Sunday, December 30, 2007

French Bloggers Critique ITSSD University of Miami InterAmerican Law Review Article: Brazil's IP Opportunism Threatens U.S. Private Property Rights

A Free Society? WIPO: Civil Recourse to Penal Sanctions

By Clarisse McClellan (pseudonym)

Days ago, one should not read the records of the sessions of WIPO especially that part in the proceedings of the 4th session of the Advisory Committee on Enforcement:

1.3 REASONS TO INFLICT CRIMINAL PENALTIES FOR IMPAIRED INTELLECTUAL PROPERTY RIGHTS 12. Whether to implement them through penalties and remedies why Civilians are insuffisants 13. It can be short, provide the answer 14: "The civil remedies are not effective because criminals are criminals. They do not respect the law and they put in the service of carrying out their activities. Criminal means strategic and tactical designed to evade the system. Justice, both civil and criminal. "

Getting counterfeiting from civil to criminal is more than merely provide tougher penalties is the fact of the forgery to evolve towards a form of delinquency. It seems to me that the desire to counterfeiting at the stage of the crime is proof of protectionism in major publishers or Grandparents' having rights "that are no longer of Civilian Persons but simple structures. This seems to demonstrate the approach to change copyright law publisher.

The situation is difficult but it's even worse when you see in the famous 4th session, the accreditation of the ITSSD…

ITSSD is a kind of structure that do not understand too how the GNU General Public License. Dans leur document Brazil’s IP Opportunism Threatens U.S. In their paper Brazil's IP Opportunism Threatens US Private Property Rights , there is a nice explanation of the GNU General Public License:

According to two legal experts, "the GPL license essentially requires a business model centered around programming and support services to generate profit," rather than one based on the software product itself or on its derivatives.350

Of course, there are companies that sell the software using the GNU General Public License that the media is not the only source of income. Regarding the two experts, who have carried out in 2006, an article called: "The Truths and Myths of Open Source Software." Which makes me really afraid is that the vision of the ITSSD is linked to a model that is not economically viable because he prefers an economic model that centralizes exchanges between several large companies. A dynamic economy needs a lot of exchange, constant innovation and keeping the same economic liberties among participants. I do not see that the approach of free software and open standards that allow it… Could we imagine a thriving economy without using the Internet open standards that have enabled the creation of the Internet?

French translation accessible at:




Wednesday, December 26, 2007

Open Source for Cost Effective Drug Discovery

Dr. Samir K

the new Director-General of the CSIR is all set to unleash the open source revolution in drug discovery and biotechnology. The Economic Times Reports: “For the first time ever, India plans to launch an innovate drug discovery programme roping in global IT firms, researchers, companies, and young minds at scientific laboratories to invent drugs at a fraction of the cost of an MNC-developed drug. Drug discovery has hitherto been the forte of MNC pharma giants.The government has begun discussions with Sun Microsystems to set up web-management tools for an ‘open source’ drug discovery project, which works similar to a popular online encyclopaedia formed by articles contributed and edited by the brightest minds worldwide.

The first project would be to develop medicines for tuberculosis and later extend to other diseases like malaria and AIDS.Under the proposed project, researchers attached to institutions like the Royal Society of UK, Imperial College of London, Medicine Sans Frontiers and various Indian universities will have an opportunity to work on a drug discovery process even at an individual level. What’s more, the contribution would also fetch reward and recognition. Corporates like the Kinetic Group, entities like the Welcome Trust and various corporate groups would sponsor these rewards.

The project is likely to be implemented either by the Council of Scientific and Industrial Research (CSIR) itself or the Institute of Genomics and Integrative Biology.‘We have already built a database of the requirements for developing drugs for infectious diseases. This would be hosted online, where individual experts could contribute in solving specific aspects of the drug discovery. Specific contracts will then be assigned to individual contract manufacturers and clinical research organisations,’ the project’s architect and CSIR’s new director general Samir K Brahmachari told ET.

‘The chemical entities thus developed will instantly become generics as the knowledge will be in public domain. This is diametrically opposite to the concept of intellectual property protection, which involves legal expenses to bar others from applying their minds on the invention,’ Mr Brahmachari said. Mr Brahmachari also heads the department of industrial research. ‘When a thousand young students contribute in solving a complex puzzle, we are empowering them to be the knowledge leaders of tomorrow.

For researchers at state-owned laboratories, it offers an exiting challenge of social importance,’ he added. It is likely that generics makers, like Ranbaxy and Cipla, could be more interested, than MNCs, as it would be volume-based. MNCs are more keen on low-volume high-value brands.If successful, the project would also challenge MNC drug makers claims that they invest billions of dollars in risky experiments hoping to develop one useful drug.

The project will get one-third funding from the government, one-third from international sources and the rest from philanthropic entities.” Sounds like a fantastic idea! Dr. Brahmachari’s open source strategy appears not only to challenge the notion that patents are necessary for innovation, but also the notion that investment for mass production needs monopoly incentives through patents. Look out for Spicy IP’s interview with Dr. Brahmachari in the coming week!

Most Indian drug majors too in line for patent protection

14 Dec, 2007, 0046 hrs IST,Khomba Singh, TNN


It’s not just global drug discovery majors that are seeking patent protection. Out of the 8,000 drug patent applications in India filed between 1995 and 2004, about 40% are from Indian pharma companies.

Domestic majors such as Ranbaxy Laboratories, Dr Reddy’s Laboratories and Cipla have filed over 100 patent applications each. Between 1995 and 2004, the Indian patent office received over 8,000 patent applications related to medicine.

Ranbaxy Laboratories, India’s largest drug maker, has claimed protection for 112 drugs during the period, including few which are at various stages of clinical development. In addition, Ranbaxy has also filed 30 patents in 2006, including seven for new drug delivery systems (NDDS), which are in advanced stages of development.

Similarly, other pharma majors such as Cipla and Dr Reddy’s Laboratories have each sought protection for over 100 drugs, says Dr Amit Sengupta who reviewed the mailbox applications in India in collaboration with the health ministry. However, many of these applications, both from global MNCs and Indian companies, are frivolous which may not qualify as a candidate for a patent.

According to Professor Carlos M Correa, a former member of the World Health Organisation (WHO) Commission on Intellectual Property, Innovation and Public Health (CIPIH), many of the patent applications worldwide are merely ‘new laboratory techniques’ and therefore would not qualify for patents. “The pipeline of discovery drugs are drying up. While there are around a million applications in the US, only 20 new chemical entity (NCE) got US Food and Drug Administration’s approval in 2005 compared to 51 in 1997,“ he said.


Companies are now merely tinkering with the existing drug and seeking patent applications for the same. Only 2-3 application from each of the Indian companies are serious contenders for a patent, Dr Sengupta added. However, some innovator companies feel that there are many innovations which deserve patent protection. “Innovations are either patentable or non-patentable. Patent offices are getting mature to weed out those inventions which do not merit a patent and one should look at the actual data of patents rejected before a claim like this is made, “ Novartis India vice-chairman and MD Ranjit Shahani said.

Since India became trade-related aspects of intellectual property rights (TRIPS)-compliant in 2005, both global and Indian companies have rushed to claimed protection for new drugs or innovations. If drugs get patented, the innovator company will get exclusive marketing right for 20 years. Few global companies have already got patent for drugs in cancer, anti-Aids and other therapeutic areas.



Dear Mr. Prime Minister: With the 2005 amendments, the Indian patent regime has come a long way. Indeed, India is turning out to be a trendsetter of sorts. Asian countries such as the Philippines are in the process of modelling their patent regime on the Indian Patents Act.

Sadly however, the current state of affairs at the Indian patent office (IPO) leaves much to be desired. Whilst there are a number of issues for concern, we focus on two of the most pressing ones.

1. Creating Comprehensive Patent Database

Firstly, despite India’s IT prowess, we do not have a full-fledged electronic patent database as yet. As you can appreciate, such a resource is of tremendous value to all patent stakeholders—inventors, industry, policy makers, civil society, academicians and members of the public. Most importantly, it will be a blessing for patent examiners. Owing to their inability to readily access prior patent application, they are currently handicapped in their examinations.

Some information is made available electronically by the IPO, but this is far from ideal. Critical components of a patent application, such as the claims and the complete specification are not available. It bears noting that almost all the major patent offices worldwide provide comprehensive patent information via publicly accessible databases. It also bears noting that the National Informatics Center (NIC), an agency of the Ministry of Information Technology, was tasked with the responsibility of creating a comprehensive patent database. Despite receiving funds for this task from WIPO as far back as 1993-96, they have not been able to deliver!

2. Uploading Patent Office Decisions

Secondly, it is lamentable that patent office decisions are never published. Illustratively, there are over 7000 pharmaceutical applications to be examined and many of them are under opposition. The patent office has accepted or rejected several cases, relying in part on section 3(d), an innovative section unique to India.

Pharmaceutical patents impact not just the applicant and his/her opponent, but also the man/woman on the street interested in accessing affordable medicines—a sentiment that has formed the basis of our well thought out patent regime. You will therefore appreciate the importance of making these decisions public. Greater public scrutiny of patent office decisions is likely to spur more transparency and accountability.

Currently, one has to write to the patent office and specifically request individual decisions—a terribly inefficient way of doing things. Today, most decisions by Indian courts are uploaded onto their respective websites within few days of the judgment being handed down. We therefore request you to urge the concerned authorities to do the same for patent office decisions. It will interest you to know that patent office decisions were published for a short period in the 1990’s.

A revival of this trend is absolutely essential, albeit in an “electronic” format and in a more timely fashion. Here again, as you may know, most advanced patent jurisdictions have websites that contain such information. In short, a website detailing comprehensive patent information, including patent office decisions will create more transparency and make the IPO more accountable. It will also equip stakeholders with timely information on patents. This will in turn lead to a more informed use of the patent system and better policy suggestions.

We therefore humbly request you to take this up on a priority basis. You will appreciate that the two concerns outlined above are not very resource intensive. More importantly, they will be an excellent example of India leveraging its IT prowess to achieve a worthwhile public policy goal.

