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Cables that mention Novartis

Posted By James Love On September 8, 2011 @ 11:50 pm In Uncategorized | Comments Disabled

September 6, 2011
KEI staff review of Wikileaks cables (/wikileaks ^[1])

Feb 28, 2003 | Turkey | Consulate Istanbul | Differences Among U.s. Firms Give Rise To New Association Of Research-based Pharmaceutical Companies ^[2]

In Janauary 2003, a “Association of Research Based Pharmaceutical Companies” (AIFD) was formed in Turkey. The founding companies include Novartis, Sering AG, Novo, Bayer, Solvay, Lundbeck Astrazeneca, Sanofi-Synthelabo, Organon and Lilly. According to Lilly’s General Manager Roberto Guiusti, the association was created to purse the research industry’s “legitimate entitlements,” which the cable describes as “full implementation of intellectual property rights and the discontinuation of disciminatory practices against imports.”

Jul 10, 2003 | Jordan | Embassy Amman | Phrma Group Forms To Support Iraq ^[3]

On March 20, 2003 the United States and allies invaded and then occuplied Iraq. On Jul 20, 2003, the US Department of State sent a cable describing a new PhRMA working group to provide recommendations to Iraqi authorities on establishing a pharmaceutical regime. The cable notes that “These major, innovative companies, which have mainly been shut out of the Iraqi market for over a decade, have substantial experience and resources that could be brought to bear on some of the difficult issues Iraq’s health sector faces.” The companies mentioned by name in the cable were Bristol Myers Squib, Schering Plough, Pfizer, Novartis, Eli Lilly, Wyeth, Glaxo Smith Kline, Schering AG, and Boehringer Ingelheim. The cable notes that the PhRMA members:

. . . understand that this is a medium term objective and that a necessary part of restoring their access is establishment of an Iraqi legal and regulatory regime for pharmaceutical products that covers issues like intellectual property protection, drug registration, pricing, and distribution. They also understood that the immediate task of CPA is to examine pending OFF contracts and to wind down the program. In the meantime, the group will begin meeting and working to develop their ideas. One of the members noted, for example, that Jordan’s IPR laws could provide a model for Iraqi laws.

¶16. (SBU) Privatization/FDI: The GoS has been reluctant to privatize a number of key industries including telecommunications, insurance, and banking. The state exerts significant influence over these sectors either as a direct owner or as a majority shareholder through a combination of state-owned funds. Although its figures improved substantially last year as a result of Swiss-owned Novartis’ acquisition of Lek Pharmaceuticals for nearly US$900 million

Dec 20, 2004 | Italy | Embassy Rome | Italy/biotech: Ban On Four Gm Corn Varieties Overturned By Italian Court ^[7]

¶2. (U) On November 29, 2004, the Regional Administrative Tribunal (TAR) of Lazio (which includes Rome) annulled the Amato Decree, which since August 2000 had banned commercialization in Italy of four biotech corn varieties: BT 11 (Novartis), MON810 (Monsanto), MON 809 (Monsanto) and T25 (Aventis). All four varieties had already been authorized by the EU and marketed for both food and feed uses. In its decision, the court noted that “in the years of commercialization experience in the whole EU territory, as well as in the United States are no reports that these products have caused serious and irreversib threats” to human health. The ruling quotes a series of scientific recommendations, coming from different sources, speaking in favor of the safety of these products.

¶5. (U) By way of background, on August 4, 2000, Giuliano Amato, the Italian Prime Minister at the time, issued a decree (later called the “Amato Decree”) in response to a campaign launched in the fall of 1999 by some environmental groups against seven GM products (four corn and three rapeseed varieties). The Amato decree was published in the Italian Official Gazette on August 8, 2000, and became effective on August 23. It “suspended” the commercialization and use of four GM corn varieties already authorized by the EU and marketed for both food and feed uses: BT 11 (Novartis), MON 810 (Monsanto), MON 809 (Monsanto) and T 25 (Aventis), while the three rapeseed varieties were dropped from the decree.

Dec 27, 2004 | Italy | Embassy Rome | Cartagena Protocol On Biosafety – Italy ^[8]

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RESTRICTIVE “AMATO” DECREE ANNULLED
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¶4. (SBU) Ref C reports the annulment of a four-year old Italian law called the “Amato Decree”, affecting GMOs rather than living modified organisms. We believe that this recent court action represents a positive step toward a more science-based Italian biotechnology policy. Under Italian law, both sides in the dispute may still appeal the annulment, but Post has no reason to believe that either side will take this step.

¶5. (U) By way of background, on August 4, 2000, Giuliano Amato, the Italian Prime Minister at the time, issued a decree (later called the “Amato Decree”) in response to a campaign launched in the fall of 1999 by some environmental groups against seven GM products (four corn and three rapeseed varieties). The Amato decree was published in the Italian Official Gazette on August 8, 2000, and became effective on August 23. It “suspended” the commercialization and use of four GM corn varieties already authorized by the EU and marketed for both food and feed uses: BT 11 (Novartis), MON 810 (Monsanto), MON 809 (Monsanto) and T 25 (Aventis), while the three rapeseed varieties were dropped from the decree.

¶6. (U) On November 29, 2004, the Regional Administrative Tribunal (TAR) of Latium annulled the Amato Decree. The ruling resulted from a lawsuit submitted in November 2000 by three leading seed companies and a biotech association. The ruling concurred with the European Court of Justice’s opinion that such a ban was justifiable only if a Member State could demonstrate scientific evidence of risk to humans. Four years under the Amato Decree has affected U.S. exports to Italy; in particular, the decree law obstructed Italian imports of U.S. corn products, such as corn gluten feed and corn oil, as well as corn, even during a year of drought here in Italy. ¶7. (SBU) COMMENT: It remains to be seen whether U.S. corn and corn products can reestablish their presence in the Italian market. END COMMENT. SEMBLER

¶20. Pharmaceuticals Amount of State control: No monopoly policy, but manufacturing and trade subject to control by the Ministry of Health. Foreign investors are allowed to enter into JV with Vietnamese partners or to establish 100 percent foreign owned enterprises in Vietnam to manufacture and distribute pharmaceutical products in the local market. As for import activities, only SOEs are allowed to be involved; private enterprises that want to import pharmaceuticals have to ask SOEs to do that on their behalf. Under Decision 155 issued on August 24,2004, certain SOEs engaged in the distribution sector will be equitized, but the state will retain a controlling interest. All pharmaceutical products have to be registered with and the retail price of pharmaceuticals has to be informed to the Pharmaceutical Management Department. For the time being, the Government has allowed for parallel import. Production share controlled by State: Percent: State Non-state FIE Medical ampoule: 84.6 15.3 0.1 Liquid medicine: 83.7 7.9 8.4 Tablets: 83 14.1 2.9 Sector regulated by: Pharmaceutical Management Department (Ministry of Health) Major SOE’s: Vietnam Pharmaceutical General Corporation, with 18 members Key Associate SOE’s: Sanofi Pharma Vietnam Rhone- Poulenc Rorer Non-State market shareholders: Hitsamisu Rohto Mentholatllm Novartis (wholly foreign-owned) Do Thanh Pharmaceutical Co.Ltd.

