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Major Amendments in the Indian Patents Law & Practice

Preface

Indian Patent Attorneys, Examiners and other IPR professionals will have to remove several expressions close to their heart from their daily lexicon. The age old prosecution steps of 'Putting the Application in Order for Acceptance', 'Notice of Acceptance', 'Advertisement of Notice of Acceptance', 'Opposition before Grant', 'Sealing of Patent' etc. have no place in Indian patent practice any more.

On December 26, 2004 the President of India promulgated an Ordinance to amend the national patents law. The Ordinance came into force on January 1, 2005 marking the culmination of a decade long efforts by the Government of India to make the Patents Act compliant with the TRIPS Agreement. A Presidential Ordinance is, however, a temporary legislative measure. It will cease to operate at the expiration of six weeks from the reassembly of the Parliament. The Government of India has the onerous task of getting the Patents Amendment Bill, 2003 passed by the Parliament, which contains the same provisions as that of the Ordinance. However, the rights and obligations created by the Ordinance are ordinarily not extinguished by any subsequent event.

The Patent Rules were amended pursuant to the promulgation of the Patents (Amendment) Ordinance, 2004 (hereinafter the Ordinance). The new set of Rules [known as the Patents (Amendment) Rules, 2005] was notified by the Government of India on December 28, 2004 and came into force on January 1, 2005. The new rules made sweeping changes in the Indian patent prosecution system.

This article highlights the major amendments introduced by the Patents (Amendment) Ordinance, 2004 and the Patents (Amendment) Rules, 2005. The article is divided into 2 sections, the first section deals with the substantive amendments and the second section deals with the procedural changes.

Section I

Substantive Amendments

1. Product Patents for 'Food', 'Drug' and 'Pharmaceuticals' The Ordinance repealed the controversial Section 5 of the Indian Patents Act, 1970. For over three decades only processes were patentable in respect of inventions relating to 'food, drug, and medicines' and 'substances produced by chemical processes'. From 1st January, 2005, patents will be granted for all categories of inventions.

2. Restrictions on 'New Use' diluted The 'new use for a known substance' was not patentable so far. The Ordinance amended this provision and qualified the word 'new use' with the prefix 'mere'. This makes only 'mere new use' unpatentable. While the interpretative scope of this amendment is yet to be seen, it is likely that this provision would lead to the acceptance of 'Swiss-Type Claims' in India.

3. Patentability of Computer Programs - India moving closer to the EPO practices The Patents Act originally excluded Computer program per se and mathematical and business methods from patentability. There has been wide spread criticism on the ambiguity of the wording of the law. The Ordinance attempts to remove this ambiguity by specifying that a computer program in combination with hardware is patentable. Also, it is specified that the technical applications of computer programs to industry is patentable.

4. No more 'Exclusive Marketing Rights' and 'Mail Box' Applications The Ordinance repealed the provisions concerning 'Exclusive Marketing Rights' (EMRs) and 'the WTO/Mail Box' Applications. This is yet another provision that was subjected to heated debates at the WTO and in the Indian Parliament. EMRs are transitional protection for inventions relating to medicines and agro-chemicals that India had to provide for 10 years ending January 1, 2005. India failed to do so, until 1999, which led to disputes at the WTO. The Ordinance recognizes all EMRs granted and provides that all EMR applications currently pending will be treated as the Request for Examination of the corresponding Mail Box Application.

5. WTO Doha Concessions recognized - Compulsory License for export of patented pharmaceutical products The Doha Declaration on TRIPS and Public Health permitted export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity. The Ordinance recognizes this provision. Compulsory license shall be available for export of patented pharmaceutical products like the antiretroviral drugs to countries like the South Africa.

6. Representations can be made opposing the grant of patent (known in India as pre-grant opposition) So far India provided for opposition to patent applications once the application is accepted and the acceptance is advertised in the Gazette of India. The Ordinance has provided for post grant opposition. The Ordinance, however, includes a provision to file Representations by any person as soon as the application is published opposing the grant of patent. The Representation may include a statement and evidence to prove that the subject invention is not patentable. However, a Representation shall be entertained only when a request for examination of the application has been filed.

Section II

Sweeping Changes in the Indian Patent Prosecution System

This section analyses the amendments in the rules of patents prosecution in India and attempts in find implications of these amendments from a practical perspective.

