Transferring Assets to Your Trust Takes Paperwork

Let’s review the question by the widow whose
husband recently passed away. Now that he has
died, she has learned that there were some assets
that he owned that were never placed into the
trust’s ownership.

Those of you who have taken my free online Multi-Media
course know that probate is a court process used to pass
title to assets we own at the time of our death.

The way a trust avoids probate is by taking title of your
assets out of your name individually and placing the assets
into the title of the trustee of your trust. The trust
instrument then contains language that describes who takes
over as trustee when you pass away.

In order for a revocable living trust to work and avoid
probate, you have to transfer title to your assets to the
trustee of the revocable living trust.

Failing to keep assets in the title of the revocable living
trust was one of the biggest mistakes I came across in my
legal career.

People would set up a revocable living trust, years would
pass by (with them buying and selling assets), and they would
get sloppy and not put title to their new assets into the
revocable living trust.

Only after a death occurred did we learn that they had
been sloppy in the titling of their assets.

Can this be fixed after death? Sometimes, but that is the
topic of another article.

For this article, let’s focus on the point that a
revocable living trust will work only on those assets that
you give it.

To get the most out of your revocable living trust,
you should review your assets with your professional
advisor to make sure you are holding title in the correct
way.

Usually, it will be as follows: John Smith and Jane Smith,
trustees of the Smith Revocable Trust, dated January 1, 2005.

Good luck and until next time,

Phil Craig

P.S. Feel free to forward this on to any friends.

Phil Craig is a licensed attorney and entreprenuer.
He started practicing law at age 25 in 1979.
He does not take on any more clients, but is
advisor to some of the biggest names in the internet
world. He shares his knowledge gained over the
last 25 years at his Living Trust Secrets newsletter site:
click here=========>http://www.LivingTrustSecrets.com

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The Truth About Common Law Marriage

There is a difference between common law marriage and cohabitation. In some cases if you are a cohabitant, you could be considered single and in some cases if you are common law married you are considered married as if you did it the traditional way.

The difference between cohabitation and common law marriage is critical. If you are a cohabitant, you may be legally considered single; if you are common law married, you are legally considered married to the same degree as if you had a ceremony. So, how do you know if you are married in the eyes of the law? Common law marriages are recognized in only certain states, including the District of Columbia, Alabama, Colorado, Iowa, Kansas, Montana, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas and Utah.

In order to qualify for a common law marriage, you and your partner, in general, must agree either in writing or orally to enter into a husband/wife relationship, hold yourselves out as husband and wife and acquire a reputation as a married couple. The length of time you’ve cohabitated may play a role in the determination of common law marriage. Common law marriages typically are limited to heterosexual couples.
If you and your partner live in any of the states that recognize common law marriages and do not want the state to consider you as married, you may wish to consult with a lawyer and create a document that would establish your relationship as unmarried cohabitants.

Jeffrey Broobin is a free-lance writer on family and finance issues; his main goal is to help people during their complicated period of life.
Website: http://www.legalhelpmate.com Email: jeffreyb@legalhelpmate.com

Top Tricks Dealers Use To Keep You from Getting Rid of Your Lemon

Taking back your “LEMON” or compensating you for your
inconvenience is the Legal obligation of the car company.
Unfortunately, this costs them money and many will go to great
lengths to keep you from taking advantage of your rights under
the Lemon Laws.

Here are five (5) common “tricks” car companies use to avoid
their Legal obligations to consumers:

* Dealer Trick #1 - Saying you do not have the right number of
repair attempts. The Law is very specific in regards to this
matter. But dealers commonly mis-code the reason for the visit
so it “appears” that you have not been there for the same
reason.

* Dealer Trick #2 - Saying the defect never existed or it’s not
the same defect. This is one of our favorites - the old
“Loophole.” A bit insulting isn’t it - as if you were imagining
the car breaking down on Interstate 70.

* Dealer Trick #3 - Saying the defect is not “Substantial.” The
fact is that the defect does not need to be substantial under
the Federal Lemon Law. The defect must substantially impair the
use, value or safety under the State Lemon Law only. And you do
not want the dealer determining if it was “substantial” anyway!

* Dealer Trick #4 - Saying the consumer abused or neglected the
vehicle. This is the quick “responsibility shift”- your fault
not ours. This is typically a bunch of baloney. For example, if
the vehicle is advertised as an off road vehicle, it can be
taken off road. If you have kept reasonable service records this
“trick” is easily dealt with.

* Dealer Trick #5 - Saying “That’s Normal” or “They All Do
That.”

Today’s vehicles should be reliable and operate as advertised.
Settling for defects you “can live with” was never part of the
bargain when you bought your new vehicle.

Should You Hire a Vioxx Lawyer?

