PCT Recent changes and prospective new changes Louis O. Maassel, Consultant on PCT Matters

1. World Intellectual Property Organization PCT Recent changes and prospective new changes Louis O. Maassel, Consultant on PCT Matters The 17th Annual Intellectual Property Law Conference Washington DC April 11-12, 2002

2. FILING OF INTERNATIONAL APPLICATIONS CONTAINING LARGENUCLEOTIDE AND/OR AMINO ACID SEQUENCE LISTINGS

3. Part 8 of the Administrative Instructions Section 801, Filing of International Applications Containing Sequence Listings Section 802, Format and Identification Requirements Relating to International Applications Containing Sequence Listings Section 803, Calculation of Basic Fee for International Applications Containing Sequence Listings Section 804, Preparation, Identification and Transmittal of Copies of International Applications Containing Sequence Listings Section 805, Publication and Communication of International Applications Containing Sequence Listings; Copies; Priority Documents Section 806, Sequence Listings for Designated Office (Published on 11 January 2001 in the PCT Gazette No. 02/2001)

4. Section 801, Filing of International Applications Containing Sequence Listings • An international application containing disclosure of nucleotide and/or amino acid sequence listings may file such disclosure • (i) only on an electronic medium in computer readable form, or • (ii) both on an electronic medium and on paper in written form. • It will continue to be possible to file the international application with the sequence listing in only paper form • A copy of the sequence listing on an electronic medium in computer readable form for use by the International Searching Authority and/or the International Preliminary Examining Authority, may accompany or be filed later than the international application

5. Section 802, Format and Identification Requirements Relating to International Applications Containing Sequence Listings • Where the sequence listing is filed in computer readable form: • (i) if contained on more than one electronic carrier, they should be numbered, for example, DISK 1/3, DISK 2/3, DISK 3/3 • (ii) where more than one copy is filed, each copy should be labeled, for example, COPY 1, COPY 2, COPY 3 • Where replacement carrier in computer readable form is furnished containing the entire sequence listing, it should be marked, for example, “SUBMITTED FOR CORRECTION”, “SUBMITTED FOR RECTIFICATION”, “SUBMITTED FOR AMENDMENT”

6. Section 803, Calculation of Basic Fee for International Applications Containing Sequence Listings • The International Basic Fee payable under new Section 803 has two components • (I) a basic component based on the total number of pages including the request, description (excluding the sequence listing part if also filed on paper), claims, abstract and drawings} • (ii) an additional component, in respect of the sequence listing, equal to 400 times the per sheet fee. Currently 400 x $9 = $3,600

7. Cost Comparison 1, Small listing, 10 sheets, paper only Total Basic Fee = $497 2. Small listing, 10 sheets, Computer readable form only Total Basic Fee = $4,007 3, Medium listing, 500 pages, paper only Total Basic Fee = $4,907 4. Medium listing, 500 pages, Computer readable form only Total Basic Fee = $4,007 5, Large listing, 1000 pages, paper only Total Basic Fee = $9,407 6. Large listing, 1000 pages, Computer readable form onlyTotal Basic Fee = $4,007

8. OPTIONAL DECLARATIONS AS PART OF THE REQUEST TO FULFILL NATIONAL PHASE REQUIREMENTS

9. Simplified procedures for meeting national phase requirements (1) – provides option of including in the request certain declarations containing standardized wording relating to matters which may be required by designated/elected Offices: • the identity of the inventor • the applicant’s entitlement to apply for and be granted a patent • the applicant’s entitlement to claim priority of an earlier application • an oath or declaration as to inventorship (for the US designation only) • non-prejudicial disclosures or exceptions to lack of novelty

10. Simplified procedures for meetingnational phase requirements(2) – Applicants may correct or add any of the declarations containing standardized wording until the expiration of 16 months from the priority date (or even later, provided that the declaration is received by the International Bureau before the technical preparations for international publication have been completed) – The receiving Office or International Bureau may invite the applicant to correct any declaration that is not worded in accordance with the standardized wording – The declarations containing standardized wording will be communicated to the designated Office or Offices concerned and also be mentioned in the published pamphlet – Declarations regarding non-prejudicial disclosures or exceptions to lack of novelty will be published as part of the pamphlet

11. Simplified procedures for meetingnational phase requirements(3) Limits documents and evidence which may be required under national law • If a declaration has been furnished, no documents or evidence as to that matter may be required by the designated Office unless that Office may reasonably doubt the veracity of the declaration (except evidence concerning non-prejudicial disclosures or exceptions to lack of novelty The signature to the request also acts as the signature for all attached declarations, except for the declaration of inventorship for the USPTO which must be signed by the inventor/applicant(s)

