The Andhra Journal of Industrial News
(An International Electronic Digest Published from the United States of America)
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Chief Editor: Prof. Sreenivasarao Vepachedu
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Issue 66

5111 Kali Era, Virodhi Year, Bhadrapada month
2067 Vikramarka Era, Virodhi Year, Bhadrapada month
1931 Salivahana Era
Virodhi Year, Bhadrapada month
 2009 AD, September





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More than 35 million people around the world are living with Alzheimer's disease or other types of dementia, says the most in-depth attempt yet to assess the brain-destroying illness -- and it's an ominous forecast as the population grays. The new count is about 10 percent higher than what scientists had predicted just a few years ago, because earlier research underestimated Alzheimer's growing impact in developing countries.
Barring a medical breakthrough, the World Alzheimer Report projects dementia will nearly double every 20 years. By 2050, it will affect a staggering 115.4 million people, the report concludes.

While age is the biggest driver of Alzheimer's, some of the same factors that trigger heart disease -- obesity, high cholesterol, diabetes -- seem to increase the risk of dementia, too. Those are problems also on the rise in many developing countries. The report notes that in India, such terms such as "tired brain" or "weak brain" are used for Alzheimer's symptoms amid widespread belief that dementia is a normal part of aging — when it's not.  That mistake isn't confined to the developing world. Even in Britain, the report found, just over half of the families caring for someone with dementia believed the same thing.

After analyzing dozens of studies, the scientists projected 35.6 million cases of dementia worldwide by 2010.  That includes nearly 7 million people in Western Europe, nearly 7 million in South and Southeast Asia, about 5.5 million in China and East Asia and about 3 million in Latin America.  The report puts North America's total at 4.4 million, although the Alzheimer's Association of the U.S. uses a less conservative count to say more than 5 million people in this country alone are affected. The disease afflicts one in eight people 65 and older, and nearly one in two people over 85.
The report forecasts a more than doubling of dementia cases in parts of Asia and Latin America over the next 20 years, compared with a 40 percent to 60 percent jump in Europe and North America.  The report urges the World Health Organization to declare dementia a health priority and for national governments to follow suit.

The number of Americans taking antidepressants doubled to 10.1 percent of the U.S. population in 2005 compared with 1996, increasing across income and age groups, a study found.  An estimated 27 million U.S. people ages 6 and older were taking the drugs by 2005, while their use of psychotherapy declined, according to Columbia University research published in the August issue of the Archives of General Psychiatry.  The surge in antidepressant use propelled that class of treatments to become the top-selling U.S. medicines in 2005, surpassing blood-pressure prescriptions, the study said.  The trend fueled sales of such antidepressants as Eli Lilly & Co.s Prozac, Forest Laboratories Inc.s Celexa and Pfizer Inc.s Zoloft. The research found more growth in the class of antidepressants known as selective serotonin reuptake inhibitors and a decline in tricyclic antidepressants.

Another Vaccine for Girls
A panel of experts this week backed U.S. approval of a second vaccine against human papilloma virus (HPV). The virus causes most cases of cervical cancer. Gardasil, made by Merck & Co., has been approved since 2006. The new vaccine is Cervarix, the Associated Press reported. It is made by GlaxoSmithKline. Both vaccines prevent two types of HPV that cause 70% of cervical cancer cases. Gardasil also protects against two other types of HPV that cause only genital warts. In a separate vote, the panel also urged that Gardasil be approved for prevention of genital warts in boys. This would be a second use for the vaccine. It now is given to girls and young women to prevent cervical cancer.

Ocular Allergy
Approximately 60 to 90 million Americans suffer from ocular allergy. Allergic conjunctivitis, the most common allergy affecting the eyes, is caused by exposure to certain allergens such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Ocular itching is the most common symptom of ocular allergy, reported by more than 75% of allergy patients. Current treatments for allergic conjunctivitis include antihistamines, mast cell stabilizers and anti-inflammatories. Based on data from IMS Health, in 2008 approximately 6.6 million prescriptions were filled for ocular allergy treatments, resulting in sales of approximately $560 million. The U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older. Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%, Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, and Istalol® (timolol maleate ophthalmic solution) 0.5% are trademarks of ISTA Pharmaceuticals. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.

