Trans-Pacific Partnership Agreement Amendment Bill: Patent Term Extensions

Transcription

1 Trans-Pacific Partnership Agreement Amendment Bill: Patent Term Extensions Proposed Regulations MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 1 TPP Amendment Bill: Patent Term Extension Proposed Regulations

2 How to have your say Submissions process The Ministry of Business, Innovation and Employment (MBIE) seeks written submissions on the issues raised in this document by 5pm on Monday 8 August Your submission may respond to any or all of these issues. We also encourage your input on any other relevant issues. Where possible, please include evidence to support your views, for example references to independent research, facts and figures, or relevant examples. Please also include your name and (if applicable) the name of your organisation in your submission. Please include your contact details in the cover letter or accompanying your submission. You can make your submission: By sending your submission as a Microsoft Word document to: tpp.ip.policy@mbie.govt.nz. By mailing your submission to: Business Law Building, Resources and Markets Ministry of Business, Innovation & Employment PO Box 1473 Wellington 6140 Please direct any questions that you have in relation to the submissions process to: tpp.ip.policy@mbie.govt.nz. Use of information The information provided in submissions will be used to inform the Government s development of the regulations required to implement the patent term extension provisions in the Trans-Pacific Partnership Agreement Amendment Bill. We may contact submitters directly if we require clarification of any matters in submissions. Except for material that may be defamatory, MBIE intends to upload PDF copies of submissions received to MBIE s website at MBIE will consider you to have consented to uploading by making a submission, unless you clearly specify otherwise in your submission. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 1 TPP Amendment Bill: Patent Term Extension Proposed Regulations

3 Release of information Submissions are also subject to the Official Information Act Please set out clearly in the cover letter or accompanying your submission if you have any objection to the release of any information in the submission, and in particular, which parts you consider should be withheld, together with the reasons for withholding the information. MBIE will take such objections into account and will consult with submitters when responding to requests under the Official Information Act If your submission contains any confidential information, please indicate this on the front of the submission. Any confidential information should be clearly marked within the text. If you wish to provide a submission containing confidential information, please provide a separate version excluding the relevant information for publication on our website. Private information The Privacy Act 1993 establishes certain principles with respect to the collection, use and disclosure of information about individuals by various agencies, including MBIE. Any personal information you supply to MBIE in the course of making a submission will only be used for the purpose of assisting in the development of policy advice in relation to this review. Please clearly indicate in the cover letter or accompanying your submission if you do not wish your name, or any other personal information, to be included in any summary of submissions that MBIE may publish. Permission to reproduce The copyright owner authorises reproduction of this work, in whole or in part, as long as no charge is being made for the supply of copies, and the integrity and attribution of the work as a publication of MBIE is not interfered with in any way. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 2 TPP Amendment Bill: Patent Term Extension Proposed Regulations

4 Contents Patent Term Extension: Proposed Regulations... 4 Purpose... 4 The request for extension of term... 5 Request for extensions of term for unreasonable delays in grant... 5 Request for extension of term of a patent for unreasonable curtailment of the effective patent term... 6 Additional Information... 6 Time limits for filing a request for extension of term... 7 Extensions of term for unreasonable delays in grant... 7 Extensions of term for unreasonable curtailment of the effective patent term Extensions of time for requesting extensions of term Extensions of term for unreasonable delays in grant: disregarded periods Opposition to extensions of term Procedure for opposition Manner of requesting an opposition Time limits for filing an opposition to an extension of term Fees Appendix 1: Proposed list of Disregarded Periods for the purposes of proposed s111b(2) of the Act MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 3 TPP Amendment Bill: Patent Term Extension Proposed Regulations

