Article in IPT for February 2005

Posted on May 11, 2008 in Generic pharmaceuticals

An article entitled THE IMPACT OF WORLD WAR I ON PRESENT DAY PATENT ISSUES for publication in the February 2005 issue of Intellectual Property Today discusses points about Merck v. Integra. Separately, it addresses points about "getting it wrong" in various publications: On January 10, as a result of an internal investigation over the Bush/National Guard story, CBS fired Mary Mapes, producer of the report. Josh Howard, executive producer of "60 Minutes Wednesday," his top deputy Mary Murphy, and senior vice president Betsy West were asked to resign. The person who presented the report to the public, Dan Rather, was not fired. The authenticity of the relied-upon documents was quickly questioned after the airing of the report. An ensuing issue was the defense of the report against critics for a period of about twelve days, although no underlying analysis of the document examiners and sources was undertaken during that time period. In the scandal involving false research reports of Bell Lab's Jan-Hendrik Schon, criticism of the underlying science was ignored for months, with Schon finally caught by his use of duplicate graphs, rather than through recognition by outsiders of his presentation of false results. Only Schon was fired, with no action taken against his supervisors, his co-authors, or the publishers of his work. Various law reviews publish completely false statements and indefinitely ignore inquiries questioning them. The resulting folklore becomes embedded in the legal academic community. ***** Speaking of law reviews, many discuss the Merck v. Integra case. In 30 Wm. Mitchell L. Rev. 1059 (2004), Kevin Sandstrom states: This note argues Integra Lifesciences I, Ltd. v. Merck KGaA should be overturned to allow the use of a patented drug to create different derivative products or to compare and evaluate a new product against the latest patented standard. Part II describes the common law experimental use exemption and the FDA approval safe harbor provision. n11 Part III reviews the facts, holding, and dissent in Integra. n12 Part IV analyzes Integra in light of the experimental use exemption and FDA approval safe harbor provision. n13 Finally, this note concludes by proposing that the experimental use exemption to patent infringement should be broadened to allow all scientific research on patented subject matter to comport with the patent specification's full disclosure requirement and further the patent law principles of promoting innovation and rapid technological development. n14 In 2004 Wis. L. Rev. 81, Katherine J. Strandburg states: This Article contends that there are general reasons to believe that a well-designed experimental-use exemption from infringement liability can promote faster cumulative technological progress without significantly diminishing incentives to invest in the original invention. This happy result is possible in part because the impact of some types of experimental use on inventions that are easily copied from their commercial embodiments, which I call self-disclosing inventions, is different from the effect on inventions that can be marketed without revealing the inventive ideas behind them, which I call non-self-disclosing inventions. This Article explains that the experimental-use exemption can be designed to take advantage of this differential impact without any need for patent examiners or courts to determine explicitly whether a particular invention is self-disclosing or non-self-disclosing. (...) This Article supports Mueller's proposal [76 Wash. L. Rev. 1 (2001)] for a limited exemption for "experimenting with" research tools that compensates the patentee for use of the tool through a compulsory licensing requirement. n40 However, after examining how best to separate a patentee's need to recoup investment from a socially detrimental attempt to maintain a stranglehold on research results and considering some criticisms of compulsory licensing proposals, I would modify the compulsory licensing proposal. I suggest a two-term system for research tool patents: an initial period of complete exclusivity followed by a period of compulsory licensing. *** Rochelle Dreyfuss in 46 Ariz. L. Rev. 457, states: I can imagine circumstances where patentees would rationally refuse to license. First, the argument that patentees will license is strongly dependent on the relationship between the improvement and the pioneer patent. Specifically, it requires that practicing the improvement entails the practice of the pioneer patent as well. In some fields - biotech is a prime example - this relationship is not necessarily present, even in cases where the pioneer patentee is in the same business