The New Patent Regime

2017 ◽  
Author(s):  
Murphy Halliburton
Keyword(s):  
Low Cost ◽  
Standard Of Care ◽  
Patent Law ◽  
New Drugs ◽  
Essential Medicines ◽  
System P ◽  
Patent Laws ◽  
Patent Applications ◽  
Indian Supreme Court ◽  
Silver Lining

This chapter examines efforts to resist the implementation of the new patent regime in India out of concern for the price of essential medicines. The Indian pharmaceutical sector has been a principle source of low cost medicines for developing countries, but may no longer be able to produce inexpensive copies of medications patented elsewhere. India’s WTO-compliant patent law has a silver lining, however, since it requires companies to demonstrate increased effectiveness of new drugs over the standard of care, provisions against “evergreening” of patents that are not required by US patent laws. Activists in India have been able to defeat several recent patent applications under this provision. The pharmaceutical giant Novartis challenged this provision in the Indian Supreme Court while at the same time the company was holding patents for medical products that were derived from India’s indigenous ayurvedic medical system.

scholarly journals The Surprising Resilience of the Patent System

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Patent Law ◽  
Patent System ◽  
Legal Doctrine ◽  
Legislative Reform ◽  
System P ◽  
Patent Rights ◽  
Legal Challenges ◽  
New Business ◽  
Patent Applications

The patent system seems in the midst of truly dramatic change. The lasttwenty years have seen the rise of a new business model – the patent troll– that grew to become a majority of all patent lawsuits. They have seen asignificant expansion in the number of patents granted and a fundamentalchange in the industries in which those patents are filed. They have seenthe passage of the most important legislative reform in the last sixtyyears, a law that reoriented legal challenges to patents away from courtsand toward the Patent and Trademark Office (PTO). And they have seenremarkable changes in nearly every important legal doctrine, from patenteligibility to obviousness to infringement to remedies.These changes have prompted alarm in a number of quarters. From the 1990sto the 2000s, as the number of patents and patent troll suits skyrocketed,technology companies and academics worried about the “crisis” in the patentsystem – a crisis of overprotection that might interfere with rather thanpromote innovation. By 2015, as patent reform took effect and the SupremeCourt undid many of the Federal Circuit’s expansions of patent rights, itwas patent owners who were speaking of a crisis in the patent system – acrisis of underprotection that might leave innovators without adequateprotection. Depending on one’s perspective, then, the sky seems to havebeen falling on the patent system for some time.Despite the undeniable significance of these changes in both directions,something curious has happened to the fundamental characteristics of thepatent ecosystem during this period: very little. Whether we look at thenumber of patent applications filed, the number of patents issued, thenumber of lawsuits filed, the patentee win rate in those lawsuits, or themarket for patent licenses, the data show very little evidence that patentowners and challengers are behaving differently because of changes in thelaw. The patent system, then, seems surprisingly resilient to changes inthe law. This is a puzzle. In this article, I document this phenomenon andgive some thought to why the fundamental characteristics of the patentsystem seem resistant to even major changes in patent law and procedure.The results pose some profound questions not only for efforts at patentreform but for the role of the patent system in society as a whole.

Constructing an Objective History of the U.S. Patent System

2020 ◽  
pp. 65-88
Author(s):  
Jonathan M. Barnett
Keyword(s):  
Patent Law ◽  
Patent System ◽  
Antitrust Law ◽  
Historical Trends ◽  
Qualitative Evidence ◽  
System P ◽  
Injunctive Relief ◽  
History Of ◽  
Patent Applications ◽  
The U.S

This chapter presents a history of the U.S. patent system based on quantitative and qualitative evidence relating to patentees’ expectations that courts will uphold the validity of contested patents, find infringement, and award injunctive relief against infringing parties. Additionally, this chapter describes historical changes in antitrust law that have impacted patentees’ ability to enter into licensing and other patent-dependent transactions. Based on these features of patent law and antitrust-related patent law, supplemented by background institutional developments, the history of the U.S. patent system during 1890–2006 consists of three periods: (i) a strong-patent, weak-antitrust period from 1890 through the mid-1930s; (ii) a weak-patent, strong-antitrust period from the late 1930s through the 1970s; and (iii) a strong-patent, weak-antitrust period from the early 1980s through 2006. Historical trends in the volume of patent applications by U.S. inventors are consistent with this division of U.S. patent history.

