Nearly every day I’m beset by news about high drug prices and how patents are to blame, at least in large part. There is little dispute about high drug prices - statistics reveal the bad news about how the consumer in the U.S. pays more for medications than anywhere else in the world. What has been difficult for me to understand is the connection between drug prices and health care, even assuming that patents are to "blame" for high drug prices.
An opinion article in "Business Day" that was posted online ("South Africa: ‘Ethical’ Drugs Miss Heart of Matter" ) effectively debunks the cause and effect of patents and lack of access to medicines, instead maintaining that "the price of medicines is only of marginal relevance to health care in poor countries." Among the several examples used to support his case, India is highlighted. The author points out that despite India’s government prohibiting patents for pharmaceuticals - in the belief that it would reduce costs of drugs - poor people in India still lack basic health care. Furthermore, even though drug prices did decrease, in 2005, only an estimated 12,000 of 5 million AIDS patients receive the cheap AIDS drugs. The problem is the health-care infrastructure.
The poor in the U.S. suffer from similar circumstances. Just this morning on CNN Heath report, I learned that although black women have breast cancer at 1/2 the rate of white women, a black woman is twice as likely to die from the disease. The reason is not due to genetics or more aggressive cancers in black women, but simply from lack of information, and especially lack of support services. (Watch video on topic )
The debate on the evil, or at least non-humanitarian, consequences of patents only serves to sidetrack from the real issue.No tags for this post.
The May 2006 issue of the Bulletin of the World Health Organization (WHO) contains many articles on health, treatments and intellectual property. Link
Volume 84, Number 5, May 2006, 337-424
IN THIS MONTH’S BULLETIN
WHO’s Commission on Intellectual Property Rights, Innovation and Public
Health; Open access and copyright as alternatives to patents; Access to
medicines as a human right; Should genes be patented?; Access to
life-saving medicines stumbles on trade rules; Rich and poor countries
divided on patent treaty; Meeting the need for treatment: the
initiatives; Bulletin interview: do patents work for public health?
In 2001, at a WTO (World Trade Organization) meeting in Doha, Qatar, a declaration by member countries gave voice to world health problems and provided a mandate for implementing a solution within the framework of the TRIPS (Trade-related aspects of intellectual property) agreement to facilitate access to medications.
…we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.
The solution finally forged was to waive the restriction in TRIPS with respect to
pharmaceutical patents that products made under compulsary licenses
must be "predominantly for the supply of the domestic market" of the
Member country granting such a license. The waiver has now been made permanent.
In a previous post, "The Public Patent Foundation Requests a Re-exam of the Latest Axel Patent", I reported that Columbia University had acquired and was enforcing a new patent (US Patent 6,455,275) claiming co-transformation of CHO (Chinese Hamster Ovary) cells. CHO cells are frequently used in the production of human proteins.
The litigation involving a handful of companies that balked at paying more royalties has taken an interesting turn; Columbia U has agreed to not enforce the patent against the companies (covenant not to sue). The patent has not been invalidated however, and the re-examination of the patent continues at the US Patent and Trademark Office.No tags for this post.
Who owns key aspects of RNAi technology in Australia and the United States is being contested. In Australia, Nucleonics, Inc. has filed a request for reexamination of Benitec and CSIRO owned Australian Patent No. 743316, citing 24 prior art documents to support their claim that the patent is invalid for lack of novelty and lack of an inventive step among other reasons. In March 2004 in the United States, Benitec sued Nucleonics and others for infringement of their U.S. Patent No. 6,573, 099. Benitec has also filed an opposition in Australia to a seminal patent in the field, the Fire/Mello patent, which is licensed to Nucleonics. Another opposition in Australia, to a Syngenta RNAi patent, has been filed by both Benitec and CSIRO. Because RNAi is such an important new technology, it is likely that more challenges will emerge.
RNAi is post-transcriptional gene silencing, an event in which genes are stopped from expressing in a sequence-specific manner. The silencing is mediated through targeted mRNA degradation. RNAi is believed to offer potential solutions to turning off genes involved in a variety of unwanted conditions, including viral diseases and cancer.No tags for this post.
A recently issued patent US Patent No. 6,781,030, that has claims for methods of cloning mammals, including humans, has been criticized by some (see, 68 PTCJ 485, 27.08.2004), as violating a Congressional amendment barring funding for patents “on claims directed to or encompassing a human.” The US Patent and Trademark Office (USPTO) has responded to these charges, insisting that the ‘030 patent does not violate the Congressional Amendment to the Consolidated Appropriations Act, 2004.
The USPTO looked to the Congressional Record that contained discussions of the amendment. In the Record, the sponsor of the Amendment clarified that it would not “affect claims directed to or encompassing … methods for creating, modifying, or treating human organisms.”No tags for this post.
IP Strategy Today is an on-line journal published by bioDevelopments-International Institute, in collaboration with individuals at SWIFTT with financial support by the Rockefeller Foundation. The latest issue contains three articles dealing with intellectual property rights and human health issues:
(1) Keusch GT. 2004. Intellectual Property and Licensing and their Impact on Global Public Goods for Health Options for Public Sector and Academic Leadership. IP Strategy Today No. 10-2004. pp. 1-22.
(2) Saha R, K Satyanarayana and CA Gardner. 2004. Building a “Cottage Industry” for Health (and Wealth) The New Framework for IP Management in India. IP Strategy Today No. 10-2004. Pp. 23-58.
(3) Oehler J. 2004. The Role of Milestones in Licensing Deals to Assure Access to Health Products in Developing Countries. IP Strategy Today No. 10-2004. Pp. 59-70.