In the US, PTA (patent term adjustment) or PTE (patent term extension) is a law under 35 U.S.C. 154, accommodates for delays caused by the US Patent and Trademark Office during patent prosecution for applications filed on or after June 8, 1995. If the US patent and Trademark office fails to examine a patent application in time, the patent term will be extended. Therefore, PTA is an addition to the patent term (20 years) of the US patent. However, the duration of adjustment of the patent term can be reduced if the applicant fails to provide reasonable efforts to conclude prosecution of the patent application.
Calculation of PTA:
Duration of PTA can be calculated as:
PTA = Type-A delay + Type-B delay + Type-C delay – Applicant’s Delay – Overlap
(i) Type-A delay (35 U.S.C. 154(b)(1)(A))
This type of delay is caused by the USPTO in the following scenarios:
- When the USPTO fails to issue the first office action within 14 months of the filing of the application and fails to respond to an applicant’s reply within 4 months.
- When the USPTO fails to issue a patent within 4 months after the issue fee has been paid.
Type-A delay is sometimes referred to as “14-4” rule.
(ii) Type-B delay (35 U.S.C. 154(b)(1)(B))
This takes care of the responsibility of PTO (examiner) to conclude patent prosecution within 3 years of filing, failing which there will be a delay accrued for every day beyond the specified period.
(iii) Type-C delay (35 U.S.C. 154 (b)(1)(C))
Type-C delay provides an extension for delays caused by PTA type-B appeals, interferences, or secrecy orders.
(iv) Applicant’s delay (35 U.S.C. 154(b)(2)(C))
Applicant’s delay can be accrued through various following factors:
- Delays due to failure of the applicant to respond within 3 months of mailing of an Office action.
- Delays due to the abandonment of the application.
- Delays due to the submission of a supplemental reply or “other paper” unless requested by the examiner.
- Delays due to failure to file an appeal brief in compliance with 41.37 within three months from the date on which a notice of appeal to the Patent Trial and Appeal Board was filed.
If the applicant’s delay exceeds type-A, B and C delays, PTA will be zero.
(v) Overlap (35 U.S.C. 154(b)(2)(A))
If there is any overlap between two or more delays (A or B or C), then the benefit of only one delay will be provided.
PTA correction:
If any patentee is unhappy with the calculation of PTA performed by PTO, he/she can file a petition within 2 months (in some cases it is extendable up to 5 months) of the issue date of the patent.
Revised rules for PTA announced by USPTO:
On 16th July 2020, USPTO released revised rules for PTA calculations in view of Supernus (Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019)). According to the revised rules, now the applicant’s delay will be calculated in the following manner to exclude periods corresponding to the consequences to the USPTO of applicant’s failure to engage in reasonable efforts.
- Deferral of issuance under 37 CFR 1,704 (C)(2):
From: “the period of adjustment … shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under §1.314 was filed and ending on the date the patent was issued”.
To: “the number of days, if any, beginning on the date a request for deferral of issuance of a patent under §1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued”.
- Abandonment of an application under 37 CFR 1,704 (C)(3):
From: “if any, beginning on the date of abandonment or the date after the date the issue fee was due and ending on the earlier of: (i) the date of mailing of the decision reviving the application or accepting late payment of the issue fee; or (ii) the date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed”
To: “ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed”.
- Filing of a preliminary amendment under 37 CFR 1.704 (C)(6):
From: “the period of adjustment…shall be reduced by the lesser of (i) the number of days, if any, beginning on the day after the mailing date of the original Office Action or Notice of Allowance and ending on the date of mailing of the supplemental Office Action or Notice of Allowance; or (ii) four months.”
To: “the period of adjustment…shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed.”
- Submission after a Patent Trial and Appeal Board (PTAB) or Federal court decision under 37 CFR 1.704(c)(9)
From: “the period of adjustment…shall be reduced by the lesser of: (i) the number of days, if any, beginning on the day after the mailing date of the original Office Action or Notice of Allowance and ending on the mailing date of the supplemental Office Action or Notice of allowance; or (ii) four months.”
To: “…the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a Federal court and ending on the date the amendment or other paper was filed.”
- Submission after a Notice of Allowance under 37 CFR 1.704(c)(10)
From: “the period of adjustment…shall be reduced by the lesser of: (i) the number of days, if any, beginning on the date the amendment under §1.312 or other paper was filed and ending on the mailing date of the Office Action or notice in response to the amendment under §1.312 or such other paper; or (ii) four months.”
To: “the number of days, if any, beginning on the day after the date of mailing of the Notice of Allowance under 35 U.S.C. 151 and ending on the date the amendment under §1.312 or other paper was filed.”
Countries without PTE or PTA laws:
Countries such as India, Brazil, Mexico, China, Thailand, Indonesia, Hong Kong etc. have a lack of a system of patent term extension or patent term adjustment. In these countries patent term is provided only for 20 years even if the regulatory authorities delay in the patent prosecution process.
Countries with PTE or PTA laws other than US:
Countries like EP, AU, JP, TW, Israel, Russia, South Korea, Singapore, Columbia etc. have a sound system for PTE or PTA.
European Union:
In EP drug and plant-related patent’s term can be extended on the basis of supplementary protection certificate (SPC). This SPC was introduced to handle the time lost by way of granting an application.
Israel:
In Israel extension of patent term is allowed for patents related to medical composition and medical devices. A patentee can file an application for PTE within 60 days from the grant of marketing approval of the medical composition and medical devices from the Ministry of Health.
Japan:
In Japan, patent term extension is provided for pharmaceuticals and agrochemicals for maximum 5 years. An application for extension of the patent term must be filed within three months of the first regulatory approval of the product.
Singapore:
In Singapore, patent term extension is provided for pharmaceuticals products for maximum 5 years which is equivalent to Supplementary Protection Certificates (SPC) issued for pharmaceutical patents in Europe. An application for a patent term extension needs to be made within 6 months from the date of grant of the patent and the date of marketing approval was obtained.
Australia:
In Australia, patent term extension is provided for pharmaceuticals products or the one produced by a process involving the use of recombinant DNA technology. An application for a patent term extension needs to be made within 6 months from the date of grant of the patent and the date of regulatory approval was obtained.
Taiwan:
In Taiwan, a patent term extension can be sought for a pharmaceutical or an agrochemical-related patent under the condition that the first market approval for practising said patent is not secured until two years after patent publication.
Russia:
The patent term extension is applicable to the whole of Confederation of Russia for maximum 5 years.
South Korea:
In South Korea, all patent applications filed on or after March 15, 2012 are applicable for filing a patent term adjustment agreement within 3 months from the date patent is issued.
Columbia:
In Columbia, a patent term adjustment can be sought for a pharmaceutical patent application to compensate patent owners in the event of unjustified delays by the Columbian Patent Office in issuing patents. A patent owner must request an adjustment of the patent term within two months of the date of issuance of a patent.
Author: Kankana Mazumdar, Sr. Patent Engineer, Neropat IP