5 Patent Term Extension: Proposed Regulations Purpose 1. The purpose of this consultation document is to seek public feedback on proposals for the regulations required to implement the patent term extension provisions in the Trans-Pacific Partnership Agreement Amendment Bill (the Bill). This Bill is currently before the Foreign Affairs, Defence and Trade Select Committee. 2. The Bill and the separate regulations which are the subject of this document are necessary for New Zealand to comply with the obligations contained in the Intellectual Property Chapter of the Trans-Pacific Partnership (TPP). The amendments introduced by the Bill, and the regulations, will only take effect from the date that TPP enters into force for New Zealand. 3. The Bill was introduced to Parliament on 9 May, and is currently being considered by the Foreign Affairs, Defence and Trade Committee. The Committee has called for public submissions on the Bill. Further details are available on the Parliament website Clause 75 of the Bill will, when it enters into force, amend the Patents Act 2013 (the Act) to introduce a new subpart 10A to provide for the granting of patent term extensions for: unreasonable delays in patent grant; and unreasonable curtailment of the effective term of a patent covering a pharmaceutical substance or a biologic as a result of the Medsafe s marketing approval process. These amendments are required to implement obligations contained in the intellectual property chapter of the Trans-Pacific Partnership Agreement (TPP). 5. Regulations will be required to implement these patent term extension provisions. The regulations will provide for procedural matters, such as time limits for filing a request for an extension of term, the form and content of any documentation required, and procedures for third parties to oppose extensions for unreasonable curtailment. The new regulations will be incorporated into the Patents Regulations The Bill also provides for the making of regulations setting out the time periods to be disregarded by the Commissioner of Patents when determining whether there has been unreasonable delays in grant. 7. The patent term extension provisions are contained in proposed new sections 111A 111O of the Patents Act Section 111A(1) and s111d(1) provide that any request for extension of term under these sections must be made by the patentee in the prescribed manner. 1 See MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 4 TPP Amendment Bill: Patent Term Extension Proposed Regulations

6 8. Under s244 of the Act, the power to make regulations to prescribe the manner in which a thing is done includes the power to prescribe when, where and how the thing must be done. This permits the making of regulations setting time limits for requests for extension of term or oppositions. 9. In the case of the provision for patent term extension for unreasonable delay in grant, the Bill provides for regulations to be made specifying the time periods to be disregarded when determining whether there has been unreasonable delay. 10. Requests for extension of term must be made during the patent term and within the prescribed time limit (see s111a(2) and s111d(2)). That is, the time limit must be prescribed in the Regulations. The patent term expires twenty years after the patent date defined in s103 of the Act. 11. This document sets out the issues that have been considered by MBIE in formulating its approach to the proposed fees. It seeks input from interested parties on the proposed fees and the likely costs and benefits of the proposals. The request for extension of term 12. In addition to any requirements imposed by the Act, the request must must conform to the requirements of regulation of the Patents Regulations In addition to the information required by the Act and regulation 15, the request will need to include: A statement confirming that there are no relevant proceedings before the court in respect of the patent. This is because proposed new s111n provides that the Commissioner must not make a decision on a request to extend the term of a patent if the patent is the subject of proceedings such as infringement or revocation proceedings, or any other proceeding in which the validity of the patent or a claim of the patent is in dispute. The prescribed fee. Request for extensions of term for unreasonable delays in grant 13. All of the information that the Commissioner requires to make a decision as to whether or not an extension of term should be granted is available to the Commissioner on the IPONZ database. We consider that there is no need to require the patent owner to provide any additional information at the time of filing the request. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 5 TPP Amendment Bill: Patent Term Extension Proposed Regulations

7 Request for extension of term of a patent for unreasonable curtailment of the effective patent term 14. For these requests, the following information will also be required: A statement specifying: o the pharmaceutical substance per se or biologic in respect of which the extension of term is requested (new s111d(1)(a) in clause 75 of the Bill limits extensions to pharmaceutical substances per se and biologics); and o the claims of the patent that include within their scope the pharmaceutical substance per se or biologic (new s111d(1)(a) in clause 75 of the Bill requires the pharmaceutical substance or biologic to fall wholly within the scope of the claims). A statement that the marketing approval to which the certificate from Medsafe relates is the first marketing approval of a product containing the pharmaceutical substance or biologic in respect of which the term extension is requested (see new s111d(2)(c) in clause 75 of the Bill). The statement could be provided either: o by the applicant for extension; or o in the certificate provided under proposed s111d(2)(c). Additional Information 15. We propose that the Commissioner of Patents should be provided with the power to request further information if she considers it necessary to make a decision on whether to grant an extension of term. 16. If the Commissioner does require further information, we propose this must be filed within three months of the date the request for extension of term is filed. This is consistent with the approach taken in regulations 110 and This time limit would be extendable under regulation 161. Manner of making a request for extension of term Question 1: Do you agree with the content of the proposed regulations regarding the manner in which a request for extension of term must be made? If not, why do you disagree? Question 2: Should the applicant for extension of term for unreasonable curtailment be required to declare that the marketing approval referred to in the request is the first marketing approval for the pharmaceutical substance involved, or should this be contained in the declaration from Medsafe? Why? 2 Regulations 110 and 116, which deal with requests to restore lapsed patents or abandoned or void applications, also allow the Commissioner to request further information. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 6 TPP Amendment Bill: Patent Term Extension Proposed Regulations