Aug 10, 2005 | France | Embassy Paris | Economic Patriotism, Economic Intelligence, And Protecting France’s Corporate “jewels” ^[13]

¶3. (C) The current government’s emphasis on employment creation combined with the public’s fears of outsourcing and job losses created the perfect backdrop for what French economist Elie Cohen has described as Danone’s carefully orchestrated campaign against a Pepsi takeover “threat.” While Danone could hardly be construed as a strategic company, President Chirac and PM de Villepin may have seen an excellent – and cost free – opportunity to score political points by publicly “defending” a French company with a call to “economic patriotism.” Last year, then-Finance Minister Sarkozy initiated a similar public response by persuading Novartis, the Swiss pharmaceutical group, not to bid for Aventis against Sanofi, a French rival.

Pharmaceuticals Sectors/Pricing
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¶8. (U) The roughly 300 pharmaceutical companies in France, employing 18,500 and spending USD 3.5 billion in R&D, have annual sales of USD 41 billion, of which USD 17 billion are exports. Imports are about USD 10 billion. Almost all top U.S. firms (Pfizer, Abbott, etc.) have a presence in the French market, and many have research facilities. French firms account for only 40 percent of local production. France ranks third worldwide in sales, behind the U.S. and Japan. Drugs represent about 22 percent of health care spending. As part of a policy of containing health care costs, government intervention has led to prices generally lower than in unregulated European markets such as Germany or the UK. Nevertheless, French OTC drugs, with 8 percent of the market, represent one of the smallest market shares in Europe, although it is growing. Virtually the whole population is covered by medical insurance that reimburses 65 percent of total pharmaceutical sales, though reimbursement rates vary by category of drug, from zero to 100 percent. The French government views pharmaceuticals as a key industry, hence its aggressive support of SanofiSyntholoabo in 2004 to buy Aventis to “save” it from the Swiss Novartis.

Licensing Agreements – Wave of the Future?
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¶7. (SBU) A case in point is Hikma’s licensing agreement with Eli Lilly to market the brand Cialis (tadalafil) for erectile dysfunction. Hikma places the drug throughout its markets in the MENA region, although Lilly still manufactures the pills and continues to hold the data exclusivity-registration rights. Hikma pays Lilly a royalty on its Cialis sales. Most Jordanian companies would not have the sales force or marketing tools to handle this type of drug placement. They would just prefer to follow their short-term success models: secure the manufacturing rights and bring the drug molecule to the markets they already have, according to a PhRMA observer.

¶8. (SBU) However, the number two pharmaceutical company in Jordan – Dar Al Dawa – reportedly has a similar licensing arrangement with Novartis, and observers expect more such deals in the future. It remains to be seen if these licensing deals can cross over to a generic manufacturing scheme by which originator companies share their formulae and processes in return for some control of their drugs’ market access even beyond the patent life.

May 10, 2006 | Japan | Embassy Tokyo | Daily Summary Of Japanese Press 05/10/06 ^[20]

Novartis, a prominent Swiss pharmaceutical company, plans to export pharmaceutical products produced in Singapore to the Indian market as early as 2008. It is now constructing a plant in Singapore to manufacture medicines for high blood pressure and cardiac diseases, by investing approximately 180 billion dollars. [KEI note: probably not 180 billion dollars]

May 19, 2006 | Cyprus | Embassy Nicosia | Cyprus 2006 Special 301 Notification (intellectual Property) ^[21]

¶3. (U) Cyprus has welcomed the creation of two new NGOs concerned with IPR issues so far this year. On May 12, the local representatives of the leading international pharmaceutical research companies establish the “Pharmaceutical Association of Research and Development Companies of Cyprus” or KEFEA (from its Greek acronym). Members include U.S. giants Merck, Sharp, and Dohme (MSD), Wyeth, and Eli Lilly. Other members include GlaxoSmithKline (UK), Novartis (Swiss), Boehringer Ingelheim (German), Bayer (German), and Sanofi Aventis (French). In January five leading Cypriot professionals formed the Initiative for the Promotion of Research and Competitiveness in Cyprus (IPRCC) dedicated among other things to improve the competitiveness of the Cypriot economy by lobbying the government to ensure strong IPR enforcement.

Jul 3, 2006 | Poland | Embassy Warsaw | Poland: Weighing In On Pharm Price Cuts ^[22]

The Ministry of Health,s decision to impose a 13 percent cut in the official price for imported pharmaceutical products was implemented on July 1, 2006. We believe urgent action is nonetheless needed in order to shake the Polish government out of its complacent attitude toward these discriminatory actions. By all accounts, the price cuts are the brainchild of Deputy Minister of Health Boleslaw Piecha. Piecha, unlike Minister of Health Religa, is a PIS party member and appears to be the real power at the Ministry. Piecha and Religa, according to some anecdotal reports, have been engaged in a minor power struggle for calling the shots at the Ministry. These price cuts have fostered an uncommon unanimity among affected U.S. and other non-U.S. LAWG companies, a list of which includes the following: – Abbott – AmGen – Baxter – Bristol Myers Squibb – Janssen Cilag – Eli Lilly – Glaxo Smith-Kline – Merck – Novartis – Pfizer – Sanofi-Aventis – Schering-Plough – Wyeth

This issue has been remarkable to the extent that we have had significant EU member state support in our lobbying efforts. British, French, German, and Danish Embassy officials have made representations (with the British, at least, using Embassy-suggested talking points) to the Polish government protesting the price cuts. Our colleagues at USEU have also been active in presenting our arguments to the Commission, further sensitizing EU and Polish officials on all fronts to the seriousness of this issue.