12. Rule 4.17 oath or declaration as to inventorship for USPTO • Only necessary to include prior applications filed in a country other than US, having a filing date earlier than the earliest priority date claimed in the request form • All inventors need to be named in the same declaration • need for signature/date (possibly on different copies of declaration); except when filed together with the international application and if the request form is signed by all inventors • The signature does not have to be an original • USPTO accepts a seal as signature when the international application is filed with receiving Offices which accept seals as signatures

13. Rule 4.17 Declarations • Do not use national forms for declarations in the international phase, for instance, a combined declaration of inventorship and a power of attorney • When a declaration is furnished after the international filing date, no further page fee is required • If a defective declaration is not corrected during the international phase: • no sanction in the international phase • DOs/EOs may accept defective declarations

14. Actions taken by the PCT Assembly (Oct. 3, 2001) 1. PCT Article 22 time limit modified and Rule 90bis consequentially amended 2. Maximum number of designation fees reduced 3. Amendment of EPO ISA/IPEA Agreement 4. Amendment of ESPTO Agreement 5. PCT Reform status 6. IMPACT/Electronic filing status

15. Modification of Article 22 time limit (1) • The PCT Assembly: • modified the time limit under Article 22(1) to enter the national phase under Chapter I from 20 to 30 months • entered into force on April 1, 2002 • applicable to all international application for which the 20 month time limit has not yet expired on 1 April 2002 and for which the acts necessary to enter the national phase have not yet been performed

16. Modification of Article 22 time limit (2) • transition--30 month time limit under Chapter I not applicable in respect of any designated Office that has notified the International Bureau by January 31, 2002 that, and for as long as, the modification is not compatible with its national law • IMPORTANT NOTE: Since not all Contracting States will be able to give immediate effect to this modification in their national law, applicants must be aware of States in which they will have only 20 months under Chapter I • Rules 90bis.1, 90bis.2 and 90bis.3 amended so that the time limit for withdrawal is 30 months in all cases

17. Modification of the time limits fixed in Article 22(1) Notifications that the modification is not compatible with national laws were received from the Offices (in their capacity as designated Offices) of the following States (24) AU Australia BG Bulgaria BR Brazil CH Switzerland CN China DK Denmark EE Estonia FI Finland GB United Kingdom HR Croatia HU Hungary IL Israel JP Japan KR Republic of Korea LU Luxembourg NO Norway SE Sweden SG Singapore SK Slovakia TZ United Republic of Tanzania UG Uganda YU Yugoslavia ZA South Africa ZM Zambia

18. The current PCT System 20 Enter national phase Chapter I International publication (months) 19 0 12 16 18 or * File local application File PCT application International search report File demand Enter national phase International preliminary examination 30 * Applicant must decide whether to file demand by 19 months or enter national phase by 20 months Chapter II

19. The new PCT System (as of April 1, 2002) Chapter I 20 30 International publication (months) 19 0 12 16 18 Enter national phase or* File local application File PCT application International search report File demand International preliminary examination** * For all designated States to which new Article 22(1) does not yet apply, the applicant must decide whether to file demand by 19 months or enter national phase by 20 months ** If the applicant wants to receive an international preliminary examination report, he must file a demand 30 Chapter II

20. Reasoning behind Article 22 modification (1) • Continued growth in PCT filings has generated enormous increase in workload, in particular, for IPEAs • Modification is intended to avoid crisis while keeping an appropriate balance between interested parties • Significant proportion of applicants use the IPE procedure only in order to delay entry into the national phase (i.e., to “buy time”)

21. Reasoning behind Article 22 modification (2) • it was intended that, as a result of the modification: • IPEAs will have to process demands and produce written opinions and IPERs only in cases where applicant has real interest in the results of the IPE procedure • IPEAs will have more time to focus on those applications and will be able to better maintain the quality and timeliness of the IPERs that they produce • IPEAs will be in a better position to respond to the expected future growth in PCT filings

22. Reduction in maximum number of designation fees payable • Amendment of the Schedule of Fees • until as from • 31 December 2001 January 2002 • Maximum number • of designation fees • payable: 6 5 • effectively means 7% decrease for more than 2/3 of PCT applicants another similar reduction planned for 2003 (in Program and Budget) • sixth consecutive year where filing fees reduced--by 1 January 2003, effectively 45% decrease since 1997

