How a large biotechnology company teamed with a translation service provider to define best practices

According to the World Intellectual Property Organization, nearly 100,000 pharmaceutical and biotechnology patent applications are filed each year around the world, and the trend is increasing. These companies have very little room for error in the work they conduct each day. As a result, the translations of these patent applications need to be completely accurate, which requires a translation service provider who follows best practices. These best practices include centralized processes, highly specialized teams, quality control, terminology management and advanced technologies.

By following them, they will ultimately reduce office actions and litigation risks, as well as decrease time to grant. 

This case study will highlight how a large biotechnology company worked with their translation service provider to develop a series of best practices for the translations of their intellectual property, focused primarily on their patent applications. Readers will come away with an understanding of how their multinational enterprises can leverage these best practices to get improved quality, reduced time to grant and more filings for the budget.

 


Raw materials intended to be used for Gene, Cell and Tissue therapies: legal and regulatory considerations

This paper offers some insights on the European regulatory situation with respect to raw materials used in production of gene, cell and tissue therapy products, including advanced therapy medicinal products. By focusing on the existing EU and French rules, the purpose of this paper is to review the content and scope of the measures restricting their placing on the market and/or use, the legal implications and hence key challenges ahead. Also known under the specific term ‘ancillary products’ in France, raw materials are subject to a fragmented regulatory environment that could indirectly hinder innovation in this rapidly evolving area. Taking account of contamination risk that could originate from such materials, the question as to whether it is necessary to assure their quality and safety by means of one or various regulatory instrument(s) does not arise. Nevertheless, it is vital that, in a sector as innovative as this one, an appropriate and more predictable regulatory regime applies in Europe, which requires undertaking a constructive work aimed at harmonising the rules in relation to production of and trade in raw materials intended to be used for advanced therapies while ensuring the EU objective of public health protection: a work already in progress.


Drug Patent Expirations for December 20 2013

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FDA Orange Book archives from 2005 to present

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Drug Patent Expirations for December 20 2013

TradenameApplicantGeneric NamePatent
Expiration

AEROSPAN HFA

Acton Pharms

flunisolide

Dec 20, 2013

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





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Drug Patent Expirations for December 17 2013

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Journal of Commercial Biotechnology

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Drug Patent Expirations for December 17 2013

TradenameApplicantGeneric NamePatent
Expiration

AGENERASE

Glaxosmithkline

amprenavir

Dec 17, 2013

DEFINITY

Lantheus Medcl

perflutren

Dec 17, 2013

MYLOTARG

Wyeth Pharms Inc

gemtuzumab ozogamicin

Dec 17, 2013

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





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Drugs

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more than 80,000 U.S. and international patents.

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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

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 December 17 2013

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 December 17 2013

TradenameApplicantGeneric NamePatent
Expiration

AGENERASE

Glaxosmithkline

amprenavir

Dec 17, 2013

DEFINITY

Lantheus Medcl

perflutren

Dec 17, 2013

MYLOTARG

Wyeth Pharms Inc

gemtuzumab ozogamicin

Dec 17, 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 December 16 2013

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FDA Orange Book archives from 2005 to present

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developers, and their patents

Drug Patent Expirations for December 16 2013

TradenameApplicantGeneric NamePatent
Expiration

FROVA

Endo Pharms

frovatriptan succinate

Dec 16, 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 December 13 2013

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Drug Patent Expirations for December 13 2013

TradenameApplicantGeneric NamePatent
Expiration

ABREVA

Glaxosmithkline

docosanol

Dec 13, 2013

LUPRON DEPOT-PED

Abbvie Endocrine Inc

leuprolide acetate

Dec 13, 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 December 11 2013

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

DrugPatentWatch -- sales, statistics, drug application information

Advertise
here

This newsletter is
a free service of DrugPatentWatch

DrugPatentWatch offers comprehensive details on FDA approved drugs,
developers, and their patents

Drug Patent Expirations for December 11 2013

TradenameApplicantGeneric NamePatent
Expiration

CYMBALTA

Lilly

duloxetine hydrochloride

Dec 11, 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.


Biotech in Countries Starting with 'I' – Part 5

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 thoughts have been returning to biotechnology in Israel and how it has benefited from the state’s exceptional technology linkages. Just ten years ago, innovative life sciences was the […]


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