Sep 6, 2006 | France | Embassy Paris | French Election 2007: Nicolas Sarkozy — The Candidate Who Might Change France ^[23]

¶10. (C) At the same time, Sarkozy understands that the French want to be protected and that they are comfortable with a high degree of state involvement in the economy. The current controversy over the privatization and merger involving the national gas company (GDF) and a the energy giant Suez exemplifies the persisting sensitivity of loosening state control over the economy in France. Sarkozy’s record — he is above all a pragmatic politician — as a “liberalizing” policy practitioner is quite mixed. For example, during his tenure as Finance Minister (March-November 2004), when confronted by labor union resistance to significant privatization of state utilities, Sarkozy compromised. He worked hard — and offered government assistance — to keep factories threatened with closure operating in France. Spurred by public complaints about rising prices in supermarkets, he negotiated “voluntary” price controls with major chains. He practiced “patriotic liberalism” in helping engineer the merger of a large French pharmaceutical company (Aventis) with a larger French pharmaceutical firm (Sanofi) rather than with Sanofi’s foreign rival (the Swiss firm, Novartis). By and large, the public approved Sarkozy’s protectionist actions.

Oct 30, 2006 | Germany | Embassy Berlin | German Health Minister Schmidt Traveling To U.S. ^[24]

¶1. (SBU) SUMMARY. Minister of Health Ulla Schmidt travels to New York and Washington October 29 – November 4 to meet with pharmaceutical companies, consumer groups, and attend a Commonwealth Fund symposium on health care policy. The trip is billed by the Ministry of Health as another opportunity for Schmidt to discuss German efforts at containing health care costs and gathering information from the U.S. and other sources on differing approaches to management of health care costs. Schmidt is not scheduled to meet with USG officials directly, but her participation in the Commonwealth Fund’s event will allow her to engage with Secretary of Health Leavitt. This trip is the third to the U.S. in 2006. END SUMMARY.

¶2. (SBU) Schmidt arrives in New York on Sunday, October 29. In New York she will focus on pharmaceutical pricing and innovation. Schmidt has three meetings planned. The first, with Eon Labs, a subsidiary of Novartis specializing in generics, will focus generic drugs. The second event is with the new CEO of Pfizer, which the Ministry of Health has billed as an introductory meeting. The third meeting in New York is with AARP to discus Medicare part D. (NOTE. Originally Schmidt ws going to hold a round table discussion with th CEOs of major U.S. pharmaceutical companies, but according to MOH contacts, most of the CEOs wer unavailable. The AARP event was scheduled as areplacement. END NOTE.)

¶4. (SBU) One subject for possible discussion with Schmidt and the German delegation in the context of health care reform and cost containment is the U.S. experience in the use of contracts and price bargaining between insurers and health care providers, e.g., pharmaceutical companies. Such a discussion could directly support the on-going dialogue over pharmaceutical pricing in Germany. Another topic is how to care for uninsured and bring them into the system. Germany currently has 300,000 uninsured, a number that has increased dramatically in the past few years.

¶6. (SBU) Suwit said that discussions were ongoing with Swiss-based Novartis, which had apparently agreed to provide nine free boxes of one of their drugs for every box sold in Thailand, essentially a 90 percent reduction in price. Suwit did not specify the drug, but Novartis’ cancer drug Gleevec earlier had been mentioned as a target. Suwit said that although an Indian generic was available for 15 times less the originator’s price, a compulsory license could still be avoided if discussions were fruitful.

Apr 5, 2007 | Russia | Embassy Moscow | Russian Duma: Split Health Ministry In Two ^[29]

The Government’s drug benefits program known as the “DLO” have problems with financing when more people than expected opted to monetize their benefits in 2006, and those who remained in the program overburdened the system by obtaining expensive drugs. The DLO’s financing is having a negative impact on some U.S. and foreign pharmaceutical companies. A substantial portion of certain U.S. drug companies’ total sales to Russia in 2006 were under the DLO, and they are holding significant overdue accounts receivable that the government has yet to pay Some other major foreign firms face major exposure. Swiss drugmaker F. Hoffman La Roche supplies heart medications, anti-cancer drugs, and immuno-suppressors. According to our sources, it is still owed at least $70 million for 2006 sales. Over 75 percent of Novartis’ sales and nearly half of Sanofi-Aventis’ sales in Russia were under the DLO during 2006.

¶5. The Developing Country Vaccine Manufacturers Network (DCVMN) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) provided industry perspectives. Both committed to work with countries and the WHO leadership to address pandemic preparedness, and to develop approaches for funding, allocating and distributing potential vaccines. IFPMA said industry is investing in increased vaccine supply, and expects current production capacity to double in the next two to three years. IFPMA also noted vaccine manufacture is highly complex, is highly regulated, and must be compliant with good manufacturing practices – a validation process that can take many years. IFPMA said industry is prepared to contribute to global stockpiles once their scope and magnitude has been defined. DCVMN noted it is already providing the bulk of vaccines purchased by United Nations agencies, and, with support from the international community, could establish the capacity to produce H5N1 vaccines.

¶6. Switzerland provided an industrialized-country perspective on increasing access to vaccines. Noting it has already purchased enough H5N1 pre-pandemic vaccines for the entire Swiss population (although not mentioned, this purchase was from GlaxoSmithKline and Novartis), Switzerland said it had also entered into an advance purchase contract for one dose of pandemic vaccine for each Swiss citizen. Noting that a country?s first obligation is to its own people, Switzerland argued that having met that obligation first allowed it to then secure government funds to support global stockpiles, either through donations or financial contributions. To do this, Switzerland said it was exploring issues related to legal liability, differential pricing, and advance purchase commitments, and would continue to work with the WHO Secretariat on these issues.

¶7. Reacting to Switzerland?s presentation, Thailand said it had quickly calculated that it must have cost Switzerland USD20 per person to provide this vaccine coverage, a cost no developing country could afford. And, Thailand asked, if all the rich countries did the same, how many vaccine doses would be left for the rest of the world?

