DNA as Patentable Subject Matter and a Narrow Framework for Addressing the Perceived Problems Caused by Gene Patents

Concerns about the alleged harmful effects of gene patents— including hindered research and innovation and impeded patient access to high-quality genetic diagnostic tests—have resulted in overreactions from the public and throughout the legal profession. These overreactions are exemplified by Association for Molecular Pathology v. U.S. Patent and Trademark Office, a 2010 case in the Southern District of New York that held that isolated DNA is unpatentable subject matter under 35 U.S.C. § 101. The problem with these responses is that they fail to adequately consider the role that gene patents and patents on similar biomolecules play in facilitating investment in the costly and risky developmental processes required to transform the underlying inventions into marketable products. Accordingly, a more precisely refined solution is advisable. This Note proposes a narrowly tailored set of solutions to address the concerns about gene patents without destroying the incentives for companies to create and commercialize inventions derived from these and similar patents

The Eye Alone Is the Judge: Images and Design Patents

Design patents are an area of intellectual property law focused entirely on the visual, unlike copyright, patent, trademark, trade secret, or the various sui generis protections that have occasionally been enacted for specific types of innovation. Judges and lawyers in general are highly uncomfortable with images, yet design patents force direct legal engagement with images. This short piece offers an outsider’s view of what design patent law has to say about the use of images as legal tools, why tests for design patent infringement are likely to stay unsatisfactory, and what lessons other fields of intellectual property, specifically copyright, might take from design patent

A Budding Theory of Willful Patent Infringement: Orange Books, Colored Pills, and Greener Verdicts

The rules of engagement in the brand-name versus generic-drug war are rapidly changing. Brand-name manufacturers face increasing competition from Canadian manufacturers of generic drugs, online drug companies, and Wal-Mart® Super Centers deciding to cash in by turning a piece of the generic prescription drug business into a huge marketing campaign with offerings of generic drugs for four dollar prescriptions. Other discount drug providers are likely to follow suit in hopes of boosting customer traffic and sales of their generic drugs. Now, more than ever before, attorneys representing owners of pharmaceutical patents need to be creative with their damages theories to maximize recovery and help their clients recoup the investments in research and development necessary to bring new and innovative drugs to the marketplace. This article suggests a novel theory of willful infringement to assist a patent owner in recovering treble damages and attorneys’ fees

The Promising Viral Threat to Bacterial Resistance: The Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives

Bacteriophages, or “phages,” are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer’s front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. § 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof

The Promising Viral Threat to Bacterial Resistance: The Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives

Bacteriophages, or “phages,” are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer’s front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. § 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof

Can Post-Grant Reviews Improve Patent System Design? A Twin Study of US and European Patents

This paper assesses the impact of adopting a post-grant review institution in the US patent system by comparing the “opposition careers” of European Patent Office (EPO) equivalents of litigated US patents to those of a control group of EPO patents. We demonstrate several novel methods of "twinning" US and European patents and investigate the implications of employing these different methods in our data analysis. We find that EPO equivalents of US litigated patent applications are more likely to be awarded EPO patent protection than are equivalents of unlitigated patents, and the opposition rate for EPO equivalents of US litigated patents is about three times higher than for equivalents of unlitigated patents. Patents attacked under European opposition are shown to be either revoked completely or narrowed in about 70 percent of all cases. For EPO equivalents of US litigated patents, the appeal rate against opposition outcomes is considerably higher than for control-group patents. Based on our estimates, we calculate a range of net welfare benefits that would accrue from adopting a post-grant review system. Our results provide strong evidence that the United States could benefit substantially from adopting an administrative post-grant patent review, provided that the post-grant mechanism is not too costly

