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| Biotechnology Law and Related Issues
Biotechnology Update Report No. 25
Ethics, Society and Biotechnology 1. Want to Buy a Baby? EMAIL AD: ORFEXPRESS™-Clones were constructed by cloning the entire coding sequences (ORFs, from start to stop) from a collection of highly curated and verified full length genes from both public and private sources, into a unique vector system. In addition to being manufactured to be compatible with Invitrogen Corporation’s Gateway™ Technology, the ORF in vector is flanked with multiple unique restriction enzyme sites, which makes it also compatible with classical cloning systems. The purchase of Clones is accompanied by a limited label license under U.S. Patents 5,888,732; 6,143,557; 6,171,861; 6,270,969; 6,277,608 owned by Invitrogen, Corp. only to use the product for the internal research purposes of the purchaser. For information on purchasing a license to use the purchased product for purposes other than the internal research of the purchaser, contact the Director of Licensing at Invitrogen, Corp., 1600 Faraday Avenue, Carlsbad, CA 92008. The trademark is owned by Invitrogen Corporation. 2. Opinion: Biotech Labeling Should Focus on Risk, Not Techniques Henry Miller of the Hoover Institute says biotech labeling "should focus on factors known to be related to risk, not the use of certain techniques." He describes mandatory biotech labeling as a "punitive tax on a superior technology." Miller predicts that if people wish to avoid biotech foods, niche markets such as organics will arise.
International Politics and Biotechnology 1. Subject: [Ip-health] India: Patent Offices on a Hiring Binge as Applications Pile Up Times News Network CHENNAI: As companies gear up to the needs of an intellectual property-led economy, the demand for patent examiners and a host of other IPR professionals is rising. To cope with the spate of patent applications, the government is in the process of recruiting 165 patent examiners for its patent offices, said Rajeev Ranjan, director, department of industrial policy and promotion, ministry of commerce and industry. This is in addition to the 60 patent examiners from different areas of technology, he said, adding the demand is likely to grow at the same pace over the next few years. Consider this, India has been a designated state in over 2.4 lakh patents applications filed during the last four years. This is an indication of the country importance in this field he said. Designated states are those countries where an international patent application, filed under Patent Cooperation Treaty (PCT), will have effect. Since this treaty, even while allowing applications to different countries at one go, demanded no change in the local patent laws, it has proved quite popular, he said. According to Anil Sinha, senior programme officer for developing countries, PCT division, World Intellectual Property Organisation (WIPO), the job creation will extend to other areas in knowledge creation and knowledge protection, including more jobs for lawyers, evaluators, auditors". With only an estimated 300 patent agents in the country, the supply is far below the demand. Not only has the country been targeted for patent applications, various organisations in the country are applying for international patents under PCT, he said. In the first six months of this year Council for Scientific and Industrial Research (CSIR) has filed 101 patents, next only to Blowindow Gene Development from China (136 patents) among the developing countries. Other Indian organisations to file patent applications through PCT are Ranbaxy Laboratory (27), Dr Reddy (9), Orchid Chemicals and Pharmaceuticals (6, Sun Pharmaceuticals (5). In 01, CSIR had filed 89 patent applications, Ranbaxy 23, Dr Reddy 16, Biocon India 12, Lupin 7, Orchid 7 and Panacea Biotec 5 patent applications. Rajeev Ranjan and Anil Sinha were in Chennai in connection with WIPO National Seminar on The Patent Cooperation Treaty organised by WIPO in cooperation with Department of Industrial Policy and Promotion and Institute of Intellectual Property Development. 