——- HEALTH ——-
¶6. (U) After months of delay, the Madras High Court dismissed a petition filed by the Swiss pharmaceutical firm Novartis that challenged section 3d of the newly framed Indian Patent Act (IPA) claiming it violated article 27 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Section 3d of the IPA prohibits patenting modifications to an existing drug unless the modified drug is significantly more effective than the originally patented product. Novartis had sought patent protection for a new version of its leukemia drug Gleevec, known in India as Glivec. The court concluded it lacked jurisdiction and directed Novartis to take up the issue with the WTO Dispute Settlement Body.

PHARMA PATENT ISSUES AMPLIFIED
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¶6. (U) On August 27, Swiss pharmaceutical giant Novartis announced that it will move hundreds of millions of planned investment dollars from India to China, citing insufficient protection in India for intellectual property. This announcement stems from Novartis’s recent legal disappointment in Chennai, where the High Court upheld the rejection of Novartis’s patent application for its leukemia drug Glivec.

¶7. (U) Then on August 28, the Kolkata patent office rejected Eli Lilly’s patent application for Forteo, a drug used to treat osteoporosis, on grounds of incremental innovation, prior knowledge, and failure to demonstrate improved efficacy. Forteo is the only biotechnology-based osteoporosis drug available in India, and Eli Lilly had already released the product, anticipating approval of their patent request.

Sep 18, 2007 | India | Embassy New Delhi | Ambassador Discusses Ceo Forum Issues With Planning Commission Deputy Chairman Ahluwalia ^[37]

¶2. (SBU) The Ambassador noted that the CEO Forum was unique in that it was one of the few private sector forums that attracted great interest and attendance from senior government officials. It was therefore important that the September 24 discussion focus on critical issues including infrastructure financing and the impact of inadequate IPR protection on foreign investment in India that has lead to the recent decision by the Swiss pharmaceutical company, Novartis, to pull out of India after its latest patent application was denied. Ahluwalia agreed and said that he hoped the U.S.-India civil nuclear agreement would not be on the agenda since the ball was in India’s court to move forward in a process well known to everyone. Ambassador noted that, at some point, prospects for U.S. private sector investment in India’s civil nuclear industry would be an appropriate discussion topic at the CEO Forum, but not until the Agreement had been operationalized. Ahluwalia said that he would discuss with Foreign Secretary Menon keeping the civil nuclear agreement off the agenda, and Ambassador said that he would take it up with Under Secretary Burns.

Sep 21, 2007 | Japan | Embassy Tokyo | Japanese Morning Press Highlights 09/21/07 ^[38]

TOP HEADLINES Mainichi: Novartis Pharma to exempt Ritalin from medicines for depression

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GOI TAKES GOOD STEPS ON INTELLECTUAL PROPERTY; GSK TAKES ONE FOR THE TEAM
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¶11. (U) The central government on Monday authorized the Madras High Court to exclude S. Chandrasekaran from the Intellectual Property Appellate Board that will review the rejection of Novartis’ patent application for its leukemia drug Glivec. Novartis had moved to have Chandrasekaran removed because he was Controller General of Patents in Chennai when the original application was rejected. The Madras High Court has not yet announced whether it will remove Chandrasekaran from the Board.
¶12. (U) According to the Business Standard, the GOI is also considering tighter export restrictions for pharmaceuticals, including close scrutiny of the exporters themselves and limitation of outgoing pharmaceuticals to ports that have on-site facilities for drug testing. The daily indicated that this move comes in response to the European Commission’s having declared India the leading supplier of counterfeit drugs to the EU.
¶13. (U) GlaxoSmithKline, meanwhile, announced that it has withdrawn its patent application for its antiretroviral combination drug Trizivir, saying that the move was in the public interest and part of a routine review of the company’s patent applications.

Oct 31, 2007 | Turkmenistan | Embassy Ashgabat | Turkmenistan: Eli Lilly Re-enters Market With Diabetes And Cancer Drugs ^[41]

LILLY’S PLANS IN TURKMENISTAN ¶2. (SBU) Eli Lilly Vostok S.A. has decided to re-enter the market here and has initiated the registration process to market its diabetes and cancer treatment medications. The company recently won a tender for diabetes treatment products, based on price. However, because the company has not been active in Turkmenistan, the Ministry subsequently gave the tender to Novartis. Lilly was active in the market here until 2000, but pulled out because of unspecified financial difficulties — possibly related to the difficult business environment, including the dual exchange rate and problems repatriating profits.

Nov 1, 2007 | Thailand | Embassy Bangkok | Fda Chief Expects No More Cl’s ^[42]

¶2. In a courtesy call by Econ Counselor and Econoff on October 25, Dr. Siriwat said he thought there “shouldn’t have to be more compulsory licenses,” but emphasized this was his personal opinion and he could not speak for the Ministry of Public Health. The Ministry is considering breaking patents on four cancer drugs distributed by three European companies, following on the issuance of compulsory licenses on two HIV/AIDS medicines and a heart drug over the last year. The four cancer drugs are distributed by Swiss-owned Novartis and Roche, and French-owned Sanofi-Aventis. Dr. Siriwat said initial discussions beginning October 18 had gone well and companies had responded positively, particularly Roche. Siriwat explained the Ministry’s long-held position that Thailand’s public health system was unable to cover the costs for expensive life-saving drugs and compulsory licenses were necessary to widen access. He assured that generic versions would be provided only to the poor under the RTG’s universal health care program. Dr. Siriwat claimed the Thai program “will actually expand the companies’ market in Thailand,” as those who can afford the drugs, such as patrons of private hospitals and those with commercial health insurance, will still pay the current prices.

Nov 16, 2007 | India | Embassy New Delhi | New Delhi Weekly Econ Office Highlights For The Weeks Of November 5 – 16, 2007 ^[43]

NOVARTIS WINS BATTLE BUT UNLIKELY TO WIN THE WAR
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¶5. (SBU) The Chennai High Court ruled on November 13 that a two-member bench of the Intellectual Property Appellate Board (IPAB) could hear Novartis’s appeal against the decision of the Indian Designs and Patents Office to refuse a patent for its anti-cancer drug Glivec. One of the lawyers involved in the case told Consulate Chennai that the order effectively blocked the participation of IPAB member S. Chandrasekaran, who headed the patent office when it rejected Glivec, before being appointed to the IPAB. Novartis was opposed to Chandresekaran’s participation as an IPAB member reviewing the Glivec case, arguing that he would be biased since he led the patent office that originally rejected Novartis’s patent application. The lawyer added that this judgment would also effectively end Chandrasekaran’s participation in a number of cases before the IPAB. However, the lawyer is still pessimistic about Novartis’s chances for securing a patent for Glivec.

