News
University of Colorado licences out vaccine composition Soligenix acquires patent for vaccine stabilization technology Clinical-stage biopharmaceutical company, Soligenix, Inc. (NJ, USA), announced that the US Patent Office has granted patent 8,444,991, entitled, ‘Method of preparing an immunologically-active adjuvant-bound dried vaccine composition’. The patent’s claims encompass composition-of-matter and method claims for ThermoVax™, a vaccine-stabilization technology developed at the University of Colorado (CO, USA) and exclusively licensed to Soligenix. Developed by researchers John Carpenter and Theodore Randolph, the method overcomes the problems associated with freeze-drying vaccines containing aluminum adjuvants while attempting to engineer them to withstand extremes of temperature. The ThermoVax™ method is novel in that it eliminates the need for cold-chain production, transportation and storage of alum-adjuvanted vaccines by rendering the salt stable at elevated temperatures. According to Christopher Schaber, President and Chief Executive Officer of Soligenix, “The granting of the thermostabilization patent is a significant milestone for the ThermoVax™ program and is a critical component in our commercialization strategy for vaccines that can avoid the increased costs and logistical burdens The ThermoVax™ method is associated with cold chain storage and novel in that it eliminates the distribution.” It is reported that a high need for cold-chain production, proportion of vaccine doses are wasted transportation and storage of alum due to destruction as a result of leaving adjuvanted vaccines by rendercold-chain temperature ranges. ing the salt stable at elevated Schaber continued, “We expect that temperatures. the introduction of an effective technology for long-term stabilization of vaccines has the potential to be a major advance in the national effort to develop effective countermeasures and therapies for significant biothreats and emerging pathogens. We have initiated discussions with a number of vaccine companies and non-profit organizations regarding the potential for collaboration on heat-stable versions of their vaccine candidates.” The technology is being developed with financial support from the National Institutes of Allergy and Infectious Diseases under cooperative grant agreement U01 AI 082210.
The editorial team welcomes suggestions for timely, relevant items for inclusion in the news. If you have newsworthy information, please contact: Gino D’Oca, Managing Commissioning Editor, Future Science Ltd, Unitec House, 2 Albert Place, London, N3 1QB, UK Tel.: +44 (0)20 8371 6090; E-mail: [email protected]
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News
Source: Soligenix announces issuance of US patent for its ThermoVax™ technology: www.soligenix.com/news.aspx?titleId=419
10.4155/PPA.13.41 © 2013 Future Science Ltd
Pharm. Pat. Analyst (2013) 2(4), 443–445
ISSN 2046-8954
443
Bankruptcy administrators sell off hundreds of nanotechnology patents Sales of patents from bankrupt nanotechnology provider could generate wealth of interest
FOR SALE
A portfolio of more than 400 patents is being put up for sale by the bankruptcy administrators of NanoInk (IL, USA), whose products include nanoscale technologies with applications in pharmaceutical science. After shareholders withdrew investment, the patents were offered up for sale along with other assets such as equipment, inventory and licenses to third-party technology. The patents, which cover jurisdictions such as the US, Japan, China and Europe, can be acquired in a
Patent expiry prompts drug site sale
News
Global pharmaceutical company Pfizer (NY, USA) has recently announced the sale of its Little Island-based manufacturing site (Cork, Ireland). Acquired in 2001, Little Island has been the manufacturing site for all intermediates and API of the company’s anti-cholesterol drug Lipitor ®. Since the mid-2000s, Pfizer maintained annual sales of Lipitor of over US $12 billion, but following US patent expiry in 2011, the company has reported a 55% drop in sales of its former blockbuster drug. The decision to sell the plant, according to Pfizer spokesperson Karen O’Keeffe, was due to “over capacity within manufacturing globally,” reporting that several key products have come off patent and the global demand has declined. Since Lipitor’s patent expiry, Pfizer has been competing with generic manufacturers such as Ranbaxy (Haryana, India) and Teva Pharmaceutical Industries (Petah Tikva, Israel). The site, which manufactures APIs for a number of new cancer drugs as well as Lipitor, will move its operations to the nearby Ringaskiddy site in 2014. Until a buyer is found it will not be confirmed whether the remaining employees at the site will retain their positions. Source: Pfizer puts Lipitor site up for sale as patent expiration causes over-capacity: www. in-pharmatechnologist.com/Ingredients/Pfizer-Puts-Lipitor-Site-Up-For-Sale-as-PatentExpiration-Causes-Over-Capacity
444
www.future-science.com
single package or in various lots. News website, AzoNano.com regards the sale as one of a kind, claiming “It is unlikely that any similar collection of equipment and IP will come to market in the foreseeable future.” It remains unclear whether the patents will be able to generate the necessary major interest from prospective buyers. Deals such as ARM and AST’s acquisition of MIPS’ patents appear to have been motivated by the desire to keep assets away from competitors that may try to assert them against the eventual buyers at a later stage.