8 Time limits for filing a request for extension of term 17. If a request for an extension of term is not filed within the prescribed time limit, patent owners will not be able to obtain an extension of term even if one of their patents might otherwise be eligible for extension. What factors should be taken into account when determining what the time limits should be for filing a request for extension? The following factors seem to be the most relevant: certainty for third parties as to whether or not patents that might be eligible for extension will be extended; the time limit should provide adequate time for patent owners to decide whether or not to request an extension of term, and gather any documentation required; and the avoidance of extensions of patent term that will not be used (see paragraphs below). 18. In relation to the first of these factors, once a patent expires, anyone may exploit the invention covered by the patent. Ideally, third parties should be able to enter the market as soon as possible after patent expiry. To do this, they will need to know, reasonably well in advance, whether or not a patent that might be eligible for extension will have its term extended, so that they can decide when to begin their preparations for market entry. 19. Third parties will be able to get an indication of whether a patent might be elgible for extension by looking at publicly available information on the Intellectual Property Office of New Zealand (IPONZ) and Medsafe websites. 20. Under the Act, patents must be kept in force through payment of annual renewal fees. If a renewal fee is not paid, the patent lapses and the invention covered by the patent can be exploited by anyone. Many patents lapse prior to the expiry of the normal twenty year term. This will usually be because the invention covered by the patent is no longer providing significant value to the patent owner. 21. If requests for extension of term have to be made too early in the patent term, some patent owners could incur unnecessary expense in requesting extensions of term for patents that they later leave to lapse. In such cases the extension would not be used. In addition, there would be unnecessary costs imposed on IPONZ in considering requests for extension of term that might not be used. Extensions of term for unreasonable delays in grant 22. Taking the factors described in paragraph 17 into account, there appear to be three possible options for setting time limits for requesting an extension of term of unreasonable delays in grant: Option 1: the request for extension may be made any time up to the normal expiry date of the patent. Option 2: the request for extension may be made any time up to a period of years prior to the expiry date of the patent. Option 3: The request for extension must be made shortly after patent grant. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 7 TPP Amendment Bill: Patent Term Extension Proposed Regulations

9 Option 1: Request made at any time before patent expiry 23. Under this option, patentees could make requests for patent term extension at any time up to the date that the normal patent term expires. This option reduces the likelihood of extending patents that might be left by patent owners to lapse. If the patent had been kept in force until near the end of the normal twenty year term, the invention covered by the patent is likely to be commercially valuable, and the patent will probably run its full term. Patent owners would have ample time after grant of the patent to decide whether to make a request for extension of term. 24. However, this option leaves third parties potentially uncertain as to whether a patent that might be eligible for extension will actually receive an extension until close to, or even after, the expiry of the normal twenty year term. While patent owners would be free to apply for extensions at any time up to the normal patent expiry date, they may well decide to leave any request until the last minute to maximise uncertainty for third parties. 25. This could cause third parties to delay entering the market with a product incorporating the invention covered by the patent, even if no request for extension of term had been made, or one had been made but not granted. This would unnecessarily delay market entry by third parties. It could impose costs on society, particularly if the product involved was a generic pharmaceutical. 26. The potential costs imposed on society under this option would be much greater than for options 2 and 3. They would be likely to be much greater than any unnecessary costs imposed on patent owners through requesting extensions for patents that they later allow to lapse. For this reason, this option is not preferred. Option 2: Request for extension of term must be made at any time up to several years prior to patent expiry (preferred option) 27. Under this option, requests for extension of term could be made up to a date that was several years prior to patent expiry. Patent owners would have ample time after grant of the patent to decide whether to make a request for extension of term. 28. If the date by which requests must be made is not too far from the normal expiry date (for example no more than five or six years), the number of unecessary extensions for patents that are later left to lapse would be smaller than for option 3. By that date patent owners would probably have a good idea of whether they would allow the patent to lapse prior to expiry, and therefore whether it was worth requesting an extension of term. 29. Third parties would know reasonably well in advance of the expiry of the normal twenty year term whether a particular patent would have its term extended. This should enable them, if they wished, to enter the market promptly after patent expiry. They would not have to worry that their preparations will be upset by an extension of term. 30. Under this option, third parties would get reasonable notice of extensions of term, while patent owners would be less likely to have to seek extensions for patents that they were MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 8 TPP Amendment Bill: Patent Term Extension Proposed Regulations

