scholarly journals Technology Development Through Pooling ARV Drug Patents: A Vision from China

2010 ◽  
Vol 4 (1) ◽  
pp. 54-59 ◽  
Author(s):  
Li Liu ◽  
Hongzhou Lu
Keyword(s):  
Generic Drug ◽  
Patent Protection ◽  
Technology Development ◽  
Generic Drugs ◽  
Patent Application ◽  
Chinese Government ◽  
Compulsory Licensing ◽  
Drug Companies ◽  
Patent Pool ◽  
Drug Patents

Unaffordable prices still bar the end-users in China from accessing ARV drugs. Patent protection of ARV drugs has dramatically limited the availability of these lifesaving drugs to AIDS patients in China. The way Chinese government can go to breakthrough the ARV drug patents are suggested as: -  Make more generic drugs available through compulsory licensing, impartment from other countries or building ARVs plants by partnerships between governments or generic drug companies. -  Do a thorough and detailed research on the patent application of ARV drugs to find out the loophole. -  Try patent pool to make AIDS medicines more affordable and appropriate for patients.

Recent Developments in Health Law

2012 ◽  
Vol 40 (1) ◽  
pp. 165-170
Author(s):  
Brenna Jenny
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
Tort Law ◽  
Drug Manufacturer ◽  
Recent Change ◽  
Brand Name ◽  
Drug Companies ◽  
Drug Regulations ◽  
Recent Developments ◽  
The Individual

When the Supreme Court in PLIVA v. Mensing determined that certain state tort law failure-to-warn claims against generic drug companies were pre-empted by federal drug regulations, the pronouncement was met with substantial criticism. In light of the Court's decision two years earlier in Wyeth v. Levine, where the Court allowed a similar claim against a brand-name drug manufacturer to proceed, many complained the resulting Levine-Mensing dichotomy created an arbitrary distinction between brand-name and generic drugs, allowing an injured patient's ability to recover to hinge solely on the happenstance of whether the individual had taken the brand-name or generic version. But, although Mensing cut back significantly on the ability of plaintiffs to make state law failure-to-warn claims against generic drug manufacturers, the case did not completely prohibit such claims. Instead, the Court banned only failure-to-warn claims premised on an argument that the generic drug company needed to change its label in order to meet state tort law duties. If plaintiffs can advance other theories independent of a formal label change, such as a failure to adequately warn a physician about a recent change to the drug's label, then they may still be able to proceed against generic drug manufacturers.

MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

2013 ◽  
Vol 1 (3) ◽  
pp. 1-6
Author(s):  
Pankaj Kashyap ◽  
Eshant Duggal ◽  
Parveen Budhwar ◽  
Jitendra Kumar Badjatya
Keyword(s):  
Generic Drug ◽  
Patent Protection ◽  
Drug Approval ◽  
Approval Process ◽  
Generic Medicines ◽  
Healthcare Provision ◽  
Pharmaceutical Markets ◽  
Global Issue ◽  
Drug Approval Process ◽  
High Level

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process. 

scholarly journals Towards a Patent Pool for HIV Medicines: The Background

2010 ◽  
Vol 4 (1) ◽  
pp. 33-36 ◽  
Author(s):  
Michelle Childs
Keyword(s):  
Pharmaceutical Product ◽  
First Line ◽  
Middle Income ◽  
Compulsory Licensing ◽  
Middle Income Countries ◽  
Medical Needs ◽  
Patent Pool ◽  
Patent Rights ◽  
Systematic Solution ◽  
Foreign Ministry

Recent WHO guidelines for antiretroviral therapy recommend switching to less toxic, but more expensive medicines for first-line and second-line ART, raising questions about the financial sustainability of many AIDS treatment programmes. At the same time, many key generic producing countries such as India now grant pharmaceutical product patents so competition between multiple manufacturers will not be able to play the role it has in bringing down the price of newer drugs. Overcoming these patent barriers will require a range of solutions, such as restricting patentability criteria, or compulsory licensing. One additional systematic solution is provided by the patent pool, a collective solution to the management of patent rights, initially presented by Médecins Sans Frontières to the French Foreign Ministry and subsequently the UNITAID Executive Board in 2006. A patent pool must not be implemented at any costs, but answer medical needs, be based on economic realities and meet the access needs of the developing world, including middle-income countries.

