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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

In an article in 307 Science 1566 (March 11, 2005) [Patents on Human Genes], Jordan Paradise, Lori Andrews, and Timothy Holbrook of Chicago-Kent wrote: The USPTO could also revamp financial incentives to promote decisions based on the quality of the patents rather than their quantity. Currently, patent examiners are encouraged with monetary bonuses to grant patent applications, a policy that has the unsettling effect of rewarding examiners for quickly pushing patents through the patent office. Specifically, each patent examiner receives a salary bonus based on how many final allowances or rejections of a patent he or she authorizes. Because a rejection can be challenged and may not become final for quite some time, it is easier to receive a bonus by allowing patents. (citing to Merges, Berk Tech L J, 14, 577 (1999)). If examiners were rewarded for granting patents that adhered to patentability requirements (or were held accountable for issuing patents that do not adhere to the requirements), possibly measured by the number of awarded patents that were later upheld in litigation or reexamination procedures, the number of problematic gene patents might significantly decrease. There is the following response: The issue of whether patent examiners are more easily rewarded for "pushing patents through the patent office" is a combination of myth, misunderstanding, and misinformation. Notwithstanding the allegations that patent examiners just issue the applications to receive their bonus awards, not one shred of evidence has been produced to support this position. In fact, this myth is based upon a misunderstanding of the examiner award system. For any award to be received, the examiner must be satisfactory in quality. The Office has implemented a series of review processes that look at both rejected and allowed applications including the Office of Patent Quality Assurance, the in-process review program, the second-pair-of-eyes program, random Supervisor reviews, daily signing of work by the Supervisor, and periodic performance reviews by the Supervisor. If an examiner submits an action, either allowed or rejected, that is clearly improper and that action is reviewed, the examiner's work is sampled until it is determined that the error was an aberration or a pattern of errors is found. Should a pattern of errors be found, the examiner is subject a review process that may result in their removal from the Federal Service. Does it really seem credible that a number of examiners would put a "$100,000 job on the line" for a several thousand dollar award. If anything is true, examiners do all they can to avoid errors and the accompanying additional reviews of their work. Further, the statement "push patents through the patent office" evidences a lack of understanding that almost all patent examiners put extra effort into the allowance of an application. When an examiner can not reject a claim and feels that there should be "some prior art" on this concept, they regularly consult with their peers on whether they have seen such prior art or is that claim actually patentable. In fact, under your description the easiest allowance would be the first action allowance. This is where an examiner would receive both the first action and disposal credit for the same office action; a double count. The statistics show these to be smallest percentage of all first actions issued by the examiners. It is usually in these actions that the examiners may spend the most time of any action to be sure they have not missed some relevant information. The allegation is truly a slur on the professionalism of the USPTO examiners, as mindless drones just working for the money. Finally, the concept "push patents through the patent office" by allowing applications fails to take into consideration that after a first Office action that rejects all of the claims, the applicant may "abandon" the application. Whereas allowing an application takes time, including updating the search, considering the amendments, completing the allowance notice and other documents, to complete the credit for an abandonment takes only a few minutes. Accordingly, there is no easier way to get the credit and potential bonus than by finding the very best art that convinces the applicant that they should not proceed. Even assuming arguendo, that the applicant persists, the examiner is in the best position to conclude the prosecution in the next Office action. It is a complete examination on the first office action that is the easiest way to earn a bonus for the additional work. Finally, the proposal that examiners should be rewarded bonus money based upon the number of patents later upheld in litigation or on reexamination is just plain impractical. Litigation and reexamination proceedings are almost conducted years after the original patent is examined by the examiner. Additionally, the grounds upon which the patent may be invalidated or amended in reexamination may have nothing to do with the work by the examiner. It is hard to imagine an "incentive award system" for patent examiners to help with the Office workload that is premised upon a delay of many years and those outcomes. [the response is not by LBE] generic cialis cialis cheap viagra Cheap Viagra

