By: Jennifer D. Cieluch Antitrust laws have been notoriously lenient in the patent realm, the underlying reason being that patents’ grant of exclusion create monopolies that defy antitrust laws in order to incentivize innovation. Thus, antitrust violations have rarely been found in the patent cases. But after the Supreme Court’s holding in FTC v. Actavis, brand name pharmaceutical companies may need to be more cautious when settling Hatch-Waxman litigation with potential patent infringers. Both brand-name drug manufacturers and generic drug manufacturers have incentives to settle cases by having the brand-name pay the generic in exchange for delaying their entry into the market. While courts usually found that these reverse-payment settlements did not violate antitrust laws, the Supreme Court recently held that they sometimes can, even if the settlement’s anticompetitive effects fall within the scope of the exclusionary potential of the patent. The Court tried to take the middle ground after rejecting several bright line rules promulgated by appellate courts, including the Third Circuit’s “quick look” presumption against reverse payment settlements and the Second, Eleventh, and Federal Circuit’s “scope of the patent” test. This note finds that the Supreme Court’s ruling will make the Hatch-Waxman legal landscape murky and, therefore, difficult
Category: Patents & Technology
Understanding the Backlog Problems Associated with Requests for Continued Examination Practice
By: Sean Tu One of the greatest problems facing the current patent administration is a long patent pendency period. This study focuses on Request for Continued Examination (RCE) practice, and its effects on the current patent application backlog problem. RCEs are used to continue prosecution after a patent examiner has issued a final rejection. However, now that RCEs are placed on an examiner’s special docket, some examiners may pick up prosecution one to two years after the last action. Accordingly, there are great inefficiencies that may be created by this delay, such as relearning issues and questions from the previous action, diminished value of examiner interviews, and a higher likelihood of transfer to a new examiner. This study suggests that the RCE problem may be much worse for some art units compared to others. Specifically, the RCE problem is unevenly distributed between certain art units with technology center 1600 (biotechnology and organic chemistry) suffering the most from unexamined RCEs, while technology center 2800 (semiconductors, electrical and optical systems and components) remain unaffected. This RCE backlog can result in a delay of approximately three years for some art units. Possible solutions to the RCE problem include creating a two-track examiner specialization
Pleading Patents: Predicting the Outcome of Statutorily Heightened Pleading Standards
By: Arjun Rangarajan The tension between an extremely barebones Federal Rules of Civil Procedure Form 18 for patent infringement lawsuits and Supreme Court case law through Twombly and Iqbal has made it difficult for courts to dismiss frivolous patent litigation at the complaint stage. In this article, I look at the Federal Circuit’s treatment of Twombly and Iqbal, empirically evaluate 12(b)(6) motions from various district courts, and summarize local patent rules from the Eastern District of Texas. I conclude that the biggest likely impact of statutorily heightening and defining patent pleading standards through the proposed Innovation Act would be to provide much-needed uniformity in the endeavor of gatekeeping weak lawsuits, without serious adverse impact. Download Full Article (PDF) Cite: 13 Duke L. & Tech. Rev. 195
What’s It Worth to Keep a Secret?
By: Gavin C. Reid, Nicola Searle, Saurabh Vishnubhakat This article is the first major study of protection and valuation of trade secrets under federal criminal law. Trade secrecy is more important than ever as an economic complement and substitute for other intellectual property protections, particularly patents. Accordingly, U.S. public policy correctly places a growing emphasis on characterizing the scope of trade secrets, creating incentives for their productive use, and imposing penalties for their theft. Yet amid this complex ecosystem of legal doctrine, economic policy, commercial strategy, and enforcement, there is little research or consensus on how to assign value to trade secrets. One reason for this gap is that intangible assets in general are notoriously difficult to value, and trade secrecy by its opaque nature is ill-suited to the market-signaling mechanisms that offer at least some traction in other forms of valuation. Another reason is that criminal trade secret law is relatively young, and the usual corrective approaches to valuation in civil trade secrecy are not synonymous with the greater distributive concerns of criminal law. To begin to fill this gap, we examine over a decade of trade secret protection and valuation under the U.S. Economic Espionage Act of 1996.
The Resurrection of the Duty to Inquire After Therasense, Inc. v. Becton, Dickinson & Co.