Thanking you, we remain, Most sincerely yours, Shamnad Basheer Mrinalini Kochupillai Aysha Shaukat Prashant Reddy Duncan Bucknell Sumathi Chandrasekharan For: SpicyIP CC: Dr. Sam Pitroda, Chairman,The National Knowledge Commission Mr Kamal Nath, Minister for Commerce and Industry Mr Kapil Sibal, Minister for Science and Technology Dr. Montek Singh Ahluwalia, Deputy Chairman, Planning Commission

WIPO Consults On Protecting Traditional Knowledge, Genetic Resources

By Catherine Saez

How best to protect traditional knowledge, traditional cultural expressions and genetic resources against misappropriation and misuse was the main theme of a recent community consultation in the form of a roundtable organised by the World Intellectual Property Organization (WIPO).

The WIPO event on 10-12 December came in response to “the strong level of interest expressed by many national authorities and community representatives in sharing experience and developing dialogue and cooperation on practical initiatives to build capacity for appropriate protection.” The event was announced two weeks before it took place. WIPO said it aims to strengthen the practical capacity of holders of traditional knowledge (TK), traditional cultural expressions (TCEs, or folklore) and genetic resources (GR). It is preparing, among other things, a TK documentation toolkit, guidelines and a database for GR, and a creative heritage project.

The informal roundtable was organised around four workshops (creative heritage, TK and GR in the patent system, TK toolkit, and “customary law”) where participants were invited to share views and experiences. Work was then reported to all participants for discussion. Jacob Simet, rapporteur of the creative heritage session, said that “a great part of the problem could be addressed at the institutional and community level.” He said the misappropriation of TK and TCEs is worsened by tourism, thereby creating a dilemma for communities as it provides benefits while at the same time acting as an agent of misappropriation when, for example, tourists take photographs or film indigenous communities.


On the database project, participants on the closing day generally agreed that each country has a different level of examination and thus the database structure should be put together in a standardised and prescribed language taking into consideration local needs and focusing on the goals reflected in the recently adopted WIPO Development Agenda.

In the current system, patent examiners use an array of databases, according V K Gupta, a panel co-convener. “A system should be set up to ease the work of patent examiners,” he said, and suggested a systematic use of metadata, which provide greater detail. Many participants were concerned about protection of the database, which they said should not enter the public domain, but instead should be reserved for the sole use of patent examiners at the risk of betraying the trust of contributors. Xuan Li of the intergovernmental South Centre asked how the database was going to protect the rights of TK holders in cases such as Chinese traditional medicine that uses very complex plant preparations with over 20 ingredients. It would be very difficult to determine novelty in a patent application involving such products, she said.

Participants appeared to concur and said that patent examiners should be skilled and trained in different specialties. Li said that in the case of Chinese medicine it would be additionally difficult to examine a patent application given that China has 55 ethnic communities, each with their own preparations. The toolkit workshop synthesised the benefit and danger of documentation, according to participants.

The issue of confidentiality in particular was put forward as the group shared their questions about whose interest lies behind documentation, who is funding it and what kind of problem would arise if the databases were linked to funders. Brendan Tobin, rapporteur on the TK toolkit workshop, said that “if you can’t enforce the obligation of confidentiality, you need to take this into consideration.” He also said it was important to ensure that the TK databases are, in the main, established and maintained by communities, and that ownership of management structure should, where possible, be with local communities.

The potential danger of “catastrophic” disclosure, with the database “going wild on the Internet” also was a serious concern for the roundtable participants, with the effort to protect traditional knowledge possibly having, in this scenario, the reverse effect. According to WIPO’s Antony Taubman, the organisation has no initiative to establish a database but “would only ever work with existing initiatives, and would rather be a portal for access for patent examiners.” It should be a practical tool enhancing both protection and patent quality, he said.

WIPO has been working on different initiatives to address the issue of misappropriation of TK, TCEs and GR for the last five years, Taubman said. “WIPO wants to take it to the operational level,” he said, emphasising the organisation’s wish to produce non-binding guidelines meant to reflect best practices. The first phase of the guidelines, which currently are being written, is to reach out and solicit experiences and opinions. The first draft is expected to be released early next year. Roundtable participants recognised a need for capacity building and introducing safeguard mechanisms to protect the database. Manuel Ruiz from the Third World Network mentioned that the Honey Bee Database, which involves grassroots innovations, is an initiative that has won the trust of the communities. Catherine Saez may be reached at

Wednesday, December 19, 2007

Patents Assume Increasing Global Importance Value Reflected in the Steady Increase of United States and Foreign Issued Patents

Despite fundamental challenges, including increasing hurdles to obtain and enforce proprietary rights, the centuries-old United States patent system is still regarded as a reliable mechanism for inventors and product developers to preserve the legal protections covering their technological achievements.

An enduring value is that patents instill confidence that the necessary legal exclusivity will be available for those seeking to recoup often sizeable investments during their products’ lifetimes. This is evident in the steady increase in issued patents over the years.

In a single year, 1996, the United States and foreign patent offices issued 121,805 patents. A decade later in 2006, the number of patents issued was 196,436, an increase of 38%. There was a 32% difference in the U.S. patents alone issued in 1996 and 2006, that is, an increase from 69,419 to 102,267, respectively. From the inception of patents to the end of 1996, a total of 3,455,886 were issued by the U.S. and foreign countries, while the U.S. alone issued 1,910,390, according to data from the U.S. Patent and Trademark Office.

In April 2005, Massachusetts Institute of Technology’s Technology Review magazine reported that the $150 billion earned globally from patent licensing that year was expected to grow by some 30% a year for the next several years. On that basis, earnings from patent licensing fees could exceed $250 million this year.

The right to patent an invention has its genesis and mandate in the U.S. Constitution. “As patent law evolved, one of the purposes was to encourage disclosure of inventions so that science could benefit and progress—in return, the inventor was granted a limited-term government monopoly,” says Lita Nelsen, director of Technology Licensing at MIT.“The basic premise is that you expose your invention to the public such that interested parties learn from it, in exchange for a monopoly,” says Mike Slessor, managing director, Office of Technology Transfer, California Institute of Technology.

Technology driven businesses are by far the largest users of patents. Contract research and engineering services companies and the technology transfer and licensing operations of research universities, among others, are also involved. Nelsen says that in university licensing, “Patents are used to accelerate the movement of state-of-the-art research into the economy by providing an incentive for companies to invest in early stage, unproven technologies.” She acknowledges that universities in general constitute a small player in the overall patent world, compared to commercial entities. “The fruits of university researchers’ efforts are not products but very early risky development opportunities, which if placed in the public domain will cause people to wait until someone else demonstrates that they actually work,” says Nelsen.

University licensing received a boost from the passage of the 1980 Bayh-Dole Act—before which less than 250 patents a year were granted to universities. MIT had some form of licensing since the 1930s, but prior to the act, universities were not very conscious of patents. “Their policies were either nascent or non-existent, and they may have coped with it on an ad-hoc basis—then once Bayh-Dole came in, there was much more uniformity,” Nelsen explains.This act allows universities to retain ownership of inventions funded with federal research grants.

The universities’ end of the bargain requires them to file for patent protection and pursue commercialization. Hundreds of leading universities operate highly efficient and capable technology licensing offices and, like MIT and CalTech, the patents they acquire and manage come almost exclusively from efforts of researchers within their university. Considerable cooperation exists among universities and their researchers.

“This is a societal mission rather than a competitive business,” says Nelsen.“Our job is to find out if our researchers’ ideas are new, generally via extensive literature searches,” says Nelsen. The next step is to weigh the effort and money to secure a patent, against investor interest, she notes. Most patents are used defensively, to ward off competitors. “Legally, patents are a mechanism to exclude potential competitors. A university has little interest in this exclusionary approach because it is not in competition with the commercial world. “We are, however, interested in getting interested parties to invest early in as yet unproven technologies,” explains Nelsen. “So we give them the right to exclude others.”

MIT’s licensing office has dealt with leading-edge technologies such as light emitting diodes (LED), computer caching of large amounts of data over multiple servers, diagnostics for bladder cancer, agents for heart imaging, superconductors, and advanced battery technologies, among others, according to Nelsen. The office also oversees inventions in laboratory instrumentation. “A number of our faculty members are now working on microfluidics, which is likely to be important in anything from cell counting to chromato- graphy,” says Nelsen. Every year, the MIT technology transfer group sees some 500 technology disclosures from which it acquires about 200 to 300 new patents. It grants about 100 licenses, and starts some 25 to 30 companies a year, some of which are now quite substantial. “In numerical terms, we have had the most impact in biotechnology,” says Nelsen.

“CalTech’s licensing office is here solely to help researchers and inventors navigate the post-invention, pre-commercialization stages of getting their technologies to market,” says Slessor. Success stories include image sensor technology that was used in the Voyager and Cassini space missions. “This is at the forefront of low-power, high- performance image sensors,” Slessor adds. Another huge success was the gene sequencer that became a foundation for Applied Biosystems human genome mapping work. Slessor says that his group gets about 200 to 300 disclosures a year from researchers. “For about two-thirds of those we pursue, we get at least a U.S. patent. If there is a good business case, we will seek foreign protection as well.” Over its ten years in existence, the CalTech technology transfer office initiated about 150 start-up companies. This is a hugely important area for technology-driven companies.

Bill Munroe, director of Licensing and Business Development at Beckman Coulter, states, “Patents and intellectual property are an ever growing focus in the field of medical diagnostics. We are certainly very active in trying to obtain patents for the technologies we develop, as well as obtain licenses that are necessary for some of the products we want to introduce. We expend much time and effort to make sure we understand the landscape.” “As we go forward, there will be an even greater need for this, especially when it comes to novel content such as the assays that run on the equipment. Certainly, the fundamental technologies that go into some of the equipment are patented, and you need to acquire licenses to practice some of those technologies.“That is key for getting into certain areas, and is particularly true in the area of molecular diagnostics and hematology where we are very active,” says Munroe. He adds that while patenting technologies is central in the R&D and product development processes, “We don’t make product decisions because of a patent; we make patent decisions because of products.”

