Monopolies over many life-saving drugs have led to high prices that remain out of reach for patients in the developing world, leading to a crisis of access over these essential medicines. High intellectual property barriers harm not only access to medicines, but can also impact future innovation. In … Read more
Issue Archives
FDA FDA Enforcement of Criminal Liability for Clinical Investigator Fraud
FDA FDA Enforcement of Criminal Liability for Clinical Investigator Fraud
Clinical investigator fraud is a very real problem, and falls squarely within FDA’s mandate to protect the public health. The Eighth Circuit has held that under this mandate, FDA has the authority to impose affirmative duties to protect the public health by promulgating relevant regulations. … Read More
Clinical investigator fraud is a very real problem, and falls squarely within FDA’s mandate to protect the public health. The Eighth Circuit has held that under this mandate, FDA has the authority to impose affirmative duties to protect the public health by promulgating relevant regulations. … Read more
Finding a “Fit”: Gene Patents and Innovation Policy
Finding a “Fit”: Gene Patents and Innovation Policy
The district court’s decision in Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (the Myriad litigation) that isolated DNA does not constitute patentable subject matter because the isolated DNA is not markedly different from the naturally occurring DNA sequence redrew the … Read More
The district court’s decision in Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (the Myriad litigation) that isolated DNA does not constitute patentable subject matter because the isolated DNA is not markedly different from the naturally occurring DNA sequence redrew the … Read more
Induced Infringement as a Strict Liability Claim: Abolishment of the Specific Intent Requirement
Induced Infringement as a Strict Liability Claim: Abolishment of the Specific Intent Requirement
This Note argues that the specific intent requirement for § 271(b) should be abolished. It shows that the language of § 271(b) does not provide textual support for the specific intent requirement. Additionally, it argues that the specific intent requirement is contrary to early case law before … Read More
This Note argues that the specific intent requirement for § 271(b) should be abolished. It shows that the language of § 271(b) does not provide textual support for the specific intent requirement. Additionally, it argues that the specific intent requirement is contrary to early case law before … Read more
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Open Source and the Age of Enforcement
Open Source and the Age of Enforcement
The last five years have seen the first serious enforcement efforts by licensors of open source software, so we are truly at the dawning of the age of enforcement. But open source claims are not like other claims. Understanding the distinctions between open source software claims and other … Read More
4 Hastings Sci. & Tech. L. J. 267
The last five years have seen the first serious enforcement efforts by licensors of open source software, so we are truly at the dawning of the age of enforcement. But open source claims are not like other claims. Understanding the distinctions between open source software claims and other … Read more