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Issue 71
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5111 Kali Era, Virodhi
Year, Magha
month
2067
Vikramarka Era, Virodhi
Year, Magha month
1931
Salivahana
Era, Virodhi
Year, Magha
month
2010 AD, February
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Patent Law in the
Philippines
The Philippines Quality Medicine Act amends the IP Code to state that the
mere discovery of a new form of a new property of a known substance which
does not result in the enhancement of the known efficacy of that substance,
or the mere discovery of any new property or new use for a known substance,
or the mere use of a known process unless such known process results in a
new product that employs at least one new reactant is non-patentable.
In addition, a patent owner has no right to prevent third parties from using
a patent without his authorization after a drug or medicine has been introduced
in the Philippines or anywhere else in the world by the patent holder or
by any party authorized to use the invention. The act also grants the right
to import drugs and medicines to any government agency or any private third
party.
In the case of drugs and medicines, the patent owner has no right to prevent
the testing, using, making or selling of the invention including any data
related thereto, solely for purposes reasonably related to the development
and submission of information and issuance of approvals by government regulatory
organizations required under any law of the Philippines, or of another country
that regulates the manufacture, construction, use or sale of any product.
Upon recommendation of the secretary of the Department of Health, the director-general
of the Intellectual Property Office can grant a compulsory license for the
importation of patented drugs and medicines, with reasonable compensation
to the patent owner. The president of the Philippines also has the
power to impose maximum retail prices over any or all drugs and medicines
listed in Section 23 of the act, which include: those indicated for treatment
of chronic illnesses and life threatening conditions such as, but not limited
to, endocrine disorders, cardiovascular diseases, skin diseases, pulmonary
diseases, neuropsychiatric disorders or other infectious diseases; those
indicated for prevention of pregnancy; and anesthetic agents.
The Philippine Patent No. 29149 for Atorvastatin, marketed under the brand
name Lipitor, was issued by the IPO after having gone through a thorough
examination and was deemed to meet all the criteria for patentability based
on the above Philippine laws. Pfizer filed a complaint for patent infringement
and damages against Unilab for selling its generic anticholesterol drug Avamax,
which is priced 30 percent lower than Pfizer’s. Unilab claims that
according to the IP Code, as amended by the Cheaper Medicines Act, the patent
should not have been granted since it failed to meet the requirements for
patentability. Unilab claims the patent is merely an attempt at “evergreening,”
an abuse of the patent system by patent holders that seek to perpetuate their
monopoly over a product beyond the period allowed by law. Unilab contends
that there is nothing inventive about the Atorvastatin covered by Patent
No. 29149 since it is nothing but an isomer of the Atrovastatin compound
already disclosed in U.S. Patent No. 4,681,893 (which discloses NCE atorvastatin)
and Philippine Patent Nos. 24661 and 26330.
So, the question is why does Unilab not make NCE which is off patent, instead
of selling the isomer which is covered by the patent? Obviously, the isomer
is better than the NCE. Of course, according to reports, Lipitor (the isomer)
was the largest-selling drug in the world in 2006, earning its producers
$12.9 billion in sales the same year alone. In 2008, Lipitor sales internationally
were at $13 billion. Now you know why Unilab wants to make the isomer and
seeks to invalidate the patent, not anything else. Not because poor
people of the Philippines are suffering from overeating rich fatty foods,
obesity or cholesterol problems! It is all about money and who makes it.
WHY ARE DRUGS EXPENSIVE IN THE U.S.? WHILE AMERICA PAYS FOR RESEARCH
AND DEVELOPMENT OF NEW DRUGS, OTHER COUNTRIES TAKE PROFITS AND CREDIT IN
THE NAME OF HELPING POOR.
GENERIC V. INNOVATOR
Shortly after he became chief executive officer of Eli Lilly & Co. in
April 2008, John Lechleiter, a former lab scientist, sent his senior executives
a gift. It was a small digital clock counting down, second-by- second, to
Oct. 23, 2011. That’s the day the drugmaker’s $5- billion-a-year schizophrenia
pill, Zyprexa, goes off patent. Next to the countdown were four words: “Do
what we do.”