News website, AzoNano. “ com regards the sale as one of kind… ” Law firm McDermott Will & Emery recently conducted a study into patenting in the nanotechnology industry. The research found that published nanotech patent applications in the USA had grown by approximately 150% between 2006 and 2011, while grants in the space almost doubled over the same time period. The study also found that some of the largest IP-holding organizations, such as Samsung and IBM, were already the leading holders of patents in the field in the USA. The surge in investment in nanotechnology from industry leaders suggests that there may be opportunities for licensing, assertion and sale within the field. Although the NanoInk patents are specific in relation to authentication and security, they could have significant potential if they are well drafted and have extensive applications beyond than their original intention. Sources: Iam-magazine.com: Nanotech patent sell-off may generate interest from bigname buyers: www.azonano.com/news. aspx?newsID=27398
future science group
Vermont Governor passes law to protect against patent trolling Patent trolls, those who abuse the pharmaceutical patent system by making deceptive claims of infringement in a bid to extort money, will now be prevented from their practice under a new measure passed by Peter Shumlin, Governor of Vermont (VT, USA). The first of its kind in the US, the new law is designed to protect companies and will allow courts to pass judgment on whether a claim is deceptive, specifying factors that could be used as evidence as well as providing damages to companies in Vermont that been forced to pay wrongful settlements.
Speaking about the new measure, The Governor said, “This bill will help to protect our good Vermont businesses from unscrupulous patent trolls who take advantage of them through bad faith claims of patent infringement. It will help us grow jobs.” Under the act it will also be possible for the Attorney General to conduct civil investigations and bring civil action against violators. Acknowledging that the law is the first of its kind, President of the American IP Law Association, Jeffrey Lewis said, “It’s, as far as we can tell, a novel approach for states to try to do, this sort of bootstrapping, if you will, of the unfair competition laws to try to address patent assertions.” In accordance with the new law, the state recently filed a patent-trolling lawsuit against a Delaware-based company, suing MPHJ Technology Investments (NC, USA) and its subsidiary companies operatIntelligence business provider GBI research (NY, USA) has recently pubing in Vermont. It was alleged that MPHJ lished a report detailing the development of a highly dynamic market in had a patent relating to the scanning of the field of neurodegenerative diseases in the coming years. The report also documents and their attachment via email, outlinesexpectations in regard to numbers of patent expiries and new drug and that MPHJ were sending threatenapprovals. ing letters to small businesses in Vermont. According to the report it is expected that the Alzheimer’s disease market Bryan Farney, an attorney for MPHJ, said will decline, reflecting the lack of major developments in recent years and that the company was aware of investigation the looming expiration of patents on several key products. In contrast, the under the Attorney General and stopped its Parkinson’s disease market is predicted to grow as expensive products such activities in Vermont during the review, he as Duodopa, manufactured by Abbott Laboratories (Il, USA), are patent apsaid of the investigation, “We think that we proved in the USA. It is also expected that the aging populations of the deare attempting as best we can to legitimately veloped world will increase the number of patients requiring treatment for identify people who are using the client techsuch diseases. nology, which has been admitted and issued Also assessed in the report were the treatment-usage patterns, pipeline by the U.S. Patent office and try to figure a analysis, market characterization and the licensing deal trends in Alzheimer’s reasonable licensing fee from them.” disease, Parkinson’s disease, amyotrophic lateral sclerosis and Huntington’s Eric Goldman, Professor of IP Law at disease. The current therapeutic environment in the treatment of the disSanta Clara University (CA, USA) is unsure eases across the top seven developed markets was also detailed. The report whether a state has the authority to regulate aims to aid businesses in the strategizing of product launches by allowing such matters, “We’re not sure if states can even them to grasp the competitive environment, understand the impact of major have a voice in the matter, so there’s a question patent expiries and assess the potential impact of current late-stage pipeline about whether the law will even stand. But molecules for neurodegenerative disease. that’s part of why this is such a novel approach.”
Parkinson’s disease new product entries set to boost market, claims report
Source: Vt Gov signs law against false patent claims: www.abcnews.go.com/US/wireStory/ vt-gov-signs-law-false-patent-claims-19238192#. UZ8hrKxwZjp
News
Source: Neurodegenerative Diseases Market to 2018 – New product entries in both niche and broader Parkinson’s disease treatment will boost market despite patent cliff: www. prnewswire.com/news-releases/neurodegenerative-diseases-market-to-2018---newproduct-entries-in-both-niche-and-broader-parkinsons-disease-treatment-will-boostmarket-despite-patent-cliff-200221391.html
– All news stories written by Phoebe Heseltine.