10 likely to allow to lapse. To achieve this balance, the time limit would probably have to be no less than five or six years prior to patent expiry. 31. The effect of this option is that requests for extension of term would have to be filed no more than fourteen or fifteen years after the patent date. Under current or likely IPONZ examination timeframes, it would be highly unlikely that any patent application would be pending for this length of time. Option 3: Request for extension made shortly after patent grant 32. Under this option, a request for extension of term must be made within a short period of the grant of the patent. One disadvantage of this approach patent owners might not know at this point whether or not they will allow the patent to run its full term. 33. This could mean that they may incur the cost of requesting extensions that are not actually used, but which have been requested just in case they may be of value to the patent owner. This could also impose unnecessary costs on IPONZ. 34. Patents that might be eligible for extension of term for unreasonable delays in patent grant are likely to be granted years before the expiry of the normal twenty year patent term. If any extensions of term are granted shortly after patent grant, this will provide third parties with ample notice of which patents will be extended. 35. This option has the potential to impose significantly lower costs on society than option 1, and is about the same as option 2 in this respect. However, it is likely to mean that some patent owners may incur unnecessary costs in requesting extensions of patents that they later allow to lapse. Processing requests for extensions of term that are never used will also impose unneccessary costs on IPONZ. 36. If this option was adopted, we propose that requests for extension of term would have Time limit for requesting extensions of term for unreasonable delays in patent grant Question 3: Which of the three options discussed do you prefer? Why do you prefer this option? Question 4: Options 2 and 3 require the setting of time limits for making requests for extension of term. If either of these options was adopted, what do you think the time limit should be? to be made no more than six months after grant of the patent. This should be ample time for patent owners to make a decision as to whether or not to request an extension of term. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 9 TPP Amendment Bill: Patent Term Extension Proposed Regulations

11 Extensions of term for unreasonable curtailment of the effective patent term 37. Extensions of patent term for unreasonable curtailment of the effective patent term for pharmaceuticals are only available if marketing approval for the pharmaceutical substance covered by the patent is obtained after the grant of the patent (see proposed s111f(1)(a)). The date that marketing approval is obtained can be some years after patent grant. 38. Taking this factor into account, and the factors discussed earlier in relation to extensions of term for unreasonable delays in patent grant, this paper discusses the following options: Option 1: the request for extension may be made at any time up to the normal expiry date of the patent; Option 2: the request for extension of term must be made at any time up to several years prior to patent expiry. Option 3: the request for extension of term must be made at any time up to a short period after grant of the first marketing approval. Option 1: Request made at any time before patent expiry 39. This option is effectively the same as option 1 described above in relation to extensions for term for unreasonable delays in patent grant. The same advantages and disadvantages apply. Option 2: Request for extension of term must be made at any time up to several years prior to patent expiry 40. Under this option, requests for extension would be able to be made up to a prescribed period (for example five or six years) before expiry of the normal twenty year term, or no more than a prescribed period after the date of marketing approval, whichever is later. This provides for the situation where the first marketing approval is granted late in the life of the patent. 41. This would minimise the likelihood that term extensions were requested and granted but not actually used for patents that were later left to lapse through non-payment of renewal fees. As discussed in relation to option 3, however, such extensions are are likely to be infrequent for patents covering pharmaceuticals. Option 2 therefore offers little or no advantage in this respect. 42. A disadvantage of this option is that third parties might not know until well into the patent term whether or not a particular patent would be granted an extension. While patent owners could make a request for an extension soon after marketing approval is granted, they may well delay making a request until as late as possible to maximise uncertainty for third parties. 43. This option does not seem to have any advantages over option 3. A disadvantage of this option is that it may leave third parties uncertain about whether or not a term extension will be granted. On this basis, this option is not preferred over option 3. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 10 TPP Amendment Bill: Patent Term Extension Proposed Regulations