24. Amendment of the Agreement with the European Patent Organization acting as ISA and IPEA (1) • The PCT Assembly approved the amendment of: • the agreement allowing EPO, as of 1 November 2001, to limit its competence as ISA/IPEA according to the following criteria (or a combination thereof): • nationality or residence of the applicant (to EPC States and those States whose national Offices do not act as ISA and IPEA) • number of applications • certain technical fields • any such limitation will become effective, at the earliest, one month from receipt by the International Bureau of a notification by the EPO

25. Amendment of the Agreement with the European Patent Organization acting as ISA and IPEA (2) • Details of limitation were defined only when the EPO officially notified the International Bureau • Affects the amount of ISA and IPEA work done by the EPO for US origin international applications • Considerations: • The EPO has been serving as an ISA and IPEA for all PCT member States • In view of the significant increases each year in the number of international applications being searched and examined by the EPO as ISA and IPEA, it has not been able to timely process PCT and EPO work

26. Limitations set by the EPO for US applicants • The EPO will not carry out international search for international applications filed after March 1, 2002 by a resident or national of the US for certain inventions in the areas of: • Biotechnology • Business method related inventions

27. Amendment of ESPTO Agreement • The PCT Assembly approved the amendment of: • the agreement as to the functions of the Spanish Patent and Trademark Office as ISA, appointing it as IPEA • effective date will be sometime in 2002, subject to notification

28. PCT Reform • The Assembly: • noted the report of the first meeting of the Committee on PCT Reform • approved the establishment of a Working Group on PCT Reform which would meet in November 2001 and March 2002 • Committee would meet after the two Working Group sessions

29. Impact Project and Electronic Filing • The Assembly noted both the Information Management for the Patent Cooperation Treaty (IMPACT) progress report and Electronic Filing Project status report

30. More Information • PCT Assembly, 30th (13th ordinary) session, Geneva, September 24 to October 3, 2001 • documents PCT/A/30/2 to 6 • document PCT/A/30/7 “Report” (October 3, 2001) • http://www.wipo.int/eng/document/govbody/wo_pct/index_30.htm

31. PCT Electronic Filing

32. PCT Electronic FilingThe need for PCT E-Filing • Mandated by PCT Assemblies to: • adopt a technical standard and legal framework • develop an e-filing system based on PCT-EASY • No product available that met PCT requirements • PLT: PCT standard will become the general standard • PLT: IT support for developing countries • PCT processing at WIPO and IMPACT

33. PCT Electronic Filing Basic concepts (1) • Establish a system: – for electronic filing and processing of international applications, other documents, correspondence, etc. – for any Office which is prepared to accept such filing (no Office or Authority would be obliged to receive or process such filings) – which will include the creation of electronic records which should be acceptable in all designated States – which will include the creation of electronic records which should be acceptable in all designated States

34. PCT Electronic Filing • Basic concepts • • Electronic filing will be facilitated by PCT electronic filing software (based on PCT-EASY and being created by WIPO; in 2001, 32% of PCT filings prepared using PCT-EASY and 7000 registered users) • • PCT electronic filing is not currently operational.The PCT Rules now contain a broad set of enabling provisions relating to electronic filing (PCT Rules 89bis and 89ter) • The standards and other details will, at least initially, be set out in the PCT Administrative Instructions and the Rules will not enter into force until the Administrative Instructions and related technical standard are promulgated

35. PCT Electronic FilingLegal framework (1) • E-filing optional for applicants and Receiving Offices • Annex F technical requirements must be complied with • electronic document format; means of transmittal; electronic package; electronic filing software; virus-free; electronic signature • Receiving Offices may specify options available under Annex F • but Receiving Offices must accept international application complying with “basic common standard” • Receiving Offices may decline to accept non-compliant international application

36. PCT Electronic FilingLegal framework (2) • “Grandfather” clause exempting Receiving Offices that already operate different e-filing systems, subject to notification of International Bureau • Procedures for receipt, acknowledgement, notification of non-compliance, access to records, etc. • Package must use (PKI) digital signature of sender, but application may be signed by applicant using basic electronic signature • but Receiving Offices may insist on digital signature by applicant for later communications • Record copy and home copy are kept in electronic form; search copy may be in electronic form if ISA wishes

37. PCT Electronic FilingLegal framework (3) • Backup copies on paper prepared by applicant or Receiving Office may be substituted for electronic file as a correction under Rule 26 • Basic fee (excess page component) calculated as if international application were printed on paper • Special provisions concerning failed transmission and virus infection • ROs’ requirements must be notified to IB and published • Same rules apply to ISAs, IPEAs and IB as to ROs • and to communications between them

