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USPTO's New Rules
IP in China Phthalidomide Fast-Track Grants Going Green Biofuels, Crime against Humanity? Alzheimer Test Top Layoffs in 2007 BMS to Cut Jobs Tapestry to Cut Jobs GlaxoSmithKline to Cut Jobs Novartis to Cut Jobs King to Cut Jobs NICE Recommends Abbott's Humira Abbott's Dual-Variable Domain USPTO's New Rules The AIPLA has now filed an amici brief in support of GSK’s motion for a preliminary injunction to stop enforcement of the PTO’s new rules. According to the AIPLA, the limitations on claims and continuations severely inhibit the constitutional guarantee and thus create an irreparable harm to current applicants. http://www.patentlyo.com/patent/2007/10/rule-changes-tr.html The exact effects of the Supreme Court's KSR International Co. v. Teleflex, Inc. 72 Fed. Reg. 57526 decision are still being sorted out, but more obviousness arguments are being brought to invalidate patents, both in the courts and before the U.S. Patent and Trademark Office, and that more patents are in turn being invalidated on obviousness grounds. On October 10, 2007, the United States Patent and Trademark Office (PTO) issued examiner guidelines for determining obviousness under the U.S. Supreme Court’s ruling of April 30, 2007, in KSR International Co. v. Teleflex, Inc. 72 Fed. Reg. 57526. Both the ruling and the guidelines clarify the standards for findings of obviousness and require patent examiners to document and make explicit their rationale for an obviousness rejection of a patent application. USPTO Guidelines: http://www.uspto.gov/web/offices/com/sol/notices/72fr57526.pdf IP in China China has been putting into place an IP system comparable to those in the West to address protection of trademarks, patents, copyright and trade secrets. Chinese IP laws are similar to those enacted around the World. However, there are both legal and cultural differences. The patent laws of China provide for invention patents, utility model patents and design patents. Invention and utility model patents allow protection of new technical inventions whilst design patents allow protection of the appearance of a product. Whilst utility model applications are not examined to the same extent as invention patents, they offer protection for only 10 years compared with 20 years for invention patents. Companies should therefore consider filing for both utility model protection and invention patent protection in case there are difficulties obtaining the desired patent protection via the more demanding examination procedure of invention patents. Phthalidomide Thalidomide is a sedative, hypnotic, and multiple myeloma medication and a potent teratogen. Thalidomide was first developed by German pharmaceutical company Grünenthal. It was sold from 1957 to 1961 in almost 50 countries. Thalidomide was chiefly sold and prescribed during the late 1950s and early 1960s to pregnant women, as an antiemetic to combat morning sickness and as an aid to help them sleep. Thalidomide was one of the first drugs that was clearly shown to be a human teratogen and probably has caused more known severe malformations in humans than any other drug as a result of its use by pregnant women. Thalidomide is racemic – it contains both left- and right-handed isomers in equal amounts. One enantiomer is effective against morning sickness in pregnant women and the other is teratogenic and causes birth defects. Because of the concern over birth defects, thalidomide was withdrawn from the market in most countries in late 1961. Thousands of thalidomide babies were born in Europe. Were it not for Frances Oldham Kelsey, a reviewing medical officer at the Food & Drug Administration, thousands more might have been born in the U.S. She joined FDA in 1960. Her first assignment was thalidomide. Her dogged insistence on safety data prevented the drug approval in the U.S. The thalidomide disaster resulted in changing FDA procedures of drug approval and focused attention on the distribution of investigational drugs. Because of thalidomide, new drug candidates now are tested for the ability to cause birth defects. Kelsey retired in 2004 after 45 years at FDA. It turns out that thalidomide has potent anti-inflammatory effects that can ease erythema nodosum leprosum, a painful inflammatory condition associated with Hansen's disease, also known as leprosy. In addition to being anti-inflammatory, thalidomide also is a potent antiangiogenic and immunomodulatory agent and has been shown to be effective against previously untreatable cancers. Celgene is seeking approval for its use against multiple myeloma. The International Myeloma Foundation said published data provides encouraging news for nearly half the patients newly diagnosed with myeloma, patients who are 65 and older. The results of a multi-center clinical trial show adding thalidomide to the standard treatment, melphalan and prednisone, increased