Contract research and engineering service companies like Invetech, KMC Systems, Battelle, Stratec and Cambridge Consultants among others provide product development services to large numbers of client companies. “The business model is fee for service,” says Andreas Knaack, director, Instrument Design and Development with Invetech. “This means that we are hired to develop products as fast as possible with the maximum value for money, when you consider cost against product benefits and product features.” Knaack says that Invetech works somewhat differently from a number of contract researchers in that they transfer all patents and other intellectual property to the clients who engage and pay for Invetech’s services. “When a company outsources the development of technology, it is critical that there be a clear understanding of who will own the IP generated in the process,” says Knaack. “We provide the full complement of ideas to our clients, and we work with them to identify the ideas that are worth patenting. This is quite pivotal to our clients. They need to protect their business positions.”

Invetech works on very early research, such as new detection technology in spectrophotometers, as well as with products that are already well defined by clients but which need detailed solutions. Both situations offer opportunities for Invetech to help enhance its clients IP portfolio, according to Knaack. In the future, he sees a trend toward smaller technology— samples, reagent volumes, footprint—and the need for greater throughput with larger instrumentation. In clinical diagnostics, one of Invetech’s areas of focus, he sees more movement toward point-of-care testing, which will require smaller-sized consumables, and more use of microfluidics, nanotechnology and highly sensitive optics.

In the near future, CalTech’s Slessor does not anticipate dramatic changes in the patent arena. “As companies increasingly look for good innovations outside their R&D departments, there will be more pressure on university researchers to come up with ideas,” he says.

Beckman Coulter’s Munroe notes that patents may become harder to enforce in the future. Legal adjustments in the standards for obviousness may provide patent infringers a new basis for arguing that a patent is invalid. Proposed changes such as limiting the number of claims and continuations in patent applications would make it more difficult to obtain patents—and if you do get them, it will be more difficult to enforce them, he notes.“

Assuming that some of the proposed changes to our patent laws do not happen, I do not see any dramatic changes in the next several years. I envisage the continuation of a system that essentially works,” says Nelsen. This is important, she adds, because “patents and intellectual property are becoming increasingly important around the world.”

Bernard Tulsi is a freelance writer based in Newark, Delaware. He may be contacted at or by phone at 302-266-6420.

Foolish Academics Prescribe Wrong Antidote for Developing Country Diseases: Fewer Patents & More Compulsory Licenses Will Cause More Harm Than Good

Fewer Patents, More Compulsory Licenses: The Knock-Off Effects of India's Strict Patent Act and Thailand's Compulsory Licenses

By Professor Brook K. Baker

Health GAP

December 11, 2007

Activists have long claimed that access to medicines campaigns set precedents that have a snowball effect. What we are now seeing, given India's victory against Novartis in the drug company's challenge to section 3d of the India Patent Act and given Thailand's highly publicized campaign to issue compulsory licenses on both AIDS and heart disease medicines, is a new wave of patent withdrawals and a growing wave of compulsory licenses.


This reciprocal wave action creates a wider opening for continuing access to newer and lower costs medicines. But the promise of this opening will only be realized if more countries amend their patent acts to take advantage of the TRIPS-compliant, definitional flexibilities that India has enacted and if more countries use the TRIPS-compliant flexibilities for issuing compulsory licenses for generic medicines that Thailand has used.


Patent victories

In the summer of 2006, following massive August 7 protests in Bangalore and Bangkok, GlaxoSmithKline withdrew its patent application for lamivudine/zidovudine (Combivir or Combid), an important first-line combination antiretroviral, both in India and, perhaps even more significantly, in Thailand. The withdrawal in India was clearly obligatory under India's new Patent Act 2005, which has strict standards preventing patenting of mere combinations of existing medicines, and was relatively straightforward, even under Thailand's easier, more "Westernized" patenting standards. Combivir was a simple fixed-dose combination of two earlier discovered drugs and involved neither newness nor an inventive step. The principal new "ingredient" in the combination was silicone - a trivial addition graphically represented by Indian demonstrators when they dumped sand in front of the Glaxo office. The anti-Combid victory in Thailand was reminiscent of an earlier activist victory in 2004 where a robust civil society movement forced Bristol Myers Squibb to abandon its patent on ddi. Although Glaxo saw the writing on the wall, Novartis did not and tried to mount a TRIPS and constitutional challenge to section 3d of the Indian Act.

Once again protestors mounted an international campaign, and good lawyering by the Lawyers Collective and others resulted in a resounding defeat for Novartis in the Chennai High Court, in August, when all of Novartis's efforts to undermine India's strict standards for patentability were defeated.

At the time, activists claimed that the Novartis case had critical implications for access to medicines, certainly for AIDS drugs, but for other medicines as well. There were thousands of patent applications waiting in the India 1995-2005 patent "mailbox," the vast majority of which involved minor tweaks on pre-1995 medicines. If Novartis had won, many of those patent applications would have been pursued and many might have succeeded. However, with Novartis's defeat, the pharmaceutical industry began to strategically review its mailbox filings, and its new filings as well, to weed out the clearly unmeritorious applications.

The most recent example is further withdrawals by GlaxoSmithKline of two ARV patent applications, on Abacavir and Trizivir (GSK drops claims on two AIDS medicines, The Economic Times, 7 Dec 2007). Sources report that Glaxo's decision to withdraw those applications was in response to Novartis's loss and was undertaken to avoid a patent-defeat precedent that might have undermined its attempts to pursue patent claims in countries with weaker patent standards.

The growing evidence of India's success in stopping the flow of patent applications on trivial variations of existing products should lend courage to activists and patent reformers in other countries. India has clearly set a new and defensible standard for patenting only truly innovative pharmaceutical products. The Philippines parliament is already considering a statutory amendment in line with section 3d of the Indian Act, but the momentum should not stop there. Other countries can lighten the load on their under-resourced patent offices and ensure high standards of patentability for medicines by taking the route forged by India.

The Indian success has also been reinforced by the availability of pre-grant opposition procedures, which allow consumer groups, generic companies, and IP specialists to intervene and challenge weak patent applications. There are already fifteen pre-grant oppositions in India concerning AIDS medicines and the number is likely to grow as public interest groups begin to appreciate the importance of stopping 90-95% of the patent applications on pharmaceutical patents that can be rejected under the Indian standard even though they sail through the U.S. patent office.


Compulsory licensing victories

Activists in Thailand have waged a near decade-long campaign to convince the Thai government to issue compulsory licenses on AIDS medicines.

Although the first effort in 1999 concerning ddi was unsuccessful because of fears of U.S. trade retaliation, activists persisted and new leadership in the Thai Health Department issued compulsory licenses on efavirenz, lopinavir/ritonavir, and clopidrogel in late 2006 and early 2007. Of course, Thailand was not the first developing country to issue compulsory licenses on AIDS medicines. Malaysia and Indonesia had done so earlier for first-line regimens, and over half a dozen countries had done so in Africa as well. However, in terms of middle-income countries with large populations living with HIV/AIDS, Thailand was the first to issue licenses on higher-cost, second-line medicines. Brazil had threatened such licenses, but in the end had improvidently settled for price concessions instead.

The impact of Thailand's leadership is immediately apparent. Shortly after Thailand's bold move, Brazil issued a compulsory license on efavirenz on May 4. Indonesia did so even earlier, in March of 2007, though, unlike Brazil, its license drew little attention from Big Pharma, the USTR, or the army of right-wing think tanks that have mounted a global disinformation campaign about the legality and propriety of compulsory licenses.

Emboldened by Thailand, Indonesia is considering additional licenses on tenofovir, videx, and lopinavir/ritonavir. The proactive Ministry of Health in Thailand is also continuing to weigh additional government use C.L.s on four cancer medicines and up to 20 additional products for treating hypertension, diabetes, and hyperlipideamia. Lawyers in South Africa have petitioned the Competition Commission to obtain additional licenses on efavirenz, both to promote competition but also to allow co-formulation of fixed-dose combinations.

Most of the licenses thus far have been issued for government use. This form of licensing has certain advantages because it is widely practiced in rich countries, including the U.S., because it obviates the need for prior negotiations with the drug company, and because it reserves the private sector to the patent holder's monopoly control, undermining claims that all profits are foregone and that research and development will be undermined.

However, there are also some drawbacks to government use licenses, especially when one considers how much pressure has been brought to bear on Thailand even though it carved out a private-sector monopoly reserve for Big Pharma. The first drawback, not so apparent in Thailand as perhaps in other countries, is that many poor people cannot access medicines in public sector pharmacies, which often experience stock-outs or otherwise fail to carry essential medicines. These patients must therefore rely on private sector pharmacies where monopoly pricing prevails. Thus, in countries where high disease burdens persist and where major portions of the population are de facto dependent on private-sector pharmacies, government use licenses may be an imperfect solution to access on the ground. The second drawback is that having two pricing regimes in the same country, high private-sector prices and low public-sector prices, encourages "arbitrage," or more accurately theft and resale of public sector medicines to private sector consumers. Third, avoiding negotiations may be overrated since governments can set short time limits for such negotiations and insist on strict pro-access terms whether by regulation or negotiation demands.

The impact of Thailand's compulsory licensing victories will be lessened if other developing countries do not follow suit. In fact, a better scenario will arise when developing countries cooperate more vigorously in the selection and timing of compulsory licenses. Generic producers are most likely to invest the $1-$1.5 million dollars needed to formulate a generic equivalent if they can see a sizeable market in developing countries that aggregate their collective demand. In addition, with larger, more secure, and more predictable markets, more producers will enter the market and more producers will manufacture at efficient economies of scale. The combination of competition and efficiency will result in lower prices and more secure and redundant sources of supply.

The strongest way for countries to cooperate may well be through creation of patent pools that allow the collective management of both compulsory and voluntary licenses (negotiations on both in- and out-licenses).

Alternatively, developing countries could form regional "buying groups" and/or work intensively with the Clinton Foundation (at least for ARVs).

However, in order to be able to take advantage of their South-South strength, countries will need to be more proactive both in amending their patent legislation to allow maximum use of TRIPS-compliant flexibilities and in utilizing those flexibilities to actually issue compulsory licenses.

