News
Supreme Court of India rejects Novartis’ cancer drug patent Court rejects Novartis’ application to patent a newer version of Glivec® on the grounds of failing tests of invention and patentability that, “The court was reminded of its duty to uphold the rights granted by the statute and that an error of judgement by it will put life-saving drugs beyond the reach of the multitude of ailing humanity, not only in this country but in many developing and underdeveloped countries, dependent on generic drugs from India.” International aid organizers, Medecins Sans Frontières, expect the decision to be a relief for patients and doctors in developing countries who depend on affordable medicines from India. According to Unni Karunakra, International President of Medecins Sans Frontières, “The Supreme court’s decision now makes patents on the medicines we need less likely. This marks the strongest possible signal path to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.” In 2006, the Chennai Patent Office initially rejected Novartis’ patent application for Glivic on the grounds that it failed the requirements of section 3(d) of India’s 2005 Patents Act, which dictates that new forms and new uses of known substances cannot be patented unless the efficacy is significantly increased. Ranjit Shahani, Novartis’ India chairman described the ruling as, “A setback for patients that will hinder
10.4155/PPA.13.28 © 2013 Future Science Ltd
Pharm. Pat. Analyst (2013) 2(3), 299–301
“
This marks the strongest possible signal path to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.
”
News
Initially filed by Novartis (Basel, Switzerland) in 1998, the patent application for an updated version of the company’s Glivec® (imatinib) cancer drug has been rejected by the Supreme Court of India. The cost of treatment with Glivec is approximately US$2600 per month, per patient, while the generic version is only approximately $17. It is expected that the ruling will deter international drug companies from obtaining renewed patents for updated versions of existing drugs. According to Pratibha Singh, a lawyer for Indian drug maker Cipla (Mumbai, India), which manufactures a generic version of Glivec, “Patents will only be given for genuine inventions and repetitive patents will not be given for minor tweaks to an existing drug.” The Supreme Court detailed its decision in a 112-page document noting that the questions involved were debated “intensely and at great length” and “within a very broad framework”. The court was urged to keep private monopoly at a minimum. The document also declared that, “Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as the ‘pharmacy of the world’.” The report further stated
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medical progress for diseases without effective treatment options.” He added, “We strongly believe that the original innovation should be recognized in patents to encourage investment in medical innovation, especially for unmet needs. Novartis will continue to file patents for India and to invest in the country, but with caution.” – Written by Phoebe Heseltine Sources: Indian Supreme Court delivers verdict in Novartis case: www.msf.org.uk/ Novartis_verdict_20130402.news; Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India: www. novartis.com/newsroom/media-releases/ en/2013/1689290.shtml
Otsuka buys commercialization rights to Lundbeck Alzhemier’s drug Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan) have reportedly paid up to US$150 million for the rights to an investigational Alzheimer’s drug developed by central nervous system disorder pharmaceutical company, Lundbeck (Copenhagen, Denmark). The selective receptor antagonist, Lu AE58054, will enter Phase III clinical trials in late 2013 and will consist of several studies involving more than 2500 patients with mild-to-moderate Alzheimer’s disease. Ulf Winberg, Chief Executive Officer of Lundbeck said, “There is a serious global unmet medical need regarding treatments for Alzheimer’s disease and the two partners, with their development capabilities, commercial experience and geographical reach, will provide a solid foundation in the development of Lu AE58054.” It is reported that the two companies, who have worked together since 2011, will share sales, commercialization and development costs. Otsuka will be granted co-commercialization rights to Lu AE58054 in the USA, Canada, east Asia and the major European and Nordic