2. Hans-Ruedi Wiedmer Pharma Affiliate Programmes Geneva, 31 October 2002 Dear Hans-Ruedi, We are writing to follow-up on your offer to donate a quantity of Viracep (nelfinavir 250mg)for use in our HIV/AIDS project in Ukraine. We appreciate your offer of a one-off donation of ten boxes of 270 tablets of nelfinavir 250mg in place of our original order requesting a preferential price. We understand that your offer would be on an exceptional basis, without prejudice for future shipments to Ukraine or to any other destination. We note that our original order of ten boxes was to cover three months of nelfinavir for 35 patients currently under treatment. However, we wish to emphasise that our approach to you was not to seek a special deal restricted to our patients, such as this donation offer, but rather to secure a fair price. MSF works closely with the Ukrainian government and both parties are looking for a sustainable, long-term solution to address nelfinavir needs in the Ukraine. As you know, this drug is on the WHO Model List of Essential Medicines, which means that it satisfies "the priority health care needs of the population". There were 250,000 HIV-positive adults in Ukraine in 2001, according to the Report on the Global HIV/AIDS Epidemic 2002 (UNAIDS), a significant proportion of whom may eventually need a protease inhibitor-containing regimen. This is why we are requesting a price of 715 USD per patient per year for our field missions, for the government and other NGOs. We think this is fair, considering the fact that this would represent a 85%discount off the Swiss price. As you are undoubtedly aware, the other five originator companies selling ARVs have reduced their prices between 80-95% in developing countries. We kindly request that, since the patients who need this drug in Ukraine are facing treatment interruption, you respond before close of business on Monday 4 November. MSF remains committed to working with Roche wherever possible to ensure sustainable access to quality medicines for people with HIV/AIDS in developing countries. Your sincerely, Raffaella Ravinetto 3. Plan to Curb Illicit Medicines Trade The European Commission is due to publish proposals on October 30 to curb the illegal diversion into the European Union of vital life-saving medicines destined for the world's poorest countries. The draft Regulation calls for strict customs procedures for consignments of medicines leaving the EU, checks on imports into the EU of medicines manufactured in developing countries and new packaging rules. The illegal trade has soared since the EU and other rich nations agreed last year to waive the usual licensing rules on key medicines for poor countries - particularly in Africa - suffering from health crises. Many cheap medicines intended to save the lives of thousands of poor Africans suffering from HIV-AIDS and other diseases are cynically sent back to Europe and sold at high prices by corrupt officials and middlemen. The proposal - in the form of a draft Regulation - was sent through the Commission in almost record time after the pharmaceutical industry alerted officials to the problem. The draft suggests imposing strict customs procedures to ensure that consignments of essential medicines are tracked as they leave the EU for the target countries. Similarly, checks will be made on imports into the EU of medicines that have been manufactured in the developing countries themselves. However, the current problems stem from medicines made in the EU, as the poorest countries do not yet have the capacity to produce the medicines themselves: pharmaceutical companies now provide the poorest countries with medicines at the lowest possible prices. The proposals also include plans to differentiate the essential medicines from the ones used on the European market by packaging them differently. The Commission is also expected to launch an awareness campaign about the issue and offer technical assistance to help the countries concerned set up the necessary customs mechanisms. At the World Trade Organisation Ministerial in Doha, Qatar, last November, developing countries had demanded that laws surrounding drug patents should be relaxed to improve access to cheap drugs that fight disease like malaria and AIDS (*). Under the agreement, countries can seek a waiver on public health grounds from strict WTO rules which guarantee drug patents for 20 years. But even at the time there were fears in the pharmaceutical sector that a relaxation in patent rules could open the door for pirate products and threaten the sector's Euro 330 billion in annual revenues. Drug companies have warned that their ability to offer preferential prices to the developing world would be in question if the diversions continue, as they depend upon the income generated in rich countries