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5109 Kali Era, Sarvajit
Vikramarka Era, Sarvajit
The USPTO has published amended, final patent rules that will take effect
on November 1, 2007, limiting the use of continuing patent applications and
requests for continued examination that can be filed during patent prosecution.
The new rules limit the number to five independent claims and 25 total claims
that may be presented in an application family that contains patentably
indistinct claims. If these numbers are exceeded, applicants must file an
Examination Support Document (ESD) prior to a first Office Action (OA).
A restriction requirement is not considered to be a first office action
although it may be included with a first OA. The 5/25 claim rule is not
limited to applications filed on or after November 1, 2007. It is applicable
to all pending applications that have not received a first OA by that date.
The PTO has heightened the standard for a claim to be considered a dependent
claim by requiring incorporation by reference of all the limitations of
the claim to which it refers and requiring the claim to specify a further
limitation of the subject matter of the previous claim. Claims that do not
meet these standards will be considered independent claims and count against
the limit of five.
The rule changes were intended to cut down the backlog of applications
in its queue, but which also has IP attorneys and inventors on edge.
As a result, the Patent and Trademark Office was sued by an inventor. Dr.
Tafas argues the changes suppress scientific progress and violate the Patent
Act and the U.S. Constitution. Tafas invented a high throughput diagnostic
microscope sold through his company, Ikonisys. He also has a patent pending
on a method for improving automotive efficiency. Tafas protects these inventions
through patents and has now sued the USPTO. Tafas asks the E.D. Virginia
District Court for a declaration that the PTO’s newly finalized rules are
in conflict with the Patent Act and are thus invalid.
The proposed amendment to Section 284 may leave patent holders who wish
to obtain enhanced damages for pre-litigation willful infringement open
to the risk of being sued first by the accused infringer, say some attorneys.
Changes to Continued Examination:
A new set of proposed Markush rules were published in the Federal Register
on August 10, 2007. Highlights:
An intra-claim restriction is proper unless all species share a feature
that is substantial and essential for common unity.
A claim may not incorporate part of the specification by reference unless
Markush alternatives must be substitutable; may not encompass other alternatives;
may not be a set of further alternatives; and must not make the claim difficult
The U.S. Patent and Trademark Office dealt Pfizer Inc. another blow in
the company's ongoing fight to hang onto its patents to the world's best-selling
drug, cholesterol treatment Lipitor, when it rejected the drugmaker's bid
to extend one of the patents.
Stents and Jobs
Drug-oozing heart stents became the fastest-selling medical device in
modern history, and a cash cow for Johnson & Johnson and Boston Scientific
Corp., because of the device's ability to prevent scar tissue from forming
new blockages after artery-clearing surgery. The U.S. market peaked at $3.1
billion in 2005, when the global market hit $5.2 billion, according to Toronto-based
Millennium, which surveys hospitals performing artery-opening surgery called
angioplasty. In about four years, some six million people worldwide were implanted,
a modern record for medical devices.
But the market reversed course in mid-2006, after research indicated drug-coated
stents slightly raise the risk of life-threatening blood clots months or
years after they're implanted, unless people stay on an anti-clotting drug.
The safety questions about the stents have triggered steep sales declines
and job cuts for the makers, and are expected to shrink the U.S. market by
one-third this year, a $1 billion drop just four years after the tiny gizmos
were introduced. J&J is cutting nearly 5,000 jobs due in part to
a stent decline after studies questioned the devices' safety and effectiveness
in preventing heart attacks and bypass surgery. Boston Scientific is preparing
its own cuts after its stock hit a five-year low and its credit rating sank
below junk-bond status.
Update: The challenge to Section 3(d)
On 6 August, the High Court in Chennai dismissed the writ petition challenging
the constitutionality of Section 3(d), and deferred to the World Trade Organization
(WTO) to resolve the TRIPS compliance question. It appears that the case
has created a lot of publicity about this section of Indian patent law. However,
Novartis has to go for the real battle before the WTO.
Section 3(d) Explanation: 'For the purposes of this clause, salts, esters,
ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures
of isomers, complexes, combinations and other derivatives of known substance
shall be considered to be the same substance, unless they differ significantly
in properties with regard to efficacy.'
Many people believe erroneously that Novartis' appeal is an attempt
to restrict the availability of medicines to people who may not be able
to afford them, conveniently forgetting the fundamental fact that new drugs
need protection to encourage innovation which in turn creates much needed
new drugs for everybody. Generic manufacturers should not be able
to cheaply produce copies of patented drugs to supply the large market in
India or elsewhere. In this particular case, new polymorph of Glivec
is one of the many drugs available for the same disease including Glivec
generic version. Novartis patent for Glivec polymorph would not preclude
local manufacturers from producing generic versions of the previous formulation.
Now that the earlier version of Glivec has become generic, Novartis developed
a polymorph, which has a better bioavailability that should be protected
by a patent. Obviously, bioavailability increases efficacy required under
section 3(d) of Indian Patent Law. However, if the Indian law doesn't recognize
bioavailability and such polymorphs as new patentable entities, Novartis
is out of luck. That, of course, sadly will end patenting in India of new
polymorphs, salts, ethers etc, unless WTO decides otherwise. Whatever
may be the outcome, hopefully, there will be some clarity in Indian law,
thanks to Novartis.
