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Newspaper: The Hindu Business Line
Section: Corporate
Date: 30th July, 2010
Page: 5
US court rules Gemzar patent
invalid, says Sun
Our Bureau
Mumbai, July 29
Sun Pharma said that the US Court of Appeals for the
Federal Circuit upheld an earlier judgment by another
court against Eli Lily – stating that certain
claims made by Lilly on its cancer drug Gemzar were
invalid.
Gemzar is a registered trademark of Eli Lilly and
Co and the US Appeals Court affirmed the judgment
of the US District Court for the Eastern District
of Michigan against Eli Lily, finding certain claims
of US Patent No 5,464,826 invalid, a note from Sun
said.
The appeal arose out of a lawsuit that Eli Lilly
filed against Sun Pharma in connection with Sun's
submission of an Abbreviated New Drug Application
(ANDA) for a generic version of Gemzar. The ANDA,
if approved by the US regulator, would allow Sun to
make and sell gemcitabine, the generic similar version
of Gemzar, in the US.
In the Michigan lawsuit, Eli Lilly had said that
Sun Pharma's ANDA infringed certain claims from the
5,464,826 patent and US Patent No 4,808,614 that describe
gemcitabine and its uses, the active ingredient in
Gemzar, a note from Sun said.
Earlier, the Michigan District Court had ruled against
Eli Lily stating that the asserted claims of the 5,464,826
patent were invalid for obviousness. The Appeals Court
agreed with the ruling of the District Court, and
noted that the Michigan Court had correctly followed
the Federal Circuit's precedent regarding double patenting.
The '826 patent, now ruled invalid, would have expired
on November 7, 2012, and would have had pediatric
exclusivity through May 7, 2013. The '614 patent,
not part of the appeal, expired on May 15, 2010, but
has pediatric exclusivity through November 15, 2010,
Sun said.
Newspaper: The Financial Chronicle
Section: My Brands
Date: 30th July, 2010
Page: 7
Sun wins patent case against
Eli
By PTI & Kumar Shankar Roy Jul 29 2010 , New Delhi/Bangalore
Tags: News
The US Court of Appeals for the Federal Circuit has
affirmed a lower court's finding that one of Eli Lilly
& Co.'s patents for cancer drug Gemzar is invalid
for double-patenting. This comes as a shot in the
arm for India's largest drug-maker by market value,
Sun Pharmaceutical, which wants to make a generic
version of the drug that reported global sales of
over $1 billion in 2009.
Sun Pharma, though not a first filer for this product,
triggered the successful patent challenge against
Lilly's 6th largest product. Eli Lilly has several
patent infringement cases currently pending against
generics who want to offer their own versions of gemcitabine
like Teva, Hospira and Novartis's Sandoz unit. Gemcitabine
is the active ingredient in Gemzar, which is approved
to treat cancers of lungs, pancreas and breast cancer.
The appeals court on Wednesday upheld the ruling
by Judge George Caram Steeh of the US District Court
for the Eastern District of Michigan delivered in
August 2009 that US Patent '826 was invalid for “obviousness-type
double-patenting”.
The Federal Circuit Court ruled that the '826 patent
was invalid because it repeated a method of using
Gemzar to treat cancer that was previously seen in
Lilly's patent on the compound for Gemzar, US Patent
Number '614. "In light of the earlier ’614
patent’s description of gemcitabine’s
use in treating cancer, the asserted claims of the
later ’826 patent, which recite a method of
using gemcitabine to treat cancer, are not patentably
distinct from the ’614 patent’s claim
to gemcitabine,” said the court opinion, a copy
of which is with Financial Chronicle.
The ruling may open the market for generic Gemzar
three years earlier than it would have done if Lilly
had triumphed. "The company has also been favoured
in the Gemzar case by the US appellate court and would
be able to launch the same on patent expiry,"
wrote Sriram Rathi, pharma analyst, Centrum Broking,
to clients in a note.
But Lilly strongly disagrees with the ruling by the
US court. "We continue to believe that our Gemzar
method-of-use patent should be found valid and should
remain in effect until mid-2013," said Robert
A Armitage, senior VP and general counsel for Lilly.
"We will consider all possible legal options,
including a request for a further review of this panel
decision by the full court."
The court decision does not allow for the immediate
entry of generic gemcitabine in the US market.
Newspaper : Business Standard
Date : July 28, 2010
Page : 6
IGL hopes its Delhi success
story is not just gas
Ajay Modi / New Delhi
With India’s gas production outpacing its crude
oil production in 2009-10, the hankering for gas allocation
has increased, too, but the lack of adequate gas infrastructure
has seen the country losing out on gains from falling
international prices. In a six-part series, Business
Standard takes a look at the need for adequate infrastructure,
even as cities are changing with relatively new gas
lifelines.
