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IP Hall of Fame Value of IP Patent License Agreements: 10 Pitfalls Clean Renewable Energy Bonds (CREBs) AstraZeneca buys MedImmune Zelnorm Withdrawal Herbal Medicine in US and India Biotech in EU US BioVenture in the Indian Continent Biotech Drugs Generic Ambien Genetic Wonder Drug IP Hall of Fame The IP Hall of Fame honours those who have made an outstanding contribution to the development of intellectual property law and practice. Devised and developed by leading IP publication Intellectual Asset Management magazine, it identifies individuals who have helped to establish intellectual property as one of the key business assets of the 21st century. The aim is not only to acknowledge the vital role played by these innovators in fostering today's vibrant IP environment and ensuring its continued health, but also to show how central IP is to the global economy and to the wellbeing of people around the world. The first 23 inductees to the IP Hall of Fame included two US presidents, a Japanese prime minister and one of France's greatest authors. Both Thomas Jefferson and James Madison were honoured for their insistence that intellectual property rights be specifically safeguarded by the US Constitution, while Korekiyo Takahashi was recognised as the founding father of Japan's patent system. Victor Hugo, meanwhile, was nominated as a prime mover behind the creation of the Berne Convention on Copyright, which to this day helps safeguard the rights of authors and other copyright owners in over 150 countries. Other inductees included the great American inventor Thomas Edison and Sir Edward Coke, a 17th century English courtier who played a pivotal role in the foundation of modern patent rights. Among the inductees from the present day were Microsoft's IP chief Marshall Phelps and Bruce Lehman, a former Commissioner of the US Patent and Trademark Office and Under-secretary of Commerce during the Clinton presidency. European representatives include Klaus-Dieter Langfinger, head of IP at BASF and a prime advocate for IP rights in Europe. A full list of Academy members can be found here. http://www.iphalloffame.com/info/Members.aspx Value of IP Business Week magazine recently published that the Coca-Cola trademark has been valued in $70,450 million dollars. However, an intangible asset wouldn't be worth anything without proper protection. Nowadays, Intellectual Property valuation is a reference point in order to take important business decisions. Recently, a group of bipartisan legislators in both the Senate and House of Representatives introduced patent reform bills - the Patent Reform Act of 2007. The bills can be found at: Senate: http://www.patentlyo.com/patent/files/PatentReform2007.SENATE.pdf House: http://www.patentlyo.com/patent/files/PatentReform2007.SENATE.pdf Some highlights:
The National Academy of Sciences Report on the patent system is a thoughtful and balanced roadmap for reform. The NAS's four-pronged set of patent quality and patent litigation reforms, based upon a comprehensive and inclusive four-year study, can be found here: http://www.patentsmatter.com/issue/key_principles.php. For more on Patent Reform visit: http://www.patentlyo.com/patent/2007/04/patent_reform_a_1.html http://271patent.blogspot.com/search/label/patent%20reform http://www.patenthawk.com/blog/2007/04/patent_reform_principles_1.html#more http://patentdocs.typepad.com/patent_docs/2007/04/they_just_dont_.html http://www.mondaq.com/article.asp?articleid=47856&email_access=on Patent License Agreements: 10 Pitfalls When drafting or negotiating a patent license agreement, a number of pitfalls should be avoided or at least have their effects reduced. Failing that, the rights and interests of the company, which you represent, might be affected, if not altered. Whether you are the patent licensor or the patent licensee, you will find hereinafter the 10 main points that should be borne in mind so as to reduce or remove the major risks occurring upon drafting and negotiating such patent license agreement. http://www.mondaq.com/article.asp?articleid=46966&email_access=on&login=true Clean Renewable Energy Bonds (CREBs) The Internal Revenue Service (IRS) recently issued Notice 2007-26 (Notice) soliciting applications from qualified issuers (including political subdivisions) for allocations of volume cap to issue clean renewable energy bonds (CREBs) for eligible clean renewable energy projects. Applications must be filed with the IRS by July 13, 2007. CREBs are "tax-credit" bonds authorized in an initial amount of $800 million by Congress in the Energy Incentives Act of 2005. In 2006, Congress increased the authorized amount of CREBs from $800 million to $1.2 billion and also extended the last date for the issuance of CREBs to December 31, 2008. Before a qualified issuer can issue CREBs, it must first obtain an allocation of volume cap from the IRS. Last year, the IRS allocated the initial $800 million of volume cap