The U.S. Patent Term Adjustment (PTA)

Speaking of the protection period of invention patents in various countries, except for a few countries, most countries have a maximum period of 20 years from the date of application. The protection period of patents is of vital significance to patentees, especially to pharmaceutical companies with millions of profits. The following is a brief introduction to the distinctive U.S. Patent Term Adjustment (hereinafter referred to as PTA). The rational use of PTA will strive for greater rights and interests for the right holders.

What is PTA?

In 1999, the United States Patent and Trademark Office (USPTO) shortened the validity period of patents in order to avoid undue delay, and the United States Congress made corresponding provisions for the adjustment of patent term in the American Inventor Protection Act (AIPA). If it is necessary to adjust the patent term, the USPTO will issue a decision on the adjustment of the patent term when issuing the patent certificate. Since the implementation of the PTA mechanism, after many cases, the USPTO has updated this provision many times and tends to be reasonable.

How is PTA calculated?

The calculation of PTA includes two parts. The first part is the adjustment of patent term caused by USPTO examination delay (Period of adjustment of patent term due to examination delay) stipulated in 37 CFR (Regulations for the Implementation of U.S. Patent Law) 1.703. The second part is the reduction of patent term caused by applicant's delay stipulated in 37 CFR 1.704 (Reduction of period of adjustment of patent term). In short, the number of days of patent term adjustment is equal to the number of days of the first part minus the number of days of the second part. Its specific provisions are as follows:

1. The adjustment of patent term due to the delay of USPTO examination (37 CFR 1.703), mainly includes the following situations:

(1) The examiner shall issue the examination results to the applicant within 14 months from the application date, including the notice of reduction (Restriction Requirement), the notice of non-final examination opinions (Non-Final Rejection), the notice of authorization (Notice of Allowance), etc. The number of days exceeding 14 months is the delay caused by the examiner, which is only applicable to cases authorized after January 14, 2013; and the examiner should submit an answer to the notice of examination opinion (including the Non-Final Rejection of the notice of non-final examination opinion, the Final Rejection of the notice of final examination opinion, etc.), or make an appeal (review) request, or the Patent Trial and Appeal Board (Patent Trial and Appeal Board) or a federal court (Federal Court) to make a final decision on the appeal, or even the next review conclusion is issued within 4 months from the date when the applicant pays the authorization fee, etc. If the next review conclusion is not issued to the applicant within this period, the number of days exceeding 4 months is the delay caused by the USPTO review. This is also commonly referred to as a type A delay (A delay);

(2) From the date of application to the patent grant announcement date (issue date), the number of days exceeding 3 years is the delay caused by the USPTO review. This is commonly referred to as Class B delay. Such delay shall not be included in the number of days within 3 years if:

a) The number of days from the date when the applicant submits the request for continuing examination (Request for Continued Examination, RCE for short) to the date when the authorization notice is issued;

B) Delays due to conflict proceedings (interference proceeding) or retrospective proceedings (derivation proceeding);

c) Delays caused by confidentiality of an invention and patent withholding (Secrecy of certain inventions and withholding of patent);

d) Delay due to appeal to the Patent Trial and Appeal Board, which only applies to cases authorized after September 17, 2012.

Please note that delays due to conflict or retrospective proceedings, confidentiality and withholding, or appeals to the Patent Trial and Appeal Board in cases authorized after September 17, 2012, do not include the time when various circumstances overlap during this procedure (to the extent that the periods are not overlapping).

(3) This adjustment is calculated from the expiration date of the patent and does not include the overlap of the above periods, and the time of mailing or transmission of the certificate is not taken into account.

(4) This patent term adjustment does not apply to cases where the principle of waiver (terminal disclaimer) at the end of the period applies.

Reduction in patent term due to applicant delay (37 CFR 1.704)

(1) Due to the applicant's reasons, including the failure to timely follow up the official processing or the extent of the review, the part of the number of days that caused the official to delay the conclusion of the review shall be deducted from the patent adjustment period referred to in the aforementioned 37 CFR 1.703.

(2) If the applicant fails to reply to any notice of examination opinion (including rejection, objection, argument) issued by the Patent Office within three months, the number of days exceeding the official period shall be deducted from the adjustment period referred to in the aforementioned 37 CFR 1.703.

(3) Delays in the progress of the application (including processing or review) caused by the applicant's failure to actively advance the application, including: filing a request for suspension, a request for delaying authorization, giving up an application or delaying payment of authorization fees, failing to file a request for recovery within two months of giving up the notice, failing to submit a request for transferring a provisional application to a non-provisional application in a timely manner, submitting preliminary amendments or other amendment documents within one month before the date on which the examiner issues an examination opinion or the authorization notice, if the examiner needs to issue supplementary examination opinions or supplementary authorization notice, the text of the reply examination opinions is omitted due to negligence, the supplementary reply documents or other documents are submitted without the request of the examiner after the submission of the reply text, and the amendment or other documents are submitted within one month before the date of the examination opinions or authorization notice issued by the examiner after receiving the relevant decision of the Patent Trial and Appeal Board or the Federal Court, as a result, the examiner needs to issue supplementary review opinions or supplementary authorization notice, submit amendments after the authorization notice is issued (except for submitting RCE request), fail to submit appeal brief in time, submit RCE request after the authorization notice is issued, and the application is not in a state to be reviewed within eight months after the application date (in condition for examination), etc., according to their specific circumstances, shall be deducted from the period of adjustment referred to in the 37 CFR 1.703 as defined above.

(4) The submission of IDS or the submission of an RCE request as a result of IDS will not be considered as a delay in the progress of the application (including processing or review) caused by the above-mentioned failure to actively advance the application. However, it should be noted that the comparison document included in this IDS is the first reference, in addition, the applicant, inventor, agent, etc., who has a substantial connection with the application, shall not receive the relevant case notice earlier than 30 days before the IDS is submitted, that is, if the IDS is submitted more than 30 days after the date of receipt, the corresponding date will be deducted from the adjustment period referred to in the aforementioned 37 CFR 1.703.

(5) The recovery request for the reduction of the term adjustment (request for reinstatement of reduces PTA) will not be regarded as the delay in the progress of the application (including processing or review) caused by the above-mentioned failure to actively promote the application.

(6) Before the Patent Office issues any notice of examination opinions or authorization notice (whichever comes first), corrections to the specification, drawings, sequence lists, etc. will affect the calculation of PTA.

The above is a general introduction to the relevant legal provisions of PTA. Due to the complexity of PTA regulations and the fact that the United States is case law, the regulations are still in the process of continuous improvement and amendment. Therefore, in specific practice, it is still necessary to refer to the relevant laws and regulations updated by the USPTO at that time to avoid unnecessary losses to the parties.

　　http://www.lungtinsz.com/index.php?c=msg&id=425&