拜登短视的专利攻击威胁美国创新
【中美创新时报2024年6月9日编译讯】（记者温友平编译）拜登政府正在悄悄推进一项可能摧毁美国高科技经济的提案。白宫表示，该计划旨在“击败大型制药公司”。但实际上，它将摧毁各个领域的投资。对此，《国会山报》（The Hill）发表了保罗·R·米歇尔（Paul R. Michel）的如下观点述评。
该提案在功能上改写了 1980 年的一项法律，即拜杜法案（Bayh-Dole Act），该法案允许大学在联邦拨款支持下为有前景的发现申请专利，然后将这些专利独家授权给私营部门合作伙伴进行进一步开发和商业化。
在拜杜法案之前，政府保留了联邦资助研究的专利权，并没有授予这些专利的独家许可。实际上，如果没有独家许可，很少有公司愿意冒着数百万美元的风险将早期技术商业化。因此，很少有发明能从实验室走向市场。
拜杜法案出台后，创新开始腾飞。过去三十年，该法案为美国产出增加了约 1.9 万亿美元，并催生了数千家鼓舞人心的初创公司。拜杜法案让消费者可以买到数百种产品，从药品和疫苗到电池技术和电子产品。
该法案的起草者提出了一项名为“介入”的小安全条款，允许政府介入并重新授权联邦资助的专利，如果某所大学不努力授权专利，或者被许可人不努力将发现推向市场。
白宫现在表示，这个从未使用过的介入条款可以作为削减处方药和其他消费品成本的魔杖。如果官员认为最终产品价格过高，政府的新指导方针鼓励各机构撤销独家专利许可。
作为一名在联邦法官席上审理专利案件超过 20 年的人，我可以向你保证，这些官僚是错误的。三月法案旨在防止特殊情况，而不是政府干预的广泛工具。
参议员伯奇·拜伊 (Birch Bayh)（印第安纳州民主党）和鲍勃·多尔 (Bob Dole)（堪萨斯州共和党）明确表示，他们的立法不允许政府为市场上广泛供应的产品定价。自吉米·卡特 (Jimmy Carter) 以来，每一位总统都听从拜伊和多尔对自己法律的解释，但拜登总统显然认为他的前任是错误的。
然而，拜登政府扭曲数十年历史的法律以获得政治胜利的努力可能不会以拜伊-多尔法案结束。法律文件表明，政府还在推进对第 1498 条的彻底重新解释，这是一项第一次世界大战时期的法规，旨在为专利所有者提供合理的补偿，如果政府在战争或其他直接政府责任期间侵犯了他们的技术。
近年来，一些活动家和立法者声称，政府可以援引第 1498 条没收专利，并授权仿制药制造商生产专利品牌药的廉价仿制品，然后根据医疗保险和医疗补助等保险计划向公众出售。
就像新的进军指导方针一样，这一行动方针在法律上绝对没有坚实的基础。首先，1498 仅适用于直接为政府使用而生产的产品：法院一再这样说。防弹头盔或军用车辆的防刺轮胎可能符合条件，但政府计划仅购买用于消费者使用的处方药绝对不符合条件。
更重要的是，第 1498 条的文本明确指出，专利所有者在侵权情况下应获得“合理和全部赔偿”，这意味着纳税人将为滥用法律产生的任何暂时“节省”承担责任。
从法律细节来看，要求扭曲拜杜法案和第 1498 条的呼声存在更大的问题。这些提案本质上将建立政府运营的专利许可，由政客和官僚而不是市场来决定哪些价格是“合理的”，哪些不是，以及哪些公司将生产它们。
面对这种不确定性，许多公司将对专利保护失去信心。这将抑制创新，减缓经济增长，具有讽刺意味的是，随着新技术的开发减少，从长远来看，这将导致获取专利的机会减少。而且，不仅仅是制药业面临风险；这两项提案同样适用于所有高科技、专利密集型行业的消费品。
已经有充分的理由认为，政府的强行进入提案及其明显滥用第 1498 条的意愿正在影响公司的投资决策，并降低它们与大学合作的意愿。他们的投资者也会受到阻碍。
为了获得政治利益而破坏我们微妙平衡的专利制度是短视和危险的，尤其是在美国的技术优势面临来自中国等竞争对手日益增长的威胁的情况下。拜登政府应该专注于加强而不是破坏美国创新和繁荣的基础。
保罗·R·米歇尔法官（已退休）于 1988 年至 2010 年在美国联邦巡回上诉法院任职。他是创新促进委员会的董事会成员。
题图：2023 年 12 月 14 日星期四，拜登总统在马里兰州贝塞斯达的国家卫生研究院谈论处方药成本。(AP Photo/Andrew Harnik)
附原英文报道：
Biden’s shortsighted patent attacks threaten American innovation
BY PAUL R. MICHEL, OPINION CONTRIBUTOR – 06/04/24
The Biden administration is quietly advancing a proposal that could devastate America’s high-tech economy. The White House says the plan is about “beating Big Pharma.” But in reality, it would decimate investment across a variety of sectors.