countries. According to Taro Iwamoto, President of Otsuka, “The global collaboration between Otsuka and Lundbeck continues to grow stronger with the addition of Lu AE58054. Not only does the product further enhance the synergy between the companies, as we work together to bring to the market solutions for better health, Lu AE58054 is a potentially promising development in a very difficult disease area.” – Written by Phoebe Heseltine Source: Lundbeck and Otsuka further expand their alliance and enter into collaboration for the development and commercialization of Lu AE58054 in development for Alzheimer’s disease: http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=750931
News
Premacure and neonatal eye drug acquired by Shire Pharmaceutical manufacturer Shire Plc., (St Helier, Jersey) has recently announced its purchase of privately held Premacure (Uppsala, Sweden), which will expand the company’s portfolio into the area of neonatology. Currently in Phase II clinical trials, Premacure has been developing a protein replacement therapy for the prevention of retinopathy of prematurity (ROP), the most common cause of visual loss in childhood. It is estimated that each year approximately 15,000 preterm infants in the USA are affected by ROP, with 1100–1500 of these cases requiring medical treatment and 400–600 becoming blind. In preterm infants, early separation from the maternal circulation results in a loss of specific growth factors, such as IGF-1, which can result in ROP. The new therapy is designed to restore IGF-1 in the preterm infants to the levels found in normal utero development. Shire has stated that it will make an up-front payment followed by contingent payments based on success of the product and commercial milestones. The firm will expand into the field “while maintaining its focus on developing novel therapies for the treatment of rare diseases with high unmet medical need.” Flemming Orskov, incoming Chief Executive of Premacure said of the deal, “This investigational protein has the potential to provide a first-in-class treatment that may minimize the development and complications arising from ROP.” – Written by Phoebe Heseltine Source: Shire acquires Premacure AB: www.shire.com/shireplc/en/media/shirenews?id=741
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future science group
USPTO re-issues Pfizer’s Celebrex® patent
Pfizer has recently announced that the USPTO has granted the company a reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®. The basic patent was due to expire on 30 May 2014; however, the USPTO’s recent decision allows the patent to be marketed for an additional 18 months without generic competition. The patent will now expire on 2 December 2015, which includes 6 months of pediatric exclusivity.
Now that the patent has been “reissued, Pfizer has filed law suits against Teva, Actaivs, Lupin and Apotex…
”
“Continued development of new medicines that enhance patient lives is supported by protecting IP and innovation,” said Amy Schulman, executive Vice President and general counsel for Pfizer. “We are pleased with the reissuance of this patent protecting the invention of using celecoxib to treat osteoarthritis and other approved conditions, and have initiated legal proceedings to enforce our IP rights through 2 December 2015.” Now that the patent has been reissued, Pfizer has filed law suits against Teva, Actaivs, Lupin and Apotex, each of which filed an abbreviated new drug application in the in the US District Court for the Eastern District of Virginia (VI, USA) for the infringement of the reissue patent for the generic versions of the drug to seek approval into the market in May 2014. In 2012, sales of Celebrex reached over US$2 billion, where market analysts predicted sales to fall in early 2014; however, with the recent decision, revenue streams for the blockbuster drug will remain constant for a time yet. – Written by Alexandra Sklan
future science group
