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Issue 51
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5110 Kali Era, Sarvadhari
Year, Jyestha
month
2066
Vikramarka Era, Sarvadhari
Year, Jyestha
month
1930
Salivahana
Era, Sarvadhari
Year, Jyestha
month
2008
AD, June
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Content
Patent
Exhaustion
In a unanimous decision rendered on June 9, 2008, the U.S. Supreme Court
confirmed the continued vitality of the patent exhaustion doctrine — the principle
that limits the patent rights that survive an initial authorized sale of
a patented item — and expanded the doctrine in two key respects. First, the
Supreme Court reversed the Federal Circuit and held that the doctrine of
patent exhaustion applies not only to patented products, but also patented
methods. Second, the Supreme Court addressed the issue of the extent to which
the components sold must embody a patent in order to trigger exhaustion and
held that provided the components substantially embody the patent, the initial
authorized sale of the components exhausts the patent. The Court was also
careful to parse out and disclaim any holding with respect to potential contractual
rights of the patent owner, suggesting that while the patent owner could not
seek patent damages after the patent is exhausted with the first sale, contractual
remedies may be available. http://www.mondaq.com/article.asp?articleid=62282&email_access=on
USPTO's Obviousness
Guidelines
The PTO's Obviousness Guidelines have the following rules for making an
obviousness rejection based on the obvious to try reasoning:
(1) a finding that at the time of the invention, there had been a recognized
problem or need in the art, which may include a design need or market pressure
to solve a problem;
(2) a finding that there had been a finite number of identified, predictable
potential solutions to the recognized need or problem;
(3) a finding that one of ordinary skill in the art could have pursued the
known potential solutions with a reasonable expectation of success; and
(4) whatever additional findings based on the Graham factual inquiries may
be necessary, in view of the facts of the case under consideration, to explain
a conclusion of obviousness.
http://www.patentlyo.com/patent/2008/06/obvious-to-try.html
Merger
Invitrogen has agreed to acquire all of the shares of Applera's Applied Biosystems
in a $6.7 billion cash and stock deal. The Invitrogen/Applera combo,
to be called Applied Biosystems, will have $3.5 billion in annual sales and
will be based in Carlsbad, CA. The companies say they'll be able to
shave $125 million in costs following the merger. In a release, the company
said it would hold a major presence in key areas like genetic analysis, proteomics,
cell biology and cell systems.
South
Korea Invalidates Pfizer’s Patent
A patent court in South Korea on June 26 ruled in favor of five local pharmaceutical
companies involved in a dispute with multinational Pfizer, company officials
said. The court upheld a lower court ruling, which dismissed claims
by the global drugmaker that the five firms breached its patent for the cholesterol-lowering
drug Lipitor.
The Korean Intellectual Property Tribunal in July last year ruled in favor
of the local companies, which include Dong-A Pharmaceutical and Boryung Pharmaceutical.
The tribunal invalidated the patent related to Lipitor. Although the
original Korean patent for the drug expired in May last year, Pfizer extended
it to 2013 by modifying the patent.
It marked the second victory this month for South Korean drugmakers in patent
disputes with multinationals. On June 9 French drugmaker Sanofi-Aventis
lost a lawsuit against Boryung Pharmaceutical over its treatment for colorectal
cancer.
An Australian court passed a favorable order for Ranbaxy Laboratories in
its patent proceedings against Pfizer with regard to 'Atorvastatin'. The
Federal court had ruled that one of Pfizer's patents was invalid for inutility,
false suggestion and misrepresentation in obtaining the grant of Australian
patent. However, the court at the same instant delivered the verdict that
a proposed Ranbaxy generic product under a different patent infringed Pfizer's
basic 'Lipitor' patent.
Pfizer has announced in June an agreement to head off generic competition
for its flagship drug until November 2011. The drug maker said that it had
settled patent litigation with Ranbaxy Laboratories, an Indian maker of generic
drugs that had threatened to market its own version of Lipitor, the world's
best-selling medicine.
