The Andhra Journal of Industrial News, January 2006, Issue 22, Vepachedu Educational Foundation

Contents

The US Patent and Trademark Office Proposes Sweeping Changes to Examination Rules
India's Patent System
Textile Industry in India
Dell Wins in India
New Drug for Arthritis
Sutent for Cancer Approved
Inhaled Insulin Approved
Ranexa Approved for Chronic Angina
Alprazolam Extended-release Tablets
i-STAT(R) CHEM 8+ cartridge, a diagnostic test
First Immune Globulin Subcutaneous
Gates and Britain Fight Tuberculosis
Biotechnology Grant Program in New York
How to Build a Pharmaceutical Factory?
Fast Track Grant by FDA
CIP-Fenofibrate, a cholesterol drug
Sulfonyl Unrea Drugs are Dangerous
Test for STD
Fertility Test Kit for Men
Stem Cell Banks in India

The US Patent and Trademark Office Proposes Sweeping Changes to Examination Rules

India's Patent System
India’s patent system underwent radical changes in terms of infrastructure as the patent offices in Delhi, Mumbai, Calcutta and Chennai have moved into new office buildings. Now, the Delhi Patent Office is operating out of a spacious campus with modern IT infrastructure and other facilities. The office modernization and recruitment of numerous patent examiners have resulted in clearing off the back log of long pending patent applications. However, the standards in the examination procedure continue to be old, e.g. the conventional practice of oral hearings and personal interviews still continue. The subjective interpretations of legal provisions by different examination units in the same patent office are still inconsistent.

Textile Industry in India
Geographical Indications of Goods are defined as that aspect of industrial property which refer to the geographical indication referring to a country or to a place situated therein as being the country or place of origin of that product and conveys an assurance of quality and distinctiveness which is due to its origin in that defined geographical locality, region or country. This prevents the commercial benefits being "hijacked" by some other country. Geographical Indications are part of the Trade Related Intellectual Property Rights (TRIPS) agreement signed under the WTO framework.

The Indian Union geographically has a rich heritage of products that could identified by the origin of each such product, which are unique to each place. A similar copy product cannot be obtained from any other region, even within the country itself, if Geographical Indications are obtained.

The Government of India requested the Andhra Pradesh Textiles Development Committee (APTDC) to identify all handloom products, which can be registered under the system. APTDC would also be given a commission for carrying out a countrywide survey to locate such goods. Some Textile industry applications that have been applied for are: Solapur Chaddar, Solapur Terry Towel, Kotpad Handloom Fabric, Mysore Silk, Kota Doria, Bhavani Jamakkalam, Kullu Shawl, Orissa Ikat etc. Items for which GI registration was applied in 2005 include the famous Kancheepuram Silk sarees from Tamilnadu and Banarasi Silk Sarees from Uttar Pradesh. Mysore Silk Sarees, made-ups, ties and yarn from Karnataka have got their registration already.

Dell Wins in India
Dell, the global brand name in the area of computer hardware, software and IT consulting services, after a long legal battle that extended over three years, succeeded in establishing exclusive rights over its unregistered trademark "Dell" in India in the case of Dell Computers Corpn. V. Arun Kumar and ors. 2005 (31) PTC651 (Del.)

New Drug for Arthritis
Bristol-Myers Squibb Co. said the FDA has approved a new drug to treat moderate to severe cases of rheumatoid arthritis, a chronic disease that afflicts more than 2 million Americans.
The drug acts by suppressing part of the immune system to treat rheumatoid arthritis, which is marked by swelling, stiffness and pain in the linings of the joints. The linings become inflamed after the body's immune system acts against them. Treatments for rheumatoid arthritis typically involve immunosuppressants. Abatacept uses a new mechanism, blocking the activation of T-cells. When T-cells proliferate, they play a role in the body's immune response. The drug, abatacept, is to be marketed as Orencia and is designed to be given intravenously. The company, based in New York, intends to start selling it by the end of February.

Sutent for Cancer Approved
FDA News on January 26, 2006 reported (http://www.fda.gov/bbs/topics/news/2006/NEW01302.html), "The Food and Drug Administration (FDA) today announced approval of Sutent (sunitinib), a new targeted anti-cancer treatment for patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer. Today's action marks the first time the agency has approved a new oncology product for two indications simultaneously. Sutent, which received a priority review and was approved in less than six months, is a tyrosine kinase inhibitor working through multiple targets to deprive the tumor cells of the blood and nutrients needed to grow."

