Pharmaceutical inventions: when is the granting of a patent justified?

International Journal of Intellectual Property Management

Volumn 1, Issue 1-2, 2006, Pages 4-21

  Correa, Carlos M ^a  

^a UNIVERSIDAD DE BUENOS AIRES   (Argentina)

Author keywords

combinations; dosage forms; metabolites; optical isomers; patentability requirements; pharmaceutical formulations and compositions; pharmaceutical patents; polymorphs; prodrugs; salts; second indications

Indexed keywords

EID: 78449269662     PISSN: 14789647     EISSN: 14789655     Source Type: Journal    
DOI: 10.1504/ijipm.2006.011019     Document Type: Article

References (56)

1. China Daily (2005) March 31.
2. Chisum, D. and Jacobs, M. (1992) Understanding Intellectual Property Law, Matthew Bender, New York, pp.2–14, 2–15.
3. Cook, T., Doyle, C. and Jabbari, D. (1991) Pharmaceuticals Biotechnology and the Law, Stockton Press, New York.
4. Correa, C. (2001a) Trends in Drug Patenting. Case Studies, Buenos Aires, Corregidor.
5. Correa, C. (2001b) ‘Health and intellectual property rights’, WHO Bulletin, Vol. 79, No. 5, p.381.
6. Correa, C. (2004) ‘Ownership of knowledge-the role of patents in pharmaceutical R&D’, WHO Bulletin, Vol. 82, No. 10, pp.784–787.
7. Correa, C. (2005) An Agenda for Patent Reform and Harmonization for Developing Countries, Paper presented at the Bellagio Dialogue on ‘Intellectual Property and Sustainable Development: Revising the agenda in a new context’, ICTSD, 24–28 September, Bellagio, Italy, available at www.ictsd.org.
8. Dratler, J. (1999) Intellectual Property Law, Commercial, creative, and Industrial Property, Law Journal Press, New York.
9. Evenson (1987) ‘International invention: implications for technology market analysis’, in Griliches, Z. (Ed.): R&D, Patents, and Productivity, University of Chicago and National Bureau of Economic Research, Chicago, p.124.
10. Federal Trade Commission (FTC) (2003) To Promote Innovation: The Proper Balance of Competition and Patent Law Policy, available at htpp://www.ftc.gov.
11. Foray, D. (2004) ‘The patent system and the dynamics of innovation in Europe’, Science and Public Policy, Vol. 3, No. 6, pp.449–456.
12. Grubb, P. (1999) Patents for Chemicals, Pharmaceuticals and Biotechnology. Fundamentals of Global Law, Practice and Strategy, Clarendon Press, Oxford.
13. Hansen, B. and Hirsch, F. (1997) Protecting Inventions in Chemistry. Commentary on Chemical Case Law under the European Patent Convention and the German Patent Law, WILEY-VCH, Weinheim.
14. Jaffe, A.B. and Lerner, J. (2004) Innovation and its Discontents: How our Broken Patent System is Endangering Innovation and Progress, and What to do About it, Princeton University Press, Princeton.
15. Scherer (1987) ‘Comment’ on R.E. Evenson, ‘International invention: implications for technology market analysis’, In Griliches, Z. (ed.) R&D, Patents, and Productivity, University of Chicago and National Bureau of Economic Research, Chicago, p.124.
16. Soto Vázquez, Cárdenas y Espinosa, Parra Cervantes y Cassaigne Hernández (2001) Protección a la Inventiva Farmacéutica.
17. World Bank (2001) Global Economic Prospects and the Developing Countries 2002, Washington DC, p.147.
18. According to of the US law, for example, “[A] person shall be entitled to a patent unless the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States …” (35 U.S.C Section 102(a)) In responding to a question about the novelty standard applied under this Section, the US held that in the TRIPS Agreement there was ‘no prescription as to how WTO Members define what inventions are to be considered ‘new’ within their domestic systems’ and, hence, that its legislation was ‘perfectly consistent with the provisions of the TRIPS Agreement’ (document IP/Q3/USA/1, May 1, 1998).
19. See below.
20. ‘Incremental innovations’ (as opposed to ‘major’ innovations’) are modifications, such as improvements or adaptations of existing products and processes. Irrespective of their practical usefulness, such improvements may be obvious to develop for a person having ordinary skills in the art.
21. Scherer noted almost two decades ago: “As the bleary-eyed reviewer of some 15,000 patent abstracts in connection with research … I was struck by how narrowly incremental (adaptive?) most ‘inventions’ are” (Scherer, 1987) See also Correa (2001a, 2001b, 2004).