As the first company to file with federal regulators to market a generic
version of Lipitor, Ranbaxy has rights under the Hatch-Waxman Act to 180
days of generic market exclusivity. During that six-month period, the maker
can price generic drugs fairly close to the brand-name version. Prices generally
decline sharply when other generic competitors can enter the market.
The settlement agreement does not prevent other generic companies from challenging
the Lipitor patent, but Ranbaxy's "first filer" rights in the United States
eliminate much of the incentive to do so. Pfizer currently faces a
generic-Lipitor challenge in Canada from Apotex, a drug company in Toronto
known for aggressively litigating patent cases. Lipitor is the world's best-selling
drug, generating nearly $12.7 billion in 2007 sales and representing a quarter
of Pfizer's total $48.61 billion revenue.
Indian Patent Applications
Global and Indian generic companies are in a hurry to seek patents for drug
in India, filing applications for process and composition patents. Teva,
an Israel based generic company, tops the list, beating Indian and American
companies. Ranbaxy, India's largest drug maker, and Eli-Lily, a US
based research company, are next in line filing 225 and 86 drugs respectively.
A total of 10,000 applications were received by the Indian patent office
recently.
China’s Eyes on GSK
According to China Intellectual Property Office's website, the patients in
the country are demanding for compulsory licensing for allowing the domestic
companies to manufacture the medicine 'Lamivudine' and market it at a lower
price. The alleged reason behind such demand is supply of Lamivudine
during the second half of 2007. GlaxoSmithKline (GSK) owns the Patent
and marketing rights for Lamivudine in China.
Crystalline Form
Circumvented
Ranbaxy Labs got the tentative approval from the USFDA to manufacture and
market Valganciclovir Hydrochloride Tablets, 450 mg. Ranbaxy is First Para
IV filer generic company and is entitled for 180 days exclusivity. Ranbaxy
and innovator Roche are in litigation on US6083953 (Expiry: Mar 29, 2015)
which covers 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-3-hydroxy-1-propanyl-L-valinate
hydrochloride (Valganciclovir) in crystalline form as product. Ranbaxy
has designed around the '953 patent by preparing their formulation by amorphous
form of Valganciclovir (as patent covers crystalline form). Roche in its
complaint has alleged that on stability Ranbaxy product will convert to crystalline
form. Innovator Roche got approval on this product on Mar 29, 2001
for the treatment of Cytomegalovirus and is mainly used for eye infection,
on absorption this drug is converted into the body into Ganciclovir by esterase
enzymes present in intestine and liver.
Virtual Humans
in Drug Discovery
In the not too distant future drug development work will be revolutionized
by new computer technology that will "test" experimental therapies on virtual
humans, says a new report from PricewaterhouseCoopers. The new computer-based
human model will be instantly adapted to represent every disease, says Steve
Arlington. And the cost of drug discovery can be cut by as much as two thirds.
That sort of brave new world would engineer a profound change for drug
developers, who take years and hundreds of millions of dollars to advance
a drug--often finding out in late-stage trials that they don't work as expected.
It's also the kind of model that better suits an approaching age of personalized
medicine, when a new generation of therapies will be developed that are more
narrowly designed to address disease. Another sensible way to change the
approval process would be to allow regulators to approve a drug for use in
small populations and then expand its use as more data becomes available.