to a total of 610 projects. For more visit: http://www.mondaq.com/article.asp?articleid=47312&email_access=on AstraZeneca buys MedImmune AstraZeneca has been struggling recently to come up with new therapies, but has been dealt a series of setbacks. The latest came when the drug giant announced that it is abandoning an experimental heart drug. AstraZeneca has abandoned its collaboration with AtheroGenics on its cardiac drug AGI-1067 after the drug failed to perform better than a placebo in a Phase III clinical trial last month. AstraZeneca paid a $50 million licensing fee for development rights to the therapy, which now revert back to AtheroGenics. The pharma company needs some big late-stage products in the pipeline. However, buying MedImmune won't bring much help on that score. AstraZeneca paid more than a billion dollars recently for Cambridge Antibody, but the MedImmune deal is the biggest buyout since the company was formed in 1999 by the merger of Astra and Zeneca. MedImmune, the Gaithersburg, MD-based biotech company announced that it had agreed to sell out to AstraZeneca for $15.6 billion in cash. Zelnorm Withdrawal Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve constipation after it was linked to a higher chance of heart attack, stroke and worsening heart chest pain that can become a heart attack, federal health officials said. Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said in a public health advisory. Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the FDA said. Herbal Medicine in US and India Last year, the U.S. Food and Drug Administration (FDA) has for the first time approved a special extract of green tea as a prescription drug for the topical (external) treatment of genital warts caused by the human papilloma virus (HPV). The new drug, called Veregen (Polyphenon E) an ointment is the first prescription botanical (herbal) drug approved by FDA under the "new" drug amendments of 1962 that required drugs to be proved both safe and effective, prior to marketing in the U.S. Given the thousands of years of history of Ayurveda and natural medicine, you may assume that this drug is developed by an Indian company. But no, MediGene, a German company developed the above named herbal drug and it is marketed by Bradley Pharmaceuticals, USA. http://bradpharm.com/. http://phx.corporate-ir.net/phoenix.zhtml?c=70567&p=irol-newsArticle_print&ID=974062&highlight= The active drug ingredient, Polyphenon® E, represents a proprietary mixture of phytochemicals produced from a partially purified water extract of green tea leaves. Green tea, brewed from the leaves of the tea plant (Camellia sinensis), is one of the most popular beverages worldwide. Unlike leaves used for black or oolong teas, leaves used to prepare “green” tea do not undergo a fermentation process. Therefore, green tea retains higher levels of highly antioxidant polyphenolic compounds known as catechins. (http://www.fda.gov/cder/foi/label/2006/021902lbl.pdf) Polyphenon E® Ointment is a product of global development. In 1997, Epitome Pharmaceuticals Ltd., a privately owned Canadian company (Halifax, Nova Scotia) licensed from Mitsui Norin, Ltd. (Tokyo, Japan), a patented method of treating external genital warts through the topical application of Polyphenon® E green tea extract, the patent for which extends through 2017. Epitome sublicensed the technology to MediGene AG of Munich, Germany, which collaborated in two multi-center Phase II clinical trials. In 2003 MediGene extended its license to include the treatment of hyperplasia caused by papilloma viruses. In 2004 MediGene conducted two Phase III trials, one in Europe and another in the Americas. Based on these trial results, MediGene submitted a New Drug Application (NDA) to the FDA Center for Drug Evaluation and Research in September 2005. FDA accepted the NDA for filing in early December 2005. In India, there are about 17,000 species of higher plants and of which, 7500 are known for medicinal uses. This proportion is the highest for plants known for their medical purposes in any other country of the world. After years of apathy, the Pharmaceuticals Export Promotion Council, under the Ministry of Commerce, along with Ayush (ayuerveda, yoga, unani, siddha and homeopathy) is working on to standardize some herbal products and register the product through a research panel. The Government is proposing to resource map all medicinal plants available in the country. Biotech in EU The European Union has put together a set of recommendations aimed at fostering the continent's biotech industry, which has traditionally lagged far behind the U.S. in raising funds for emerging companies. The EU is looking for more public-private partnerships to provide the cash needed for research, new incentives for start-ups and more support for companies trying to manage the continent's complex set of patent rules. An industry trade group, EuropaBio, said that it has its doubts about the plan, largely because member countries