1. Forms Simplified Two separate Forms have been used for filing a PCT National Phase Application and a convention priority or ordinary patent application. While Form 1 was used for convention or Ordinary Patent Applications, Form 1A was used for PCT National Phase Applications. This system has been changed. For all types of patent applications (Convention Priority, PCT National Phase, Patent of Addition, Divisional Application and Ordinary Application) now a same Form 1, as amended, is used. The format of the Form 1 has also been changed into a computer friendly one, keeping in view of the prospect of moving into an e-filing system in the near future.

2. Statement and Undertaking regarding Foreign Applications The period within which the Statement and Undertaking regarding foreign applications must be filed is 3 months from the date of filing of the Indian patent application. In the case of PCT National Phase application in India, this period is 3 months from the date of filing the National Phase Application in India, the Rule clarifies. As regards the Applicant's continuing obligation to furnish information regarding the prosecution of corresponding applications, there is a change in the time frame. Earlier the time limit was 30 days from the date of Receipt of the Office Action. It has been increased to 3 months.

3. Only 1 year to file the Complete Specification The extension of 3 months to file Complete Specification after filing a provisional application has been omitted. Now only a period of 12 months from the date of filing of the application shall be allowed to file the complete specification.

4. Request for Examination When an application is published, a Request for Examination (RFE) can be filed in Form 18. Various timelines have been prescribed for filing the Request for Examination. Ordinarily the deadline to file RFE is 36 months from the date of application or date of priority whichever is earlier. In the case of WTO/Mail Box Applications, the deadline to file RFE is 36 months from the date of application or date of priority or 12 months from January 01, 2005. In the case of a Divisional Application, the deadline to file RFE is 36 months from the date of application or date of priority or 6 months from the date of filing of the Divisional Application whichever is later.

(5. Early Examination of National Phase Application Early examination of PCT National Phase Application (31 months is the time to enter the national phase) is now possible by filing an express request in Form 18 along with a fee of INR 14,000 (if the Applicant is a legal entity). The regular fee for Request for Examination (if the Applicant is a legal entity) is only INR 10,000.

6. Examination of Applications The time frame for examination of patent applications has been substantially changed. Earlier the time period to put the application in order for acceptance was 12 months from the date of the first office action. In the meantime, the first office action had to be replied within 4 months of its receipt. The new Rules prescribe a total time period of 6 months to put the application in order for grant. This period is extendable by 3 months. Also a timeline has been accorded for scheduling a hearing. Now, for seeking an opportunity to be heard, a request has to be made on a date earlier than 10 days of the final date of putting the application in order for grant. However, if a request for hearing is made within a period of 1 month from the date of communication of First statement of objections, the Controller may fix a date and time for hearing irrespective of whether the Applicant has refiled his application. Upon filing the RFE, the Controller of Patents will refer the application to an Examiner. The law does not prescribe a time limit to do so, however says the Controller must do so at the earliest. The Examiner, on receipt of such reference must issue an Office Action within 1 month and not later than 3 months from the date of reference.

7. Publication of Applications All patent applications (exceptions on grounds of secrecy directions are provided) will be published on the expiry of 18 months from the date of application or the date of priority whichever is earlier. An early publication (before the expiry of 18 months) is possible by filing a request in Form 9.

8. Opposition The Ordinance and the Rules have changed the age-old system of pre-grant opposition in India. So far an accepted patent application used to be advertised for purposes of opposition. Only if there was no opposition within the time limit prescribed for any interested person to oppose the grant of patent (or if the opposition is overruled), a patent would have been granted. The Ordinance provides for post-grant opposition. However, it introduced the system of receiving Representations opposing the grant of patent upon publication of the application. Representation can be filed by any person within 3 months from the date of publication or 3 months before grant whichever is earlier. Representation will be considered when RFE is filed. Notice of Opposition must be filed in Form 7. The Notice must be filed within 1 year from the date of publication of the grant of patent. The Ordinance envisages the constitution of an Opposition Board to hear patent oppositions. The 3-member board will not include the Examiner who examined the application. The Board will issue reasoned recommendations within 3 months of the date of reference of the opposition to the board.

9. Assignment So far there has been a requirement to register all transactions concerning a patent with the patent office within 6 months from the date of execution of the document concerning such transaction. Typically these transactions included 'assignments', 'mortgages', 'licenses', 'share in a patent', or 'creation of any interest in a patent'. This position is changed. While the law continues to mandate that such transaction must be in writing, there is no more the requirement of registration of the documents for it to be valid and enforceable.