Lilly must pick up the pace of drug development so it can replace revenue
lost when three top- selling medicines lose patent protection in the next
few years, Lechleiter said in an interview in his Indianapolis office. The
company stands to lose $10 billion in annual sales to generic competition
by the end of 2016, almost half of its 2009 revenue, one of the steepest
percentage losses resulting from patent expirations among the six biggest
U.S. drugmakers.
When Lilly faced challenges before, “each and every time the answer has been
new, innovative products,” said Lechleiter, whose office wall displays the
Periodic Table of Elements, the foundation tool for chemists, his first career
as a Ph.D. from Harvard University in Cambridge, Massachusetts. Lilly’s
blood-thinner Effient, approved in July, only pulled in $27 million in revenue
in 2009, competing against Bristol-Myers Squibb Co.’s $6 billion-a-year Plavix.
Lilly suffered two high-profile failures in July and August, when a multiple
sclerosis drug candidate and an osteoporosis product fell short of expectations
in clinical trials; while generic companies keep looking for the next blockbuster
to poach to make money in the name of poor people.
While the governments of so-called poor countries do nothing to support innovation
of new drugs in their countries, the American government spends millions
of dollars in support of new drugs, in addition to billions of dollars spent
by the innovator industry. Pharmaceutical companies screen thousands of compounds
for the ability to bind a target before they hit upon a promising drug candidate,
which will further go through a rigorous process of evaluation involving
billions of dollars, e.g., U.S. drug safety reviewers have recommended that
GlaxoSmithKline PLC's diabetes drug Avandia be pulled from the market after
concluding it is more dangerous to the heart than a rival medicine.
Recently, the U.S. Food and Drug Administration and the National Institutes
of Health unveiled an initiative designed to accelerate the process from
scientific breakthrough to the availability of new, innovative medical therapies
for patients. The initiative involves two interrelated scientific disciplines:
translational science, the shaping of basic scientific discoveries into treatments;
and regulatory science, the development and use of new tools, standards and
approaches, to more efficiently develop products and to more effectively
evaluate product safety, efficacy and quality. Both disciplines are needed
to turn biomedical discoveries into products that benefit people.
In addition, the NIH and the FDA will jointly issue a Request for Applications,
making $6.75 million available over three years for work in regulatory science.
The research supported through this initiative should add to the scientific
knowledge base by providing new methods, models or technologies that will
inform the scientific and regulatory community about better approaches to
evaluating safety and efficacy in medical product development. The
effort will rely on the NIH's vast experience supporting and facilitating
new discoveries in the laboratory and clinic and the FDA's more than 100
years of experience and knowledge in the regulation and approval of drugs,
biologics and medical devices.
Abbott Acquires Solvay
Abbott announced Feb. 16 that it has completed its $6.2 billion acquisition
of Belgium-based Solvay Pharmaceuticals, “providing Abbott with a large and
complementary portfolio of pharmaceutical products and expanding Abbott’s
presence in key global emerging markets.” The acquisition also includes
Solvay’s vaccines business, which will provide Abbott entry into the expanding
global vaccines market. Solvay also has a small molecular diagnostics unit
that will become part of Abbott’s diagnostics organization upon the transaction
close. Abbott notes that it has a strong portfolio of specialty pharmaceuticals
and Solvay brings successful, consistently performing products—including
branded generics—that will further diversify Abbott’s pharmaceutical business.
