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TWN Info Service on Intellectual Property Issues (Oct06/02) 10 October 2006
Below is a selection of interesting news articles. The
first story is about debate in The
second story is regarding the pressure by a senior health official from
US, William Steiger (who also happens to be President HW Bush's godson)
to withdraw a WHO-sponsored publication that is critical of The
third story is about an appeal by Novartis in Finally, a story by BBC on Merck’s sales tactics that has resulted in it being suspended from the Association of the British Pharmaceutical Industry. Best
Wishes
Date: 05/10/2006 URL: http://www.thehindu.com/2006/10/05/stories/2006100502911100.htm Opinion - News Analysis: DATA EXCLUSIVITY AND NATIONAL INTEREST Sarah Hiddleston In an exercise in non-transparency, the UPA Government is set to concede Data Exclusivity privileges to pharmaceutical multinationals and amend drug registration laws without public debate. IN
A major win for multinational pharmaceutical companies, the government
looks set to alter the laws that govern drug registration in After more than four months of debate behind closed doors, the Satwant Reddy interministerial committee is expected to recommend that India's drug regulatory authority is enlisted in the protection of multinationals' clinical trial data for five years. The Drugs Controller General of India (DCGI) will be prevented from checking the safety of generic competitor drugs against an originator's clinical trial data through theoretical proof of bioequivalence. Multinational companies, backed by the United States, claim that this constitutes "unfair commercial use" under the ambiguous Article 39.3 of the World Trade Organisation's Trade Related aspects of Intellectual Property Rights (TRIPS) agreement. Opponents, referring to the opinion of legal experts, contend that this clause was meant to prevent industrial espionage and not provide exclusive rights. They argue that DE will force generic competitors to delay the production of generics at low prices, and that this is not only anti-competitive but has serious implications for the price and availability of medicines. The minutes of the committee meeting of September 6, which are with The Hindu , show that representatives from the Departments of Health, Economic Affairs and the ICMR strongly oppose DE measures for the reasons stated above. In response the Department of Industrial Policy and Promotion has suggested seven safeguards. Four of the safeguards go some way towards limiting the scope of DE provisions. Two allay fears of blanket application regardless of the innovativeness of the drug or public health emergencies; they restrict application to "new chemical entities not previously used in any other application" and allow for a waiver in compulsory licensing cases. Two other safeguards act against the incentives DE would create to a) delay the introduction of originator drugs into the Indian market, and b) sell them at high prices; they date the start of the DE period from the first date of marketing exclusivity anywhere in the world and recommend price checks to ensure accessibility. The remaining safeguards, however, fail to address the issues they attempt to resolve. Further, they highlight the complications involved in attempting to integrate two different legal and regulatory systems with separate functions, namely patent protection and market registration. First,
DE will apply with "prospective effect" only to new chemical
entities developed after Secondly, the period of the DE protection term will not exceed the patent term. However, this creates a link between drug registration and patent registration that is administratively difficult and ethically questionable. It will require the DCGI to verify the patent status of each product and develop the expertise to assess whether the patent is valid and will be infringed. It also provides a loophole for DE on drugs with patents that are later challenged and proven invalid. More importantly, this link will require the DGCI, a national regulatory body, to stand in judgment on a private right; patents should be enforced by the right holders, not a government authority. Thirdly,
a mechanism will enable the domestic pharmaceutical industry to manufacture
generic drugs for export to countries without DE laws, but deny market
access in The Satwant Reddy Committee report will be submitted within the next 15 days, after which a draft bill amending the Drugs and Cosmetics Act will be drawn up. Recognising
the difficulties of grounding the changes in the grey area of Article
39.3, the committee is instead likely to justify DE in terms of If the Government is genuinely committed to acting in the national interest, it should make the amendments public and invite democratic debate. © Copyright 2000 - 2006 The Hindu _________________________________________________ http://www.ip-watch.org/weblog/index.php?p=409&res=1024_ff&print=0 US
SEEKS REVIEW OF WHO PUBLICATION POLICY AFTER REPORT ON 28/9/2006 By Tove Iren S. Gerhardsen
A
senior “The WHO Secretariat’s decision to publish the South Centre report seriously undermines my confidence in the veracity and reliability of assurances I received from senior staff in the Office of the Director General,” William Steiger, special assistant to the secretary for international affairs at the US Department of Health and Human Services wrote to Acting WHO Director General Anders Nordström in August. The letter <http://www.ip-watch.org/files/28-09-2006%2016;21;26.PDF>, obtained by /Intellectual Property Watch/, asserts that the joint report of the WHO and the South Centre, the Geneva-based intergovernmental group of developing countries, “spuriously characterizes the trade policy of the United States as a threat to public health, and it makes unnecessarily inflammatory and prejudicial recommendations as to how the United States can improve its trade policies.” It also “singles out several member states for criticism,” Steiger said. Steiger said he would address the specifics of his charge in a subsequent letter to Nordström. In the meantime, however, he asked Nordström to “withdraw this publication and remove the WHO logo from it.” The report