10. Term of Patent The Ordinance has clarified that the term of patent for International Application filed under the PCT designating India shall be 20 years from the International Filing Date.

11. Annuity Payments - Time Frame The Rules provide for 6 months extension of time to pay the first annuity or any succeeding annuity which is payable at the expiration of the 2nd year from the date of the patent or the succeeding year, respectively. To seek such an extension a request must be filed in Form 4 with the fee of INK 1200 per month.

12. Foreign Filing Permit The Ordinance has introduced the system of a mandatory foreign filing permit for Indian residents to file patent applications outside India. Accordingly, any person resident in India must obtain a written permission from the Controller of Patents before filing a patent application outside India unless a corresponding application is filed in India 6 weeks prior to the date of filing the foreign application. While this provision may ensure the export of local originating patentable technologies and higher governmental revenue, it may be an added liability if the subject matter of the invention is not a patentable category as per the Indian law, but patentable elsewhere (as for example computer software per se, business methods, methods of treatment and so on). A foreign filing permit is required even for PCT International Applications filed at the Indian Patent Office as the Receiving Office. The request for Foreign Filing Permit must be filed in Form 25 with the fee of INR 4000. Typically, the request will be disposed off in 3 months.

13. Grace Period The grace period for filing patent applications in case of anticipation by prior display of the invention in an exhibition, description of the invention in a paper read by the inventor before a learned society or publication in the transactions of a learned society has been increased from 6 months to 1 year.

14. Filing Documents with the Patent Office If a document is electronically transmitted to the Patent Office it is deemed to have been filed. However, an additional fee for per page faxed has been prescribed. The Rules, however, stipulates that 'the electronic transmission must be duly authenticated'. The expression 'duly authenticated' has been left undefined making this important provision (especially when the Patent Office is about to go fully online) unclear.

15. Payment of Fee Traditionally the rule has been that fee once paid will never be reimbursed. It seems the Government intends to dilute this rule to some extend. A new amendment adds the word 'ordinarily' to say that 'fee once paid shall not ordinarily be refunded'.

16. Inventor's Declaration There has been a provision in Indian patent practice to file a 'Declaration as to Inventorship' in Form 5. This is typically to enable the Applicant of a Provisional Patent Application to add on the names of the subsequent inventors while filing the Complete Patent Application. As such, all patent applications with Complete Specification (like the convention Priority Applications and PCT National Phase Applications) are outside the purview of this requirement. The Rules now clarify that even in the case of PCT National Phase Applications, the Inventors' Declaration is not required.

17. Translation of PCT Applications In the case of PCT National Phase Applications, which were not filed or published in English, the English translation of the application is acceptable if it is duly verified by the Applicant or even a person duly authorized by the Applicant.

18. Priority Documents If a PCT National Phase Application has not met with the requirement u/r 17.1 (a) & (b) of the Regulations under the PCT, the Applicant must file a verified English translation of the priority document within 3 months from the date of an invitation to do so by the Patent Office. The new Rules prescribe that such verification can be done by the duly authorized patent agent.

19. Rights of Patent Applicant An applicant for patent in India shall have the like privileges and rights as if a patent for the invention has been granted on and from the date of publication. The applicant, however, cannot institute proceedings for infringement until grant; the Ordinance clarifies. As regards the WTO/Mail Box Applications the rights of a patentee shall accrue only from the date of grant.

20. Deposition of Biological Material In the context of an application disclosing a biological material, now such material can be deposited with an international depository authority under the Budapest Treaty. The deposit must be made no later than the date of filing the patent application in India and a reference thereof must be made in the specification. The time period for making such a reference in the specification has been specified now as 3 months from the date of filing the application. Conclusion The Patents (Amendment) Ordinance, 2004 and the Patents (Amendment) Rules, 2005 (hereinafter the Rules) are aimed at making the Indian patent system fully compliant with the TRIPS Agreement. But another important achievement of the Ordinance and the Rules is the progressive change it introduced in the patent prosecution system in India. However, the sudden increase in the government fee is rather unreasonable. Hopefully there will be yet another change in the Rules, when the Ordinance get substituted by an Act of the Parliament.