1. EBS Law Term 2013 Intellectual Property Law Patent Law: Introduction Prof. Martin Senftleben VU University Amsterdam Bird & Bird, The Hague

2. Intellectual property domains technology commerce culture patent law trademark law copyright law

3. Contents definition international treaties criteria of protection exclusions from patentability

4. Definition

5. A patent is an exclusive right in an industrial invention that is granted upon request...great inventions: penicillin transistor...small inventions: post-it stickers Lego bricks

6. International treaties

7. International WIPO: The Paris Convention for the Protection of Industrial Property (1886/1967) WTO: The Agreement on Trade-Related Aspects of Intellectual Property Rights (1994) WIPO: The Patent Cooperation Treaty (PCT, 1970)

8. Criteria of protection

9. Art. 27(1) of the TRIPS Agreement ‘...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.’

10. Novelty Subject matter is not new if it belongs to the state of the art....to determine on the basis of the situation at the filing date (when applying for a patent for the first time) the priority date (when subsequently filing patent applications in further countries of the Paris Union)

11. Paris Union

12. filing a patent application in one country of the Union 12 months subsequent filings in other Union countries Priority right (art. 4 of the Paris Convention)

13. State of the art =everything that is made publicly available decisive: can a person skilled in the art carry out the invention on the basis of the information made available? essential: keeping the invention secret before applying for a patent (protection of trade secrets via unfair competition law (see art. 39 TRIPS))

14. Still new? publications in foreign languages earlier, not yet published patent applications talks, presentations, product proofs demonstration to visitors...(-) demonstration at official or officially recognized international exhibitions...(+) because of temporary protection granted under art. 11 Paris Convention

15. Inventive step...when the invention is non-obvious for a person skilled in the art....to determine on the basis of the situation at the filing date (first application) the priority date (subsequent applications in countries of the Paris Union)

16. The person skilled in the art artificial, objective standard (average) specialist –has working experience in the relevant field of technology –has standard knowledge –knows the specific, relevant state of the art

17. In practice contents of patent claims –not new if all elements can be found in one single prior source (mostly earlier patent or earlier patent application); –not inventive if all elements can be derived from several prior sources, the combination of which is obvious. from the perspective of a person skilled in the art, considering that person’s standard knowledge

18. Industrial application...when the subject matter can be applied to any field of industry. Industry is to be understood in a broad sense, including not only ‘industry and commerce proper’ but also ‘agricultural and extractive industries’ (art. 1(3) of the Paris Convention).

19. The field of industry ‘Industrial property shall be understood in the broadest sense and shall apply not only to industry and commerce proper, but likewise to agricultural and extractive industries and to all manufactured or natural products, for example, wines, grain, tobacco leaf, fruit, cattle, minerals, mineral waters, beer, flowers, and flour.’ (art. 1(3) of the Paris Convention)

20. Exclusions from patentability

21. Art. 27(2) of the TRIPS Agreement Inventions may be excluded if this is necessary to protect the ordre public or morality; protect human, animal or plant life or health; avoid serious prejudice to the environment.

22. Art. 27(3) of the TRIPS Agreement Members may also exclude diagnostic, therapeutic and surgical methods for the treatment of humans or animals; plants and animals other than micro- organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

23. engine of innovation ethical questions developing countries: biodiversity Discussion on biotech inventions US: Diamond vs. Chakrabarty, 447 U.S. 303 (1980) lead of the US and Japan over the EU EU: Biotech Directive 98/44/EC (1998)

24. Art. 3 EC Biotech Directive ‘... inventions... shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.’ ‘Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.’

