Law Commons^™

What's Not Natural Phenomena? Let's Consider A Three-Step Innovative Concept Test For Composition Of Matter Claims, Sydney Hancock

IP Theory

Biotechnology innovation is rapidly growing, especially in the realm of biotech. This growth leads to questions about patent subject matter eligibility of natural phenomena. For example, currently the human genome and microbiome are being extensively studied, bacteriophages are being edited, animals are being cloned, and CRISPR is widespread. Additionally, composition of matter patent claims give the most protection to patent holders. Therefore, knowing when a natural phenomenon veers into human innovation is important for courts, lawyers, and innovators in the era of biotechnology and genetic engineering.

Part I discusses the history of Supreme Court cases on natural phenomena subject matter …

Crispr, Like Any Other Technology: Shedding Determinism & Reviving Athens, Jon Khan

Canadian Journal of Law and Technology

This article examines current narratives surrounding CRISPR (clustered regularly interspaced short palindromic repeats) and the current Canadian treatment of this novel biotechnology. It argues that Canada’s current approach to genetic research and CRISPR appear to have succumbed to the false narrative of technological determinism. It argues that Canada must buck the narrative and alter the current status quo in two principal ways: Canada should pursue more somatic CRISPR clinical trials in humans and permit pre-clinical germline editing. To design a regulatory regime for clinical germline editing and better guidance on somatic CRISPR clinical trials, Canada should engage Deliberative Polling to …

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Biotechnology Patent Law Top Ten Of 2018 Broad Wins, Sovereignty Loses, And Patent Dance, Kevin E. Noonan, Andrew W. Torrance

Akron Law Review

In this article, we discuss what we consider to be the ten important and influential biotechnology patent law judicial decisions of 2018. These hinged on a variety of patent doctrines. An abbreviated new drug application (ANDA) for the multiple sclerosis drug Ampyra set the stage for the Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2018) decision, in which the Court of Appeals for the Federal Circuit (Federal Circuit) provided guidance on how to conduct an obviousness analysis (35 U.S.C. §103). The Berkheimer v. HP Inc. (Fed. Cir. 2018) decision, although addressing a software invention, provided valuable insight into …

Data Exclusivities In The Age Of Big Data, Biologics, And Plurilaterals, Peter K. Yu

Peter K. Yu

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards.

One topic linking all three developments together concerns the establishment of international standards to protect clinical …

Is Dna Really A Natural Product? It's Time To Separate Fact From (Legal) Fiction: An Examination Of Dna Patentability As A Biological Algorithm In The Post-Myriad Era, Nicholas Ulen

Chicago-Kent Law Review

In 2013, the United States Supreme Court delivered its landmark decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., holding isolated DNA unpatentable, thereby invalidating the claims of thousands of DNA patents in the process. The opinion, delivered by Justice Thomas, reasoned that the act of separating DNA from the body did not sufficiently transform the molecule beyond what naturally exists. Yet the Court found that line to be crossed when it held certain artificially synthesized complementary DNA molecules coding for the exact same gene patentable. Unlike the Federal Circuit, the Court focused its analysis not on the …

Data Exclusivities In The Age Of Big Data, Biologics, And Plurilaterals, Peter K. Yu

Texas A&M Law Review

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards.

One topic linking all three developments together concerns the establishment of international standards to protect clinical …

Computational Experimentation, Tabrez Y. Ebrahim

Faculty Scholarship

Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …

A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch

Seattle University Law Review

The patent system in the United States was forever changed with the introduction of the Leahy-Smith America Invents Act (AIA) in September of 2011. The AIA brought sweeping changes to American patent law in order to align the U.S. with much of the rest of the world by changing the invention priority from a “first to invent” to a “first to file” system. The first section of this note will provide a brief overview of the substance of inter partes reviews and some of the most critical negatives that have become apparent since 2013. The second section of this Note …

State Biotechnology Oversight: The Juncture Of Technology, Law, And Public Policy, Christine C. Vito Ph.D.

