IP law update
- Biotech patents need no further guidelines: EU report
- Cancer drug patents to begin expiring
- China approves generic anti-AIDS drug whilst patented
- Pharmaceutical patent extension policy review announced
- Report argues patent laws not helping poorer countries
- US genome sequence patents surpass all other countries
Biotech patents need no further guidelines: EU report
12 September - In a European Commission report to be published later this month, the need for further guidelines on the biotechnology patenting directive is to be rejected. Instead, the Commission is to focus upon the scope of protection for DNA sequences, and the possibility of obtaining patents arising from human stem cells.
[Source: Research Europe; SPIN News]
Cancer drug patents to begin expiring
16 September - Analysts have announced that cancer drugs worth more than US$15bn are to lose patent protection over the next decade. Drugs which are scheduled to cease being protected include AstraZeneca's Tamoxifen, which is to lose US protection in February next year. The drug, representing a high standard in both prevention and treatment of breast cancer, generated US$1,024m of sales in 2001. Also to cease protection (in 2004) is Bristol-Myers Squibb's platinum-based drug, Paraplatin, used in the treatment of ovarian and lung cancers. The end of patent protection is expected to see a significant number of new generics enter the market, making drugs more available to developing countries. The analysts also note that the launch of generic equivalents such as cancer drug paclitaxel (a generic version of Taxol) has already been very successful.
[Source: Reuters Health - Richard Woodman]
China approves generic anti-AIDS drug whilst patented
16 September - Chinese pharmaceutical company Desano Shanghai has announced it has received permission from Government regulators to manufacture a generic version of the anti-AIDS drug, ddl, currently protected in China by a patent owned by Bristol-Myers Squibb. The drug is currently widely used, as it slows the effects of AIDS. The exemption has been granted because the US company's patent only extents to the tablet form of the drug. Desano's generic version of ddl is seemingly exempt, as it is a powder. However commentators have speculated that the express Government approval may indicate efforts on behalf of the Chinese Government to pressure foreign drug-makers to lower their prices for imported drugs to treat endemic diseases such as AIDS, which affects over one million Chinese.
[Source: Associated Press - Martin Fackler]
Pharmaceutical patent extension policy review announced
18 September - The Australian government is to review policy considerations surrounding pharmaceutical patent extensions and springboarding arrangements. The review will primarily investigate the reasons behind patents expiring later in Australia than in comparable countries, which prevents the manufacture and export of generic drugs and could prevent Australia from developing export opportunities. It will also consider the effectiveness of springboarding arrangements and options for providing generic pharmaceutical manufacturers with access to export markets, once the term of the Australian patent has expired. A discussion paper and terms of reference have been released, and submissions in response to these are invited. Options considered in the discussion paper include:
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Amending the Patents Act to peg the expiry of the patent extension to the earliest date of regulatory approval in countries like the USA and in the EU;
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Amending the Patents Act to peg the expiry of the patent extension to the earliest date of patent extension expiry in a comparable country; and
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Amending the Patents Act to allow an exception to infringement, for export during the patent extension period.
Copies of the discussion paper and terms of reference can be obtained by contacting Rodney Cruise.
[Source: IPmenu.com]
Report argues patent laws not helping poorer countries
14 September - A new report by Britain's Commission on Intellectual Property Rights argues that intellectual property regimes in developed countries are contributing to poorer countries remaining in a poor financial state. The report claims that TRIPS has not been effective in reducing the "gap" in access to medications between the developed and developing world. To combat this problem, the report's authors argue a need for IP laws to be relaxed and adapted, to assist developing countries to gain effective access to technology, medicines and research. Measures could include such countries setting their own "patent agendas" and allowing access to generic versions of drugs still under patent protection. Additionally, diagnostic and surgical methods should be excluded from patents. Companies that share technology with poorer countries should be rewarded, perhaps with tax breaks.
[Source: BMJ - Zosia Kmietowicz]
US genome sequence patents surpass all other countries
17 September - A new US National Science Foundation report has detailed how between 1980 and 1999, US-based companies and academic institutions filed more international patent applications for human genome sequences than all other countries combined. The report was based upon international patent families, covering inventions (a patented genome sequence) for which IP protection has been sought in more than one country - counting in this way makes international comparisons more accurate. US organisations filed 5,610 patent family applications during this time, compared with 989 from 12 EU countries. An additional 1,211 international patent family applications were filed by 18 non-EU nations. The report also indicates that in the US and EU, corporations dominate DNA patenting overall, but that the type of organisation actively patenting sequences varies from country to country. In contrast, in countries including Australia, Canada and China, many more universities than corporations apply for DNA patents.
[Source: GenomeWeb]