These products complement Abbott’s presence and expertise in specialty markets
such as cardiovascular disease, neuroscience and gastroenterology, and include
treatments for men’s and women’s hormonal health, and exocrine pancreatic
insufficiency, which is associated with several underlying conditions such
as cystic fibrosis and chronic pancreatitis. Solvay Pharmaceuticals
is now part of Abbott’s global Pharmaceutical Products Group. Werner Cautreels,
CEO of Solvay Pharmaceuticals, will serve in a transitional role and will
then leave the company. Based on the timing of the close, Abbott expects
the acquisition to add approximately $2.9 billion to Abbott’s 2010 total
reported sales—only slightly down from the September prediction of $3 billion—with
the majority of those sales outside the U.S. The acquisition will also add
approximately $500 million to Abbott’s annual pharmaceutical research and
development investments.
Search for New Drugs
The search for new therapeutic agents is time-consuming and expensive. Pharmaceutical
companies may have to screen thousands of compounds for the ability to bind
a target molecule before they hit upon a promising drug candidate. A group
of Biophysicists at LMU Munich led by Professor Dieter Braun, a member of
the Cluster of Excellence "Nanosystems Initiative Munich" (NIM), and a partner
in NanoTemper (an LMU spin-off), have now developed a unique technology called
"microscale thermophoresis" that allows to measure intereactions under close-to-native
conditions, thus improving the decision making process in drug development.
The technique takes advantage of the Soret effect – the tendency of molecules
to drift along temperature gradients, usually from warm to cold. If a compound
encounters and binds to another molecule, its thermophoretic parameters change,
and its trajectory may even be reversed. This phenomenon can be exploited
to determine whether a molecule that is known to play a causative role in
a given disease binds to a test substance. In the test, which can be carried
out directly on blood samples, the thermodiffusion of a labelled biomolecule
of interest is measured in the presence and absence of a candidate binding
agent. If the two bind together to form a complex, the resulting change in
their thermophoretic behaviour can be detected. "Detection of binding activity
is the first step on the road to a new drug", says Braun. "The new method
also has potential applications in medical diagnostics, and in food and environmental
monitoring." http://www.eurekalert.org/pub_releases/2010-02/lm-ahr022410.php
US is the New Third
World
Cook county state's attorney anita alvarez told a u.s. senate hearing that
some young chicagoans are practicing "survival sex" and selling their bodies
for food, clothing or a safe place to sleep, Alvarez, addressing a
subcommittee looking into human trafficking, told of a girl who didn't want
her pimp to face charges because he bought her a subway sandwich whenever
she wanted one. another girl had sex for cash to buy food and clothing, unable
to rely on her mother, a drug addict. The hearing was called by Sen.
Dick Durbin, D-Ill., chairman of the Subcommittee on Human Rights and the
Law. He estimated that 100,000-plus U.S. children become sex-trafficking
victims every year. Compare this to India with 1.3 billion ppulation.
The Ministry of Women and Child Development reported presence of 2.8 million
sex workers in India, with 35.47 percent of them entering the trade before
the age of 18 years. (http://en.wikipedia.org/wiki/Prostitution_in_India)
UK- Life Sciences Super Cluster
The U.K. Life Sciences industry employs over 120,000 people and invests approximately
£4.6 billion into R&D. The U.K. government has recently announced
their plans for a new U.K. Life Sciences Super Cluster - a scheme where industry,
academia and the National Health Service work together to deliver new treatments
for chronic disease. The pilot project is being supported by a £1 Million
investment from the government and the first Super Cluster will launch later
this year in the area of immunology and inflammation, focusing on diseases
such as asthma and rheumatoid arthritis. The unveiling of this new
scheme comes in addition to recent measures to help the U.K. maintain a competitive
edge in translational medicine, including the Patent box and Innovation Pass
initiatives, to better compete on a global stage and attract inward investment.
http://nds.coi.gov.uk/clientmicrosite/content/Detail.aspx?ReleaseID=410611&NewsAreaID=2&ClientID=431
Generics in Europe
The European Generic Medicines Association (EGA) is advocating for changes
to regulatory framework of the European Union with respect to the marketing
of generics and biosimilars in the European Union. The EGA is seeking to
enhance tax and R&D incentives for generic and biosimilar research and
clinical trials. The generic manufacturers are also seeking to expedite market
authorizations by eliminating patent linkage and applying a harmonized single
market approach to approvals. http://www.egagenerics.com/pr-2010-01-21.htm
The European Commission continues to scrutinize the pharmaceutical sector
and patent settlement agreements between innovator and generic pharmaceutical
companies. The European Commission's July 2009 Pharmaceutical Sector Inquiry
Report focused on the behavior and practices of the "originator industry."