Deadly Malaria
An emerging new form of malaria poses a deadly threat to humans, research has shown. It had been thought the parasite Plasmodium knowlesi infected only monkeys. But it has recently been found to be widespread in humans in Malaysia, and the latest study confirms that it can kill if not treated quickly.  The work, by an international team, appears in the journal Clinical Infectious Diseases.  The increase in tourism in Southeast Asia may mean that more cases are detected in the future, including in Western countries.  Although the new form of the disease has so far been concentrated in South East Asia, the researchers warn that tourism to the region could soon see cases appearing in Western countries too. Malaria kills more than a million people each year. It is caused by malaria parasites, which are injected into the bloodstream by infected mosquitoes.  Of the four species of malaria parasite that often cause disease in humans, P. falciparum, found most commonly in Africa, is the most deadly. Another parasite, P. malariae, found in tropical and sub-tropical regions across the globe, has symptoms that are usually less serious.  P. knowlesi had been thought only to infect monkeys, in particular long-tailed and pig-tailed macaques found in the rainforests of South East Asia. But following work by a team at the University Malaysia Sarawak it has now been recognised as a significant cause of disease in humans.  The latest study shows that P. knowlesi can easily be confused with P. malariae under the microscope. However, unlike its cousin, P. knowlesi has the ability to reproduce every 24 hours in the blood - meaning infection is potentially deadly.

More Accurate Drug Discovery Process
Cancer and cell biology experts at the University of Cincinnati (UC) have developed a new mass spectrometry-based tool they say provides more precise, cost-effective data collection for drug discovery efforts. Preliminary studies have shown that the new mass spectrometry tool—known as MALDI-QqQMS (matrix-assisted laser desorption ionization-triple quadruple mass spectrometer)—provides a superior means of measuring the enzyme reactions critical to drug discovery at speeds comparable to currently available high-throughput screening systems at significantly lower costs. The approach developed by the UC group also holds appeal in that it has multiplexing capabilities—making it possible to, measure inhibitors for two or more enzymes with one pass through the compound repository. Typical assays start with one target enzyme and that is tested against an entire compound repository to look for inhibitors. Once inhibitors are identified, researchers must then follow up on each one to see if it has any validity as a drug target.

Magnetism to Turn Drugs On and Off
Many medical conditions, such as chronic pain, cancer and diabetes, require medications that cannot be taken orally, but must be dosed intermittently, on an as-needed basis, over a long period of time. A few delivery techniques have been developed, using an implanted heat source, an implanted electronic chip or other stimuli as an "on-off" switch to release the drugs into the body. But thus far, none of these methods can reliably do all that's needed: repeatedly turn dosing on and off, deliver consistent doses and adjust doses according to the patient's need.
A the team of scientists at Children's Hospital Boston, funded by the National Institutes of Health, have devised a solution that combines magnetism with nanotechnology.  The team created a small implantable device, less than ½" in diameter, that encapsulates the drug in a specially engineered membrane, embedded with nanoparticles (approximately 1/100,000 the width of a human hair) composed of magnetite, a mineral with natural magnetic properties. When a magnetic field is switched on outside the body, near the device, the nanoparticles heat up, causing the gels in the membrane to warm and temporarily collapse. This opens up pores that allow the drug to pass through and into the body. When the magnetic force is turned off, the membranes cool and the gels re-expand, closing the pores back up and halting drug delivery. No implanted electronics are required.
The device is described in the journal Nano Letters (published online September 8, DOI: 10.1021/nl9018935).

Combination Therapy for Hypertension
The US Food and Drug Administration (FDA) has approved Valturna(®) (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure. This is the first approval for Valturna, which is indicated for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
Valturna combines in a single pill valsartan, the active ingredient in Diovan(®), the number one selling branded high blood pressure medicine worldwide, and aliskiren, the active ingredient in Tekturna(®), the only approved direct renin inhibitor (DRI). Valturna offers significantly greater blood pressure reduction than either valsartan or aliskiren alone.

The single-pill combination Valturna targets the RAAS in two ways. The valsartan component blocks, at the receptor level, the action of angiotensin II, an important end product of the RAAS that causes blood vessels to tighten and narrow. The aliskiren component reduces angiotensin II levels by directly inhibiting renin, an enzyme produced by the kidneys that starts a process which leads to formation of angiotensin II. An overactive RAAS is an important contributor to high blood pressure in many patients. By targeting two key points within the RAAS, Valturna helps blood vessels relax and widen so blood pressure is lowered.