CONCLUSION ———-
¶10. (SBU) Biotech may be touted as Taiwan’s future, but as our interlocutors in the biotech industry asserted, it will neither supplant the information technology (IT) sector nor dominate Taiwan’s future industrial development. As biotech expands, Taiwan could combine its IT strength with biotech in such areas as bioinformatics or computational biology. Serious deficiencies remain in Taiwan’s biotech aspirations, however, including the inability to bridge the divide between patents and marketing, and the lack of legal experts to help certify products for use overseas. This problem goes to the fundamental issue of Taiwan’s corporate structure, which has traditionally been composed of small family-run businesses. In order to see their product reach global markets, the small, highly-specialized firms which dominate Taiwan’s biotech sector have to seek partners with the drug majors. This strategy recently led Swiss drug giant Novartis to sign an agreement with Taiwan authorities to develop biotech through cooperative efforts on clinical trials, drug research, and training. Taiwan needs to attract biotech talent, provide sufficient incentives to retain that talent, convince researchers of the sector’s potential and, most importantly, develop and train legal and IPR experts to complement and support research talent by ensuring innovations are protected and marketed. As Taimed’s Tsai indicated, it may take at least 20 years for Taiwan’s biotech industry to reach maturity.

Jan 3, 2008 | Brazil | Embassy Brasilia | Brazil: Ambassador Finds Opportunties For Public Health Cooperation In Meeting With Health Minister ^[46]

REACHING OUT TO THE PRIVATE SECTOR ¶10. The Minister offered to meet with representatives of the pharmaceutical industry and others in the private sector to brief them on the role he sees they could play in Brazil’s health sector, which would include the topic of intellectual property rights. The Ambassador said he would work with the American Chamber of Commerce in Sao Paulo to arrange for an invitation to speak on this subject early in 2008. The Minister pointed out that the “Mais Saude” has a significant component regarding working with the private sector. For the first time there was a line item in the four-year plan for industry. Moreover, he was pleased to announce that Novartis had just decided to build a US$ 500 million facility in the northern state of Pernambuco, turning down Singapore and Italy.

ROCHE PATENT GRANTED IN INDIA UNDER REVIEW AFTER REJECTION IN U.S.
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¶8. (SBU) Business daily The Mint reported Tuesday that India’s Controller General of Patents is conducting an inquiry into the Chennai Patent Office’s grant of a patent to Roche’s anti-infection drug, valganciclovir, which Roche sells under the name Valcyte. The same drug was refused a comprehensive patent in the U.S. in 1994, on grounds that the drug was neither novel nor non-obvious, though the USPTO did grant a patent for the crystalline form of the drug. The Mint quoted a Roche representative as saying that the U.S. rejection is not relevant because of differing patent laws. However, Roche declined to comment on the fact that Indian Patent Law prohibits the patenting of any drug invented prior to 1995. (Comment: Roche has previously been the subject of some suspicion because it has won patents for drugs believed to be only incremental innovations, while other companies, such as Novartis, have had similar patents rejected. End comment.)

NOVARTIS CASE DELAYED
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¶3. (U) The Indian Supreme Court Monday stayed the order of the Madras High Court regarding the constitution of the Intellectual Property Appellate Board (IPAB) set to handle Novartis’s appeal of its patent rejection for the leukemia drug Glivec. The appeal was scheduled for Monday but will now be delayed until the matter is resolved. Novartis had objected to the inclusion of technical expert S. Chandrasekharan on the IPAB because Mr. Chandrasekharan had been the Controller General of Patents at the time when the original patent application for Glivec was refused. The Madras High Court had subsequently ruled that the IPAB could hear Novartis’s appeal without a technical expert. This prompted generic-drug manufacturer Natco Pharma to appeal to the Supreme Court that an IPAB without a technical expert could not effectively evaluate the case.

Feb 14, 2008 | Thailand | Embassy Bangkok | New Health Minister Promises Review On Compulsory Licenses ^[53]

¶3. (SBU) During his 16-month term in the coup-installed government, former Minister Mongkol na Songkhla issued three compulsory licenses (CLs) on patented anti-retrovirals (for AIDS treatment) and a blood thinner, citing unreasonably high prices and the inability of patients to afford the medicines. In his closing days in office, Mongkol signed authorizations for CLs on four more drugs used to treat cancer patients, though the Ministry has yet to implement the licenses by importing generic copies. The four drugs include Novartis’ breast cancer drug letrozole and its leukemia and gastrointestinal cancer drug imatinib, Sanofi-Aventis’ breast and lung cancer drug docetaxel, and lung cancer drug erlotinib from Roche. (Note: U.S. companies manufacture two of the three drugs originally affected by CLs, the most recent three are made by European pharmaceutical companies.) Although MOPH issued a CL for imatinib, the Ministry stated that it would not exercise the CL unless there were access problems under Novartis’ Glivec International Patient Access Program. Under the GIPAP program, MOPH negotiated a deal for free access to imatinib for any Thai patient who has an income of less than 1.7 million Baht per year. The only CL implemented thus far is for Merck’s efavirenz, though Merck claims that the number of patients using the generic product is a small fraction of the number that Minister Mongkol claimed would be served. Other already issued CLs may be difficult to implement. It is not clear whether a generic exists for Abbott’s Aluvia, and Sanofi-Aventis is engaged in a protracted legal battle in both Thailand and India over implementation of the CL for Plavix.

Feb 23, 2008 | Thailand | Embassy Bangkok | Thailand 2008 Special 301 Submission ^[54]

¶16. (SBU) In the latter half of 2007 the MoPH notified three European pharmaceutical manufacturers that it was considering compulsory licenses on four additional cancer drugs and invited the companies for discussions before making its decision. Little progress was made and in January 2008 the Minister of Public Health announced he had signed compulsory licenses on all four drugs. However, the Ministry stated that it would not exercise the compulsory license on Novartis’ Imatinib as the company had agreed to expand its access program, but left open the option to use the license at a later date if access was impaired.