are being urged to take voluntary action. The EU and the U.S. each have about 2,000 biotech companies, but U.S. developers gained $3.1 billion in venture funds in 2004 compared to $1.4 billion for European companies. The relative lack of funding has hampered the growth of European drug developers, who gained 34.8 percent of European drug patents to the Americans' 41.4 percent share. US BioVenture in Indian Continent The U.S. venture firm MPM Capital has created a partnership with India's Reliance Life Sciences aimed at injecting fresh capital into the continent's life sciences industry. RLS has become a partner in MPM BioVentures IV, a $550 million fund, which will budget a portion of its investment dollars for Indian biotech companies. The two firms are also considering the potential of a new seed fund that would be devoted to Indian companies. The move is a welcome development for India's biotech sector, which has been long on potential and short on cash. It also offers another glimpse at the increasingly global structure of drug development, as companies develop international strategies for cutting costs and shortening development time frames. Biotech Drugs Biotech treatments, which are derived from naturally occurring proteins and often given by injection, are expected to make up 26 percent of total prescription spending in 2010, compared with about 20 percent in 2006. The increase is due largely to higher prices and new uses for drugs originally approved for rare conditions. Generic companies, such as Mylan Laboratories Inc. and Teva Pharmaceuticals Ltd., have long sought federal approval to market generic versions of biotech drugs made by Amgen Inc. and Genentech Inc. among others. The competitive stakes are high - for the companies and for consumers. Biotech drugs can cost tens of thousands of dollars for a year's supply. Already, $12 billion of the drugs sold each year no longer have patent protection, but under current law, generic companies cannot sell similar versions. The Senate is expected to vote soon on the one major pharmaceutical bill that is expected to pass this year. The bill is nearly guaranteed to pass because it reauthorizes the user fee program that helps fund the agency's drug review budget and the odds are growing that the biotech generics issue won't be included. After Democrats took control of Congress last year, generic firms renewed lobbying for approval to produce biotechs, emphasizing the potential for reining in escalating health care costs. But the biotech industry argues, as it has for more than a decade, that the complexity of their products would make it difficult for generic drug companies to safely copy them. Despite safety concerns many experts, including a former FDA commissioner, think generic biotech is inevitable for the United States, and point out that the European Union already allows the practice. And consumer groups, such as AARP and Families USA, have joined the Generic Pharmaceutical Association to lobby for the law change. As momentum behind the issue has increased, the Biotechnology Industry Organization trade group has suggested it is willing to compromise. Generic Ambien U.S. health officials have approved 13 cheaper generic alternatives to Ambien, a blockbuster sleeping pill from France's Sanofi-Aventis, the Food and Drug Administration said. The controversial drug, also known as zolpidem tartrate, has been linked to potentially dangerous risks such as driving while asleep and allergic reactions. Like Ambien and other popular sleep drugs, the new generics will also have to carry warnings on their product labels, the FDA said. Manufacturers cleared to make generic versions include Mylan Laboratories Inc., Teva Pharmaceutical Industries Ltd., Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Apotex Inc. and Synthon Pharmaceuticals Inc. Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc. and Lek Pharmaceuticals also won FDA approval. Genetic Wonder Drug Made by PTC Therapeutics, a pill known as PTC124 has been staggeringly successful in animal models. A study published today in Nature magazine shows that in mice with a mutation that causes Duchenne muscular dystrophy, the drug starts dystrophin production and restores their muscles to health. The research also suggests it should also work against more than 1,800 other genetic illnesses. The drug is able to repair faulty genes in the body that lead to crippling illness, and is already in the early stages of human trials after promising results in mice. Scientists say that if the trials go well, it could be licensed as early as 2009. The pill works by effectively forcing the body to ignore genetic mutations, and to produce normal proteins, rather than the mutated versions which lead to disease. Patients would have to take it throughout their lives. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, womenfitness.net, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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