Novel Drugs and Biologics of 2016: A Boom for Neurodrugs in the Pipelin

2017 ◽  
Vol 10 (5) ◽  
pp. 3809-3814
Author(s):  
D Samba Reddy
Keyword(s):  
Muscular Atrophy ◽  
Clinical Care ◽  
New Drugs ◽  
Essential Medicines ◽  
High Demand ◽  
The Past ◽  
Novel Drugs ◽  
Innovative Products ◽  
Cns Drugs ◽  
The U.S

This article provides a brief overview of novel drugs approved by the U.S. FDA in 2016.  It also focuses on the emerging boom in the development of neurodrugs for central nervous system (CNS) disorders. These new drugs are innovative products that often help advance clinical care worldwide, and in 2016, twenty-two such drugs were approved by the FDA. The list includes the first new drug for disorders such as spinal muscular atrophy, Duchenne muscular dystrophy or hallucinations and delusions of Parkinson’s disease, among several others. Notably, nine of twenty-two (40%) were novel CNS drugs, indicating the industry shifting to neurodrugs. Neurodrugs are the top selling pharmaceuticals worldwide, especially in America and Europe. Therapeutic neurodrugs have proven their significance many times in the past few decades, and the CNS drug portfolio represents some of the most valuable agents in the current pipeline. Many neuroproducts are vital or essential medicines in the current therapeutic armamentarium, including dozens of “blockbuster drugs” (drugs with $1 billion sales potential).  These drugs include antidepressants, antimigraine medications, and anti-epilepsy medications. The rise in neurodrugs’ sales is predominantly due to increased diagnoses of CNS conditions. The boom for neuromedicines is evident from the recent rise in investment, production, and introduction of new CNS drugs.  There are many promising neurodrugs still in the pipeline, which are developed based on the validated “mechanism-based” strategy. Overall, disease-modifying neurodrugs that can prevent or cure serious diseases, such as multiple sclerosis, epilepsy, and Alzheimer’s disease, are in high demand. 

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

Acute Rejection Following Kidney Transplantation: State-of-the-Art and Future Perspectives

2020 ◽  
Vol 26 (28) ◽  
pp. 3468-3496
Author(s):  
Emilio Rodrigo ◽  
Marcio F. Chedid ◽  
David San Segundo ◽  
Juan C.R. San Millán ◽  
Marcos López-Hoyos
Keyword(s):  
Kidney Transplantation ◽  
Acute Rejection ◽  
Rescue Therapy ◽  
Standard Of Care ◽  
Rejection Rate ◽  
New Drugs ◽  
High Dose ◽  
Current Standard ◽  
Antibody Mediated Rejection ◽  
Cellular Rejection

: Although acute renal graft rejection rate has declined in the last years, and because an adequate therapy can improve graft outcome, its therapy remains as one of the most significant challenges for pharmacists and physicians taking care of transplant patients. Due to the lack of evidence highlighted by the available metaanalyses, we performed a narrative review focused on the basic mechanisms and current and future therapies of acute rejection in kidney transplantation. : According to Kidney Disease/Improving Global Outcomes (KDIGO) guidelines, both clinical and subclinical acute rejection episodes should be treated. Usually, high dose steroids and basal immunosuppression optimization are the first line of therapy in treating acute cellular rejection. Rabbit antithymocytic polyclonal globulins are used as rescue therapy for recurrent or steroid-resistant cellular rejection episodes. Current standard-of-care (SOC) therapy for acute antibody-mediated rejection (AbMR) is the combination of plasma exchange with intravenous immunoglobulin (IVIG). Since a significant rate of AbMR does not respond to SOC, different studies have analyzed the role of new drugs such as Rituximab, Bortezomib, Eculizumab and C1 inhibitors. Lack of randomized controlled trials and heterogenicity among performed studies limit obtaining definite conclusions. Data about new direct and indirect B cell and plasma cell depleting agents, proximal and terminal complement blockers, IL-6/IL-6R pathway inhibitors and antibody removal agents, among other promising drugs, are reviewed.

scholarly journals Generation of High-Yield, Functional Oligodendrocytes from a c-myc Immortalized Neural Cell Line, Endowed with Staminal Properties

2021 ◽  
Vol 22 (3) ◽  
pp. 1124
Author(s):  
Mafalda Giovanna Reccia ◽  
Floriana Volpicelli ◽  
Eirkiur Benedikz ◽  
Åsa Fex Svenningsen ◽  
Luca Colucci-D’Amato
Keyword(s):  
Cell Line ◽  
Low Cost ◽  
Neural Cell ◽  
New Drugs ◽  
High Yield ◽  
Time Saving ◽  
Interacting Protein ◽  
Neuronal Marker ◽  
Differentiation Status