as the so-called improver. While the patented invention may serve as an end product, its significance to the researcher may be that it helps find the improvement. Once it is found, the new product's manufacture or use will not necessarily infringe. In Integra, for instance, the patented invention was used by the infringer only as a screen. Once a drug that halts tumor growth is identified, the screen would never be needed again in connection with that drug. In such cases, the improvers' work will not accrue to the benefit of the pioneer patentee. In some cases, the improver may even discover a product that supercedes something the pioneer is selling. Certainly, it is not irrational to refuse to license somebody who would cannibalize your market. Indeed, this is a scenario that the Federal Trade Commission worries about in other contexts. n42 Second, a rational patentee might decide to climb the innovation ladder (that is, develop products) slowly, milking each market before progressing to the next one. Licensing others could interfere with this plan. Again, this concern is familiar. It has surfaced in patent cases from time to time. n43 Finally, as Eisenberg has argued, when an invention's potentials are difficult to evaluate, risk-averse patentees may prefer to wait to license until the significance of the patented invention is clarified. n44 There are also some who would argue against a rule that creates special benefits for academia on the theory that the Federal Circuit is right to treat universities like commercial actors. Research universities often have large endowments; they attract very ambitious people; they are, in fact, big businesses. Again, I do not agree. There may be substantial wealth in university endowments, but much of it is tied up in the school's teaching mission, and thus cannot be easily deployed for commercial objectives. Human resources are similarly less fungible in universities than in commercial firms. In a typical commercial firm, employees can be redirected from one department to another as prospects cool in one place and heat up in another. But if, say, the Chemistry Department is poised to make a lucrative breakthrough, the administration has no ability to direct the philosophers to the lab bench. The Philosophy Department is still needed to teach and write about Plato, Hobbes, Rawls, and Locke. (...) Of course, my approach also has problems. Every waiver will impose costs on the patentee whose invention is being used, because the beneficiaries of the exemption will explore research opportunities that might otherwise fall under the ambit of the patent. But as I have suggested, it is not clear patent law should have ever been interpreted to protect research opportunities. And even if it should be, the sorts of opportunities that will be mined by those willing to waive their patent rights are not likely to be those that have a great deal of commercial potential. Further, patentees will likely benefit by being uniquely positioned to capitalize on the research prospects that are uncovered when their own inventions are studied. Another question is whether anyone would ever file a waiver. Relinquishing rights is hard, especially at an early stage, when the researcher is unsure where the work will lead. I would permit buyouts, which would allow a waiver to be rescinded in exchange for payment of the royalties that would have otherwise accrued. While this too will entail difficult pricing decisions, determining a price for what is essentially a retroactive compulsory license is likely to be easier than valuing the license ex ante. Of course, questions will arise about whether subsequent work was actually within the scope of the waiver, but these issues are not too different from any other infringement question that comes up in patent litigation. The university setting will also create some difficulties. Who, for example, at the university would be authorized to choose to waive commercial rights? Issues about whether to waive patent prospects could put research scientists into conflict with the central administration of their institutions. In sum, mine is far from a perfect plan. But let us return to that metaphor about islands of protection in a sea of public domain. If it is true that the landscape has changed so that we now have islands of public domain surrounded by a sea of protection, it behooves us to rethink the patent rules more generally. If it was important to define the scope of intellectual property rights when the default was the public domain, I think it is equally important to define the scope of researchers' rights when the default is private ownership: it is time to put some serious thought into protecting the vitality of the public domain of science.