AstraZeneca (London, UK) has recently announced that it has entered into a settlement agreement in its US patent infringement litigation against Actavis (NJ, USA) and Egis Pharmaceuticals (Budapest, Hungary) regarding its cholestrol drug Crestor®. Under the agreement, Actavis and Egis concede that Crestor patent is valid, enforceable and would be infringed by Watson’s generic versions of the drug, its rosuvastatin zinc product and its rosuvastatin calcium product. Under the terms of the agreement, Actavis is permitted to begin selling its generic version of Crestor and its rosuvastatin zinc product beginning 2 May 2016, at a fee to AstraZeneca of 39% of net sales of Watson’s products until the end of pediatric exclusivity on 8 July 2016. The entry date could be earlier and the fees eliminated in certain circumstances. Actavis’ rosuvastatin zinc alternate salt product previously received tentative approval from the US FDA in August 2011, but would not be generically substitutable for Crestor and would have required Actavis to convert patients from rosuvastatin calcium. Under the agreement, Actavis also concedes that it will not carry on with its appeal of a decision by the US Court of Appeals for the Federal Circuit in December 2012 that upheld the validity and enforceability of the Crestor patent. Paul Bisaro, President and Chief Executive Officer of Actavis, said, “This agreement ensures that consumers will benefit from an earlier launch of a rosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a nongenerically substitutable product if Actavis had proceeded to launch the alternate product.” With the litigation over concerning one of AstraZeneca’s biggest blockbuster drugs, the company can now focus on other recent ventures, including its recent deal with Moderna Therapetuics to develop messenger RNA Therapeutics™ in cardiometabolic diseases and cancer, as well as the formation of an Integrated Translational Research Center for cardiovascular and metabolic disease and regenerative medicine with the Karolinksa Institutet (Stockholm, Sweden). – Written by Alexandra Sklan Sources: AstraZeneca settles litigation over CRESTOR patent: www.astrazeneca. com/Media/Press-releases/Article/20130325--astrazeneca-settles-litigation-overcrestor-patent; Actavis reaches agreement with AstraZeneca to launch a generic version of Crestor® in 2016: http://ir.actavis.com/phoenix.zhtml?c=65778&p=irolnewsArticle&ID=1799778&highlight=; AstraZeneca and Moderna Therapeutics announce exclusive agreement to develop pioneering messenger RNA Therapeutics™ in cardiometabolic diseases and cancer: www.astrazeneca.com/Media/Press-releases/ Article/20130321--astrazeneca-and-moderna-therapeutics-pioneering-messenger-RNAtherapeutics; AstraZeneca and Karolinska Institutet to create Integrated Translational Research Centre: www.astrazeneca.com/Media/Press-releases/Article/20130321--astrazeneca-and-karolinska-institutet-create-Integrated-Translational-Research-Centre
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]
Pharm. Pat. Analyst (2013) 2(3)
News
Source: United States Patent & Trademark Office grants Pfizer reissue patent for Celebrex® (celecoxib capsules): http://pfizer.newshq. businesswire.com/press-release/united-statespatent-trademark-office-grants-pfizer-reissuepatent-celebrex-celecoxib-
Litgation over for AstraZeneca’s Crestor® drug
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Supreme Court of India rejects Novartis’ cancer drug patent Court rejects Novartis’ application to patent a newer version of Glivec® on the grounds of failing tests of invention and patentability that, “The court was reminded of its duty to uphold the rights granted by the statute and that an error of judgement by it will put life-saving drugs beyond the reach of the multitude of ailing humanity, not only in this country but in many developing and underdeveloped countries, dependent on generic drugs from India.” International aid organizers, Medecins Sans Frontières, expect the decision to be a relief for patients and doctors in developing countries who depend on affordable medicines from India. According to Unni Karunakra, International President of Medecins Sans Frontières, “The Supreme court’s decision now makes patents on the medicines we need less likely. This marks the strongest possible signal path to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.” In 2006, the Chennai Patent Office initially rejected Novartis’ patent application for Glivic on the grounds that it failed the requirements of section 3(d) of India’s 2005 Patents Act, which dictates that new forms and new uses of known substances cannot be patented unless the efficacy is significantly increased. Ranjit Shahani, Novartis’ India chairman described the ruling as, “A setback for patients that will hinder
10.4155/PPA.13.28 © 2013 Future Science Ltd
Pharm. Pat. Analyst (2013) 2(3), 299–301
“
This marks the strongest possible signal path to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.