Indraprastha Gas Ltd, or IGL, shows all the benefits
of having a free run in a lucrative market. The sole
supplier of compressed natural gas (CNG) and piped
natural gas in the national capital region has doubled
its turnover and profits over the last five years.
That is not bad for a company which was created out
of necessity when the Supreme Court, following a public
interest suit, ordered in July 1998 that all public
transport vehicles in Delhi move to CNG and a network
of at least 70 filling stations be created for them.
Spurred on by authorisation from the government last
month, the company has now entered Ghaziabad, which,
alongside Noida, is a breeding ground for large housing
complexes (in other words, potential customers who
would want to get rid of the tyranny of cumbersome
cylinders).
FACTFILE
CNG Compression capacity : 36.40 lakh Kg/day
No of stations : 241
No of CNG vehicles in Delhi/NCR : 3,40,000
No of domestic customers : over 1,90,000
No of Large Commercials : 52
No of Small Commercials : 305
Operational cost of CNG vehicles is 62 per cent lower
than petrol and 27 per cent lower than diesel.
Net sales (2009-10) Rs 1,078 crore
Net profit (2009-10) Rs 215.49 crore
Gurgaon in NCR is way behind Delhi in city gas connectivity.
It has only a handful of CNG stations run by Haryana
Gas Company and virtually no piped gas connectivity.
However, experts doubt that Delhi’s success
would be replicated elsewhere. The doubters include
L Mansingh, the chairman of downstream regulator Petroleum
and Natural Gas Regulatory Board, who attributes the
development of the CNG network in Delhi primarily
to the Supreme Court’s intervention.
Many are also quick to point out that the company’s
filling stations in Delhi’s prime locations
continue to have long queues.
The running cost of a car on CNG, despite a recent
price rise of Rs 5.60 a kg, remains about 62 per cent
cheaper than those run on petrol and 27 per cent cheaper
than the diesel ones. That ensures enormous interest
of buyers in CNG vehicles. The fact that many of them,
given the tank capacity, need to visit a filling station
every couple of days does nothing to shorten the queues.
IGL, though, remains sanguine. The queues, it says,
would vanish once it is allowed to operationalise
the 40-odd stations which are stuck in the maze of
clearances.
“We have been proactive in expanding the CNG
pump network. However, due to the long-drawn licensing
process involving various departments, 40 stations
are unable to dispense CNG. The licensing process
takes up to six months in most cases and that is the
only thing coming in the way. It is not a delay at
our end,” IGL Managing Director Rajesh Vedvyas
told Business Standard.
In the last financial year, IGL set up 60 stations.
Another 39 are in different stages of development.
By March next year, the company hopes to have 280.
“We have doubled our capacity to service the
CNG consumers in the last three years and invested
over Rs 1,000 crore. This is no mean achievement,”
Vedvyas said.
On the piped natural gas, Vedvyas said the company
had been unable to dig for pipes as large parts of
the city are already dug up in preparation for the
Commonwealth Games, to be held in October. “We
have 190,000 piped natural gas connections across
Delhi and NCR. We plan to give 60,000-70,000 new connections
every year in Delhi and 10,000-15,000 in NCR. There
is no dearth of resources,” said Vedvyas.
In Ghaziabad, its new territory, IGL is facing problems
because the GAIL pipeline, which feeds IGL’s
network in east Delhi, has limited capacity. “We
are setting up a spur pipeline to address this problem.
This pipeline should be completed by October,”
said Vedvyas.
That, the company would hope, will establish that
IGL’s Delhi success story is not just gas.
Newspaper : Financial Chronicle
Date : July 28, 2010
Page : 9
ONGC, IOC stake sale still
uncertain
By Siddhartha P Saikia,New Delhi
Will government sell its stake in largest explorer
ONGC and biggest oil marketing company IOC remains
a million dollar question, at least for now. Finance
and petroleum ministries seem to differ on the timing
of stake sale in ONGC and IOC.
Differences between both finance and petrol¬eum
ministries came to fore at a news conference held
to launch the follow on offer (FPO) of Engineers India
(EIL).
Disinvestment secretary Sumit Bose told newsmen clearly
that FPOs from these two companies are not on its
timetable for this financial year. Bose said: “Nothing
is on the table.”
Petroleum secretary S Sundareshan begged to differ,
albeit indirectly, creating a flutter. Sundar¬eshan
said, “The matter will be considered during
the course of this year.”
Following persistent que¬s¬tions from news¬per¬sons
asking for a timeline to divest in the oil companies
next financial year, Bose clarified, “Nothing
is on the table.”
Post de-regulation in petrol prices, hike in diesel,
domestic cooking gas and kerosene rates last month;
oil companies have banked heavily on revival of investor
confidence in them. Sub¬sidy burden for upstream
companies is expected to be lower while OMCs are free
to sell petrol at market-determined price.
Meanwhile, disinvest¬ments secretary Sumit Bose
listed the half a dozen companies in which the government
may sell equity to meet Rs 40,000 crore target in
the current fiscal year. At present, it has undertaken
process for selling its stake in five companies.
