New Home
Posted on March 3, 2009
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The new home of the Law Offices of G. Mathew Lombard, P.C. Blog may be found at:
Please also visit:
Outsourcing of Pharma Clinical Trials
Posted on February 20, 2009
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The New York Times writes about the so-called “outsourcing” of drug clinical trials. The Times relies on an article appearing in The New England Journal of Medicine. Specifically, the researchers suggest “an ethical quagmire when drugs intended for wealthy nations are tested on people in developing countries. The authors suggest that human volunteers in foreign countries may be unduly influenced with the promise of financial compensation or free medical care to participate in clinical trials.”
The authors also question whether the results of trials in developing countries may be directly translated to American (or, presumably, Western) patients.
The article’s authors have their critics. Some claim the authors used too simplistic data mining to raise an alarm and lack (or have not presented) hard evidence of widespread ethical or scientific problems.
Dr. Ezekiel J. Emanuel, the chairman of bioethics at the Clinical Center of the National Institutes of Health in Bethesda, Md., seems to support the outsourcing of clinical trials: ”More places outside the United States are participating in research — is that a bad thing?”
Dr. Emanuel cited a clinical trial of the Merck drug Gardasil, a vaccine against the human papilloma virus, that was conducted in Costa Rica, where there is a high incidence of the disease. “This is the kind of case where it is a good thing.”
Whatever the interpretations, the use of offshore clinical trials is growing. In the last 10 years, the proportion of United States-based researchers who direct clinical trials registered with the federal Food and Drug Administration has declined significantly, while the percentage of F.D.A.-registered researchers outside the United States has significantly increased, according to a report in January by the Tufts Center for the Study of Drug Development in Boston.
In 1997, about 86 percent of F.D.A.-registered principal investigators were based in the United States, the Tufts study said. By 2007, only about 54 percent of about 26,000 F.D.A.-regulated chief scientists who conducted clinical trials that year were based in the United States.
In the end, Dr. Emanuel concludes, “It’s not a sufficiently nuanced concern to give it credibility.”
Pharma Industry Agrees to Moratorium
Posted on January 2, 2009
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The pharmaceutical industry has agreed, as of 1 January 2009, to a voluntary moratorium on the distribution of free s0-called branded goodies to physicians. These include Post-It pads, pens, tongue depressors, etc. with drug names.
The code was drafted by Pharmaceutical Research and Manufacturers of America, an industry group in Washington. It bars drug companies from giving doctors branded pens, staplers, flash drives, paperweights, calculators and the like. While the move has its supporters and its critics, most agree that it is at least a good “first step”.
To see which companies have signed on to the code, please visit here.
TRUVIA vs. PUREVIA
Posted on December 24, 2008
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On 11 December 2008, it seems, The Coca-Cola Co. opposed Pepsico’s various applications for PUREVIA and PURE VIA based on its pending application for TRUVIA. Coca-Cola’s TRUVIA application covers natural sweeteners in Class 30. Pepsico’s PUREVIA applications covers breakfast cereals, vitamin enhanced water and soft drinks, and natural sweeteners.
This should be interesting. I know that these parties are probably two of the fiercest competitors on the planet, but I’m not sure how I feed about Coca-Cola’s chances here.
Service by…
Posted on December 24, 2008
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Sheriff? Mail? Letters rogatory? How about by Facebook?
In an apparent first in Australia and, likely the world, a judge has approved a plan to serve a default judgment on a non-appearing defendant via the social networking website, Facebook.
The court okayed the Facebook approach after all other efforts failed, according to attorney Mark McCormack, who represented the creditor side in the mortgage foreclosure case.
Interesting…
Congratulations!
Posted on December 18, 2008
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The firm wishes to extend its heartfelt congratulations to its client, Galderma, which recently obtained FDA approval for its new acne treatment EPIDUO. EPIDUO is adapalene/benzoyl peroxide. It is supplied as a gel and is intended to treat acne when comedones, papules, and pustules are present.
The FDA approved EPIDUO on December 8, 2008.
Again, congratulations to Galderma. We are happy we have been able to work with you on this new and exciting product.
I Hope This Gets A Lot of Use
Posted on December 17, 2008
Filed Under Business of TMs, Trademarks, USPTO | Leave a Comment
In trying to find some information about an Examining Attorney, I stumbled across a new (to me) site. It is http://www.usptoexaminers.com. According to USPTO Examiners, its mission is:
USPTO Examiners is a website designed for professionals to anonymously review, rank, and learn about a patent examiner or a trademark examining attorney who works at the United States Patent and Trademark Office (USPTO).
Patent examiners and trademark examining attorneys are public employees who help determine the technological and economical future growth of each industry and business in the world. A simple word such as “allowed” or “rejected” from a patent examiner or a trademark examining attorney could grow or financially burden a company, business, or individual. Accordingly, it is extremely important for the USPTO to have well trained patent examiners and trademark examining attorneys who understand that each of their decisions could benefit and/or harm an industry, business, and/or individual. Having highly competent patent examiners and trademark examining attorneys will result in the USPTO issuing high quality patents and trademarks.
I agree. I hope this site flourishes and becomes a useful resource for practitioners and the supervisors at the USPTO.
Palin’s Favorite Store to Change Name
Posted on November 17, 2008
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When Out of the Closet (California), a non-profit HIV/AIDS company, learned about Out of the Closet (Alaska), Gov. Palin’s favorite second-hand clothing shop, the California non-profit promptly demanded that Alaskan store change its name.
Ms. Arvold, owner of the Alaskan store, has agreed to change the name of her store by year’s end.
Naked M&Ms?
Posted on November 16, 2008
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The Naked Cowboy, of NYC Times Square fame, (aka Robert Burck) has dropped his lawsuit against Mars, Inc. for trademark infringement.
Movie Titles in Conflict
Posted on November 14, 2008
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This article is an interesting discussion of what happens when a movie studio objects to the title of another studio’s film.
An excerpt:
keep looking »But glancing at the posters for Fox’s “The Day the Earth Stood Still” and the Asylum’s “The Day the Earth Stopped,” you’d hardly know the difference. And both have release dates scheduled for mid-December.
Well, maybe not. Or at least not if Fox has anything to say about it. This week, the studio quietly took action against the Asylum, firing off a lengthy cease-and-desist letter and hiring attorneys to go after the prolific purveyor of high-end, low-budget knockoffs of Hollywood blockbusters.
Not familiar with Asylum’s oeuvre? Perhaps you missed “Snakes on a Train,” which hit DVD right around the time New Line’s “Snakes on a Plane” debuted in theaters. Or May’s “Street Racer,” which debuted a couple of weeks after Warner Bros.’ “Speed Racer.” How about last summer’s “Transmorphers?” You get the idea. Produce a movie with themes similar to an upcoming blockbuster, then borrow a trick from the porn industry and title it something comically derivative, create parallel marketing materials and take advantage of the millions the studios spend to promote their hits.
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