If you or a beloved family member has suffered a Vioxx related heart attack, other cardiovascular problems, or a Vioxx induced stroke then you may be eligible to be part of a Vioxx class action suit or individual Vioxx litigation case.

The grounds for filing a Vioxx stroke, heart attack, or sudden death litigation case are based on releasing and marketing Vioxx as a safe alternative for chronic pain. Vioxx and other NSAID (non-steroidal, anti-inflammatory drugs) were not tested long-term to determine its patient safety factor. A few years passed before the FDA advised Merck to properly post warnings on the label. During that time-frame, thousands of doctors prescribed Vioxx to thousands of patients impervious to the imminent health threat that lay ahead.

How much does a Vioxx lawsuit cost?
———
Most Vioxx law firms will accept clients on a contingency fee basis. There is no fee, unless and until there is a recovery. If nothing is recovered during your Vioxx lawsuit then the client pays nothing. The contingent fee is based on a pre-agreed percentage of the recovery depending on the complexity and risks involved in your Vioxx case.

What’s the difference between a Vioxx class action suit, individual litigation, and MDL (multi district litigation)?
———
In a Vioxx class action suit, individuals who have similar cases would be “joined together” in a “class” to prosecute their claims in a “more efficient” manner. This process begins when one person (or more) agrees to serve as the class representative. This “class rep” is then subject to approval by the court. There are a series of requirements that the court reviews — but most significantly, whether the claims of the “class rep” are typical of the claims of other members of the proposed class. The class representative is proceeding not only on his or her own behalf, but also on behalf of all others who are similarly situated. In this case, there is only ONE lawsuit, the result of which binds all class members. In order to determine if the class will receive fair and adequate representation, the court will generally consider whether the attorney for the class has experience in handling class actions and/or claims similar to those of the proposed class. In addition, the court will determine whether there are any conflicts in the interests of the class members.

In individual Vioxx litigation, each person’s lawyer prosecutes their case, apart from any other cases. If a lawyer has multiple clients, each client would receive individual attention and would have their own Vioxx lawsuit.

Even with individual Vioxx litigation, some cases end up in Federal court, due to a diversity of citizenship between the claimant and Merck. In these cases, the individual claim gets temporarily consolidated with other cases in Federal court. But this consolidation is ONLY for the purposes of discovery, and does not impact the right to an individual trial for that person’s Vioxx lawsuit. The MDL gives each person the benefit through judicial economy and efficiencies of scale. For example, if Merck is also being sued by 10,000 other Vioxx plaintiffs across the country, just taking depositions in all the various jurisdictions could delay the trial date by years. But when all those individual Vioxx lawsuits are consolidated for discovery, it helps to save time and money for the Vioxx clients. In addition, it places the Vioxx plaintiffs on a more level playing field.

A family member recently had a stroke. He was taking Vioxx for two years. Should we be contacting a Vioxx law firm regarding Vioxx litigation?
—-
Yes, at least have a so you know your rights and understand what is at stake.
What are the alternatives to Vioxx?
Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs are Celebrex (celecoxib) and Bextra (valdecoxib). If you are considering taking Celebrex or Bextra, contact your doctor about the risks involved. Bextra has some serious side effects. Click here for more information about Bextra side effects.

Basically, all of the NSAIDs have risks when taken long-term, especially for gastrointestinal (stomach) bleeding, but also kidney and liver toxicity. Vioxx is also related to the nonselective NSAIDs — ibuprofen and naproxen. Now that Vioxx has gone under the microscope perhaps the FDA will require more testing for Celebrex and Bextra.

Are Cox-2 inhibitors more effective than traditional NSAIDs for arthritis pain?
—–
Opinions vary. Many doctors feel that Cox-2 inhibitors have never been shown to be more effective than traditional NSAIDs like ibuprofen and naproxen. If gastrointestinal safety is an issue, patients are prescribed protective drugs like proton-pump inhibitors to lower their risk even more. Cox-2 inhibitors have bigger and more exorbitantly expensive marketing campaigns. Cox-2 inhibitors also cost much more than traditional NSAIDs.

What is rofecoxib?
—
Rofecoxib is the generic scientific term for the compound that is marketed as Vioxx.

Will Vioxx be recalled?
—
No, Merck is voluntarily withdrawing Vioxx from the marketplace; a Vioxx recall is not necessary.

Can my pharmacist continue to refill my prescription for Vioxx?
—–
No, Merck has initiated a market withdrawal in the United States at the pharmacy level. This means Vioxx will no longer be available at pharmacies. Talk to your doctor about what medication is right for you.