”
News
Initially filed by Novartis (Basel, Switzerland) in 1998, the patent application for an updated version of the company’s Glivec® (imatinib) cancer drug has been rejected by the Supreme Court of India. The cost of treatment with Glivec is approximately US$2600 per month, per patient, while the generic version is only approximately $17. It is expected that the ruling will deter international drug companies from obtaining renewed patents for updated versions of existing drugs. According to Pratibha Singh, a lawyer for Indian drug maker Cipla (Mumbai, India), which manufactures a generic version of Glivec, “Patents will only be given for genuine inventions and repetitive patents will not be given for minor tweaks to an existing drug.” The Supreme Court detailed its decision in a 112-page document noting that the questions involved were debated “intensely and at great length” and “within a very broad framework”. The court was urged to keep private monopoly at a minimum. The document also declared that, “Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as the ‘pharmacy of the world’.” The report further stated
ISSN 2046-8954
299
medical progress for diseases without effective treatment options.” He added, “We strongly believe that the original innovation should be recognized in patents to encourage investment in medical innovation, especially for unmet needs. Novartis will continue to file patents for India and to invest in the country, but with caution.” – Written by Phoebe Heseltine Sources: Indian Supreme Court delivers verdict in Novartis case: www.msf.org.uk/ Novartis_verdict_20130402.news; Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India: www. novartis.com/newsroom/media-releases/ en/2013/1689290.shtml
Otsuka buys commercialization rights to Lundbeck Alzhemier’s drug Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan) have reportedly paid up to US$150 million for the rights to an investigational Alzheimer’s drug developed by central nervous system disorder pharmaceutical company, Lundbeck (Copenhagen, Denmark). The selective receptor antagonist, Lu AE58054, will enter Phase III clinical trials in late 2013 and will consist of several studies involving more than 2500 patients with mild-to-moderate Alzheimer’s disease. Ulf Winberg, Chief Executive Officer of Lundbeck said, “There is a serious global unmet medical need regarding treatments for Alzheimer’s disease and the two partners, with their development capabilities, commercial experience and geographical reach, will provide a solid foundation in the development of Lu AE58054.” It is reported that the two companies, who have worked together since 2011, will share sales, commercialization and development costs. Otsuka will be granted co-commercialization rights to Lu AE58054 in the USA, Canada, east Asia and the major European and Nordic countries. According to Taro Iwamoto, President of Otsuka, “The global collaboration between Otsuka and Lundbeck continues to grow stronger with the addition of Lu AE58054. Not only does the product further enhance the synergy between the companies, as we work together to bring to the market solutions for better health, Lu AE58054 is a potentially promising development in a very difficult disease area.” – Written by Phoebe Heseltine Source: Lundbeck and Otsuka further expand their alliance and enter into collaboration for the development and commercialization of Lu AE58054 in development for Alzheimer’s disease: http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=750931
News
Premacure and neonatal eye drug acquired by Shire Pharmaceutical manufacturer Shire Plc., (St Helier, Jersey) has recently announced its purchase of privately held Premacure (Uppsala, Sweden), which will expand the company’s portfolio into the area of neonatology. Currently in Phase II clinical trials, Premacure has been developing a protein replacement therapy for the prevention of retinopathy of prematurity (ROP), the most common cause of visual loss in childhood. It is estimated that each year approximately 15,000 preterm infants in the USA are affected by ROP, with 1100–1500 of these cases requiring medical treatment and 400–600 becoming blind. In preterm infants, early separation from the maternal circulation results in a loss of specific growth factors, such as IGF-1, which can result in ROP. The new therapy is designed to restore IGF-1 in the preterm infants to the levels found in normal utero development. Shire has stated that it will make an up-front payment followed by contingent payments based on success of the product and commercial milestones. The firm will expand into the field “while maintaining its focus on developing novel therapies for the treatment of rare diseases with high unmet medical need.” Flemming Orskov, incoming Chief Executive of Premacure said of the deal, “This investigational protein has the potential to provide a first-in-class treatment that may minimize the development and complications arising from ROP.” – Written by Phoebe Heseltine Source: Shire acquires Premacure AB: www.shire.com/shireplc/en/media/shirenews?id=741
300
www.future-science.com
future science group
USPTO re-issues Pfizer’s Celebrex® patent
Pfizer has recently announced that the USPTO has granted the company a reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®. The basic patent was due to expire on 30 May 2014; however, the USPTO’s recent decision allows the patent to be marketed for an additional 18 months without generic competition. The patent will now expire on 2 December 2015, which includes 6 months of pediatric exclusivity.
