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.
Merck proposal on Mevacor shot down by FDA panel
Posted on May 11, 2008 in Generic pharmaceuticals
An FDA panel voted 20-3 against a proposal from Merck and Johnson & Johnson for a nonprescription, low dose version of Mevacor, part of the statin family of drugs used to lower cholesterol and heart disease risk. The Food and Drug Administration usually follows the recommendations of the advisory panels. Cheap Viagra Generic Viagra viagra cheap cialis
Merck/Novartis - Sugar Wars: Januvia vs Galvus
Posted on May 10, 2008 in Antibiotic
Watch out US diabetics - you are about to become "human guinea pigs" in the latest Big Pharma goldrush! As the first two drugs in a new diabetes-treatment class near U.S. approval, a survey of physicians shows a vast majority intend to start prescribing the products right away. Merck's Januvia is expected to win clearance any day, while Novartis' Galvus may be approved next month. Both drugs are DPP-4 inhibitors, which are designed to enhance the body's ability to lower elevated blood sugar and could become an important new way to control type 2 diabetes, the most common form of the disease. DPP-4 inhibitors would join metformin, Avandia and Actos as oral medicines designed to control blood sugar. A survey of about 60 endocrinologists, general practitioners and internists (who already had at least some awareness of the drugs) found that virtually all will use either Januvia or Galvus alone or in combination with other treatments. Of those physicians, about 90 percent of primary care practitioners said they intend to use Januvia and Galvus, while 95 percent of endocrinologists said they intended to use them. The survey was conducted by Reuters Primary Research, which researches industry issues and trends for institutional investors. Source. Insider's view: stand back, it's gonna be a riot. Let's just hope that the side effect profile of these new medicines is better understood than those other new diabetes medicines the PPAR's. You remember them.......Pargluva?. Sphere: Related Content buy cheap cialis cheap cialis cheap viagra buy cilais
Online Pharmacies- Is Off-Label Marketing linked to the Presidential Race?
Posted on May 09, 2008 in Prescriptions
a recent diary breeze The Healthcare Website poses a extravagant motif, Is Off-Label Trading dependent to the Presidential Race? Heres the article The daily Click has obviated the need being Wes Craven, George Romero along divers fright film creators. For we contain that article from Brandweek bearings the chief counsel at Pfizer commits that the FDA violates recover tongue rights under the First Growth completed restricting Pharma companies from promoting their drugs off-label, i.e., through unapproved uses. Owing to I’m a high First Reformation creature, card-carrying ACLU branch within good gamut, but that is a libertarian perversion of the First Regeneration that is orthodox of Reagan-Bush corporate lackeys. It reminds me of arguments from the prerequisite division legal cabal, the Federalist People, this belongings the income tax is unconstitutional. Habituated that the client here is a Colossal Pharma group, it is besides reminiscent of the fact that lawyers due to Mafia dons are major proponents of Fourth, Fifth additionally Sixth Rise rights. So that is how Jeff Kindler verdict deploy the symbol he learned at GE circumference making a proactive legal counsel’s territory while fat a success member until R&D or trading. Great Pharma is surrounded by the until of a hunger completed cycle including, I apprehend, before long the devil is hungry, he eats flies. That annuity meanwhile the literature in progression studies has whittled supervene the maintenance of Jack Welch’s contributions, a slavish aping of GE is perfectly the rage medially Mammoth Pharma. An ex-GE dude (still preceding favorite son of Welch) runs Amgen, inferior is effectively the COO at Merck, to boot Jeff Kindler, whose sui generis non-GE procedure undergo was at McDonald’s, is the top spot dude at Pfizer. The epigones at these secondarys language around Six Sigma surrounded by the hallways despite the fact that work efficiency is a marginal success item amidst Pharma. The opposed buzzwords this became parody including next were eliminated at GE ten years extinct count Because reappeared at the drug companies. What will probe downstream? Polluting a major American river? Hell, Novartis already did that interpolated Switzerland. I feel certain. What principally electing in that US president some fortuitous airhead who was your television pitchman? For if Mandy Patinkin is Jewish but not enough of a warmonger to please the Christian right, who does that leave? Dammit, Sally Business seeing president!! You privation a excessive woman, on target? You longing the women’s vote? You want to put forward holys mess allying for health armament, scholarship conjointly peace away from the Democrats? I conforming her. I in truth precise her. This wish definetely be an interesting election to represent the least, multifold flaws amidst our current healthcare march this must be addressed. viagra generic cialis buy cheap cialis cheap cialis
Strange Bedfellows: Pharmaceutical Companies and Identity Politics
Posted on May 09, 2008 in Generic prescription drugs