It was alleged that innovators had caused undue delays in generic market
entry. The Report appears to have prompted legal proceedings against
pharmaceutical companies such as Servier and Lundbeck and the European Commission
has recently sent "requests for information" to a number of other pharmaceutical
companies seeking copies of patent settlement agreements conducted between
innovator and generic companies executed in the last 18 months. Further,
a number of unannounced inspections targeting the legal departments of many
large pharmaceutical companies of were conducted in late 2009. The
Commission's Report notes concerns relating to 'defensive' patents and regulatory
complaint strategies. http://www.pharmatimes.com/WorldNews/article.aspx?id=17288
Mergers and
Acquisitions in 2009
In 2009, the landscape of mergers and acquisitions (M&As) by the top
50 pharmaceutical companies (ranked by sales in 2008) was dominated by mega-mergers,
with three deals exceeding the US$40 billion mark. Beyond these deals there
was significant, if smaller, activity, with 21 of these companies embracing
M&As as part of a diverse range of strategies. Overall, the 50
top-tier companies were involved in 44 completed M&A deals in 2009, a
small increase above the 42 such deals completed in 2008. The total value
of the deals in 2009 was a massive $190 billion compared with $48 billion
in 2008, but more than 80% of the 2009 figure is attributable to just three
deals: Pfizer–Wyeth ($68 billion), Roche–Genentech ($47 billion) and Merck–Schering-Plough
($41 billion). Taking this into account, the remaining spending of $34 billion
represents a reduction of around 30% compared with 2008….
Market expansion was also a major driver of acquisitions in 2009, with companies
seeking to expand their presence in their current operational markets as
well as to enter other new regions, including the emerging markets. The most
active company in this area was Sanofi–Aventis, which spent more than $3
billion on three deals to expand its presence in India, Mexico and Brazil.
http://www.nature.com/nrd/journal/v9/n2/pdf/nrd3114.pdf
Sanofi Cuts Research
Sanofi-Aventis has been cutting down the amount of money it's spending on
R&D. In its annual report, the pharma giant revealed that it had shaved
seven percent out of its R&D budget last year as it restructured its
pipeline.
After recounting its success advancing new drugs for ovarian cancer and mid-stage
vaccine programs, Sanofi,which has recently inked a series of new collaborations
with biotech companies like Regeneron and Syntiron, also said that it had
decided to drop its program for the cancer drug larotaxel and had terminated
six Phase I development projects. Sanofi’s R&D portfolio is comprised
of 49 projects in clinical development of which 17 are in Phase III or have
been submitted to the health authorities for approval.
Proper Assignments
Board of Trustees of the Leland Stanford Junior University v. Roche Molecular
Systems, Inc., 583 F.3d 832 (Fed. Cir. 2009), highlights the critical importance
of proper assignment language in contracts which purport to transfer an inventor's
rights in his or her inventions to the entity with whom the inventor is employed
or otherwise engaged. A contract which merely provides that the inventor
"agrees to assign" his rights vests the assignee with, at most, equitable
title in the inventions. A subsequent contract in which the inventor
"hereby assigns" those same rights to a separate assignee will defeat the
earlier assignment. http://www.mondaq.com/unitedstates/article.asp?article_id=93890&lk=2
Recalculation
Of U.S. Patent Terms
The United States Patent and Trademark Office (PTO) has released guidelines
explaining how patentees of recently issued patents may request the recalculation
of the terms of their patents. This guidance arose from the Court of Appeals
decision in Wyeth v. Kappos in January 2010, which held that the PTO had
previously misapplied the statutory provisions relating to patent term adjustments.