Can I get a refund on unused Vioxx?
——-
Yes. Merck requires patients to mail back the unused Vioxx in the original container, along with a pharmacy receipt to:
NNC Group – Merck Returns
2670 Executive Dr.
Indianapolis, IN 46241
Include a note with the patient’s name, address, and phone number. Merck will reimburse the cost of the full prescription plus regular shipping.

Will there be a Vioxx class action suit?
——
Yes. There will be class actions. However, we will only be representing individual plaintiffs, and NOT filing any class actions.

I’m taking Vioxx now. What should I do?
——-
Consult with your doctor for further instructions. He may tell you to stop taking Vioxx. Merck is recommending people stop taking Vioxx.

How much does a Vioxx lawsuit cost?
——-
Most Vioxx law firms will accept clients on a contingency basis. That means you do not pay the law firm any money unless you win the case.

Monheit Law handles MDL and individual cases. They can be found at http://www.monheit.com

About the Author

Michael Monheit, Esquire is the managing attorney for Monheit Law. The practice is focuse on plaintiff personal injury cases and Vioxx Lawyers info can be found at Vioxx Lawyer - Monheit Law

PERSONAL INJURIES IN COMMON CARRIER ACCIDENTS

There are laws governing the operations of common carriers and these laws differ from state to state. However, it’s the Federal Government that regulates all the interstate common carrier laws while the individual states take care of the intrastate regulations.

In cases of common carrier accidents the sustained injuries of the passengers will determine the degree of liability to be paid by the carrier. In addition, the court will also examine whether the common carrier has make use of the required equipment as well as applied a reasonable degree of skill in order to prevent accidents from happening. The law also requires that a common carrier be strictly required to employ the highest degree of care as well as make use of safety measures in order to make sure that its passengers arrived at their destination unharmed.

There some state law that stipulates that a common carrier does not have an absolute responsibility of ensuring its passenger’s safety however there should be utmost care when transporting passengers to refrain from accidents. And with this as premise the common carrier is therefore liable for any injuries sustained by its passengers from accidents that could have been avoided if only the carrier was careful. The carrier is expected by law to act like a cautious person in its operation of the transportation services.

Likewise, depending again on the state law covering the area where the accident happens if ever a personal injury arises as a result of the carrier’s noncompliance to the safety laws only then will the carrier be held totally liable for the personal injuries suffered by its passengers. Another obligation of a common carrier is to give out warning to its passengers of the dangers that exist inside the carrier. Like standing in an aisle where a passenger may likely to be thrown out of the carrier however there are stubborn passengers who just can’t be told, with this type of passengers if ever there really comes an accident involving them then the carrier will not be held responsible or may be subjected to only a half or partial liability.

For those who have suffered personal injury due to common carrier accidents there is a limit to the filing period for damages. The filing period is termed as the “Statute of Limitations”. The statute of limitation provides the time frame as to when a lawsuit for personal injury may be filed. And if ever a case got filed after the statute even if the case is legitimate the injured party then losses all his or her rights to recovery.

For comments and suggestions about the article kindly visit Personal Injury Attorney Services

About the Author

Jinky C. Mesias is a graduate of Bachelor of Science in Business Administration Major in Business Management. She is at present an Associate Manager of a Life Insurance Corporation and a freelance writer.

Why your Personal Injury Case is taking too Long

Being disturbed is never new to someone who has become
aggravated and dissatisfied in something. This is also factual
after you file your personal injury lawsuit; you will be
disappointed at your lawyer because such a long time passes
between the time the lawsuit has started and any settlement or
trial. In most states, the other person’s insurance company owes
you no duty to settle quickly. Your case can be settled before
trial or drag on long after the trial is over.

There are quite a few things that can slow down your personal
injury case. One is detection - where the insurance company is
appropriate to discover everything about you and the accident.
You and your lawyer will need to get together all the medical
records, bills and other certification of your injuries. Some of
these must be obtained in a precise way to make them permissible
at trial. This often takes instance and money.

Next are depositions - where the insurance company’s lawyer will
ask you in great aspect about your injuries, your medical
history, the accident itself, and your behavior. You’ll likely
to be subjected to grilling over the smallest of details. Then,
you have motion hearings - where the insurance company lawyers
may have what feels like an endless capacity to file motions and
go to hearings on motions.

In addition, intervention is one more factor that slows down
your case. Many courts are forcing lawyers to arbitrate or
adjudicate cases prior to trial. Mediation is normally a
settlement conference without the official procedure of court.
Arbitration is a different breed, however. It’s often an
obligatory “mini-trial” of the case in front of an arbitrator or
panel of judges who listen to an informal presentation of the
matters involved in your case. We also have trials which are
planned on the court’s schedule, not the lawyers’ schedule.
Cases from time to time take years to be scheduled for trial,
especially in some major urban areas. Having a case that is two
or three years old before going to trial isn’t unusual.

