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Drug Patents Under the Spotlight. Sharing practical knowledge about pharmaceutical patents
(2003; 40 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. Four key concepts to understanding drug patents
Open this folder and view contents3. The patent system should respond to countries' public interest
View the document4. How to read and use the patent table
View the document5. Conclusions
View the document6. References
View the documentAnnex A - Patent Table
View the documentAnnex B - The anatomy of a patent
 

6. References

[1] Integrating Intellectual Property Rights and Development Policy, Report of the Commission on Intellectual Property Rights, London, September 2002. The full report is available at www.iprcommission.org

[2] For explanations of these terms, see e.g. www.accessmed-msf.org

[3] Médecins Sans Frontières and the Drugs for Neglected Diseases Working Group, Fatal Imbalance - The Crisis in Research and Development for Drugs for Neglected Diseases, Geneva, September 2002.

[4] Médecins Sans Frontières, Untangling the Web of Price Reductions - A pricing guide for the purchase of ARVs in developing countries, Geneva, December 2002.

[5] UNCTAD, The TRIPS Agreement and Developing Countries, New York and Geneva, 1996.

[6] Professor W.R.Cornish, Intellectual Property: Patents, Copyright, Trade Marks and Allied Rights, Sweet and Maxwell, 4th ed 1999, section 5-70.

[7] In the UK, see e.g. Merill Dow Pharmaceuticals Inc v H.N.Norton & Co 1996 RPC 76.

[8] For further discussion, see e.g. C.Correa, Trends in drug patenting: Case studies, Corregidor, 2001.

[9] Indeed an advertisement for a conference in 2002 in London (" Legal Strategies for Maximising Pharmaceutical Patent Life Cycles") included a session on " Extending Patent Life By Patenting Beyond the Basic Compound Claim: Which Patents Are Enforceable?". Topics to be discussed include "What are the latest types of patent claims to be filed beyond the basic compound claim? How enforceable are these claims? How do they stand up in court? Claims to formulation, process, product by process, polymorph, metabolite, patenting means of delivery, dosage regime, patenting combination therapies (what support is needed to patent? Is there a need for clinical trials to show benefit?), second medical use claims (new indications, what will the EPO currently let you get away with?)".

[10] C.Correa, Integrating Public Health Concerns into Patent Legislation in Developing Countries, South Centre, 2nd edition, Geneva, September 2001. TRIPS Art 27.1 states that "Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application…". TRIPS does not limit how each of the inventions in the list above must be seen i.e. whether they have to be seen as new, inventive or industrially applicable. TRIPS Art 27.3 states that "Members may also exclude from patentability (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals". Patent applicants have been tireless in trying to find ways round this (optional) prohibition. Note that this exclusion only applies to methods and not to products relating to those methods. Diagnostic kits for HIV testing may be patented as products even though the method of diagnosis itself may not.

[11] There is such a thing as an international patent application however. A system is administered by WIPO under the Patent Cooperation Treaty (PCT) which allows the filing of international (or "PCT") patent applications. When a PCT patent application reaches a certain stage in the PCT patent application process however it "splits" up into national/regional patent applications.

[12] There are four regional patent offices worldwide, that have been established by a treaty amongst the countries of the region, and that grant regional patents (the European Patent Office or EPO, the Eurasian Patent Office or EAPO, the African Regional Industrial Property Organization or ARIPO, and the African Organization of Intellectual Property or OAPI in French). In OAPI, only regional patents valid for all member countries can be granted, whereas in EPO, EAPO or ARIPO countries, patents may be applied and granted either nationally or regionally.

[13] For example, in South Africa, 42 pharmaceutical companies sued the Government on the motive that the proposed Medicine Act was unconstitutional. This is different from the dispute that arose between the US and Brazil in 2001, where the US was complaining that compulsory licenses provisions of the Brazilian patent law were not compliant with the TRIPS Agreement (although they finally abandoned the case in the course of negotiations).

[14] A good example of which is the American pharmaceutical industry association PhRMA and its annual reports to the US Trade Representative (the so-called "Special 301" submissions) where it can and often does call on the US government to take action against countries whose patent laws are not thought sufficient for its Members' needs.

[15] With the exceptions of customs authorities assisting patent holders at borders (TRIPS Articles 51-60) and potentially criminal procedures (TRIPS Article 61).

[16] Although action can also be taken if a patent holder has strong fears that a patent infringement is going to take place. TRIPS Article 50.1 provides for such "provisional measures". If it is too easy to obtain injunctions, major practical problems may arise.

[17] E.g. article 130 of the Indonesian Patent Law 2001.

[18] TRIPS Art. 6 and 30.

