Mayo Framework and Preemption Question: what is patentable under 35 USC 101. The question of patentable subject matter is nominally grounded in the statute 35 U.S.C. § 101: patent rights to anyone who “invents or discovers any new and useful process, machine, manufacture, or composition of matter.”
During the course of enforcing the law, the Supreme has interpreted that the statute also prohibits patents on abstract ideas, products of nature, and natural phenomena.
In Mayo v. Prometheus at the Supreme Court raises the question of whether a patent claim that covers correlations between blood tests and patient health is ‘patentable’ under 35 U.S.C. § 101. The Court’s analysis creates a framework for patent eligibility in which almost any method claim of “the law of nature” can be invalidated.
Prometheus has a method patent of analyzing the effectiveness of thiopurine drugs for treating gastrointestinal disorders. Prometheus offers a blood test which analyzes metabolite levels of thiopurine drugs in patients. Mayo sought to offer a competing blood test at a lower price.
Prometheus promptly sued Mayo for infringement.
Claim 1 of the relevant patent reads as follows:
(1) A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×10^8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
1. The preemption question
One of Mayo’s principal arguments in its brief and at oral argument is that Prometheus’s patent preempts the use of a law of nature — namely, the relationship between metabolite levels and patient health.
Justice Kennedy began the preemption questioning by asking whether a system of measurements that continually monitor drug retention would be patentable. Mayo’s counsel responded that it would depend on the breadth of the claims. “Claim specificity is key.” According to Mayo, if Prometheus’s patent had provided competitors room to develop different, more accurate metabolite levels it may have passed the 101 test. But, in this case Prometheus’s patent preempted any reduction in dosage if a patient’s metabolite levels were above 400 pmol. In Mayo’s view, “incidental” steps added to a natural phenomenon were insufficient to avoid preemption. Thus, any patent consisting only of a natural phenomenon and “incidental steps” would be preempted under Mayo’s test.
The Supreme Court agrees with Mayo’s argument in its decision.
the US Patent & Trademark Office has since distributed a short memorandum to its examiners providing guidance.
Examiners must continue to ensure that claims, particularly process claims, are not directed to an exception to eligibility such that the claim amounts to a monopoly on the law of nature, natural phenomenon, or abstract idea itself. In addition, to be patent-eligible, a claim that includes an exception should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea conventional steps specified at a high level of generality appended thereto.
The Supreme Court found that because the laws of nature recited by the patent claims – the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm – are not themselves patent eligible, the claimed processes are likewise not patent-eligible unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations.
什么技术在美国是被专利保护的？美国专利法规定了4大类别：新的有用的1）方法；2）机器；3）生产物；4）合成物。
在执行专利法过程中，最高法院在对专利法的保护范围阐释中，进一步排除了下列内容的专利保护：1）抽象想法；2）自然产物；3）自然现象。
在Mayo v. Prometheus专利侵权案中，Prometheus有一个方法专利，即通过检测病人血液中硫化嘌呤的量来确定医疗效果。Prometheus 提供一个血液检测试剂盒。该试剂盒使用这个专利方法来检测病人血液。Mayo也提供一个相似的试剂盒，只是价格更便宜。Prometheus于是起诉Mayo 专利侵权。
当大法官问，连续监测一个药物在血液中的含量可不可以被专利保护时，Mayo 的律师的观点是，应该取决于专利权诉求范围。如果该专利权诉求范围可以允许竞争对手改进检测范围，而不仅仅是自然现象，就可以被专利保护。
最高法院判Mayo 没侵权，Prometheus 专利无效。
美专利局于是出笼了专利审查指导，要求专利审查员在审查方法专利时，进一步考虑该专利申请是否具有比仅仅描述自然现象远多的应用内容。
