Patent Portfolio of CSIR
Generic Drug Industry
Dangers of TCE
Massachusetts-based Forrester Research predicted in a recent study that by
2015, more than 40,000 U.S. legal jobs will be sent overseas, costing lawyers
$4.3 billion in lost wages. It’s not surprising that companies are seduced
by the idea of offshoring. The cost benefits alone are astounding.
Legal outsourcing vendors such as U.S.-based Lexadigm and India-based Atlas
Legal Research charge $60 to $80 per hour per lawyer. Paralegals and
junior associates in the U.S. charge three or four times that amount for
the same work. The Indian lawyers employed by these companies handle low-end
legal services. Document review, online and legal research, patent applications,
contract and other document drafting, litigation support and paralegal services
typically fall under this category. While the cost factor seems to weigh
heavily in favor of India, the deal seems equally profitable in the Indian
context with an estimated $12 billion by 2016, according to an estimate.
Intellectual property was once considered the most boring subject in the
world and a totally irrelevant subject in India. However, things have
changed today, as the world has changed. The old industrial era has
been supplanted by a new knowledge based economy in which ideas and innovation
have become valuable. Many companies realize now that if they don't claim
their stake in the future, they will wake up and discover one day that their
competitors own all the patents to exclude them from the business.
Market giants like Microsoft started using their patents as competitive weapons.
Thus, once dreaded boring patent lawyers are attracting small crowds at party
gatherings! People are trying to patent every idea - silly to ground
breaking. Is a bird diaper patentable? Yes, of course, see US patent
2882858. Is urinal for women while standing patentable? Yes, of course,
see urinal for use by females (United States Patent 4,683,598). However,
it should be noted that the purpose of a patent is to protect one's inventions
from being stolen by others. Nobody steals a worthless item or idea.
Obviously, you don't need to protect such worthless or useless inventions
by an expensive US patent costing about $ 25000 to procure, which only prevents
others from using, offering to sell, selling or manufacturing the patented
invention in the US. Accordingly, it would be wise to spend money on patenting
inventions after you determine the potential market value of your inventions.
Once you have an IP portfolio, it is important to perform IP due diligence,
a legal exercise, wherein skilled IP counsel defines, examines and analyzes
an IP portfolio of a target company to sell or out-license. Whether you are
the target company or the buyer in a business transaction involving IP, the
due diligence involves revealing the value of the intangible assets – patents,
trade marks, copyrights and trade secrets – by examining the strength, scope
and enforceability of the IP, the ownership rights surrounding the IP, and
the future potential to be derived from the IP. The breadth and depth of
these inquires usually are directly proportional to the importance of the
IP and its corresponding impact on the value of the transaction.
India, the sleeping giant, is also waking up to this reality of the global
knowledge-based economy. "To be noticed, you need a portfolio of patents,"
says in Nature
Dr. Raghunath Mashelkar, head of India's largest funding body, the Council of Scientific and Industrial
Research (CSIR), equivalent of NIH in the US. "Patent or perish"
is the slogan of Dr. Mashelkar. Dr. R. K Gupta enunciates the policy
of CSIR, "the approach of the CSIR has been to file a patent on any new finding
that meets the criteria, whether or not the agency wants to commercialize
it." However, the article entitled "Is India's
'patent factory' squandering funds?" in the journal Nature
in July 2006, reports the above quotes and questions the Indian prudence
in patenting strategy in view of a particular patent on an extract
from cow's urine.
In all fairness, it should be noted that FDA approved horse urine extract,
sold by Wyeth, has been prescribed for women in the US for hot flashes or
night sweats. Millions of American women have been using horse urine
extract. Just because Indians developed something from cow's urine,
there is nothing to laugh at. However, the difference between the Wyeth's
American horse urine and CSIR's Indian cow's urine is in the economics.
Wyeth has been making money by selling horse urine to American women, while
India's CSIR has not yet made a penny on the patented cow's urine.
In general, vast majority of companies are simply unaware of the often-enormous
economic and competitive values that lie untapped within their patent portfolios.