22. In an early US court decision Justice Bradley stated that “[I]t was never the object of [the patent] laws to grant a monopoly for every trifling device, every shadow of a shade, of an idea, which would naturally and spontaneously occur to any skilled mechanic or operator in the ordinary progress or manufactures.” (Atlantic Works v. Brady, 107 U.S. (17 Otto) 192, 1883) Fifty years later Justice Douglas stated that a new device, to be patentable, “must reveal the flash of creative genius” (Cuno Engineering Corp., 314 U.S. 84, 51 U.S.P.Q. 1, 1941) (quoted in Chisum and Jacobs (1992)). The US policy on the matter has significantly changed, however, since these statements were made, as the patent office and courts applied a less rigorous concept of non-obviousness. See, e.g., Federal Trade Commission (FTC) (2003) and Jaffe and Lerner (2004).
23. See, e.g., World Bank (2001), recommending that developing countries generally apply strict criteria for the granting of patents.
24. See below the so-called ‘Markush claims’.
25. For instance, patent HK1005851 (1999–01-29) claims ‘oral presentation forms for pantoprazole, which consist of a core, an intermediate layer and an outer layer which is resistant to gastric juice’; in patent application number WO 96/01623 (1996–01-25) Astra claims “an oral pharmaceutical multiple unit tableted dosage form comprising tablet excipients and pellets formed by core material containing omeprazole or one of its single enantiomers or an alkaline salt of omeprazole or one of its single enantiomers, optionally mixed with alkaline compounds, covered with one or more layers, at least one of which is an enteric coating layer …”
26. Examination Guidelines for Patent Applications relating to Medical Inventions in the UK Patent Office (March 2004), Claims to pharmaceutical compositions, Compositions adapted to a particular use, Paragraph 114, available on http://www.patent.gov.uk/patent/reference/mediguidlines/index.htm.
27. Examination Guidelines for Patent Applications relating to Medical Inventions in the UK Patent Office (March 2004), Claims to pharmaceutical compositions, Compositions adapted to a particularuse, Paragraph114, available on http://www.patent.gov.uk/patent/reference/mediguidlines/index.htm.
28. For instance, claims on the combination of Aspirin 325 mg. + Carisoprodol 200 mg. + Codeine Phosphate 16 mg were granted in the USA, with expiry date 13/08/2002.
29. For example, EP0584001 (1994–02-23) covers products containing an anti-neoplastically effective amount of taxol and sufficient medications to prevent severe anaphylactic-like reactions.
30. See Glaxo Group Ltd’s Patent (2004) RPC 43. Report of Patent, Design and Trade Mark Cases (RPC) (Sweet and Maxwell).
31. For instance, patent application WO2006039692 (2006–04-13) refers to a “solid dosage form for oral administration of ibuprofen comprising a modified release formulation of ibuprofen which provides an immediate burst effect and thereafter a sustained release of sufficient ibuprofen to maintain blood levels at least 6.4 g/ml over an extended period of at least 8 hours following administration of a single dose.”
32. A method of treatment or therapeutic method is a set of steps, that may include the administration of a medicine, applied to the human (or animal) body to treat or cure a disease.
33. Examination Guidelines for Patent Applications relating to Medical Inventions in the UK Patent Office (March 2004), Claims to pharmaceutical compositions, Compositions adapted to a particular use, Paragraph 120, available on http://www.patent.gov.uk/patent/reference/mediguidlines/index.htm
34. See an analysis of this issue below.
35. For instance, GB19860008335 (1993–04-30) claimed improved pharmaceutical salts of amlodipine, particularly the besylate salt, and pharmaceutical compositions thereof. These salts find utility as anti-ischaemic and anti-hypertensive agents.
36. ‘Evergreening’ is a patenting strategy consisting of acquiring patents on minor, often trivial, modifications of existing pharmaceutical products or processes in order to indirectly extend the period of patent protection over previously patented compounds.
37. For instance, EP0831098 (1998–03-25) claims a compound which is olanzapine dihydrate wherein the dihydrate is crystalline Dihydrate B olanzapine polymorph having a typical x-ray powder diffraction pattern (given in the patent document).
38. Chinese Guidelines, Chapter 10. Several Provisions for the Examination of Applications for Patent for Invention in the Field of Chemistry.