… Patentees considering seeking recalculation of their patent terms should
also assess whether to concurrently pursue a civil action, especially if
they are submitting their recalculation requests to the PTO close to the
end of the 180-day period and if it is unclear whether the PTO will confirm
a correction by the expiry of the period for requesting reconsideration.
http://www.mondaq.com/unitedstates/article.asp?articleid=93428&email_access=on
The USPTO has not yet indicated whether it will apply Wyeth retroactively.
Under 37 C.F.R. § 1.705(d), a request for reconsideration of patent
term adjustment must be filed within two months of patent issuance. However,
it may be advisable for certain patent owners to request that the USPTO suspend
the two-month limitation on requests for reconsideration in order to comply
with correct patent term adjustment re-calculation. Petitions for correction
of an erroneous term should be filed sooner rather than later to reflect
appropriate diligence. Patentees that have any questions about Wyeth or the
potential for requesting an additional patent term should contact a patent
attorney in the near future.
Idera Pharmaceuticals is challenging recently enacted interim procedures
for revising patent term extensions as being inequitable. Idera filed
suit on January 29, 2010, asserting that the Patent Office calculation ("Patent
Office new math") truncated extension days from two of their patents and
challenging the equity of the interim procedures. Idera alleges in the complaint
(http://react.bracewellgiuliani.com/reaction/announcements/10_166_1.pdf)
that the Wyeth decision "constitutes a change in law sufficient to invoke
the doctrine of equitable tolling" with regard to the '554 patent.
Equitable tolling, as explained by the Federal Circuit in Serdarevic v. Advanced
Medical Optics Inc., 532 F.3d 1352, 1363 (Fed. Cir. 2008) on the doctrine,
will not allow a statue of limitations to run against a plaintiff who is
unaware of its possible cause of action.
Patenting Strategy
Filing patent applications needs to be carefully planned to obtain maximum
benefit from the patent system. Industries based on life science take
considerably more time to develop a product than those based on mechanical,
electrical and software, because testing of inventions on live subjects takes
time and money, while mechanical, electrical and software based inventions
can be tested and improved rapidly.
Within a year of the filing of a provisional application, a complete international
application should be prepared and filed along with applications in any non-PCT
countries of interest. Signaling your intentions to competitors, a publication
of the patent application occurs six months after this, i.e., 18 months from
the priority filing. Then, at the 30/31 month, the applicant has to
enter national stage in PCT countries of interest. This timing may
not suit the long development cycles in the drug and agricultural industry.
To warrant the expensive filing of international patent applications, one
needs to know if the product is likely to work, whether there is a market
and the final form of the product so that you can get robust patent protection.
It is possible to delay filing applications or shift filing dates of applications
if a particular project is taking longer than expected to become market ready.
However, one has to watch out for research publications that are unwisely
tied to promotions and bonuses of scientists by the management in the industry,
because publication before patent application filing adversely affects the
patentability and the ability to juggle priority dates.
It may be a good idea to delay filing a patent application until you have
some confidence in the invention. However, in a highly competitive
area, the risk of losing the priority date is imminent. Withdrawing
an early filed provisional patent application and re-filing it is an option.
However, it should be considered only when you are confident that there are
no intervening publications or applications filed by your competition. Filing
a broad generic patent application for a concept is dangerous because of
the risk that without specific examples it may not get granted.
However, this can act as a deterrent against competition until you file a
more specific embodiment of the invention in a continuation-in-part or a
selection application which requires unexpected results over the generic
disclosure. It is essential to have a proper IP strategy and to have controls
in place to prevent premature publications.
