On September 3, Swiss-based pharmaceutical giant Novartis launched the first American “biosimilar”—a copycat version of a complex biologic drug. Novartis is offering it’s product Zarxio at a wholesale price that is 15% less than the wholesale price of the product it mimics: [...]
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In the wake of the government’s indictment against members of Unit 61398, the Shanghai-based cyberunit of the People’s Liberation Army, economic cybertheft against private industries continues to rise. Last week, the FBI issued a private warning to industries that another high-level group of Chinese hackers [...]
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The Medical Device Amendments of 1976 (MDA), to the Food, Drug, and Cosmetic Act (FDCA), divide medical devices into three classes according to user risk. Class I devices pose the least risk; Class III devices pose the most. Class I devices are subject to general controls such as labeling requirements. Class II devices are subject to [...]
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Welcome to another semester at the JETLaw blog! Our patent eligibility symposium is coming up on Jan. 24, and we are soliciting questions for the panel moderators to consider.
The Supreme Court grants cert in the Aereo case, which pits the over-the-air TV streaming upstart against the big broadcasting [...]
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In the news . . .
Google and NSA team up to fight cyberattacks.
Scientists discover energy teleportation.
Seventh Circuit upholds prison ban on Dungeons & Dragons against First and Fourteenth Amendment challenge.
Australian copyright holders lose ability to compel ISP assistance. Meanwhile, new Aussie [...]
Continue Reading →In September 2009, the FDA adopted a new regulation banning flavored tobacco. The ban specifically targets candy and fruit-flavored cigarettes. While this issue may be obscure to some, for others, it’s a big deal–their favorite brands of cigarettes have been made illegal with little public debate while the country is occupied with a tanking economy [...]
Continue Reading →Pfizer offered a major “mea culpa” last week when it agreed to pay $2.3 billion in fines for the “largest combined federal and state health care fraud settlement in the history of the Department of Justice.” The pharmaceutical company has ended up in this less than esteemed position as a result of its [...]
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Most people agree that a generic biologics pathway for the U.S. Food and Drug Administration (FDA) approval of these drugs would be a boon to consumers, but different parties seem to be at odds on the exact exclusivity period that the pharmaceutical companies should be given from their generic drug competitors.
These generic biologics [...]
Continue Reading →Look for Over the Counter but Under the Radar: Direct-to-Consumer Genetic Tests and FDA Regulation of Medical Devices in the Spring 2009 issue (Vol. 11, No. 3) of the Vanderbilt Journal of Entertainment and Technology Law. The Abstract for the Note follows:
Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. [...]
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