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.

Indirect Exploitation of Intellectual Property Rights By Corporations and Investors

Competitive pressures and rent-seeking behaviors have motivated companies and investors to develop indirect techniques for beneficially exploiting third-party intellectual property rights (IPRs) that qualitatively depart from the direct exploitation tools honed during the past thirty years of the pro-patent era. Among other things, companies have realized that they do not even need to own IPRs in order to consequently benefit from their exploitation. This phenomenon is labeled here “IP privateering” because of its similarities to an historic method of waging war on the high seas. This Article classifies IP privateering as a species of aggressive non-practicing entities (NPEs). The parameters of this newly identified strategy are probed using a variety of methods. The apparent evolution of this indirect IPR exploitation strategy is also traced among companies. A typology for IP privateering is provided that identifies the key variables associated with this strategy. Examples of privateering, both actual and hypothetical are discussed. The identified privateering scenarios, while small in number, have amounted to well over $3 billion in rent collections and have possibly saved sponsoring companies an order of magnitude more in avoided revenue losses. The infrastructure that supports privateering is discussed as well as how a possible patent oversupply may facilitate this strategy. The social utility of privateering is examined from various points of view including corporate, SME, investor, and inventor. Further questions are posed regarding IP privateering and aggressive NPEs (observing that both actors are likely supported financially by participants operating in the investment capital market), the need for ownership transparency in the innovation system, and whether the legislator should more explicitly design an innovation system that includes boundaries for various IPR strategies.

Practical Considerations In The Indirect Deployment Of Intellectual Property Rights By Corporations And Investors

 

Competitive pressures and rent-seeking behaviors have motivated companies  and investors to develop indirect techniques for beneficially exploiting third-party intellectual property rights (IPRs) that qualitatively depart from the direct exploitation tools honed during the past thirty years of the ongoing pro-patent era. Companies and investors have learned that they do not even need to own IPRs in order to consequently benefit from their exploitation. This phenomenon is labeled here “IP privateering” because of its similarities to an historic method for waging war on the high seas. This Article probes certain practical limitations of this newly identified strategy. Specifically, this Article explores of the range of counterattacks available to the target of a privateering operation and finds that but for certain specific scenarios related to antitrust and market manipulation, the typical target will likely be required to prove that the privateer’s litigation was frivolous before any effective attack can be launched on the sponsor. This Article also explores how the rise of market intermediaries coupled with an oversupply of patents simplifies the sponsor’s task of equipping a privateer operation.

Bitcoin: An Innovative Alternative Digital Currency

Bitcoin is a digital, decentralized, partially anonymous currency, not backed by any government or other legal entity, and not redeemable for gold or other commodity. It relies on peer-to-peer networking and cryptography to maintain its integrity. Compared to most currencies or online payment services, such as PayPal, bitcoins are highly liquid, have low transaction costs, and can be used to make micropayments. This new currency could also hold the key to allowing organizations such as Wikileaks, hated by governments, to receive donations and conduct business anonymously. Although the Bitcoin economy is flourishing, Bitcoin users are anxious about Bitcoin’s legal status. This Article examines a few relevant legal issues, such as the recent conviction of the Liberty Dollar creator, the Stamp Payments Act, and the Federal Securities Acts.

Beyond Confusion – Survey Evidence of Consumer Demand and the Entire Market Value Rule

The doctrine of apportionment serves to limit recovery for patent infringement to the economic value contributed by the infringed patent. However, the entire market value rule allows plaintiffs to base their recovery on the entire value of a product, if an infringing feature of the product is the basis for consumer demand for the product. Large damages awards produced by the application of the entire market value rule have prompted appeals for damages reform. In the recent America Invents Act, the legislature did not address damages reform, noting that the judiciary is currently reinvigorating the doctrine of apportionment. Indeed, the Federal Circuit has recently provided such reform by heightening the evidentiary burden for consumer demand, implying that empirical evidence of consumer demand will be necessary in order to apply the entire market value rule. This Note examines issues related to the admissibility and relevancy of empirical evidence of consumer demand, including how such evidence may be used to apportion damages and effect policy.

Customers, Co-workers and Competition: Employee Covenants in California after Edwards v. Arthur Andersen

California law is well settled that most contractual provisions prohibiting competing with or soliciting customers of a former employer are unenforceable under California Business and Professions Code 16600, unless the activity involves misappropriation of trade secrets or confidential information. Nonetheless, case law appears to hold that a restriction on one type of post-employment activity— hiring away former co-workers—might still be permitted. In 2008, the California Supreme Court once again addressed the scope of section 16600. This Note examines employee nonsolicitation covenants in light of that decision, including whether they remain legally defensible, and whether they retain any value for the employer in today’s social-media-connected society.