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 intellectual property claims is key to reacting to open source claims gracefully, effectively, and with a minimum of embarrassment and cost.  This Article provides a survey of where we stand today and demonstrates how this area of law has developed.  We will be soon nearing the point where catalogs of open source claims in articles like this one will no longer be sensible or useful, but for now, seeing where we have been neatly explains where we are.

The Medicines Patent Pool: Promoting Access and Innovation for Life-Saving Medicines Through Voluntary Licenses

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 order to address this problem, a proposal for a “patent pool” emerged that would rely on voluntary licenses by patent holders to enable the production of more affordable generic medicines. This article briefly describes the history of patent pools before focusing specifically on the UNITAID-supported Medicines Patent Pool. It analyzes the specific licenses of the Medicines Patent Pool, noting both the positive aspects and areas where future licenses could be improved. In addition to identifying areas for improvement, this article explores the mechanisms, including those that de-link innovation from monopoly pricing, that can be used to achieve these goals and encourage greater participation in the Medicines Patent Pool.

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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.  FDA did promulgate such regulations, and the Eighth Circuit held that a failure to follow these regulations is a violation of section 355(i) of the FDCA.  A violation of section 355(i) is considered a violation of section 331(e), and a violation of 331(e) can result in criminal sanctions under section 333(a).  Thus, this tenuous chain of statutes allows the government to bring criminal charges against fraudulent criminal investigators.

The Park Doctrine itself should also be utilized against clinical investigators.  Even if investigators are unaware of wrongdoing, they have the “responsible relationship” with the documents.  Also, currently clinical investigators are beholden to the sponsors, who ultimately sign their paychecks. If they are aware they will be liable, and subject to criminal penalties under the Park Doctrine, even when they are unaware of any problems, they will be more likely to seek out problems and report any wrongdoing they discover.

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 lines of patentable subject matter.  The Federal Circuit has subsequently overturned that holding; however, it remains unclear whether gene patents serve the patent system’s underlying objective to encourage innovation.  For the most part, courts have defined what constitutes patentable subject matter, but as the Myriad litigation demonstrates, courts may not be the best institution to consider these complex policy issues.  In light of the Myriad litigation, this Note examines whether there are better institutional alternatives.

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 the enactment of the 1952 Patent Act and is in conflict with many aspects of patent law including the utilitarian policies, the doctrine of equivalents and basic risk allocation.  Finally, this Note demonstrates that the overlapping scope of § 271(b) and § 271(c) necessitates the specific intent requirement because Congress intended § 271(b) with its generic language to cover a broader scope of indirect infringement than the specific situation of § 271(c).  Instead, inducement of § 271(b) should be considered as a strict liability claim.