Mar 28, 2008 | Vietnam | Embassy Hanoi | Tifa Meetings Focus On Trading Rights, Ipr And Market Access ^[55]

PHARMACEUTICAL IP ISSUES AND MARKET ACCESS
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¶15. (SBU) Officials from the Ministry of Health’s (MOH) Drug Administration told the U.S. delegation that pharmaceutical companies (including Swiss firms Novartis and Astra-Zenica) have filed five applications thus far under Vietnam’s regulations for protection of data submitted in drug registration dossiers. All five applications have been denied based on MOH officials’ assessments that the products have been on the market “for years” in other countries and that the data is therefore publicly available and undeserving of protection in Vietnam. MOH officials then described their process for assessing whether each dossier merits protection, including research to see whether the information in the dossier is a trade secret. (Note: Pharmaceutical companies had separately told the delegation that MOH also required them to submit evidence of the costs of their clinical trials so as to prove that the data was the product of “remarkable investments.” End note.) The U.S. delegation expressed concerns that the evaluation process the officials described is not consistent with the system Vietnam explained it would use to meet its WTO and BTA commitments during previous discussions. MOH agreed that it would send the U.S. side an official response describing the reasons for refusal in these five cases and listing the conditions that companies must meet to merit data exclusivity.

¶16. (U) Bisbee also asked the Drug Administration officials for clarification on a recent GVN circular seeking to regulate drug prices in Vietnam by referencing prices for those drugs in other countries in the region. Specifically, he raised concerns that this policy appears to only focus on the drug prices of foreign firms but not those of domestic drug producers. The Vice Director of the Drug Administration Nguyen Van Thanh responded that the circular was passed to avoid “sudden surges” of drug prices in Vietnam and to protect Vietnamese consumers and patients from paying “unreasonably high” prices. Initially insisting that the policy does not discriminate against foreign firms, Thanh ultimately admitted that it puts in place different systems to evaluate the prices used by foreign firms and by those who do not export. He agreed to report this issue to his ministry’s leadership, and will respond to the USG in writing. Thanh also committed to answer U.S. questions about which activities foreign drug companies are permitted to conduct in Vietnam, and to address requests about how Vietnam’s clinical trial requirements (i.e., drug companies can not rely on clinical trials performed in any other country to seek registration in Vietnam) relate to plans for further ASEAN integration on drug registration.

May 1, 2008 | Syria | Embassy Damascus | International Visitor Experience Leads To First Damascus Breast Cancer Walk ^[56]

¶3. [U] The walk received sponsorship from a number of local and international private and public sector institutions, including: Total E&P, MPI (pharmaceutical company), SyriaTel, Syrian Arab Red Crescent, Shami Hospital, Novartis Oncology, Bank Audi, Health World (magazine), Arabesque FM (106.9), Kodak, and Carestream Health. While donations were solicited at the walk, the main goal was awareness rather than fundraising. The government also lent its support. The Deputy Minister of Health, Dr. Mohammad Jamil Al-Owayed, spoke at the finish line about the importance of breast cancer awareness, early detection, and praised the Breast Cancer Society for its work.

Aug 1, 2008 | Russia | Embassy Moscow | Russia Rises As Major Center For Clinical Drug Trials ^[57]

¶2. (SBU) The number of clinical trials approved in Russia grew by 11 percent in 2007 compared to 2006, and by 16 percent in 2006 compared to 2005, according to data compiled by the Federal Service for Health and Social Development (Roszdravnadzor). Russia has emerged as the clear leader among the BRIC countries with a total of 713 FDA clinical drug trials currently on-going (Brazil is in second place with 390 FDA clinical drug trials), according to CenterWatch, a clinical drug trial listing and information service. Some 50 percent of drug trials in Russia are in late-stage, Phase III testing. Foreign firms sponsored over 65 percent of all drug trials approved in Russia in 2007. Leading multinational pharmaceutical companies such as Sanofi-Aventis, Merck, GlaxoSmithKline, Boehringer Ingelheim and Novartis have become leaders in Russia’s clinical drug trials market. The most popular areas of clinical drug trial research are treatments for cardiovascular disease, cancer, psychiatry (including medicines for depression and schizophrenia), and neurology (medicines for multiple sclerosis and Parkinson’s disease).

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Russia’s Advantages in Clinical Drug Research
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¶4. (SBU) The centralized medical system in Russia is perfect for clinical drug trials, because large numbers of patients with similar illnesses are found at the same treatment centers, according to our CRO and pharmaceuticals contacts. The relatively high quality of Russian doctors also means that the quality of the trials is often as good as trials conducted in Western Europe. Although many Russian doctors do not speak English, there are six times more doctors in Russia per capita than in India. The high amount of treatment-naive patients in Russia (i.e., patients who have never before received medicine or treatment for a particular ailment) offers a large pool of potential test subjects that is not available in many other countries.

¶5. (SBU) One CRO representative told us that the main disadvantage of clinical drug trials in Russia is the high customs duties for imports of drugs used in trials. Other experts cite the 1.5-month-long paralysis of the economy during the summer ‘dacha’ season and strict regulations for drug trials from Roszdravnadzor as additional concerns. Even so, the waiting period for trial approvals from Roszdravnadzor is only three months in Russia, as opposed to eight to twelve months in China. Many industry players consider that the high customs duty is offset by the comparatively low costs of conducting drug trials in Russia. The cost savings in Russia stem primarily from the relative ease in recruiting and enrolling large volumes of patients.

Dec 2, 2008 | Switzerland | Embassy Bern | Bilateral Relationships With Switzerland And The Principality Of Liechtenstein ^[58]

(U) Switzerland’s highly advanced and diversified economy has so far proven comparatively resilient in the global financial crisis. The Swiss government estimates that GDP growth will fall from roughly 1.9% in 2008 to a maximum 1.0% in 2009. Switzerland,s GDP in 2007 totaled 512 billion CHF ($450 billion), resulting in a per capita GDP of about $60,000, according to the IMF. Only three percent of Swiss wage-earners take home less that 3,000 CHF per month, and one out of five Swiss pensioners has a net worth of more than 1,000,000 CHF. Unemployment is 2.3%. Switzerland is home to a disproportionate number of large European multinationals, and global companies such as Nestl, Novartis, Roche, Credit Suisse and UBS gave the Swiss Stock Exchange a market capitalization equal to roughly 2/3 that of Germany’s.