Finally, compilation of issues is the last. You may also have
complexity collecting from the insurance company or the person
accountable for your injury. The insurance lawyer will have to
have a check or outline issued by the company. And before they
send you money, you will be compulsory to sign a release
document and file some sort of notice motion. These things also
postpone the payment.

For more related articles, you may visit
http://www.attorneyservicesetc.com

Is Injury Compensation Important?

Imagine you were driving your car and you stopped at a traffic light. Suddenly, BANG! Your car is hit from behind at about 15 miles per hour. You leap out of your car to have a look. Your bumper is bent, your boot lid is open and your tail lights are smashed……..but the main thing is, you are OK.

You exchange details with the person that hit you and you carry on, albeit rather annoyed that you will have to sort things out the next day. Later on that evening, you realise your neck and shoulders are a bit stiff and you have a bit of a headache. The next day, you feel worse and make an appointment to visit your GP who fits you in the day after that, by which time, you feel a bit worse. Diagnosis is whiplash and you may recover in a week or two. However, it might take a month or two. You just do not know.

Whilst at the doctors, ask him/her what the best course of action is to aid your recovery and follow that advice. If after two weeks, things have not improved, go back to your doctor and make it clear that the symptoms persist and ask if there are any other recommendations he can make. Perhaps physiotherapy, osteopathy, alternative medicines or treatments?

In all honesty, if you make a full recovery from your injury in two weeks or so, it is not really worth making a claim for financial compensation. The hassle and time and potential expense to insurers does not justify the very small amount of compensation that might be offered. We are talking about £250.00 or £500.00 here.

If, on the other hand, your injury persists much more than two weeks, it is well worth seeking advice from a solicitor or a personal injury claims handling company. You can start the process of making a claim for compensation, confident that you are entitled to compensation for your genuine injury.

Some injuries are far more obvious. If you have broken bones or deep cuts, it is immediately obvious to you that recovery time will be significantly longer than a few weeks. You can seek the necessary advice after you have seen the doctor or, perhaps, had to visit the hospital.

Yes, compensation for your suffering is important, but the most important thing is your health and a speedy recovery. Every effort should be made to help with recovering from your injury and if this takes longer than you had hoped, the financial compensation will eventually follow…

–

Kevin stokes is the owner of Injury Claims Solutions and has been dealing with personal injury and clinical negligence claims since 1993. He is a member of the Claims Standards Council and the Association Of Personal Injury Lawyers, and is accredited by the Law Society Of England And Wales.

Data Exclusivity: The Indian Position

Introduction:

Data exclusivity refers to a practice whereby, for a fixed period of time, test and other data provided to the drug regulatory authority (“DRA”) of a country (to demonstrate the efficacy and safety of a medicinal product [1]) in order to obtain an authorization to place the product on the market in that country, are not allowed to be used to register a therapeutically equivalent generic version of that product. Oftentimes, this data arises out of many years of research and clinical trials and is very expensive for the originator of the drug to produce. The framework for pharmaceutical regulation and authorization attempts to protect the investment of companies in their innovations by providing periods of so-called data exclusivity.

In essence, data exclusivity refers to a period during which no third party applicant can rely on data filed by the original applicant for a marketing authorization. Accordingly, during this exclusivity period any subsequent applicant would need to have generated its own data to support the safety and efficacy of the product. It has, therefore, been argued, that data exclusivity is a misleading term; a more appropriate term would be market exclusivity.

The most important international agreement dealing with the use of data submitted for regulatory approval is the World Trade Organization (“WTO”)’s Agreement on TRIPS. Article 39.3 of TRIPS (reproduced below) obliges countries to protect against unfair commercial use of confidential data on new chemical entities submitted by companies to obtain approval for marketing new drugs from a regulatory agency. However, not all WTO member states have enacted data exclusivity laws as described. This is because Article 39.3 allows considerable discretion as to what member states must do. Nowhere does Article 39.3 state that countries should provide exclusive rights to the originator of the data for a given period or a minimum term of protection.

More importantly, it is not clear whether the phrase “unfair commercial use” includes use of the originator’s data by the regulatory agency to assess applications by generic competitors. This has been argued not to amount to “unfair commercial use” so long as the regulatory agency does not disclose the data to the generic competitor. In terms of this interpretation, Article 39.3 does not require data exclusivity.

On the other hand, according to the research-based pharmaceutical industry, the only way to effectively protect test data against unfair commercial use is to provide an exclusivity period for the use of the data.

Both the Office of the United States Trade Representative and the European Union (”EU”) have urged that Article 39.3 of the TRIPS Agreement established an exclusivity obligation. According to the EU, all that is left to member countries is the determination of the duration thereof.

