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Monthly Archives: November 2013

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Drug Patent Expirations for November 17 2013

TradenameApplicantGeneric NamePatent Expiration
SURFAXIN
Discovery Labs
lucinactant
Nov 17, 2013

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


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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

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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.

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

Embryo and stem cell research: Views from the USA

Go to paper

ABSTRACT: Presents a study that examined the history, ethical debates and religious views regarding embryo and stem cell research in the U.S. Effect of the abortion debate on embryo research in the U.S.; Reason behind the reluctance of the federal government to fund therapeutic research; Role of the private sector in the development of embryo and stem cell research.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

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

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Drug Patent Expirations for November 16 2013

TradenameApplicantGeneric NamePatent Expiration
EXPAREL
Pacira Pharms Inc
bupivacaine
Nov 16, 2013

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


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  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

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 is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

My maiden guest post for the Biotechblog last focused on the global impact of reduced funding for innovative bio-pharma development on clinical research and the threat to the global clinical research enterprise.   At that point the clinical research sector in India looked like an outlier with year-on-year increases in clinical trials and revenues projected to grow from $450 million in 2011 to $1b by 2016.  Now as we approach the end of 2013, that rosy scenario appears increasingly unrealistic.  India’s clinical research sector faces an uncertain future, with allegations including lack of informed consent and poor treatment of illiterate Indian patients.

Responding to civil society allegations of corruption and fraud, the Indian Supreme Court has intervened directly in the conduct of clinical research in India, suspending or freezing hundreds of clinical trials.  While it is tempting to put the blame for lax enforcement of standards on the recent influx to India of MNC clinical trials, India’s Parliamentary Standing Committee on Health and Family Welfare identified similar shortcomings in oversight of both domestic Indian companies and MNCs alike, going back several years in time.

Well ahead of the Indian Supreme Court decisions in 2013, the Parliamentary Standing Committee reported in May of 2012 that  the Central Drugs Standards Control Organization (CDSC) – the primary watchdog responsible for drug safety and related clinical research – had long since been captured by the industry it was charged with regulating:

The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured. p. 9  

The Parliamentary Standing Committee cited systematic fraud, for example, in the case of Cipla’s application for approval of cancer drug Pirfenidone.  The Committee concludes that Cipla never undertook the required Phase III clinical trial in India, and yet the company received marketing approval nonetheless.

Not only the regulators, but Indian academics and specialist hospital physicians are also compromised in the process.  The Committee’s report to the both chambers of Parliament continues, documenting that the company coordinated or otherwise controlled simultaneous submission 4 separate letters of recommendation of approval from institutions located in Delhi, Mumbai, Chandighargh and Secunderabad – all received exactly on the same day 2-7 2010 and diarized by DCGI office under consecutive references 4877, 4878, 4879 and 4880.” (p. 34)

(In October of 2010, Cipla issued a glowing press release announcing the launch of the “World’s First Generic Pirfenidone in India, Giving Hope to Suffers of IPF (Idiopathic Pulmonary Fibrosis)”  Despite the strong documentation presented to both Houses of Parliament supporting the contention that the Cipla did not conduct any clinical trials at all prior to approval of this first generic copy of a serious cancer drug, it remains on the market in India and internationally via Canadian online pharmacies – caveat emptor.)

Now the India Supreme Court process has taken matters to the other extreme, creating onerous and unrealistic new clinical research requirements and freezing clinical research in India, far exceeding requirements under the  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, known as ICH. These include mandatory compensation requirements for patients, and use of audio and visual recordings of informed consent, among others.  Paradoxically, by imposing more stringent obligations than exceed ICH standards, the Indian Supreme Court rulings further reduces the likelihood that India can build needed capacities for ethical clinical research in compliance with international compliance.

In this context,  a clinical research advocacy group known as: People for the Advancement of Clinical Research – India, has lodged an online petition at Change.org and petitioning Supreme Court of India: “Allow the Review and Approval Process for Clinical Trial Applications to Resume.” The Change.org petition provides compelling reasons for the continuation of clinical trials in India – identifying the existing standards and the extraordinary new measures now required under the recent Indian Supreme Court decisions.  Everything in the petition is both true and  yet sadly irrelevant given what we know to be the unfortunate ground realities documented by the 2012 Parliamentary Standing Committee report.

The Change.org petition seeks to reinstate the status quo ante without any serious reflection on how things have gone wrong, or suggestions on how to change a drugs development culture that tolerates cutting of corners and even outright fraud.  All good intentions aside, Indian academics, industry and government agencies together have shown remarkable effectiveness at evading and undermining India’s compliance with ICH standards.

The Indian Supreme Court may have got it wrong, but the Change.org petition does not get it right.

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

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

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Drug Patent Expirations for November 12 2013

TradenameApplicantGeneric NamePatent Expiration
TECHNESCAN MAG3
Mallinckrodt
technetium tc-99m mertiatide kit
Nov 12, 2013

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


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

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 November 8 2013

TradenameApplicantGeneric NamePatent Expiration
ACIPHEX
Eisai Inc
rabeprazole sodium
Nov 8, 2013
ACIPHEX SPRINKLE
Eisai Inc
rabeprazole sodium
Nov 8, 2013

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


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

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 November 5 2013

TradenameApplicantGeneric NamePatent Expiration
PROPECIA
Merck
finasteride
Nov 5, 2013

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


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

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 November 2 2013

TradenameApplicantGeneric NamePatent Expiration
SAMSCA
Otsuka America Pharm
tolvaptan
Nov 2, 2013

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


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

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.

Drug Patent Expirations for November 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
SAMSCAOtsuka America Pharmtolvaptan5,258,510Nov 2, 2013
PROPECIAMerckfinasteride5,571,817Nov 5, 2013
ACIPHEX SPRINKLEEisai Incrabeprazole sodium5,045,552*PEDNov 8, 2013
ACIPHEXEisai Incrabeprazole sodium5,045,552*PEDNov 8, 2013
TECHNESCAN MAG3Mallinckrodttechnetium tc-99m mertiatide kit5,573,748Nov 12, 2013
EXPARELPacira Pharms Incbupivacaine6,132,766Nov 16, 2013
SURFAXINDiscovery Labslucinactant5,407,914Nov 17, 2013
SUSTIVABristol Myers Squibbefavirenz5,519,021*PEDNov 21, 2013
ATRIPLAGileadefavirenz; emtricitabine; tenofovir disoproxil fumarate5,519,021*PEDNov 21, 2013
JEVTANA KITSanofi Aventis Uscabazitaxel5,438,072Nov 22, 2013
CHILDREN'S ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ALINIARomarknitazoxanide5,578,621Nov 26, 2013
CHILDREN'S ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ALLEGRASanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ZOLINZAMerckvorinostatRE38506Nov 29, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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With prior BiotechBlog intern Fintan Burke moving on to some exciting new projects, I have time to train a few more aspiring writers.

(Professionals seeking to submit guest posts to BiotechBlog or to the Journal of Commercial Biotechnology should visit the Publishing Opportunities page).

Prospective interns are advised to see Fintan’s contributions and the other guest content. The schedule and deliverables are flexible, to accommodate your school schedule.
To apply for a BiotechBlog internship please send me writing samples, your resume, and a statement of interests to info@thinkbiotech.com.