Abstract
The patent-eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, principles of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon a pronounced expansion in its definition of patent-eligible subject matter, particularly with respect to software and business method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics from the public and private sectors arguing that the threshold for patent-eligibility needs to be raised in order to ensure that patents fulfill their constitutional objective of encouraging innovation rather than impeding it. The courts and PTO appear to have heard these critics, and have begun to actively rein in the scope of patent-eligible subject matter. This shift in the swing of the patent-eligibility pendulum will likely have a profound impact on the patentability of innovations arising out of the pharmaceutical and biotechnology industries, particularly those relating to diagnostics and personalized medicine. In this article, I discuss the current status of the patent-eligibility doctrine, how it is that we got here, and what the future might hold, particularly for the life science industries.
Keywords: Chakrabarty, LabCorp, Metabolite, Prometheus, Classen, Ariad, thiopurine, fundamental principle, machine or transformation test, Patents, Bilski, patent eligibility, patentable subject matter, personalized medicine, diagnostics, Pharmaceutical Industry, patent-eligibility doctrine, combover” hairstyling techniques, mc2, hydrocarbons, Federal Circuit Court of Appeals, misnomer, synthetic polynucleotides, adrenaline, cellular milieu, NF-B, homo-cysteine, human chorionic go-nadotropin, Down syndrome, prostaglandin H syn-thase-2, COX-2 spe-cific inhibitor, human KCNE1 gene, gas chromatography, mass spectrometry, Abbott test, NF-B-mediated intra-cellular signaling, NF-B pathway, raloxifine, Rader's dire prognosis, BRCA1 gene, human KCNE1
Current Topics in Medicinal Chemistry
Title: Bilski: Assessing the Impact of a Newly Invigorated Patent-Eligibility Doctrine on the Pharmaceutical Industry and the Future of Personalized Medicine
Volume: 10 Issue: 18
Author(s): Christopher M. Holman
Affiliation:
Keywords: Chakrabarty, LabCorp, Metabolite, Prometheus, Classen, Ariad, thiopurine, fundamental principle, machine or transformation test, Patents, Bilski, patent eligibility, patentable subject matter, personalized medicine, diagnostics, Pharmaceutical Industry, patent-eligibility doctrine, combover” hairstyling techniques, mc2, hydrocarbons, Federal Circuit Court of Appeals, misnomer, synthetic polynucleotides, adrenaline, cellular milieu, NF-B, homo-cysteine, human chorionic go-nadotropin, Down syndrome, prostaglandin H syn-thase-2, COX-2 spe-cific inhibitor, human KCNE1 gene, gas chromatography, mass spectrometry, Abbott test, NF-B-mediated intra-cellular signaling, NF-B pathway, raloxifine, Rader's dire prognosis, BRCA1 gene, human KCNE1
Abstract: The patent-eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, principles of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon a pronounced expansion in its definition of patent-eligible subject matter, particularly with respect to software and business method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics from the public and private sectors arguing that the threshold for patent-eligibility needs to be raised in order to ensure that patents fulfill their constitutional objective of encouraging innovation rather than impeding it. The courts and PTO appear to have heard these critics, and have begun to actively rein in the scope of patent-eligible subject matter. This shift in the swing of the patent-eligibility pendulum will likely have a profound impact on the patentability of innovations arising out of the pharmaceutical and biotechnology industries, particularly those relating to diagnostics and personalized medicine. In this article, I discuss the current status of the patent-eligibility doctrine, how it is that we got here, and what the future might hold, particularly for the life science industries.