Knowledge Process Offshoring
Knowledge Process Offshoring (KPO) involves the offshore outsourcing of
knowledge-driven or "high end" processes that require specialized domain expertise,
such as R&D, insurance underwriting and risk assessment, financial analysis,
data mining, investment research, statistical analysis, tax preparation,
engineering and design, animation, graphics simulation, medical services,
clinical trials, legal services and more. Unlike the ITO and BPO market
sectors, which create cost savings solely through leveraging economies of
scale and "rules based" process expertise, KPO accesses the global talent
pool to carry out processes that demand specialized analytical and technical
skills as well as the exercise of judgment and decision-making. The strategic
driver for KPO is to add value by providing high quality business expertise
and superior productivity through improved time to market in addition to
realizing the traditional cost reductions through arbitrage of labor markets
that have made ITO and BPO successful.
KPO, a new wave of global outsourcing to India, is following on the heels
of the remarkably successful Indian market for information technology outsourcing
(ITO) and business process outsourcing (BPO). KPO offers significant potential
benefits, but with possible greater reward comes risk, and KPO involves
a number of key issues and risks that must be carefully evaluated when considering
a KPO transaction in India. Read more here: http://www.mondaq.com/article.asp?articleid=51196&email_access=on
Structuring any outsourcing transaction requires careful planning. In today’s
environment, outsourcing customers would be well-advised to ensure that
their outsourcing transactions are structured to preserve the ability to
engage in multi-process outsourcing (MPO) transactions. To preserve such
ability, customers should incorporate terms and conditions into their outsourcing
contracts that enable ongoing flexibility in their relationships with their
Read more here: http://www.mondaq.com/article.asp?articleid=51186&email_access=on
General Motors of Canada Ltd. will cut 1,200 jobs at an Ontario truck plant
in January 2008, a move the Canadian Auto Workers Union says shows the effect
of slumping U.S. housing and credit markets on the already struggling auto
industry. GM Canada spokesman Stew Low said the layoffs were part of
the company's plan to keep its inventory in line with production and offset
some of the value that was lost as a result of incentive plans. Consumers
were in no mood to buy a car this month as they faced rising mortgage payments
and roiling financial markets, and some analysts already predict 2007 will
be the worst year for U.S. auto sales in nearly a decade.
Ranbaxy Laboratories Limited (RLL), announced that the company has received
tentative approval from the U.S. Food and Drug Administration to manufacture
and market Galantamine Hydrobromide Tablets, 4mg (base), 8mg (base), and 12mg
(base). Galantamine is indicated for the treatment of mild to moderate dementia
of the Alzheimer's type. Total annual market sales for Razadyne were $130.0
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug
Administration has granted final approval for the Company's Abbreviated New
Drug Application (ANDA) to market its generic version of Novartis’ Famvir®
(Famciclovir) Tablets, 125 mg, 250 mg and 500 mg. The brand product had annual
sales of approximately $200 million in the United States for the twelve months
ended June 30, 2007, based on IMS sales data.
The U.S. Food and Drug Administration today approved Somatuline Depot (lanreotide
acetate injection) for the treatment of acromegaly, a rare and potentially
life threatening disease in adults caused by abnormal secretion of growth
hormone (GH), commonly from a benign tumor located in the pituitary gland
located in the brain. FDA designated Somatuline Depot orphan status because
the drug treats a rare disease and meets other criteria. Orphan products are
developed to treat rare diseases or conditions that affect fewer than 200,000
people in the United States. The Orphan Drug Act provides a seven-year period
of exclusive marketing to the first manufacturer who obtains marketing approval
for a designated orphan product. Acromegaly affects approximately 15,000
people in the United States and Canada and is most commonly found in middle-aged
adults. Patients with acromegaly have reduction in life expectancy of 5 to
10 years. The drug will be marketed by Beaufour Ipsen, Paris, France.
Evithrom (human thrombin)
The U.S. Food and Drug Administration approved Evithrom (human thrombin),
a blood-clotting protein used to help control bleeding during surgery. Evithrom
is the first human thrombin approved since 1954 and is the only product currently
licensed. It is derived from human plasma obtained from carefully screened
and tested U.S. donors and has undergone steps to further reduce the risk
for transfusion-transmitted diseases. Evithrom is indicated as an aid to stop
oozing and minor bleeding from capillaries and small veins and when control
of bleeding by standard surgical techniques is ineffective or impractical.
The product is applied to the surface of bleeding tissue and may be used in
conjunction with an absorbable gelatin sponge. Evithrom must not be injected
into blood vessels, which would result in serious clinical complications and
may even be fatal. Evithrom is manufactured by Omrix Biopharmaceuticals, Ltd.,
Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound
Management, a division of Ethicon, Inc., Somerville, N.J.
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, womenfitness.net,
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