November 2, Dear AIPPI National Groups:

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1 November 2, 2011 Dear AIPPI National Groups: As many of you are aware, the United States Congress passed the America Invents Act ( AIA ) into law on September 16, The America Invents Act includes provisions such as prior user rights, post-grant review (oppositions), and transition to a first-to-file system, that bring the U.S. laws more into compliance with the patent laws of the rest of the world. The provisions of the America Invents Act can be found at 112hr1249eh.pdf. The U.S. Patent and Trademark Office ( USPTO ) has asked for comments related to these provisions, and has particularly requested comments from AIPPI. Under the U.S. legal system, the AIA is a law or statute, which cannot be changed by the USPTO. However, the USPTO has the duty to implement the statute, e.g., in the form of Title 37 of the Code of Federal Regulations (CFR), to help guide how such statutes will be interpreted and applied. Generally, this process is called rulemaking, though the terms rules and regulations often are used interchangeably. The USPTO is currently drafting new regulations, which we expect will begin to be published in the U.S. Federal Register shortly. Once the proposed regulations are published, the public will have a short time period in which to submit comments. However, the USPTO has specifically given AIPPI-US the opportunity to provide any comments we may have to help them prepare these new regulations now, rather than waiting until the proposed new regulations have published. Two of the first areas in which the USPTO has requested comments relate to the scope of prior user rights ( and international patent protection options for small businesses ( Additionally, the USPTO has requested preliminary comments on the AIA generally. We in the U.S. Group have agreed to compile and submit comments to the USPTO, and for this purpose, we request your answers to the following questions.

2 1 Prior User Rights (See AIA 5, Defense to infringement based on prior commercial use (H.R ), codified as amended in 35 U.S.C. 273) 1.1 Does your country recognize prior user rights, and, if so, to what extent? 1.2 What is the frequency or regularity with which prior user rights are utilized or asserted in 1.3 How does the prior user rights regime operate in 1.4 What are the advantages/disadvantages of the prior user rights regime in your country? 1.5 If prior user rights are not available in your country, please provide your opinion why you believe prior user rights are or are not needed in your country. 1.6 Please share your experiences in analyzing the correlation, if any, between prior user rights and start-up enterprises and the ability to attract venture capital to start new companies in your country. 1.7 Please share your experiences in analyzing the effect, if any, of prior user rights on small businesses, universities, and individual inventors in your country. 1.8 Please provide any other comments you may have concerning prior user rights under the AIA and your suggestions for USPTO regulations for implementing the same. 2 International Patent Protection for Small Businesses (See AIA 31 (H.R )) 2.1 Does any private or public/governmental entity in your country provide any financial or other support to small business inventors for assistance with the costs associated with filing, maintaining, or enforcing international patents? 2.2 If so, does the assistance in your country take the form of loans, grants, or otherwise? 2.3 Are there necessary qualifications to determine recipients of such assistance in 2.4 Are there any limitations on the amount or type of such assistance that may be offered in 2.5 If such assistance is not currently offered in your country, would you favor or oppose the future offering of such assistance? 2.6 Overall, how important is patent protection for small businesses in 2

3 2.7 Do small businesses in your country face barriers to growth and competitiveness, both domestically and internationally, if they do not seek international patent protection early in the innovation process? 2.8 What role does international patent protection play in internationalization strategies (e.g., franchising, exporting, foreign-direct-investment, etc.) of small businesses in For what sectors is this role more or less significant? 2.9 Please provide any other comments you may have concerning international patent protection for small businesses and, more particularly, your suggestions for USPTO regulations for implementing the AIA in this regard. 3 First-to-File and Derivation Proceedings (See AIA 3 (H.R ), codified as amended in 35 U.S.C. 135 (defining derivation)) 3.1 Is your country operating under a first-to-invent or a first-to-file system for determining inventorship? 3.2 If first-to-file, has this had any impact, positive or negative, on small businesses in 3.3 What rules or systems are in place in your country to prevent the theft of inventions or to provide remedies for derivation? 3.4 What evidentiary standards and procedures do you want to recommend to the USPTO for conducting derivation proceedings? 3.5 Please provide any other comments you may have concerning the use of a first to file system and/or derivation proceedings for helping to guide the USPTO regulations implementing the AIA. 4 Genetic Testing (See AIA 27 (H.R )) 4.1 What, if any, procedures are in place in your country establishing the availability of independent confirming genetic diagnostic test activity? 4.2 If such procedures are in place, what, if any, impact do the current procedures have on testing results and performance, on patients, and on patentees/licensees in 4.3 What role does insurance coverage play on the provision of genetic diagnostic tests in 4.4 Please provide any other comments you may have concerning genetic testing for helping to guide the USPTO regulations implementing the AIA. 3