future science group
Pharm. Pat. Analyst (2013) 2(4)
445
University of Colorado licences out vaccine composition Soligenix acquires patent for vaccine stabilization technology Clinical-stage biopharmaceutical company, Soligenix, Inc. (NJ, USA), announced that the US Patent Office has granted patent 8,444,991, entitled, ‘Method of preparing an immunologically-active adjuvant-bound dried vaccine composition’. The patent’s claims encompass composition-of-matter and method claims for ThermoVax™, a vaccine-stabilization technology developed at the University of Colorado (CO, USA) and exclusively licensed to Soligenix. Developed by researchers John Carpenter and Theodore Randolph, the method overcomes the problems associated with freeze-drying vaccines containing aluminum adjuvants while attempting to engineer them to withstand extremes of temperature. The ThermoVax™ method is novel in that it eliminates the need for cold-chain production, transportation and storage of alum-adjuvanted vaccines by rendering the salt stable at elevated temperatures. According to Christopher Schaber, President and Chief Executive Officer of Soligenix, “The granting of the thermostabilization patent is a significant milestone for the ThermoVax™ program and is a critical component in our commercialization strategy for vaccines that can avoid the increased costs and logistical burdens The ThermoVax™ method is associated with cold chain storage and novel in that it eliminates the distribution.” It is reported that a high need for cold-chain production, proportion of vaccine doses are wasted transportation and storage of alum due to destruction as a result of leaving adjuvanted vaccines by rendercold-chain temperature ranges. ing the salt stable at elevated Schaber continued, “We expect that temperatures. the introduction of an effective technology for long-term stabilization of vaccines has the potential to be a major advance in the national effort to develop effective countermeasures and therapies for significant biothreats and emerging pathogens. We have initiated discussions with a number of vaccine companies and non-profit organizations regarding the potential for collaboration on heat-stable versions of their vaccine candidates.” The technology is being developed with financial support from the National Institutes of Allergy and Infectious Diseases under cooperative grant agreement U01 AI 082210.
The editorial team welcomes suggestions for timely, relevant items for inclusion in the news. If you have newsworthy information, please contact: Gino D’Oca, Managing Commissioning Editor, Future Science Ltd, Unitec House, 2 Albert Place, London, N3 1QB, UK Tel.: +44 (0)20 8371 6090; E-mail: [email protected]
“
”
News
Source: Soligenix announces issuance of US patent for its ThermoVax™ technology: www.soligenix.com/news.aspx?titleId=419
10.4155/PPA.13.41 © 2013 Future Science Ltd
Pharm. Pat. Analyst (2013) 2(4), 443–445
ISSN 2046-8954
443
Bankruptcy administrators sell off hundreds of nanotechnology patents Sales of patents from bankrupt nanotechnology provider could generate wealth of interest
FOR SALE
A portfolio of more than 400 patents is being put up for sale by the bankruptcy administrators of NanoInk (IL, USA), whose products include nanoscale technologies with applications in pharmaceutical science. After shareholders withdrew investment, the patents were offered up for sale along with other assets such as equipment, inventory and licenses to third-party technology. The patents, which cover jurisdictions such as the US, Japan, China and Europe, can be acquired in a
Patent expiry prompts drug site sale
News
Global pharmaceutical company Pfizer (NY, USA) has recently announced the sale of its Little Island-based manufacturing site (Cork, Ireland). Acquired in 2001, Little Island has been the manufacturing site for all intermediates and API of the company’s anti-cholesterol drug Lipitor ®. Since the mid-2000s, Pfizer maintained annual sales of Lipitor of over US $12 billion, but following US patent expiry in 2011, the company has reported a 55% drop in sales of its former blockbuster drug. The decision to sell the plant, according to Pfizer spokesperson Karen O’Keeffe, was due to “over capacity within manufacturing globally,” reporting that several key products have come off patent and the global demand has declined. Since Lipitor’s patent expiry, Pfizer has been competing with generic manufacturers such as Ranbaxy (Haryana, India) and Teva Pharmaceutical Industries (Petah Tikva, Israel). The site, which manufactures APIs for a number of new cancer drugs as well as Lipitor, will move its operations to the nearby Ringaskiddy site in 2014. Until a buyer is found it will not be confirmed whether the remaining employees at the site will retain their positions. Source: Pfizer puts Lipitor site up for sale as patent expiration causes over-capacity: www. in-pharmatechnologist.com/Ingredients/Pfizer-Puts-Lipitor-Site-Up-For-Sale-as-PatentExpiration-Causes-Over-Capacity
444
www.future-science.com
single package or in various lots. News website, AzoNano.com regards the sale as one of a kind, claiming “It is unlikely that any similar collection of equipment and IP will come to market in the foreseeable future.” It remains unclear whether the patents will be able to generate the necessary major interest from prospective buyers. Deals such as ARM and AST’s acquisition of MIPS’ patents appear to have been motivated by the desire to keep assets away from competitors that may try to assert them against the eventual buyers at a later stage.