12 Option 3: Request must be made no later than a short period after the date of patent grant or marketing approval (preferred option) 44. Under this option, the request for extension of term would need to be made within a short period after the grant of first marketing approval. The period of time would have to be long enough to enable the patent owner to obtain the certificate required under proposed s111d(2)(c) of the Act. 45. If the first marketing approval was not granted until close to expiry of the normal patent expiry date, this could result in an extension being granted shortly before, or even after, the normal expiry date. A grant of approval close to the normal expiry date is usually because the application for approval was filed late in the patent term. 46. As set out earlier in this document, it would normally be undesirable to allow requests for extension of term to be made shortly before the normal patent expiry date, due to the uncertainty this causes for third parties. In this case this would include generic pharmaceutical manufacturers and PHARMAC. 47. Generic pharmaceutical manufacturers will generally not begin preparations for marketing a generic version of a patented pharmaceutical until the patented version has received marketing approval. This suggests that they would be unlikely to be disadvantaged if a patent is extended where marketing approval for a patented pharmaceutical were not granted until late in the patent term. 48. A significant advantage of this option is that it would mean that third parties would normally know shortly after marketing approval was granted whether a particular patent would be granted an extension of term. 49. One potential disadvantage would be that this could result in patent term extensions being requested and granted but not actually used for patents that are later allowed to lapse through non-payment of renewal fees. However, the proportion of patents covering pharmaceuticals that run their full twenty year term is much greater than for non-pharmaceutical patents. Adopting this option is unlikely to result in the grant of extensions that are not actually used by the patent owner. 50. We propose that, if this option is adopted, that patent owners must make a request for extension of term no more than six months after the date that marketing approval was granted. This is the approach taken under the s71 of the Australian Patents Act Time limit for requesting extensions of term for unreasonable curtailment of the effective patent term Question 5: Which of the three options discussed do you prefer? Why? Question 6: Options 2 and 3 would impose time limits by which a request for extension must be made. If one of these options was adopted, what do you think the time limits should be? Why? MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 11 TPP Amendment Bill: Patent Term Extension Proposed Regulations

13 Extensions of time for requesting extensions of term 51. If time limits are to be set for requesting extensions of term, this raises the question of what, if any, extensions of these time limits should be available. 52. All of the options for requesting patent term extension for unreasonable delays in grant enable a patent owner to request extensions 6 months or more after patent grant. Patent owners will be in a position to know, very soon after patent grant, whether their patent might be eligible for extension. On this basis, there seems to be no reason to provide for extensions of time. We propose that there should be no provision for extension of the time limit. 53. In the case of extensions of term for unreasonable curtailment of the patent term for pharmaceutical patents, option 1 would almost always mean that patent owners would be able to request an extension of patent term at least 6 months, and usually several years, after the grant of marketing approval. This should be ample time to obtain the certificate required under proposed s111d(2)(c) of the Act. If this option was adopted, there would seem to be no justification in providing for extensions of time for making a request for extension. 54. Adoption of option 3 would mean that patent owners would have no more than six months to make a request for extension. In most cases this should be sufficient for applicants to obtain the certificate from Medsafe required under proposed s111d(2)(c) of the Act. 55. It is possible that there may be some circumstances where the patent owner has not been able to obtain the certificate within the six months allowed. This might be because the patent owner has disputed the content of the certificate that Medsafe proposes to provide. In such cases, it may be appropriate to provide for an extension of time to make a request for extension to allow the dispute to be resolved. 56. If extensions of time for making a request for extension of term are available, the fact that a request for extension of time has been made will appear on the IPONZ database. This will give third parties notice that a request for extension of term will likely be made. Extensions of the time limit for requesting extensions of term for unreasonable curtailment of the effective patent term Question 7: Should the time limit for requesting extension of term for unreasonable curtailment be extendable? If so, what extension should be available? Question 8: Under what circumstances should an extension be granted? Extensions of term for unreasonable delays in grant: disregarded periods MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 12 TPP Amendment Bill: Patent Term Extension Proposed Regulations