When India's CSIR performs due diligence and sells or licenses out patents
and when CSIR makes money from the patented Indian cow's urine, just like
Wyeth makes money from horse urine, then Mr. Suresh Chandran, who reportedly
had a laugh at it, would applaud and then Dr. Ramarao Alla (AV Ramarao),
who reportedly said in Nature "A lot of money is going down the drain
in the name of patents", might approve the process and the expenditure!
It's about time India patented and exploited her inventions. Hat's off to
CSIR and hope it will continue the trend. Welcome to the new global
battlefield of Intellectual Property! The race is on!
Stem cell research promises to help fill gaps where current medicine falls
short. Many scientists believe the treatment of strokes, heart disease, cancer
and birth defects could benefit from stem cell research, along with Parkinson's
and Alzheimer's disease. Stem cells promises to be the biggest boon for humans
against the risk of deadly diseases. http://edition.cnn.com/2006/TECH/science/04/14/fs.stemcellprofile/.
Hyderabad seems to be a center for stem-cell medicine in India. The
privately owned L. V. Prasad Eye Institute in Hyderabad pioneered techniques
as early as 2001. Dorairajan Balasubramanian, Chairman of the National Task
Force on Stem Cell Research and a member of the CNN Future Summit Nominating
Committee, has been using stem cells to treat patients at the L.V. Prasad Eye Institute in Hyderabad
to restore sight. The institute says it has used transplanted stem cells
to treat more than 240 patients with damaged corneas. Two other private hospitals
in Hyderabad are using stem-cell therapy to treat damaged heart muscle, and
plans are in place in other hospitals and clinics in the city to use stem
cells to regenerate the liver in cirrhosis sufferers and the pancreas in
India’s biotech boom could even dwarf software in coming years if you trust
the most optimistic projections. State governments like Karnataka, Tamil
Nadu, and Andhra Pradesh are bending over backward to lure firms into their
“genome valleys.” Foreign firms and research institutes are rushing
in. The Hyderabad-based Center for Cellular
and Molecular Biology’s (CCMB) 85-million rupee research facility, the
first of its kind in Asia, has been hunting for new genes and proteins that
may help identify the genetic root of diseases like cancer. However, almost
all the biotech products so far have been indigenous versions of existing
products. It is beyond any Indian drug firm to even think of bringing out
a novel product, let alone new drugs. Stem cell research might deliver what
is missing - a new cure- from India. America's rejection of stem cells may
be a boon for Indian scientists.
The use of embryonic stem cells has become a social issue in America. Many
researchers in Europe and Asia are also constrained by government regulations,
and some still face outright bans on the work. Many Christian religious
groups find the idea of using cells from human embryos - that would otherwise
be wasted anyway- to help suffering patients morally unacceptable. They argue
the human stem-cell experiments amount to murder, while wars, wars-on-terrorism
and terrorism go unabated killing hundreds of human lives per day from Congo
to Iraq to Kashmir. It is alright to do research on monkeys and dogs and
even human volunteers, but it is not ok to do research on the embryonic cells
frozen to thrown away later, they argue.
A week after George W. Bush cast his first veto, of a bill to permit federal
funding of stem-cell research, the European Union decided that some of its
public research budget could be used for the same end, albeit with some restrictions,
as some central European members, supported by the Catholic Church, were
against. The decision cleared the way for the adoption of the EU's 54-million-euro
(65-billion-dollar) research budget for 2007-2013 aimed at catching up with
research in the United States and boosting Europe's sluggish economy.
Europeans aren't the only ones trying to profit from the U.S. restrictions.
Big and small countries such as China, India, Singapore, Australia, Japan,
South Korea etc. are all vying for a share of the large biotech demand in
the world. (Stem
cell centers in the world)
Singapore in particular, is going all out to promote stem cell research in
the country. http://www.lifenews.com/bio1453.html.
Singapore is looking to replace South Korea as the number one international
destination for stem cell research and is luring top scientists from around
the globe with modern, high-tech labs and large sums of government money.
The country has invested billions of dollars in this field and plans to become
the number one international stem-cell research destination in the world.
But Singapore is spending so much it's standing out in the crowd. It has
already put in $4 billion U.S. into biotechnology and has committed another
$8 billion by 2010, according to an AP report. The nation has named its research
Mecca Biopolis and has a sprawling facility 10 stories tall and connected
by impressive skywalks. For Alan Colman, an English biochemist and a leader
of the British team that created the first cloned mammal in 1997, steamy
Singapore has become the destination. The progress of Singapore in
biotechnology is such that wealthy mothers from Thailand are depositing their
newborn baby’s blood in Cord blood banking services available in Singapore.
