Archive for March, 2013

Bowman v. Monsanto: Revisiting the Exhaustion Doctrine and its Application to Biotechnology and Digital Technologies

On February 19, 2013, the U.S. Supreme Court heard oral argument in Bowman v. Monsanto – the first case to directly present the question of how the Exhaustion Doctrine should apply to patents relating to biotechnology and digital technology inventions.  The Petitioner, Vernon Hugh Bowman, asserts that the Exhaustion Doctrine should be extended to advanced agricultural technologies where the technology itself is contained in genetically modified seeds that may be reproduced through successive generations of seeds without limitation, and that companies like Monsanto can instead rely on remedies found in contract law to protect its commercial interests.  The Respondent, Monsanto Corporation, supported by the U.S. Government, (not surprisingly) disagrees, contending that an extension of the Exhaustion Doctrine of this magnitude would undercut effective patent protection for inventions that may reproduce perfectly over generations, undermining R&D in innovative technologies.  
During the Bowman v. Monsanto oral argument on February 19th, the Justices focused on the broad scope of the exception sought by the Petitioner to patent rights for GM seed as an extension of the Exhaustion Doctrine to biotechnology and digital technology inventions, and did not appear persuaded either that the only reasonable use of the soybeans by Bowman was to plant them or that right holders would find effective modes of protection through contract law.  The Justices noted that this was the first case to present the intersection of the Exhaustion Doctrine and effective protection for inventions that may be reproduced across generations – that intersection to be the issue of greatest interest to the Court in  Bowman v. Monsanto, where the Court may be unlikely to create a sweeping exception to patent rights for biotechnology or digital technology inventions that has not been contemplated by the Congress.

Full details at the Journal of Commercial Biotechnology


Developing Cell Therapies: Enabling cost prediction by value systems modeling to manage developmental risk.

This work quantifies the highest risk activities and interdependencies in cell therapy new product development (NPD).  A simulation model based upon an activates based and information driven  approach of the Design Structure Matrix (DSM), using Latin Hypercube sampling methods with discrete event simulation evaluated the interdependencies between critical development tasks.  Input data was collected from quarterly financial reports of cell therapy developers and developmental milestones as reported in company press releases and publications.  .

Successfully planning and managing development processes is problematic in an emerging industry lacking precedents and standardised technology platforms.   Methods of understanding and reducing developmental uncertainty and risk are needed to aid resourcing decisions.  A particular requirement is to understand the impact of process and clinical development, in this highly regulated sector.

Results from the model quantify the probability and impact of process iterations and failures that impact cost and duration of cell therapy NPD.  High impact areas quantified are the interdependence of Phase 1 clinical trials and investment, the scaling of the manufacturing process from Phase 1 to Phase 2 and Phase 2 to Phase 3.  The model also allows for the calculation of the probability of NPD success for given resource levels, time constraints and market conditions.  An application comparing alternative regulatory approaches indicates that the current favoured strategy of targeting an orphan indication gives little benefit for the tested clinic al indication because of reduced clinical trial recruitment rate.  While specifically developed for cell therapy NPD this modelling approach has potential application across the wider biotechnology industry.

Full details at the Journal of Commercial Biotechnology


Drug Patent Expirations for Mar 11 2013

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Who are the leading pharmaceutical patent challengers? A report on<br />
Paragraph IV challenges

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Drug Patent Expirations for March 11 2013

Tradename Applicant Generic Name Patent
Expiration
FLO-PRED Taro prednisolone acetate Mar 11, 2013

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



DrugPatentWatch
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Future drug patent expirations by month

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Months?

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Drug Patent Expirations for Mar 5 2013

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FDA Orange Book archives from 2005 to present

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Drug Patent Expirations for March 5 2013

Tradename Applicant Generic Name Patent
Expiration
NATROBA Parapro Llc spinosad Mar 5, 2013

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



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Infographics

Which pharmaceutical companies have the most drugs

Which Companies Have the Most Branded
Drugs?

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DrugPatentWatch Serves Your Competitive Intelligence
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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
  • Sales data (top 200 drugs)
  • 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.


Which Drugs Have the Most Patents?

This chart shows the pharmaceutical drugs with the most patents still in force. The drugs with the most active patents are COMBIVENT RESPIMAT, KALETRA, ADVAIR HFA,FLOVENT HFA, VIVITROL, THALOMID, VYVANSE, OSENI, REVLIMID, and VENTOLIN HFA. For more infographics, see the DrugPatentWatch Pharmaceutical Innovation Infographics. Do you have a response to this infographic? Respond in the comments section below.


Drug Patent Expirations for Mar 2 2013

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

FDA Orange Book archives from 2005 to present

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here

This newsletter is
a free service of DrugPatentWatch

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developers, and their patents





Drug Patent Expirations for March 2 2013

Tradename Applicant Generic Name Patent
Expiration
LUNESTA Sunovion Pharms Inc eszopiclone Mar 2, 2013
RECLAST Novartis zoledronic acid Mar 2, 2013
ZOMETA Novartis zoledronic acid Mar 2, 2013

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



DrugPatentWatch
Infographics

Which pharmaceutical companies recieved the most drug approvals last<br />
year

Which Companies had the Most Drug
Approvals Last Year?

More
infographics &raquo





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
  • Sales data (top 200 drugs)
  • 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.


See you in Pittsburgh in Early April

I will be in Pittsburgh from April 4-5th to give  a talk at Carnegie Mellon’s business school, Tepper, and at the Innovation in Healthcare Technology Conference. I will be providing perspectives on changing dynamics in the biotechnology industry based on my work with the Journal of Commercial Biotechnology, and Scientific American Worldview, and my globalization research collected […]


A Long Road to an Informed Public Opinion

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. Bioethics in the public eye has been recognised as an integral part of modern biology research for a while […]