“Process for divestment in Power Grid Corporation
of India, Coal India, Hindustan Copper, Steel Authority
of India and Manganese Ore (India) has been under¬taken,”
Bose said.
The government has already divested its 10 per cent
stake in Satluj Jal Vidyut Nigam Limited (SJVNL) that
fetched Rs 1,068 crore.
When asked, if divest¬ment in these companies
will be able to meet its target, Bose said: “This
will not add up to Rs 40,000 crore.” The disinvestment
secretary didn’t divulge details of companies
in which the Centre may consider selling stakes. Government
plans to raise Rs 977 crore on the higher end of the
price bend from EIL’s public issue that opened
on Tuesday.
Newspaper : Financial Chronicle
Date : July 28, 2010
Page : 11
Energy reforms must for growth
By BK Chaturvedi
The introduction of reforms process in the 1990s
led to structural change in the economy. With larger
participation of private players, the GDP growth rates
gradually picked up. With energy–GDP elasticity
being around one, the economy required higher energy
inputs for the growth. The broad strategy in this
direction has been to open up the energy sector to
private investments and thereby step u growth.
In the petroleum sector, the New Exploration and
Licensing Policy (NELP) was launched in 1999 to attract
private investment in oil exploration, foreign technology
and capital. More than 230 blocks have been awarded
during eight rounds of NELP bids and it has started
showing results, with major gas discoveries in the
KG Basin in the east coast, and large heavy oil discovery
in Rajasthan with likely peak production of 8 million
tonnes per annum. Exploration in many of these blocks
is continuing and more discoveries are possible. Policy
changes have also led to the awarding of a large number
of blocks to private players for coal exploration
with 47 billion tonnes of coal reserves potential
in captive mining.
A bill was also introduced to open up the coal sector
further for private investment. The new Electricity
Act, 2003, further strengthened the initiatives and
developed the legal framework for investment by private
players. Promoting open access and purchase of power
from private power generating companies by state utilities,
based on identified bidding criteria, has led to increased
interest by private players in setting up new power
plants. The last two decades have seen policies promoting
private competition, liberalisation and development
of a legal framework for promoting larger investments.
Similar policies have also been followed in the field
of atomic power plants. After uranium has become available
from international companies, based on agreement with
countries of the nuclear suppliers group, rapid expansion
of atomic energy has been planned. To develop clean
energy, consistent with climate change issues, a new
National Solar Mission has been launched to develop
20,000 mw power. An Integrated Energy Policy (IEP)
which suggested a framework and made projections for
the next two decades, has been approved by the government.
Petroleum oil refining capacity has grown by more
than three times from 58 million tonnes (1990), to
about 180 million tonnes at present through large
scale private sector participation. The west coast
of India is now becoming a major hub for export of
petroleum products.
Reforms in petroleum and natural gas pricing are
taking shape gradually. The import of LNG at Dahej
and Hazira LNG terminals has facilitated gas availability
to a large number of non-power and fertiliser consumers.
Price reforms for petroleum products for industrial
fuel and feedstocks were implemented during early
2000 when price of naphtha, furnace oil and ATF were
made market-determined.
However, the government till May 2010 fixed the price
of petrol, diesel, kerosene, LPG and natural gas produced
by NOCs. The natural gas price for the gas produced
by NOCs is now oil index-based with floor and cap
and is close to the market price parity. Recently,
in June, the government decided to keep petrol prices
linked to market price parity, while diesel prices
are yet to be linked to market price parity. High
economic growth of six to nine per cent during the
past two decades has been possible due to the reforms
made by the government in the energy sector.
To achieve a high economic growth of 9 per cent and
more during the next 10–20 years, it would be
important to implement full-scale reforms in the energy
sector, as large share of energy is likely to be met
from imports in the future. However, it would also
be important to implement highest level of efficiencies
for energy use by various sectors to achieve a low
carbon economic growth for the country during the
next 10–20 years.
There are several challenges to the energy sector
in the coming years. Poor financial health of power
distribution utilities that are with the state governments
is a serious gap. The lack of investments in transmission
and distribution network, poor governance, non-revision
of tariff and free power to farmers has led to poor
health of these utilities. They are likely to incur
more than Rs 40,000 crore of annual losses according
to 2009-2010 estimates. The challenge in the sector
will be to privatise the distribution network, step
up investments, promote open access and improve governance.
The growing need for power will require substantially
higher domestic availability of coal. Issues of the
environment will have to be resolved quickly. Work
on new mines must start early, demand-side management
of energy will require measures on energy efficient
equipment, new strategies for setting up 660/800 mw
power plants, additional capacities from gas and nonconventional
sources and higher energy efficiency in industry and
power appliances, like air conditioners, agriculture
pumpsets will have to be worked out.
The author is member of Planning Commission and former
cabinet secretary
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