average survival to more than 4 years, a year and a half more than the same treatment without thalidomide. The study comes from the French Intergroupe Francophone Myélome, and is published in the current issue of the medical journal Lancet. The International Myeloma Foundation would like all patients to have the same ready and safe access to thalidomide as they do in the United States. Thalidomide was approved in the U.S. for newly diagnosed myeloma in 2006 where it was developed as THALOMID® by the Celgene Corporation along with the industry-leading S.T.E.P.S. risk management program to ensure that all patients have safe access to is clinical benefits. The International Myeloma Foundation conducts research and providing education, advocacy, and support for myeloma patients, families, researchers, and physicians worldwide. The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses in four key areas: research, education, support and advocacy. http://myeloma.org/ Fast-Track Grants The Bill & Melinda Gates Foundation has committed $100 million over five years to add a fast-track grant arm to its global health philanthropy efforts. The initiative is called Grand Challenges Explorations, which is intended to encourage scientists to pursue unorthodox ideas that could lead to new vaccines, diagnostics, and drugs for people in poor countries. The program expands the foundation's Grand Challenges in Global Health initiative, which was launched in 2003 to take on 14 specific global health problems, including improving the delivery and stability of vaccines and stopping insects that transmit diseases. Funding proposal applications will be short and, once submitted, on a fast-track for review. The initiative ties into a trend among nonprofits of finding creative ways to finance cutting-edge research in disease areas that big pharma cannot afford to. For example, because cystic fibrosis affects only about 30,000 children in the U.S., it doesn't attract much interest from pharmaceutical companies that are not in charity business and whose survival and their scientists' and other employees' salaries depend on the earnings from products sold in the market. So in 1998, the Cystic Fibrosis Foundation (CFF) made a bold move of adding a new component to its research-funding strategy: enticing for-profit companies to get involved in cystic fibrosis research by absorbing the early financial risk involved in developing new drugs. The foundation would receive a financial return, such as a royalty on a drug, that would be plowed back into the foundation to keep the drug development cycle going. For more foundations that are helping research visit: http://pubs.acs.org/cen/coverstory/85/8519cover.html. Usually, venture capitalists investing in a start-up company get their money back through an initial public offering (IPO) or the licensing of a drug to a big pharmaceutical maker. But compared with the gung-ho investors during the heyday of biotech IPOs, investors today want to see a lot more data from clinical trials before they will buy shares in a new firm. The nonprofit support is particularly useful to scientists whose research is in the difficult-to-fund idea stage. Gates' Grand Challenges Explorations grants will be awarded several times a year on a rolling basis, and each round of funding will focus on a handful of topics or themes. The foundation will begin soliciting proposals in the first half of 2008; the first grants are expected to be awarded later that year. In January, the Michael J. Fox Foundation (MJFF) launched its own fast-track grant program, the Rapid Response Innovations Awards, designed to provide seed funding for early-phase projects focused on Parkinson's disease. The program's goal is to support ideas before researchers drop them because it takes too long to fill out an application. (http://pubs.acs.org/cen/news/85/i42/8542notw3.html) Going Green After seven years on the U.S. auto market, hybrid gas-electric vehicles have gone from being merely an environmentalist's political statement to a legitimate option for mainstream car buyers. And analysts think the hyper-efficient cars have only just begun their push onto America's highways. "They really are leaving the niche market and coming into the mainstream," says Kevin Riddell, automotive analyst for J.D. Power and Associates. http://bankrate.com/brm/news/auto/car-guide-2007/20070801_cars_hybrids_a1.asp?caret=3a Concerns about climate change, national security and pollution have coalesced to make intellectual property an increasingly important issue for energy companies, which have stepped up research and development, as well as patent applications, geared toward creating and protecting technology to tackle these issues, experts say. Biofuels, Crime against Humanity? The United Nations special rapporteur on the right to food, Jean Ziegler, said he feared biofuels would bring more hunger. The United Nations expert has