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Legal Memo

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A trademark protects any phrase, symbol, and/or design that identify the source or origin of the goods or the services of one party from those of others. Federal registration are not required but recommended, as it adds value to the goods or services set forth in the registration. Trademarks can be licensed to third parties, it to third parties, be sold with a specified value or used as equity for business development. A patent protects the functional expression of an idea, it grants the property right to the inventor in exchange for public disclosure of the invention. In order to qualify for a patent, an invention must be novel, useful and non-obvious. A registered patent can be used to raise funds for business, licensed or sell the invention. A copyright protects works of authorship, the specific creative expression of an idea through any medium of artistic expression that has been tangibly expressed. Copyright provides licensing fee and royalty payments.

Copyright’s filing fee is small, registration period is relatively short, and the examination process is administrative. For trademark, the filing fee is much higher with a longer registration period, and an adversarial examination process. Registration and filling are desirable but not requite for both copyright and trademark, however it is a necessary step for issue patent. Both Copyrights and patents are under federal law while trademark laws differ in each state. There is also a federal trademark law. Once a work is created, it is under copyright protection, but registration is still necessary for protection defending. Trademarks and patents exist only when you register them and received approval. 
The expiry term also varies. The duration of copyrights varies, but normally one can last for the creator’s lifetime plus another seventy years. A patent will last for twenty years after the filling data. Both cannot be revived once expired while trademark can be renewed. Trademarks are issued for a finite period, but theoretically, it could last forever. U.S. rights valid internationally for copyright, but separate examinations and fillings are required for patent and trademark.
Any confidential information, which are unknown to the public, gives an enterprise competitive advantage and can derive independent economic value, can be considered as trade secret Any unauthorized use of these information other than the information holder could be considered as a violation towards the trade secret. (1) The purpose of trade secret protection is to against unfair competition, while the information that constitute trade secrets varies base on the each individual case and specific provisions. The trade secret law covers the protected confidential information for an unlimited period with no need for registration procedures. Legal action can be taken if there is any purposely breaching of the trade secret.

Trade secrets laws vary significantly by country and countries utilize different designations for the trade secrets law. In fact, trade secrets protection is the least harmonized intellectual property protection system since countries have different interpretations on the constitution of trade secrets. In the United States, Trade Secrets are protected through State laws. Some countries, especially the developing and underdeveloped countries, still have no trade secret laws in place. In these countries, the protections towards trade secrets are through different branches of their legal system, the most common case is to utilize patent law as the alternative for trade secrets protection.

There are some best practices regarding protecting trade secrets for MNEs. Some fundamental and should be continuously improving ones are: Require non-disclosure agreements; limit the distribution of confidential information; Have employees sign non-disclosure agreements; closely monitor company networks and protect electronic data; record and store all the documents. Last but not least, always prepare a contingency plan if trade secrets are breached and take proactive legal actions if necessary.

The virologist, Stephan Becker , at the University of Marburg in Germany is part of a consortium of scientists that is ready to do a safety trial of one of the candidate vaccines for Ebola. But the vaccine doses he's supposed to test on 20 German volunteers are still in Canada. Negotiations with the U.S. company that holds the license for commercialization of the vaccine—which contains a gene for the Ebola surface protein stitched into a livestock pathogen known as vesicular stomatitis virus (VSV)—have needlessly delayed the start of the trial, Becker and several other scientists tell Science. "It’s making me mad, that we are sitting here and could be doing something, but things are not moving forward,” Becker says.
Today and tomorrow, Ebola scientists and representatives from companies and regulatory bodies are meeting at the World Health Organization’s (WHO’s) headquarters in Geneva, Switzerland, to discuss how to speed up clinical development of vaccines, a process that normally takes years. More and more public health specialists believe that vaccines will have an important role to play in stopping the catastrophic outbreak in West Africa, which has so far caused at least 6553 cases and more than 3000 deaths in Guinea, Sierra Leone, and Liberia. (Those are the reported numbers; the real toll is known to be much higher.)