25. EBS Law Term 2013 Intellectual Property Law Patent Law: Acquisition Prof. Martin Senftleben VU University Amsterdam Bird & Bird, The Hague

26. Contents registration procedure term of protection registration strategies portfolio management

27. Registration procedure

28. Examination systems application formal substantive a.novelty b.further requirements refusal grantoppositionexamination

29. Registration systems application formal substantive a.novelty b.further requirements refusal grantoppositionexamination () ()

30. Pros and cons Examination system legal certainty high long procedure expensive settlement of disputes in the framework of the office procedure Registration system legal certainty low short procedure cheap settlement of disputes in court proceedings

31. Term of protection

32. The term of protection ‘The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date.’ (art. 33 TRIPS) extensions in certain technical fields? –pharmaceutical products requiring marketing approval (can take several years) –supplementary protection certificates in certain countries (example: EU)

33. Registration strategies

34. filing a patent application in one country of the Union 12 months subsequent filings in other Union countries Starting point: priority right (art. 4 PC)

35. national registrations regional: European Patent Convention (EPC) bundle of rights having the same effect as national patents Different routes of registration Patent Cooperation Treaty (PCT): international registration

36. International route: Patent Cooperation Treaty

37. Local patent application followed within 12 months by multiple foreign applications claiming priority under Paris Convention: - multiple formality requirements - multiple searches - multiple publications - multiple examinations and prosecutions of applications - translations and national fees required at 12 months Some rationalization because of regional arrangements: ARIPO, EAPO, EPO, OAPI 0 12 File application locally File applications abroad (months) Starting point: traditional system

38. (months) File PCT application 120 30 International search report & written opinion 16 18 International publication (optional) File demand for International preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability Typically a national patent application in the home country of the applicant What is the PCT? Overview PCT system

39. (months) File PCT application 120 30 International search report & written opinion 16 18 International publication (optional) File demand for international preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability Typically filed in same national patent office--one set of fees, one language, one set of formality requirements--and legal effect in all PCT States: effect international application = national patent application What is the PCT? Overview PCT system

40. (months) File PCT application 120 30 International search report & written opinion 16 18 International publication (optional) File demand for International preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability Report on state of the art (prior art documents and their relevance) + initial, non-binding patentability opinion: applicant can evaluate the application What is the PCT? Overview PCT system

41. (months) File PCT application 120 30 International search report & written opinion 16 18 International publication (optional) File demand for International preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability Disclosing to world content of application in standardized way What is the PCT? Overview PCT system

42. (months) File PCT application 120 30 International search report & written opinion 16 18 International publication (optional) File demand for international preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability Request an additional patentability analysis on basis of amended application What is the PCT? Overview PCT system

43. (months) File PCT application 120 30 International search report & written opinion 16 18 International publication (optional) File demand for international preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability Additional patentability analysis, designed to assist in national phase decision- making: again a preliminary, non- binding opinion What is the PCT? Overview PCT system

44. (months) File PCT application 120 30 International search report & written opinion 16 18 International publication (optional) File demand for international preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability Express intention and take steps to pursue to grant in various states What is the PCT? Overview PCT system

45. Fees for: --translations --Office fees --local agents 0 12 File local application File applications abroad (months) Traditional (months) File PCT application 1230 International search report & written opinion 1618 International publication (optional) File demand for international preliminary examination File local application Enter national phase 2228 (optional) International preliminary report on patentability PCT 0 Fees for: --translations --Office fees --local agents Why use the PCT? Comparison of the systems

46. Success of the PCT system more time for decision making: 30 instead of 12 months PCT form accepted by any Contracting Party = no rejection on formal grounds evaluation and amendment of the invention prior to national phase major costs of filing in different countries are postponed

47. EBS Law Term 2013 Intellectual Property Law Patent Law: Protection Prof. Martin Senftleben VU University Amsterdam Bird & Bird, The Hague

48. Contents exclusive rights exceptions other use without authorization

49. Exclusive rights

50. Art. 28(1) of the TRIPS Agreement ‘A patent shall confer on its owner the following exclusive rights: a.where the subject matter of a patent is a product, to prevent third parties […] from the acts of: making, using, offering for sale, selling, or importing for these purposes that product;…’

51. Art. 28(1) of the TRIPS Agreement b.where the subject matter of a patent is a process, to prevent third parties […] from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.’