to fund the research and development for the world's future medicines. AIDS drugs diverted. It was pharmaceutical giant GlaxoSmithKline that pushed hardest for the proposal after seeing Euro 18 million worth of batches of HIV/AIDS drugs Combivir, Epivir and Trizivir return to the European market. The drugs were to be sold at significantly discounted prices to clinics in Senegal, Ivory Coast, the Republic of Congo, Togo and Guinea-Bissau. Regulators in Belgium discovered them after they stopped a consignment on its way to the Netherlands, although Germany, the United Kingdom and Switzerland are other key markets for the diverted consignments. For Glaxo, which launched an 'Access Initiative' two years ago to provide cheap HIV/AIDS drugs to African countries, the diverted medicines represent between one seventh and one quarter of those supplied. Glaxo estimates that 28 shipments of the drugs were diverted through July of this year, totaling close to 3 million doses. The drugs then moved into the normal wholesale chain and were sold at European prices - up to Euro 6 a tablet instead of the 80 cents Glaxo charges in Africa. Glaxo has been authorized by courts to conduct raids in Belgium, The Netherlands and Germany to get their products back. Although the diverted Glaxo's trade concerned medicines produced before the Doha agreement, the pharmaceutical industry says that the problems are set to rise significantly with the WTO measures. An estimated 28.5 million people are infected with the HIV, the virus that causes AIDS. At least 6 million HIV positive people could benefit from the drugs and most of those will die without them. The latest World Health Organisation figures show that only 27,000 have got access to the vital medicines through the two-year-old United Nations deal called Accelerated Access. 4. Doctors Group: German Drug Firms' Prices Skirt Law FRANKFURT (Reuters Health) - Pharmaceutical companies in Germany are manipulating prices to skirt the intent of a new law designed to increase use of lower-priced generic drugs, according to the chairman of the National Association of Statutory Health Insurance Physicians (KBV). Dr. Manfred Richter-Reichhelm said Tuesday that doctors would like to cut drug spending, but he maintained that the "price and product policies" of drug firms have made it impossible. Richter-Reichhelm's comments came the day after a widely publicized annual drug report claimed that public health insurance drug spending could be cut by 20%--or about 4.2 billion euros in 2001--without a loss in quality of care if doctors would prescribe more generic drugs and avoid certain expensive medicines with no clear therapeutic advantages. He said drug firms are bringing so-called "show medicines" to market at "totally excessive prices." The intent is not to sell the show drugs,but to stretch the bottom third of the price range higher, meaning that more expensive drugs in the class can be covered by public health insurance, he asserted. For example, one company brought to market a product for stomach ulcers at a price of more than 500 euros, he said. The expensive new medicine raised the highest price of drugs in the bottom third of the class to 82.83 euros from 33.65 euros, he claims.
American Law and Biotechnology 1. From ABA Section on Intellectual Property Law; August 2002: Genetic Engineering Of Humans (Resolution 1003-1) Resolved, that the Section of Intellectual Property Law opposes, in principle, the adoption of any patent law interpretation that would extend enforcement of rights under a patent covering a genetic engineering invention in such a way as to affect any person’s control of his or her own body because it includes or incorporates such an invention or to limit the civil or human rights of any person in whom such invention is incorporated. 2. Medicare payments to drop The U.S. Centers for Medicare and Medicaid Services said effective Jan. 1, Medicare will pay less for some drugs and medical devices, while increasing its outpatient care budget by 5.6% to $18.7 billion. The Detroit News/Bloomberg (11/1) 3. Enforcement and Litigation Conference: Nov. 12 to 13 Join industry, government and legal experts Eric Blumberg, Lawrence McDade, Richard Cooper, James Sheehan and others to discuss litigation and enforcement in drug and medical device law. Don't miss FDLI's conference on Enforcement and Litigation Issues in Drug and Medical Device Law, Trouble in Court and How to Stay Out of It! Register today!