China: 50%
of counterfeit goods come from China
"China was the main source country for [intellectual property rights] infringing
articles with 54% of the total amount."
http://digg.com/business_finance/15_Facts_About_China_That_Will_Blow_Your_Mind
Pakistan’s a Threat
Pakistan is rapidly becoming the fourth most populous country in the world
and lacks the infrastructure for educating its surging population and the
economy for employing them. “Time is running out to put appropriate policies
in place. The absence of this may result in large-scale unemployment and
immense pressure on health and education systems. In short, a socio-economic
crisis may take place, making the demographic dividend more of a demographic
threat,” said Durr-e-Nayab of the Pakistan Institute of Development Economics.
History shows that economic instability increases the potential for conflict
among nations. No wonder Pakistan has become the center of terrorism.
Indian
Medical Devices Technology Park
Medical devices and supplies market in India is expected touch USD 1.7 billion
in 2010, growing at the rate of 23% annually in the coming years from the
current Rs. 5750 crores, according to a recent sector report by National
Institute of Pharmaceutical Education and Research by (NIPER), Ahmedabad.
Affordability by patients, increased awareness on health care, improved hospital
infrastructure and the increased disease patterns are listed as the primary
drivers boosting the growth medical devices industry. Free market environment,
a developed industry and investment in health infrastructure are amongst
other factors that the growth of high quality medical devices industry.
Despite strong growth rates, the market remains disproportionately small,
ranking among the top 20 in the world, but with a very low per capita spending.
Among the segments in the medical devices market diagnostic equipment leads
with Rs. 2000 crores, surgical equipment supplies worth Rs 1300 crores comes
second and imaging and electronic treatment devices follow with Rs 1300 crores
and Rs. 1000 crores respectively. The segment, including the
medical instruments and appliances used in specialties such as ophthalmic,
dental and other physiological classes, accounts for 26% of the total market
followed by orthopedic/ prosthetic goods segment accounting for 19% of the
total market. Medical supplies such as bandages and disposables such
as syringes, needles and catheters together constituted 21% of the total
market. The other equipments which are in demand are high end specialty electro
medical equipments that accounted for 11% of the total market. X-ray apparatus
accounted for 10% of the total market.
Another high growth segment in the medical devices industry is diagnostic
kits. Diagnostic kits have a growth rate of 30% and a market size of USD
133 million in 2005. They include the reagents and the medical kits. With
over fifty companies operating in diagnostic kits, the market has seen several
interesting trends.
Imports constitute over 50% of the market. Most imported products have high
gross margins. Currently, the high value imported products include cancer
diagnostic, medical imaging, ultrasonic scanning, plastic surgery equipment
and polymerase chain reaction technologies. The medical devices market
for exports from India is estimated around USD 509 million with a CAGR of
22.15%.
It is expected that indigenous production of world-class medical devices
will also bring down the overall healthcare costs to considerably low levels.
Accordingly, a medical technology park dedicated to the production of medical
and pharmaceutical products and equipment has been launched at Irungattukottai
near Chennai, the capital city of the southern Indian state of Tamil Nadu.
The new facility, named Trivitron Medical Technologies Park, is a joint venture
of the leading medical technology company Trivitron Healthcare Private Ltd
and Aloka Ltd of Japan, a pioneer in the diagnostic ultrasound technology.
The 25 acres-Trivitron Medical Technologies Park is designed to house 10
international medical technology manufacturers. Trivitron Medical Technologies
Park’s neraly 20,000 sq ft facility includes internal corridors, raw material
storage area, material IN & UT areas have an epoxy coated flooring etc.
Medical products and equipment ranging from ultrasound systems, color dopplers,
X–ray machines, C-arms , in-vitro diagnostic reagents and instruments, cardiology
diagnostic instruments, critical care instruments, modular operating theatres,
operating theatre lights and tables and implantable medical devices will
be manufactured at Trivitron Medical Technologies Park.
Trivitron Healthcare Pvt Ltd has already signed joint ventures with leading
international medical devices manufacturers including Brandon Medical, UK,
ET, Cardio line, Italy, Johnson Medical, Sweden and Bio-systems, Spain for
setting up more facilities at the park.