[19] Paragraph 5(d).of the Doha Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2).

[20] Ibid 1, p. 119.

[21] A mechanism can be provided as well which allows opposition to the grant of a patent before it takes place.

[22] TRIPS Article 32 provides that "An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available".

[23] Ibid 1, p. 114, and ibid 10.

[24] Ibid 1.

[25] For example WIPO Nationally Focused Action Plans (NFAPs).

[26] It seems that the European Patent Office guidelines for patent examiners are widely used in many patent offices.

[27] See e.g. the letter from Sir Leon Brittan, Vice-President of the European Commission, to Thabo Mbeki, Vice-President of South Africa, March 23rd 1998 (on file with the Chicago Journal of International Law).

[28] See the report from a conference by MSF, the Consumer Project on Technology, Oxfam and HAI in April 2001. http://www.accessmedmsf.org/upload/reportsandpublications/26420021519443/report.pdf

[29] Correa, C. and Musungu, S.F. The WIPO Patent Agenda: The Risks for Developing Countries, South Centre, Geneva, November 2002.

[30] Ibid 10, p. 47.

[31] This will be used as an example as the TRIPS Agreement provisions on patentability were substantially modelled on those of the EPC. Also, many other patent offices use the EPO Guidelines for Examination as a guide in the application of their own law. For the text of the EPC see http://www.european-patent-office.org/legal/epc/index.html and for Guidelines as to its application in practice see http://www.european-patent-office.org/legal/gui_lines/index.htm.

[32] Or before the priority date where available, in accordance with Art 89 EPC.

[33] Where it would be possible to learn how the product works from the sole examination of the product.

[34] It will be assumed for this discussion of novelty and the other sections below that the patent application is being examined by a patent examiner before being granted but this is not always the case and the same considerations apply to e.g. a patent judge testing a patent in court.

[35] Ibid 1, p. 116.

[36] Countries that have not signed the Paris Convention have generally included provisions acknowledging the right of priority in their patent legislation. Article 2.1 TRIPS now obliges WTO Members to comply with "Articles 1 through 12, and Article 19, of the Paris Convention (1967)" (which includes priority issues) whether or not they have signed the Paris Convention.

[37] The "state of the art" is the same general concept as the one applied for novelty, except that it excludes patent applications filed but not published.

[38] See also e.g., "person of ordinary skill", ibid 10, p. 44.

[39] See e.g., EPO Guidelines, CIV, 9.6

[40] Although not every country requires an unexpected effect. Ibid 10, p. 44.

[41] Ibid 1, p. 116.

[42] Watal, J. Intellectual Property Rights in the WTO and Developing Countries, Kluwer Law International 2001, p. 104.

[43] Ibid 10, pp.20-25.

[44] EPC Art 54(5).

[45] The Swiss claim deals with a situation where a known compound is already known to have a medical use. A medicine may have been made using that compound for the known medical use. Now somebody finds that the medicine can also be used for a different medical use (i.e. a second or subsequent medical use over the one already known). Can they obtain patent protection? The new medical use looks a lot like a method of medical treatment, which is not patentable in Europe. In a remarkable "smoke and mirrors" flourish, the Swiss patent office decided to allow a patent claim for this which was aimed at the process of manufacturing the medicine (even if it was exactly the same process as for manufacturing the medicine for the first medical use) seemingly deciding that it became new just because the medicine is now used for a different purpose than before. Many people have said that pretending this is about a manufacturing process instead of a method of medical treatment is just a way too get round the ban on patenting methods of medical treatment in Europe. Despite these and other objections, Swiss claims are now allowed in Europe and elsewhere.

[46] In the UK, "In the interests of common progress, the Patents Court proceeded to accept the same casuistry [as EPO and the Swiss Patent Office]", ibid. 6, section 5-75.

[47] In the UK it was "not within the "second medical use" exception to claim a medicament so formulated that it would release the drug taxol over three hours instead of 24, thus reducing its side effects", ibid. 6, section 5-76.

[48] Ibid 42, p. 105.

[49] The Andean Community includes Bolivia, Colombia, Ecuador, Peru and Venezuela.

[50] Industrial Property Act, 2001, section 21(3)(e).

[51] Ibid 1, p. 50.

[52] The drug had been patented by Pfizer in Peru for several years to control the symptoms of angina, a heart condition.

[53] For more on this case, see Patents and Medicines in Peru, an MSF document available at www.accessmed-msf.org

[54] Note that the TRIPS Agreement uses the term "person skilled in the art" in Art 29 but not Art 27.