Research suggests that up to 85% of hypertensive patients may need multiple medications to help control their blood pressure, underscoring the need for effective combination treatments. High blood pressure affects approximately 74 million, or nearly one in three, US adults. Although high blood pressure can be easily diagnosed and often successfully managed, approximately 36% of US adults treated with antihypertensive medication do not have their blood pressure controlled. If left untreated, high blood pressure can lead to stroke, heart attack, heart failure, kidney failure and vision problems.

Lilly Cuts Jobs
Seeking to cut costs and bring new drugs to market more quickly as its best-sellers go off-patent, drugmaker Eli Lilly & Co. will eliminate 5,500 jobs over two years and reorganize into five business units.  The Indianapolis company said it will reduce its work force by nearly 14 percent, to 35,000 from the current 40,500, by the end of 2011. The new total excludes hirings in high-growth emerging markets and Japan.

Lilly hopes to cut annual costs by $1 billion per year over the same time, and will organize itself into the following units: cancer, diabetes, established markets, emerging markets, and Elanco, its animal health business.

Bayer v. Union of India

Nexavar, currently cleared for fighting tumors of the kidney and the liver, is one of the Bayer’s most promising drugs, projected to have up to 2 billion euros ($2.82 billion) in annual sales.  Nexavar is the tosylate salt of sorafenib, a synthetic compound targeting growth signaling and angiogenesis.  Sorafenib tosylate blocks the enzyme RAF kinase, a critical component of the RAF/MEK/ERK signaling pathway that controls cell division and proliferation.  In addition, sorafenib inhibits the VEGFR-2/PDGFR-beta signaling cascade, thereby blocking tumor angiogenesis.
Sorafenib was approved by the U.S. Food and Drug Administration (FDA) on December 20, 2005, and received a European Commission marketing authorization on July 19, 2006.  On July 31, 2007, India approved sorafenib tosylate (200 mg) (  The European Commission granted marketing authorization to Nexavar (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, on October 30, 2007.  Sorafenib obtained FDA approval for the treatment of advanced hepatocelluar carcinoma in November 2007.

In the US, Bayer has two patents US7235576 and US7351834, which expire in 2020, listed in the Orange Book. At issue is an Indian patent issued by the Government of India.

Bayer’s Writ Petition
Bayer filed a writ petition seeking restraining the Drug Controller General of India granting a drug license to Cipla, a generic company, to manufacture, sell and distribute its drug “Nexavar,” under the generic name “Soranib.”

The Delhi High Court had issued an injunction against the Drug Controller General of India (DCGI) and stopped processing Cipla’s drug application in 2008 (November 7, 2008 interim order).

On August 18, 2009, Justice S. Ravindra Bhatt of the Delhi High Court rejected Bayer’s plea and ordered Bayer to pay the costs of litigation and penalties for indulging in unnecessary litigation.  The penalty was Rs 675,000 (USD 13,878).

Bayer’s Appeal
Bayer appealed.  On September 4, 2009, a Delhi High Court Division Bench, comprising Chief Justice A. P. Shah and Justice Manmohan, directed the DCGI to process the license application of Cipla, and upheld Justice Bhatt’s verdict, including the penalty.

Issues before the Court
1) Whether a combined reading of the Drugs Act and the Patents Act lead to the conclusion that no marketing approval can be granted to applicants for drugs or formulations, of which others are patent owners, by reason of Section 2 of the Drugs Act, read with Sections 48 and 156 of the Patents Act.

2) Whether drugs or formulations which infringe patents are “spurious drugs” under the Drugs Act.

Current Law in India
The Indian patent law was changed in 2005  to conform to the TRIPS requirements, thereby reintroducing the product patent regime after 35 years of vacuum.

Drug Controller General of India (DCGI) is responsible for the drug approval process under Drugs and Cosmetic Act .

Currently, there is no law in India that links the drug approval with patents, called patent linkage . Patent linkage contains four ingredients:
a) a requirement of identification of relevant patents to the drug, if any, and listing them by an NDA holder, (exists in the Indian law)
b) a mechanism by which a generic drug makers who intends to market a branded drug must certify that the patents listed by the NDA holder are either invalid or not infringed,
c) such certification should be considered an act of infringement of the patent in question and courts, if an infringement suit is brought by the NDA holder, should have jurisdiction over such infringement actions to review the patent validity, and
d) such an infringement action should automatically result in a delay of the approval up to 30 months or until the case is disposed off properly in the court.