Given the urgency, it's inexplicable that one of the candidate vaccines, developed at the Public Health Agency of Canada (PHAC) in Winnipeg, has yet to go in the first volunteer's arm, says virologist Heinz Feldmann, who helped develop the vaccine while at PHAC. "It’s a farce; these doses are lying around there while people are dying in Africa,” says Feldmann, who now works at the Rocky Mountain Laboratories of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in Hamilton, Montana.
At the center of the controversy is NewLink Genetics, a small company in Ames, Iowa, that bought a license to the vaccine's commercialization from the Canadian government in 2010, and is now suddenly caught up in what WHO calls "the most severe acute public health emergency seen in modern times.” Becker and others say the company has been dragging its feet the past 2 months because it is worried about losing control over the development of the vaccine. But Brian Wiley, vice president of business development at NewLink Genetics, says the company is doing all it can. "Our program has moved forward at an unprecedented pace,” he says. Even if it took another few months, “we would still be breaking a record in terms of getting this into patients.” Wiley says the holdup is "the administrative process": agreeing on a protocol, getting collaborators to sign the right contracts, securing insurance in case something goes wrong.
Marie-Paule Kieny, a vaccine expert and WHO assistant director-general, disputes that NewLink is dragging its feet. "We have so far been able to resolve issues along the way, to get moving as fast as possible,” she says.
Phase I trials for another candidate vaccine, which has Ebola genes stitched into a chimp adenovirus, started in early September in the United States and the United Kingdom. “We have human safety data in about 20 people and everything looks good so far,” says Ripley Ballou, who's in charge of GlaxoSmithKline's (GSK’s) Ebola vaccine program in Rixensart, Belgium. Further trials are planned for Switzerland, Mali, and Uganda; Ballou says altogether about 150 volunteers will receive the single-dose vaccine.
A stock of the Canadian-developed VSV vaccine is stored at PHAC in Winnipeg. The Canadian government owned 1500 doses, 800 to 1000 of which it has donated to WHO; the rest are owned by NewLink Genetics.
Scientists say WHO's vials could have already been shipped to the research centers planning to do phase I trials. One such trial is scheduled at the Walter Reed Army Institute of Research in Silver Spring, Maryland; other studies, by a consortium that includes WHO and Becker, are on the drawing boards in Hamburg, Germany, in Geneva, and at sites in Kenya and Gabon. PHAC is ready to ship the doses "at a moment’s notice,” a representative says.
But for a clinical trial to start, regulators require information about how the vaccine was manufactured, and that resides with NewLink Genetics, which has been slow to release it, people familiar with the negotiations say. Wiley says he does not “know what the logistics are” on the manufacturing information. He adds that NewLink wants to be in charge of all safety trials. “I don’t think that it is unreasonable that we would want to be in control of the trial and move that forward," Wiley says.
Kieny acknowledges that the VSV vaccine is lagging behind GSK's candidate, which she says may be "due to the fact that the partnership behind [the GSK vaccine] is more experienced.” She hopes that the planned trials at Walter Reed will start soon; those in Europe and Africa can hopefully start in late October or early November, she says. Wiley says contracts may be signed at the meeting now taking place in Geneva.
Part of the problem may be that NewLink is a small company, with about 100 employees, that has concentrated on immunotherapies to fight cancer in recent years. The Biomedical Advanced Research and Development Authority—a U.S. government agency tasked with speeding up the development of emergency drugs and vaccines—recently sent two staffers to Ames to help NewLink file documents needed by the U.S. Food and Drug Administration, a U.S. government representative says. “Our engagement of outside help has nothing to do with our competence, but with the urgency around this matter,” Wiley says.
The number of Ebola cases is now almost doubling every 3 weeks. From the outset, public health experts have stressed that the world knows how to contain Ebola outbreaks: find patients early and treat them using very strict hygiene, trace and monitor their contacts, and bury the dead swiftly and safely. But given this epidemic's magnitude, that has become all but impossible, says PHAC’s Gary Kobinger. "You would need an army of epidemiologists for that.” That has made the fast development of vaccines crucial.
"In the beginning, we figured that the epidemic would be over by the time we have a vaccine ready,” says Anthony Fauci, director of NIAID in Bethesda, Maryland. "But as the epidemic has gone on and gotten dramatically out of control, it has become clear that we may need this vaccine to actually contain the epidemic.” That does not mean conventional containment strategies shouldn't still be used aggressively, and they need to be scaled up drastically, says Michael Osterholm, who heads the Center for Infectious Disease Research and Policy at the University of Minnesota, Twin Cities.
At the WHO meeting today and tomorrow, experts are discussing the many thorny issues that will arise if one or both of the vaccines successfully pass their phase I trials. From then on, they should be distributed widely in the affected countries, says Jeremy Farrar, an epidemiologist and head of the Wellcome Trust research charity in London. “I think the big question now is how do we do this while gathering sufficient safety and efficacy data to be confident that we are doing good,” Farrar says.
Fauci believes that a randomized, controlled trial, in which people receive either the actual Ebola vaccine or an unrelated shot such as the hepatitis B vaccine, will be needed. "If you are going to deploy a vaccine widely within a country, you better be sure it’s effective,” he says. But others don’t see the use of placebos as an option. "You create a group of people who are not vaccinated and they don’t know it,” Kobinger says. “If I were a volunteer, I would not be comfortable with this personally.”
Farrar agrees; what's more, a placebo-controlled study just isn't feasible, he says. “We are talking about a totally destroyed health care system across Liberia and, to an extent, Sierra Leone," Farrar says. "We just have to be practical.” That doesn't mean scientists will be unable to say if the vaccine works, he says. Urban areas like Monrovia will inevitably receive the vaccine before it reaches other, more rural parts of the country; scientists can compare the incidence of Ebola in both areas, in a so-called step-wedge study design. "If you have a 90% effective vaccine, you will see that immediately.”
Supply is likely to be a problem. GSK has pledged to produce about 10,000 doses by the end of the year, paid for by the Wellcome Trust and others. The company is already working on how to scale up production, however, if data from the first volunteers show that the vaccine does not cause harm and their immune systems have responses similar to what protected monkeys in experiments that attempted to infect them with Ebola virus. First signs of that could be available in less than a month, Ballou says. "We would not start producing very large numbers unless we had some evidence that the vaccine has a potential to work,” he says.
Production of the VSV vaccine is already being ramped up. The more than 800 vials now stored in Winnipeg could yield a few thousand doses, Kobinger says, depending on the exact amount needed per dose. “We’re manufacturing additional supply as we speak," Wiley says. "And we expect to have the capacity to manufacture tens of thousands of doses by the end of the year.” Two other vaccines, another one based on VSV and one using a modified poxvirus, are a few months behind in development.
At this week's meeting, experts will again discuss who gets the vaccine first. Most participants at an earlier ethics meeting said health workers should have priority, because they are essential in fighting Ebola while also at a high risk of contracting it. Moreover, the protection of a vaccine could help convince doctors and nurses to work in the affected countries. The vaccine would also be given to others involved in the outbreak, such as cleaners, ambulance drivers, or burial teams, Farrar says. But offering the vaccine to patients' families could increase the likelihood that they come forward, which would help detection and control.
Participants at the earlier panel agreed that children and pregnant women were particularly vulnerable and should also be prioritized.
Another question is which country to concentrate on. Should early doses be sent to Liberia, where the epidemic seems to be growing the fastest, or to Guinea, which has been on the verge of containing Ebola at least twice? "You could make a good case for either one," says Brian Greenwood, an epidemiologist specializing in vaccines at the London School of Hygiene & Tropical Medicine, who is chairing a session at the meeting. "These are all very difficult questions, and this is why you do need to get a lot of brains together of the people that really know about this from different aspects and try to come to some sort of a consensus.”
Questions remain over why a made-in-Canada experimental Ebola vaccine is still sitting in a Winnipeg laboratory instead of being dispensed in West Africa, with a scientific journal suggesting that an intellectual property dispute may be to blame.