The Political Economy of the Research Exemption in American Patent Law

This Article approaches the research exemption, and related legal developments, as a case study in the political economy of patent law. Part I recounts the history of the research exemption, touching briefly on historical origins but emphasizing developments since the 1970s in legislative, executive, and judicial forums. It also examines changes during the same time frame in related areas of patent law, like the Bayh-Dole legislation and the attempted repeal of state immunity from patent infringement liability. These legal developments indirectly affected the research exemption, or implicated similar concerns about imbalance in the patent system and the use of patents to tax, control, or inhibit research activity. Part II analyzes this history to illustrate and expand upon two major themes in the political economy of patent law, namely the surprising persistence of faulty economic ideology in patent policymaking and the institutional bias exhibited by the Court of Appeals for the Federal Circuit in shaping modern patent law. One major conclusion is that together these forces have created an excessively complex and ill-designed policy environment that is placing a significant strain on the national research system, a strain that executive agencies and the courts have tried to alleviate through ad hoc agreements and modifications of other patent doctrines, like the doctrine of subject matter eligibility

The Political Economy of the Research Exemption in American Patent Law

This Article approaches the research exemption, and related legal developments, as a case study in the political economy of patent law. Part I recounts the history of the research exemption, touching briefly on historical origins but emphasizing developments since the 1970s in legislative, executive, and judicial forums. It also examines changes during the same time frame in related areas of patent law, like the Bayh-Dole legislation and the attempted repeal of state immunity from patent infringement liability. These legal developments indirectly affected the research exemption, or implicated similar concerns about imbalance in the patent system and the use of patents to tax, control, or inhibit research activity. Part II analyzes this history to illustrate and expand upon two major themes in the political economy of patent law, namely the surprising persistence of faulty economic ideology in patent policymaking and the institutional bias exhibited by the Court of Appeals for the Federal Circuit in shaping modern patent law. One major conclusion is that together these forces have created an excessively complex and ill-designed policy environment that is placing a significant strain on the national research system, a strain that executive agencies and the courts have tried to alleviate through ad hoc agreements and modifications of other patent doctrines, like the doctrine of subject matter eligibility

Undergraduate Research Journal, Volume 15

Table of Contents: The Effects of Snorkel-Based Tourism on the Behavior of Reef Fishes / by Savannah Clapp, Lauren Rowsey, and Jordan Grant (p.1-18) -- People Broken Into Pieces Trying to Join: Byzantine Erotica and the Provocative Paradox / by Kendall DeBoer (p.19-28) -- The Legacy of 1830 Land Cover on Present-Day Massachusetts Forest Composition / by Sofie McComb (p.29-58) -- The Role of Labels in Making Inferences about Group Categorization / by Subhashini Madhavan (p.59-76) -- Transcending Autobiography: Simultaneity and Meaning in Elisabet Ney’s Lady Macbeth / by Kendall DeBoer (p.77-92) -- Comparison of Microbial Diversity in Local Wasps and Plant Surfaces / by Dylan Fall and Jo-anne Holley (p.93-104) -- Ambiguity in Biotechnology Patent Policy: Lessons from Association for Molecular Pathology v. Myriad Genetics, Inc. / by Chari Noddings (p.105-126) -- About the uncountability of the number of irrational powers of irrational numbers evaluated as rationals and solutions’ estimation for xx=y and xx =y / by Anca Andrei (p.127-133)Senate of College Council

Something more is necessary: are genes and genetic diagnostic tests statutory subject matter for US patents?

In a recent decision (AMP v. USPTO) from the US District Court, patent claims directed at DNA sequences corresponding to human genes and to diagnostic tests based on such genes have been found to be invalid, primarily on the basis that the DNA molecules claimed, which included cDNA, primers and probes, are 'products of nature' and are thus unpatentable. If upheld, this decision will have considerable impact on the ability of biotechnical companies and universities to patent the results of their research. In this article, we will explain the basis for this decision and discuss the appropriateness of patenting discoveries and their (obvious) uses in the light of this fascinating case. While our focus will primarily be on the product claims, diagnostic method claims were also revoked in AMP v. USPTO on the basis that they were for mental acts or did not involve any 'transformation of matter'. This will be discussed in the light of the recent US Supreme Court decision in Bilski v. Kappos, which focused on the patent-eligibility of process claims