Sutent was approved for the treatment of patients with gastrointestinal stromal tumors (GIST) whose disease has progressed or who are unable to tolerate treatment with Gleevec, the current treatment for GIST patients. While studying the treatment in patients, researchers conducted an early (interim) analysis of data that showed Sutent delayed the time it takes for tumors or new lesions to grow in patients with this rare type of stomach cancer. Specifically, the median time-to-tumor progression (TTP) for patients treated with Sutent was 27 weeks compared to 6 weeks for patients who were not treated. FDA also granted accelerated approval for Sutent in the treatment of patients with advanced renal cell carcinoma (RCC). In contrast to the approval for GIST, which was based on the drug's ability to delay the growth of the tumors, this approval was based on Sutent's ability to reduce the size of the tumors in patients. An overall response rate ranging from 26-37 percent was found in patients with metastatic kidney cancer whose tumors had progressed following cytokine-based therapy. Sutent will be distributed by Pfizer Labs, Division of Pfizer, Inc. in New York, NY

Inhaled Insulin Approved
The first inhaled version of insulin won U.S. approval on Friday, offering an alternative for some of the daily shots millions of diabetics use to control blood sugar and prevent complications from the disease. The Pfizer Inc. product, Exubera, was approved for adults with either Type 1 or Type 2 diabetes. Industry analysts forecast sales will top $1 billion a year. More than 5 million Americans use insulin daily to manage blood sugar levels and prevent complications such as heart disease, blindness and limb amputations. FDA officials said they also were advising against use of Exubera in patients with lung conditions such as asthma or chronic obstructive pulmonary disease until more research determines if inhaled insulin is safe for them. The Exubera inhaler, which was invented by Nektar Therapeutics Inc., weighs about four ounces and is about the size of an eyeglass case when closed, Pfizer said. Side effects include coughing, shortness of breath, sore throat and dry mouth, the FDA said. As with any insulin, patients may develop low blood sugar and should monitor their levels regularly.

Ranexa Approved for Chronic Angina
CV Therapeutics, Inc. announced on January 27 that the U.S. Food and Drug Administration (FDA) has approved Ranexa(TM) (ranolazine extended-release tablets). The approved indication is as follows: Ranexa is indicated for the treatment of chronic angina. Because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs. Ranexa should be used in combination with amlodipine, beta blockers or nitrates. The effect on angina rate or exercise tolerance appeared to be smaller in women than men.

Alprazolam Extended-release Tablets
Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Alprazolam Extended-release Tablets, 0.5 mg, 1 mg, 2 mg and 3 mg. Alprazolam Extended-release Tablets are the AB-rated generic equivalent of Pharmacia's and Upjohn's Xanax XR(R) Tablets, which had U.S. sales of approximately $100 million for the 12-month period ending June 30, 2005, according to IMS Health.

i-STAT(R) CHEM 8+ cartridge, a diagnostic test
Abbott announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its i-STAT(R) CHEM 8+ cartridge, a new point of care diagnostic test used to quickly assess basic metabolic status of patients in emergency rooms, clinics, surgical suites and other critical care settings. The CHEM 8+ cartridge is designed for use with the i-STAT, a market-leading automated hand-held blood analyzer that performs a comprehensive panel of critical tests at the patient's bedside in only a few minutes, producing lab-quality results that allow health care professionals to make on-the-spot diagnosis and treatment decisions for their patients. The new CHEM 8+ cartridge is a single-use, in vitro diagnostic test that combines a battery of basic metabolic tests -- including sodium, potassium, chloride, ionized calcium, total CO(2), glucose, blood urea nitrogen (BUN) and creatinine -- with measurements for hematocrit and hemoglobin into a single test. The i-STAT CHEM 8+ cartridge provides a rapid snapshot of the most critical homeostatic processes: glycemic control, electrolyte balance and renal function, right at the patient's side and using just a few drops of blood.

First Immune Globulin Subcutaneous
ZLB Behring announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Vivaglobin® (Immune Globulin Subcutaneous [Human]), an immunoglobulin (Ig) replacement therapy for treating patients with primary immunodeficiency (PI). Vivaglobin is the first and only FDA-approved subcutaneous (SC) Ig treatment, and can be safely self-administered by PI patients under a physician's care in the United States. Vivaglobin is manufactured and marketed by ZLB Behring.

Gates and Britain Fight Tuberculosis
Microsoft Corp's founder Bill Gates pledged $900 million to fight tuberculosis on Friday, kick-starting a $31 billion funding drive against a disease which kills one person every 15 seconds, while Britain on pledged 41.7 million pounds ($74.43 million) to tackle tuberculosis in India. Tuberculosis has reached alarming proportions in Africa and other poor countries, where co-infection with HIV/AIDS makes a deadly combination. "This is a very tough disease. It is going to take all of us -- private sector, the pharmaceutical companies, philanthropy and governments in countries that have the disease -- to participate as well," Gates told reporters at the World Economic Forum in Davos. WHO believes the project can break the back of tuberculosis globally but full implementation would cost an estimated $56 billion over the next decade, including $47 billion for controlling the disease and $9 billion for research into new drugs and vaccines. That represents an overall increase of $31 billion over currently projected funding. A total of 27 new TB drugs are in development and four vaccines are in early-stage clinical trials.