By: Brandee N. Woolard Balancing a duty to a tribunal and a duty to a client can paralyze a lawyer. The task raises difficult questions about how to reconcile competing obligations as an advocate and as an officer of the court. Individuals licensed to prosecute patent applications must decide how to honor both their obligations to the Patent and Trademark Office (PTO) and their obligation to successfully prosecute patent applications. This burden can result in willful blindness, where the patent attorney or patent agent (“patent practitioner”) limits inquiry into information that may bar a patent application. The recent Federal Circuit opinion in Therasense may have eliminated the judicial “duty to inquire” doctrine that kept these obligations in balance. This Issue Brief argues that there is a need to protect against willful blindness and proposes a resurrection of the eliminated doctrines. Download Full Article (PDF) Cite: 12 Duke L. & Tech. Rev. 41
Carbons Into Bytes: Patented Chemical Compound Protection in the Virtual World
By: B. Thomas Watson “Virtual” molecular compounds, created in molecular modeling software, are increasingly useful in the process of rational drug design. When a physical compound is patented, however, virtual use of the compound allows researchers to circumvent the protection granted to the patentee. To acquire protection from unauthorized use of compounds in their virtual form, patentees must directly claim the virtual compound. But Supreme Court decisions such as Bilski v. Kappos and Mayo Collaborative Services v. Prometheus Laboratories, Inc. call into question whether virtual compound claims are patentable subject matter under § 101. Using the guidance offered by the Supreme Court and Federal Circuit, this Issue Brief argues that virtual compound claims are not abstract ideas and therefore, consistent with patent policy, qualify as patentable subject matter. Download Full Article (PDF) Cite: 12 Duke L. & Tech. Rev. 25
In Ambiguous Battle: The Promise (And Pathos) of Public Domain Day, 2014
By: Jennifer Jenkins On the first day of each year, Public Domain Day celebrates the moment when copyrights expire, and books, films, songs, and other creative works enter the public domain, where they become, in Justice Brandeis’s words, “free as the air to common use.” Educators, students, artists, and fans can use them with neither permission nor payment. Online archives can digitize and make them fully available without the threat of lawsuits or licensing demands. Sadly, in the United States, as a result of copyright term extensions, not a single published work will enter the public domain in 2014. In fact, almost no works created during most readers’ lifetimes will become completely free for them to redistribute and reuse, unless the rights holders affirmatively decide otherwise. In this Article, I will briefly trace the history and consequences of this legally imposed impoverishment of the public domain. But, I argue, this is only part of the story. Increasingly, private initiatives are trying to build zones of legal freedom that simulate some attributes of the public domain. At the same time, there are global copyright reform efforts to limit the negative effects of term extension, at least with regard to “orphan works”—those
After Prometheus, Are Human Genes Patentable Subject Matter?
By: Douglas L. Rogers On April 15, 2013, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on the question, “Are human genes patentable?” This article argues that human genes are not patentable and that isolating a gene from its surroundings in a human body—or creating synthetically what exists in nature as DNA—does not cause the DNA to become patentable subject matter. The isolated DNA segments of claim 1 have the identical nucleotide sequence and the same function as native DNA, and the isolated DNA of claim 1 do not reflect the marked changes required under Chakrabarty, or the inventive step required under Prometheus, to change an unpatentable product of nature into patentable subject matter. Claim 2 describes those nucleotides in the DNA sequence that code for the polypeptide identified in the Myriad Genetics patent specification and simply reflects the genetic code, an unpatentable law of nature. Since no inventive step has been added to the law of nature, claim 2 constitutes unpatentable subject matter under Prometheus. The Federal Circuit’s contrary decision in Myriad Genetics disregards 150 years of Supreme Court cases that physical phenomena found in nature and laws of nature are
The America Invents Act 500: Effects of Patent Monetization Entities on US Litigation
By: Sara Jeruss, Robin Feldman, & Joshua Walker Any discussion of flaws in the United States patent system inevitably turns to the system’s modern villain: non-practicing entities, known more colorfully as patent trolls. For many years, however, discussions about non-practicing entities have been long on speculation and short on data. In 2011 Congress directed the nonpartisan Government Accountability Office to study the effects of non-practicing entities on patent litigation. At the request of the GAO, we collected and coded a set of patent lawsuits filed over the past five years. This article presents our analysis of the data and its implications. The data confirm in a dramatic fashion what many scholars and commentators have suspected: patent monetization entities play a role in a substantial portion of the lawsuits filed today. Based on our sample, lawsuits filed by patent monetizers have increased from 22% of the cases filed five years ago to almost 40% of the cases filed in the most recent year. In addition, of the five parties in the sample who filed the greatest number of lawsuits during the period studied, four were monetizers and only one was an operating company. Download Full Article (PDF) Cite: 11 Duke L.
Cooking Protestors Alive: The Excessive-Force Implications of the Active Denial System
By: Brad Turner The Active Denial System (ADS) is unlike any other nonviolent weapon: instead of incapacitating its targets, it forces them to flee, and it does so without being seen or heard. Though it is a promising new crowd-control tool for law-enforcement, excessive-force claims involving the ADS will create a Fourth Amendment jurisprudential paradox. Moreover, the resolution of that paradox could undermine other constitutional principles—like equality, fairness, and free speech. Ultimately, the ADS serves as a warning that without legislation, American jurisprudence may not be ready for the next generation of law-enforcement technology and the novel excessive-force claims sure to follow. Download Full Article (PDF) Cite: 11 Duke L. & Tech. Rev. 332