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Monthly Archives: June 2013

On April 1, 2013, the Supreme Court in India handed down its decision to dismiss Swiss drug maker Novartis AG's attempt to win patent protection for its cancer drug Glivec. In doing so, the Supreme Court held that incremental improvements or modifications to an existing drug are not patentable under India’s patent laws. While the ruling may have allowed India to maintain its ability to manufacture generic drugs, the ruling has increased the challenges that pharmaceutical and biotechnology companies face in obtaining patent protection in India. In the long term, these challenges may prove to have far greater implications for the biotechnology industry that go beyond merely the patentability of one drug product. In view of this recent decision, pharmaceutical and biotechnology companies are undoubtedly re-evaluating their foreign patent strategies.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for June 18 2013

TradenameApplicantGeneric Name Patent Expiration
RILUTEK
Covis Pharma Sarl
riluzole
Jun 18, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


DrugPatentWatch Infographics

Which pharmaceutical companies have the most drugs

Which Companies Have the Most Branded Drugs?

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  • Patent litigation
  • Clinical trial information
  • International patent families
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  • Patent maintenance
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  • Paragraph IV challenges
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  • Drug Master Files
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See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for June 11 2013

TradenameApplicantGeneric Name Patent Expiration
ZAVESCA
Actelion Pharms Ltd
miglustat
Jun 11, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


DrugPatentWatch Infographics

Which pharmaceutical companies listed the most drug patents last
year

Which Companies Listed the Most Drug Patents Last Year?

More infographics »

DrugPatentWatch Serves Your Competitive Intelligence Needs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for June 16 2013

TradenameApplicantGeneric Name Patent Expiration
INVEGA SUSTENNA
Janssen Pharms
paliperidone palmitate
Jun 16, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


DrugPatentWatch Infographics

Which pharmaceutical companies listed the most drug patents last
year

Which Companies Listed the Most Drug Patents Last Year?

More infographics »

DrugPatentWatch Serves Your Competitive Intelligence Needs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

DrugChatter - How do people like their drugs?A common challenge faced pharmaceutical industry analysts, pharmacists, and other healthcare professionals is obtaining objective information on recently approved drugs. Often the only source of information in the first months after a drug’s launch is from sales representatives who may not have access to raw clinical data.

DrugChatter fills this gap by tapping into the DrugPatentWatch database and mining social media to bring you public opinions on recently-approved drugs . DrugChatter also provides details on the most discussed drugs, and can supplement focus groups with its profiles of pharmaceutical drug ads.

I invite you to take a look at this new site in development, and let me know what you think.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for June 7 2013

TradenameApplicantGeneric Name Patent Expiration
FUZEON
Roche
enfuvirtide
Jun 7, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


DrugPatentWatch Infographics

Top
selling drugs

What are the Top-selling Drugs?

More infographics »

DrugPatentWatch Serves Your Competitive Intelligence Needs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for June 4 2013

TradenameApplicantGeneric Name Patent Expiration
ADVAIR HFA
Glaxosmithkline
fluticasone propionate; salmeterol xinafoate
Jun 4, 2013
FLOVENT HFA
Glaxo Grp Ltd
fluticasone propionate
Jun 4, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


DrugPatentWatch Infographics

Top
selling drugs

What are the Top-selling Drugs?

More infographics »

DrugPatentWatch Serves Your Competitive Intelligence Needs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

This guest post is from the BiotechBlog Intern,  Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.

Earlier this year the International Service for the Acquisition of Agri-biotech Applications (ISAAA) reported that for the first time the developing world has taken over responsibility for producing over half (52%) the commercially available Genetically Modified (GM) crops worldwide. While the majority of these seeds can be traced to Western companies, the current state of native GM research in both the African and Asia-Pacific regions are both growing and have noticeable similarities; in both areas only a handful of countries serve as the growth poles for a region with scattered levels of GM policies and research institutions.

In Sub Saharan Africa, both South Africa and Burkina Faso have been recognised in a UNDP paper as instigating modern commercial biotechnology in the region. Similarly India, China and The Philippines are credited with the quick adoption of GM crops in their regions with cotton, maize and canola being the leading crops. While social debates over GM crops echo many of the issues in the developed world, a unique complaint in the African region is the involvement of the dominant seed companies in native biotech agriculture development projects by controlling the supply of seeds, these companies can be seen to be taking over the traditionally held role of the farmer in creating the best possible crop variety. In effect, what sovereign genetic engineering there was (via breeding) in the region is being removed. In Asia problems seem to stem from the sheer variety of GM legislation levels for each country. A 2008 list compiled by APCoAB illustrates the varying extent of legislation established by governments; from India’s extensive policies covering trade and biosafety to Mongolia only offering a 2005 framework for development.