In addition to Article 39.3, there have been other bilateral arrangements and regional free trade agreements signed or under negotiation by the US in the wake of the failure of multilateral negotiations in the WTO, which contain data exclusivity provisions. The most significant of the trade negotiations wrapped up by the USTR is Central American Free Trade Agreement (”CAFTA”).

The Indian Position

In 2003, the Government of India issued a statement that –

“the Government does not have a position on data exclusivity at the moment. But it is clear that we have no obligation under TRIPS (trade- related aspects of intellectual property rights) to have provisions for the same in the country.”

The Government of India was of the opinion that Article 39.3 only requires WTO members to protect the test data against any “unfair commercial use” or “unfair competition”. It neither includes market exclusivity to the innovator nor does it create market protection. The rationale/basis for such a view has originated from the term “unfair competition” as described by the World Intellectual Property Organization (“WIPO”), that “the repression of unfair competition is not concerned with exclusive rights, but is directed against acts of competition contrary to honest practices in industrial or commercial matters, for example in relation to undisclosed information (trade secrets).”

Since the repression of “unfair competition” does not advocate any kind of exclusive rights nor the word “exclusivity” has been mentioned anywhere in the Article, the demand to give market exclusivity to pharmaceutical companies or the innovator on the basis of Article 39.3 would be unfair.

Also, a Government official reportedly stated that –

“TRIPS only requires us to protect test data against unfair use under Article 39.3, but there is nothing that says that we have to provide marketing exclusivity. Interpretations vary depending on which side you are on. It is only when a case comes up at the Appellate Authority at WTO can there be clarity……Under the existing circumstances, it is highly unlikely that marketing exclusivity would be provided for any period of time. It would be possible only if TRIPS is modified, which one cannot see happening. With new products not coming to the market, new uses are being found for the existing ones. While patents would not cover these, data protection is being seen by American companies as a new form of intellectual property right to effectively extend patent life.”

It was clear that at that point India did not consider itself to be under any obligation to enact any data exclusivity laws. The domestic sector including the Indian Pharmaceutical Alliance (“IPA”), does not believe the Indian Government should concede to any demand for data exclusivity. The IPA says that –

“TRIPS does not call for market exclusivity as understood in the USA or EU. Regulatory authorities are not prohibited from relying upon such data for determining the safety and efficacy of a previously approved product, when marketing approval is sought by generic manufacturers who do not infringe patents. This is particularly necessary to obviate the social and economic costs of repetitive animal and human testing.”

The IPA is also against “ever-greening” of patents. They argue that if data exclusivity in the country is allowed for say, five years, and a patented drug is introduced in the 17th year of the 20-year patent life, it could effectively extend the patent to 17 plus five equaling 22 years. If data exclusivity is introduced, they argue that the exclusivity period should not run beyond the life of a patent.

However, multinational pharma companies are almost unanimous in their view:

“More product introductions, research and development and clinical trials business will come to the country only if data exclusivity is in place. This is even more important to us than patents.” But Indian firms and authorities say “these are all claims; we will have to see how much of it happens even if data exclusivity is enforced in the country.”

It is contended that the pressure from the multinational companies primarily based in the EU and USA, is against the spirit of Doha Declaration, where it was stated that, the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. It was further stated that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.

Thus, on the one hand it is feared by the MNCs that the lack of data exclusivity will affect contract research and manufacturing. On the other hand, Indian pharmaceutical companies are afraid that it will delay the launch of off-patent expiring drugs and result in higher prices for medicines.

Under the rapidly changing international trade scenario and intense lobbying of multinational pharmaceutical companies, India was forced to assess its stand on Article 39.3. An inter-ministerial committee was constituted to examine the issue afresh and to examine whether data protection can be offered under the existing legal provisions. The committee also sought suggestions from various ministries including ministries of science and technology, agriculture and commerce & industry. While the committee in its draft report acknowledged that the existing Drugs and Cosmetics Act does not provide any form of protection for the data submitted by authorities for approval of drugs, the Ministry of Health, in its recommendations, stated that India already has necessary legal provisions to protect data submitted by innovator companies, hence there is no need for any further protection. The committee suggested to incorporate certain changes in the Drugs and Cosmetics Act so as to allow the protection of the undisclosed drug data submitted to the regulator by the pharmaceutical companies[2] .

Patent Amendment Act, 2005

January 1 2005 marked the culmination of a long, often controversial process of amending India’s IPR laws to bring them in conformity with the TRIPS norms. Though the deadline of January 1, 2005 has gone by and the Patents (Amendment) Act of 2005 passed and made effective from January 1, 2005, however, there is no provision therein introducing data exclusivity.