It's been more than six weeks since the Canadian government promised to donate the vaccine to the international community to help fight the ongoing Ebola outbreak.

Sponsored Links Want to place your ad here?Advertise on AOL Huffington Post - Canada | | Buy a link here | | |

About 800 to 1,000 doses of the vaccine, which was developed at the National Microbiology Laboratory in Winnipeg, are supposed to be shipped to West Africa.

The federal government has said the delay is with the World Health Organization, which is helping to determine who should get the vaccine and how to ship the doses properly.

But a story published this week on ScienceInsider, a news website of the journal Science, raises the theory that a U.S.-based company that purchased a licence to the vaccine's commercialization from the federal government is "dragging its feet."

The article by Berlin-based journalist Kai Kupferschmidt cites scientists who are concerned that NewLink Genetics is "worried about losing control over the development of the vaccine."

"The scientists I talked to are unhappy. They feel it could have gone faster," Kupferschmidt told CBC News on Thursday. "The question becomes, who's in control of this process?"

Brian Wiley, NewLink's vice-president of business development, told Kupferschmidt the company is doing all it can, but the holdup has to do with administrative processes.

"We would still be breaking a record in terms of getting this into patients" even if it took another few months, Wiley was quoted as saying in the article.

Canada says it still owns patent

For months, CBC News has been asking what the Canadian government received from NewLink Genetics and another company, Defyrus/LeafBio, in exchange for licensing rights for the experimental Ebola vaccine and the ZMapp drug cocktail, respectively.

It's also not known whether Canada still has a voice in the development and dissemination of the treatments.

Officials with the Public Health Agency of Canada have maintained that the contracts are confidential, but they affirm that Canada still owns the patent and the intellectual property.

"The Canadian government holds the patent for this vaccine and has licensed the rights to NewLink Genetics through its wholly owned subsidiary BioProtection Systems to commercialize the product," an agency spokesperson stated in an email to CBC News.

"The agency retained rights related to research and emergency response."

With the number of Ebola cases almost doubling every three weeks, and scientists fearing they could be losing the battle, Kupferschmidt said the need for a vaccine is growing.
 
"I do wonder whether it isn't possible to somehow cut through all that red tape and try to help get this vaccine on the road as fast as possible," he said.

Dr. Gregory Taylor, Canada's chief public health officer, was asked on Thursday about what the issue was with the delay in getting the Canadian-made vaccine out.

"In terms of the vaccine, it's not a stall as much as this has never happened before. The WHO has never done this before," Taylor said.

"The world has never done this before with an experimental vaccine. If one of the vaccines actually injured someone or hurt someone, it would set everything back.
 
"You already have people who don’t trust the West coming in, people who are hiding because they believe that the westerners are bringing the virus in," he added. "If you add medications that actually injure someone, that would be extremely difficult."

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