Neural stem cells represent a powerful tool to study molecules involved in pathophysiology of Nervous System and to discover new drugs. Although they can be cultured and expanded in vitro as a primary culture, their use is hampered by their heterogeneity and by the cost and time needed for their preparation. Here we report that mes-c-myc A1 cells (A1), a neural cell line, is endowed with staminal properties. Undifferentiated/proliferating and differentiated/non-proliferating A1 cells are able to generate neurospheres (Ns) in which gene expression parallels the original differentiation status. In fact, Ns derived from undifferentiated A1 cells express higher levels of Nestin, Kruppel-like factor 4 (Klf4) and glial fibrillary protein (GFAP), markers of stemness, while those obtained from differentiated A1 cells show higher levels of the neuronal marker beta III tubulin. Interestingly, Ns differentiation, by Epidermal Growth Factors (EGF) and Fibroblast Growth Factor 2 (bFGF) withdrawal, generates oligodendrocytes at high-yield as shown by the expression of markers, Galactosylceramidase (Gal-C) Neuron-Glial antigen 2 (NG2), Receptor-Interacting Protein (RIP) and Myelin Basic Protein (MBP). Finally, upon co-culture, Ns-A1-derived oligodendrocytes cause a redistribution of contactin-associated protein (Caspr/paranodin) protein on neuronal cells, as primary oligodendrocytes cultures, suggesting that they are able to form compact myelin. Thus, Ns-A1-derived oligodendrocytes may represent a time-saving and low-cost tool to study the pathophysiology of oligodendrocytes and to test new drugs.

Development of a method for detecting trace metals in aqueous solutions based on the coordination chemistry of hexahydrotriazines

The Analyst ◽  
2015 ◽  
Vol 140 (15) ◽  
pp. 5184-5189 ◽  
Author(s):  
Rudy J. Wojtecki ◽  
Alexander Y. Yuen ◽  
Thomas G. Zimmerman ◽  
Gavin O. Jones ◽  
Hans W. Horn ◽  
...  
Keyword(s):  
Heavy Metals ◽  
Coordination Chemistry ◽  
Trace Metals ◽  
Aqueous Solutions ◽  
Detection System ◽  
Low Cost ◽  
System P ◽  
Chemical Indicator

The detection of trace amounts (<10 ppb) of heavy metals in aqueous solutions is described using hexahydrotriazines as a chemical indicator and a low cost fluorimeter-based detection system.

scholarly journals P033 Randomised controlled trial on the efficacy of Audio-visual Health Educational materials on CPAP ADherence: The AHEAD trial

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A32-A32
Author(s):  
C Ellender ◽  
C Samaranayake ◽  
B Duce ◽  
M Boyde ◽  
S Winter ◽  
...  
Keyword(s):  
Health Literacy ◽  
Low Cost ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Eligibility Criteria ◽  
Cpap Adherence ◽  
Low Health Literacy ◽  
Significant Difference ◽  
Educational Videos ◽  
Video Education

Abstract OSA is a prevalent chronic disease with significant health implications, for which achieving &gt;4 hours/night on continuous positive airway pressure (CPAP) is essential for effective treatment. Educational videos to improve CPAP adherence are of interest as a low-cost intervention, however trials have shown mixed results. This study aimed to compare CPAP usage following standard of care education (SOCE), with the usage following the addition of educational videos, customised to incorporate low health literacy communication, motivational and self-efficacy techniques. Methods Adults with OSA recommended treatment with CPAP, were recruited and randomised in a single blinded method, to watch short educational videos following their in laboratory CPAP study or SOCE. The primary outcome was CPAP usage at 2mths and secondary outcomes were usage at 12mth and proportion of patients with adequate usage &gt;4hrs/night. Results 195 patients met the eligibility criteria and were randomised to video education (n = 96) or to SOCE (n = 99). There was no significant difference in compliance at 2mths (median usage 1.7hrs IQR 0–6.2 SOCE, 4.4hrs IQR 0–6.7 video education p = 0.1), however at 12mths there was increased usage in the video education arm (median 0hrs IQR 0–5.4 standard of care, 3.8hrs IQR 0–6.87 p = 0.05). The proportion with adequate CPAP usage &gt;4hrs/night at 12mths was higher in the video education group (33, 33% versus 48, 50% p = 0.01). Conclusions Long-term adherence to CPAP is enhanced by the addition of educational videos that incorporate low health literacy communication and motivational techniques, compared to SOCE.

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