14 57. Under proposed s111b of the Act, the Commissioner of Patents must disregard the periods of time set out in s111b(2) when determining whether or not there has been unreasonable delay in grant. Proposed s111b(3) provides that regulations may be made specifying periods of time, not inconsistent with proposed s111b(2) that must be disregarded. 58. There are two approaches to dealing with the disregarded periods:: Option 1: have no regulations, with the determination of which time periods fall within the scope of proposed s111b(2) being let to the Commissioner or the High Court; or Option 2: provide a non-exhaustive list of the periods to be disregarded in regulations. Option 1: No regulations 59. Under this option, there would be no regulations, and the Commissioner of Patents would decide which time periods ought to be disregarded. For this purpose the Commissioner could publish guidelines on which periods she considers fall within the scope of proposed s111b(2). 60. Any disputes relating to whether a particular time period should be disregarded would initially be determined through a hearing before the Commissioner under s208 of the Act. The Commissioner s decisions could be appealed to the High Court under s214 of the Act. 61. The main disadvantage with this option is uncertainty for both patent owners and third parties as to which periods would be disregarded. This could make it difficult for patent owners and third parties to determine whether a particular patent might be eligible for extension. 62. It could take many years to build up sufficient case law about which periods could or could not be disregarded. This could impose significant costs on patent owners, particularly if Commissioner s decisions were appealed to the High Court. The time taken to determine any appeals would also add to uncertainty for third parties about whether or not a particular patent would be extended. Option 2: Specify the periods in regulations (preferred option) 63. If this option is adopted, regulations would provide a non-exhaustive list of those time periods that the Commissioner must disregard. This will provide a high degree of certainty for patent owners and third parties, and will signficantly reduce the number of disputes. 64. Any disputes would probably only involve time periods that were not prescribed in the regulations. There are likely to be few, if any of these. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 13 TPP Amendment Bill: Patent Term Extension Proposed Regulations

15 65. This option is the preferred option. A list of time periods that we propose should be prescribed in the regulations for the purposes of proposed s111b(3) is attached to this document as Appendix 1. Disregarded Periods Question 9: Which of the two options discussed do you prefer? Why? Question 10: Considering the list of disregarded periods proposed in Appendix 1, are there any time periods on that list that you consider should not be disregarded? Why? Question 11: Considering the list of disregarded periods proposed in Appendix 1, are there any periods that are not on the list, but that you consider should be there? 66. There is no intention to provide regulations regarding the periods to be disregarded in the Certificate from the Regulator (Medsafe) provided under new s111f(2) in clause 75 of of the Bill. This is because Medsafe s procedures are not governed by formal regulations, unlike the procedures for processing patent applications set out in the Patents Act Instead, the issue of the periods to be disregarded will be dealt with through practice guidelines to be developed by Medsafe. Opposition to extensions of term 67. New s111h in clause 75 of the Bill provides that any person may oppose an extension of term for unreasonable curtailment of the effective patent term due to the marketing approval process. The procedural steps that any opponent and the patent owner must follow are not set out in new s111h, they are left to the regulations. 68. In deciding what sort of opposition procedure should be adopted, and the time limits for filing a notice of opposition, the interests of the opponent and the public have to balanced against those of the patent owner. If a person considers that there are grounds to oppose the grant of an extension of term, it is in the public interest that the Commissioner has as much information as possible to inform her decision. Procedure for opposition 69. There is a question of what procedure should be adopted for an opposition to an extension of term. The Act contains a number of provisions for opposition procedures: s87 opposition to a request to amend a complete specification after acceptance; s92 opposition to the grant of a patent; s120 opposition to restoration of a lapsed patent; and s127 opposition to restoration of a void or abandoned patent application. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 14 TPP Amendment Bill: Patent Term Extension Proposed Regulations