¶15. (S//NF) Following is the 2008 Critical Foreign Dependencies Initiative (CFDI) list (CI/KR organized by region):
Novartis Vaccines and Diagnostics GmbH, Marburg, Germany: Rabies virus vaccine

¶4. (SBU) Brazil became a party to the CBD on February 28, 1994. It rushed to put in place rules governing access and benefit sharing of genetic resources. In 1995, Senator Marina Silva proposed legislation to regulate access and benefit sharing. In response to a contract in June 2000 between Novartis and Bioamazonia, the government prepared a Provisional Measure, which was subsequently revised and reissued on August 23, 2001 as Provisional Measure No. 2186-16. Since then there have been various decrees and other implementing rules in the field. The government is working on a proposal for a new and very detailed law about the collection of biological materials and access to and benefit sharing of genetic resources and traditional knowledge. A draft of that proposal was released in 2008 for public comment. The proposal has not yet been finalized for submission to congress. COMMENT. The legislative process in Brazil is usually long and unpredictable So it is unclear exactly when legislation on genetic resources will be enacted by congress. END COMMENT.

Apr 30, 2009 | Nigeria | Embassy Abuja | Nigeria: Counterfeit Meds Enforcement Training In Lagos ^[65]

¶3. (U) Participants were drawn from the Nigerian Customs Service (NCS), the Federal Intellectual Property Law Association of Nigeria (IPLAN), the Standards Organization of Nigeria (SON), and the National Agency for Food and Drug Administration and Control (NAFDAC). Officials from all the major border posts, ports and airports attended. In addition, a cross section of companies attended the IP trade fair – Eli Lilly, Proctor & Gamble, GlaxoSmithKline, Bic, Johnson & Johnson, Janssen-Cilag, Pfizer, Wahl Razors, Beiersdorf, Unilever, Novartis and Sanofi-Aventis. Experts from the World Border Organization, World Customs Organization and Ghanaian Customs Excise and Preventive Service provided their expertise. The Economic and Financial Crimes Commission (EFCC) was invited to participate at the working level but did not.

¶11. (SBU) At the IP trade fair, Eli Lilly, Proctor & Gamble, GlaxoSmithKline, Bic, Johnson & Johnson, Janssen-Cilag, Pfizer, Wahl Razors, Beiersdorf, Unilever, Novartis and Sanofi-Aventis set up stations. Groups of GON officials received 30 minute presentations on specific examples of counterfeit products being sold in Nigeria. The companies demonstrated how to tell the difference between counterfeit and genuine products, and provided check lists and contact information to contact them if officers come across questionable goods. For example, Procter & Gamble explained that legitimate “Pampers” diapers are produced locally in Ibadan and that the company does not produce nor import diapers from Asia to Nigeria. Therefore if Customs Officers observe a shipment of “Pampers” from Asia they should seize it immediately, contact Procter and Gamble and a company rep will come to the location to help with the investigation.

¶12. (SBU) The companies were happy to participate but lamented that much more needs to be done by the GON. Several reps said that from 50-80% of the drugs found in pharmacies in Nigeria are counterfeit.

India Rejects Novartis Patent for Cancer Drug Glivec
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¶12. (U) The Intellectual Property Appellate Board (IPAB) rejected the grant of a patent for Glivec, a drug for cancer treatment developed by German multinational Novartis. Five pre-grant oppositions were filed in the period May-July 2005 against the Glivec patent application. Novartis filed a writ petition challenging the constitutionality of Section 3(d) of the 1970 Patents Act before the Madras High Court. As a result, the Supreme Court ordered GOI to hire a technical member within the IPAB to judge the Novartis appeal to the five opposition orders of the Drug Controller of Indiathat declined to pursue the patent application.
¶13. (U) On June 26, the IPAB ruled against the grant of the patent due to its lack of “significantly enhanced efficacy,” claiming that only “therapeutic efficacy” qualified under Section 3(d) and properties claimed to be displayed by Glivec did not amount to an increase in “therapeutic efficacy”. (Note: IPAB’s decision stands in contrast to Glivec’s approved patents in 35 countries. The court also did not accept additional supporting material from Novartis, stating that only material supplied on the date of applying for the patent could be considered while deciding the present challenge to the Controller’s decision. End Note.)

Aug 10, 2009 | Belgium | Embassy Brussels | Belgium Estimates 900 New Cases Of H1n1; Vaccine Tests Begin ^[69]

FIRST TESTS OF H1N1 VACCINES
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¶3. (U) Belgian press reported on August 10 that vaccines against H1N1 are being tested for the first time in hospitals in Antwerp and Ghent on some 600 healthy volunteers. The test vaccines developed by Novartis will contain different doses of the influenza virus so that researchers can determine the most effective composition. Belgian newspapers report that the first vaccines against H1N1 should be on the market in Belgium in October if everything goes according to plan.

Sep 2, 2009 | Taiwan | American Institute Taiwan, Taipei | H1n1 Highlights Taiwan’s Shortcomings In Risk Communication As Cases And Acrimony Mount ^[70]

Sep 8, 2009 | Germany | Embassy Berlin | H1n1 Update: 17,265 Confirmed Cases ^[71]

Sep 8, 2009 | Chile | Embassy Santiago | Sept. 8 Santiago Media Report ^[72]

Intellectual Property
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¶7. Pharmaceutical laboratory Bago has requested access to information on five pharmaceutical products. The laboratories that own these products — Novartis, Roche, and GlaxoSmithKline – have objected, stating that this entails revealing entrepreneurial secrets and violates intellectual property rights. Bago wants access to the “specifications” that are submitted to the Public Health Institute , claiming the right to public information. Given the complexity of this case, the Transparency Council is looking to U.S. courts and other international organizations for jurisprudence (El Mercurio, 9/6).