Spurious drugs as defined under the Drug Act are those drugs that are fraudulant, adulterated and involve unauthorized use of trademarks.  Generic drugs are never spurious drugs.

Bayer’s arguments

1) Bayer alleges generic drugs that infringe patents are “spurious drugs,” as defined under section 17B of the Drugs Act, because they are imitations of patented drugs. Further section 17B requires DCGI to not to provide license to market a drug under a trade name or registered mark owned by another entity . 
2) Bayer contends that courts should impose a linkage between patents and drug approvals. Section 2 of Drugs Act provides that application of other laws is not barred by the Dangerous Drugs Act, 1930.  Section 48 of Patent Act confers rights on patentees to prevent infringers (from making, using, altering, selling or importing).
3) Bayer contends that Cipla’s reliance under section 107A(a), a Bolar like provision, is erroneous, as it is intended for submission of information required for the approval of a generic drug for marketing in India after the expiry or revocation of the patent of the branded product.

Cipla’s arguments
1) Cipla contends that generic version of a branded drug is not a “spurious drug” as defined under section 17B, as it requires deception.
2) Cipla contests the linkage argument in that i) the grant of regulatory approval is not “making, using, offering for sale, selling or importing” of a patented invention and hence not an infringement of a valid patent, ii) infringement cannot be assumed at the insistence of the patentee, and iii)  Bayer’s patent is not valid.
3) Cipla alleges that section 107A(a), Bolar provision, clearly exempts from patent infringement any acts of making, using, offering for sale, selling or importing” of a patented invention.
4) Cipla submits that Bayer is free to bring an infringement suit, and Cipla is free to counter claim revocation of the patent.
5) Cipla contends that DCGI has no expertise to determine the validity of a patent, and the Drug Act does not oblige the DCGI to determine the validity of a patent and infringement prior to approval of a drug.  DCGI is statutorily obligated to issue a license if an applicant fulfilled the essential requisites of the drug application process.

DCGI Arguments
1) The DCGI contends that the Patent Controller, the Intellectual Property Appellate Board (IPAB) and the courts are the proper authorities to determine patent validity and infringement, but not the DCGI. The DCGI has no expertise to determine complex patent issues.
2) The DCGI argues that the Patents Act provides for a counter claim of revocation of a patent in an infringement suit, which remedy should not be taken away by an injunction to another party like DCGI.  Every manufacturer has to submit patent information related to the drug, which has mere information status, and the DCGI has no legislative mandate to withhold approval of a drug marketing license based on a patent. 
3) The DCGI contends that patent rights are private rights and therefore the State, i.e., DCGI, cannot enforce such private rights.

The DCGI's stand is similar to FDA's stand in the US.

The Delhi High Court Opinion
    (1)  The court concluded that a combined reading of Section 2 of the Drugs Act, with Sections 48 and 156 of the Patents Act did not establish the patent linkage, sought for by the petitioner.  
    (2)  The court concluded that unpatented drugs are not “spurious drugs” under the Drugs Act of India.
In view of the above conclusions, the court dismissed the writ petition and fined Bayer for bringing a frivolous suit.

On appeal, the decision was upheld by a Division Bench of the Delhi High Court.

Based on the existing law, Bayer had no opportunity to link Patents with Drug Act.  Bayer attempted and failed to create a linkage through judicial process and was fined for their baseless petition, properly.

Bayer can bring a patent infringment suit.  However, Indian courts may not issue an injuction until the disputed Indian patent is proved valid and infringed.  The Indian Judiciary does not recognize the presumption of validity of Indian patents, issued by the Government of India (see recent cases of Roche and Braun, where courts were anti-patent and did not issue injuctions against generic drug makers like Cipla).

Source: The primary sources cited above,  BBC News, New York Times (NYT), Washington Post (WP), Mercury News,, Chicago Tribune, CNN, 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.

Copyright ©1998-2009
Vepachedu Educational Foundation, Inc
Copyright Vepachedu Educational Foundation Inc., 2009.  All rights reserved.  All information is intended for your general knowledge only and is not a substitute for medical advice or treatment for special medical conditions or any specific health issues or starting a new fitness regimen. Please read disclaimer.

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(Om! Lead the world from wrong path to the right path, from ignorance to knowledge, from mortality to immortality and peace!)
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