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5111 Kali Era, Virodhi
Vikramarka Era, Virodhi
Year, Bhadrapada month
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
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
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.
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
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. http://www.healthnews.uc.edu/news/?/9225/
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).
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) (http://cdsco.nic.in/New%20Drugs%20Approved%202007.htm).
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
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
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
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.
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.
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.
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
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).
primary sources cited above,
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Washington Post (WP), Mercury News,
Bayarea.com, Chicago Tribune, CNN, USA
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(DC), the Hindu, Hindustan Times,
Times of India, AP, Reuters, AFP,
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