has been in the public domain for a year but was only recently published in hard copy. The study entitled, “The use of flexibilities in TRIPS by developing countries: Can they promote access to medicines?” was co-published by the WHO and the South Centre, the Geneva-based intergovernmental organisation. It was co-authored by the South Centre’s Sisule Musungu and WHO’s Cecilia Oh. The WHO declined to comment, as it normally would not comment on a letter from a member state, a WHO spokesperson said. The department that Oh works in, which is responsible for intellectual property issues, said it had not been informed about the letter. Oh declined to comment for this story. The study was published during the comment period of a WHO intellectual property rights commission that led to the creation of a new WHO intergovernmental group on IP rights and public health still being set up this autumn. The new group’s secretariat is now headed by Howard Zucker <http://www.who.int/dg/adg/zucker/en/>, the assistant WHO director general for health technology and pharmaceuticals, who also worked at the Health and Human Services Department where Steiger works, which has raised concern among some sources that possible undue pressure could be imposed on the IP project. Musungu,
one of the authors, told /Intellectual Property Watch/ that the letter
reveals /Intellectual Property Watch/ tried to reach the HHS on numerous occasions but was not able to get a comment by press time. Zucker’s office said he is currently travelling. He also previously cited the WHO’s “lack of competence in this area and its failure to consult with other relevant international organisations, such as the World Trade Organization and the World Intellectual Property Organization.” Steiger said he wrote on 30 March 2004 to former WHO Director General Lee Jong-wook regarding his office’s “lack of review of the various reports and studies” the WHO publishes. He said he was then assured that a review process had been set up, which is why he is “dismayed to see the publication on flexibilities” that are available to developing nations to use for public health reasons under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Steiger said he expects a “full review” of the WHO’s publication policy at the Executive Board meeting scheduled for January 2007. Study Requested by Independent WHO IP Commission One source questioned Steiger’s argument that the WHO does not properly review what it publishes as the study was in fact commissioned by the WHO in October 2004. It was part of the consultation round leading to the WHO report by the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which was published in April 2006. Twenty-two studies were commissioned by the CIPIH, and have been listed on the CIPIH’s website <http://www.who.int/intellectualproperty/studies/en/>, although some of them are not linked. A draft version of the study in question was presented at a workshop at the WHO in May 2005, first for an expert panel and later for all interested parties, two attendees said. It was also available on the CIPIH’s website. The four topics of the workshops were: disease burden, intellectual property, innovation and capacity building, according to the CIPIH website. The South Centre study was presented under “intellectual property” along with eight other expert presentations. Two of the other presenters from that panel said that they had not been commissioned to do a study but had been given a topic by the CIPIH and provided an expert view. A member of the WTO secretariat chaired the IP session on these nine studies on 30 May, 2005, a source said. The final study was ready in August 2005. Musungu, who said he had not been informed about the letter by the WHO, said the WHO commission asked the authors to analyse the use of TRIPS flexibilities by developing countries. They were further asked to examine the potential effects of bilateral and regional free trade agreements with regards to possible impact on public health, and analyse recent agreements. The South Centre and the WHO split the publishing costs of the report, which was published under a South Centre report series, and 4,000 copies were made, Musungu said. He said the CIPIH secretariat had given the go-ahead to publish the study. The study and the CIPIH report lead to a resolution which again has led to the setting up of an intergovernmental working group on intellectual property rights at the WHO (/IPW/, Public Health, 19 September 2006 <http://ip-watch.org/weblog/wp-trackback.php?p=398>). It is expected to meet for the first time on 4 December. AS
NOVARTIS CHALLENGES New
Delhi/Geneva, 26 September 2006 – A challenge against Novartis is challenging a crucial part of the Indian law that protects patients from the patenting of trivial improvements of known molecules. Novartis is also seeking to have the January 2006 decision to reject its patent application for the cancer drug Gleevec reversed and is seeking review by the Chennai High Court. “If
Novartis’ challenge against the Indian patent law is successful, a key
safeguard that can protect the production of affordable medicines will
be lost,” said Ellen ‘t Hoen, Policy Director at MSF’s Campaign for
Access to Essential Medicines. “People the world over who rely on Organization
rules on intellectual property. The Indian patent law has strict criteria
regarding which inventions qualify for patenting, and allows for any
party to oppose a patent before it is granted. In 2005, cancer groups
filed the first ever ‘pre-grant opposition’, against Novartis’ patent
application for Gleevec. MSF has supported similar oppositions filed
by patient groups in “The
public health safeguards of the Indian Patent law have given hope to
many who depend on generics manufacture. The Novartis litigation is
a direct challenge to those safeguards,” said Leena Menghaney, MSF Campaigner
in Novartis claims that Section 3(d) of the Indian Patents Act is not compliant with the WTO rules outlined in the agreement on Trade-related Aspects of Intellectual Property (TRIPS). Section 3(d) formed a substantial part of the basis on which the Gleevec patent was originally denied. Many public interest and health groups will be watching the case closely, as the Gleevec patent order set an important precedent for the examination of other drug patent applications. Background NOVARTIS