Sep 14, 2009 | Singapore | Embassy Singapore | Singapore Pushing R&d And Poaching Talent ^[73]

¶7. (SBU) Many other scientists are lured to Singapore through personal connections resulting from collaborative work and scientific conferences hosted here. Biomedical scientists from Novartis working in Singapore told Poloff that they learned of research opportunities in Singapore through existing collaborative relationships between Singapore institutions and U.S. universities and government agencies (e.g., NIH and the National Science Foundation (NSF)). When the scientists traveled to Singapore for conferences or consultations, they were offered lucrative positions based on the recommendations of the local scientists or institutions. Singapore played host for the second time this summer to U.S. graduate students participating in the NSF East Asia and Pacific Summer Institutes program, and at the opening ceremony the local university faculty made a strong pitch for the U.S. students to consider moving to Singapore for post-graduate work.

Sep 30, 2009 | Oman | Embassy Muscat | Oman Confronts H1n1 ^[74]

Oct 21, 2009 | Ecuador | Embassy Quito | Presidential Decree On Compulsory Licensing Expected Soon ^[75]

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COMMENT AND REQUEST
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¶6. (SBU) Despite Pena’s claim that Correa’s principal interest is access to medicine, we believe that his primary objective is promotion of local production, both on ideological grounds and possibly in response to specific requests by close associates in the local pharmaceutical industry. Among those close associates are Renato Carlo, President of the Chamber of Small Industries in Guayaquil and former President of ALFE, the association of local pharmaceutical producers, and the Ayala family (Rafael and Mauricio) who own Farmayala. Both allegedly contributed financial resources to President Correa’s presidential campaign and Carlo is also a close friend from school. Econ and FCS officers continue to consult with representatives of U.S. pharmaceutical companies and have suggested they present President Correa with data that would help dispel his misperceptions regarding the extent to which wholesale compulsory licensing will yield a substantial increase in local production. The Embassy has also reached out to other diplomatic missions and conveyed an interest in collaborating. Although concerned, neither the French nor the Swiss Missions have yet approached the GoE on the issue. According to our contact at the French Embassy, the local EU delegation is calling a meeting next week with representatives of Member States to devise a common approach. While not a member of the EU, the Swiss Embassy expects to join the EU meeting next week. The major French pharmaceutical companies in Ecuador are Sanofi-Aventis and Salvie; the Swiss companies are Roche and Novartis. The German Mission did not convey a high level of interest in pursuing the issue with the GoE. We will follow up with the British Mission over the next couple days. HODGES

Oct 22, 2009 | Portugal | Embassy Lisbon | Pharma Companies Discuss Portugal Market Issues ^[76]

INDUSTRY GROUP PRESENTS CHALLENGES, SEEKS EMBASSY GUIDANCE
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¶2. (SBU) On September 24 the Charge d’Affaires, Senior Commercial Officer, and Poleconoff attended a roundtable breakfast meeting organized by the Local American Working Group (LAWG) of the Pharmaceutical Association in Portugal. Also in attendance were: UK Ambassador Ellis, Swiss Ambassador Shaller, German Econ Counselor Deichmann, and French Econ Counselor Monne. Company representatives included General Managers from Abbott Labs (U.S.), Amgen (U.S.), Bristol-Myers Squibb (U.S.) Janssen-Cilag (U.S.), Pfizer (U.S.), Merck Sharp & Dohme (U.S.), Schering-Plough (U.S.), AstraZeneca (U.K.), GlaxoSmithKline (U.K.), Bayer (Germany), Novartis (Switzerland), Roche (Switzerland), and Aventis (France).

¶3. (SBU) The LAWG called the meeting to discuss market access issues. In particular, they identified several “key priority” problems with the regulatory environment, including unstable pricing policies, GOP reimbursement delays, capricious and opaque revenue caps, and lax enforcement of patent rights. Although these problems have been repeatedly raised by industry in recent years, this was the first time that the LAWG sought to coordinate its messaging and strategy development with all diplomatic and industry players simultaneously, and is an approach post has urged them to develop.

Oct 30, 2009 | Czech Republic | Embassy Prague | H1n1 Preparedness In The Czech Republic ^[77]

Nov 3, 2009 | China | Consulate Hong Kong | Macau Health Care: Able To Handle Current H1n1, But Concerns About Future Surge ^[78]

Nov 12, 2009 | Serbia | Embassy Belgrade | Serbia Declares H1n1 Epidemic ^[79]

Nov 18, 2009 | Mexico | Consulate Monterrey | Nuevo Leon Projects Increase In H1n1 Cases ^[80]

Nov 20, 2009 | Portugal | Embassy Lisbon | Portugal Pharmaceutical Companies Plan Roundtable Meeting ^[81]

¶2. (SBU) On November 10 the Charge d’Affaires, Senior Commercial Officer, and Poleconoff attended a meeting organized by the Local American Working Group (LAWG) of the Pharmaceutical Association in Portugal. Also in attendance were: UK Ambassador Ellis, Swiss Ambassador Shaller, and German Econ Counselor Deichmann. There were also company representatives from Abbott Labs (U.S.), Amgen (U.S.), Janssen-Cilag (U.S.), Merck Sharp & Dohme (U.S.), Eli Lilly (U.S.), AstraZeneca (U.K.), GlaxoSmithKline (U.K.), Novartis (Switzerland), Boehringer Ingelheim (Germany), and Aventis (France). This meeting followed up on issues discussed in the September 24 meeting (reftel).

Dec 17, 2009 | Dominican Republic | Embassy Santo Domingo | Pharma Industry Laments Lack Of Patent Protection ^[82]

See discussion at: Dominican Republic: December 2009 meeting between PhRMA and US Embassy to discuss CAFTA+ demands on patent protection ^[83]. Novartis plays an important role in this cable discussing pressure on Dominican Republic over drug patents.

¶2. (SBU) On December 2, the ChargC), PolEcon Counselor, and EconChief met with a delegation of pharmaceutical industry representatives who were calling on Government of the Dominican Republic (GoDR) officials to address problems in the patent-approval process. The delegation included: PhRMA (the Pharmaceutical Research and Manufacturers of America), Mary Fernández Rodríguez ^[84], the group’s local counsel.

Jan 22, 2010 | Serbia | Embassy Belgrade | Serbia: Almost 700 Confirmed Cases Of H1n1 Influenza; Low Demand For Vaccine ^[85]

Jan 26, 2010 | Austria | Embassy Vienna | 2010 Investment Climate Statement For Austria ^[86]

Feb 10, 2010 | Vietnam | Consulate Ho Chi Minh City | Hcmc Economic Police Strike Again, Making Grab For Fake Viagra ^[87]

^[88] ^[89] ^[90]