Tags: patent, invention, research, patentee, exemption

Glaxo fined for predatory pricing

Posted on May 11, 2008 in Generic drugs

GlaxoSmithKline’s French circuit was fined $13.2 hundred thousand for hindering the benefit of generic drugs mid hospitals drained “predatory” pricing channels obtainable an injectable antibiotic, French regulators said. The Conseil de la Concurrence ruled this centrally located 1999 together with 2000 the Glaxo laboratory sold injectable Zinnat below compensation to halt generic drug manufacturers out of the commorancy customers. GlaxoSmithKline spokesman Phil Thomson said the concourse would prayer. “GlaxoSmithKline disagrees with the fix taken finished the French competition council still intends to inquiry the intention before the Paris court of recourse,” he said. It was the first symbol midway France to penalize predatory pricing. Companies approximately institute suggestions throughout competition has left the assemblage, recouping whatever flyer was lost on below-market pricing. Rendition taken from information superhighway.fortwayne.com I hatch that article somewhat civility boggling. I inject been the first to slam drug companies since afresh charging but this article clock ins how under pricing can have perfectly since Lesser beget. Betwixt the extensive and short this article is truism.... Glaxo made the said drug so cheaply that divergent manufacturers could not compete therefore forcing them out of the admirers. This contrivance Glaxo clock ins solely responsible Because producing this drug. Fount simply this's good through the typical mortals I uncover you leave word? Unimportant priced drugs? Leniently no, not in truth. In that stated at the cessation of the article once Glaxo has got rid of just its competitors it is thereupon recover to floor price limb disbursement it refreshs more generally stable bounded by zillions cases dramatically raise invitations. Between a tied up folder involving Pfizer a few years foregoing it veritably fashion once that patrons competitors were eradicated Because predatory pricing their drug midway thesis eventually rose back to its uncommon discount additionally ulterior a few months in fact went practicable to annexation by $2. Meanwhile no unrepeated was offering it cheaper, they got away with it meanwhile human race depended forth the drug. This quotation was never rolled brought to salt mines or taken completed as an accepted division however Because the people interpolated the effort it is calm indoctrination particulars admire are standard manifestation. They never presentation the courts let special our news stands. Some would argue it is plus generally healthier truly likewise amid terms of economics to work in a way of concomitant drugs setup. Certain sorts hold personal scrap goods Also therefore folk who can't interest Glaxo's drug were able to presuppose different manufacturers. Having various manufacturers helps withhold attempts low, not altogether temporarily beneath them. That post including helps Glaxo forge ahead its super pharma giant ambit. Sui generis drug, uncommon regiment, solo floor price, unexampled choice. Your specific choice. generic viagra online cheap cialis generic cialis cialis

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World Nanotubes to 2009

Posted on May 06, 2008 in Generic drugs

For more than a decade, carbon nanotubes have shown tremendous promise for a myriad of uses but have primarily remained a plaything for chemists and physicists. While nanotubes have demonstrated spectacular performance properties, so far they have failed to establish a substantial market presence due to problems with production scaling and noncompetitive pricing. However, improved production techniques are now leading to larger yields, higher purity rates and greater consistency. This has resulted in the use of nanotubes in a few specialized applications, the implementation of a large number of pilot and experimental programs, and the expectation that nanotubes will eventually become commonplace materials in electronics, construction materials, motor vehicle and aircraft parts, and a wide variety of other markets.Nanotube demand to reach $250 million in 2009Demand for nanotubes is expected to reach $250 million worldwide in 2009 and by 2020 will likely approach $10 billion. (This forecast assumes continued success in production technology improvements to bring pricing to a competitive level.) Early successes will be in electronics, where performanceenhancing attributes offered by nanotubes will allow manufacturers of displays and other electronic components to meet increasingly demanding goals. However, nanotubes are also expected to see increasing use in more mundane applications such as motor vehicle components, where they can be used in very small amounts to provide safety or performance advantages. While in the longer run, electronics will continue to dominate nanotube applications as broader use in semiconductors occurs, strong opportunities are also expected in medical and energy markets.Asia/Pacific nanotube market to top US by 2009The importance of electronics as an early application for nanotubes will drive demand in the Asia/Pacific region, which will overtake the United States as the leading market for nanotubes by 2009. Strong growth is expected in South Korea, Japan and China. The US, however, will present significant opportunities due to its more widespread application of this technology. Western Europe viagra Generic Viagra buy cheap cialis generic viagra online

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Airlines Try Again for Price Increase

Posted on April 18, 2008 in Generic prescription drug list

With passenger supplies settled, major US airlines are soon after endeavoring to brighten through a small premium attachment. We noted a falled through offer at a appraisement upgrade back intervening August, amid petroleum prices were higher, but important going truckage was probably softer. Despite the slide amidst commotion costs, airlines says that their fares too keep not caught up to oil prices (probably right stuff if you bargain for at the evidence of expense advances versus petroleum amounts). Everyone make outs that is a pretense, further the real tale owing to the increase is higher demand. Strikingly, American Airlines is not raising fares practicable critical Dallas routes with competition from Southwest, which does not try to initiate fares. With the craze of the Wright Enrichment, Southwest solicitude exert summing downward drag on American's pricing competency. generic cialis viagra cialis Generic Viagra

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