Are Patents Impeding Medical Care and Innovation?

Gold, E. Richard; Kaplan, Warren; Orbinski, James; Harland-Logan, Sarah; N-Marandi, Sevil

doi:10.1371/journal.pmed.1000208

Cited by 52 publications

(39 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…On the other hand, patents significantly increase the price of devices and may decrease innovative efforts in the corresponding field. Gold et al give a thoughtful analysis of the value and limitations of the present practices of patent legislation 25. The market restrictions in the developing world to modern device or pharmaceutical therapy is a particularly serious issue 25.…”

Section: Iprs Patent Issues and Publicationmentioning

confidence: 99%

See 1 more Smart Citation

Barriers to medical device innovation

Bergsland

Elle

Fosse

2014

MDER

View full text Add to dashboard Cite

The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably.

show abstract

Section: Iprs Patent Issues and Publicationmentioning

confidence: 99%

“…Gold et al give a thoughtful analysis of the value and limitations of the present practices of patent legislation 25. The market restrictions in the developing world to modern device or pharmaceutical therapy is a particularly serious issue 25. Alternatives to the present patent practice have been suggested 26…”

Section: Iprs Patent Issues and Publicationmentioning

confidence: 99%

Barriers to medical device innovation

Bergsland

Elle

Fosse

2014

MDER

View full text Add to dashboard Cite

show abstract

“…African researchers too often cannot afford access to important copyrighted peer-reviewed publications, thus jeopardising the ability of their countries to develop medicines, including medicines for diseases neglected by the large pharmaceutical multinationals (Gold et al, 2010). Data exclusivity, a monopoly on data obtained from human trials on the safety and efficacy of new medicines that is included in TRIPS and other treaties, not only restricts access to medicines but problematically privatises benefits from the participation of volunteers.…”

Section: Access To Medicines and A2kmentioning

confidence: 99%

Neglect of the Human Rights Dimension in African IP Policymaking

Rens¹,

Pfumorodze²

2015

Afr. j. inf. commun. (Online)

View full text Add to dashboard Cite

show abstract

“…Patents have the goal of stimulating the creation of new technologies with practical applications through the grant of exclusive rights to make, use, sell, and import inventions for a period of 20 years (and longer in some jurisdictions and under some circumstances). However, the economic impact of patents in the life sciences and their role in stimulating innovation and attracting industry investment in R&D, especially in smaller markets outside of the United States, have been hotly debated (14).…”

Section: Why Focus On Ipr Management and Not Ipr Regimens?mentioning

confidence: 99%

Recalibrating Intellectual Property Rights to Enhance Translational Research Collaborations

2012

Self Cite

View full text Add to dashboard Cite

Multisectoral collaborative models for drug and therapeutic research and development (R&D) are emerging, requiring a recalibration of how intellectual property rights (IPRs) are used. Although these models appear promising, little study has been conducted on the optimal blend of sharing and exclusion as mediated through the proactive use or nonuse of IPRs. This Commentary is a call for a combination of theoretical and empirical analyses to build a comprehensive understanding of the interplay between formal IP laws, institutions that administer and manage IPRs, and the use of IPRs in practice to better construct and manage collaborations. Such analyses require outcome metrics formulated to measure the success of therapeutic outcomes and to capture the complexity of a highly networked R&D environment.

show abstract

Are Patents Impeding Medical Care and Innovation?

Abstract: This month's debate examines whether the current patent system is crucial for stimulating health research or whether it is stifling biomedical research and impeding medical care.

Cited by 52 publications

References 29 publications

Barriers to medical device innovation

Barriers to medical device innovation

Neglect of the Human Rights Dimension in African IP Policymaking

Recalibrating Intellectual Property Rights to Enhance Translational Research Collaborations

Contact Info

Product

Resources

About