The proposal functionally rewrites a 1980 law known as the Bayh-Dole Act, which allows universities to patent promising discoveries they make with the support of federal grant funding and then exclusively license those patents to a private sector partner for further development and commercialization.
Prior to Bayh-Dole, the government retained patent rights on federally funded research and did not grant exclusive licenses for those patents. In practice, few companies were willing to risk millions of dollars to commercialize early-stage technologies if they did not hold exclusive licenses. As a result, very few inventions made it from the lab to the marketplace.
After Bayh-Dole, innovation took off. The law has added around $1.9 trillion to U.S. output over the last three decades and has led to the creation of thousands of inspiring start-up firms. Hundreds of products — ranging from medicines and vaccines to battery technologies and electronics — are available to consumers thanks to Bayh-Dole.
The law’s authors included a minor failsafe provision called “march in” allowing the government to step in and relicense federally funded patents if a university is making no effort to license the patent, or if a licensee is making no effort to bring the discovery to market.
It is this never-used march-in clause that the White House now says can be used as a magic wand to slash the cost of prescription medicines and other consumer goods. The administration’s new guidance encourages agencies to revoke exclusive patent licenses if bureaucrats think the resulting products are too expensive.
As someone who spent over 20 years on the federal bench adjudicating patent cases, I can assure you that these bureaucrats are mistaken. March-in was intended as a protection against exceptional cases, not as a broad tool for government intervention.
Sens. Birch Bayh (D-Ind.) and Bob Dole (R-Kansas) clearly stated that their legislation does not permit government price setting for products that are widely available on the market. Every president since Jimmy Carter has deferred to Bayh and Dole’s interpretation of their own law, but President Biden evidently believes that his predecessors were mistaken.
Yet the Biden administration’s efforts to twist decades-old laws to achieve political wins may not end with Bayh-Dole. Legal filings suggest that the administration is also advancing a radical reinterpretation of Section 1498, a World War I-era statute meant to provide patent owners with reasonable compensation if the government infringes on their technology during a war or other direct government responsibility.
In recent years, a few activists and lawmakers have claimed that the government can invoke Section 1498 to confiscate patents and authorize generic drug manufacturers to produce cheap copies of patented brand-name drugs, which would then be sold to the public under insurance programs like Medicare and Medicaid.
Like the new march-in guidance, this course of action has absolutely no sound basis in law. First, 1498 only applies when a product is produced directly for government use: courts have repeatedly said so. Bulletproof helmets or no-puncture tires for military vehicles may qualify, but prescription drugs merely purchased by government programs for consumer use most definitely do not.
More importantly, the text of Section 1498 clearly says that patent owners are due “reasonable and entire compensation” in cases of infringement, meaning taxpayers would be on the hook for any temporary “savings” misuse of the law generates.
Zooming out from the legal minutia, there is a bigger problem with calls to twist both Bayh-Dole and Section 1498. These proposals would essentially establish government-run patent licensing, with politicians and bureaucrats, not markets, deciding which prices are “reasonable” and which are not, and which companies will produce them.
In the face of such uncertainty, many companies will lose faith in patent protections. This will chill innovation, slow economic growth and, ironically, lead to reduced access in the long run as fewer new technologies are developed. And it is not just pharmaceuticals at risk; both proposals would apply equally to consumer products across every high-tech, patent-intensive sector.
Already, there is good reason to think that the administration’s march-in proposal, and its apparent willingness to misuse Section 1498, are impacting companies’ investment decisions and reducing their willingness to partner with universities. Their investors will likewise be deterred.
Upsetting our delicately balanced patent system to score political points is shortsighted and dangerous, especially as America’s technological edge faces growing threats from competitors like China. The Biden administration should focus on strengthening, not undermining, the foundations of American innovation and prosperity.
Judge Paul R. Michel (ret.) served on the United States Court of Appeals for the Federal Circuit from 1988 to 2010. He is a board member of the Council for Innovation Promotion.