The current, countervailing strategy of Big Pharma, besides USTR intimidation and even product withdrawals, seems to be the use of strategic price discounts and restrictive licensing. Although these concessions look tempting in the short-run - since they reduce the treat of trade sanction and product embargoes - they are futile in the long run since they are Pharma controlled and because they deter generic entry. An even greater danger is presented by so-called free trade agreements where the United States attempts to impose TRIPS-plus intellectual property protections that hamper countries ability to ensure access to medicines for all.


The space that has been created by activist-backed defense of India's strict patent standards and by activist-prompted issuance of multiple compulsory licenses in Thailand is one of the most promising outcomes of AIDS advocacy in 2007. Hard fought precedents have been won, but enemies in Big Pharma and in the U.S. government are hard at work plotting a reversal of fortune. It is only by building on these recent victories - by rejecting more patents, by issuing more compulsory licenses, and by opposing TRIPS-plus IPR provisions - that activists and pro-access forces in developing countries can create a momentum that cannot be stopped.

Standing still is not an option.

Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy

French WTO Director General Promotes Further Weakening of IP by Encouraging CBD Issue Proposals
Intellectual Property Watch
5 December 2007
Members Seek To Raise TRIPs Amendments In WTO Negotiations
By William NewWorld Trade Organization members seeking changes to international rules on trade and intellectual property rights moved this week to include the debate on their proposals in an upcoming deadline for the broader trade negotiations at the WTO. But opponents continued to resist moving the issues to negotiation.
At issue is a proposal to raise the level of trade protection for geographical indications (distinctive products named for places) on a variety of products to the level already enjoyed by wines and spirits, and a separate proposal to require the disclosure of the origin of biological resources and traditional knowledge in patent applications.
Both proposals would require amending the 1995 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). At a high-level consultation with WTO Deputy Director General Rufus Yerxa (on behalf of Director General Pascal Lamy) on 3 December, proponents put forward new papers calling for agreement to consider the IP negotiations in the broader trade talks as part of a “single undertaking.”
The new papers call on the upcoming WTO General Council meeting to accept the GI and biodiversity negotiations in a “horizontal modalities decision” on negotiating parameters being considered for late January or early February. This would allow continued negotiation on the details of the proposed TRIPS amendments under the broader talks covering issues such as agricultural and non-agricultural market access and services.
The consultations on the GI extension and biodiversity issues comes under the “implementation” issues of the Doha Round of negotiations, described in Article 12 of the Doha Declaration (see below). The declaration from the 2005 Hong Kong ministerial stated under Article 39 that consultations should continue to try to resolve the issues.
The General Council meets on 18-19 December. At recent General Council meetings, Lamy has included in his report as chair of the Trade Negotiations Committee a brief reference that Yerxa held consultations and would continue to do so. It is possible this time that Lamy will mention the new proposals, sources said.
The GI and CBD groups at the consultation explicitly linked discussion on the two topics, sources said.
TRIPS Article 22 gives products with characteristics particular to a geographical location protection by allowing the rejection of trademarks on products that mislead consumers as to the place of origin. But members such as some in Europe feel this protection has been insufficient and may actually be causing a blurring of the distinction between the original products and variations from elsewhere since the latter must mention the original region on their labels.
So the proponents are seeking to extend the higher level of protection that is granted to wines and spirits under TRIPS Article 23. This would limit the use of GI-protected names only to those coming from the original region.
As an “element of flexibility,” as a proponent put it, existing exceptions to GI protection would be continued and adapted as agreed by all sides. The exceptions would not be rolled back, as may have been proposed in the past by Europe. The proponent stressed that the proposal does not introduce new concepts but rather brings the discussion into the same context as other negotiations. The details would be negotiated later, the source said.
On the biodiversity and traditional knowledge proposal, often referred to as the CBD issue for its relationship with the UN Convention on Biological Diversity, the proposal would establish an obligation for patent applicants to disclose the origin and include prior informed consent and access and benefit sharing with the affected communities.
The European Union, Norway and Switzerland have offered more limited variations on the developing country CBD amendment proposal.
Opponents of the GI extension have raised concern about its impact on the mandated GI register for wines and spirits. Proponents would like to have the register cover other products if extension is granted, but this would be up to all members to negotiate, a proponent said.
Opponents also appeared to have restated concern over possible “extra-territoriality,” the imposition of protection on other countries when one country protects a term and registers it in the system, sources said.
There are three groupings of members around these issues, according to sources. The “friends of geographical indications” includes the European Union, Guinea, India, Jamaica, Kenya, Kyrgyz Republic, Macedonia, Madagascar, Morocco, Pakistan, Sri Lanka, Switzerland, Tanzania, Thailand and Turkey.
The “disclosure group” includes Bolivia, Brazil, Colombia, Cuba, Dominican Republic, Ecuador, India, Peru, Thailand, the African Group, Least-Developed Countries group and other developing countries such as China.
The third group of countries opposes both proposals, with a few exceptions. Opposing the GI extension proposal are: Argentina, Australia, Canada, Chile, Costa Rica, New Zealand, South Africa, Taiwan, and the United States. Opposing the CBD proposal is: Argentina, Australia, Canada, Costa Rica, Japan, South Korea, New Zealand, Taiwan, and the United States. Japan and Korea do not oppose the GI proposal. Chile and South Africa do not oppose the CBD proposal.
The GI paper is considered a “Jobs” paper, which is unofficial but is in the WTO system and available to members. The CBD paper is technically a “non-paper,” but could be changed to a Jobs paper at some point, a source said.
William New may be reached at

Monday, December 10, 2007

Why It Takes a Village (To Afford a Prescription)

I once heard columnist George Will refer to a general election as a futile narcissistic exercise. I thought that proposition ridiculous at the time, but now I find it harder to argue against. The Bush administration has embroiled us in a costly, unpopular and seemingly endless war, and the Democratic congress repeatedly sacrifices the public interest to public relations, the promises of comity and bipartisanship long forgotten. Both parties have been irresponsibly spendthrift. Never before have I heard so many veteran policy wonks wish a plague on both their houses.However, when it comes to the intrusiveness of the regulatory agencies that affect our lives repeatedly and profoundly every day - dictating which detergents, medicines, foods, bug-repellents, herbicides, appliances and automobiles we can buy, and at what price - there is a palpable difference between the parties. I was reminded of that by a recent report, "Prescriptions for Drug Safety: Reforming U.S. Prescription Drug Regulations to Protect Consumers," by the Center for American Progress (CAP), a liberal organization that serves as a home for many old Clinton administration officials. The organization is headed by John Podesta, Bill Clinton's former White House chief of staff, and its fellows include Tom Daschle, the former senate Democratic leader; Gene Sperling, former economic adviser to President Clinton; and Bill Schulz, a senior FDA official during the Clinton administration. This group believes that big government "can improve the lives of everyday Americans by playing an active role in solving social and economic problems," and its roster reads like a self-styled, ready-to-go list of senior political appointees in a Hillary Clinton administration. That's what worries me.In spite of increasingly more powerful and precise technologies for drug discovery, purification and production during the past twenty years, development costs have skyrocketed. On average it takes 12-15 years and costs over a billion dollars to bring a drug to market. Of that amount, capitalized out-of-pocket preclinical costs and clinical testing each account for about half. Chasing these skyrocketing costs, between 1995 and 2006 U.S. research-based drug companies' expenditures on clinical trials almost tripled, to $43 billion, while the number of drugs approved decreased by about two-thirds. The number of marketing approval applications to the FDA and the number of approvals are now at a ten-year low. So what do the CAP folks propose for FDA "reform?" (In other words, what could we expect President Hillary's regulatory agenda to be?) Changes that will push drug development costs further into the stratosphere and ensure that even fewer innovative new medicines become available. The CAP proposals include:O Elimination of much of the patent exclusivity allowed under current law to compensate drug innovators for regulatory delays, which would favor generic drug companies' ability to compete with the research-intensive, innovator companies. That would lower drug prices in the short term, to be sure, but it's tantamount to eating your seed corn: A 1994 study - at a time when drug development was much cheaper - showed that only 3 in 10 approved drugs ever recoup their development costs, and the change proposed by CAP would make it even harder for innovator drugmakers.O An end of direct-to-consumer advertising - in spite of the fact that studies have shown that it spurs patients to visit their physicians at an earlier time, to discuss their symptoms. O "Discourage the proliferation of 'me too' drugs by requiring that new drugs go through extensive comparative clinical trials and are tested for safety and efficacy." This meddling in the drug development process demonstrates a lack of understanding of clinical medicine.
First of all, new drugs are already extensively tested for safety and efficacy. (That's where most of the billion dollars in development costs goes.) Second, comparative studies in which a new drug is tested against another approved medicine (as opposed to testing against a placebo) can be hugely expensive because vast numbers of patients may be required to show statistically significant superiority. The folks at CAP seem not to understand that "me, too" drugs - which are not very different from already-approved medicines - are an important element in individualizing therapy for each patient. Because patients' responses to medicines are widely variable, physicians need to be able to choose among various drugs for the same disease or symptom. This is especially true, for example, for patients who are suffering from infections, pain from any cause, psychiatric disease, or cancer. It is the reason that the medical literature and FDA-approved drug labeling use terms like "first-line" and "second-line" therapy. Often, the first choice, or guess, about which medicine to use on an individual patient fails, and we try a second one. A requirement for comparative clinical trials versus existing approved therapies is an inappropriate and dangerous standard. O "Create an independent Center for Post-Market Drug Evaluation and Research outside of the FDA to establish an effective system for post-marketing surveillance of drugs." The problem with this is that the new organization would have as its single raison d' tre the removal of drugs from the marketplace. We have already seen the confusion and damage wrought by antipathy to safe, effective and important drugs by zealots within the FDA who are focused on drug safety but who fail to give due consideration to drug benefits or to the need for a choice of drugs for a given purpose. Recent allegations from the media and others that insufficient attention is paid to drug safety, and new legislation have caused an already risk-averse agency to become even more conservative and defensive in its decision-making. In recent years, the FDA has steadily made it more difficult to initiate and perform the clinical testing of new drugs, and regulators have seldom been called to account for the unnecessary suffering and deaths of patients who don't get the new drugs they need in a timely way. The FDA has required ever larger numbers of patients in clinical trials; its demands for post-marketing clinical trials have proliferated wildly; and "risk management" plans for newly approved drugs have been inconsistently applied, punitive and often more appropriate for weapons-grade plutonium than prescription drugs. According to a 2006 survey of biopharmaceutical companies' views of FDA oversight, more than a third of companies complained that the FDA had changed its position in the middle of the testing of a product, while more than half said that the FDA "needs the most improvement" in "risk-based decision-making," which is supposed to be its essential stock in trade.Times are tough for drug development, they are deteriorating, and the return to government of the old Clinton crowd will make things far worse. Their approach to governance exemplifies Milton Friedman's observation that only in government do we observe the failure of a program and conclude that we need to expand it. What is especially ominous is that the liberal Democrats' plan for the FDA offers only a microcosm of the likely impacts on our lives that would be wrought by the big-government, nanny-state crowd.Henry I. Miller, a physician and fellow at Stanford University's Hoover Institution, was at the NIH and FDA from 1977 to 1994. He is the author, most recently, of "The Frankenfood

