“Overbroad and improperly disclosed claims should not be allowed, but certain ‘discoveries’ are patentable. “
From left: Laura Smalley, Judge Paul Michelle, Mike Kotler, and Thomas Stoll.
One of the panels for last year’s IPWatchdog’s Life Sciences MastersTMs The series addressed the thorny issue of patent eligibility. I chaired the panel. Patent Eligibility and the Life Sciences Industry – What’s Next?At , speakers discussed the impact of Section 101 jurisprudence on innovation in the life sciences industry, informed by an enthusiastic audience. Do court-made restrictions on patent-eligible subject matter strike the right balance, or are unpredictable court decisions harming life sciences investment and research?
While the majority view held that patent eligibility reform was necessary to provide clarity and encourage certain types of inventions, the Panel argued that it would be necessary to prevent “discoveries” from being monopolized. He also expressed the view that some form of Section 101 jurisprudence was needed to , can also undermine innovation.
Discovery should be patentable
In my view, there is nothing inherently wrong with patenting a “discovery”. Many “discoveries” are highly innovative and beneficial to society. Overly broad and improperly disclosed claims should not be allowed, but certain “discoveries” are patentable. But, as the Supreme Court said, “Even groundbreaking, revolutionary, or brilliant discoveries, by themselves, do not satisfy his Section 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 US 576, 591 (2013).Continue innumerable However, the Federal Circuit has felt constrained in preserving what has been characterized as a “breakthrough invention.”[s]” is not patent eligible. See, eg, Ariosa Diagnostics, Inc. vs. Sequenom, Inc., 788 F.3d 1371, 1381 (Fed. Cir. 2015).of Airythe claims directed to the application of the breakthrough discovery that maternal plasma contained cell-free fetal DNA were directed to a “natural phenomenon” with the addition of “routine and conventional procedures,” Not covered by patent. Ditto. at 1378. Although the Court of Appeals for the Federal Circuit agreed that the invention “revolutionized prenatal care,” the claims were invalidated. identification. At 1379, Judge Lynn concurred, stating that the claimed method was “groundbreaking” and, as a result, the first commercially available “noninvasive prenatal diagnostic test for fetal aneuploidy.” said to have brought Ditto. 1381.
Even if we recognize that claims directed to natural principles and phenomena are “discoveries” rather than “inventions,” why should such “discoveries” be denied patent protection? Sections 1, 8, and 8 allow Congress to grant inventors exclusive rights (patents) to their “discoveries.” Section 101 does not specifically exclude “discoveries” or contain exceptions to subject matter eligibility. In fact, the Act specifically considers discovery patents. 35 USC § 101 (“Anyone who invents or discovers a new and useful process . does not seem possible. Discovering and putting into practice these principles and phenomena requires as much (and often more) research, innovation, and effort than inventions that fall within the definition of patent-eligible subject matter. As noted by the Federal Circuit’s opponents, “original concepts arise not only from the creative and unconventional application of the laws of nature, but also from the originality and novelty of the discovery of the laws themselves. ” Ariosa Diagnostics, Inc. vs. Sequenom, Inc.809 F.3d 1282, 1289 (Fed. Cir. 2015) (objected).
Claims Based on Anecdotal Evidence
Concerns expressed regarding patent claims that appear to be directed to laws of nature or principles of nature have led to concerns that patents may be compromised by preventing the use of abstract ideas, naturally occurring phenomena, and laws of nature that are the fundamental building blocks of technology. The law should not prevent discovery. Mayo collaboration serve. v. Prometheus Labs., Inc.; 566 US 66, 86 (2012). However, this concern is often repeated by the Supreme Court and other courts without supporting evidence. And even when evidence is cited, rational thinking may differ. I have claimed that look A number of stakeholders expressed opposing views when commenting on PTO-P-2021-00320054. Moreover, while patents on naturally occurring DNA have been shown to be detrimental to innovation, there is little evidence that patents of ‘discoveries’ are detrimental to innovation in other fields. In fact, as former Federal Circuit Chief Judge Paul Michelle detailed, there is enough evidence that the lack of credible patent protection in key areas of technology is reducing investment and commercialization in these areas. I have proof. For example, promising diagnostics for lupus, Alzheimer’s disease, metastatic cancer, and schizophrenia have not been commercialized due to the chilling effect of the subject eligibility laws for the life sciences. .
Claims that patents inhibit basic research tend to be based on anecdotal evidence. Empirical studies have shown that “fundamental” researchers tend to ignore patent infringement and patent owners do not enforce their patents in this context. look Christopher M. Holman, The Critical Role of Patents in the Development, Commercialization, and Utilization of Innovative Genetic Diagnostic Tests, Center for the Protection of Intellectual Property at 4, July 2014 (“Critical Role”). Even if that concern were correct, this argument ignores that discoveries would not have been made, research would not have been conducted, or commercialization would not have been completed without the incentives provided by the patent system. I’m here. Many “discoveries” require large investments. As of 2013, it was estimated that commercializing the diagnostic method would cost him $20 million to over $100. look Dolginov and others., To solve a mystery!How much does it cost to develop and launch a diagnostic15 Jan 2013. While it is easy to point to evidence of alleged harms arising from patents, such as the market price impact of having a single provider, the lack of available treatments is How is it quantified? Will that cost be considered in the Section 101 analysis?
