Patents are territorial, which means that to enforce the patent it must be filed in a specific jurisdiction (country) specifically. A patent application filed in India therefore must be filed in each country individually. The individual patents can be filed directly via convention route or indirectly via PCT route.
Once a PCT application is filed with WIPO it is known as the International application, an International Search Report (ISR) together with a written opinion regarding patentability is issued after a Search Authority is nominated who perform an International Search on the patent application and provide opinion on patentability. The ISR and the written opinion are published separately and often serve as a platform for substantive examination of the International application by the designated Offices after National Phase entry.
The ISR helps an applicant to decide if it is worthwhile to pursue as an International application at the National Phase. If the ISR is adverse it saves the applicant time and enormous amount of investment in filing National Phase Applications and cost of prosecution in each individual jurisdiction. Under article 19, in case of an adverse report an applicant can modify the claims and then enter National Phase. The patentability of the claims can be verified by applying for a paid search IPER (International Preliminary Examination Report) as WIPO also allows amendment of claims after an ISR and IPER.
Similarly, if the ISR is favorable the applicant can decide to take appropriate steps right away. Hence, the ISR and the written opinion prove very important for an applicant to decide the future of the International Application.
ARTICLE – 19
Amendment of the Claims Before the International Bureau
- The applicant shall, after having received the international search report, be entitled to one opportunity to amend the claims of the international application by filing amendments with the International Bureau within the prescribed time limit. He may, at the same time, file a brief statement, as provided in the regulations, explaining the amendments and indicating any impact that such amendments might have on the description and the drawings.
- The amendments should not go beyond the scope of disclosure in the international application as filed.
- If the national law of any designated State permits amendments to go beyond the said disclosure, failure to comply with paragraph (2) shall have no consequence in that State or else is liable for objection.
What is allowed under Art. 19?
Article 19 allows amendments to the claims only accompanied by a statement explaining the basis of amendments to the claims. The statement is limited to 500 words. An Article 19 amendment must be filed in the language in which the international application will be published. The amendments need to be filed within 2 months from the date of issue of ISR.
What is not allowed under Art. 19?
Amendments to the description and drawings are not allowed under Article 19. Article 19 amendments cannot be filed before the ISR is established.
What paperwork is required to amend claims of an International Application under Art. 19?
- A complete set of the amended or replacement claims.
- An accompanying letter which must indicate the differences between the originally filed claims and amended claims plus the basis for such amendments.
- A Statement under Article 19 (Optional).
What should be provided in the accompanying letter?
The letter, which must accompany the replacement sheets containing amendments to the claims, must indicate firstly the differences between the claims as filed and those as amended and secondly the basis for the amendments in the application as filed. This should be done by stating, whether:
- the claim is unchanged,
- the claim is cancelled;
- the claim is new;
- the claim is the result of the division of a claim as filed,
- the claim amended etc.
The basis for the amendments has to be indicated so that the examiner may, by consulting those precise references in the application, assess whether the amendments contain subject matter which extend beyond the disclosure of the application as filed. Therefore, non-specific indications such as “see the description as filed” or “see the claims as filed” are generally not considered sufficient for an indication of the basis for the amendment.
Example:
Original claim as claim in Claim 1 was:An expression vector ——-comprises a signal sequence; wherein,
The signal sequencecomprises a DNA sequence belonging to the group consisting of Seq. ID A and Seq. ID B; and
the expression vector comprising of xxxx base pairs represented by Seq. ID X wherein the signal sequence is Seq. ID A.
Written opinion on the ISR of PCT application stated that the claim is unclear and it first provides a broader definition of the vector composition and it also limits the expression vector with specific sequence Seq. ID A.
With respect to the claims, the submitted substituted claim pages include the following:
- Claim 1 is amended as a result of division of Claim 1;
- Claims 2-6 unchanged;
- Original claim 7 cancelled;
- New Claim 7 is added as a result of division of Claim 1; and
- Claims 8-10 are new.
Basis of amendment of claim 1: Claim 1 has been divided in order to make the claim clear as per Article 6 of PCT. Accordingly Claim 1 is amended in page 20 line 9 & 10 and now indicates that An expression vector —– comprises a DNA sequence belonging to the group consisting of Seq. ID A and Seq. ID B. The basis for this amendment can be found in the original claim 1 as filed.
Basis of amendment of claim 7: The originally filed claim 7 is cancelled and replaced with a new claim 7 which is a result of division of originally filed claim 1 per Article 6 of PCT. Claim 7 now indicates An expression vector —— comprising of xxxx base pairs represented by Seq. ID X, and the basis of this amendment can be found in the original claim 1 as filed.
Basis of amendment of claim 8-10: The claims 8-10 are new and dependent on the new claim 7. The basis of amendment of claim 8 can be found on line 11-13 in page 17 in the detailed description as filed; the basis of amendment of claim 9 can be found on line 6-8 in page 14 in the detailed description as filed; and basis of amendment of claim 10 can be found in the original claim 1 as filed.
How should the claims be presented in the replacement sheets?
The replacement sheets containing the amended claims should not, however, contain marked-up text; they should contain clean text only.
Under what situation should one amend the claims under Art. 19?
If the ISR indicates that the claims are confusing and unclear, the applicant is provided an opportunity to amend the claims to better define the scope of the claims for the purposes of provisional protection in those designated States whose national law provides for such protection.
Conclusion
The PCT route for international patent filing not only provides the applicant additional time to enter National Phase in designated states (within 20 months, 30 months, or 31 months from priority date) and additionally provides an ISR and/ or IPER which helps applicant to amend claims to facilitate prosecution during National Phase.