Sunday, December 2, 2007

Killing Healthy Patents

By Peter Pitts
Published 11/26/2007 12:07:45 AM

Ah, the glorious patent -- such a simple concept, and yet so utterly essential to a properly functioning society. In basements and R&D departments across the country, innovators are hatching newfangled gadgets, widgets, and services -- products that will fuel economic growth and improve lives -- because they are reasonably confident that a patent will prevent competitors and criminals from stealing their inventions.The folks at pharmaceutical companies are no different. Yes, that's right, drug companies, like most innovators, are in business to make money. They invest huge sums in research that leads to life-saving medical advances, and they hope to be rewarded for their efforts. Without strong patents protecting new drugs and processes, much of the research simply cannot continue.How distressing, then, that the U.S. Senate has taken up a bill that would pretty much decimate patents as we know them. The Patent Reform Act of 2007, a version of which has already passed the House, would require every patent application to be published on the Internet only 18 months after filing.Considering the years of research underlying most medical innovations, it is madness to require pharmaceutical companies to reveal their secrets so early. It seems even more unfair when you consider that it often takes in excess of 36 months after filing a patent to actually have it approved. This means that competitors and criminals will have a window of at least 18 months to replicate new drugs and medical research.Proponents of the bill claim that medical patents are being applied to inventions that are so small that they routinely overlap. They add that since many patented chemicals and processes are discovered through incremental advances, competing claims on them have stifled progress in the medical field.But as any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Companies more often profit by improving existing chemicals and making processes more efficient than by revolutionizing the whole field with new products. And even the smallest innovations are made only after large amounts of very expensive research.What's more, those clamoring for congressional action are seriously exaggerating the problems of the present system. They often cite, for example, the case of Myriad Genetics, a company that in 1998 patented a test for a genetic variation that, according to the company's website, increases a woman's risk of breast cancer.Instead of licensing its expertise, Myriad has decided to charge clinicians $3,000 a pop to perform the test. And since it will not open the test to outside scrutiny, other researchers have been unable to verify the procedure's effectiveness. Critics say the public has been ill-served.It is true that $3,000 seems expensive for a test, but one should not underestimate the cost of developing this procedure. And in any case, as Claire Driscoll, Director of the National Human Genome Research Institute, recently told Reason magazine, situations like Myriad's are the exception. "In my 10 or 15 years of doing this," she said, "I hear the same five or six examples [including Myriad Genetics] repeated over and over."The vast majority of patents are on medicines and procedures that have undergone extensive outside scrutiny. According to the Center for the Study of Drug Development at Tufts University, of every 5,000 compounds tested, only 250 enter pre-clinical testing, only five make it to clinical testing, and only one eventually receives FDA approval. There is no reason why a medicine so thoroughly vetted should not enjoy the protection of a patent that prevents outsiders from snooping into the specifics of how it works.Even as the U.S. Congress considers weakening America's patent law, officials in other countries are recognizing the importance of protecting intellectual property. Singapore, for example, has made a point of luring biotech and drug companies with promises to protect their inventions. "No pharmaceutical company is going to have its precious patents disclosed," former Singaporean Prime Minister Lee Kwan Yew told Der Spiegel magazine in 2005.Indeed, America's strong patent law is a major reason why many pharmaceutical companies are still based here, instead of, say, Canada, where laws are weaker. If the Senate passes the Patent Reform Act of 2007, some companies might pack up and leave. Or, more worryingly, they might simply halt research on what could be tomorrow's life-saving cures.Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.

A mistake to weaken U.S. patent rights,intellectual-property/cat200003_doc706703123.html

Copyright 2007 Newark Morning Ledger Co.All Rights Reserved
The Star-Ledger (Newark, New Jersey)
November 26, 2007 Monday

Congress is considering legislation to change America's patent system. The bill would change the means by which patent lawsuits are filed, reduce punishments for infringement and, most consequentially, reward patents to the first person to file with the government, not the first person to invent.
Advocates claim that the proposed changes would bring the American patent system in line with the European one. Litigation procedures would be streamlined and international cooperation enhanced.
But as a member of the Italian Parliament who is deeply familiar with the European patent system, I believe such a move would be a step backward for patent rights in the United States. It also would retard the efforts of Italy's Parliamentary Productivity Committee to import American-style intellectual property protections into our dormant and overregulated pharmaceutical and biotechnology sectors.
For the most part, support for the congressional measure is coming from the technology industry, which has long called for lawmakers to weaken the protections offered to patent holders. Citing the nearly 200 patent infringement lawsuits that technology firms have faced in just the past 21 months, large companies like Microsoft and IBM contend that patent reform would provide them with the flexibility needed to invent new products without fear of lawsuits.
Support is also coming from special-interest groups that blame strong patent protection for America's high drug prices. Too often, these advocates claim, pharmaceutical companies receive patent protection on new and expensive drugs that are simply updated versions of drugs that already exist.
But these supporters ignore the fact that the United States leads the world in research-based innovation, particularly in the health sciences, by virtually any measure. Fifteen years ago, Europe produced 80 percent of the world's new drugs, while the United States lagged far behind. Today, the situation has reversed and the United States produces 80 percent of new drugs.
It's easy to see why - the U.S. pharmaceutical industry spends roughly $5 billion more annually than Europe does on research and development. Europe's rate of investment growth lags as well. While the amount of money spent by U.S. pharmaceutical firms on research grew by 9.7 percent last year, it grew by only 5.3 percent in Europe.
These disparities are directly attributable to the relative weakness of Europe's patent system. Only if a pharmaceutical firm can recoup its initial investment - $800 million per drug, by most accounts -will it make the massive outlays necessary to invent a new cure in the first place.
Italy's pharmaceutical industry is a prime example of how Europe's patent system retards the sector's growth.
Consider two facts: Italy possesses the world's seventh-largest economy and is home to the second-highest number of drug companies per person in the European Union. In other words, the pharmaceutical industry plays a huge role in the Italian economy.
Yet not one of Italy's drug manufacturers is among the 50 largest worldwide. Not coincidentally, Italy ranks 27th in the world in property protection - well behind most EU countries, according to the International Property Rights Index.
Ignoring this relationship is unwise.
Other nations have had considerable success in following the American model of strong patent protection. Thirty years ago, for instance, Japan modified its copy-friendly laws to grant full patent protection for 15 years. Consequently, research and development spending has skyrocketed, such that Japan today is among the world leaders in pharmaceutical research and development. Canada, too, has experienced a great deal of growth in its knowledge-based industries since strengthening its patent system 20 years ago.
In an age of rapid globalization, national competitiveness is among the most important issues that policymakers can address. For far too long, Europe's leaders have given short shrift to intellectual property standards, and today, our once-proud and innovative firms are paying the price. Italy has suffered a great deal and faces many challenges in reclaiming its rightful place as a source of pharmaceutical research.
As a European working to restructure my country's patent system by following the U.S. model, I can express nothing but puzzlement at Congress' quest to tear down the legal structure that has put the United States at the forefront of pharmaceutical innovation.
Daniele Capezzone is a member of the Italian Chamber of Deputies.
Infobox: America's strong patent protections have helped make research-based innovation possible and have served as a model for other countries.

We Italians are getting the medicine we pay for—and dying as a result.,%202007.pdf?binID=462

Sicko Europe

Wall Street Journal
August 3, 2007; Page A9


Rome -- We live in an age of unprecedented medical innovation. Unfortunately, most of today's cutting-edge research is conducted outside Europe, which was once a pioneer in this field. About 78% of global biotechnology research funds are spent in the U.S., compared to just 16% in Europe. Americans therefore have better access to modern drugs. One result is that in the U.S., the annual death rate from cancer is 196 per 100,000 people, compared to 235 in Britain, 244 in France, 270 in Italy and 273 in Germany.

It is both a tragedy and an embarrassment that Europe hasn't kept up with the U.S. in saving and improving lives. What's to blame? The Continent's misguided policies and state-run health-care systems. The reasons vary from country to country, but broadly speaking, the custodians of public health budgets aren't devoting the necessary resources to get patients the most modern and advanced medicines, and are happier with the status quo. We often see news headlines about promising new cures and vaccines next to headlines about patients who can't get life-saving drugs as politicians impose ever stricter prescription controls on doctors.

The human toll can be measured in deaths and unnecessary suffering. It also costs us a lot of money. Prevention is cheaper than treatment. Modern medicine can prevent many medical complications that would otherwise require hospitalization and other expensive care. For every euro spent on new medicine, national health-care systems could save as much as €3.65 in later treatments, according to a National Bureau of Economic Research study.

This situation is especially dire in Italy. The government has capped spending on pharmaceuticals at 13% of total health-care expenditures while letting expenses for infrastructure and staff skyrocket. From 2001 to 2005, general health expenses in Italy grew by 31% while expenditure on medicines increased a mere 1.7%. Italian patients might well have been better off if the reverse was the case, but the state bureaucrats who make these decisions refuse to acknowledge the benefits of advanced drugs.

Also as a result, pharmaceutical research in Italy is falling behind even faster than in the rest of Europe. In 2004, pharmaceutical R&D spending was €3.9 billion in Germany, €3.95 billion in France and €4.78 billion in Britain, compared to only €1.01 billion in Italy.