39. http://www.uspto.gov/web/offices/pac/mpep/index.htm.
40. See http://www.patent.gov.uk/patent/reference/biotechguide/index.htm.
41. http://www.patent.gov.uk/patent/reference/mpp/ss1–6.pdf.
42. “A compound, in the sense of Patent Law, is every chemical entity that can be reliably differentiated from another chemical entity, through the provision of sufficient, suitable parameters. Fundamentally, compounds having the same chemical composition are identical. This does not apply for special forms of compounds having the same chemical composition, if these forms could not be produced, despite their chemical composition being known.” (Grubb, 1999, pp.197–199)
43. It is estimated that over a quarter of known pharmaceuticals present this property. See, e.g., Cook et al. (1991, p.84).
44. For example CA2111971 (1993–01-21) claimed a process for obtaining a substantially pure enantiomer of ibuprofen. The process utilises first an enantiomerically enriched mixture of ibuprofen obtained from kinetic resolution, diastereomeric crystallisation or asymmetric synthesis processes. This enriched mixture is dissolved in a solvent and solid racemic ibuprofen is separated, leaving mother liquor comprising the solvent and the enriched enantiomer substantially free of the other enantiomer.
45. See patent US 6509353 (2003–01-21) claiming methods and pharmaceutical compositions employing a terfenadine metabolite and a leukotriene inhibitor for the treatment or prevention of inflammation or allergic disorders, such as asthma, or symptoms thereof. Also included are methods and compositions employing a terfenadine metabolite, a leukotriene inhibitor, and a decongestant for the treatment or prevention of inflammation or allergic disorders, such as asthma, or symptoms thereof.
46. See, e.g., Grubb (1999, pp.212, 213). Another conflict arose with regard to a Bristol Myers patent over the monohydrate form of cephalosporin, which is metabolised in the body from a semi-hydrate form developed by Zenith. See, e.g., Soto Vázquez, Cárdenas y Espinosa, Parra Cervantes y Cassaigne Hernández (2001), p.54.
47. For instance, the application WO03077855 (2003–09-25) covers MEK inhibitors useful in the treatment of hyperproliferative diseases, such as cancer and inflammation, and pharmaceutically acceptable salts and prodrugs thereof.
48. For instance, patent EP0584001 (1994–02-23) claims ‘products containing an anti-neoplastically effective amount of taxol and sufficient medications to prevent severe anaphylactic-like reactions formulated and packaged for separate or sequential or simultaneous use in cancer therapy with a patient over a period of about 24 hours or less’.
49. Guidelines for examination in the European Patent Office, Part C, Chapter IV (Patentability). (4.) Industrial application, (4.2) Surgery, therapy and diagnostic methods, http://www.european-patent-office.org/legal/gui_lines/e/c_iv_4_2.htm.
50. A well known example of a ‘second indication’ patent relates to sildenafil citrate. The patent has been invalidated, however, in some jurisdictions. In China, for instance, Pfizer filed the patent application in May 1994. The State Intellectual Property Office granted it after 70 years of examination. Upon a challenge by twelve domestic pharmaceutical companies and a Beijinger, the Patent Re-examination Board invalidated the patent on the ground of insufficient disclosure of the claimed invention (China Daily, March 31, 2005).
51. The formulation of these claims, deemed to have been first introduced by the Swiss patent office, is of the type “use of x for the manufacture of product y to treat disease z”.
52. See Examination Guidelines for Patent Applications relating to Medical Inventions in the UK Patent Office (March 2004) First medical use, Section 2(6), Paragraph 64.
53. Guidelines for examination in the European Patent Office, Part C, chapter IV (Patentability), (4.1) Industrial application, (4.2) Surgery, therapy and diagnostic methods
54. Part C, Chapter IV (Patentability), (4.1) Industrial application, (4.2) Surgery, therapy and diagnostic methods.
55. Discoveries are not deemed ‘inventions’ and hence, patentable in most jurisdictions. The European Patent Convention, for instance, explicitly excludes them from patentability.
56. Like in the case of the Agencia Nacional de Vigilancia Sanitaria (ANVISA) of Brazil.