A recourse open for India is to provide for data exclusivity, making it mandatory that the time period of such exclusivity must lapse within the 20 years patent period granted under the Patents Act. For instance, the period of protection may not exceed 5 to 6 years (or as may be agreed) calculating the same from the first date of global registration of the patent. Such a move will evade the possibility of ever-greening of patents.

However, it seems unlikely for India to take into consideration the above approach because the “data exclusivity” demand means further restriction on public disclosure aspect of the patenting system which not only implies the de facto continuation of the monopoly of existing patent holders but also research institutions would not have access to this data, impeding further research. In addition, if compulsory/non-voluntary patents were granted, the working of such patents would be difficult in the absence of data, the domestic sector during the course of market exclusivity would not be able to duplicate even its own data for taking marketing approval even when they may be granted compulsory license for meeting the demands of the country of the patented products.

Keeping in view the above situation, the legislature, as of now, has resorted to the Bolar exemption provision vide Section 107A of the Patents Act. The Bolar exemption strikes a careful balance between promoting invention and ensuring that consumers have timely access to cheaper generics, after the expiry of the patent. Section 107A of the Patent Act provides that any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India or any country other than India as well as importation of patented product by any person from a person duly authorized under law to produce, sell or distribute the product will not be considered as an infringement of the patent rights. In order to avoid the loopholes, OPPI requested the Government to explicitly state that Bolar provisions will be used only for research and development and not for manufacturing and stockpiling.

Conclusion

So, what does future hold? According to an industry source, “India signed TRIPS for product patents only after the Indian industry realised its benefits and pushed for the same in the government. The decision of data exclusivity could largely rest on what domestic pharma lobbies for.”

Thus, it appears that the Government may not grant data exclusivity to pharmaceutical companies that are seeking to market their products in India. Instead, it may give limited protection to them and anyone found guilty of leaking protected information will be prosecuted under the Official Secrets Act, 1923[3].

Whether or not India enact data exclusivity laws, it should be kept in mind that:

Article 39.3 does not need protection for data that is already public;
Protection is required only for new chemical entities. Countries have considerable discretion in defining “new” and can exclude applications for second indications, formulations, etc.;
Before granting protection, regulators can ask applicants to prove that the data for which protection is sought is the result of significant investment; and
Article 39.3 only seeks protection against unfair commercial use and countries are allowed considerable discretion in defining ‘unfair’ use.

These interpretations have been supported by the US and Canadian Supreme Court decisions.

It is apparent that the Government of India wants to go slow on the demand of data exclusivity. It is suggested that India should adopt the model of such countries with manufacturing potential, but weak drug development capabilities which provide trade secret form of protection for undisclosed data submitted for approval. This will adequately satisfy the obligations under Article 39.3 of TRIPs and at same time ensure availability of drugs at affordable cost.

——————————————————————————–

This Article does not, and should not be construed, to constitute legal advice. It is not a substitute for legal advice from qualified counsel.

——————————————————————————–

Endnotes:

[1] Medicinal product is any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances that may be administered to human beings or animals with a view to making a medical diagnosis, or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.

[2] It is proposed to add a new Section 18A for prohibition and liability for disclosure of information and to amend Drugs & Cosmetics Rules, 1945. The amendment to Rule 122 A and 122 B seek to ensure that for drugs approved/marketed in other countries, the importer will submit to the local authority, only data from local clinical trials and not data approved abroad. In the Insecticides Act 1968, it is proposed to provide additional provisions for data protection under the Section 9 and by way of amendments to Form I.

The introduction of Section 18A will ensure that no person is entitled to the license under sub-section (c) of Section 10 or under section (c) of Section 18 for a drug unless approved by the licensing authorities in accordance with the Rules prescribed under the Drugs & Cosmetics Act. For approval under subsection (1), the licensing authorities may ask for submission of undisclosed information by the applicant. The licensing authority will have to keep undisclosed such information submitted under sub-clause (2) for new drugs, unless the government by notification seek disclosure of such information in public interest. The applicant will be entitled to injunction, compensation, or account of profit from any person using the information submitted under subsection (3) in violation of breach of confidence. Such violation will be liable for prosecution under the Official Secrets Act, 1923.

In addition, the Organization of Pharmaceutical Producers of India (“OPPI”) has requested the Government to amend Schedule ‘Y’ of the Drugs & Cosmetics Act to include provision for data exclusivity for a period of 6 years from the date of marketing approval.

[3] The Official Secrets Act, which is generally propagated as an adequate safeguard for data protection, deals with the wrongful communication of information entrusted to regulatory authorities and does not check reliance of such undisclosed data while granting marketing approvals to other entrants.