16 70. The actual procedures are set out in the Patents Regulations There are effectively two approaches set out in the Patents Regulations: the procedures set out for oppositions under sections 87 and 92 of the Patents Act 2013; or the procedures set out for oppositions under sections 120 and 127 of the Patents Act Of the two approaches, the procedure for opposition under sections 87 and 92 are the most complex. The patent applicant must go through up two two rounds of filing evidence, and the opponent up to three, before the Commissioner of Patents makes a decision (see regulations 89 and 94). 72. In oppositions filed under sections 120 and 127 of the Patents Act 2013, the patent owner or patent applicant is only required to file a counterstatement to the notice of opposition filed by the opponent (see regulations , and ). 73. Procedures like those set out in regulations 89 and 94 are likely to take longer and be more expensive than those set out in regulations or The question of what type of opposition procedure should be adopted in regard to extensions of patent term will turn on the complexity of the evidence required. More complex evidence may require procedures like those in regulations 89 and 94. If the evidence is less complex procedures like those in regulations or may be better. 75. It is noted that the approach to oppositions to extensions of term taken in the Australian Patents Act 1990 is to adopt the same opposition procedure as that used for opposition to the grant of a patent. 76. The Ministry has no preference at this stage we will consider public submissions before making a final decision. Procedure for opposition to extension of term for unreasonable curtailment of the effective patent term Question 11: Of the possible opposition procedures discussed, which do you prefer? Why? Question 12: If you do not prefer either of the procedures discussed, what other procedures could be used? Manner of requesting an opposition 77. It is proposed that the opponent must file a notice of opposition setting out the ground or grounds on which the opponent opposes the extension of term. The opponent will also need to file a statement of case setting out the facts that the opponent wishes to rely on, and the relief sought. The relief will usually be refusal of the request for extension of term, although it could be the grant of a shorter extension than the patent owner would otherwise be granted. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 15 TPP Amendment Bill: Patent Term Extension Proposed Regulations

17 Time limits for filing an opposition to an extension of term 78. This relates to when a notice of opposition to the grant of an extension of time must be filed. The time limit would run from the date that the grant of an extension of term is notified in journal under new s111k(1) in clause 75 of the Bill. 79. The time limits provided for in the existing opposition procedures in the Regulations are as follows: section 87, s123 and s127 oppositions: 2 months after the date the relevant request is advertised in the journal3 (Regulations 89, 112 and 118; section 92 oppositions: 3 months from the date of publication of the complete specification (Regulation 93). 80. In the case of s87 and s92 oppositions, the time limit can be extended by one month if the patent applicant does not consent to an extension, or two months if the applicant does consent (Regulations 89 and 93). These time limits cannot be extended if the request for extension is received after the period for filing the notice of opposition has expired. In the case of s123 and s127 oppositions, the time limit cannot be extended at all. Time limit for filing a notice of opposition to an extension of term for unreasonable curtailment of the effective patent term Question 13: What should the time limit be for filing a notice of opposition to an extension of term? Question 14: Should the time limit for filing a notice of opposition to extension of term for unreasonable curtailment be extendable? If so, what extension should be available? Under what circumstances should an extension be granted? 81. The Ministry has no preference at this stage, and will make a final decision after considering public submissions. Fees 82. IPONZ is funded entirely by third party fees. These are charged to persons who apply to register the intellectual property rights for which IPONZ is responsible, and to third parties who interact with IPONZ in respect of those rights, such as persons opposing or challenging the grant of the rights. 83. IPONZ has not yet had the opportunity to model the likely costs involved in administering the proposed patent term extension provisions, and no fee estimates are available. However, it is likely that the basis for setting fees for requests for extensions of term will be the same as for other fees that is, that is the fees will likely be set below the actual cost of administering the procedures involved, with costs subsidised by renewal fees as authorised by s243(2)(a) of the Act. 3 The journal is the journal published under s206 of the Act. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 16 TPP Amendment Bill: Patent Term Extension Proposed Regulations

18 84. On this basis, the fees will likely be similar to the fees for requesting restoration of lapsed patents or void or abandoned applications, (currently $100 + GST). The fee for filing a notice of opposition would likely be the same as that in the current schedule of fees, $350 + GST. 85. Annual renewal fees will also be charged on any extensions granted. Although these have not been modelled by IPONZ either, as a guide, the renewal fees for the 15 th 19 th years of the patent are $350 + GST per year. Any renewal fees charged on extended patent terms will be at least at this level. Fees Set out above are tentative estimates of likely fee levels that would be charged in relation to requests for extension of term, and in relation to the filing of notices of opposition to extension of term. Question 14: Do you think that such fee levels are reasonable? If not, should the fees be higher or lower than the estimates given? Why? MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 17 TPP Amendment Bill: Patent Term Extension Proposed Regulations