Part of the problem is that regional authorities manage most of Italy's health-care spending. A strike by health-care personnel has an immediate impact on the region, but the consequences of cutting the budget for medicines are only felt in the long term and distributed across the nation. Hence, local authorities continue to focus on personnel and infrastructure in an age when medical research has become the most efficient way to improve public health.

Most recently, some Italian regions decided to drastically expand the scope of reference pricing, in open defiance of the central government. Reference pricing is used in most European countries to reduce government spending on medicine and is one of the reasons the Continent is lagging behind in pharmaceutical research. New drugs are grouped with existing drugs used to treat the same medical condition, and the government typically limits reimbursement to the cheapest price in the reference group. This way, patients are discouraged from using the most modern and more expensive medicine.

The Italian regions, however, are taking reference pricing one step further by grouping together drugs that do not necessarily have identical therapeutic effects. This way, the reference groups grow larger, and the regions can save more money. But patients are forced to choose between paying high out-of-pocket expenses or the risk of taking the wrong medicine.

This is a tragic state of affairs in a country with a higher natural demand for advanced medicine than most others in Europe. The older people get, the more likely they are to get ill, and today 20% of Italians are 65 years of age or older -- by far the largest percentage of any European country. The proportion is projected to rise to 24.5% by 2020.

Italian leaders have a responsibility to prevent parochialism from undermining public health and pharmaceutical research. But it is worth repeating that the combination of an aging population and an inefficient health-care system is a European, not exclusively Italian, problem.

It is time for politicians and regulators to confront our backward health-care systems and unleash the powers of medical research. Besides expanding drug budgets, European countries should work together to deregulate the pharmaceutical industry – for instance, by speeding up the approval process for new drugs.

The EU can better ensure that drug patents are adequately protected both in Europe and around the world against compulsory licensing and other infringements. Finally, we should give medical researchers tax incentives to slow the brain drain to the U.S. -- much like Ireland is attracting artists with favorable tax laws.

We Europeans are getting older; we should be getting wiser, healthier and happier, too.

Mr. Capezzone is the president of the productivity committee of the Italian Chamber of Deputies.

Trade Analyst Raises Concerns Ahead of EU-US Summit

Nathan Staff Writer
April 10, 2007

( - A trade analyst is raising concerns that an upcoming summit of European leaders hosted by President Bush may result in a rolling back of some intellectual property rights (IPR) in the United States.The summit, scheduled for April 30, will bring European Union leaders to the White House to address a host of issues, including nuclear non-proliferation, reconstruction in Iraq and Afghanistan, and transatlantic trade.One of the summit's goals will be finding ways to "reduce regulatory and trade barriers," according to the White House's February announcement of the meeting. The discussions could include intercontinental cooperation on intellectual property regulations."If the White House secures regulatory harmonization ... at the E.U. rather than the U.S. level, I am truly concerned that it would seriously undermine the constitutionally protected private property rights of U.S. owners," trade analyst Lawrence Kogan wrote in a paper cautioning against cooperation."Private U.S. intellectual property rights are under international assault by foreign governments that are intent upon securing transfer of U.S. scientific and technological know-how at concession rate prices," he said.Kogan told Cybercast News Service Friday that he doesn't think Bush has a particular interest in loosening American IPR regulations, but that he "is being pushed politically into considering things that he otherwise wouldn't have considered."He said the influence from Brussels -- the E.U. headquarters -- as well as from some Democrats in the U.S. Congress, is pushing the administration toward more "open source" intellectual property rules, favoring "shared knowledge" over private interest."They don't have a concept of the Fifth Amendment in Europe," Kogan said, referring to the U.S. Constitution's amendment requiring "just compensation" for private property to be taken for public use.Specifically, weakened property rights could make it easier for international governing bodies to put compulsory licenses on some pharmaceutical technologies so medicines created in the U.S. could be cheaply produced by other companies for fighting disease in the developing world.Kogan predicts that adopting more open intellectual property regulations would have "a chilling effect on American investment, invention and innovation, and threaten the long-term national economic and technological security interests of the United States."A spokesman for the Office of the United States Trade Representative (USTR), the agency that develops international trade policy and oversees trade negotiations with other countries, did not return calls requesting comment for this article.On its website, the USTR states that it "recognizes the critical importance of intellectual property and innovation to the enhanced productivity and future growth of the U.S. economy" and that it "uses a wide range of bilateral and multilateral trade tools to promote strong intellectual property laws and effective enforcement worldwide."The European Union in 2006 made the USTR's "watch list" for intellectual property rights protection. The E.U. joined 33 countries in making the list of trade partners with "underlying [intellectual property rights policy] problems."Until 2005, the USTR placed the E.U. on its "priority watch list," which designates countries that "do not provide an adequate level of IPR protection or enforcement." China and Russia currently top the priority watch list.The E.U. made the watch list in 2006 "because of concerns over E.U. rules concerning geographical indications," which are marks used on goods that have characteristics related to a specific geographic region -- such as olive oil produced in Tuscany -- according to the World Intellectual Property Association. The E.U.'s approach to protection of geographical indications worries the USTR office, which stated in the report that "concerns remain with respect to this new regulation's impact on the rights of trademark owners, which the United States continues to analyze."

Noticiário - Seleção Diária de Notícias Nacionais - 30/Novembro/

Zero Hora
Assunto: EconomiaTítulo: 1b "Fazer papel de Robin Hood não é correto" Data: 16/04/2007Crédito:
Evento Entrevista: Lawrence Kogan, presidente do Instituto para o Comércio, Padronização e Desenvolvimento Sustentável dos EUA
\nZero Hora - Como a queixa formal dos Estados Unidos contra a China feita na\nsemana passada, que envolve questões de direito intelectual, deve afetar o\ntratamento do assunto no mundo? \u003cbr\>\nLawrence Kogan - A questão levada à Organização Mundial do Comércio (OMC) é em\nparte política e em parte legal. Ainda está na primeira fase. Mas tem o efeito\nde fazer a China perceber como essa questão é importante. No caso da\nfalsificação e da pirataria, talvez o governo chinês esteja fazendo de conta\nque não vê. Essas atividades representam emprego para muitas pessoas, mas isso\nnão as torna corretas. \u003cbr\>\nZH - Como é possível tratar com justiça a propriedade intelectual em países\nricos e pobres, já que as oportunidades na área são muito diferentes? \u003cbr\>\nKogan - O direito de propriedade antecede a questão da propriedade intelectual.\nSe não houver proteção, as pessoas não terão interesse em desenvolver direitos\nnessa área. Os pobres têm idéias, mas não sabem como destravar esse conhecimento\ne colocá-lo no mercado - não têm mecanismos legais e contatos no universo dos\nnegócios. Assim, não percebem os benefícios. \u003cbr\>\nZH - Como o senhor avalia a iniciativa do Brasil de fazer acordos para fabricar\nremédios, especialmente anti-Aids? \u003cbr\>\nKogan - Nos EUA e na lei da OMC, está estabelecido que, quando um governo toma\numa patente em nome do interesse público, tem de pagar indenização. O Brasil\nameaçou quebrar as licenças, e isso reduziu o valor dos produtos. Isso não é\njusto. É compreensível que os governos queiram preços mais acessíveis, a lei\namericana também prevê os genéricos, mas após um período de três a seis anos. O\nBrasil não respeitou esse período. Todos entendemos que é importante garantir\nacesso para as pessoas, mas fazer papel de Robin Hood não é a maneira certa.\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"3\" face\u003d\"Times New Roman\"\>\u003cspan style\u003d\"font-size:12.0pt\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"3\" face\u003d\"Times New Roman\"\>\u003cspan style\u003d\"font-size:12.0pt\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\>",1]
Zero Hora - Como a queixa formal dos Estados Unidos contra a China feita na semana passada, que envolve questões de direito intelectual, deve afetar o tratamento do assunto no mundo? Lawrence Kogan - A questão levada à Organização Mundial do Comércio (OMC) é em parte política e em parte legal. Ainda está na primeira fase. Mas tem o efeito de fazer a China perceber como essa questão é importante. No caso da falsificação e da pirataria, talvez o governo chinês esteja fazendo de conta que não vê. Essas atividades representam emprego para muitas pessoas, mas isso não as torna corretas. ZH - Como é possível tratar com justiça a propriedade intelectual em países ricos e pobres, já que as oportunidades na área são muito diferentes? Kogan - O direito de propriedade antecede a questão da propriedade intelectual. Se não houver proteção, as pessoas não terão interesse em desenvolver direitos nessa área. Os pobres têm idéias, mas não sabem como destravar esse conhecimento e colocá-lo no mercado - não têm mecanismos legais e contatos no universo dos negócios. Assim, não percebem os benefícios. ZH - Como o senhor avalia a iniciativa do Brasil de fazer acordos para fabricar remédios, especialmente anti-Aids? Kogan - Nos EUA e na lei da OMC, está estabelecido que, quando um governo toma uma patente em nome do interesse público, tem de pagar indenização. O Brasil ameaçou quebrar as licenças, e isso reduziu o valor dos produtos. Isso não é justo. É compreensível que os governos queiram preços mais acessíveis, a lei americana também prevê os genéricos, mas após um período de três a seis anos. O Brasil não respeitou esse período. Todos entendemos que é importante garantir acesso para as pessoas, mas fazer papel de Robin Hood não é a maneira certa.