52. Problem 1: identical product may be obtained with a different process process A process D process B process C

53. Art. 34(1) of the TRIPS Agreement ‘…if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. Therefore, Members shall provide, in at least one of the following circumstances, that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary,…’

54. Art. 34(1) of the TRIPS Agreement ‘…be deemed to have been obtained by the patented process: a.if the product obtained by the patented process is new; b.if there is a substantial likelihood that the identical product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used.’

55. Art. 34(3) of the TRIPS Agreement ‘In the adduction of proof to the contrary, the legitimate interests of defendants in protecting their manufacturing and business secrets shall be taken into account.’

56. Problem 2: further products may be required to obtain the final product fathermothersonfinal production of compact discs

57. A is holder of a UK process patent for the production of ‘father’ discs at a particular pressure. He wants to prevent B from importing final discs. B uses the patented process in China to obtain father discs and carry out the further production steps. He offers the final discs in the UK. Process patent infringement? (UK: Pioneer Electronics vs. Warner Music) fathermothersonfinal production of compact discs

58. Art. 28(1) of the TRIPS Agreement b.where the subject matter of a patent is a process, to prevent third parties […] from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.’ answer depends on national interpretation of ‘obtaining directly’

59. Exceptions

60. Art. 30 of the TRIPS Agreement ‘Members may provide for limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.’

61. expiry generic version protected medicine exempts use of the patented invention for tests necessary to obtain marketing approval for pharmaceutical products US: Roche Products vs. Bolar Pharma Example: ‘Bolar’ exception

62. Example: experimental use ‘The rights conferred by a Community Patent shall not extend to: [...] acts done for experimental purposes relating to the subject-matter of the patented invention.’ (art. 27(b) Community Patent Convention) testing claimed properties or different indications (+)...insofar as the experiments are directed to the substance itself use for commercial research?

63. Other use without authorization

64. Art. 31 of the TRIPS Agreement problem of compulsory licenses detailed list of requirements, such as –efforts to obtain regular authorization –national emergency –limited scope and duration according to purpose –non-exclusive, non-assignable –predominantly for the domestic market –payment of adequate remuneration –judicial review

65. Problem: flexible enough for sufficient access to medicine? ‘national emergency’? ‘predominantly for the domestic market’?

66. Art. 31(l) of the TRIPS Agreement problem of later patents involving an important technical advance of considerable economic significance in relation to the prior invention specific requirements –cross-license on reasonable terms for the owner of the first patent –use authorization with regard to the first patent is non-assignable except with the assignment of the second patent

67. Problem: flexible enough for markets with small, incremental innovative steps? ‘important technical advance’? ‘considerable economic significance’?

68. The end. contact: m.r.f.senftleben@vu.nl

69. ANNEX: Interpretation of Patent Claims

70. Interpretation of Patent Claims central elements of a patent application: –claims –description, drawings different approaches to interpretation: –literal (wording of the claims) –teleological (core of the inventive idea) additional consideration: equivalents

71. the same function in the same way with the same results Equivalents

72. doctrine (+) no need to specify each and every variant of the invention in the specification doctrine (-) more detailed claims advisable to close potential loopholes for competitors Impact in practice

73. Different approaches in countries of the European Patent Convention ‘Epilady’ saga (1990-1993) plaintiff –holds patent rights to ‘Epilady’, a gadget for removing body hair with a coiled spring defendant –applies same inventive idea –but: uses a rubber tube instead of the coiled spring DE and NL: infringement (+) UK: infringement (-)

74. UK approach: three questions variant having material effect upon the way the invention works? –if yes, infringement (-) if no: absence of material effect obvious at the date of patent publication? –if no, infringement (-) if yes: claim indicating that strict compliance with the primary meaning of the terms essential to the invention? –if yes, infringement (-)

75. UK approach: three questions inherent problem: last question takes the court back to interpretation critique led to departure from the test –Kirin-Amgen vs. Hoechst Marion Roussel, [2005] RPC (9), 169 –no mechanical application, in particular less helpful in case of complex chemical or biotechnological inventions –example: claim to a whole group of chemical compounds expected to have similar characteristics