19 Appendix 1: Proposed list of Disregarded Periods for the purposes of proposed s111b(2) of the Act Periods that it is proposed to deem to be disregarded periods in the Patents Regulations 2014 for the purposes of proposed s111b(2) of the Act are set out below. The wording is indicative only, and not intended to be the final wording of the proposed regulation. It is intended that the list will be non-exhaustive: i. The interval between the date of issue of an examination report under s65 and the date of receipt of a substantive response to the examination report as defined in s67(6). ii. iii. If the patent applicant has requested a postponement of acceptance under s75, the period between the making of the request and the date that is specified in the request. If a patent applicant makes a request to amend a complete specification under s85 after acceptance, but before grant: a. the time period between the date the notice was issued under regulation 88(1) and the date of receipt of a response that satisfies the Commissioner that the amendment should be allowed; or b. if no response that satisfies the Commissioner is received, the time period between the date of the notice issued under regulation 88(1) and the date that the requestor withdraws the request, or the date that is four months after the date of the notice, if no notice of withdrawal is received. iv. If an notice of opposition to a request for amendment under s85 is filed under s87, the time period between the date of publication in the journal under s86 of the request for leave to amend, and the date of the hearing under s87(2)(b). v. If an opposition under s87 is filed, but withdrawn before a hearing under s127(3) is held, the time period between the date of publication in the journal under s86 of the request for leave to amend, and the date the opposition is deemed to be withdrawn. vi. vii. viii. If a hearing is requested in respect of a patent application under s208 of the Act, and the hearing request is withdrawn before a hearing is held, the interval between the date the Commissioner received a request for a hearing and the date the Commissioner was notified of the withdrawal of the hearing request. If a decision is issued by the Commissioner following a hearing under s208 in respect of a patent application, and the decision indicates that the application will be accepted if amendments acceptable to the Commissioner are made, the interval between the issue of the Commissioner s decision and the receipt of amendments acceptable to the Commissioner. If an assertion is filed under s90, any period of time between the issue of a request under Reg. 91(2) by the Commissioner for information from the person making the assertion, and the receipt of information from that person. MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 18 TPP Amendment Bill: Patent Term Extension Proposed Regulations

20 ix. If the Commissioner re-examines a patent application under s94 of the Act, any periods of time between the issue of a report by the Commissioner under s97 and the receipt of a response from the patent applicant. x. The period between the date of acceptance of a patent application under s74 and the date on that is three months after this date, where no opposition under s92 is filed. xi. If a patent application is abandoned under sections 35, 64 or 68, or is void under s71 or s51(1)(d), and an application to restore the application is made under s125: a. the period of time between date on which the application was deemed abandoned or void, and the expiry of the period for giving notice of opposition under s127, where no opposition is filed; b. if an opposition under s127 is filed, the period of time between the date the patent application was deemed to be abandoned or void, and the date of the hearing under s127(3); or c. if an opposition under s127 is filed, but withdrawn before a hearing under s127(3) is held, the time period between the date of filing of the notice of opposition and the date the opposition is deemed to be withdrawn. xii. xiii. xiv. xv. xvi. If an opposition to an accepted application is filed under s92, the period of time between the date that is three months after the date of acceptance filed and the later of: a. The date that opponent s evidence in reply is filed under regulation 94(6); and b. If the opponent does not file evidence in reply, the date that the applicant s evidence is filed under regulation 94(5); and c. The date that the opponent s evidence is filed under regulation 94(4). Where interlocutory hearings under s208 are held in respect of a patent application where a notice of opposition has been filed under s92 or s127, the periods of time between the date on which the hearing was held and the date that the Commissioner s decision was issued must be subtracted from the time periods prescribed in the preceding 2 paragraphs (these are delays attributable to the Commissioner). If a decision is issued by the Commissioner following a hearing under s93(a) in respect of a patent application, and the decision indicates that the application will be granted if amendments acceptable to the Commissioner are made, the interval between the issue of the Commissioner s decision and the receipt of amendments acceptable to the Commissioner. If, in proceedings before the Commissioner in relation to a patent application, the Commissioner halts proceedings under regulation 159 on the application of a party, the time period between the date on which proceedings were halted, and the date that they are recommenced. Where an appeal to a court is made in respect of a patent application by a person other than the Commissioner, the time period between the date on which the appeal is lodged and the date on which the final determination of the court is issued (this would include further appeals to the Court of Appeal and Supreme Court if they are made). MINISTRY OF BUSINESS, INNOVATION & EMPLOYMENT 19 TPP Amendment Bill: Patent Term Extension Proposed Regulations