\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"3\" face\u003d\"Times New Roman\"\>\u003cspan style\u003d\"font-size:12.0pt\"\>English Translation:\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cb\>\u003cfont size\u003d\"3\" color\u003d\"#336666\" face\u003d\"Times New Roman\"\>\u003cspan lang\u003d\"PT\" style\u003d\"font-size:12.0pt;color:#336666;font-weight:bold\"\>Newsletter - Selection Daily News\nNational-30/Novembro/2007 \u003c/span\>\u003c/font\>\u003c/b\>\u003c/p\>\n\n\u003cp\>\u003cb\>\u003cfont size\u003d\"3\" color\u003d\"#336666\" face\u003d\"Times New Roman\"\>\u003cspan lang\u003d\"PT\" style\u003d\"font-size:12.0pt;color:#336666;font-weight:bold\"\>Zero Hora\u003c/span\>\u003c/font\>\u003c/b\>\u003cb\>\u003cfont color\u003d\"#336666\"\>\u003cspan lang\u003d\"PT\" style\u003d\"color:#336666;font-weight:bold\"\> Zero Hour\n\u003c/span\>\u003c/font\>\u003c/b\>\u003c/p\>\n\n\u003cp\>\u003cb\>\u003cfont size\u003d\"3\" color\u003d\"#333333\" face\u003d\"Times New Roman\"\>\u003cspan lang\u003d\"PT\" style\u003d\"font-size:12.0pt;color:#333333;font-weight:bold\"\>Assunto:\u003c/span\>\u003c/font\>\u003c/b\>\u003cfont color\u003d\"#333333\"\>\u003cspan lang\u003d\"PT\" style\u003d\"color:#333333\"\> Economia\u003c/span\>\u003c/font\>\u003cfont color\u003d\"#333333\"\>\u003cspan lang\u003d\"PT\" style\u003d\"color:#333333\"\> \u003cb\>\u003cspan style\u003d\"font-weight:bold\"\>Subject:\u003c/span\>\u003c/b\> Economy \u003cbr\>\n\u003cb\>\u003cspan style\u003d\"font-weight:bold\"\>Título: 1b "Fazer papel de\nRobin Hood não é correto"\u003c/span\>\u003c/b\> \u003cb\>\u003cspan style\u003d\"font-weight:bold\"\>Title:\n1b \u003c/span\>\u003c/b\>\u003c/span\>\u003c/font\>\u003cb\>\u003cfont size\u003d\"4\" color\u003d\"#333333\"\>\u003cspan lang\u003d\"PT\" style\u003d\"font-size:14.0pt;color:#333333;font-weight:bold\"\>"Doing role of\nRobin Hood is not correct"\u003c/span\>\u003c/font\>\u003c/b\>\u003cfont color\u003d\"#333333\"\>\u003cspan lang\u003d\"PT\" style\u003d\"color:#333333\"\> \u003cbr\>\n\u003cb\>\u003cspan style\u003d\"font-weight:bold\"\>Data:\u003c/span\>\u003c/b\>\u003cspan\> 16/04/2007\u003c/span\> \u003cb\>\u003cspan style\u003d\"font-weight:bold\"\>Date:\u003c/span\>\u003c/b\>\n16/04/2007 \u003cbr\>\n\u003cb\>\u003cspan style\u003d\"font-weight:bold\"\>Crédito:\u003c/span\>\u003c/b\> \u003cb\>\u003cspan style\u003d\"font-weight:bold\"\>Credit:\u003c/span\>\u003c/b\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"margin-bottom:12.0pt\"\>\u003cfont size\u003d\"3\" color\u003d\"#333333\" face\u003d\"Times New Roman\"\>\u003cspan lang\u003d\"PT\" style\u003d\"font-size:12.0pt;color:#333333\"\>Evento\u003c/span\>\u003c/font\>\u003cfont color\u003d\"#333333\"\>\u003cspan lang\u003d\"PT\" style\u003d\"color:#333333\"\> Event \u003cbr\>\n\u003cspan\>Entrevista: Lawrence Kogan, presidente do Instituto\npara o Comércio, Padronização e Desenvolvimento Sustentável dos EUA",1]

English Translation:
Newsletter - Selection Daily News National-30/Novembro/2007
Zero Hora Zero Hour
Assunto: Economia Subject: Economy Título: 1b "Fazer papel de Robin Hood não é correto" Title: 1b "Doing role of Robin Hood is not correct" Data: 16/04/2007 Date: 16/04/2007 Crédito: Credit:
Evento Event Entrevista: Lawrence Kogan, presidente do Instituto para o Comércio, Padronização e Desenvolvimento Sustentável dos EUA
\nInterview: Lawrence Kogan, president of the Institute for Trade, Standards and\nSustainable Development of the USA \u003cbr\>\n\u003cspan\>Zero Hora - Como a queixa formal dos Estados Unidos\ncontra a China feita na semana passada, que envolve questões de direito\nintelectual, deve afetar o tratamento do assunto no mundo?\u003c/span\> Zero Hour-How\nthe formal complaint in the United States against China made last week, which\ninvolves issues of law intellectual, should affect the treatment of the subject\nin the world? \u003cbr\>\n\u003cspan\>Lawrence Kogan - A questão levada à Organização\nMundial do Comércio (OMC) é em parte política e em parte legal.\u003c/span\> Lawrence\nKogan The question brought to the World Trade Organization (WTO) is partly\npolitical and partly legal. \u003cspan\>Ainda está na primeira\nfase.\u003c/span\> Still in the first phase. \u003cspan\>Mas tem o\nefeito de fazer a China perceber como essa questão é importante.\u003c/span\> But has\nthe effect of making the Chinese understand how this issue is important. \u003cspan\>No caso da falsificação e da pirataria, talvez o governo\nchinês esteja fazendo de conta que não vê.\u003c/span\> In the case of counterfeiting\nand piracy, perhaps the Chinese government is doing in mind that does not see. \u003cspan\>Essas atividades representam emprego para muitas pessoas,\nmas isso não as torna corretas.\u003c/span\> These activities represent employment\nfor many people, but that does not make right. \u003cbr\>\n\u003cspan\>ZH - Como é possível tratar com justiça a\npropriedade intelectual em países ricos e pobres, já que as oportunidades na\nárea são muito diferentes?\u003c/span\> ZH-How can deal with justice intellectual\nproperty in countries rich and poor, as the opportunities in the area are very\ndifferent? \u003cbr\>\n\u003cspan\>Kogan - O direito de propriedade antecede a questão\nda propriedade intelectual.\u003c/span\> Kogan - The right to property before the\nissue of intellectual property. \u003cspan\>Se não houver\nproteção, as pessoas não terão interesse em desenvolver direitos nessa área.\u003c/span\>\nIf there is no protection, people will have no interest in developing rights in\nthat area. ",1]
Interview: Lawrence Kogan, president of the Institute for Trade, Standards and Sustainable Development of the USA Zero Hora - Como a queixa formal dos Estados Unidos contra a China feita na semana passada, que envolve questões de direito intelectual, deve afetar o tratamento do assunto no mundo? Zero Hour-How the formal complaint in the United States against China made last week, which involves issues of law intellectual, should affect the treatment of the subject in the world? Lawrence Kogan - A questão levada à Organização Mundial do Comércio (OMC) é em parte política e em parte legal. Lawrence Kogan The question brought to the World Trade Organization (WTO) is partly political and partly legal. Ainda está na primeira fase. Still in the first phase. Mas tem o efeito de fazer a China perceber como essa questão é importante. But has the effect of making the Chinese understand how this issue is important. No caso da falsificação e da pirataria, talvez o governo chinês esteja fazendo de conta que não vê. In the case of counterfeiting and piracy, perhaps the Chinese government is doing in mind that does not see. Essas atividades representam emprego para muitas pessoas, mas isso não as torna corretas. These activities represent employment for many people, but that does not make right. ZH - Como é possível tratar com justiça a propriedade intelectual em países ricos e pobres, já que as oportunidades na área são muito diferentes? ZH-How can deal with justice intellectual property in countries rich and poor, as the opportunities in the area are very different? Kogan - O direito de propriedade antecede a questão da propriedade intelectual. Kogan - The right to property before the issue of intellectual property. Se não houver proteção, as pessoas não terão interesse em desenvolver direitos nessa área. If there is no protection, people will have no interest in developing rights in that area.
Os pobres têm idéias, mas não sabem como\ndestravar esse conhecimento e colocá-lo no mercado - não têm mecanismos legais\ne contatos no universo dos negócios.\u003c/span\> The poor have ideas, but do not\nknow how to unlock that knowledge and put it on the market-have no legal\nmechanisms and contacts in the world of business. \u003cspan\>Assim,\nnão percebem os benefícios.\u003c/span\> So, do not realize the benefits. \u003cbr\>\n\u003cspan\>ZH - Como o senhor avalia a iniciativa do Brasil de\nfazer acordos para fabricar remédios, especialmente anti-Aids?\u003c/span\> ZH-How do\nyou evaluate the initiative of Brazil to make agreements to manufacture drugs,\nespecially anti-Aids? \u003cbr\>\n\u003cspan\>Kogan - Nos EUA e na lei da OMC, está estabelecido\nque, quando um governo toma uma patente em nome do interesse público, tem de\npagar indenização.\u003c/span\> Kogan-In the USA and in the law of the WTO, is\nestablished that when a government takes a patent on behalf of the public\ninterest, must pay damages. \u003cspan\>O Brasil ameaçou quebrar\nas licenças, e isso reduziu o valor dos produtos.\u003c/span\> Brazil threatened to\nbreak the licenses, and this reduced the value of the products. \u003cspan\>Isso não é justo.\u003c/span\> This is not fair. \u003cspan\>É compreensível que os governos queiram preços mais\nacessíveis, a lei americana também prevê os genéricos, mas após um período de\ntrês a seis anos.\u003c/span\> It is understandable that governments want more\naffordable prices, the American law also provides the generic, but after a\nperiod of three to six years. \u003cspan\>O Brasil não respeitou\nesse período.\u003c/span\> Brazil has not respected this period. \u003cspan\>Todos entendemos que é importante garantir acesso para as\npessoas, mas fazer papel de Robin Hood não é a maneira certa.\u003c/span\> All\nbelieve it is important to ensure access for people, but do role of Robin Hood\nis not the right way. \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"3\" face\u003d\"Times New Roman\"\>\u003cspan style\u003d\"font-size:12.0pt\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003c/div\>\n\n\u003c/div\>\n\n\n",0]
Os pobres têm idéias, mas não sabem como destravar esse conhecimento e colocá-lo no mercado - não têm mecanismos legais e contatos no universo dos negócios. The poor have ideas, but do not know how to unlock that knowledge and put it on the market-have no legal mechanisms and contacts in the world of business. Assim, não percebem os benefícios. So, do not realize the benefits. ZH - Como o senhor avalia a iniciativa do Brasil de fazer acordos para fabricar remédios, especialmente anti-Aids? ZH-How do you evaluate the initiative of Brazil to make agreements to manufacture drugs, especially anti-Aids? Kogan - Nos EUA e na lei da OMC, está estabelecido que, quando um governo toma uma patente em nome do interesse público, tem de pagar indenização. Kogan-In the USA and in the law of the WTO, is established that when a government takes a patent on behalf of the public interest, must pay damages. O Brasil ameaçou quebrar as licenças, e isso reduziu o valor dos produtos. Brazil threatened to break the licenses, and this reduced the value of the products. Isso não é justo. This is not fair. É compreensível que os governos queiram preços mais acessíveis, a lei americana também prevê os genéricos, mas após um período de três a seis anos. It is understandable that governments want more affordable prices, the American law also provides the generic, but after a period of three to six years. O Brasil não respeitou esse período. Brazil has not respected this period. Todos entendemos que é importante garantir acesso para as pessoas, mas fazer papel de Robin Hood não é a maneira certa. All believe it is important to ensure access for people, but do role of Robin Hood is not the right way.

