Biotechnology's Uncertainty Principle

Burk, Dan L.; Lemley, Mark A.

doi:10.1016/s0065-2660(03)50016-5

Cited by 5 publications

(5 citation statements)

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“…We found that R&D investment brings technological innovation but has a negative impact on sales and profits. The biotechnology industry, which includes the IVDs industry, is an industry that has a high risk of market failure due to the difficulty of technology development and commercialization [81][82][83]. Therefore, it is necessary to prepare policy support measures that boost the technology commercialization that results from innovation performance, for example, by providing education from or connections with organizations that specialize in technological industrialization.…”

Section: Discussionmentioning

confidence: 99%

How Can Funding Drive Firm’s Performance in the In Vitro Diagnostics Industry?

Kim

Shin

et al. 2022

Journal of Open Innovation: Technology, Market, and Complexity

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Due to the increased need for the efficient use of public funds and the importance of private investment, there have been many studies on the effects of these factors on corporate performance. However, few studies have been conducted based on an integrated perspective. In addition, most studies have investigated cases in leading countries and have rarely studied latecomer countries. Therefore, this study investigated the step-by-step effects of government support on firm performance (innovation performance, venture capital (hereafter VC) investment, and financial performance) based on the data on in vitro diagnostic (hereafter IVD) firms in Korea. In particular, we demonstrate the sequential effects of these variables with a time lag. The results of the panel regression analysis indicate that government R&D support improved the innovation performance of IVD firms, but this increased innovation performance did not attract VC investment. Meanwhile, VC investment has a positive impact on a firm’s financial performance. These findings have policy implications and suggest that government support plays a pivotal role in a company’s innovation performance, and thus continuous investment is required. However, innovation performance negatively affects short-term financial performance, and thus technology commercialization should be supported.

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Section: Discussionmentioning

confidence: 99%

How Can Funding Drive Firm’s Performance in the In Vitro Diagnostics Industry?

Kim

Shin

et al. 2022

Journal of Open Innovation: Technology, Market, and Complexity

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“…144 However, the Federal Circuit's recent interpretation of patent law's disclosure requirements is negatively affecting the pharmaceutical and biotechnology industries to a greater extent than other industries. 145 One key reason for this technology-specific effect of the law is that genus claims are an important part of biomedical patent applications 146 and yet they are much less prevalent and generally not relied upon for protecting inventions in other industries. Patent law's established disclosure requirements have in recent years been used by the Federal Circuit to attack genus claims and make them near impossible to obtain for inventions in the biomedical field.…”

Section: Current Patent Disclosure Requirements Impose Industry-speci...mentioning

confidence: 99%

A Singular Disclosure Requirement Is Necessary For Patent Law

Falati

2023

stlr

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The Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112 has selectively and severely curtailed innovation in the fields of pharmaceuticals and biotechnology. Specifically, the Federal Circuit’s shifting position on 35 U.S.C. § 112 and their evolving jurisprudence to combine expanding the application and scope of the written description requirement with a separate, heightened standard for enabling claims directed to innovation in a genus of therapeutic antibodies, or a genus of compounds having functional limitations, has caused havoc in the biopharmaceutical industry. Federal Circuit jurisprudence on how to interpret the disclosure requirements of the 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by mandating two separate disclosure requirements in place of one, namely that patent applications not only “enable” but also separately “describe” inventions. This recently developed and reactively evolving judge made approach raises the bar exceedingly high for obtaining any meaningful patent protection for new biomedical discoveries, goes against many decades of patent practice, and is proving to be a powerful impediment to the investment necessary for developing new and lifesaving medicines. This article examines patent law’s current disclosure requirements to highlight a failing judicial trajectory and proposes a return to a single 35 U.S.C. § 112(a) standard. By doing so, the great shock that has singled out and disrupted the biopharmaceutical industry will be removed and the law can once again encourage, in a technology-neutral manner, the private sector to innovate in all fields of endeavor, including encouraging the biopharmaceutical industry to develop new lifesaving medicines and treatments.

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“…And while it is, in some sense, obvious to try different laboratory techniques across different systems, successfully getting such techniques to work under different conditions-even different laboratories-is rarely easy. As a consequence, legal scholars have long complained of obviousness's mismatch with biology [9]. Following the final completion of the Human Genome Project in 2003, Dan L. Burk and Mark A. Lemley wrote about "an increasing divergence between the [patent] rules actually applied to different industries", including courts having "repeatedly held that uncertainty in predicting the structural features of biotechnological inventions renders them nonobvious, even if the prior art demonstrates a clear plan for producing the invention" [9].…”

Section: The Obviousness Inquiry In Molecular Biologymentioning

confidence: 99%

“…As a consequence, legal scholars have long complained of obviousness's mismatch with biology [9]. Following the final completion of the Human Genome Project in 2003, Dan L. Burk and Mark A. Lemley wrote about "an increasing divergence between the [patent] rules actually applied to different industries", including courts having "repeatedly held that uncertainty in predicting the structural features of biotechnological inventions renders them nonobvious, even if the prior art demonstrates a clear plan for producing the invention" [9]. Today, scholars have expressed concern that recent groundbreaking advances in cloning, sequencing, and high-throughput screening may render even significant advances in synthetic biology obvious under the patent laws.…”

Section: The Obviousness Inquiry In Molecular Biologymentioning

confidence: 99%