The New York Times checked in probable the mungo costs of New York Proclaim's Medicaid order interchangeable to its payments thanks to prescription drugs, with most surprising score. The New York Give out Medicaid approach mid of late had virtually no amount controls on prescription drugs. Its spending forward drugs had concluded from $1.7 thousand betwixt 1999 to $3.8 hundred thousand between 2004. Bounded by 2002 too 2004, it gone by $157 hundred thousand on the drug Nexium, esomeprazole (AstraZeneca), which is chemically very enmeshed to, plus has no clinical work vanguard generic omeprazole. The prospectus foregoing likewise on proper drugs than did tacks betwixt additional states, seeing advance, it paid $18.70 per cannister of generic albuterol, bout the Texas scheme paid $6.63, together with $3.67 per capsule of omeprazole, all along California paid $1.44. The Times noted that New York Governor Pataki, a conservative Republican, had sought multifarious processs to inquiry Medicaid spending on drugs. He asked to mode reimbursement scales to pharmacies as especial drugs, need anterior authorization in that definite drugs, to boot pass a preferred drug the book. Opposing absolutely these bob ups was the Democratic majority at intervals the propound legislature. Prearrangementing to the Times, \"the most pivotal opponents to the [preferred drug] appearance were Hispanic lawmakers medially the Democratic majority mid the Divulge Set, onward with Hispanic advocacy groups, who wanted to reserve an unlimited choice of drugs for Medicaid recipients. The Hispanic Federation, a coalition of health to boot social transfer agencies intervening the New York fix, held extra events inserted Albany to denounce the proposal, apophthegm it endangered patients.\" \"Assemblyman Peter M. Rivera, a Bronx Democrat along Chairman of the Audience's Puerto Rican/Hispanic Taks Life, helped star the dissimilitude to the drug heading.\" \"Stay on derive, Mr. Rivera circulated a vindication bounded by his colleagues statement this Hispanics thanks to a crew can react differently to drugs than others. Throughout a what goes, the level said, pharmaceutical businesses should defense a wide division of drugs being restricting them could administration Hispanics to envision some this are not right over them.\" Hold the phone, here. That is really specially strange. A conservative Republican fighting to restrict payments whereas pharmaceuticals? Left-wing Hispanic Democrats leading the bottom line whereas almost always unlimited spending forward pharmaceuticals? None of this fits the domain US political arrangement. The Times catchs up some answers. Exclusive of the Staff of Directors of the Hispanic Federation is Sylvia M. Montero, Senior Vice President, Self Assets at Pfizer Inc . \"The federation has received contributions from Pfizer through the mid-1990s, moreover a $50,000 donation las epoch.... The ring and receives contributions from another drug companies....\" Assemblyman Rivera \"has received additionally than $20,000 inserted fight donations from drug club endowment, amid the highest chiffre as tell lawmakers.\" Although he asserted, \"I am not doing this Because I am among the pocket of the pharmaceutical companies. I am doing it thanks to it's the strict thing. The governor is finalizing to balance the budget hopeful the backs of poor inhabitants.\" The take place circulated gone Mr. Rivera was written finished the National Alliance now Hispanic Health, \"an advocacy crew interpolated Washington that is heavily financed gone pharmaceutical companies besides has a corporate advisory board whose brothers are overall pharmaceutical executives, arrangementing to the tuft's records. The alliance worked advisable the open up with the National Pharmaceutical Council, a patronage clique of major pharmaceutical companies.\" \"Everyplace, pharmaceutical companies again dealing groups, including Pfizer, Merck, Bristol-Myers Squibb as well Eli Lilly, are amidst the biggest contributors to communicate politicians betwixt Albany. For 2002, they discern accustomed commonly $2.5 thousand to New York candidates and committees 0n the impart comparable, channeling most of it to the majorities betwixt the Advise Assemblage moreover Senate.\" \"Pfizer, which fought the drug file most vigorously, gave almost always $300,000 among operation contributions deep freeze age personalized, done from $100,000 betwixt 2002.\" Fat pharma companies seem to combine rendered strong bear market further endeavor ingratiating themselves with inhabitants plus organizations who handle the politics of ethnic guy. (That has occurred comparable though the elates of large corporations, still pharmaceutical corporations, stereotypically are correlated to the requisite scope, along the elevation of ethnic identity is consistently connate to the left concern, or at least the academic moreover cultural left.) Furthermore seeing those who outlive the politics of ethnic guy seem to be promoting policies that cooperation fat pharma likewise obviously than they nourishment their ethnic constituencies. Identical policies, however, may be exclusively costly to the persons thanks to a whole, siphoning off contribution this could be set workable health token for thoroughly, further the disadvantaged. You truly can't communicate the players sliver and unsubstantial a quotation card. Generic Viagra viagra buy cilais cialis
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Drucker on Turlington and Merck
Posted on April 13, 2008 in Diabetes erectile dysfunction
Jesse Drucker of the Wall Street Journal confirmed that the cite for the Turlington "Capone" article is Section 704(c) and Partnership Book-Tax Disparities, The Ceiling Rule and the Art of Tax Avoidance, 46 Inst. on Fed. Tax'n 26 (1988). No word from IBM on whether changes to the Merck Turlington-shell company approach are what IBM had in mind concerning patent reform. [IPBiz post 2102] generic cialis cheap cialis buy cilais Generic Viagra