condemned the growing use of crops to produce biofuels as a replacement for petrol as a crime against humanity. The growth in the production of biofuels has helped to push the price of some crops to record levels. He complained of an ill-conceived dash to convert foodstuffs such as maize and sugar into fuel, which created a recipe for disaster. It was, he said, a crime against humanity to divert arable land to the production of crops which are then burned for fuel, and called for a five-year ban on the practice. The growth in the production of biofuels has been driven, in part, by the desire to find less environmentally-damaging alternatives to oil. The United States is also keen to reduce its reliance on oil imported from politically unstable regions. But the trend has contributed to a sharp rise in food prices as farmers, particularly in the US, switch production from wheat and soya to corn, which is then turned into ethanol. The IMF also voiced concern that the increasing global reliance on grain as a source of fuel could have serious implications for the world's poor. Dan Purkis, a consultant engineer, puts home-brewed fuel into the tanks of his 4x4, even though he is based in Aberdeen - the oil capital of the UK. He recycles used vegetable oil from a local restaurant. Restaurants throw away between 50 and 100 liters a week which would otherwise go to landfill. Once he gets it home, he puts the oil through a series of refinements: - Allows sediment in the oil to settle to the bottom of the bottle - Pumps and filters the top 70% of the oil; it is pure enough to put straight into his car - Treats the remaining sludge and converts it into biodiesel by adding methanol and caustic soda - Heats the oil, causing it to react with the caustic soda The waste product from this process is glycerin, which has to be washed out of the biodiesel with soap and half-water to half-fuel. He then composts the glycerin. Drivers who want to reduce their impact on the environment can apply for a grant to convert their car to run on waste cooking oil. The West Wales Eco Center launched a scheme converting diesel-powered cars to vegetable oil in December 2005. Alzheimer Test According to a paper published in the online edition of the British journal Nature Medicine, preliminary studies by a team of scientists at Stanford show the test is yielding promising results in predicting which patients with mild memory loss are at high risk of developing Alzheimer's disease. Top Layoffs in 2007 2007 has been a rough year for a number of the pharmaceutical and biotech industry’s biggest players. Concerns about patent expirations, falling sales due to drug safety concerns, redundancy from acquisitions, competition from generics and a general need to streamline operations contributed to these companies’ decisions to cut employees. Check out this list of the top five pharma and biotech layoffs of 2007 for more on the cuts and a look at what these companies are doing to turn things around. 1. Pfizer - 10,000 jobs 2. AstraZeneca - 7,600 jobs 3. Bayer - 6,100 jobs 4. Johnson & Johnson - 5,000 jobs 5. Amgen - 2,600 jobs BMS to Cut Jobs Bristol first indicated in July it would be cutting jobs but hasn't yet released details. Bristol has about 43, 000 employees, according to its Web site. BMS has begun eliminating jobs as part of a cost- savings program, and more jobs will be cut in coming weeks and in 2008, the drug maker's chief said. James Cornelius, the CEO, said the company would release details at a meeting with analysts and investors in New York in early December. Tapestry to Cut Jobs Tapestry Pharmaceuticals, Inc., announced a plan to focus all of its resources on advancing TPI 287's on-going and previously announced clinical trials. As part of the strategic plan, Tapestry is reducing its employee base by 28 percent. Tapestry Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development of proprietary therapies for the treatment of cancer. GlaxoSmithKline to Cut Jobs GlaxoSmithKline said it would now take action to improve performance. It will take 1.5 billion pounds in charges in a bid to save as much as 700 million pounds by 2010, a move that will include streamlining manufacturing, changing its selling model, improving efficiencies and job cuts. GlaxoSmithKline currently has 149 projects in clinical development, with 33 key assets currently in phase III development or registration. Work is nearly complete on a 137 million dollar expansion to the Glaxo-Smith-Kline biotechnology plant in Hamilton. The expansion will allow the company to triple its production of a component added to vaccines to enhance their effectiveness. GSK officials say the plant will eventually employ 300 people. Novartis to Cut Jobs Novartis said that it would cut 1,260 jobs in the U.S. in an effort to help it respond to increased U.S. regulatory demands and a more aggressive and competitive generics industry in the U.S. King to