Alfred Adebare is a consultant having fourteen (14) years experience, of which the last ten (10) years has been spent in India advising on complex and substantial cross border commercial transactions. Alfred’s practice focuses on all aspects of cross border transactions including acquisitions in the areas of infrastructure, power, oil & gas, project finance, venture capital, private equity, information technology, foreign trade and capital markets.

Whiplash Legal Advice

Whiplash is a common neck and/or back injury that is usually the result of rapid acceleration or speeding up quickly or sudden slowing or stopping, called deceleration. A whiplash injury is most commonly caused by the motion made by a vehicle accident. In a sudden deceleration the head is normally thrown forward rather suddenly and violently. This motion puts a brief but very severe strain on the neck. This stretches the muscles and the ligaments in the neck. This already traumatic series of motions are the normally followed by a reflex contraction of the muscles, which then results in the head being jerked in the opposite direction. The resulting whiplash injury can be the cause of a serious disruption on a person’s ability to go about the regular tasks of everyday life.

In a whiplash injury the soft tissues and sometimes even the vertebrae are severely affected. Often times the injury does not manifest itself for a day or two, but the pain and disability it can cause can last periodically up to a year. The degree of the injury as well as the severity of the pain and suffering from whiplash are quite often the subject of dispute in claims and lawsuits for damages that are caused by negligent driving.

Whiplash injuries can be quite painful and the pain it causes can sometimes be so severe that it can immobilize a person and prevent him from doing his normal everyday activities, much less work. In fact, it is not unusual to hear people suing someone for having caused them a whiplash injury. More often than not these whiplash injuries are already enough grounds for a person to file legal charges against the party or parties that caused the whiplash injury. Some people may balk at the idea of filing for damages for personal injury caused by accidents and even say that paying legal fees is just a waste of money because you are never sure if you will win the case. But truth in fact is, you have every right to file for these charges, and what’s more, you have a right to ask for compensation for the errors committed by the guilty party or parties. Besides, by filing charges against the guilty parties, you are effectively stopping them from committing the same mistakes that could result in other people suffering the injuries as you did.

When filing a personal injury case against a person/persons there are some things that should be remembered. First of all, when you are filing these charges you are basically asking for damages. There are actually two types of damages that can be asked for:

• General damages covers pain and suffering caused by the injury and/or the accident
• Specific damages are for the loss of potential earnings or for specific costs associated with the accident

When it comes to making claims regarding the accident and the injury, claims must be made within three years from when the accident occurred. If the three years lapses before any claim is made then you can’t make a claim anymore.

Mark is the webmaster for Accident claim a legal information site.

This article is free to republish provided this bio box remains with working hyperlinks.

Voting Rights Act of 1965: Rev. George Lee Remembered

Belzoni, Mississippi, a small Delta town once known for lynching and Saturday night gun fights, survived a tornado following Hurricane Katrina.

“We’re up here in the Delta, away from the coast where they really got it. We didn’t get the hurricane but we did get a tornado and it was pretty bad,” said the owner of a used car lot at the northern edge of this cotton hamlet once known as “Bloody Belzoni.”

Katrina’s subsequent winds and severe rains did in fact hurt most businesses in this community that has been slowly lifting itself up by the bootstraps since earlier days of civil rights violence.

In recent years Belzoni leaders created a marketing plan, hoping to bring in new business: colorful five and six-foot acrylic statues of smiling catfish wearing polka-dot bow ties advertise Belzoni’s newly self-acclaimed status of Catfish Capital of the World.

The catfish are scattered throughout downtown. And a catfish barbecue and Delta blues celebration takes place each summer.

For many Belzonians memories of past violence will never be erased despite marketing efforts, and it is near downtown, in a poor and vandalized neighborhood, where African Americans have placed a granite block at the beginning of a city street.

Only “George Lee Avenue” is etched into the cold stone.

But this tribute is to a beloved leader who died a violent death fifty years ago for their right to vote.
* * * *

Rev. George Washington Lee, the first black person to register to vote in Humphreys County since Reconstruction, was shot to death on a neighborhood street while driving his car on the night of May 7, 1955.

Some who knew Lee and have remained to grow old in this Delta town say their friend was a kind and brave man who was brutalized and killed by white men angered over his voting rights advocacy.

LEE AND THE SECOND of Belzoni Citizen Council’s prime targets, Gus Courts, both lived and ran small grocery businesses. Citizen’s Councils were private Klan-influenced organizations formed in the Delta in 1954 to scare black citizens away from the polls and keep integration from taking place.

Lee also preached, often using his pulpit and his printing press to urge others to take action and vote.

White officials once offered Lee protection on the condition he end his voter registration efforts, but Lee refused.

Heading the town’s new NAACP Chapter, Courts was ordered by his banker to turn over all NAACP books and when he refused, Courts was told to leave town. But he stayed.