4 5 Post-Grant Review and Inter-Partes Review (See AIA 6 (H.R ), with Post-Grant Review having to be filed within nine months of the date of patent grant and being provided for in Chapter 32 of 35 U.S.C. and Inter-Partes Review having to be filed after nine months from the date of patent grant and being provided for in Chapter 31 of 35 U.S.C.) 5.1 Are there any systems or procedures in place in your country for your Patent Office to review the validity of a patent after it has been granted? If so, what systems or procedures are available? 5.2 Have your post grant review proceedings had any impact, positive or negative, on small business in 5.3 Are the post grant review procedures in your country used very often or have they been used minimally? 5.4 Are there any issues related to patentability or validity that cannot be raised during post grant review in 5.5 Are there any issues in dispute in a post grant review proceeding that cannot be disputed in later litigation in 5.6 Are there any differences in discovery rules between post grant proceedings and litigation in 5.7 The AIA states that the USPTO shall set forth standards and procedures for discovery of relevant evidence in post-grant review and inter-partes review proceedings, but also mentions that such discovery shall be limited to the deposition of witnesses submitting affidavits or declarations and what is otherwise necessary in the interest of justice. To what extent should discovery be allowed in these proceedings under the AIA? 5.8 Please provide any other comments you may have concerning post-grant review and/or inter-partes review for helping to guide the USPTO regulations implementing the AIA. 6 Supplemental Examination (See AIA 12 (H.R )) 6.1 Are there any systems or procedures in place in your country for a patent owner to request supplemental examination of their already granted patent by your respective Patent Office? If so, what systems or procedures are available? 6.2 Have your supplemental examination proceedings had any impact, positive or negative, on small business in 6.3 Are the supplemental examination procedures in your country used very often or have they been used minimally? 6.4 Are there any issues related to patentability or validity that cannot be raised in a supplemental examination request in 4

5 6.5 Are there any issues raised in supplemental examination that cannot be disputed in later litigation in 6.6 Please provide any other comments you may have concerning supplemental examination for helping to guide the USPTO regulations implementing the AIA. 7 NPE Patent Litigation (See AIA 34 (H.R )) 7.1 Are non-practicing entities (NPEs) permitted to commence patent litigation in 7.2 If so, what percentage of such NPE cases is ultimately found to be without merit after judicial review in 7.3 What is the impact of such NPE litigation on the time to resolve patent claims in 7.4 What are the average costs of such NPE litigation in What is their impact, positive or negative, on the economy in your country, including job creation and any benefits created by NPEs? 7.5 Please provide any other comments you may have concerning NPE patent litigation for helping to guide the USPTO study and its regulations implementing the AIA. 8 Other Comments on USPTO Rulemaking under the AIA 8.1 Please provide any other comments you may have on USPTO Rulemaking under the AIA. * * * These survey questions are designed to obtain your comments on rulemaking to implement the AIA so we can prepare a submission to the U.S. Patent and Trademark Office (USPTO) on behalf of AIPPI. Please submit your responses by Friday, November 11, 2011, directly to Joshua Goldberg, Chair of the AIPPI-US Committee on USPTO Rulemaking, at jgoldberg@nathlaw.com, with a copy to Secretary General Stephan Freischem (s.freischem@aippi.org), Reporter General Thierry Calame (t.calame@aippi.org) and the General Secretariat (f.martin@aippi.org). In addition, any AIPPI members who wish to do so may submit comments directly to the USPTO via pursuant to instructions on the USPTO website. 5

6 Thank you for your support of AIPPI in this endeavor. If you would like to have a copy of the comments we provide to the USPTO, please let us know when you send your answers to the above. Sincerely, Richard Beem, President, AIPPI-US Drew Meunier, Secretary, AIPPI-US Joshua Goldberg, Chair, AIPPI-US Committee on USPTO Rulemaking 6