would go to those who make the investmentin the research and take the risk of failure — the inventors. None of that ishappening here. Instead, by passing so little of the profit to those whoperform the successful research, the system dilutes the incentive for research.We are not just incentivizing failure, we are sending those dollars to theleast inventive part of the innovation chain.
In short, incentivizing failure is ascounterproductive as the phrase sounds. Why would we want a patent system inwhich the less efficient person — the one who fails more along the way — gets alarger reward? Unless we recognize that problem, the nation may find itselfsliding quietly into an approach that undermines the contours of the patent systemfrom time immemorial, hampering our ability to innovate in crucial areas.