Once Courts was handed a list of ninety-five blacks registered in Humphreys County by a Citizens Council member who warned that anyone not removing their name from the voting list would lose their job. He later testified about his experiences before a Congressional Committee.

Both Courts and Lee had tried for years to pay poll taxes in order to vote and were finally allowed to sign the register only after the county sheriff feared federal prosecution. Casting a ballot required a separate battle.

The day of his murder, almost a year after Brown vs. Topeka Board of Education and three months before the lynching of Emmett Till in nearby Sunflower County, Rev. Lee visited with Courts to talk about the latest warning.

Lee reported getting an earlier anonymous death threat demanding he remove his name from the voting list. He told Courts that he had a strange feeling about this particular threat.

That night as Reverend Lee drove his car along Belzoni’s Church Street, two gun blasts shattered the night stillness, and the minister’s Buick sedan swerved over the curb and rammed into a frame house.

With the lower left side of his face gone, Rev. George Lee staggered from the wreckage but died during transportation to the Humphreys County Memorial Hospital.

When NAACP leader Medgar Evers arrived in Belzoni to investigate the murder of Rev. Lee, he was told by Sheriff Ike Shelton that Lee lost control of his car and died from the crash; the lead pellets found in his jaw tissues were dental fillings.

An autopsy was not necessary for the “freak accident,” Shelton said.

But at Mrs. Lee’s insistence, two black physicians examined her husband’s body and reported the tissues contained pellets “fired at close range from a high-powered gun.” They also found powder burns.

Over the next few days, Evers and two national NAACP representatives met with eyewitnesses and the full story emerged:

Lee had been followed by three men in another car.

His right rear tire was punctured by a rifle shot and as he slowed, the second car “pulled parallel and a shotgun was fired point-blank into his face. There were also descriptions of the three men, with tentative identifications.”

Evers always doubted that any FBI investigation took place, since there was never any public report “or even a solid rumor” as to what was in the report.

Rev. Lee’s murder was a cold-blooded answer to demands for equal treatment coming from more Mississippi blacks and was backed by the lies of the sheriff and local police, Evers later reported; Evers was assassinated ten years later in his Jackson driveway by a Delta Klansman and member of the white Citizens Council.

Recalled Aaron Henry of Clarksdale also a black Mississippi leader: “We felt we needed protection because the past had taught us that when one Negro is killed, stay out of town if your skin is black.”

Yet surprisingly for one of the first times, no protection was needed at the public funeral that took place in Belzoni.

“There wasn’t a white man on the streets the day of the service, except for the press. There was a great turnout of Negroes for the funeral. This large presence of Negroes and absence of whites marked a turning point,” Henry said.

* * *
As Aaron Henry predicted, the murder of Rev. Lee became a critical turning point back in 1955; his untimely death would help prompt later passage of the 1965 Voting Rights Act (VRA) – one of the most successful civil rights laws in American history, guaranteeing millions of minority voters the equal opportunity to participate in elections and have their voices heard.

VRA ended literacy tests, poll taxes and other methods of keeping blacks from voting that had long poisoned the roots of this country’s democracy. In 1964, only 300 African Americans served in public office nationwide, including just three in Congress.

But today, more than 9,100 black elected officials serve, including 43 members of Congress, the largest number ever, according to the NAACP Legal Defense and Education Fund, Inc. often simply called Inc.

The VRA also opened politics for more than 6,000 Latino public officials including some 260 elected at the state or federal level, with 27 serving in Congress. Native Americans, Asians and others who have historically encountered harsh barriers to full political participation also have benefited greatly.

Yet violations of the VRA still occur and the United States has yet to achieve the constitutional goal of equality of political opportunity.

Inc. leaders and other who support voting rights reauthorization point to three crucial sections of the Voting Rights Act that will expire in 2007 unless Congress votes to renew them:

*A requirement that states and local jurisdictions with a documented history of discriminatory voting practices submit planned changes in their election laws or procedures to the U.S. Department of Justice or the U.S. District Court in Washington, D.C. for pre-clearance. A bipartisan Congressional report in 1982 warned that without this provision, discrimination would reappear “overnight.”

* Requirements that communities with concentrations of voters who are Limited English Proficient provide them with bilingual election assistance including bilingual ballots, election materials, and pollworkers.

*The authority to send federal examiners and observers to monitor elections.

Inc. leaders and others involved in voting rights see these provisions as critical to ensuring fairness and equal opportunity for minorities in American politics:

“At a time when America is vigorously engaged in promoting the ideal of multi-ethnic democracy in Iraq and across the globe, we need to ensure that lawmakers preserve and strengthen the necessary tools to ensure the continued success of democracy here at home. Reauthorization of the 1965 Voting Rights Act is a first step.”