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 …

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 …

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 …

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 …

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.

The Biotechnology Process Patent Act Of 1995: Providing Unresolved And Unrecognized Dilemmas In U.S. Patent Law, Becca Alley

Journal of Intellectual Property Law

No abstract provided.

Useless Information: Genetic Patenting, The Usefulness Requirement, And The Effect On The “Big Freeze”, David T. Bennett

Journal of the National Association of Administrative Law Judiciary

This note considers the current state of affairs regarding patentability in the field of biotechnology, especially that of genes and DNA. Part II gives a brief background of patents in general, including the requirements that must be met for a patent to be granted, the way in which the patent process works, and the options available to a patent holder once a patent has been granted. Part III explores the history of biotechnology patents. Part IV takes a look at the relationship between patents and biotechnology, and sheds light on some of the common arguments both in favor of and …

Bioprospect Theory, James Ming Chen

Akron Intellectual Property Journal

Conventional wisdom treats biodiversity and biotechnology as rivalrous values. The global south is home to most of earth's vanishing species, while the global north holds the capital and technology needed to develop this natural wealth. The south argues that intellectual property laws enable pharmaceutical companies and seed breeders in the industrialized north to commit biopiracy. By contrast, the United States has characterized calls for profit-sharing as a threat to the global life sciences industry. Both sides magnify the dispute, on the apparent consensus that commercial exploitation of genetic resources holds the key to biodiversity conservation.

Both sides of this debate …

The Human Genome: A Patenting Dilemma, Pamela Docherty

Akron Law Review

This Comment will address the conflict between the U.S. patent laws and biotechnology by focusing on the NIH patent application.

The first part of this Comment discusses the objectives and statutory requirements of the patent system, which the NIH application purportedly did not meet. Next, this Comment focuses on the debate between NIH and its detractors. It explains NIH's reasons for its actions and discusses the criticisms leveled at the agency. Finally, this Comment presents solutions to the problems that have been uncovered by this debate regarding the patentability of genes.

Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman

Vanderbilt Journal of Entertainment & Technology Law

While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term "synthetic biology" has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …

After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough

Michigan Telecommunications & Technology Law Review

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …

Will Gene Patents Derail The Next-Generation Of Genetic Technologies?: A Reassessment Of The Evidence Suggests Not, Christopher M. Holman

UMKC Law Review

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that …

The Ethics Of Genetic Patenting And The Subsequent Implications On The Future Of Health Care, Suzanne Ratcliffe

Touro Law Review

No abstract provided.

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

What About Know-How: Heightened Obviousness And Lowered Disclosure Is Not A Panacea To The American Patent System For Biotechnology Medication And Pharmaceutical Inventions In The Post-Ksr Era, Yi-Chen Su

Marquette Intellectual Property Law Review

In KSR International Co. v. Teleflex, Inc., the Supreme Court rejected the Federal Circuit's rigid application of the teaching, suggestion, or motivation test (TSM test), and replaced it with an expansive and flexible approach, in determining the question of obviousness. Nevertheless, an expansive and flexible approach to obviousness may not be consistent with the international norms of practice if it is applied literally. The U.S. Patent and Trademark Office's literal application of the decision has essentially created another set of inflexible rules, which is contrary to the Supreme Court's intent. The Federal Circuit's recent decision in In re Kubin cautiously …