38. PCT Electronic FilingLegal framework (4) • Storage of records must be in accordance with Annex F requirements of authentication, integrity, confidentiality and non-repudiation, and have due regard to Annex F principles of electronic records management • Annex F does not apply in general to communications with designated Offices • but filing date of international application filed in electronic form must be recognized by DOs • DO may insist on digital signature by applicant for later communications

39. PCT Electronic FilingProvisions • Modifications of the Administrative Instructions were published in a special issue of the PCT Gazette No. S-04/2001 and became effective on January 7, 2002 • Part 7: Instructions Relating to the Electronic Filing and Processing of International Applications • Annex F: Standard for the Electronic Filing and Processing of International Applications • The legal and technical foundations for PCT electronic filing are now in place.

40. PCT Reform

41. PCT Reform Background (1) • August 2000: Proposal by the United States of America for reform of the PCT • Proposal for reform in two stages: • first stage: • simplification of the system • streamlining of the procedures • alignment of PCT requirements with those of the PLT • second stage: • comprehensive overhaul of the entire PCT system

42. PCT Reform Background (2) • October 2000: PCT Assembly decided to establish special body to consider proposals for reform of the PCT • May 2001: “Committee on Reform of the PCT” met and discussed proposals for reform submitted by Member States, intergovernmental and non-governmental organizations

43. Work on PCT Reform • Working Group, 1st session, was held November 2001 -- discussed issues of first stage of PCT Reform • Working Group, 2nd session, April 29-May 3, 2002 • Committee’s 2nd session, mid-2002 • Assembly’s 31st session, September-October 2002 • Further discussions, including longer-term proposals, after September 2002

44. RATIONALIZATION OF THE INTERNATIONAL PRELIMINARY EXAMINATION PROCEDURE AT THE EPO

45. RATIONALIZATION OF THE INTERNATIONAL PRELIMINARY EXAMINATION PROCEDURE AT THE EPO The continuing increase in the PCT workload at the EPO has prompted it to rationalize its procedures for IPE with effect from 3 January 2002. A central element in the rationalized procedure is that the result of the international search will serve as the basis for IPE, withoutinvolving the examiner again unless: the applicant files amendments and/or arguments, or expressly requests “detailed” (that is, non-rationalized) preliminary examination. The introduction of the EPO’s BEST (“Bringing Examination and Search Together”) project Office-wide means that the same examiner will carry out both search and substantive examination; that examiner will reach a provisional judgment which will later be set down in the first written opinion and the IPER; all the EPO’s written opinions and IPERs will focus on those core aspects.

46. Implications on preliminary examination fee Where the EPO has concluded the Chapter II procedure with a rationalized IPER, refund of two thirds of the international preliminary examination fee at the same time as it transmits the IPER. This applies to all international applications on which the EPO draws up a rationalized IPER as from 3 January 2002. If such a refund has been given during the international phase, the full European examination fee is payable in the regional phase before the EPO as elected Office. Applicants will only benefit from the 50% reduction in the European examination fee where a “detailed” IPER has been issued.

47. Additional rationalization measures The time limits fixed by the EPO for filing amendments or arguments under PCT Rule 66.2(d) will be at the lower limit of the range allowed. Discussions with the applicant will take place only after the first written opinion has been responded to, and only by telephone. As a rule, only one single written opinion will be issued. “Detailed” international preliminary examination at the EPO will focus on the claims defining the invention and the main requirements under Article 33(1). Other requirements (such as form, contents, clarity) will be covered only if this is essential for preliminary examination purposes. The written opinion and the IPER will normally contain no information concerning priority, cited documents, defects in the application, and comments on the international application.

48. Additional rationalization measures The EPO will make full use of PCT Article 34(4), and will not perform international preliminary examination in cases where it applies. No international preliminary examination would be carried out if the differences with the original application and the reasons for amendments have not been made sufficiently clear (see PCT Rule 66.8(a)). The procedure is based on information published in the Official Journal of the EPO No. 11/2001, which also includes examples of how these measures will affect applications with positive or negative international search reports; it is available on the EPO’s Internet site at: http://www.european-patent-office.org/epo/pubs/oj001/11_01/11_5391.pdf

49. RATIONALIZATION OF THE IPE PROCEDURE AT THE EPO The applicant determines whether the result of the international search becomes the basis for rationalized international preliminary examination, or whether a more detailed substantive examination is made, • if an applicant files amendments and/or arguments, or • expressly requests “detailed” preliminary examination (when filing the demand or later), the international application will always be dealt with by the substantive examiner again.