Cut Jobs King Pharmaceuticals, Inc. announced actions it is taking to accelerate a planned strategic shift, emphasizing its focus in neuroscience and hospital/acute care to maximize its long-term growth. The Company is taking these actions, which include a workforce reduction of approximately 20% and other general and administrative expense decreases, in light of recent challenges to its ALTACE® (ramipril) franchise. King expects to realize the full benefit of these initiatives commencing in 2008. The Company estimates that the 2008 cost savings from these actions will range from $75 million to $90 million. NICE Recommends Abbott's Humira The National Institute for Health and Clinical Excellence (NICE), which assesses the value of medicines in England and Wales, issued guidance for the drugs as options for adults who have unsuccessfully tried two other rheumatoid treatments. The watchdog said the so-called TNF-a inhibitors should only be continued for use if the drugs showed they were adequately working six months after beginning therapy. It said treatment should also be monitored for at least every six months. Abbott Laboratories' Humira, Amgen Inc's Enbrel, and Johnson & Johnson unit Centocor's Remicade rheumatoid arthritis drugs were recommended for use in Britain's state health service. About 400,000 people in Britain suffer from rheumatoid arthritis, which is marked by stiffness and inflammation of the joints, weakness and loss of mobility, according to the National Rheumatoid Arthritis Society. Abbott's Dual-Variable Domain (DVD) Abbott reported that its scientists are the first to discover a proprietary technology that combines the function and specificity of two or more monoclonal antibodies (mAbs) into one molecular entity that demonstrates drug-like properties and manufacturing feasibility. These molecules, called dual-variable domain Ig (DVD-Ig(TM) (http://www.abbott.com/global/url/content/en_US/60.15:15/feature/Feature_0029.htm), will allow for development of individual drug candidates that target multiple disease-causing molecules in various therapeutic categories. Published online earlier this week in Nature Biotechnology (http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt1345.html), this landmark study demonstrates a completely new platform that may be relevant to cancer, autoimmune diseases and other complicated conditions in which multiple disease-mediators are at play. Simultaneous blockage of multiple targets using DVD-Ig agents may increase efficacy in comparison to inhibition of a single target using a mAb. The process of combining two or more mAbs involves the use of molecular biology techniques, such as polymerase chain reaction (PCR), to link the regions (variable domains) of two different antibodies that target specific disease-causing molecules. The resulting molecule has two different (dual) variable domains, each of which targets a different disease-causing antigen. While other public and private research programs have endeavored to combine two antibodies into one entity, the results have been limited by poor pharmacokinetics, stability and manufacturing feasibility. Addressing only one disease target with a traditional mAb can result in limited efficacy because the disease can progress on multiple levels. For example, in rheumatoid arthritis (RA) distinct disease mediators (mechanisms) contribute towards various aspects of the disease such as inflammation, angiogenesis, pannus formation (thickened layers of granulation tissue) and bone and cartilage erosion. Therefore, targeting two or more disease mechanisms in RA may show far greater efficacy than targeting a single mechanism. Using the DVD-Ig technology, research teams at Abbott have already created a single drug candidate that targets multiple disease components, one of which is TNF-alpha, a well-established target in RA. Preclinical evaluation of this drug candidate is underway. Abbott's DVD-Ig approach has distinct technological, scientific and drug development advantages compared to mAbs and to previous efforts to create a multi-specific antibody. The approach is compatible with any antibody, including humanized mAbs, fully-human mAbs and chimeric mAbs, and can potentially be extended beyond antibodies to receptor proteins and other, similar molecules. DVD-Ig drugs also may have improved efficacy because they target multiple disease-causing molecules, and can address redundant disease processes, in which two different molecules have the same disease-causing effect. Abbott has completed technology validation on the DVD-Ig program, and is currently confirming process development and manufacturing for the technology platform. Concurrently, preclinical work has been conducted on a variety of combinations at Abbott to date. 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, 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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