Two-step Framework for Patent Infringement in the US

Statutory Framework

Patent span establishes the period of exclusiveness during which a patent is effective. In the year 1994, Congress had made certain amendments within the law for changing the period of patent term from 17 years to 20 years from the issuance date (calculated from the initial filing date for patent).

Owing to this amendments in the law, if the Patent Office issues a patent 2 years after the filing date, the resultant patent will leverage 18 years of patent term. However, if a fortunate patent examination gets completed in 7 years, then there will only be 13 years of patent term outstanding after the issuance, lesser than the 17- year term offered under the preceding law. Hence, in order to protect patent owners term loss because of any delay caused by agency during examination process, Congress amended §154 in 1999 towards restoring patent term in certain situations.

Under the PTA statute, the tenure of a patent can be prolonged to reimburse the lost patent term owing to statutorily-defined agency delay (§ 154(b) (1) (A)–(C)). But then again, PTA is subject to reduction for the delays because of applicants (§ 154(b) (2) (C)).

Section 154(b)(1) offers 3 categories of statutorily-defined delay by the Patent Office that may lead to accrual of PTA for the resultant patent, defined within § 154(b)(1)(A), (B), (C).

• “A Delay” arising due to Patent Office’s failure towards assured examination deadlines. § 154(b) (1) (A).
• “B Delay” arising when the Patent Office fails in “issuing a patent in 3 years after the initial filing date of the application.” § 154(b) (1) (B).
• “C Delay” arising during the pendency of interferences, secrecy orders as well as pleas. § 154(b) (1) (C).

Conversely, when there is delay in the examination process with the applicant’s conduct, any PTA that has accrued is lessened by that total of applicant delay. Under § 154(b) (2) (C) (i) of the PTA decree, a patent’s PTA “will be reduced by a span equal to the period of time in which the claimant failed to involve in judicious efforts towards concluding prosecution of application.”

Section 154(b) (2) (C) (ii) offers an instance of what constitutes “failure to engage in reasonable efforts” based on how long it takes for an applicant to respond to certain Office actions. Specifically, “an applicant is considered unsuccessful in engaging within the reasonable efforts in the direction of concluding the processing of an application for increasing the total of any periods of time in excess of 3 months that are taken to respond to a notice from the [Patent] Office making any rejection, objection, argument, or other request, measuring such 3-month period from the date the notice was given or mailed to the applicant.” § 154(b) (2) (C) (ii).

Section 154(b) (2) (C) (iii) approves the Patent Office to broadcast the guidelines offering additional details and instances of what constitutes “failure towards engaging in judicious efforts.” This regulation delivers that the “Director intends to propose regulations instituting the circumstances constituting the failure of an applicant to involve in judicious efforts for concluding processing or else examination of an application.

Regulatory Framework

Pursuant to its congressional authority, the Patent Office promulgated regulations for determining PTA reduction owing to applicant delay. Relevant to ‘Intra-Cellular Therapies, Inc. v. The United States Patent and Trademark Office’, appeal is 37 C.F.R. § 1.704(b) that strictly tracks the language within § 154(b) (2) (C) (ii). This regulation offers that “an applicant will be supposed to have failed towards engaging within the judicious efforts for concluding the processing of an application for the collective total of any spans of time exceeding 3 months taken to respond any notice or action by the Patent Office making any objection, rejection, argument, or any other appeal . . . .”

Section 1.704(b) has been promulgated against a setting of long-existing regulations leading patent prosecution practices. One fundamental principle pervading such regulations is a “final” Office action marking the completion of standard prosecution as of right.

Additionally, prior issuing the final Office action, an applicant has more leeway to argue their case along with amending their response claims. To appropriately respond to a non-final Office action, a “bona fide attempt to advance the application” is needed. As soon as the proceeding moves towards the post-final Office action territory, though, § 1.113(a) confines the options available for the applicant, and the patent examiner isn’t obliged to involve in further examination and review of the patent application or even applicant arguments.