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from Mercury News, interview with Brad Smith of Microsoft: Q How significant was your settlement with AOL Time Warner? A The Time Warner agreement was very important. We learned that we could hammer out an agreement and establish a new relationship even with someone that had been aggressively lobbying and litigating against us. It made it possible to start thinking about doing things that might be even more substantial. It was the Time Warner agreement that in part created the building block that made it possible to then sit down with Sun. Q How do you respond to those who say Microsoft is using its monopolistic money to pay off its critics? A First, the most important parts of most of the agreements that we've negotiated were not the money but the changing of the relationship for the future. (Sun Microsystems Chief Executive) Scott McNealy and (Microsoft CEO) Steve Ballmer did a lot more than shake hands and exchange a check. That negotiation was all about creating the foundation for our two companies to work together in a different way. Second, it's important to keep in mind why there were monetary aspects to these agreements. Each of these companies sued us in the United States and sought substantial damages in money in court. Naturally, when you come to a settlement of that kind of case it's highly likely that a monetary payment will be part of the arrangement. Q Can you talk about why Microsoft thinks patent reform is important? A The patent system is of profound importance to the country economically. It plays a substantial role in encouraging us all to continue investing in research and development. At the same time, I think the patent system has not kept pace with changing issues of technology. We see some weaknesses. . . . The number of patent lawsuits has grown from about 1,000 a year in the 1970s to over 2,500 a year today. I think the law has tilted too heavily in favor of those who hold patents. They're able to sue for treble damages by proving what's called willfulness, which is applied as too low a standard today, in our view. Q So what are you proposing? A Improve the quality of patents in this country . That can be done by ensuring that the Patent and Trademark Office -- PTO, as it's called -- has the resources necessary to really scrutinize patent applications. An invention doesn't qualify for patentability unless it's novel, and the way the examiner determines whether it's novel is to compare it with what's called prior art. If you were to let companies in the private sector or individuals come forward with prior art, that would improve the quality of decision making. And then, third, there's what's called a post-grant opposition procedure. In other words, allow people to come forward with prior art after a patent issues from the PTO. Q How much patent litigation is Microsoft involved with? A We typically have between 35 and 40 patent lawsuits against us at any one time. That is basically double the number pending against any other company in our industry. Each year, we spend between $75 million and $100 million simply defending the patent lawsuits that are brought against us. Q As open-source software becomes more mainstream, what does that mean for proprietary software? How has it changed the strategy of Microsoft? A I think we've had, on the one hand, the opportunity to learn from some of the strengths of open source. We've focused on some community-oriented projects. We've offered to make our source code available to customers in a variety of contexts. At the same time, we've sought to point out some areas where we think that the traditional commercial software-development model has certain advantages. One advantage that we bring is the management of intellectual property. We stand behind our products with our customers. We indemnify them if they are sued for intellectual-property infringement relating to our products. . . . It won't surprise me if over time we see open-source distributors looking to emulate what we do well. buy cilais cheap cialis buy cheap cialis generic viagra online

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During the second game of the World Series, Fox television commentators early-on pointed to discoloration at the base of Kenny Rogers' left thumb and raised the specter of a foreign substance. The commentators noted that St. Louis, which would be watching the Fox broadcast, would be all over this. Such does not seem to be the case. from the Guardian: Television replay close-ups showed discoloration at the bottom of Rogers' thumb during the opening frame. Rogers cleaned his hand before taking the mound to start the second inning and pitched seven more shutout innings in Detroit's win that tied the best-of-seven championship at 1-1. "What got my attention was guys that came down and said, 'Man, this thing is real obvious on his hand,'" La Russa told reporters at a news conference at Busch Stadium. "I didn't see it. But I did watch video of the other postseason games, so I had an idea of what it looked like, and I said, let's get rid of it and keep playing. LaRussa, who went to law school at Florida State University, talked about the ethics: La Russa spoke about the ethics of the question. "Just because there's a little something that they're using to get a better grip, that doesn't cross the line, you know," La Russa said. "There's a line that I think that defines the competition. "And you can sneak over the line, because we're all fighting for the edge. I always think, does it go to the point of abuse?" said La Russa, who holds a law degree. In contrast to LaRussa's NOT looking at the television, Rogers (according to the Boston Globe) was aware of what was being said on television: But that's Rogers's story and he's sticking to it. He also said he wiped his hand off because he saw on TV that they were talking about it, not because he was instructed to do so by plate umpire Alfonso Marquez. "I think once I wiped the mud off, the last seven innings were very good," Rogers said, "but I'm sure that will be lost in translation with everything." **** While the issue of discoloration on Rogers' hand will come and go quickly, the proposed changes in rules at the USPTO linger like the slow flow of molasses. A hit came up on news.google on Oct. 24 that began: In an effort to streamline the patenting process, the US Patent and Trademark Office (USPTO) is proposing two rule changes that, patent and other experts say, may end up adding cost and time for biotech companies and universities looking to obtain patents on their life science discoveries. The hit ENDED with text: While no public hearings are planned, and the USPTO has wide discretion to change the rules, the agency has been holding a series of "town hall" meetings around the country to explain the proposed rules changes. Additionally, those interested in submitting comments to USPTO can do so by mail until May 3, 2006 . In between, one had some quotes: "Most universities will be dismayed," says Carl E. Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, the tech transfer office of the University of Wisconsin-Madison. "At universities, even more so than startup biotech companies, the technology that comes off the bench is very early-stage, and often you need several continuations to understand what the invention is and its full breadth," says Gulbrandsen. Doll rejects this logic. "I have absolutely no sympathy for that because when you file an application, that invention is supposed to be complete," he says. "We are being reasonable, [the refiling process has] been a burden on the examiners." But, he continues, if applicants really do need more continuations "and can show a good and sufficient need, we will grant them." However, says Nancy J. Linck, deputy general counsel for intellectual property and trade at the Biotechnology Industry Organization trade association in Washington, DC, the biotech industry relies on continuation practice. "This [proposed] requirement just puts an increased burden on them." The URL is http://www.the-scientist.com/article/display/23177/ See also 88 JPTOS 743 (Sept. 2006). **UPDATE on Oct. 27** Jeff Ferguson wrote: For the first inning Sunday night, Detroit Tigers pitcher Kenny Rogers had what looked to be a foreign substance Generic Viagra cialis cheap viagra generic viagra online