1. Measuring Progress Toward Sustainability If the goal of sustainable development is to improve life, then we need accurate yardsticks by which to measure the results of those efforts, according to three members of the Millennium Project's Central European Node, writing in the latest issue of Futures Research Quarterly. Authors Peter Mederly, Pavel Novacek, and Jan Topercer describe a Sustainable Development Index (SD Index) developed by the group in 2000-2001. The aim of the Index, they write, is a "complex expression of the state and developmental progress of individual countries towards sustainable development." The SD Index measures factors in 14 thematic areas, including human rights, equality, life expectancy, education, indebtedness, urban and rural problems, and natural resources and land use. Countries with the best index values included Norway, Finland, Sweden, Switzerland, Austria, Canada, and New Zealand; among the worst scores were for Eritrea, Angola, Ethiopia, Mozambique, Haiti, and Cambodia. Details: Order: https://www.wfs.org/frqbkissol.htm Subscribe: https://www.wfs.org/frqorder.htm
1. Conference Opportunity BioBusiness 2003 is the premier bio-partnering event for biotech and pharma business development and licensing executives. At this senior-level international event you won't have to trawl through your 200 fellow attendees to find fellow business development and licensing professionals as these are the only biotech and pharma representatives coming! So instead of wasting your time looking for them, you can concentrate on discussing strategies with them in interactive roundtable groups or formulating future plans with them in private one-to-one meetings. Plus you can learn from the best! Hear from 16 leading pharmaceuticals and 15 world class biotechs, such as Novartis, F. Hoffman La Roche, Boehringer Ingelheim, Aventis, Genentech, Genzyme and Vertex Pharmaceuticals, who will tell you what they are currently looking for in business partners and how they see alliance and partnering strategies developing in the next five years. Book your place now! For more information, please visit www.wbresearch.com/biobusiness or contact Colin Chapman at: colin2@wbr.co.uk 2. Lawsuits Filed Against Bayer Over PPA Use Eleven people have joined about 700 others in a lawsuit against the drugmaker, claiming that it knew about the potentially harmful effects of phenylpropanolamine. Each of the 11, four of whom were under 40, suffered strokes after taking an Alka-Seltzer product containing PPA. The News & Observer (Raleigh, N.C.)/Associated Press (11/1) 3. SureBeam Awaits Federal Approval for Wider Use of Technology SureBeam, the largest irradiation company in the U.S., is still waiting to see equipment sales increase. If the FDA approves the use of irradiation on precooked and processed foods, SureBeam could see an increase in business. Los Angeles Times (free registration) (11/1)
Biotechnology and Human Health Care 1. Fierce Competition fo a Shrinking HCV Market? A New Report from BioSeeker Group Hepatitis C virus (HCV) has already caused a global epidemic, but the worst may yet be to come. Nearly 4 million people are or have been infected with HCV in the U.S. alone and a fourfold increase in the number of adults diagnosed with chronic HCV infection is projected from 1990 to 2015. The number of new infections per year, however, has declined from an average of 240,000 in the 1980s to about 25,000 in 2001. By 2020, almost all of the infected will have had the disease for more than 25 years. Between the years 2010 and 2020, most patients will then have reached an age of 55 to 75 years, many infected will die of other reasons before they will be diagnosed and started any anti-HCV therapy. In this Highlight Report, BioSeeker has focused on three classes of therapeutic approaches as they represent different therapeutic strategies, but also as they target different time spans in the HCV market: immunomodulating substances, protease inhibitors, and vaccines. The report analyzes the short, mid-range and long-term market development by studying these therapeutic approaches in different developmental stages. we have tried to assess the competition between these therapeutic strategies and to correlate this with possible market development. Due to the high competition and a shrinking market some therapies will have difficulties to reach sufficient revenues within their lifecycle. Activities from a total of 50 companies are described. For more information about this report, please visit http://www.bioseeker.com/index.asp?report=hcv1 2. Looking Into Effects of Smallpox Vaccine in Young Children In a unique move, the FDA is taking public comments on a proposal by researchers who recommended additional studies on the vaccine. At issue are ethical implications about testing on healthy children with a vaccine of a non-circulating disease, and all the safeguards that would have to go with the trials. The Miami Herald/Associated Press (10/31) 3. Ariad Pharmaceuticals Presents New Anemia Treatment The new procedure, still in its early testing stages, involves injecting a virus containing the gene responsible for producing erythropoietin into patients. Rather than receiving injections of EPO several times a week, patients would take a single pill once or twice a month to keep the gene actively producing EPO. Researchers caution that clinical trials are still several years away. The New York Times (free registration) (11/1) 4. Medicare Payments to Drop The U.S. Centers for Medicare and Medicaid Services said effective Jan. 1, Medicare will pay less for some drugs and medical devices, while increasing its outpatient care budget by 5.6% to $18.7 billion. The Detroit News/Bloomberg (11/1) Have A Great Day and Thanks For Reading Biotechnology Update Report! |
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