Maine Law Review

In a 1980 landmark decision, the Supreme Court of the United States ruled that genetically engineered lifeforms such as bacteria were patentable. The significance of this decision to the emerging biotechnology industry—an industry predicated on intellectual property rights—was incalculable. The characteristically research-intensive, capital-intensive biotechnology industry now had the economic incentive to push the technology of genetic engineering to previously unimagined extremes. The genetic engineering and recombinant DNA applications pursued by the biotechnology industry over the past ten years have engendered a spectrum of perplexing inquiries concerning ethical and moral values; agricultural, ecological and environmental matters; global competitiveness and economic priorities; …

Intellectual Property, Surrogate Licensing, And Precision Medicine, Jacob S. Sherkow, Jorge L. Contreras

IP Theory

The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of a variety of advanced therapies—Keytruda (pembrolizumab), Kymriah (tisagenlecleucel), and patisiran—have ushered in an age of “precision medicine” treatments that target patients’ specific genetic, physiological, and environmental profiles rather than generalized diagnoses of disease. Therapies like these may soon be supplemented by gene editing technologies such as CRISPR, which could enable the targeted eradication of deleterious genetic variants to improve human health. But the intellectual property (IP) surrounding precision therapies and their foundational technology remain controversial. Precision therapies ultimately rely—and are roughly congruent with—basic scientific information …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

Congress Considering Legislation Intended To Reverse The Recent Trend Toward Devaluation Of The Us Patent Right, Christopher M. Holman

Faculty Works

Decisions of the United States Supreme Court spanning the last quarter of a century that have, in the aggregate, substantially devalued the patent right. The Court’s four decisions reinvigorating and substantially raising the patent eligibility bar have probably resulted in the most critical commentary, but a host of other decisions have also served to erode the patent right in multiple dimensions, including the scope of potentially patent-able subject matter as well as the strength and enforce-ability of issued patents. In 2011 Congress joined in when it enacted the America Invents Act (AIA), which includes multiple provisions tending to devalue patents, …

Open Source Approaches In Biotechnology: Utopia Revisited, Yann Joly

Maine Law Review

Tracing its origin to Greek antiquity, intellectual property has become an institution in modern legal systems worldwide. This growing importance of intellectual property was confirmed with the 1994 adoption of the Trade-Related Aspects of Intellectual Property Rights Agreement by the World Trade Organization (WTO), which harmonized the rules of intellectual property amongst the various members of the international community on the model of developed countries. However enshrined in the legal tradition, intellectual property law has also had its share of detractors and has recently come under severe criticism. The exercise of intellectual property rights in such diverse fields of creation …

A Virtue-Centered Approach To The Biotechnology Commons (Or, The Virtuous Penguin), David W. Opderbeck

Maine Law Review

The instrumentalist emphasis of the current biotechnology intellectual property rights (IPR) debate is not surprising. In the American tradition, intellectual property law has long been justified primarily by instrumentalist concerns. Thomas Jefferson famously acceded to the “embarrassment of patent and copyright monopolies because he believed a limited monopoly would encourage the production of new scholarship and inventions. The framers' willingness to allow this embarrassment for the greater good is enshrined in the Intellectual Property Clause of the U.S. Constitution. Countless judicial opinions refer to intellectual property law as a tool that provides necessary incentives to creators and innovators. Intellectual property …

Adoption Of The Bayh-Dolye Act In Developed Countries: Added Presure For A Broad Research Exemption In The United States?, Michael S. Mireles

Maine Law Review

Numerous developed countries, most if not all members of the Organization of Economic Cooperation and Development (OECD), including Japan, France, the United Kingdom, Germany, Austria, Denmark, Norway, Portugal, Spain, and Finland, have or are considering adopting legislation similar to the Bayh-Dole Act. These countries apparently believe that passage of legislation similar to the Bayh-Dole Act will lead to the transfer of government funded research results from the university laboratory to the marketplace and other economic activity. In the United States, the birthplace of the Bayh-Dole Act (the Act), it is not entirely clear whether its passage is the direct result …