Now that the patent has been “reissued, Pfizer has filed law suits against Teva, Actaivs, Lupin and Apotex…
”
“Continued development of new medicines that enhance patient lives is supported by protecting IP and innovation,” said Amy Schulman, executive Vice President and general counsel for Pfizer. “We are pleased with the reissuance of this patent protecting the invention of using celecoxib to treat osteoarthritis and other approved conditions, and have initiated legal proceedings to enforce our IP rights through 2 December 2015.” Now that the patent has been reissued, Pfizer has filed law suits against Teva, Actaivs, Lupin and Apotex, each of which filed an abbreviated new drug application in the in the US District Court for the Eastern District of Virginia (VI, USA) for the infringement of the reissue patent for the generic versions of the drug to seek approval into the market in May 2014. In 2012, sales of Celebrex reached over US$2 billion, where market analysts predicted sales to fall in early 2014; however, with the recent decision, revenue streams for the blockbuster drug will remain constant for a time yet. – Written by Alexandra Sklan
future science group
AstraZeneca (London, UK) has recently announced that it has entered into a settlement agreement in its US patent infringement litigation against Actavis (NJ, USA) and Egis Pharmaceuticals (Budapest, Hungary) regarding its cholestrol drug Crestor®. Under the agreement, Actavis and Egis concede that Crestor patent is valid, enforceable and would be infringed by Watson’s generic versions of the drug, its rosuvastatin zinc product and its rosuvastatin calcium product. Under the terms of the agreement, Actavis is permitted to begin selling its generic version of Crestor and its rosuvastatin zinc product beginning 2 May 2016, at a fee to AstraZeneca of 39% of net sales of Watson’s products until the end of pediatric exclusivity on 8 July 2016. The entry date could be earlier and the fees eliminated in certain circumstances. Actavis’ rosuvastatin zinc alternate salt product previously received tentative approval from the US FDA in August 2011, but would not be generically substitutable for Crestor and would have required Actavis to convert patients from rosuvastatin calcium. Under the agreement, Actavis also concedes that it will not carry on with its appeal of a decision by the US Court of Appeals for the Federal Circuit in December 2012 that upheld the validity and enforceability of the Crestor patent. Paul Bisaro, President and Chief Executive Officer of Actavis, said, “This agreement ensures that consumers will benefit from an earlier launch of a rosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a nongenerically substitutable product if Actavis had proceeded to launch the alternate product.” With the litigation over concerning one of AstraZeneca’s biggest blockbuster drugs, the company can now focus on other recent ventures, including its recent deal with Moderna Therapetuics to develop messenger RNA Therapeutics™ in cardiometabolic diseases and cancer, as well as the formation of an Integrated Translational Research Center for cardiovascular and metabolic disease and regenerative medicine with the Karolinksa Institutet (Stockholm, Sweden). – Written by Alexandra Sklan Sources: AstraZeneca settles litigation over CRESTOR patent: www.astrazeneca. com/Media/Press-releases/Article/20130325--astrazeneca-settles-litigation-overcrestor-patent; Actavis reaches agreement with AstraZeneca to launch a generic version of Crestor® in 2016: http://ir.actavis.com/phoenix.zhtml?c=65778&p=irolnewsArticle&ID=1799778&highlight=; AstraZeneca and Moderna Therapeutics announce exclusive agreement to develop pioneering messenger RNA Therapeutics™ in cardiometabolic diseases and cancer: www.astrazeneca.com/Media/Press-releases/ Article/20130321--astrazeneca-and-moderna-therapeutics-pioneering-messenger-RNAtherapeutics; AstraZeneca and Karolinska Institutet to create Integrated Translational Research Centre: www.astrazeneca.com/Media/Press-releases/Article/20130321--astrazeneca-and-karolinska-institutet-create-Integrated-Translational-Research-Centre
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]
Pharm. Pat. Analyst (2013) 2(3)
News
Source: United States Patent & Trademark Office grants Pfizer reissue patent for Celebrex® (celecoxib capsules): http://pfizer.newshq. businesswire.com/press-release/united-statespatent-trademark-office-grants-pfizer-reissuepatent-celebrex-celecoxib-
Litgation over for AstraZeneca’s Crestor® drug
301
