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Monthly Archives: March 2013

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

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

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 March 11 2013

TradenameApplicantGeneric Name Patent Expiration
FLO-PREDTaroprednisolone acetateMar 11, 2013

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


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Future drug patent expirations by month

How Many Drug Patents Will Expire in the Coming Months?

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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.

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 March 5 2013

TradenameApplicantGeneric Name Patent Expiration
NATROBAParapro LlcspinosadMar 5, 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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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 RESPIMATKALETRAADVAIR HFA,FLOVENT HFAVIVITROLTHALOMIDVYVANSEOSENIREVLIMID, 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.

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 March 2 2013

TradenameApplicantGeneric Name Patent Expiration
LUNESTASunovion Pharms InceszopicloneMar 2, 2013
RECLASTNovartiszoledronic acidMar 2, 2013
ZOMETANovartiszoledronic acidMar 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
year

Which Companies had the Most Drug Approvals 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
  • 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.

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 from DrugPatentWatch.com. I look forward to meeting new and existing readers.

If you have an interest in guest-posting on BiotechBlog, an interest in submitting a paper to the Journal of Commercial Biotechnology, or have perspectives on global biotechnlogy that may be of interest to Worldview, I’d be happy to meet up — drop me a line on the contact form.

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.

Susan Kling FinstonThere is a saying that if you have a tough problem, you can find the solution if  you ask enough people – the answer is in the room.   For access early capital for biotech, it may take a whole crowd.

But first, here are a few of the latest data points on access to capital – from the developed and developing world.  Just how bad is the funding environment for early stage biotech companies in the UK trying to develop new therapies, cures and novel combination medical devices?

For start ups located outside the Golden Triangle of London, Oxford and Cambridge, the Financial Times’  adjective of choice is “awful.”  Earlier this week, the FT reported on research on funding of biotechs in the England’s northwest region, concluding:

“Despite universities in the northwest producing similar levels of research and patents they find it hard to attract investors … attracting only 5 per cent of the early stage funding for life science companies in the UK.”

Apparently, a rose by any other name would not smell so sweet to the City of London.

Given that the City – an early mover in venture finance dating back to Elizabethan times – can’t find Manchester on a map, it should not be surprising that funding for innovative biotech remains weak across the BRICS.

A new meta-analysis of investment patterns in emerging markets published in the March 2013 issue of Nature Biotechnology confirms that governments are no more effective at providing access to early capital than venture funds in emerging markets including China, India, Brazil, Russia and South Africa.

And in an austerity budget environment, more companies also are chasing each public grant dollar in developed countries.  So outside of VC comfort zones like London, Boston, and San Francisco, what is a Bio-entrepreneur to do?  Are the answers in the crowd?

Crowd-funding promises to do for access to capital what Facebook, G+, YouTube and Twitter have done for freedom of expression. Though associated more with indie-music and movies than commercial R&D, it has already scored a few early successes for biotech.

Websites like Kickstarter may provide important new ways to democratize and expand access to capital, giving early-stage companies an opportunity to reach supporters around the globe, and turning anyone with an internet connection and a laptop, tablet or smartphone into a venture philanthropist.

We know that in the 21st century no nationality has a monopoly on good ideas. If Crowd-funding works, location does not have to be destiny for emerging biotech companies looking for early financial backing.

What do you think – are the answers in the Crowd?

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, s 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.

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 now. When the Human Genome Project began, James Watson dedicated 5% of the estimated $2.7bn budget to the Ethical, Social, and Legal Issues (ELSI) that concerned the project. As funding trends change and demand for scrutiny of the field increases, the public increasingly needs to be aware of the changes and misinformation presented to them.

Above all else, research is affected by funding. Traditionally biotechnology was funded from government-affiliated agencies, venture capitalists, or deals with Big Pharma. Recently, as the Wall Street Journal noted, funding from the latter two has been dwindling since the 2008 financial crisis. This has lead to researchers applying for grants from some underused sources and in the case of the UK the creation of incentives to bridge the funding gap.

Recognition of the commercial application of biotechnology has lead to the UK’s formation of the Synthetic Biology Leadership council, whose roadmap aims for an “economically vibrant” biology sector “of clear public benefit.” Particular emphasis is put on noting that “public acceptability…cannot be adequately dealt with through communication through the public.” Professor Joyce Tait serves on this leadership council and examines the social impact of scientific developments with the Innogen Center at the University of Edinburgh. “I think what the public needs to be educated about is judging the quality of the evidence that’s presented to them” she says when contacted. “There’s a terrible tendency in this area for any group, no matter what their motivation, to bias the evidence that’s around out there to suit their case … especially when it becomes the potential for conflict.”

 

For Peter Pitts, President and Co-Founder of the Center for Medicine in the Public Interest, communicating any research benefit to the public can be a problem. “Generally speaking the only thing you read about genetically modified foods – from those who actually think they’re a good idea – are extremely technical comments that are of use to almost nobody.” For Peter, scientific jargon and rhetoric are preventing any meaningful public discussion with researchers. “I can sit in a room with scientists, I can talk shorthand and know exactly what’s going on, but everybody else is completely confused like we’re speaking in some sort of ancient Latin or something.”

 

“Every explanation has to be a 94 PowerPoint slide presentation as opposed to the quick, obvious media savvy answer.”

 

Research potential may be further overstated by the press, skewing the image of the research even more. In an interview with the Guardian, Professor Hilary Rose notes the paper’s editorial on new stem cell research (which notes it may someday “make the blind see, the crippled walk, and the deaf hear”) as an example of the misinformation supplied to the public.

Henry I Miller of the Hoover Institution at Stanford University also feels that modern science journalism needs to be redressed. “Specialty journalism is waning, and reporters often create a “moral equivalence” between opposing views of an issue, even after one viewpoint has been discredited. Newspapers are failing, and people increasingly are using websites to become “informed” about issues.” This feeling of declining speciality journalism is echoed by Peter Pitts. “Years ago a journalist covering the FDA, for example, would have been covering the FDA for years; reading the ins and outs of what was going on. Today you’re talking to people who today they’re covering the FDA, yesterday were covering a baseball game.”

Anti-GM companies are also a persistent, unregulated source of biased information for the public. There are, however, indications of public attitudes cooling as seen in a public attitudes survey last year, where extreme pro- and anti-GM attitudes shrank and the indifferent middle ground grew. “I thought that was an excellent outcome” says Prof Tait “it was no longer a politically contentious issue for a lot of people.” She notes however a tendency for anti-biotech lobbies to misreport the findings still exists. “If you actually look at the way… it’s still being represented by anti-GM pressure groups, they’re focusing on the one end of that scale and they’re not pointing out that if you look at if you look at the other end of that scale there’s an equal move in the opposite direction!”

The main risk of a poor public attitude can be seen reflected in the funding decisions made in government. “I think among politicians there’s kind of a fear of the fear of the public, in Europe in particular [there’s] a really strong concern to avoid a kind of public backlash against any particular technology, I think that’s been true for nanotechnology, which was a subject of concern about 4 or 5 years ago” explains Prof Tait. “[Public opinion] seeps through to what governments will decide to fund and that then feeds through to the opportunities there are for the scientists.”

For Peter Pitts, one way to address that is to open up social media. “I think the FDA should facilitate the use of social media by regulated entities, by pharmaceutical companies, etc – to use it more robustly and to send a green light that they want them to do that.”

“I think we can get people more excited and get more people into the fields of science relative to young kids in high school – for example, pursuing a career in science. I think that will probably help politicians support larger budgets for research …and it will also allow people to accept the benefits of the science – GM foods for example – much more readily than they do now.”

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 .