News website, AzoNano. “ com regards the sale as one of kind… ” Law firm McDermott Will & Emery recently conducted a study into patenting in the nanotechnology industry. The research found that published nanotech patent applications in the USA had grown by approximately 150% between 2006 and 2011, while grants in the space almost doubled over the same time period. The study also found that some of the largest IP-holding organizations, such as Samsung and IBM, were already the leading holders of patents in the field in the USA. The surge in investment in nanotechnology from industry leaders suggests that there may be opportunities for licensing, assertion and sale within the field. Although the NanoInk patents are specific in relation to authentication and security, they could have significant potential if they are well drafted and have extensive applications beyond than their original intention. Sources: Iam-magazine.com: Nanotech patent sell-off may generate interest from bigname buyers: www.azonano.com/news. aspx?newsID=27398
future science group
Vermont Governor passes law to protect against patent trolling Patent trolls, those who abuse the pharmaceutical patent system by making deceptive claims of infringement in a bid to extort money, will now be prevented from their practice under a new measure passed by Peter Shumlin, Governor of Vermont (VT, USA). The first of its kind in the US, the new law is designed to protect companies and will allow courts to pass judgment on whether a claim is deceptive, specifying factors that could be used as evidence as well as providing damages to companies in Vermont that been forced to pay wrongful settlements.
Speaking about the new measure, The Governor said, “This bill will help to protect our good Vermont businesses from unscrupulous patent trolls who take advantage of them through bad faith claims of patent infringement. It will help us grow jobs.” Under the act it will also be possible for the Attorney General to conduct civil investigations and bring civil action against violators. Acknowledging that the law is the first of its kind, President of the American IP Law Association, Jeffrey Lewis said, “It’s, as far as we can tell, a novel approach for states to try to do, this sort of bootstrapping, if you will, of the unfair competition laws to try to address patent assertions.” In accordance with the new law, the state recently filed a patent-trolling lawsuit against a Delaware-based company, suing MPHJ Technology Investments (NC, USA) and its subsidiary companies operatIntelligence business provider GBI research (NY, USA) has recently pubing in Vermont. It was alleged that MPHJ lished a report detailing the development of a highly dynamic market in had a patent relating to the scanning of the field of neurodegenerative diseases in the coming years. The report also documents and their attachment via email, outlinesexpectations in regard to numbers of patent expiries and new drug and that MPHJ were sending threatenapprovals. ing letters to small businesses in Vermont. According to the report it is expected that the Alzheimer’s disease market Bryan Farney, an attorney for MPHJ, said will decline, reflecting the lack of major developments in recent years and that the company was aware of investigation the looming expiration of patents on several key products. In contrast, the under the Attorney General and stopped its Parkinson’s disease market is predicted to grow as expensive products such activities in Vermont during the review, he as Duodopa, manufactured by Abbott Laboratories (Il, USA), are patent apsaid of the investigation, “We think that we proved in the USA. It is also expected that the aging populations of the deare attempting as best we can to legitimately veloped world will increase the number of patients requiring treatment for identify people who are using the client techsuch diseases. nology, which has been admitted and issued Also assessed in the report were the treatment-usage patterns, pipeline by the U.S. Patent office and try to figure a analysis, market characterization and the licensing deal trends in Alzheimer’s reasonable licensing fee from them.” disease, Parkinson’s disease, amyotrophic lateral sclerosis and Huntington’s Eric Goldman, Professor of IP Law at disease. The current therapeutic environment in the treatment of the disSanta Clara University (CA, USA) is unsure eases across the top seven developed markets was also detailed. The report whether a state has the authority to regulate aims to aid businesses in the strategizing of product launches by allowing such matters, “We’re not sure if states can even them to grasp the competitive environment, understand the impact of major have a voice in the matter, so there’s a question patent expiries and assess the potential impact of current late-stage pipeline about whether the law will even stand. But molecules for neurodegenerative disease. that’s part of why this is such a novel approach.”
Parkinson’s disease new product entries set to boost market, claims report
Source: Vt Gov signs law against false patent claims: www.abcnews.go.com/US/wireStory/ vt-gov-signs-law-false-patent-claims-19238192#. UZ8hrKxwZjp
News
Source: Neurodegenerative Diseases Market to 2018 – New product entries in both niche and broader Parkinson’s disease treatment will boost market despite patent cliff: www. prnewswire.com/news-releases/neurodegenerative-diseases-market-to-2018---newproduct-entries-in-both-niche-and-broader-parkinsons-disease-treatment-will-boostmarket-despite-patent-cliff-200221391.html
– All news stories written by Phoebe Heseltine.
future science group
Pharm. Pat. Analyst (2013) 2(4)
445