[55] An important practical point about the disclosure in the patent application is that it is aimed at telling the public how to carry out the invention. It doesn't have to explain why the invention works (an applicant may not know this), just what has to be done to make it work. When pharmaceutical companies apply for patents they will file their patent applications at a very early stage in the life of the invention. By the time they establish their priority date for an invention they will not know all that there is to know about the invention so obviously they cannot include all the information in the patent application even if they want to. A practice has developed in e.g. the European Patent Office that patent applicants are allowed to file extra material in support of the invention described in the patent application whilst the patent application is being examined. This extra material cannot be used to change what the invention is but can apparently be used to help prove that the invention is indeed inventive. This extra material goes on the public file at EPO but is not officially part of the patent document, so if and when someone looks at the patent document they will not see this extra material. This practice deserves to be scrutinised further vis-à-vis what developing country patent offices allow.

[56] The issue of translating patent documents into all necessary languages causes much political trouble in Europe. Some people believe that all technical people in Europe should be able to read English (or at least one of English, French and German) so there is no need to translate European patent documents into all European languages to get patent protection for all of Europe. Others say that language of publication is a fundamental part of the patent bargain and cannot be ignored and that a translation is little enough to ask for 20 years of monopoly rights.

[57] Another optional requirement in TRIPS Article 29 is that an applicant for a patent may be required to "provide information concerning the applicant's corresponding foreign applications and grants". Although this may add to the workload that a patent office in a developing country has to deal with, the office would at least get the benefit of knowing how other patent offices were dealing with the patent application. A potentially important question is whether having to provide "information concerning the applicant's corresponding foreign…grants" covers only the fact that a patent was granted, or whether there can be a continuing obligation to inform the patent office dealing with an application if the corresponding patents have been opposed or revoked elsewhere.

[58] Ibid 1, p. 117.

[59] The Wall Street Journal, December 1, 2000, Glaxo Attempts to Block Access To Generic AIDS Drugs in Ghana, by Mark Schoofs.

[60] Ibid 1, footnote 82 on page 55.

[61] Note that TRIPS Art 29.2 allows WTO Members to "require an applicant for a patent to provide information concerning the applicant's corresponding foreign applications and grants". As noted above, it might be argued that information concerning grants includes not only the grant itself but e.g. revocation of the grant. For further discussion on this and other related topics please refer to MSF's comments on the WIPO Patent Agenda, available at access@geneva.msf.org.

[62] See patent table, Annex A.

[63] Ibid 15.

[64] See http://www.cptech.org/ip/health/aids/gov-role.html for more information on the role of the US government in the development of HIV/AIDS drugs.

[65] Although the patent application was filed before the Thai law changed, there were "transitional" provisions in the new law, and since this patent application had not been rejected by the time the law changed, it was treated as a patent application under the new law.

[66] Thailand created a special court to deal with intellectual property disputes. Although probably helpful for those countries that can do this, it is not required by the TRIPS Agreement, see TRIPS Article 41.5, "It is understood that this Part does not create any obligation to put in place a judicial system for the enforcement of intellectual property rights distinct from that for the enforcement of law in general…".

[67] http://www.who.int/medicines/organization/par/edl/eml.shtml.

[68] Although there is no international patent, it is possible to file an international patent application, using the system of the Patent Cooperation Treaty (PCT) managed by WIPO. The applicant can "designate" all the Member Countries of the PCT, in which (s)he wishes to get a patent. The application procedure is centralized though, and it is up to each "designated" patent office to grant or reject the patent application, in conformity with its own national patent law.

[69] Note that only a European patent with a "B" at the end is a granted patent. An "A" indicates publication of a patent application.

[70] Unless some retroactive and/or transitional provisions have been included, as in Thailand or Brazil.

[71] A selection of which include: http://www.fda.gov/cder/ob/default.htm http://ep.espacenet.com/ http://patft.uspto.gov/netahtml/search-bool.html http://biotech.about.com/library/patent_expirations

[72] Although this will change in the future: an amendment to the Harare Protocol on patents granted by ARIPO was introduced in 1999 to establish that all ARIPO patents granted after that date would be subject to a 20-year patent term in all ARIPO countries.

[73] These mistakes have been corrected in the patent table.

[74] WHO/UNAIDS, Patent Situation of HIV/AIDS Related Drugs in 80 Countries, 2000. http://who.int/medicines/library/par/hivrelateddocs/patentshivdrugs.pdf

[75] Attaran A., Gillespie-White L., Do patents for antiretroviral drugs constrain access to AIDS treatment in Africa? JAMA, 2001, vol.286, No.15, pp.1886-1892.

[76] Letters to the Editor, JAMA, 2002, vol. 287, No. 7. pp. 840-842.

 

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