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Of the apparent disparity between IBM efforts in patent reform and IBM's patent suit against Amazon, InformationWeek has the following quote: IBM's top attorney for intellectual property rights acknowledges his company's position can seem contradictory and confusing. "We've referred to our patent policy as apparent schizophrenia," David Kappos says. Yet he maintains that "on a deeper level, our actions are consistent." [Also -->] Tech vendors, IBM and Microsoft principal among them, are trying to change things they don't like about the patent process. In addition to giving away patents to the open source community, IBM wants all patent applications to be subject to public review. And it's urging Congress to do away with patents--including some of its own--based on so-called business methodologies that lack technical merit. But in suing Amazon, IBM promised to "aggressively defend" its intellectual property and hunt down other companies it thinks are using its IP without permission. IBM says it tried unsuccessfully to negotiate a licensing deal with Amazon for four years before filing suit. Amazon declined to comment. The Information Week article also contains the following: U.S. Patent And Trademark Office Proposes limiting to 10 the number of times patent applicants can request a re-examination of their applications and the number of individual patent claims contained in any single application IPBiz asks: is anyone awake at Information Week? Or have they joined with Science in dispensing pure glop about patent law (see 88 JPTOS 743)? Yes, there is a reference to Lerner: "There are some pathologies in the system that need to be dealt with," Harvard Business School professor Josh Lerner says. "Patents have become too powerful and too easy to get" for an economy that's increasingly information-based, Lerner says. Yes, Information Week does note the dichotomy with IBM: IBM's strategy is to be an IP benefactor to the tech industry when it's in IBM's interest, while staunchly defending its IP rights at other times. That's hardly reassuring to entrepreneurs and startups that risk a run-in with IBM as they develop new products. IBM holds about 40,000 patents worldwide for everything from how to display ads online to the creation of an Internet checkout system. IBM patents cover "most of, if not all, e-commerce," senior VP John Kelly told The Wall Street Journal last week. Yes, there is further confusion about the patent system: What's setting off alarms in some quarters is the fact that personalized recommendation systems are widely used, and they can be generated in a number of different ways. "These kind of lawsuits hurt our whole industry," says Mary Hodder, CEO of Dabble.com, an online video-sharing service. She thinks the patent process needs tightening to prevent what she considers a proliferation of nuisance suits. "Most of the patents they grant are really for simple and basic concepts and ideas, not complex and innovative processes, which is what they're supposed to be allowing ," Hodder says. Yes, there is mention of Rivette: Last year, IBM hired Boston Consulting Group patent expert Kevin Rivette as VP for intellectual property. Rivette is author of Rembrandts In The Attic (Harvard Business School Press, 1999), a primer on how companies can profit from their IP assets. Palmisano created a technology and intellectual property unit within IBM under senior VP Kelly, dedicated to finding new markets for the fruits of its research. There is discussion of the Peer-to-patent project: Other critics suggest the vendors' moves are aimed at cementing their advantages at a time when they face rising competition from startups. In an August essay, Harvard Law School professor and tech entrepreneur James Moore argued that the collaborative patent review process proposed by IBM, Microsoft, and others will result in fewer patents being issued because it will give examiners more ammunition to shoot down applications. "If fewer patents are issued, but existing patents are not revoked, IBM and Microsoft win because they already possess vast existing portfolios," Moore writes. IPBiz notes: It is already true that fewer patents are being issued. Further, the re-examination process is still around. ** See also http://ipbiz.blogspot.com/2006/10/ibm-goes-after-amazon-nyt-mentions.html cialis buy cheap cialis viagra buy cilais

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Sun setting on nanotechnology patents??? Jon Van of the Chicago Tribune, in an article Slow patent process hurts nanotech progress; Financial backers wary of 4-year filing period presents the quote: "The impact is one of perception. When you don't get a response from a patent application filing, you don't know what else is going on." There is also text: Bruce Kisliuk, director of a patent examining group at the patent office, said the agency does face a growing backlog across all areas. "We have 700,000 applications in the pipeline," Kisliuk said. "Some are for nanotech, some not. This backlog isn't unique to nanotech." Last year, the office issued fewer patents than usual because of an initiative to improve patent quality, Kisliuk said. Note the following text about the hiring of examiners: After years of being starved for resources, the office, which has had around 4,000 examiners, hired 1,200 new ones, bringing its total strength to nearly 4,800 examiners. Another 1,200 are due to be hired this year, he said. IPBiz notes that 4,000 + 1,200 = 5,200, not "nearly 4,800." See also an earlier IPBiz post on problems of employee retention at the USPTO: http://ipbiz.blogspot.com/2006/08/examiner-hiring-and-retention-at-uspto.html Separately, recall the numerous patents in the area of buckyballs and fullerenes which issued in the 1990's and went no where. cialis generic viagra online buy cilais viagra

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