The exports mainly consist of dental instruments, surgical items and other
laboratory equipment. Prominent MNC’s operating in the Indian market
include B Braun, Becton, Dickinson and company, Bayer, Johnson and Johnson,
Phillips, Roche, Siemens and GE. Some of the domestic players hat have consolidated
their market position include, BPL Healthcare, Godrej Healthcare, Nicholas
Piramal India Ltd., Opto Circuits India Ltd. and Advanced Micronic Devices
Ltd. Roche Diagnostics is the leading player followed by Transasia,
Bayer and others such as Span Diagnostics, Piramal Healthcare, Orchid, Tulip
Diagnostics, Zephyr Biomedical, Biorad, Liliac etc.
India is also in the process of finalizing the guidelines to the manufacture,
import and sale of medical devices under Schedule M III. The Drugs
Technical Advisory Board (DTAB) which provides technical guidance to the
Central Drugs Standard Control Organization – the apex body to regulate drugs
and cosmetics – under the ministry of Health and Family Welfare has submitted
the final draft of the guidelines on medical devices to the drug controller.
The medical devices and equipment are currently notified as drugs that are
regulated under the Drugs & Cosmetics Act and Rules. However, the guidelines
will apply to inspections and other requirements under Schedule M III, which
comes as an extension to the Schedule M under India’s Drug and Cosmetics
Act that stipulates norms for the manufacturing and sales of pharmaceutical
products in the country.
In 2010, the medical devices sector in India got a booster dose from the
Union Budget 2010-11 that has initiated some measures towards fostering the
sector. The Union Finance Ministry has brought in a uniform concessional
basic duty of 5% for all medical appliances besides exempting import duty
from specified inputs for the manufacture of orthopedic implants, are good
initiatives. The budget proposes to prescribe a uniform, concessional
basic duty of 5 per cent, countervailing duty (CVD) of 4 per cent with full
exemption from special additional duty on all medical equipment. A
concessional basic duty of 5 per cent is being prescribed on parts and accessories
for the manufacture of such equipment while they would be exempt from CVD
and special additional duty. Full exemption currently available to
medical equipment and devices such as assistive devices, rehabilitation aids
etc. is being retained. The concession available to government hospitals
or hospitals set up under a statute is also being retained. For the
manufacturers of orthopaedic implants, the Budget 2010-11 has proposed an
exemption of specified inputs for the manufacture of implants from import
duty. The manufacturers complained that their inputs attracted a higher rate
of duty than the finished product. Orthopedic/ prosthetic goods segment
currently accounts for 19% of the current Rs. 5750 crores total market for
medical devices and equipment. These incentives will definitely spur
the growth momentum of the already fast-emerging medical devices and equipment
sector in India.
The ministry has also announced some tax incentives for the business of setting
up and operating “cold chain” infrastructure, which is an integral part in
the logistics for vaccines and many biotech products. An Increase in
weighted deduction on R&D expenditure up to 200 percent on in-house research
and development (R&D) expenses is one of the highlights of Union Budget
2010-11. The budget also proposes to enhance the weighted deduction
on payments made to national laboratories, research associations, colleges,
universities and other institutions, for scientific research from 125 per
cent to 175 per cent.
The excise duty on formulations will also remain unchanged at 4 percent.
The Budget has also proposed an increase in the plan allocation for the Ministry
of Health and Family Welfare from Rs 19,534 crore to Rs 22,300 crore for
the financial year 2010-11.
http://www.dancewithshadows.com/pillscribe/indian-medical-devices-market-gets-a-booster-dose-from-union-budget-2010-11/
http://www.dancewithshadows.com/pillscribe/india-opens-medical-devices-production-park-in-chennai/
Source:
The primary sources cited
above, BBC News, New York Times
(NYT), Washington Post (WP), Mercury
News, Bayarea.com, 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.
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