The African Panel on Biotechnology has recommended a “co-evolutionary” approach to developing biotech legislation. As Dr Adrian Ely – head of Impact and Engagement at Social Technological & Environmental Pathways to Sustainability (STEPS) Centre – explains the agricultural research group CIMMYT were “working within a regulatory vacuum” when it came to their recent efforts in Kenya. “They obviously have been working with the authorities and everything they’ve been doing is in the full knowledge of the authorities and where they’ve required licences they’ve had them. That’s an example where even in the absence of an actual law … legally sanctioned biosafety research was able to continue.”

For Africa a major factor hindering research development is the highly volatile nature of investment. In 2011 the Agricultural, Science and Technology Indicators held a conference in an attempt to pin down reasons for the low investment in Africa’s agricultural R&D. The financial culture of one-off donations and deals with development banks tend to leave research institutions nearing bankruptcy once the donor-funded project is finished was pointed out as one major factor. It was also illustrated using the “Volatility Coefficient” (the standard deviation of growth in R&D spending over a course of time) that Sub-Saharan Africa’s scattered R&D investment amongst countries created a far more volatile environment compared to the Asia-Pacific region. Two main sources of funding – government grants and the region’s remarkably higher level of donor contribution – were also found to be incredibly volatile, with the lack of transparency and income security in government and in particular the short term, ad hoc attitude to donor funding being the main factors in volatility.

In the Asia-Pacific region, both government policies and public opinion tend to provide the main difficulties in fostering a competitive R&D capacity. When discussing the challenges with BiotechBlog Dr Tom Burns, director of the Asia and Pacific Seed Association, notes that while India has had a history of success with GM cotton crops, the vocal anti-GM lobby is being successful in preventing edible GM crop research from being developed further. These protests may then prevent funding at a government level in response to the negativity. This approach manifested itself most clearly in 2004, when Bayer announced it was giving up on its efforts on commercialising crops in India, following several protests which included Greenpeace activists chaining themselves to their Indian headquarters.

Another, more pressing issue involves the restrictions on commercialising research due to the prohibitive cost of intellectual property licensing. Licensing out previous traits to include in a new GM crop strain under westernised intellectual property (IP) policies often mean that those crops developed in the African and Asian-Pacific region can be too expensive to compete in the market.

Such problems are less prevalent in India and China, the two emerging R&D centres of the region. China is less stringent on its IP policies and has benefited from constantly revising their seed policy to ensure that even small seed companies are able to flourish, curtailing the practice of a black market for seeds that bypass lengthy legislation and are grown without approval (the so-called “Stealth Seeds” that have been found in India and Argentina, among others). Active support from the Chinese government and self-tailored polices have meant that the country is now the 6th largest producer of GM crops in the world. India’s success with GM crops (in particular GM cotton) has lead to a more commercial achievement. As stated in an ISAAA report last year, India was transformed from a net importer to net exporter of cotton since its commercial approval in 2002, and quotes a Barnes and Barfoot estimate of GM cotton adding $9.4bn to agricultural income in the 2002-2010 period alone. This seems to have encouraged regional governments in India to pursue field trials with other crops, though this has been met with the aforementioned controversy. Nonetheless India’s recent confidence in its GM crop potential has lead to a quickened pace in research centres, increased acceptance among the farming community and just this month the introduction of a bill in government aiming to quell disinformation from anti-GM groups.

Though only in its infancy, GM crop research in these countries has nontheless already produced world-class success stories. Calestous Juma, Professor of International development at Harvard University, recently illustrated the success Nigeria’s Institute for Agricultural Research in addressing a regional challenge to the black-eyed pea crop by developing their own transgenic variety. Larger-scope institutions such as the International Treaty on Plant Genetic Resources are helping to harmonise the intellectual property and biopiracy concerns to help encourage commercialisation, while the Strengthening Capacity for Safe Biotechnology Management (SABIMA) project offers support for those countries who decide to develop their biotechnology capacity. Though it may still be too early to tell in many of these cases it appears that for the countries experiencing the greatest growth in the regions, a certain degree of autonomy and relaxed intellectual property laws have helped GM research create localised solutions to crop challenges and economic strength.

About the author:

Fintan Burke is a student at the School of Biotechnology at Dublin City University. His main fields of interest include biomedical therapies and recombinant organisms.  Fintan may be contacted at fintan.burke2@mail.dcu.ie .

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Legal and regulatory update

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ABSTRACT: The European Commission has launched a public consultation on its proposed amendments to the Medical Devices Directive (MDD) (Dir 93/42/EEC). The aim of the European Commission's proposals is to improve the coherence, transparency and effectiveness of the legislation governing medical devices in line with the recommendations of the report produced in 2002 by the European Commission's Medical Device Experts Group...

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