''regardless of whether a particular institution or entity is engaged in an endeavor for commercial gain, so long as the act is in furtherance of the alleged infringer's legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense.''[24] Duke University was not excused from potential infringement of patents covering laboratory equipment simply because the equipment was used solely for research and educational purposes, which are the core of Duke University's business. A strong argument can be made that the research exemption should be much broader, encompassing research aimed at better understanding of the claimed invention, such as how it works and whether it works as taught by the patent, how to improve on it, and how to work around it. Indeed, practically speaking, this may in fact be how patents are most commonly used. The patent law trades a period of exclusivity for disclosure and the teaching of an invention to the trade, and competitors should not have to wait for the period of exclusivity to end before learning from that disclosure and attempting to improve on it.

Little is known about how gene patents are being used, and whether they have a net beneficial or detrimental effect on scientific research and commercial product development. Patents clearly are seen as a necessary stimulus for the infusion of venture and risk capital in the biotechnology industry; less clear is the role patents play in motivating academic researchers. Little data have been generated about the licensing of biotechnology patents. These studies suggest that most genetic inventions are not patented, but when they are, they are licensed on exclusive terms.[25,26] In turn, researchers and firms appear to have developed various strategies to minimize the potential detrimental effects of the patents.[27] Nonetheless, much remains unknown about the effects of these practices on basic research and commercial competition.

Finally, a third and emerging class of gene patents is that claiming the functional use of a gene. These patents are based on the discovery of the role of genes in disease or other bodily and cellular functions or pathways, and claim methods and compositions of matter used to up-regulate or downregulate the gene. For example, a patent that was recently invalidated claimed methods and compositions of matter for the selective inhibition of the Cox-2 gene, which prevents inflammation and pain. The patent was invalidated because the patentee, the University of Rochester, failed to disclose a chemical entity that would perform such selective inhibition.[28] The patent claimed the mechanism by which two drugs, which later came to market, work—Celebrex, which is comarketed by Pharmacia (of which Searle is part) and Pfizer, and Vioxx, which is marketed by Merck.

A case similar to the Cox-2 litigation involves a patent awarded to Harvard and MIT and exclusively licensed to Ariad Pharmaceuticals. The patent claims the basic regulation of any gene by reducing the intracellular activity of the transcription factor NF-kB.[29] On award of the patent, Ariad Pharmaceuticals sued Eli Lilly for infringement by their osteoporosis drug Evista and their sepsis drug Xigris, and has asserted the patent against numerous other companies. Eli Lilly's patent applications for these two compounds themselves predate the filing of the NF-kB application.[30] Ariad Pharmaceuticals should have a hard time winning, both because, like the Cox-2 inhibition patent, the NF-kB patent fails to disclose specific agents for regulating the factor and because the company is trying to assert its patent in a way that would remove from the market chemical entities that predated the discovery and disclosure of the functional pathway by which those drugs work.

Finally, we have the case of Viagra. Pfizer, which has had its erectile dysfunction drug Viagra on the market for several years, recently received a patent claiming the molecular pathway by which Viagra works. The patent claims any selective PDE5 inhibitor used to treat impotence.[31] Immediately on allowance of its patent in late 2002, Pfizer sued Bayer and GlaxoSmithKline for their drug Levitra, and Eli Lilly and their partner Icos for their drug Cialis, both of which were proceeding toward Food and Drug Administration (FDA) approval.[32] The difference between the Viagra case and the Cox-2 case is that Pfizer actually has and claims a specific class of drugs that work by the claimed functional pathway. Whether this is an adequate basis on which to allow Pfizer to lay claim to all drugs that work by the same molecular mechanism is a fundamental legal question that looms over the pharmaceutical industry.

Getting Started With Dumbbells

Getting Started With Dumbbells

The use of dumbbells gives you a much more comprehensive strengthening effect because the workout engages your stabilizer muscles, in addition to the muscle you may be pin-pointing. Without all of the belts and artificial stabilizers of a machine, you also engage your core muscles, which are your body's natural stabilizers.

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