Export Options
About this article
Cite this article as:
M. Holman Christopher, Bilski: Assessing the Impact of a Newly Invigorated Patent-Eligibility Doctrine on the Pharmaceutical Industry and the Future of Personalized Medicine, Current Topics in Medicinal Chemistry 2010; 10 (18) . https://dx.doi.org/10.2174/156802610793176675
DOI https://dx.doi.org/10.2174/156802610793176675 |
Print ISSN 1568-0266 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4294 |
Call for Papers in Thematic Issues
Chemistry Based on Natural Products for Therapeutic Purposes
The development of new pharmaceuticals for a wide range of medical conditions has long relied on the identification of promising natural products (NPs). There are over sixty percent of cancer, infectious illness, and CNS disease medications that include an NP pharmacophore, according to the Food and Drug Administration. Since NP ...read more
Current Trends in Drug Discovery Based on Artificial Intelligence and Computer-Aided Drug Design
Drug development discovery has faced several challenges over the years. In fact, the evolution of classical approaches to modern methods using computational methods, or Computer-Aided Drug Design (CADD), has shown promising and essential results in any drug discovery campaign. Among these methods, molecular docking is one of the most notable ...read more
Drug Discovery in the Age of Artificial Intelligence
In the age of artificial intelligence (AI), we have witnessed a significant boom in AI techniques for drug discovery. AI techniques are increasingly integrated and accelerating the drug discovery process. These developments have not only attracted the attention of academia and industry but also raised important questions regarding the selection ...read more
From Biodiversity to Chemical Diversity: Focus of Flavonoids
Flavonoids are the largest group of polyphenols, plant secondary metabolites arising from the essential aromatic amino acid phenylalanine (or more rarely from tyrosine) via the phenylpropanoid pathway. The flavan nucleus is the basic 15-carbon skeleton of flavonoids (C6-C3-C6), which consists of two phenyl rings (A and B) and a heterocyclic ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Natural Naphthoquinones with Great Importance in Medicinal Chemistry
Current Organic Synthesis Cyclooxygenase as a Target for Colorectal Cancer Chemoprevention
Current Drug Targets The Implications of Sortilin/Vps10p Domain Receptors in Neurological and Human Diseases
CNS & Neurological Disorders - Drug Targets Neutralizing Endogenous VEGF Following Traumatic Spinal Cord Injury Modulates Microvascular Plasticity but not Tissue Sparing or Functional Recovery
Current Neurovascular Research Pharmacogenomics of Human Multidrug Resistance Associated Proteins
Current Pharmacogenomics and Personalized Medicine RING Finger E3 Ubiquitin Ligases: Structure and Drug Discovery
Current Pharmaceutical Design LFA-1 on Leukemic Cells as a Target for Therapy or Drug Delivery
Current Pharmaceutical Design Kinetic Models for Measuring P-glycoprotein Function at the Blood-Brain Barrier with Positron Emission Tomography
Current Pharmaceutical Design Anti-inflammatory Effects of Rosuvastatin in Healthy Subjects: A Prospective Longitudinal Study
Current Pharmaceutical Design Pharmacogenetics of Metabolic Genes of Anthracyclines in Acute Myeloid Leukemia
Current Drug Metabolism MicroRNA: Biogenesis, Function and Role in Cancer
Current Genomics Chemokines and Their Receptors: Potential Therapeutic Targets for Bone Cancer Pain
Current Pharmaceutical Design TNF-α and IL-8 in Acute Stroke and the Modulation of these Cytokines by Antiplatelet Agents
Current Neurovascular Research Meet Our Editorial Board Member
Current Medicinal Chemistry Pathophysiology of Blood-Spinal Cord Barrier in Traumatic Injury and Repair
Current Pharmaceutical Design Ghrelin: New Insight to Mechanisms and Treatment of Postoperative Gastric Ileus
Current Pharmaceutical Design Provoking Neuroprotection by Peroxynitrite
Current Pharmaceutical Design Polyphenol Supplementation as a Complementary Medicinal Approach to Treating Inflammatory Bowel Disease
Current Medicinal Chemistry Integrins in Pulmonary Inflammatory Diseases
Current Pharmaceutical Design Are Anti-Angiogenic Drugs Useful in Neurodegenerative Disorders?
CNS & Neurological Disorders - Drug Targets