Balancing Open Source Paradigms And Traditional Intellectual Property Models To Optimize Innovation, Lisa M. Mandrusiak

Maine Law Review

Copyrights and patents grant property rights to creators and inventors in order to spur further innovation through the dual approach of increasing the amount of material in the public domain and rewarding inventors and creators for their efforts. However, in recent years, it has been postulated that extensive granting of copyrights and patents may in fact stifle additional creation and development. This led to a revolt in the computer programming industry and spawned the open source movement, which provides software with its source code and a license allowing for free creation and distribution of works. This movement attempts to spur …

The European Patent Office And The European Patent: An Open Avenue For Biotechnologists And "Living Inventions", Katrina Mcclatchey

Oklahoma Journal of Law and Technology

No abstract provided.

Agricultural Biogechnology: United States Statutory Law, Jo Lynn Jeter

Oklahoma Journal of Law and Technology

No abstract provided.

The International Treaty On Plant Genetic Resources For Food And Agriculture: Friend Of The International Farmer, Steven M. Ruby

Oklahoma Journal of Law and Technology

No abstract provided.

The Effect Of The "Onco-Mouse" Decisions On The Exception To Patentability For "Animal Varieties" Under The European Patent Convention, Katrina Mcclatchey

Oklahoma Journal of Law and Technology

No abstract provided.

Do The Evolution: The Effect Of Ksr V. Teleflex On Biotechnology, Josh Harrison

Oklahoma Journal of Law and Technology

No abstract provided.

Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini

Arbitration Law Review

No abstract provided.

Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai

Faculty Scholarship

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps, the …

The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman

Faculty Works

In a span of three weeks during the spring of 2017, the U.S. Supreme Court issued three patent decisions, bringing the total number of patent decisions for the 2016-2017 term to six. This means that the October 2016 term ties the previous record of six patent decisions in the October 2014 term. This represents a tremendous increase in the number of patent decisions compared to earlier times, and particularly the early days of the Federal Circuit. For reference, during the first quarter of a century the Federal Circuit was in existence, the Supreme Court heard on average less than one …

Patent Pacifism, Clark D. Asay

Faculty Scholarship

Over the last decade, much of the patent law literature has focused on the problem of “patent trolls,” or patent owners who don’t make products, but sue others that do. The basic complaint against these types of entities is that they impose a tax on innovation without providing offsetting societal benefits. Furthermore, their patent assertions have been on the rise, with a significant percentage of patent suits now attributable to them. In short, the troll phenomenon suggests a problem of excessive patent assertions.

But despite the importance of the troll phenomenon, the fact remains that most patents are never asserted, …

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Faculty Works

There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …

Eli Lilly V. Teva: Generic Companies Infringe Under Akamai Iv In Case Of Divided Infringement, Christopher M. Holman

Faculty Works

The U.S. Supreme Court’s 2014 decision in Limelight Networks v. Akamai Technologies decision (Akamai III), in conjunction with the Federal Circuit’s stance on divided infringement claims, effectively undermined the value of method claims, particularly in the realm of pharmaceuticals, diagnostics, and other biotechnology related innovation, by limiting the ability of patentees to establish liability in cases where steps of the claimed method are performed by multiple parties. On remand, the en banc Federal Circuit in Akamai Technologies v. Limelight Networks (Akamai IV) sought to address the problem by expanding the definition of direct infringement under 271(a) to encompass more scenarios …

Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow

Other Publications

Several research institutions are embroiled in a legal dispute over the foundational patent rights to CRISPR-Cas9 gene-editing technology, and it may take years for their competing claims to be resolved. But even before ownership of the patents is finalized, the institutions behind CRISPR have wasted no time capitalizing on the huge market for this groundbreaking technology by entering into a series of licensing agreements with commercial enterprises. With respect to the potentially lucrative market for human therapeutics and treatments, each of the key CRISPR patent holders has granted exclusive rights to a spinoff or "surrogate" company formed by the institution …