http://business.timesonline.co.uk/tol/business/industry_sectors/health/article4175434.ece
Drug Review Process
On June 13, 2008, the Office of Inspector General for the U.S. Department
of Health and Human Services (the "OIG") released its report entitled "The
Food and Drug Administration's Generic Drug Review Process." The report outlined
the evaluation process for Abbreviated New Drug Applications ("ANDAs") as
well as how long the evaluations took from start to finish in 2006. Additionally,
the OIG used the report to offer recommendations to the Food and Drug Administration's
Office of Generic Drugs ("OGD") regarding how it could increase efficiency
and expedite generic drug release. Manufacturers should be aware of procedural
changes likely to affect FDA new drug approvals. Federal law requires
that submissions receive a status determination (i.e., approval or disapproval)
within 180 days of filing. However, nearly all evaluations required substantially
longer to reach completion. Prior to even entering the queue for the various
Divisions to evaluate, the OGD spends nearly 60 days simply assessing the
completeness of the ANDA. Of 535 ANDAs approved in 2006, the median approval
time was 17 months, nearly three times longer than mandated by federal law.
http://www.mondaq.com/article.asp?articleid=62438&email_access=on
Satyam’s Pharmacovigilence
Satyam Computer Services Ltd. , a leading global consulting and information
technology services provider, announced that it has formed an alliance with
Sciformix Corporation, a Westborough, Mass.-based, Life Science Knowledge
Process Outsourcing (KPO) company, to deliver end-to-end data management
services in "Pharmacovigilance." The partnership addresses the worldwide
increase in focus on drug safety, which is leading to increased volumes of
adverse events being reported to the regulatory authorities.
Abbott
Abbott opened its new Formulation Development Center at the company's headquarters
in Abbott Park, Illinois. The new facility provides leading capabilities
for the formulation of new investigational medicines that have the potential
to treat cancer and other deadly diseases. The center's technology and equipment
will help enable Abbott to expedite its development programs, potentially
bringing innovative new pharmaceuticals to patients faster. The Formulation
Development Center supports programs for both potent (drugs with highly active
ingredients that require special handling) and non-potent oral compounds.
This includes state-of-the-art capabilities for the safe formulation of potent
compounds, such as cancer therapies, that are increasingly becoming more
effective at low-dose levels.
Abbott's new facility is focused on transforming complex molecules from the
laboratory into tablets and capsules that can be used in pre-clinical and
clinical studies to determine safety and efficacy. Formulation is an important
step in the research and development process, providing a crucial link between
the laboratory and commercial manufacturing. Formulation and process work
begins shortly after a candidate molecule is identified. Initial formulations
are then refined as more information is gathered through the development
process.
The center was specifically designed with cutting-edge equipment and improvements
to advance the R&D process, including automated technologies that reduce
the time for preparing, producing and refining pilot drug formulations. In
addition, all of the equipment in the facility is aligned with the production
equipment in Abbott's commercial manufacturing sites, which will allow for
rapid scale-up of production as drug compounds move toward late-stage clinical
trials and market availability for patients.
Generic
Escitalopram for Depression
Lupin Pharmaceuticals, Inc. (LPI) announced that it has received tentative
approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram
Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration
(USFDA). Lupin's Escitalopram tablets are the AB-rated generic equivalent
of Forest Laboratories' Lexapro(R) tablets, indicated for the treatment of
major depressive disorder. The brand product had annual sales of approximately
$2.6 billion for the twelve months ended March 2008, based on IMS Health
sales data.
Sanofi Donates Vaccine
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced
its commitment to donate 60 million doses of H5N1 vaccine to the World Health
Organization (WHO) over 3 years for the establishment of an H5N1 vaccine
global stockpile.
Influenza is a disease caused by a highly infectious virus that spreads easily
from person to person, primarily when an infected individual coughs or sneezes.
An influenza pandemic is a global epidemic of an especially virulent virus,
newly infectious for humans, and for which there is no preexisting immunity.
This is why pandemic strains have such potential to cause severe morbidity
and mortality. The H5N1 viral strain has been identified by global health
authorities as being a potential cause of a pandemic. In an attempt to minimize
the impact of a pandemic, many countries are developing national and transnational
plans against a possible influenza pandemic situation. According to the World
Health Organization (WHO), there have been 383 cases of avian influenza transmitted
to humans since 2003, with 241 resulting in death.
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,
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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