Corporate Social Responsibility of Pharmaceutical Industry Towards Access to Medicine

2019 ◽  
pp. 793-832
Author(s):  
Rakhi Rashmi
Keyword(s):  
Corporate Social Responsibility ◽  
Social Responsibility ◽  
Patent Protection ◽  
Generic Drugs ◽  
World Health Organisation ◽  
Access To Medicines ◽  
World Health ◽  
Generic Medicines ◽  
Drug Manufacturing ◽  
Corporate Social

India has changed its patent policy in 2005. It was compliance to WTO TRIPs provision and after this there was prohibition on process or generic manufacturing. India is the biggest supplier of affordable generic medicines and this patent protection is said to be beneficial to novel drug manufacturing countries. The generic drugs can be a differentiation factor between lives starting point and the ending point for millions of people in developing countries. This remains an obstacle to inexpensive generic medicines which results in devastating impact on the poorer people. These patent laws allow large MNC's to place ‘profits over people'. World Health Organisation report price of medicines are important for maintaining the affordability and access of the medicines. This research evaluates the strategies and practices of Glaxo Smith Kline in contribution towards the access to medicines and their contribution of corporate social responsibility in India.

Price Comparison between Innovator and Generic Medicines Sold by Community Pharmacies in the State of Penang, Malaysia

2008 ◽  
Vol 6 (1) ◽  
pp. 35-42 ◽  
Author(s):  
Asrul Akmal Shafie ◽  
Mohamed Azmi Hassali
Keyword(s):  
Patent Protection ◽  
Generic Drugs ◽  
The State ◽  
Selling Price ◽  
Generic Medicines ◽  
Cross Sectional ◽  
Foreign Products ◽  
Generic Products ◽  
Collection Form ◽  
The Cost

Generic medicines play a key role in the affordability of pharmaceuticals. This study aims to compare price and to document the actual savings that can be achieved if generics are used by consumers in the state of Penang, Malaysia. This is a cross-sectional pilot study on the price of innovator and generic medicines for the 20 most-used medications in Malaysia. Upon consent, 20 retail pharmacies were conveniently selected. A pre-validated data collection form was used to collect their selling price from the community pharmacist. The analysis was limited to medicines in the same dosage form and dose. Those still under patent protection or combined with other active ingredients were excluded from the study. This study found that most innovator drugs are 27–90 per cent more expensive than generics. Some generic drugs are, however, more expensive than their innovator counterparts (40 per cent higher). Some locally produced generics are also more expensive than foreign products. The current findings suggest that consumers can save up to 90 per cent of the cost of their medication by using generic products. Further investigation is needed to explore the causality of the observed differences in price of products in order to increase their accessibility to the general population.

Therapeutic Equivalence and the Generic Competition Paradox

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro
Keyword(s):  
Simple Model ◽  
Generic Drug ◽  
Generic Drugs ◽  
Large Body ◽  
Medical Community ◽  
Therapeutic Equivalence ◽  
Generic Competition ◽  
Branded Drug ◽  
Fda Approval ◽  
Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

Generic Drugs—A Look Back and a Look Ahead

1990 ◽  
Vol 3 (3) ◽  
pp. 192-202
Author(s):  
Leon Lachman ◽  
Salvatore Turco ◽  
James T. O'Donnell
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
Drug Industry ◽  
Look Ahead ◽  
Look Back

This review includes the viewpoints of three pharmaceutical scientists tracing the origins of the generic drug industry, examining the recent generic drug controversies, and offering suggestions to hospital practitioners for coping with the controversies.

Global Spread of Pharmaceutical Patent Protection: Micro Evidence from the International Equivalents of Drug Patents in Japan

2017 ◽  
Vol 8 (1) ◽  
pp. 26-47
Author(s):  
Yoshimi Okada ◽  
Sadao Nagaoka
Keyword(s):  
Patent Protection ◽  
Substantial Effect ◽  
Chemical Substance ◽  
European Patent ◽  
Patent Laws ◽  
Pharmaceutical Patent ◽  
Global Spread ◽  
Year 2000 ◽  
Substantial Heterogeneity ◽  
Drug Patents

We investigate the global spread of pharmaceutical patent protection as acquired by firms, based on a novel global patent database for all significant medical drugs, including biologics, introduced in Japan. It gives us the propensity of filing and grant rate for each country for patents granted in Japan. The major findings of the study are as following. Both the filing propensity to and the grant rate of major Asian countries approached those of the OECD economies by the early 2000s for chemical substance inventions. However, substantial heterogeneity with respect to other drug inventions still exists, specifically, crystal, use, formulation or combination, suggesting significant future room for international harmonization of patent granting standards. We found clear evidence of policy impact on the spread of protection for the two largest non-OECD economies. The amendments to Patent Laws in China in 1993 had an immediate and significant impact on patent filing propensity to China (30 percentage points increase), before accession to the WTO in late 2001. Furthermore, India’s ‘mailbox application system’ had a substantial effect as filing propensity reached 80 per cent of the number of corresponding European patent applications around year 2000, prior to implementing the Trade-Related Aspects of Intellectual Property Rights for drug patents in 2005. Subject classification codes: O34, O38, K29

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