Saurabh Vishnubhakat

The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research

This case study presents the tale of the academic discovery of a rare mutation for early-onset Alzheimers disease that was patented by a sole inventor and licensed to a non-practicing entity (NPE), the Alzheimers Institute of America (AIA). Our aims are (1) to relate this story about patents, research tools, and impediments to medical progress, and (2) to inform ongoing debates about how patents affect research, disposition of university inventions, and the distribution of benefits from publicly funded research. We present an account of the hunt for Alzheimers genes, their patenting, assignment, and enforcement based on literature, litigation records and judicial decisions. While AIAs litigation eventually failed, its suits against 18 defendants, including one university, one foundation, and three non-profit organizations were costly in court years, legal fees, and expert time. Reasons for the failure included non-disclosure of co-inventors, State laws on ownership and assignment of university inventions, and enablement. We discuss the policy implications of the litigation, questioning the value of patents in the research ecosystem and the role of NPEs (“patent trolls”) in biotechnological innovation. The case illustrates tactics that may be deployed against NPEs, including, avenues to invalidate patent claims, Authorization and Consent, legislative reforms specifically targeting NPEs, reforms in the America Invents Act, and judicial action and rules for judicial proceedings. In the highly competitive research environment of Alzheimers genetics in the 1990s, patents played a minor, subordinate role in spurring innovation. The case produces a mixed message about the patent system. It illustrates many mistakes in how patents were obtained, administered, and enforced, but, eventually, the legal system rectified these mistakes, albeit slowly, laboriously, and at great cost.

Strategic Decision Making in Dual PTAB and District Court Proceedings

The post-grant review proceedings set up at the U.S. Patent and Trademark Office’s Patent and Trial Appeal Board by the America Invents Act of 2011 have transformed the relationship between Article III patent litigation and the administrative state. Not surprisingly, such dramatic change has itself yielded additional litigation possibilities: Cuozzo Speed Technologies v. Lee, a case addressing divergence between the manner in which the PTAB and Article III courts construe patent claims, will soon be decided at the U.S. Supreme Court.Of the three major new PTAB proceedings, two have proven to be popular as well as controversial: inter partes review and covered business method review. Yet scholarly analysis of litigant behavior in these proceedings has been limited thus far to descriptive data summaries or specific policy perspectives on these types of post-grant challenges, such as their impact on the well-rehearsed patent troll debate. In this article, we present what is to our knowledge the first comprehensive empirical and analytical study of how litigants use these inter partes review and covered business method review proceedings relative to Article III litigation.A major normative argument for administrative ex post review is that it should be an efficient, accessible, and accurate substitute for Article III litigation over patent validity. We assess the substitution hypothesis, using individual patents as our general unit of analysis as well as investigating patent-petitioner pairs and similar details in greater depth. Our data indicate that the “standard model” of explicit substitution — wherein a district court defendant subsequently brings an administrative challenge to patent validity — occurs for the majority (70%) of petitioners who bring inter partes review challenges. An important implication of this effect is that the PTAB should use a claim construction standard that mirrors that of the district court. With a uniform standard, PTAB claim constructions could be used by district courts in any subsequent proceedings, and the benefits of substituting administrative process for judicial process would thereby be most fully realized.Notably, however, standard substitution is not the only use of the PTAB: particularly in the area of inter partes reviews, we also see a surprising percentage of cases (about 30%) where the petitioner is not the target of a prior suit on the same patent. The frequency of these nonstandard petitioners, as well as their tendency to join the same petitions as an entity that has been sued, varies by technology. Our data on nonstandard petitioners provide some insight into the extent to which patent challengers are engaging in collective action to contest the validity of patents. Depending on the details of how nonstandard petitioning and collective action are being deployed, this activity could provide a social benefit or constitute a form of harassment.

The mouse that trolled (again).

We welcome the opportunity to respond to the commentaries on our paper—The Mouse that Trolled—by Hardy1, Sarnoff2, and Cordova and Feldman3. Their comments are academic criticism in the very best sense.We also take the opportunity to update on recent legal actions, whichwe had not predicted.This opportunity enriches our narrative history of the patenting of the APPswe mutation for early onset Alzheimer’s disease, and we hope the continued saga is of interest.

An Intentional Tort Theory of Patents

This Article challenges the dogma of U.S. patent law that direct infringement is a strict liability tort. Impermissibly practicing a patented invention does create liability even if the infringer did not intend to infringe or know about the patent. The consensus is that this is a form of strict liability. The flaw in the consensus is that it proves too little, for the same is true of intentional torts: intent to commit the tort is unnecessary, and ignorance of the legal right is no excuse. What is relevant is intent to perform the action that the law deems tortious. So for the tort of patent infringement, the question is whether liability should require that the infringer intended to perform the actions that constitute infringement. The patent statute and the few cases that have broached the question suggest the answer is yes — tortious intent should be necessary. However, patent law currently takes no position on tortious intent. The strict liability view is merely a default. This Article fills that gap by applying ordinary tort principles to patent infringement. The proposed framework offers a powerful policy lever for important issues implicating the notice function of patents, including divided infringement, claim construction, and inherency. This framework also mitigates the effects of patent assertion on risk allocation in the patent system by differentiating among makers, sellers, and users of patented innovation — a distinction that is economically important but has no principled basis in patent doctrine.