Lula Disrespects Private Property, “Taking” Foreign Investors’ DPP

By Lawrence A. Kogan

Brazilian obligatory licensing law motivated politically

Some time ago the media was discussing the right of the Thai and Brazilian governments to
declare a compulsory patent license for medicine, obtained by foreign pharmaceutical companies
that do business within those two countries. The truth is the Brazilian government concluded
\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>that the Brazilian law and\nthe WTO allow the government to issue compulsory licenses for\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>medication used to combat\nAIDS. Arguably, Lula was encouraged by the Thai government’s\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>controversial issuing of\nthree compulsory licenses. The justification for the illegal expropriation\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>of private property for Brazil was that\nit was necessary to protect the “public interest/good”,\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>according to the country’s\nConstitution and Intellectual Property Law. Lula’s government also\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>argued that these actions\nappropriately implemented Article 31 of the WTO’s TRIPS agreement,\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>that when they correspond\nwith the Doha Declaration, reflects a greater leniency in “allowing\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>governments to declare\n(subjectively) a ‘national emergency’ and to issue compulsory\nlicenses\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>for any reason, without\nconsulting with the owner of the foreign patent.”",1]

that the Brazilian law and the WTO allow the government to issue compulsory licenses for
medication used to combat AIDS. Arguably, Lula was encouraged by the Thai government’s
controversial issuing of three compulsory licenses. The justification for the illegal expropriation
of private property for Brazil was that it was necessary to protect the “public interest/good”,
according to the country’s Constitution and Intellectual Property Law. Lula’s government also
argued that these actions appropriately implemented Article 31 of the WTO’s TRIPS agreement,
that when they correspond with the Doha Declaration, reflects a greater leniency in “allowing
governments to declare (subjectively) a ‘national emergency’ and to issue compulsory licenses
for any reason, without consulting with the owner of the foreign patent.”
\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>Arguably, Brazil’s\nstance was forged and encouraged by NGOs in the developed world,\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>motivated by propaganda and\nample resources. These groups, apart from their socialist party\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>ideology, are now focusing\non the elimination of private property as their central pillar in the\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>international legal field.\nIt is clear that the Brazilian government is using the NGOs to promote a\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>new global anti-IP paradigm\nof open source access in the area of health assistance and the spread\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>of information that will\nprevent strong private property rights, particularly American patent\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>owners, publishers and trade\nsecrets. It is clear that this new world paradigm is a key part of\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>President Lula’s\nnational innovation plan.\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>",1]

Arguably, Brazil’s stance was forged and encouraged by NGOs in the developed world,
motivated by propaganda and ample resources. These groups, apart from their socialist party
ideology, are now focusing on the elimination of private property as their central pillar in the
international legal field. It is clear that the Brazilian government is using the NGOs to promote a
new global anti-IP paradigm of open source access in the area of health assistance and the spread
of information that will prevent strong private property rights, particularly American patent
owners, publishers and trade secrets. It is clear that this new world paradigm is a key part of
President Lula’s national innovation plan.
\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>Moreover, it is common\nknowledge that in the past Lula has favored the poor, the uneducated,\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>and his national labor\nunions in order to assure his reelection. This favoritism was necessary due\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>to a series of corruption\nscandals involving some of his closest collaborators, and for his\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>government’s inability\nto implement public education, pension and infrastructure measures that\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>the educated would have held\nhim responsible for. The uneducated are not better off in\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>economic or social terms\neven though they receive monthly assistance in exchange for votes\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>(Bolsa Familia program). The\ncapital markets are also not better off than what they would have\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>been, not including a\nrelative calm during the first and second quarters. In each one of these\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>",1]

Moreover, it is common knowledge that in the past Lula has favored the poor, the uneducated,
and his national labor unions in order to assure his reelection. This favoritism was necessary due
to a series of corruption scandals involving some of his closest collaborators, and for his
government’s inability to implement public education, pension and infrastructure measures that
the educated would have held him responsible for. The uneducated are not better off in
economic or social terms even though they receive monthly assistance in exchange for votes
(Bolsa Familia program). The capital markets are also not better off than what they would have
been, not including a relative calm during the first and second quarters. In each one of these
\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>well being of the people and\ntheir ability to care for themselves did not improve one bit.\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>After signing the order to “break”\nthe patent for AIDS medication, Lula advised that this could\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>occur with other licenses if\nprices cannot be afforded. Furthermore, even after various warning\u003c/span\>\u003c/font\>\u003cfont size\u003d\"2\" face\u003d\"TimesNewRoman,BoldItalic\"\>\u003cspan style\u003d\"font-size:10.0pt\"\>\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>by foreign investors that\nLula’s actions are slowing foreign direct investment into Brazil, Lula\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>has responded by saying that\nthe benefit of “breaking” the patents is to the benefit of\nBrazilians\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>and world citizens alike. If\nLula’s tone is more like Robin Hood than head of state, it’s\nprobably\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>not a coincidence.\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>",1]
cases, the groups are not less dependent than they were prior to the election. It is clear that the
well being of the people and their ability to care for themselves did not improve one bit.

After signing the order to “break” the patent for AIDS medication, Lula advised that this could
occur with other licenses if prices cannot be afforded. Furthermore, even after various warning
by foreign investors that Lula’s actions are slowing foreign direct investment into Brazil, Lula
has responded by saying that the benefit of “breaking” the patents is to the benefit of Brazilians
and world citizens alike. If Lula’s tone is more like Robin Hood than head of state, it’s probably
not a coincidence.
\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>research and development\nthat has guided foreign direct investment, scientific innovation and\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>technology, and economic\ngrowth will continue at the current pace. Lula will also not be able to\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>guarantee to small and\nmedium sized that they will have the technical capacity to compete\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>internationally. The\ngovernment is also under pressure to maintain positive relations with the\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>United\n States\u003c/span\>\u003c/font\>\u003cfont face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-family:TimesNewRoman\"\>, Brazil’s largest trade\npartner, and some hope that President Lula’s stance on\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>property rights does not\nharm the relationship.\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>In conclusion, Brazilian\nbusinesses and investors in biotechnology, pharmaceuticals, chemicals,\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>",1]
Besides the rhetoric, Lula’s government can’t provide businesses with the guarantee that the
research and development that has guided foreign direct investment, scientific innovation and
technology, and economic growth will continue at the current pace. Lula will also not be able to
guarantee to small and medium sized that they will have the technical capacity to compete
internationally. The government is also under pressure to maintain positive relations with the
United States, Brazil’s largest trade partner, and some hope that President Lula’s stance on
property rights does not harm the relationship.

In conclusion, Brazilian businesses and investors in biotechnology, pharmaceuticals, chemicals,
\u003c/font\>\u003c/p\>\n\n\u003cp style\u003d\"text-autospace:none\"\>\u003cfont size\u003d\"3\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:12.0pt;font-family:TimesNewRoman\"\>secrets and copyrights they\ncurrently enjoy will be next in Lula’s sights.\u003c/span\>\u003c/font\>\u003cfont size\u003d\"2\" face\u003d\"TimesNewRoman\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:TimesNewRoman\"\>\u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"3\" face\u003d\"Times New Roman\"\>\u003cspan style\u003d\"font-size:12.0pt\"\>The Portuguese Translation of this article appeared on page 8 within the\nJune 2007 issue of the Revista Leader Magazine, a publication of the Instituto\nDe Estudos Empresariais, Porto Alegre,\nBrasil. \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cdiv align\u003d\"center\"\>\n\n\u003ctable border\u003d\"0\" cellspacing\u003d\"0\" cellpadding\u003d\"0\" width\u003d\"72%\" style\u003d\"width:72.46%\"\>\n \u003ctr height\u003d\"39\"\>\n \u003ctd width\u003d\"100%\" height\u003d\"39\" valign\u003d\"top\" style\u003d\"width:100.0%;padding:0in 0in 0in 0in\"\>\n \u003cp style\u003d\"text-align:justify\"\>\u003cfont size\u003d\"3\" color\u003d\"black\" face\u003d\"Times New Roman\"\>\u003cspan style\u003d\"font-size:12.0pt;color:black\"\>\u003ca href\u003d\"\" target\u003d\"_blank\" onclick\u003d\"return top.js.OpenExtLink(window,event,this)\"\>Lula\n Desrespeita A Propriedade Privada ‘Tomando’ OS DPP De\n Investidores Estrangeiros\u003c/a\>\u003c/span\>\u003c/font\>\u003c/p\>\n \u003c/td\>\n \u003c/tr\>\n\u003c/table\>\n\n\u003c/div\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\> \u003c/span\>\u003c/font\>\u003c/p\>\n\n\u003cp\>\u003cfont size\u003d\"2\" face\u003d\"Arial\"\>\u003cspan style\u003d\"font-size:10.0pt;font-family:Arial\"\>",1]
software, automobile and aeronautical sectors should ask themselves if the patents, commercial
secrets and copyrights they currently enjoy will be next in Lula’s sights.

The Portuguese Translation of this article appeared on page 8 within the June 2007 issue of the Revista Leader Magazine, a publication of the Instituto De Estudos Empresariais, Porto Alegre, Brasil.
Lula Desrespeita A Propriedade Privada ‘Tomando’ OS DPP De Investidores Estrangeiros