Biotechnology Grant Program in New York
Gov. George Pataki and the Republican-led state Senate are backing a program that aims to generate $800 million in new investment in biotechnology and medical research at institutions across the state. The program, announced by Pataki and Senate Majority Leader Joseph Bruno, would create a $200 million grant initiative they hope will generate another $600 million in federal, not-for-profit and private sector matching funds. The initiative will fund research at universities and hospitals around New York. Pataki said the plan would build on the state's Centers of Excellence initiative, which has attracted $8.5 billion in new investments in university-based research and high-tech businesses.

How to Build a Pharmaceutical Factory?
"I encourage you to learn more about how you can grow your own pharmaceuticals. I'm a huge proponent of gardening. I believe if we can get foods right off the vine, then they can impart tremendous health benefits to us, above and beyond just buying fresh foods at the grocery store," Mike Adams at http://www.newstarget.com/017016.html.

Fast Track Grant by FDA
Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug means that the FDA has determined that the drug is intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate and expedite the development and review of the application for the approval of the product.

Discovery Laboratories, Inc. announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to Discovery's lead product, Surfaxin(r), for the prevention and treatment of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung Disease) in premature infants. BPD is a costly syndrome affecting premature infants. It is associated with surfactant deficiency and the prolonged use of mechanical ventilation and oxygen supplementation. Some premature babies are born with a lack of natural surfactant in their lungs. Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in Respiratory Distress Syndrome (RDS). To treat RDS, babies require a surfactant usually within one hour of birth as well as mechanical ventilation to support the babies' respiration. The lack of surfactant and use of mechanical ventilation may cause chronic injury and scarring of the lungs -- resulting in BPD.

CIP-Fenofibrate, a cholesterol drug
Cipher Pharmaceuticals Inc. (TSX: DND) announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for CIP-Fenofibrate, the Company's novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia. CIP-Fenofibrate, approved under the label as Lipofen(TM), targets a large and growing market as the three existing novel fenofibrate formulations are forecasted to exceed $1 billion in annual U.S. sales.

Sulfonyl Unrea Drugs are Dangerous
The Canadian Medical Association Journal reported that at higher daily doses sulfonylurea-type drugs were associated with an increased risk of death, but this was not seen with metformin. People with type 2 diabetes are often prescribed drugs to boost their production of insulin. The controversial belief that these so-called sulfonylurea drugs increase mortality in-patients with diabetes now gets support from the new study by researchers in Canada.

Test for STD
Chlamydia and gonorrhea are the two most common sexually transmitted diseases in the world. According to the World Health Organization, more than 300 million cases of sexually transmitted diseases occur throughout the world every year, including more than 85 million new cases of chlamydia and more than 55 million new cases of gonorrhea. About 80 percent of women and 10 percent of men who are infected do not have symptoms. An infected person can transmit either chlamydia or gonorrhea anytime whether or not symptoms are present.

Abbott announced in January that a highly sensitive new test for the simultaneous detection of the sexually transmitted pathogens Chlamydia trachomatis (CT) and Neissera gonorrhoeae (NG) has received CE Mark certification, allowing it to be marketed in the European Union. The test is designed for use on the Abbott m2000(TM), an automated instrument using magnetic particle and real-time PCR (polymerase chain reaction) technology.

Fertility Test Kit for Men
The world's first over-the-counter home fertility test for men has been developed by scientists at Birmingham University. The Fertell test works in less than an hour and gives couples an early warning of potential fertility problems. Researchers looked at samples from 150 men and they claim the test provided an accurate result in 95% of cases. They said the test, which is available now, could cut the wait for fertility treatment by up to a year. To conduct the test the man produces a sample, sets the device and within an hour will find out whether he has enough sperm to fertilize a female egg. The test works by forcing sperm to swim through a barrier mimicking the female cervix. It then measures the number of sperm, which get beyond this point. If a high enough level of active sperm is present in the sample, a red line indicates a positive test. During the development of the test the research team analyzed more than 3,000 individual sperm samples. One in 15 UK men experience some fertility problem, although about half of couples with difficulties eventually manage conception. It will be on sale nationwide in UK in high street chemist Boots for £79.99 in a kit for couples including male and female fertility tests.

Stem Cell Banks in India
Stem cells are master cells from which the body's immune and blood system originate and which can develop into cells of any organ. Blood, which is extracted from the baby's umbilical cord and placenta discarded after birth, is loaded with stem cells. Two Indian companies offer cord blood cell banking, LifeCell and Reliance Life Sciences. They have a combined repository of more than 4,000 units, with Reliance dominating with 3,000 units. It costs 60,000 rupees (1,333 dollars) for the process. 4,000 Indian parents have had the blood cells from their children frozen, to be revived in need, hoping there would be a scientific breakthrough in the meantime.

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