The benefits of research and technology published through the patent system may ultimately outweigh the research impediments and extra costs caused by patenting a “discovery.” Certain categories of “discoveries”, such as naturally occurring DNA, should be excluded from patent protection, but broad court rules prohibiting protection for most “discoveries”, especially in the life sciences, are not justified. . In the past, Federal Circuit judges have suggested that sufficiently narrow claims to so-called “discoveries” should be patentable after the discoveries have been put into practice. See Ariosa Diagnostics, Inc. v. Sequenom, Inc.809 F.3d 1282, 1291 (Fed. Cir. 2015) (Judge Dyke, Consent) (“[I]If the claims are sufficiently limited in breadth to a particular application of a new law of nature discovered and put into practice by the patent applicant, the novelty of the discovery is sufficient to provide the necessary inventive concept. I think there is. ”)
Difficult to discover and expensive to develop
Practical application of “discoveries” is generally much more difficult than simply identifying natural principles. For example, basic research may identify genes associated with inherited disorders, but additional research is “needed to identify and validate the clinical significance of genetic disorders. genetic mutation,” This requires expensive and long-term research. look A critical role 6. For example, after the discovery of the BRCA gene, Myriad (and others) had to distinguish between clinically significant and non-clinically significant mutations. Next, there was a need to quantify and validate the likelihood that patients with clinically significant variation will develop cancer. Ditto. In a 2013 patent lawsuit, Myriad Genetics said it had “invested over $500 million to implement this discovery and create molecular diagnostic tests for hereditary breast and ovarian cancers associated with the BRCA1 and BRCA2 genes.” expressed. look complaints, of the University of Utah Research Found. v. Quest Diagnostics, Inc., No. 13-0967, Document No. 2 at 4 (D. Utah 22 October 2013). Sequenom announced a new noninvasive prenatal test called the Harmony Prenatal test in 2012, reporting the results of three clinical studies and the initiation of a large clinical trial involving over 25,000 women. Did. look Declaration of Mohan Rao, Aria Diagnostics v. Sequenom, No. 3:11-cv-063931-SI, Document No. 38 at 3 (ND Cal. 8 March 2012). Until testing begins, Sequenom estimates R&D and other pre-launch costs at “around $70 million.” Ditto. The ongoing launch was expected to cost more than $70 million in 2012. Ditto.
In some cases, the discovery itself is difficult. The current antimicrobial resistance crisis, which is causing the “unidentified spread of resistant pathogens,” is due to a declining antibiotic discovery pipeline. look Lewis, K. The science of antibiotic discovery. cell 181, 29–45 (2020). But antibiotics are “the hardest type of drug to discover, but the easiest type to develop.” Ditto. at 41. Many antibiotics, including new compounds currently in the pipeline, are natural products or modified natural products. identificationin .31-32. In response to a request for comment on subject matter eligibility (81 Fed. Reg. 71485 [October 17, 2016]), the Houston Intellectual Property Law Association pointed to the impact of Section 101 on claims against texobactin, a promising new antibiotic isolated from soil bacteria. Claims against isolated texobactin have been rejected by the USPTO. innumerableApplicants eventually patented Teixobactin “and a pharmaceutically acceptable carrier that effectively solubilizes the compound” (U.S. Patent No. 9,402,878) and a method of using Teixobactin (U.S. Patent No. 9,163,065). However, such claims may be invalid under current testing. On subject eligibility, as noted by the Association, given that the career is “routine and conventional.” The novelty lies in the discovery of natural compounds that have been described as “unique”. look Ling, L., Schneider, T., Peoples, A. et al. “New antibiotics kill pathogens without detectable resistance.” Nature 517, 455–459 (2015). The broad judicial exceptions made by courts are unwarranted, given that they often require a great deal of work to reduce to embodies, uses, reflects, relies on, or applies any ideas”. Alice Corp. v. CLS Bank Int’l, 573 US 208, 217 (2014). The patentability of claims directed to laws of nature, products of nature, or abstract ideas should necessarily depend on whether other claim limitations are novel or instead “routine and conventional.” not. Uncultured organisms of soil bacteria are not useful and truly unknown until they are isolated, grown and screened. Correlations between biomarkers and disease states need to be discovered and validated. .
Judicial exceptions to patentability should be narrowed so that the application of laws of nature, products of nature, and abstract ideas “to new and useful purposes” is “eligible for patent protection.” Alice, at 217.