Some other governments have focused on importing talent. China, for instance,
has recruited scientists from top universities in the U.S. to run research
centers on the mainland.
As far as India is concerned, in 2002, the the Indian Council of Medical Research (ICMR)
in New Delhi, which belongs to the health ministry, announced a policy that
permitted therapeutic cloning and encouraged stem-cell research. The Department
of Biotechnology (DBT), which belongs to the science ministry, had also issued
guidelines the previous year. Hopefully, as Muthuswami said in Nature,
"the planned guidelines will not stop research but will ensure that there
are sufficient checks and controls on clinical practice."
Innovative drug developers are facing an unprecedented number of challenges
in maintaining revenue growth. Fewer novel drugs are being approved, a large
number of blockbusters are facing patent expiry, and public and private payers
across the major drug markets are implementing cost-containment policies
in response to sky-rocketing healthcare costs, which is affecting drug margins.
This increasing focus on cost containment is boosting the sales growth of
generics. In the US, payers are under increasing pressure to utilize cost-containment
policies, such as tiered formularies, which provide incentives to use generics
because they reduce patient co-pay for generic drugs. In Europe, factors
such as generic substitution are also helping to drive uptake. The reward
for generics companies who gain market share is significant: Datamonitor
estimates that US$157 billion (around 40%) of 2005 brand sales will be exposed
to generic competition by 2015.
Global sales of biologic products (by 56 of the leading pharmaceutical and
biotechnology companies) are growing rapidly, and are forecast to almost
double from US$56 billion in 2004 to $105 billion by 2010. Therefore, this
market represents a significant target for generics companies, but there
are higher barriers to entering the biosimilars market than the small-molecule
generics market. Key factors set to affect the biosimilars market over the
short- to medium-term include regulatory issues, marketing strategies and
the class of rDNA protein being targeted. Over the longer term, the emergence
of biosimilars from low-cost manufacturing sites plus the next generation
of so-called 'super-biosimilars' is also set to drive market growth. For
more visit: Nature
Reviews Drug Discovery 5, 535-536 (July 2006).
Dangers of TCE
Trichloroethylene, TCE, which is widely used to remove grease from metal
parts in airplanes and to clean fuel lines at missile sites. TCE is a colorless
liquid that evaporates at room temperatures and has a somewhat sweet odor
and taste. It is one of the most common pollutants found in the air, soil
and water at U.S. military bases. Until the mid-1970s, it also was used as
a surgical anesthetic. TCE also has been found at about 60 percent of the
nation's worst contaminated sites in the Superfund cleanup program. TCE is
known to cause cancer in some laboratory animals. Growing scientific evidence
suggests the most widespread industrial contaminant in drinking water can
cause cancer in people. In 2001, EPA issued a draft document saying the risks
of TCE causing cancer in humans were higher than previously thought. But that
pronouncement was dropped. EPA was blocked from elevating its assessment of
the chemical's risks in people by the Defense Department, Energy Department
and NASA, all of which have sites polluted with it. A 379-page report
from National Academy of Science recommends that EPA revise its assessment
of TCE's risks using "currently available data" -- so no more time is wasted.
EPA currently requires limiting TCE to no more than 5 parts per billion parts
of drinking water. A stricter regulation could, in turn, force the government
to require more thorough cleanups at military and other sites.
The first generic version of Zoloft, the top-selling antidepressant in the
United States, received federal approval July.
AstraZeneca PLC's Symbicort received approval for the long-term maintenance
treatment of asthma in patients 12 and older, said Food and Drug Administration.
Symbicort combines budesonide and formoterol fumarate dihydrate. It is inhaled
as an aerosol. Budesonide is an inhaled corticosteroid and provides an anti-inflammatory
effect, while formoterol is a rapid and long-lasting bronchodilator. This
asthma inhaler has already been sold overseas.
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,
Notice: The content of the articles is intended to provide general
information. Specialist advice should be sought about your specific circumstances.