FILES CASE IN CANCER PATIENTS DEMAND WITHRAWAL OF CASES On 17th May 2006 the Swiss pharmaceutical company Novartis Ltd. filed two cases, challenging both the Indian patent office’s rejection of its patent application for the cancer drug imatinib mesylate (brand name Gleevec), and the section of the new Indian patent law which formed the basis of the patent office decision. Imatinib mesylate (Gleevec) – A Drug for Cancer Treatment Imatinib mesylate (Gleevec) is a cancer drug used in the treatment of Myeloid Leukemia (cancer of the blood). It is produced and marketed internationally by the Swiss pharmaceutical company Novartis and various Indian pharmaceutical companies, such as Cipla, Hetero, Natco and Ranbaxy. Novartis
sells Gleevec at Rs. 1,20,000 ($ 2500) per patient per month in In
1998, Novartis filed an application in the Chennai Patent Office for
a patent on imatinib mesylate (Gleevec). At that time, The
latter scenario applies to the Gleevec patent application. Cancer patient’s
access to generic Gleevec affected The EMR operated like a patent monopoly,
preventing Indian pharmaceutical companies from producing affordable
generic versions of imatinib mesylate. Producers of generics were forced
to withdraw the production and sale of generic versions of the drug
in Cancer Patient Group files Patent Opposition In
2005, Indian patent office of Chennai. The Indian Patents Act allows for any person or group to oppose a patent application before it is granted and the Cancer Patients Aid Association filed an opposition on behalf of cancer patients in the Chennai patent office Chennai Patent Office rejects Gleevec patent application In January 2006, the Chennai Patent office rejected Novartis’ patent application on the grounds that the application claimed 'only a new form of a known substance.’ This order of the Chennai patent office brought relief to thousands of cancer patients as it not only prevented a patent monopoly until 2018, but also automatically cancelled the EMR Affordable versions of imatinib mesylate became unavailable after Novartis was granted the EMR.. The Gleevec patent order rejecting a 'new form of a known substance' also set an important precedent for the examination of other patent applications claiming only improvements of known molecules, including antiretroviral medicines to treat AIDS. Novartis challenges Patent Order and Indian Patent Law On 17 May 2006, Novartis filed two sets of cases in the Chennai High Court. The first case challenges the order of the Chennai Patent office, which rejected the Gleevec patent application of Novartis, following a pre-grant opposition by the Cancer Patients Aid Association. Legal representatives of the Cancer Patients Aid Association will appear on their behalf before the Chennai High Court. Novartis' constant litigation renews fears about the future availability of drugs if the patent case of Gleevec is reopened. Further, it has raised serious concerns among other patient groups, as the Gleevec patent order set an important precedent for the examination of crucial drug patent applications including those for AIDS treatment. The second case filed by Novartis challenges the constitutionality of section 3(d) of the 2005 Indian Patents Act, which was specifically introduced by the Indian parliament as a safeguard against the misuse of the product patent regime. Novartis in its petition is claiming that the section is not in compliance with the TRIPS Agreement and hence should be declared unconstitutional. Section 3 (d) of the Indian Patent Law - an important public health safeguard. The
section is aimed at preventing pharmaceutical companies from obtaining
patents on trivial improvements or new medical uses of known molecules.
When Section 3 (d) is an example of such a provision. --------------------------------------------------- http://news.bbc.co.uk/1/hi/health/5399444.stm DRUGS FIRM’S TACTICS REPRIMANDED A major drugs firm has been named and shamed over "serious breaches" of the industry's code of conduct. Merck
Sharp & Dohme Ltd, the Merck offered GPs help screening blood pressure patients, but the service was only available to doctors which used its blood pressure drug, Cozaar. Merck said it regretted the situation and took the reprimand seriously. We are working hard to reaffirm our core values and standards, and restore confidence and pride in our business practices Chris Round, managing director of MSD It is quite common for drug firms to offer such a service, but by only offering it on such a limited basis, Merck was in breach of clause two of the code. Suspension
- for a minimum of three months - means that MSD UK will be refused
involvement with the ABPI, the trade association for more than 75 companies
in the During the course of the investigation, the ABPI found MSD used Cozaar logos and called the venture the "Cozaar Nurse Audit Programme". It was alerted to the breach by a former MSD sales representative who noted the logos were used on slides for the programme. The Panel of the Prescription Medicines Code of Practice Authority (PMCPA) - which administers the ABPI Code of Practice - found that internal company documentation clearly linked the programme to the promotion of Cozaar and said the plan was "totally unacceptable". Standards Nigel Brooksby, president of the ABPI, said: "The highest possible ethical standards are required by the pharmaceutical industry in all its relationships with healthcare professionals and other stakeholders. "Breaches of the code are viewed in the most serious possible light, and this is reflected in the suspension. "However, it is reassuring to note that MSD also recognises the seriousness of the breaches, and is taking action to prevent their recurrence." Chris
Round, managing director of MSD "We are working hard to reaffirm our core values and standards, and restore confidence and pride in our business practices. "Our values and standards are not only the foundation of our company and all that we stand for, but they are the basis of our success. They always have been and they always will be."
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